Unassociated Document
As
filed with the Securities and Exchange Commission on September 30,
2010
Registration
No. 333-[__]
|
|
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
(Exact
name of registrant as specified in its charter)
Delaware
|
|
3841
|
|
26-4753208
|
(State
or other jurisdiction of
incorporation
or organization)
|
|
(Primary
Standard Industrial
Classification
Code Number)
|
|
(I.R.S.
Employer
Identification
Number)
|
4105
East Madison Street, Suite 320
Seattle,
Washington 98112
(206)
325-6086
(Address,
including zip code, and telephone number, including area code of registrant’s
principal executive offices)
Steven
C. Quay, M.D., Ph.D.
Chairman
and Chief Executive Officer
4105
East Madison Street, Suite 320
Seattle,
Washington 98112
(206)
325-6086
(Name,
address, including zip code, and telephone number, including area code, of agent
for service)
Ryan
Murr
Maggie
Wong
Goodwin
Procter LLP
3
Embarcadero Center, 24th
Floor
San
Francisco, California 94111
Phone:
(415) 733-6000
|
Kyle
Guse
K.
Amar Murugan
McDermott
Will & Emery LLP
275
Middlefield Road
Menlo
Park, California 94025
Phone:
(650) 815-7400
|
Approximate Date of Commencement of
proposed sale to the public: As soon as practicable after the effective
date of this Registration Statement.
If any of
the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, check
the following box. x
If this
Form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, please check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering. ¨
If this
Form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier registration statement for the same offering.
¨
If this
Form is a post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act, check the following box and list the Securities Act registration
number of the earlier effective registration statement for the same offering.
¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See definitions “large accelerated filer,” “accelerated file,”
and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
accelerated filer ¨
Accelerated filer ¨
Non-accelerated filer ¨
Smaller reporting company x
(Do not
check if a smaller reporting company)
|
|
CALCULATION
OF REGISTRATION FEE
|
|
|
Proposed Maximum
Aggregate Offering Price (2)
|
|
|
|
|
Units,
each consisting of one share of common stock, par value $0.001, two
Class A Warrants and one Class B Warrant
|
|
$ |
17,250,000 |
|
|
$ |
1,230 |
|
Shares
of common stock underlying Units
|
|
|
— |
|
|
|
— |
|
Class
A Warrants underlying Units
|
|
|
— |
|
|
|
— |
|
Class
B Warrants underlying Units
|
|
|
— |
|
|
|
— |
|
Common
Stock underlying Class A Warrants
|
|
$ |
345,000 |
|
|
$ |
25 |
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
17,595,000 |
|
|
$ |
1,255 |
|
(1)
|
This
registration statement and the prospectus therein covers the registration
of (A) Units with each Unit consisting of (i) one share of the Company’s
common stock (ii) two Class A Warrants exercisable one year after issuance
for one share of the Company’s common stock and (iii) one Class B Warrant
exercisable for one share of the Company’s common stock, and (B) Common
Stock underlying the Class A
Warrants.
|
(2)
|
Estimated
solely for purposes of calculating the registration fee pursuant to Rule
457(o) under the Securities Act of 1933, as
amended.
|
The
registrant hereby amends this registration statement on such date or dates as
may be necessary to delay its effective date until the registrant shall file a
further amendment which specifically states that this registration statement
shall thereafter become effective in accordance with section 8(a) of the
Securities Act of 1933 or until the registration statement shall become
effective on such date as the Commission acting pursuant to said section 8(a),
may determine.
The information contained
in this prospectus is not complete and may be changed. A registration
statement relating to these securities
has been filed with the Securities and Exchange Commission and these securities
may not be sold until that registration statement becomes effective. This
prospectus is not an offer to sell these securities and it is not soliciting an
offer to buy these
securities in any state where the offer or sale is not
permitted.
PRELIMINARY
PROSPECTUS
|
SUBJECT
TO COMPLETION
|
|
DATED
SEPTEMBER 30, 2010
|
3,000,000
Units
Comprised
of Common Stock, Class A Warrants and Class B Warrants
This is
the initial public offering of our Units. We are offering 3,000,000 Units,
with each Unit consisting of: (i) one share of common stock, (ii) two Class A
Warrants and (iii) one Class B Warrant.
Each
Class A Warrant will be exercisable, for a period of 10 days beginning on the
sixth trading day after the separation of the securities underlying the Units as
described below, to acquire one share of common stock on a cashless, net
exercise basis at a price of $0.05 per share. Each Class B Warrant
will be exercisable after one year and for a period of five years after the
Class B Warrants are separated from the Units, to acquire one share of common
stock at a price equal to 55% of the Unit offering price. We will have the
right to redeem the Class B Warrants at $0.25 per share of common stock
underlying the Class B Warrants in the event (i) the average of the closing
price of our common stock exceeds 200% of the exercise price for 10 consecutive
trading days while the warrants are exercisable and (ii) there is then an
effective registration statement with a current prospectus on file with the
Securities and Exchange Commission, or the SEC.
We expect
the initial public offering price will be between $5.00 and $7.00 per
Unit. Currently, no public market exists for our securities. We
intend to apply for listing of the Units on the NYSE Amex under the symbol
“ATOSU.” The securities underlying the Units will separate from the Units
on the 90th day
after the date of this prospectus, unless Dawson James Securities, Inc., the
representative of the underwriters, determines that an earlier separation date
is acceptable based on its assessment of the relative strengths of the
securities markets and small capitalization companies in general, and the
trading pattern of, and demand for, our securities in particular. We
intend to issue a press release announcing when such separation will
occur. Once the securities comprising the Units separate, the Units will
automatically cease trading and be cancelled, and the common stock and Class B
Warrants underlying the Units are expected to be listed on the NYSE Amex under
the symbols “ATOS” and “ATOSW,” respectively. The Class A Warrants will
not be listed for trading.
|
|
Per Unit
|
|
|
Total
|
|
Public
offering price
|
|
$ |
|
|
|
$ |
|
|
Underwriting
discount
|
|
$ |
|
|
|
$ |
|
|
Proceeds,
before expenses, to Company
|
|
$ |
|
|
|
$ |
|
|
Investing
in these securities involves a high degree of risk.
See
“Risk Factors” contained in this prospectus beginning on page 7.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved these securities or determined if this prospectus is
truthful or complete. Any representation to the contrary is a criminal
offense.
We have
granted the underwriter an option for a period of 45 days to purchase from us,
on the same terms and conditions set forth above, up to an additional 450,000
Units to cover overallotments.
The date
of this prospectus is __________, 2010.
DAWSON JAMES
SECURITIES, INC.
TABLE
OF CONTENTS
|
Page
|
Prospectus
Summary
|
1
|
Risk
Factors
|
7
|
Forward-Looking
Statements
|
18
|
Use
of Proceeds
|
19
|
Dividend
Policy
|
20
|
Capitalization
|
20
|
Dilution
|
21
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
23
|
Business
|
28
|
Management
|
57
|
Director
Compensation
|
59
|
Executive
Compensation
|
62
|
Certain
Relationships and Related Transactions
|
67
|
Principal
Stockholders
|
68
|
Description
of Securities
|
69
|
Shares
Eligible for Future Sale
|
76
|
Certain
Material U.S. Federal Income Tax Considerations
|
77
|
Underwriting
|
83
|
Legal
Matters
|
87
|
Experts
|
87
|
Additional
Information
|
87
|
Index
to Financial Statements
|
|
No
dealer, salesperson or other person is authorized to give any information or to
represent anything not contained in this prospectus. You must not rely on
any unauthorized information or representations. This prospectus is an
offer to sell only the Units and underlying securities offered hereby, but only
under circumstances and in jurisdictions where it is lawful to do so. The
information contained in this prospectus is current only as of its
date.
Unless
the context requires otherwise, in this prospectus the terms “we,” “us” and
“our” as well as the “Company” refer to Atossa Genetics Inc.
PROSPECTUS
SUMMARY
This
summary highlights some information from this prospectus. It may not
contain all the information important to making an investment decision.
You should read the following summary together with the more detailed
information regarding our company and the securities being sold in this
offering, including “Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” and our financial statements and
related notes, included elsewhere in this prospectus.
The
Company
We are a
development-stage healthcare company focused on the commercialization of
cellular and molecular diagnostic risk assessment products and related services
for the detection of pre-cancerous conditions that could lead to breast cancer,
and on the development of second-generation products and services.
Although current mammography procedures can detect cancer already present in the
breast, our products have the ability to identify pre-cancerous changes in the
breast up to eight years in advance of mammography detection. This
information allows for the implementation of preventive measures such as
lifestyle changes and pharmaceutical interventions that may prevent breast
cancer from developing or treat breast cancer earlier, if it develops. Our
primary focus is the commercialization of the Mammary Aspirate Specimen Cytology
Test, which we call the MASCT System, our patented and U.S. Food and Drug
Administration, or FDA, cleared product and related testing and analysis
services for breast conditions, including cancer.
The MASCT
System is a device and method for the collection, shipment and clinical
laboratory analysis of nipple aspirate fluid, or NAF. The clinical
analysis of NAF, which contains cells and molecular diagnostic biomarkers, is
useful in detecting breast cancer and cellular changes that may be precursors to
breast cancer. The product component of the MASCT System consists of a
reusable hand-held pump for the collection of NAF, a patient kit that includes
two NAF sample vials, and a shipment kit for the transportation of NAF samples
to our specialized cytology and molecular diagnostics laboratory to be
established in Seattle, Washington. Through our laboratory, if
successfully established, we intend to provide the MASCT System services, which
would consist of receiving and accessioning the two NAF samples from each
patient, preparing routine and immunohistochemistry, or IHC, slides from the NAF
samples, and generating a report of the findings.
We have
entered into a lease for laboratory space in Seattle, Washington and expect our
laboratory to be operational in the fourth quarter of 2010. We have also
engaged a contract manufacturer to produce 20 MASCT System pumps and 10,000
testing kits, which we intend to field test for purposes of confirming the
proper operation of the device and its ability to collect adequate NAF
samples in the fourth quarter of 2010. We intend to commence
commercial manufacturing of the MASCT System components following the completion
of this offering and expect our commercial launch of the MASCT System to occur
in the first quarter of 2011. We intend to price our NAF sample collection
device at approximately $200 per device, our patient kits at approximately $50
per kit, and the cytology and molecular diagnostics testing and analysis at
between $106 and $1,202 per patient, depending on the complexity of the analysis
performed and without taking into account any patient reimbursement from
third-party insurers.
We
anticipate that the MASCT System will be used initially in conjunction with
standard mammography or cervical Pap smear exams and has the potential to become
a critical assessment tool for identifying women at high risk for breast
cancer. Our MASCT System test is simple, quick (approximately five
minutes), convenient, painless and safe (no radiation).
Our
founder and chief executive officer, Steven C. Quay, M.D., Ph.D., invented the
MASCT System. Dr. Quay is a board-certified anatomic pathologist with
training from Massachusetts General Hospital and Harvard Medical School, and is
a former faculty member of the pathology department of Stanford University
School of Medicine. We acquired all of the ownership rights for the
patents, as well as foreign counterparts covering the manufacture, use and sale
of the MASCT System, pending patent applications for improvements, as well as
the FDA marketing authorization for the MASCT System from Ensisheim Partners
LLC, or Ensisheim, a limited liability company solely owned by Dr. Quay and his
wife, Dr. Shu-Chih Chen, who is our chief scientific officer and a member of our
board of directors.
We were
incorporated in Delaware in April 2009. Our operations to date have
consisted primarily of securing laboratory and office space, hiring laboratory
personnel, ordering equipment and supplies, engaging a third-party vendor for
the manufacture of the MASCT System in limited quantities for field testing,
securing patent rights and assignments, filing new patent applications,
acquiring FDA market clearances and securing development bids to complete
preparation for manufacturing the MASCT System. We have no other
operations. Assuming the completion of this offering and successful field
testing of the MASCT System, we expect to select one or
more large volume contract medical device manufacturers to begin
manufacturing the MASCT System for commercialization in the fourth quarter of
2010.
We have
experienced operating losses since inception. We have not yet received any
revenue and will not be in a position to expect revenue until we are able to
produce and sell the MASCT System. We anticipate that we will incur
additional losses while establishing the manufacturing of the MASCT Systems and
while we build our laboratory and hire and train personnel for our laboratory
and our sales force. In addition, Medicare and certain private insurance
carriers currently do not reimburse for the NAF collection procedure that will
be used with the MASCT System, which could delay or prevent commercial adoption
of our products and services as the absence of Medicare or insurance coverage
will require patients to fully bear the costs of the sample acquisition.
We intend to seek reimbursement for the MASCT System from third-party payors and
plan to apply for a Current Procedural Terminology, or CPT, code from the
American Medical Association, or AMA, for our device, to enable reimbursement of
the collection procedure.
The
MASCT System
The MASCT
System is intended to supplement, and not replace, mammography and is primarily
a risk assessment tool for identifying women at risk for developing breast
cancer. Using the MASCT System’s NAF collection device, a nurse or
physician’s assistant can collect a sample of NAF, which may contain cells and
molecular diagnostic biomarkers that are useful in detecting cancers and
pre-cancerous cellular changes. These changes include atypical ductal
hyperplasia, or ADH, a condition in which the cells lining the milk ducts of the
breast experience abnormal, premalignant growth, which confers a higher risk of
developing breast cancer. Analysis of the collected fluid can enable
physicians to determine and/or differentiate among normal versus premalignant
versus malignant cells. Pre-cancerous cytology changes in NAF have been
shown to occur up to eight years before cancerous changes can be detected by
mammography.
In a
study of women with normal mammograms who were undergoing breast reduction
surgery, which was conducted at the Virginia Mason Medical Center in Seattle,
Washington and published in Plastic and
Reconstructive Surgery in October 2009, the incidence of ADH was found to
be 4.4%. With approximately 94 million women age 30 and above in the
United States, this suggests that more than four million women in the United
States have undiagnosed ADH. ADH can be definitively diagnosed only by NAF
analysis or a breast tissue biopsy. In a study of approximately 2.5
million screening mammograms done between 1996 and 2005 and collected from
mammography registries participating in the Breast Cancer Surveillance
Consortium Associations, the incidence of biopsy-proven ADH was 0.4%,
suggesting that mammography fails to detect ADH in over 90% of
patients.
A number
of medical devices have been designed over the years that apply negative
pressure to the nipple to induce the expression of NAF, which is then collected
by carefully touching a capillary tube to any apparent drops of
NAF. We believe that in general, these devices are successful in
obtaining NAF from about 20% to 65% of all patients, and that this sample
collection variability has prevented the routine adoption of NAF cytology for
breast cancer screening. The MASCT System was designed to overcome this
shortcoming by placing a hydrophilic, or water seeking, membrane in contact with
the nipple during the cycles of negative pressure to “wick” fluid from the
orifice of the ducts by capillary action, thereby increasing the frequency of
obtaining NAF in women. The results of a clinical trial sponsored by
Nastech Pharmaceutical Company, Inc. of 31 women conducted in 2003 demonstrated
that the MASCT System was able to collect measurable NAF in 97% (30) of the
women tested. The NAF samples collected in this study ranged from one to
37 microliters, with an average of seven microliters, and all samples collected
were deemed to be clinically useful. No adverse events were reported in
the study.
The MASCT
System also requires no use of radiation. A study that analyzed the
results of six peer-reviewed medical research publications reported in December
2009 that low dose radiation from mammograms can increase cancer incidence by
1.5 to 2.5 fold in high-risk women, increasing the complexity of managing
high-risk patients. Unlike a biopsy, the MASCT System is a non-invasive
and painless procedure. We believe these aspects of the MASCT System may
help to generate acceptance of its use for NAF collection and
testing.
Commercialization
Strategy
We
believe that commercialization of the MASCT System will provide us with two main
revenue sources: (i) sales-based revenue from the sale of the MASCT System
device and patient kits to physicians, breast health clinics, and mammography
clinics and (ii) service, or use-based, revenue from the preparation and
interpretation of the NAF samples sent to our laboratory for
analysis.
We intend
to market the MASCT System to physicians, as well as breast health and
mammography clinics, for use in conjunction with other health screening
examinations, including annual physical examinations and regularly scheduled
cervical Pap smears and mammograms. We plan to hire a direct sales force
of approximately eight people initially to commercialize our products and
services in the Northwestern United States, where there are approximately 290
mammography clinics registered with the FDA. We believe the total
addressable market for our products and services in this region is over $100
million. Assuming a successful regional launch, we plan to expand
nationally during the first half of 2012 and intend to grow our sales force to
approximately 100 people in the United States.
We have
leased a facility for our clinical laboratory in Seattle, Washington. We
intend to establish and qualify the operations and procedures of this laboratory
in the fourth quarter of 2010, including submitting applications for
accreditation by the College of American Pathologists and for licensure by state
and federal agencies in order to allow the preparation, screening and
interpretation of cytology and for the molecular diagnostics testing of NAF
patient samples at our facility. We believe that by maintaining our own
clinical laboratory, we will be able to generate additional service revenues
through cytology and molecular diagnostic testing, in addition to the sale of
our MASCT Systems.
Trading
Market
Currently,
there is no trading market for our securities. We intend to apply for
listing of the Units, our common stock and the Class B Warrants on the NYSE Amex
under the symbols “ATOSU,” “ATOS” and “ATOSW,” respectively. The
Class A Warrants will not be listed for trading.
Risk
Factors
Our
business is subject to numerous risks as discussed more fully in the section
entitled “Risk Factors” beginning on page 7. Principal risks of our
business include, but are not limited to, the following:
|
·
|
we
will need significant additional capital to execute our business strategy
as currently contemplated;
|
|
·
|
we
have a history of operating losses and expect to incur losses for the
foreseeable future;
|
|
·
|
we
have not yet engaged any manufacturers for the production of the MASCT
System in commercial quantities and may encounter difficulties in finding
manufacturers for such production at acceptable quantities or
costs;
|
|
·
|
we
may not be successful in commercializing the MASCT System because
physicians and clinicians may be slow to adopt our
product;
|
|
·
|
our
ability to commercialize the MASCT System may be limited because Medicare
and certain insurance carriers are not expected to provide reimbursement
for use of our product;
|
|
·
|
we
may encounter difficulties in establishing, obtaining certification under
the FDA’s Clinical Laboratory Amendments, or CLIA, regulations for or
maintaining our cytology and molecular diagnostics laboratory for the
testing and analysis of NAF samples;
and
|
|
·
|
we
may not be able to hire, train or maintain the sales force necessary to
market and sell our products and services as
planned.
|
Company
Information
We were
incorporated in Delaware in April 2009. Our principal executive offices
are located at 4105 E Madison Street, Suite 320, Seattle, Washington 98112, and
our telephone number is (206) 325-6086. Our website is located at www.atossagenetics.com. Information contained
on, or that can be accessed through, our website is not a part of this
prospectus.
MASCT,
Oxy-MASCT and our name and logo are our trademarks. This prospectus also
includes additional trademarks, trade names and services marks, which are the
property of their respective owners.
Our
company name comes from Queen Atossa, daughter of Cyrius the Great and wife of
Darius I, the King of the Achaemenid Empire. In about 470 BC, she became
the first woman in recorded history to be diagnosed with breast cancer, of which
she died. The Company is dedicated to her and the millions of women who
have been, and continue to be, affected by breast cancer.
THE
OFFERING
Securities
offered by us:
|
|
3,000,000
units, or the Units. Each Unit consists of:
·
one share of our common stock;
·
two Class A Warrants, each exercisable for one share of our common
stock on a cashless, net exercise basis for a period of 10 days beginning
on the sixth trading day after the separation of the securities underlying
the Units at an exercise price of $0.05 per share;
and
·
one Class B Warrant exercisable for one share of common
stock commencing on the first anniversary of the date of this
prospectus, and remaining exercisable until the fifth anniversary of
the separation of the Class B Warrants from the Units at an
exercise price equal to 55% of the Unit offering price. We will
have the right to redeem the Class B Warrants at $0.25 per share of common
stock underlying the Class B Warrants in the event (i) the average of the
closing price of our common stock exceeds 200% of the exercise price for
10 consecutive trading days while the warrants are exercisable and (ii)
there is then an effective registration statement with a current
prospectus on file with the SEC.
|
|
|
|
Use
of proceeds:
|
|
We
intend to use the net proceeds from this offering to engage one or more
contract manufacturers to produce the MASCT System in commercial
quantities, to establish a cytology and molecular diagnostics laboratory
focused on breast cancer and to launch the MASCT System in the
Northwestern United States, including hiring and training sales
personnel. We also intend to use a portion of the proceeds from this
offering to develop a second generation of the MASCT System, to develop
additional laboratory biomarker tests and to launch a national roll-out of
the MASCT System.
|
|
|
|
NYSE
Amex Market trading Symbols:
|
|
We
intend to apply for listing of our common stock, the Units and the Class B
Warrants on the NYSE Amex under the symbols, “ATOS,” “ATOSU” and “ATOSW,”
respectively. The Class A Warrants will not be listed for
trading.
|
|
|
|
Capitalization:
|
|
6,000,063
shares of common stock outstanding before the offering (1).
15,000,063
shares of common stock outstanding after the offering and assuming full
exercise of the Class A Warrants
(1).
|
(1)
|
The
number of shares of our common stock to be outstanding before the offering
is based on 6,000,063 shares (or 13,580,000 shares, prior to the reverse
stock split effected in September 2010) of common stock outstanding as of
June 30, 2010, and excludes 1,000,000 shares of common stock reserved for
future issuance under our 2010 Stock Option and Incentive
Plan.
|
Unless
otherwise indicated, all information in this prospectus:
|
·
|
assumes
that the underwriters do not exercise their right to purchase up to
450,000 additional Units to cover overallotments, if any;
and
|
|
·
|
gives
effect to a one-for-2.26332 reverse split of our common stock effected in
September 2010.
|
SUMMARY
FINANCIAL DATA
The
following summary financial data should be read together with our financial
statements and the related notes and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” appearing elsewhere in this
prospectus. The summary financial data in this section is not intended to
replace our financial statements and the related notes. Our historical
results are not necessarily indicative of the results to be expected for any
future period.
We were
incorporated on April 30, 2009. The following statement of operations
data, including share data, for the year ended December 31, 2009 have been
derived from our audited financial statements and related notes included
elsewhere in this prospectus. The statement of operations data, including
share data, for the six months ended June 30, 2010 and the period from
April 30, 2009 (inception) through June 30, 2009, and the balance sheet data as
of June 30, 2010 have been derived from our unaudited financial statements
included elsewhere in this prospectus. The unaudited interim financial
statements have been prepared on the same basis as the audited financial
statements and reflect all adjustments necessary to fairly state our financial
position as of June 30, 2010 and results of operations for the six months ended
June 30, 2010 and the period from April 30, 2009 (inception) through June 30,
2009. The operating results for any period are not necessarily indicative
of financial results that may be expected for any future period.
|
|
April 30, 2009
(Inception) through
December 31, 2009
|
|
|
Six Months Ended
June 30, 2010
|
|
|
April 30, 2009
(Inception) through
June 30, 2009
|
|
|
|
|
|
|
(Unaudited)
|
|
Statement
of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
$21,250
|
|
|
|
$—
|
|
|
|
$—
|
|
General
and administrative
|
|
|
$101,607
|
|
|
|
274,747 |
|
|
|
524 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
operating income:
|
|
|
|
|
|
|
12,500 |
|
|
|
— |
|
Interest
income
|
|
|
— |
|
|
|
453 |
|
|
|
— |
|
Income
taxes
|
|
|
— |
|
|
|
(125 |
) |
|
|
— |
|
Net
loss
|
|
|
$(122,857
|
) |
|
|
$(261,795
|
) |
|
|
$(524
|
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per share—basic and diluted
|
|
|
$(0.03
|
) |
|
|
$(0.04
|
) |
|
|
$(0.00
|
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of shares used in share calculation—basic and
diluted
|
|
|
4,037,847 |
|
|
|
5,870,334 |
|
|
|
3,976,459 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
Balance
Sheet Data:
|
|
|
|
|
|
|
Total
assets
|
|
|
$41,198
|
|
|
|
$16,541,198 |
|
Total
liabilities
|
|
|
98,436 |
|
|
|
98,436 |
|
Stockholders’
(deficit) equity:
|
|
|
|
|
|
|
|
|
Common
Stock, $0.001 par value, 50,000,000 shares authorized and 6,000,063 and
15,000,063 shares outstanding, actual and as-adjusted,
respectively
|
|
|
6,000 |
|
|
|
15,000 |
|
Additional
paid-in capital
|
|
|
321,540 |
|
|
|
16,812,540 |
|
Accumulated
deficit
|
|
|
(384,778 |
) |
|
|
(384,778 |
) |
Total
stockholder’s (deficit) equity
|
|
|
(57,238 |
) |
|
|
16,442,762 |
|
Total
liabilities & stockholder’s equity
|
|
|
$41,198
|
|
|
|
$16,541,198 |
|
The June
30, 2010 actual and as-adjusted balance sheet data do not reflect an
increase in our authorized shares of common stock to 75,000,000 shares effected
in September 2010. The June 30, 2010 as-adjusted balance sheet data reflects
the sale of 3,000,000 Units in this offering at an assumed initial
public offering price of $6.00 per Unit, which is the mid-point of the
price range listed on the cover page of this prospectus, after deducting 10%
estimated underwriting discounts and commissions and estimated offering expenses
payable by us, and assuming the full exercise of the Class A Warrants at an
exercise price of $0.05 per share.
RISK
FACTORS
A
purchase of the Units is an investment in the Company’s securities and involves
a high degree of risk. You should consider carefully the following
information about these risks, together with the other information contained in
this prospectus, before purchasing our securities. If any of the following
risks actually occur, the business, financial condition or results of operations
of the Company would likely suffer. In that case, the value of our
securities, including the market price of the common stock, Units or Class B
Warrants could decline, and you may lose part or all of your investment in our
company.
Risks
Relating to the Company
The
Company has limited operating history and as such an investor cannot assess its
profitability or performance based on past results.
The
Company is a development stage company founded in April 2009 and as such has
limited operating history. The Company’s operations to date have consisted
primarily of securing laboratory and office space, hiring laboratory personnel,
ordering equipment and supplies, engaging a third-party vendor for the
manufacture of the MASCT System in quantities sufficient for initial field
testing, securing patent rights and assignments, filing new patent applications,
acquiring FDA market clearances, and securing development bids to complete
preparation for manufacturing the MASCT System. The Company requires
significant additional capital to achieve its business objectives, and the
inability to obtain such financing on acceptable terms or at all could lead to
closure of the business.
The
Company’s revenue and income potential is uncertain. Any evaluation of the
Company’s business and prospects must be considered in light of these factors
and the risks and uncertainties often encountered by companies in the
development stage. Some of these risks and uncertainties include the
Company’s ability to:
|
·
|
execute
its business plan and commercialization
strategy;
|
|
·
|
engage
one or more contract manufacturers to produce the MASCT System in
commercial quantities;
|
|
·
|
create
brand recognition;
|
|
·
|
respond
effectively to competition;
|
|
·
|
manage
growth in its operations;
|
|
·
|
respond
to changes in applicable government regulations and
legislation;
|
|
·
|
access
additional capital when required;
and
|
|
·
|
attract
and retain key personnel.
|
The
Company’s independent auditors have issued a report questioning the Company’s
ability to continue as a going concern.
The
report of the Company’s independent auditors contained in the Company’s
financial statements explains that the Company has not yet established an
ongoing source of revenues sufficient to cover its operating costs and allow it
to continue as a going concern. The ability of the Company to continue as
a going concern is dependent on the Company obtaining adequate capital to fund
operating losses until it becomes profitable. If the Company is unable to
obtain adequate capital, it could be forced to cease
operations.
Failure
to raise additional capital as needed could adversely affect the Company and its
ability to grow.
The
Company will need considerable amounts of capital to develop its business.
It may raise funds through public or private equity offerings or debt
financings. If the Company cannot raise funds on acceptable terms when
needed, it may not be able to grow or maintain the business. Furthermore,
such lack of funds may inhibit the Company’s ability to respond to competitive
pressures or unanticipated capital needs, or may force the Company to reduce
operating expenses, which could significantly harm the business and development
of operations. Because the Company’s independent auditors have expressed
doubt as to the Company’s ability to continue as a “going concern,” as reported
in the financial statements of the Company, its ability to raise capital may be
severely hampered. Similarly, the Company’s ability to borrow any such
capital may be more expensive and difficult to obtain until this “going concern”
issue is eliminated.
The
Company has a history of operating losses and expects to continue to incur
losses in the future.
The
Company has a limited operating history and has incurred net operating losses of
$384,778 since its inception from April 30, 2009 through June 30, 2010.
The Company has not yet received any revenues and will not be in a position to
generate revenues until it is able to produce and sell the MASCT System.
The Company will incur additional losses in connection with engaging one or more
contract manufacturers to produce the MASCT System for commercial sale, building
a sales force for the product and establishing its laboratory facilities for the
testing and analysis of NAF samples, and may never achieve
profitability.
Raising
funds by issuing equity, or debt securities, could dilute the value of the
common stock and impose restrictions on the Company’s working
capital.
If the
Company were to raise additional capital by issuing equity securities, the book
value of the then outstanding common stock would be reduced unless the
additional equity securities were issued at a price equal to or greater than the
then value of the common stock at the time of issuance of the new
securities. If the additional equity securities were issued at a per share
price less than the per share value of the outstanding shares, then all of the
outstanding shares would suffer a dilution in value with the issuance of such
additional shares. Further, the issuance of debt securities in order to
raise additional funds may impose restrictions on the Company’s operations and
may impair the Company’s working capital as it services any such debt
obligations.
Currently
Medicare and certain insurance carriers will not reimburse for the NAF
collection procedure, which could slow or limit adoption of the MASCT System or
prevent the Company from pricing the MASCT System at desired
levels.
The HALO
System, an NAF collection device similar to the MASCT System, is being sold by
Neomatrix, Inc., or Neomatrix, of Irvine, California. Previously, Cytyc,
Inc., or Cytyc, of Marlboro, Massachusetts, marketed FirstCyte, a device to
collect NAF by ductal lavage. Certain insurance carriers do not currently
reimburse for the HALO System or FirstCyte procedures. For example,
effective March 1, 2009, United Healthcare determined it would not cover the
costs of these procedures because it believes there is insufficient clinical
evidence to support efficacy for the evaluation of patients at risk for breast
cancer. Similarly, Medicare does not reimburse for the NAF collection
procedure. Lack of Medicare or insurance coverage will require patients to
bear the full costs of the NAF sample acquisition process used with the MASCT
System. As a result, and particularly in light of healthcare reform and
cost-containment initiatives being undertaken widely across the United States,
physicians and other healthcare professionals may be slow to adopt the MASCT
System and may not recommend its use in patients. The Company may be
forced to reduce the price of the MASCT System components in response to low
demand, or may not be able to sell the product and services components of the
MASCT System at acceptable margins, which would severely limit the Company’s
ability to generate revenues.
The
MASCT System and second-generation risk assessment tools, diagnostic tests and
other predictive and personalized medicine products that the Company may develop
may never achieve significant commercial market acceptance.
The
Company may not succeed in achieving commercial market acceptance of any of its
products and services. In order to market the MASCT System and to gain
market acceptance for its products and services, the Company will need to
demonstrate to physicians and other healthcare professionals the benefits of the
MASCT System and its practical and economic application for their particular
practice. Despite FDA clearance for the MASCT System, many physicians and
healthcare professionals are hesitant to introduce new services, or techniques,
into their practice for many reasons, including the learning curve associated
with the adoption of such new services or techniques into already established
procedures and the uncertainty of the applicability or reliability of the
results of a new product. In addition, the availability of full or even
partial payment for the Company’s products and tests, whether by third-party
payors (e.g. insurance companies), or the patients themselves, will likely
heavily influence physicians’ decisions to recommend or use the Company’s
products.
The
Company may not be able to establish its cytology and molecular diagnostics
laboratory for the performance of its planned testing and analytical services or
may encounter difficulties in operating or maintaining this laboratory facility,
which could cause delays and unexpected problems.
The
Company has only begun to establish its laboratory and will rely on a single
physical facility for the testing of NAF samples in Seattle, Washington.
The Company will submit applications to obtain certification for its laboratory
under CLIA and Washington state regulations, which will require that the
facility become accredited by the College of American Pathologists and meet
various standards imposed by both federal and state regulatory
authorities. There is no guarantee that the Company’s facility will be
adequate or that the Company will obtain Washington state or federal CLIA
certification for this facility as planned. The Company’s management team
does not have significant prior experience with establishing this type of
laboratory facility. In addition, if established, this facility and
certain pieces of laboratory equipment required for the performance of the
Company’s testing and analytical services would be expected to be difficult and
costly to replace and may require significant replacement lead-time. In
the event that the Company is unable to establish its intended laboratory
facility or, if after completion, such laboratory or equipment is adversely
affected by periodic malfunctions or man-made, or natural disasters, the Company
may be unable to conduct its business and meet potential customer demands for a
significant period of time.
The
loss of the services of the Company’s chief executive officer could adversely
affect its business.
The
Company’s success is dependent in large part upon its ability to execute its
business plan, manufacture the MASCT System, establish its clinical and
diagnostic laboratory, and to attract and retain highly skilled professional,
sales and marketing personnel. In particular, due to the relatively early
stage of the Company’s business, its future success is highly dependent on the
services of Dr. Quay, its chief executive officer and founder, to provide the
necessary experience to execute the Company’s business plan. The Company
does not currently maintain “key man” insurance with respect to Dr. Quay.
The loss of his services for any reason could impede the Company’s ability to
achieve its objectives, such as the commercialization of the MASCT System and
the development of a core of healthcare professionals who use the MASCT System,
particularly initially, as the Company seeks to build a reputation among
physicians and clinicians.
The
Company may experience difficulty in locating, attracting, and retaining
experienced and qualified personnel, which could adversely affect its
business.
The
Company will need to attract, retain, and motivate experienced anatomic
pathologists, cytologists, histotechnologists, skilled laboratory and
information technology staff, experienced sales representatives, and other
personnel, particulary in the Greater Seattle area as it commences its initial
launch of the MASCT System. These employees may not be available in this
geographic region. In addition, competition for these employees is intense
and recruiting and retaining skilled employees is difficult, particularly for a
development-stage organization such as the Company. If the Company is not
able to attract and retain qualified personnel, revenues and earnings may be
adversely affected.
The Company has no prior experience
with commercializing any products or services, and it will need to establish a
sophisticated sales and marketing organization in order to successfully
commercialize the MASCT System.
The
Company intends to build a direct sales force to be comprised initially of eight
sales professionals to target physicians and mammography clinics in the
Northwestern United States and plans eventually to expand its sales team to
include sales professionals nationwide. Marketing the MASCT System to
physicians and healthcare professionals will require the Company to educate them
on the comparative advantages of the MASCT System over other methods currently
used for the detection and diagnosis of breast cancer. Experienced sales
representatives may be difficult to locate and all sales representatives will
need to undergo training. The Company will need to incur significant costs
to build its internal sales force. Based on its current operating plan,
the Company expects to incur costs of approximately $3.5 million in connection
with initial hiring and building its national sales force. The Company
cannot be certain that it will be able to recruit sufficiently skilled sales
representatives, or that any new sales representatives will ultimately become
productive. If the Company is unable to recruit, train and retain
qualified and productive sales personnel, its ability to commercialize the MASCT
System and any second generation products and to generate revenues will be
impaired.
The
Company will need to engage third-party suppliers for the production of the
MASCT System in commercial quantities, and the inability to find such suppliers,
or to maintain relationships with them, could adversely affect the Company’s
business.
The
Company does not currently have any long-term contracts or arrangements with any
laboratory equipment and disposable reagent suppliers, or any device or kit
manufacturers for the production of the MASCT System and its components in
commercial quantities. While the Company has entered into a short-term
contract with a third party medical device manufacturer to produce limited
quantities of the MASCT System to permit the Company to perform field testing
prior to commercial launch, there can be no assurance that commercial quantities
of the MASCT System can be manufactured by this supplier. The Company
anticipates that it will need to rely on third-party suppliers for the continued
manufacture and supply of the MASCT System, NAF collection device and patient
collection kits and for the laboratory instruments, equipment, consumable
supplies, and other materials necessary to perform the specialized diagnostic
tests. If the Company is unable to identify third-party suppliers to
produce the MASCT System in quantities sufficient for the Company’s planned
product launch on acceptable terms, or at all, the Company will not be able to
commercialize the MASCT System and generate revenues from its sales as
planned. In addition, if at any time after commercialization of the MASCT
System, the Company is unable to secure essential equipment or supplies in a
timely, reliable and cost-effective manner, it could experience disruptions in
its services that could adversely affect anticipated results.
The
Company’s intended business to sell predictive medical products exposes the
Company to possible litigation and product liability claims.
The
Company’s business exposes it to potential product liability risks from the
MASCT System inherent in the testing, marketing and processing of predictive, or
personalized medical products. Product liability risks may arise from, but
are not limited to:
|
·
|
the
inability of the MASCT System to extract a sufficient NAF sample from the
breast, which may lead to an NAF sample size that is inadequate for proper
processing at the Company’s laboratory and insufficient for screening,
which could lead to an inaccurate assessment of the health of the
patient;
|
|
·
|
failure
by healthcare professionals to properly safeguard NAF samples collected
using the MASCT System;
|
|
·
|
the
potential loss, mislabeling or misplacement of NAF sample shipments and
test kits;
|
|
·
|
the
MASCT System is a manually operated device, and, as a result, human error
due to fatigue or distraction by the healthcare professional may result in
improper collection of NAF or application of the MASCT
System;
|
|
·
|
inadequate
cleaning of the collection pump between patients resulting in mixing of
NAF samples from two patients or NAF samples attributed to the wrong
patient;
|
|
·
|
improper
fitting of the MASCT System device to the breast;
and
|
|
·
|
inadequate
cleaning of the breast prior to applying the MASCT
System.
|
A
successful product liability claim, or the costs and time commitment involved in
defending against a product liability claim, could have a material adverse
effect on the Company’s business. Any successful product liability claim
may prevent the Company from obtaining adequate product liability insurance, in
the future, on commercially desirable or reasonable terms. An inability to
obtain sufficient insurance coverage at an acceptable cost, or otherwise, to
protect against potential product liability claims could prevent or inhibit the
commercialization of the Company’s products.
The Company’s intention to provide a
laboratory to analyze and read the NAF tests expose it to possible litigation
based on malpractice, data aggregation errors, or
misdiagnoses.
The
Company will need to establish and operate a CLIA-certified laboratory to
analyze and read NAF samples collected using the MASCT System, and intends
to report the results to referring healthcare professionals, researchers
and potential collaborators worldwide. The Company may be subject to
claims by an affected patient, healthcare provider, researcher or collaborator
if laboratory personnel make any of the following mistakes, by way of
example:
|
·
|
errors
in the analysis of the NAF tests;
|
|
·
|
incorrect
aggregation, categorization or labeling of NAF
data;
|
|
·
|
improper,
incorrect or inaccurate development of a computer database which
categorizes, analyzes, or compares NAF test data;
or
|
|
·
|
misinterpretation
of the results of the test or collected
data.
|
We intend
to maintain insurance to protect the Company against such suits, but we cannot
be certain that the insurance will be sufficient to cover potential
damages, or that it will be cost-effective for us to maintain such a
policy. Any outcome against the Company could involve significant monetary
judgments and could severely impact the Company’s financial resources and would
be expected to impair the ability of the Company in the future to obtain
malpractice, or other insurance, for its laboratory services.
If
the Company’s patent positions do not adequately protect its products, others
could compete with the Company more directly, which would adversely affect its
business.
The
Company’s commercial success will depend in part on its ability to obtain new
patents and enforce its existing patents, as well as its ability to maintain
adequate protection of other intellectual property for its technologies and
products in the United States and abroad. If the Company does not
adequately protect its intellectual property, competitors may be able to use its
technologies and erode or negate any competitive advantage it may have, which
could adversely affect its business, negatively affect its position in the
marketplace and limit its ability to commercialize its products. The laws
of some foreign countries do not protect the Company’s proprietary rights to the
same extent as the laws of the United States, and the Company may encounter
significant problems in protecting its proprietary rights in these
countries.
The
patent positions of diagnostic and medical device companies, including ours,
involve complex legal and factual questions, and, therefore, validity and
enforceability cannot be predicted with certainty, nor can we be certain that we
are not infringing the patents of others. Our patents may be challenged,
deemed unenforceable, invalidated or circumvented. The Company will be
able to protect its proprietary rights from unauthorized use by third parties
only to the extent that its proprietary technologies, existing products and any
future products are covered by valid and enforceable patents or are effectively
maintained as trade secrets, and the Company is willing and has the resources to
take enforcement action against such unauthorized use by third
parties.
The
degree of future protection for the Company’s proprietary rights is uncertain,
and the Company cannot ensure that:
|
·
|
it
was the first to make the inventions covered by each of its patents and
pending patent applications;
|
|
·
|
it
was the first to file patent applications for these
inventions;
|
|
·
|
others
will not independently develop similar, or alternative technologies, or
duplicate any of the Company’s
technologies;
|
|
·
|
any
of the Company’s pending patent applications will result in issued
patents;
|
|
·
|
any
of the Company’s issued patents will be valid or
enforceable;
|
|
·
|
any
patents issued to the Company will provide a basis for commercially viable
products, will provide the Company with any competitive advantages or will
not be challenged by third parties;
|
|
·
|
the
Company will develop additional proprietary technologies or products that
are patentable; or
|
|
·
|
the
patents of others will not have an adverse effect on the Company’s
business.
|
The
Company may be unable to adequately prevent disclosure of trade secrets and
other proprietary information.
The
Company relies on trade secrets to protect its proprietary know-how and
technological advances, particularly where it does not believe patent protection
is appropriate or obtainable. However, trade secrets are difficult to
protect. The Company relies in part on confidentiality agreements with its
employees, consultants, outside scientific collaborators and other advisors to
protect its trade secrets and other proprietary information. These
agreements may not effectively prevent disclosure of confidential information
and may not provide an adequate remedy in the event of unauthorized disclosure
of confidential information. In addition, others may independently
discover the Company’s trade secrets and proprietary information. Costly
and time-consuming litigation could be necessary to enforce and determine the
scope of the Company’s proprietary rights. Failure to obtain, or maintain,
trade secret protection could enable competitors to use the Company’s
proprietary information to develop products that compete with the Company’s
products or cause additional, material adverse effects upon the Company’s
competitive business position.
The
Company’s current patent portfolio may not include all patent rights needed for
the full development and commercialization of the Company’s products. The
Company cannot be sure that patent rights it may need in the future will be
available for license on commercially reasonable terms, or at all.
Although
the Company’s patents may prevent others from making, using or selling similar
products, they do not ensure that the Company will not infringe the patent
rights of third parties. The Company may not be aware of all patents or
patent applications that may impact its ability to make, use or sell the MASCT
System or its other proposed product or service offerings. Furthermore,
the Company may not be aware of published or granted conflicting patent
rights. Any conflicts resulting from patent applications and patents of
others could significantly reduce the coverage of its patents and limit its
ability to obtain meaningful patent protection. If others obtain patents
with conflicting claims, the Company may need to obtain licenses to these
patents or to develop or obtain alternative technology.
The
Company may not be able to obtain any licenses or other rights to patents,
technology or know-how from third parties necessary to conduct its business as
described in this prospectus and such licenses, if available at all, may not be
available on commercially reasonable terms. Any failure to obtain such
licenses could delay or prevent the Company from developing or commercializing
its proposed products and services, which would harm its business. Litigation or
patent interference proceedings need to be brought against third parties, as
discussed below, to enforce any of the Company’s patents or other proprietary
rights, or to determine the scope and validity or enforceability of the
proprietary rights of such third parties.
Litigation
regarding patents, patent applications and other proprietary rights may be
expensive and time consuming. If the Company is involved in such
litigation, it could cause delays in bringing product or service candidates to
market and harm its ability to operate.
The
Company’s commercial success will depend in part on its ability to manufacture,
use and sell products and services without infringing patents or other
proprietary rights of third parties. Third parties may challenge or
infringe upon our, or our licensors’ existing, or future patents.
Although the Company is not currently aware of any pending or actual
litigation, or other proceedings, or third-party claims of intellectual property
infringement related to the MASCT System or its product candidates, the medical
device and diagnostic industry is characterized by extensive litigation
regarding patents and other intellectual property rights. Other parties
may obtain patents in the future and allege that the use of the Company’s
technologies infringes these patent claims or that it is employing their
proprietary technology without authorization.
Legal
proceedings involving the Company’s patents or patent applications, or those of
others, could result in adverse decisions regarding the patentability of its
inventions relating to its products or the enforceability, validity or scope of
protection offered by its patents.
Even if
the Company is successful in proceedings involving its intellectual property
rights or those of others, it may incur substantial costs and divert management
time and attention in pursuing these proceedings. If the Company is unable to
avoid infringing the patent rights of others, it may be required to seek a
license, defend an infringement action, or challenge the validity of the patents
in court. Patent litigation is costly and time-consuming and the
Company may not have sufficient resources to bring enforcement actions to a
successful conclusion. In addition, if the Company does not obtain a
license, develop or obtain non-infringing technology, fail to defend an
infringement action successfully or have infringed patents declared invalid, the
Company may incur substantial monetary damages; encounter significant delays in
bringing its product candidates to market; or be precluded from participating in
the manufacture, use or sale of its product candidates or methods of treatment
requiring licenses.
Risks
Related to the Company’s Industry
The
inadvertent or unintentional failure to comply with the complex government
regulations concerning privacy of medical records could impact the Company with
fines and adversely affect its reputation.
The
federal privacy regulations, among other things, restrict the Company’s ability
to use or disclose protected health information in the form of
patient-identifiable laboratory data, without written patient authorization, for
purposes other than payment, treatment, or healthcare operations (as defined
under the Health Insurance Portability and Accountability Act, or HIPAA) except
for disclosures for various public policy purposes and other permitted purposes
outlined in the privacy regulations. The privacy regulations provide
for significant fines and other penalties for wrongful use or disclosure of
protected health information, including potential civil and criminal fines and
penalties. Although the HIPAA statute and regulations do not
expressly provide for a private right of damages, the Company could incur
damages under state laws to private parties for the wrongful use or disclosure
of confidential health information or other private personal
information.
The
Company intends to implement policies and practices that it believes will make
it substantially compliant with the privacy regulations. However, the
documentation and process requirements of the privacy regulations are complex
and subject to interpretation. Failure to comply with the privacy
regulations could subject the Company to sanctions or penalties, loss of
business, and negative publicity.
The HIPAA
privacy regulations establish a “floor” of minimum protection for patients as to
their medical information and do not supersede state laws that are more
stringent. Therefore, the Company is required to comply with both
HIPAA privacy regulations and various state privacy laws. The failure
to do so could subject it to regulatory actions, including significant fines or
penalties, and to private actions by patients, as well as to adverse publicity
and possible loss of business. In addition, federal and state laws
and judicial decisions provide individuals with various rights for violation of
the privacy of their medical information by healthcare providers such as the
Company.
Changes
in regulations, policies, or payor mix may adversely affect reimbursement for
laboratory services and could have a material adverse impact on the Company’s
revenues and profitability.
Most of
the Company’s services will be billed to a party other than the physician who
ordered the test. Reimbursement levels for healthcare services are
subject to continuous and often unexpected changes in
policies. Changes in governmental and third-party reimbursement may
result from statutory and regulatory changes, retroactive rate adjustments,
administrative rulings, competitive bidding initiatives, and other policy
changes. Uncertainty also exists as to the coverage and reimbursement
status of new services. Government payors and insurance companies
have increased their efforts to control the cost, utilization, and delivery of
healthcare services. For example, at least yearly, Congress has
considered and enacted changes in the Medicare fee schedule in conjunction with
budgetary legislation. Further reductions of reimbursement for
Medicare services or changes in policy regarding coverage of tests may be
implemented from time to time. The payment amounts under the Medicare
fee schedules are often used as a reference for the payment amounts set by other
third-party payors. As a result, a reduction in Medicare
reimbursement rates could result in a corresponding reduction in the
reimbursements the Company will receive from such third-party
payors. Changes in test coverage policies of other third-party payors
may also occur. Such reimbursement and coverage changes in the past
have resulted in reduced prices, added costs and reduced accession volume, and
have imposed more complex regulatory and administrative
burdens. Further changes in federal, state, and local third-party
payor laws, regulations, or policies may have a material adverse impact on the
Company’s business.
Failure
to participate as a provider with payors, or operating as a non-contracting
provider, could have a material adverse effect on revenues.
The
healthcare industry has experienced a trend of consolidation among healthcare
insurers, resulting in fewer but larger insurers with significant bargaining
power in negotiating fee arrangements with healthcare providers, including
laboratories. Managed care providers often restrict their contracts
to a small number of laboratories that may be used for tests ordered by
physicians in the managed care provider’s network. If the Company
does not have a contract with a managed care provider, it may be unable to gain
those physicians as clients. In cases in which it will contract with
a specified insurance company as a participating provider, it will be considered
“in-network,” and the reimbursement of third-party payments is governed by
contractual relationships. The Company’s in-network services will be
primarily negotiated on a fee-for-service basis at a discount from the Company’s
patient fee schedule, which could result in price erosion that would adversely
affect revenues. The Company’s failure to obtain managed care
contracts, or participate in new managed care networks, could adversely affect
revenues and profitability. In cases in which the Company does not
have a contractual relationship with an insurance company, or is not an approved
provider for a government program, it will have no contractual right to collect
for services and such payors may refuse to reimburse it for services, which
could lead to a decrease in accession volume and a corresponding decrease in
revenues. As an out-of-network provider, reductions in reimbursement
rates for non-participating providers could also adversely affect the
Company. Third-party payors, with whom the Company does not
participate as a contracted provider, may also require that it enter into
contracts, which may have pricing and other terms that are materially less
favorable to the Company than the terms under which it intends to
operate. While accession volume may increase as a result of these
contracts, revenues per accession may decrease.
Use of
the Company’s laboratory services as a non-participating provider is also
expected to result in greater copayments for the patient unless the Company
elects to treat them as if it were a participating provider in accordance with
applicable law. Treating such patients as if the Company were a
participating provider may adversely impact results of operations because it may
be unable to collect patient copayments and deductibles. In some states,
applicable law prohibits the Company from treating these patients as if it were
a participating provider. As a result, referring physicians may avoid use of the
Company’s services which could result in a decrease in accession volume and
adversely affect revenues.
Changes
in FDA policies regarding the “home brew” exception from FDA review for
laboratory-developed tests and reagents could adversely affect the Company’s
business and results of operations.
Laboratory
diagnostic tests developed and validated by a laboratory for its own use, also
known as laboratory developed tests, which are referred to as LDTs or “home
brew” tests, are regulated by the FDA under the federal Food, Drug and Cosmetic
Act, or FDCA. To date, the FDA has decided, as a matter of
enforcement, not to exercise its authority with respect to most “home brew”
tests performed by high complexity laboratories certified under CLIA, which is
the type of laboratory that the Company intends to establish. The
Company does not believe that the cytology or IHC testing of NAF samples in the
MASCT System are LDTs; however, the Company’s second generation biomarker tests
will be LDTs for which it does not currently intend to apply for FDA premarket
notification or approval. In addition, manufacturers and suppliers of
analyte specific reagents, or ASRs, which the Company may utilize for use in its
LDTs, are required to register with the FDA, conform manufacturing operations to
the FDA’s Quality System Regulation, or QSR, and comply with certain reporting
and other record keeping requirements. The FDA regularly considers
the application of additional regulatory controls over the development and use
of LDTs by laboratories. It is possible that the FDA will require
premarket notification or approval for LDT diagnostic tests that the Company may
develop and perform in the future. The FDA held public hearings in
the third quarter of 2010 to discuss how it will oversee LDTs. No
definitive recommendations or findings have yet come from these hearings, but it
is likely that the FDA will impose additional or new regulations affecting LDTs,
including requiring premarket notification or approval for these
tests. Any premarket notification or approval requirements could
restrict or delay the Company’s ability to provide specialized diagnostic
services and may adversely affect its business. FDA regulation of
LDTs, or increased regulation of the various medical devices used in
laboratory-developed testing, could increase the regulatory burden and generate
additional costs and delays in introducing new tests.
The
failure to comply with complex federal and state laws and regulations related to
submission of claims for services could result in significant monetary damages
and penalties and exclusion from the Medicare and Medicaid
programs.
If the
Company is successful in obtaining reimbursement from government healthcare
program, the Company will be subject to extensive federal and state laws and
regulations relating to the submission of claims for payment for services,
including those that relate to coverage of services under Medicare, Medicaid,
and other governmental healthcare programs, the amounts that may be billed for
services, and to whom claims for services may be submitted, such as billing
Medicare as the secondary, rather than the primary, payor. The
failure to comply with applicable laws and regulations could result in the
Company’s inability to receive payment for its services or attempts by
third-party payors, such as Medicare and Medicaid, to recover payments from the
Company that have already been made. Submission of claims in violation of
certain statutory or regulatory requirements can result in penalties, including
civil money penalties of up to $10,000 for each item or service billed to
Medicare in violation of the legal requirement, and exclusion from participation
in Medicare and Medicaid. Government authorities may also assert that
violations of laws and regulations related to submission of claims violate the
federal False Claims Act or other laws related to fraud and abuse, including
submission of claims for services that were not medically
necessary. The Company will be generally dependent on independent
physicians to determine when its services are medically necessary for a
particular patient. Nevertheless, the Company could be adversely
affected if it was determined that the services it provided were not medically
necessary and not reimbursable, particularly if it were asserted that the
Company contributed to the physician’s referrals to it of unnecessary services.
It is also possible that the government could attempt to hold the Company liable
under fraud and abuse laws for improper claims submitted by an entity for
services that it performed, if it were found to have knowingly participated in
the arrangement that resulted in submission of the improper claims.
The
Company’s business is subject to rapid technological innovation, and the
development by third parties of new or improved diagnostic testing technologies
or information technology systems could have a material adverse effect on the
Company’s business.
The
anatomic pathology industry is characterized by rapid changes in technology,
frequent introductions of new diagnostic tests, and evolving industry standards
and client demands for new diagnostic technologies. Advances in technology may
result in the development of more point-of-care testing equipment that can be
operated by physicians or other healthcare providers in their offices, or by
patients themselves, without the services of freestanding laboratories and
pathologists, thereby reducing demand for the Company’s services. In addition,
advances in technology may result in the creation of enhanced diagnostic tools
that enable other laboratories, hospitals, physicians, patients, or third
parties to provide specialized laboratory services superior to the Company’s or
that are more patient-friendly, efficient, or cost-effective. The
Company’s success depends upon its ability to acquire or license on favorable
terms or develop new and improved technologies for early diagnosis before its
competitors and to obtain appropriate reimbursement for diagnostic tests using
these technologies. Introduction of prophylactic treatments or cures
for breast cancer could substantially reduce or eliminate demand for its
services.
Risks
Related to This Offering, the Securities Markets and Investment in the Company’s
Securities
There
has been no prior public market for the Company’s securities and the lack of
such a market may make resale of the securities difficult.
No prior
public market has existed for the Company’s securities and the Company cannot
assure any investor that a market will develop subsequent to this
offering. The Company intends to apply for listing of its common
stock, the Units and the Class B Warrants on the NYSE
Amex. However, it does not know whether a market for the Company’s
securities will ever develop or continue. If the Company’s securities
are not listed on the NYSE Amex, or a public trading market does not otherwise
develop, you may have difficulty selling your Units, common stock or Class B
Warrants. If the Company is not successful in listing on the NYSE
Amex, it may then apply for listing of its securities on the NASDAQ Capital
Market, or have its securities quoted on the OTC Bulletin Board, or the Pink OTC
Market, Inc., an Internet-based quotation service for over-the-counter
securities. The OTC Bulletin Board and Pink OTC Markets generally
have lower trading volume and liquidity, which could result in lower trading
prices and a decreased ability to sell securities.
The
Class A Warrants to be issued in this offering will not be listed on a
securities exchange and are exercisable for a period of only 10 days beginning
on the sixth trading day after separation of the securities underlying the
Units.
Although
the Company intends to apply for the listing of its common stock, Units and
Class B Warrants on the NYSE Amex, it does not plan to list the Class A Warrants
on any securities exchange. There may be little or no secondary
market for the Class A Warrants. Even if there is a secondary market,
it may not provide enough liquidity to allow you to trade or sell the warrants
easily. Accordingly, you will need to exercise the Class A Warrants
for common stock in order to convert them into securities listed for trading on
an exchange. In addition, the Class A Warrants must be exercised
within 10 days beginning on the sixth trading day after the date on which the
securities underlying the Units separate, and will expire if not exercised
during that ten-day period. The Company intends to issue a press
release announcing the date on which separate trading of the common stock and
Class B Warrants underlying the Units will begin and the date by which the Class
A Warrants must be exercised. If you do not exercise your Class A
Warrants on or before the expiration date, you will lose all value of the Class
A Warrants.
Purchasers
of Units will be entitled to exercise the Class A Warrants and the Class B
Warrants only if they hold the Units through the dates on which the Class A
Warrants and the Class B Warrants become exercisable.
The
Company intends to apply for the listing of the Units on the NYSE Amex so that
the Units will be tradable upon the completion of this offering. The
securities underlying the Units will separate from the Units on the 90th day
after the date of this prospectus, unless Dawson James Securities, Inc.
determines that an earlier separation date is acceptable based on its assessment
of the relative strengths of the securities markets and small capitalization
companies in general, and the trading pattern of, and demand for, the Company’s
securities in particular. Each Class A Warrant will be exercisable
for a period of 10 days beginning on the sixth trading day after the separation
of the securities underlying the Units, and each Class B Warrant will be
exercisable for a period of five years after the separation of the securities
underlying the Units. Because the Class A Warrants and the Class B
Warrants will not be exercisable until the separation of the Units as described
above, purchasers of Units will be required to hold the Units through the
respective dates on which the Class A Warrants and the Class B Warrants become
exercisable in order to have the ability to exercise these
warrants.
Holders
of the Company’s common stock will incur substantial dilution as a result of the
exercise of the Class A Warrants and other issuances of securities by the
Company.
The
Company anticipates that upon the completion of this offering, it will issue
3,000,000 shares of common stock underlying the Units. An additional
6,000,000 shares of common stock are expected to be issued within 10 days after
the sixth trading day following separation of the Units as investors exercise
their Class A Warrants, which are exercisable on a cashless, net exercise basis
at a price of $0.05 per share. The issuance of additional securities
by the Company upon the exercise of these warrants, as well as stock options
that the Company has issued or may issue to employees, officers, directors and
consultants, would result in substantial dilution to the Company’s stockholders
and could adversely affect the trading price for the Company’s common
stock.
The
Company expects to receive only nominal proceeds from the exercise of the Class
A Warrants and may not receive any proceeds from the exercise of the Class B
Warrants to be issued in this offering.
Because
the exercise price of the Class A Warrants is $0.05 per share and because these
warrants are exercisable on a cashless, net exercise basis, the Company expects
to receive no, or nominal proceeds, from any exercises of these
warrants. The Class B Warrants have an exercise price equal to 55% of
the Unit price in this offering, and will be exercisable commencing on the
first anniversary of the date of this prospectus and remaining exercisable until
the fifth anniversary of the seperation of the Class B Warrants from the
Units. The Company’s stock price may trade below the Class B Warrant
exercise price, in which case the holders would not exercise the
warrants. Even if the Company’s stock price trades above the warrant
exercise price, the warrant holders may choose not to exercise these warrants
for a period of several years, or at all, or they may elect the exercise the
Class B Warrants pursuant to the cashless, or net exercise provisions in the
warrants, in which case the Company would not receive any cash proceeds from the
exercise. In addition, the Company has the right to redeem the Class
B Warrants at $0.25 per share of common stock underlying the Class B Warrants in
the event (i) the average of the closing price of the Company’s common stock
exceeds 200% of the exercise price for 10 consecutive trading days while the
warrants are exercisable and (ii) there is then an effective registration
statement with a current prospectus on file with the SEC. As a
result, the Company may not receive any proceeds from the exercise of the Class
B Warrants for several years, if at all.
The
ownership of the Company’s common stock is concentrated among a small number of
stockholders, and if its principal stockholders, directors and officers choose
to act together, they may be able to control the Company’s management and
operations, which may prevent the Company from taking actions that may be
favorable to you.
The
Company’s ownership is concentrated among a small number of stockholders,
including our founders, directors, officers and entities related to these
persons. Upon the completion of this offering, and after giving
effect to the expected full exercise of the Class A Warrants, the Company’s
directors, officers and entities affiliated with them will beneficially own
approximately 36.2% of the outstanding voting securities of the
Company. Accordingly, these stockholders, acting together, will have
the ability to exert substantial influence over all matters requiring approval
by the Company’s stockholders, including the election and removal of directors
and any proposed merger, consolidation or sale of all or substantially all of
its assets. In addition, they could dictate the management of our
business and affairs. This concentration of ownership could have the
effect of delaying, deferring or preventing a change in control of the Company
or impeding a merger or consolidation, takeover or other business combination
that could be favorable to you.
Anti-takeover
provisions in the Company’s charter documents and Delaware law could delay or
prevent a change in control which could limit the market price of the Company’s
common stock and could prevent or frustrate attempts by the Company’s
stockholders to replace or remove current management and the current board of
directors.
The
Company’s amended and restated certificate of incorporation and amended and
restated bylaws, which are to become effective upon the completion of this
offering, contain provisions that could delay or prevent a change in control of
the Company or changes in the board of directors of the Company that our
stockholders might consider favorable. For more information about these
anti-takeover provisions as well as anti-takeover provisions under the Delaware
General Corporation Law, please see “Description of Securities—Anti-Takeover
Devices.” These and other provisions in the Company’s corporate
documents and Delaware law might discourage, delay or prevent a change in
control or changes in the board of directors of the Company. These
provisions could also discourage proxy contests and make it more difficult for
an investor and other stockholders to elect directors and cause the Company to
take other corporate actions. Furthermore, the existence of these
provisions, together with Delaware law, might hinder or delay an attempted
takeover other than through negotiations with the board of
directors.
The
Company does not expect to pay dividends in the future, which means that
investors may not be able to realize the value of their shares except through
sale.
The
Company has never and does not anticipate that it will declare or pay a cash
dividend. The Company expects to retain earnings, if any, for its
business and does not anticipate paying dividends on common stock at any time in
the foreseeable future. Because it does not anticipate paying
dividends in the future, the only opportunity to realize the value of the common
stock will likely be through a sale of those shares.
FORWARD-LOOKING
STATEMENTS
This
prospectus contains, in addition to historical information, certain information,
assumptions and discussions that may constitute forward-looking statements. Such
statements are subject to certain risks and uncertainties which could cause
actual results to differ materially than those projected, or anticipated. Actual
results could differ materially from those projected in the forward-looking
statements. Although we believe our assumptions underlying the forward-looking
statements are reasonable, we cannot assure you that the forward-looking
statements set out in this prospectus will prove to be accurate. We
typically identify these forward-looking statements by the use of
forward-looking words such as “expect,” “potential,” “continue,” “may,” “will,”
“should,” “could,” “would,” “seek,” “intend,” “plan,” “estimate,” “anticipate”
or the negative version of those words or other comparable
words. Forward looking statements contained in this prospectus
include, but are not limited to, statements about:
|
·
|
our
expectations relating to the use of proceeds from this
offering;
|
|
·
|
the
progress, timing of, and amount of expenses associated with our
development and commercialization of our products and
services;
|
|
·
|
our
ability to engage third-party suppliers to manufacture the MASCT System
and its components at quantities and costs acceptable to
us;
|
|
·
|
our
ability to satisfy ongoing FDA requirements for the MASCT System and to
obtain regulatory approvals for our other products and services in
development;
|
|
·
|
the
benefits and clinical accuracy of our products and services, and whether
any product or service that we commercialize is safer or more effective
than competing products and
services;
|
|
·
|
our
ability to establish and maintain intellectual property rights covering
our products and services;
|
|
·
|
the
willingness of insurance companies and other third-party payors to approve
our products and services for coverage and
reimbursement;
|
|
·
|
our
ability to establish and maintain a sales force to market the MASCT System
and other products and services that we may
develop;
|
|
·
|
our
ability to sell our products and services at prices acceptable to
us;
|
|
·
|
our
expectations regarding federal, state and foreign regulatory
requirements;
|
|
·
|
the
accuracy of our estimates of the size and characteristics of the markets
that our products and services may
address;
|
|
·
|
our
expectations as to future financial performance, expense levels and
liquidity sources;
|
|
·
|
our
ability to attract and retain key personnel;
and
|
|
·
|
other
factors discussed elsewhere in this
prospectus.
|
This
prospectus also contains estimates and other statistical data made by
independent parties and by us relating to market size and growth and other
industry data. These and other forward-looking statements made in
this prospectus are presented as of the date on which the statements are made.
We have included important factors in the cautionary statements included in this
prospectus, particularly in the section entitled “Risk Factors,” that we believe
could cause actual results or events to differ materially from the
forward-looking statements that we make. Our forward-looking statements do not
reflect the potential impact of any new information, future events or
circumstances that may affect our business. Except as required by
law, we do not intend to update any forward-looking statements after the date on
which the statement is made, whether as a result of new information, future
events or circumstances or otherwise.
USE
OF PROCEEDS
We
estimate that the net proceeds of the sale of the Units that we are offering
will be approximately $16.0 million, or approximately $18.3 million if the
underwriters exercise their over-allotment option in full, assuming an initial
public offering price of $6.00 per Unit, which is the midpoint of the range
listed on the cover page of this prospectus, and after deducting estimated
underwriting discounts and commissions and estimated offering expenses that we
must pay.
A $1.00
increase (decrease) in the assumed initial public offering price of $6.00 per
Unit would increase (decrease) the net proceeds to us from this offering by
approximately $2.7 million, assuming the number of Units offered by us, as set
forth on the cover page of this prospectus, remains the same and after deducting
estimated underwriting discounts and commissions and estimated offering expenses
payable by us.
The
principal purposes of this offering are to obtain additional working capital to
fund anticipated operating expenses, establish a public market for
our common stock and facilitate future access to the public
markets. We estimate that we will use the net proceeds from this
offering primarily for the following purposes:
|
·
|
up
to approximately $750,000 of these net proceeds to establish a cytology
and molecular diagnostics laboratory focused exclusively on breast
cancer;
|
|
·
|
up
to approximately $1.5 million of these net proceeds to manufacture MASCT
System units needed to launch the MASCT System in Northwestern United
States as the initial market for the distribution of the
product;
|
|
·
|
up
to approximately $3.5 million of these net proceeds to hire and train
sales and marketing personnel for initial regional marketing and
subsequent national distribution;
and
|
|
·
|
up
to approximately $3.2 million of these net proceeds to develop and
commence manufacturing and commercialization of second-generation products
and services.
|
We
anticipate using the balance of the net proceeds to develop second generation
biomarker tests for tumor-related indications and complementary molecular
diagnostic assays and for general corporate purposes, such as general and
administrative expenses, capital expenditures, working capital, prosecution and
maintenance of our intellectual property, as well as the potential investment in
technologies or products that complement our business.
The
expected use of net proceeds from this offering represents our current
intentions based upon our present plans and business conditions; however, there
may be circumstances where a reallocation of funds is necessary. The
amount and timing of our actual expenditures depend on numerous factors,
including the costs of seeking regulatory approval in the United States and
abroad, the costs of establishing our planned laboratory, launching and
marketing the MASCT System and developing and testing additional applications of
the MASCT System.
A portion
of the net proceeds may be used to acquire or invest in complementary
businesses, technologies, services or products in the event that we identify
opportunities for such acquisitions, or investments that we believe are in the
best interests of our stockholders. We have no current plans,
agreements or commitments with respect to any such acquisition or investment,
and we are not currently engaged in any negotiations with respect to any such
transaction.
Management
will retain broad discretion in the allocation of the net proceeds of this
offering. An investor will not have the opportunity to evaluate the
economic, financial or other information on which we base our decisions on how
to use the proceeds.
DIVIDEND
POLICY
The
Company does not anticipate that it will declare dividends in the foreseeable
future but rather intends to retain any future earnings for the development of
the business. Payment of future cash dividends, if any, will be at
the discretion of the board of directors of the Company after taking into
account various factors, including the Company’s financial condition, operating
results, current and anticipated cash needs, outstanding indebtedness and plans
for expansion and restrictions imposed by lenders, if any.
CAPITALIZATION
The
following table sets forth the Company’s capitalization as of June 30, 2010
on:
|
·
|
an
as-adjusted basis to reflect the receipt of the net proceeds from the sale
of Units in this offering at an assumed initial public offering price of
$6.00 per Unit, which is the midpoint of the range set forth on
the cover page of this prospectus, after deducting the estimated
underwriting discounts and commissions and estimated offering expenses,
and assuming the full exercise of the Class A
Warrants.
|
A
potential investor should read this capitalization table together with the
financial statements and the related notes appearing elsewhere in this
prospectus, as well as “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” and other financial information included in
this prospectus.
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
Cash
and cash equivalents
|
|
$ |
40,098 |
|
|
$ |
16,540,098 |
|
Common
Stock, $0.001 par value, 50,000,000 shares authorized and 6,000,063 and
15,000,063 shares outstanding, actual and as-adjusted, respectively
(1)
|
|
|
6,000 |
|
|
|
15,000 |
|
Additional
paid-in capital
|
|
|
321,540 |
|
|
|
16,812,540 |
|
Deficit
accumulated during development stage
|
|
|
(384,778 |
) |
|
|
(384,778 |
) |
Total
stockholders’ (deficit) equity
|
|
|
(57,238 |
) |
|
|
21,833,012 |
|
(1)
|
The
authorized number of shares of the Company’s common stock does not reflect
an increase in the authorized shares of the Company’s common stock
effected in September 2010. The number of shares of the
Company’s common stock to be outstanding before the offering is based on
6,000,063 shares (or 13,580,000 shares prior to the reverse stock split
effected in September 2010) of common stock outstanding as of June
30, 2010, and excludes 1,000,000 shares of common stock reserved for
future issuance under our 2010 Stock Option and Incentive
Plan.
|
DILUTION
Our net
tangible book value as of June 30, 2010 was $(57,238), or $(0.01) per share
of common stock. Net tangible book value per share represents the
amount of our total tangible assets less our total liabilities, divided by the
number of shares of common stock outstanding as of June 30,
2010. After giving effect to the sale by us of 3,000,000 shares
of common stock underlying the Units being sold in this offering at an assumed
initial public offering price of $6.00 per share, which is the midpoint of the
range listed on the cover page of this prospectus, and issuance of 6,000,000
shares of common stock underlying the Class A Warrants at an assumed exercise
price of $0.05 per share, and after deducting the 10% estimated underwriting
discounts and commissions and estimated offering expenses payable by us, our pro
forma net tangible book value as of June 30, 2010 would have been
approximately $16.4 million, or approximately $1.10 per share. This
amount represents an immediate increase in net tangible book value of $1.11 per
share to our existing stockholders and an immediate dilution in net tangible
book value of approximately $4.90 per share to new
investors.
The
following table illustrates this hypothetical per-share
dilution:
Assumed
initial public offering price
|
|
|
|
|
$ |
6.00 |
|
Net
tangible book value per share as of June 30, 2010 (after giving effect to
reverse stock split effected in September 2010)
|
|
$ |
(0.01 |
) |
|
|
|
|
Increase
per share attributable to new investors
|
|
|
1.11 |
|
|
|
|
|
As-adjusted
net tangible book value per share after this offering
|
|
|
|
|
|
|
1.10 |
|
Dilution
per share to new investors
|
|
|
|
|
|
$ |
(4.90 |
) |
A $1.00
increase (decrease) in the assumed initial public offering price of $6.00 per
Unit would increase (decrease) our adjusted net tangible book value per share
after this offering by approximately $0.18 and would increase (decrease)
dilution per share to new investors by approximately $0.82, assuming that the
number of shares offered by us, as set forth on the cover page of this
prospectus, remains the same and after deducting estimated underwriting
discounts and commissions and estimated offering expenses payable by
us. In addition, to the extent any outstanding options or warrants
are exercised, you will experience further dilution.
The
following table summarizes, as of June 30, 2010, the number of shares
purchased from us, the total consideration paid or to be paid to us, and the
average price per share paid or to be paid to us by existing stockholders and
new investors purchasing a total of 9,000,000 shares of our common stock, which
represents 3,000,000 shares underlying the Units at an assumed offering price of
$6.00 per share, which is the midpoint of the price range listed on the cover
page of this prospectus, and 6,000,000 shares issuable upon exercise of the
Class A Warrants,at an exercise price of $0.05 per share, before deducting
estimated underwriting discounts and commissions and estimated offering expenses
payable by us.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per Share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Existing
stockholders (after giving effect to reverse stock split)
|
|
|
6,000,063 |
|
|
|
40 |
% |
|
$ |
327,540 |
|
|
|
2 |
% |
|
$ |
0.05 |
|
New
investors
|
|
|
9,000,000 |
|
|
|
60 |
% |
|
|
18,300,000 |
|
|
|
98 |
% |
|
|
2.03 |
|
Total
|
|
|
15,000,063 |
|
|
|
100 |
% |
|
$ |
18,627,540 |
|
|
|
100 |
% |
|
$ |
1.24 |
|
A $1.00
increase (decrease) in the assumed initial public offering price of $6.00 per
Unit would increase (decrease) the total consideration paid by new investors by
$3.0 million and increase (decrease) the percent of total consideration paid by
new investors by 0.25% assuming that the number of shares offered by us, as set
forth on the cover of this prospectus, remains the same and after deducting
estimated underwriting discounts and commissions and estimated offering expenses
payable by us.
Assuming
the underwriters’ over-allotment option is exercised in full, sales by us in
this offering will reduce the percentage of shares held by existing stockholders
to approximately 39% and will increase the number of shares held by our new
investors to approximately 9,450,000, or 61%.
The
number of shares of our common stock to be outstanding after this offering is
based on 6,000,063 shares (or 13,580,000 shares prior to the reverse stock split
effected in September 2010) of our common stock outstanding as of June 30, 2010
and excludes:
|
·
|
3,000,000
shares of common stock issuable upon exercise of the Class B Warrants,
having an exercise price equal to 55% of the Unit offering price;
and
|
|
·
|
1,000,000 shares
of common stock reserved for future issuance under our 2010 Stock Option
and Incentive Plan, which will become effective upon the completion of
this offering.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND
RESULTS OF OPERATIONS
The
following discussion of the financial condition and results of operations should
be read in conjunction with the “Summary Financial Information” and the
financial statements and the related notes included elsewhere in this
prospectus. This discussion contains forward-looking statements, which are based
on assumptions about the future of the Company's business. The actual results
will likely differ materially from those contained in the forward-looking
statements. Please read “Forward-Looking Statements” included elsewhere in this
prospectus for additional information regarding forward-looking statements used
in this prospectus.
Overview
We are a
development-stage healthcare company focused on the commercialization of
cellular and molecular diagnostic risk assessment products and related services
for the detection of pre-cancerous conditions that could lead to breast cancer,
and on the development of second-generation products and services. Although
current mammography procedures can detect cancer already present in the breast,
our products have the ability to identify pre-cancerous changes in the breast up
to eight years in advance of mammography detection. This information allows for
the implementation of preventive measures such as lifestyle changes and
pharmaceutical interventions that may prevent breast cancer from developing or
treat breast cancer earlier, if it develops. Our primary focus is the
commercialization of our patented and FDA-cleared product and related testing
and analysis services for breast cancer, the MASCT System.
Current
Operations
We were
incorporated in Delaware in April 2009 and have experienced operating losses
since inception. Our operations to date have consisted primarily of securing
laboratory and office space, hiring laboratory personnel, ordering equipment and
supplies, engaging a third-party vendor for the manufacture of the MASCT System
in limited quantities for field testing, securing patent rights, filing new
patent applications, acquiring FDA market clearances and securing development
bids to complete preparation for manufacturing the MASCT System in commercial
quantities. We have no other operations and have not received any revenues, nor
will we be in a position to expect revenues until we are able to produce and
sell the MASCT System. We expect to select a large volume contract medical
device manufacturer to begin manufacturing the MASCT System for
commercialization in the fourth quarter of 2010 at an estimated cost of
approximately $1.5 million.
We occupy
approximately 330 square feet of office space for our corporate headquarters
rent free. In September 2010, we entered into a month-to-month lease for
approximately 1,300 square feet of laboratory space at a monthly rent of $3,657.
We intend to use this space for the initial development of a laboratory for the
testing and analysis of NAF samples collected using the MASCT System and believe
that this facility will be sufficient for our planned operations over the
next 12 months. We expect that we will need to establish additional office
and laboratory space in the Greater Seattle in the second half of
2011.
We
believe that commercialization of the MASCT System will provide us with two main
revenue sources: (i) sales-based revenue from the sale of the product component
of the MASCT System to physicians, breast health clinics, and mammography
clinics and (ii) service, or use-based, revenue from the preparation and
interpretation of the NAF samples sent to our laboratory for
analysis.
We plan
to develop a specialty trained sales force to market the MASCT System on a
localized territorial basis, thereby developing personal relationships with the
healthcare professionals to whom our sales personnel can provide service and
support. We intend to develop a specialized laboratory for the processing and
analysis of the MASCT System tests submitted by client healthcare professionals.
We anticipate that we will need to develop a staff of anatomic pathologists to
read the test results. In addition to Dr. Quay, we intend to hire other
board-certified pathologists to assist in the interpretation of the NAF
samples.
In order
to execute on our long-range plans, we will use a portion of the proceeds raised
in this offering to produce and market the MASCT System. We are developing a
laboratory that will initially have only a minimal staff until such time, if
ever, that the sales of the MASCT System and demand for laboratory
interpretations can justify additional laboratory staff and sales personnel. If
funds from this offering are not sufficient to produce the MASCT System or to
develop the laboratory, we anticipate that we will have to cease operations if
we cannot obtain funds from other sources.
Critical Accounting Policies and
Estimates
Our
management’s discussion and analysis of our financial condition and results of
operations is based on our financial statements, which have been prepared in
accordance with accounting principles generally accepted in the United States,
or GAAP. The preparation of these financial statements requires us to make
estimates and judgments that affect the reported amounts of assets, liabilities
and expenses. On an ongoing basis, we evaluate these estimates and judgments,
including those described below. We base our estimates on our historical
experience and on various other assumptions that we believe to be reasonable
under the circumstances. These estimates and assumptions form the basis for
making judgments about the carrying values of assets and liabilities that are
not readily apparent from other sources. Actual results and experiences may
differ materially from these estimates.
While our
significant accounting policies are more fully described in Note 3 to our
financial statements included at the end of this prospectus, we believe that the
following accounting policies are the most critical to aid you in fully
understanding and evaluating our reported financial results and affect the more
significant judgments and estimates that we use in the preparation of our
financial statements.
Although
we have yet to generate any revenues, we expect that we will recognize product
and service revenue when the following fundamental criteria are met: (i)
persuasive evidence of an arrangement exists, (ii) delivery has occurred or the
service has been performed, (iii) our price to the customer is fixed or
determinable and (iv) collection of the resulting accounts receivable is
reasonably assured. We will recognize revenue for product sales upon transfer of
title to the customer. We will recognize revenue for services upon performance
of the service. Customer purchase orders and/or contracts will generally be used
to determine the existence of an arrangement. Shipping documents and the
completion of any customer acceptance requirements, when applicable, will be
used to verify product delivery or that services have been rendered. We will
assess whether a price is fixed or determinable based upon the payment terms
associated with the transaction and whether the sales price is subject to refund
or adjustment. We will record reductions to revenue for estimated product
returns and pricing adjustments in the same period that the related revenue is
recorded. These estimates will based on industry-based historical data,
historical sales returns, if any, analysis of credit memo data, and other
factors known at the time.
Cash
and Cash Equivalents
Cash and
cash equivalents include cash and all highly liquid instruments with original
maturities of three months or less.
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management
to make estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues and expenses
during the reporting period. Accordingly, actual results could differ from those
estimates.
Research
and Development Expenses
Research
and development costs are generally expensed as incurred. Our research and
development expenses consist of costs incurred for internal and external
research and development.
Share
Based Payments
In
December, 2004, the Financial Accounting Standards Board, or the FASB, issued
the Statement of Financial Accounting Standards, or SFAS, No. 123(R),
“Share-Based Payment”, which replaces SFAS No. 123 and supersedes APB Opinion
No. 25. SFAS No. 123(R) is now included in the FASB’s ASC Topic 718,
“Compensation — Stock Compensation.” Under SFAS No. 123(R), companies are
required to measure the compensation costs of share-based compensation
arrangements based on the grant-date fair value and recognize the costs in the
financial statements over the period during which employees or independent
contractors are required to provide services. Share-based compensation
arrangements include stock options and warrants, restricted share plans,
performance-based awards, share appreciation rights and employee share purchase
plans. In March 2005, the SEC issued Staff Accounting Bulletin No. 107, or SAB
107, which expresses views of the staff regarding the interaction between SFAS
No. 123(R) and certain SEC rules and regulations and provides the staff’s views
regarding the valuation of share-based payment arrangements for public
companies. SFAS No. 123(R) permits public companies to adopt its requirements
using one of two methods. On April 14, 2005, the SEC adopted a new rule amending
the compliance dates for SFAS No. 123(R). Companies may elect to apply this
statement either prospectively, or on a modified version of retrospective
application under which financial statements for prior periods are adjusted on a
basis consistent with the pro forma disclosures required for those periods under
SFAS No. 123.
We have
fully adopted the provisions of FASB ASC 718 and related interpretations as
provided by SAB 107. As such, compensation cost is measured on the date of grant
as the fair value of the share-based payments. Such compensation amounts, if
any, are amortized over the respective vesting periods of the option
grant.
Results
of Operations
Discussion
of Fiscal Year Ended December 31, 2009
For the
year ended December 31, 2009, we had no revenues and total expenses of $122,857,
consisting of $21,250 in expenses for research and development, or R&D, and
$101,607 in expenses for general and administrative, or G&A, costs. These
expenses included $16,250 in R&D expenses paid to Ensisheim pursuant to an
exclusive license agreement for the patents and patent applications covering the
MASCT System, and $1,348 in G&A expenses paid to a related party for rent
for our office space. Our license agreement with Ensisheim was terminated in
June 2010.
We have
yet to generate any revenues since our inception on April 30, 2009. The R&D
expenses from April 30, 2009 (inception) through December 31, 2009 totaled
approximately $21,250 and related to design and development work for the MASCT
System.
The
G&A expenses from April 30, 2009 (inception) through December 31, 2009
included $88,522 for legal and professional fees related to company
incorporation, initial set-up, patent prosecution and maintenance fees and
financial accounting and auditing fees.
Comparison of the Six Months Ended
June 30, 2010 and the Period from April 30, 2009 (inception) through June 30,
2009
For the
six months ended June 30, 2010, we had no revenues and total expenses of
$274,747, consisting entirely of G&A costs. This compares to no R&D
expenses and G&A expenses of $524 over the period from April 30, 2009
(inception) through June 30, 2009.
As
discussed below, we expect that our R&D and G&A expenses will continue
to increase in the foreseeable future, and that if we successfully complete this
offering and launch the MASCT System and our related laboratory service
offerings, we would also begin to incur sales and marketing expenses as we build
a regional and ultimately national sales force. We may limit our fixed sales and
marketing costs initially by employing temporary workers or those who are
compensated on a commission basis. However, we expect our expenditures to
increase significantly in future periods.
Research and Development
Expenses. We had no R&D expenses for the six months ended June 30,
2010 or for the period from April 30, 2009 through June 30, 2009. We expect that
R&D expenses will increase as we finalize the product design for the
first-generation MASCT System and develop a second-generation system and related
technologies.
General and Administrative
Expenses.
G&A expenses for the six months ended June 30, 2010 were $274,747,
related principally to legal and professional services in connection with our
preparation for this offering. G&A expenses for the period from April 30,
2009 through June 30, 2009 were $524, related principally to travel expenses.
The increase in expenses was attributed to the longer period in 2010 and an
increase in business activity as we prepared for this offering and engaged in
pre-commercial activity for the MASCT System. We expect that our G&A
expenses will continue to increase if we successfully complete this offering as
we add full-time accounting and finance personnel and incur additional costs as
a publicly traded company. Additionally, G&A costs will rise as we increase
headcount to help with the manufacturing and launch of the MASCT
System.
Liquidity and Capital
Resources
To date,
we have funded our operations primarily through private placements of common
stock and loans from officers. As of June 30, 2010, we had received net proceeds
of approximately $256,540
from the sale of equity securities and, as of that date, we had
approximately $32,098 of cash and cash equivalents. We issued a promissory note
for $100,000 in principal to our Chairman and Chief Executive Officer on June
30, 2010, under which the principal amount of the loan was funded to us on July
12, 2010. The report of our independent auditors contained in our financial
statements explains that we have not yet established an ongoing source of
revenues sufficient to cover operating costs and allow us to continue as a going
concern. Our ability to continue as a going concern is dependent on our
obtaining adequate capital to fund operating losses until we become profitable.
If we are unable to obtain adequate capital, we could be forced to cease
operations.
For the
six months ended June 30, 2010, we incurred a net loss of $261,920. Net cash
used in operating activities was approximately $154,266. Net cash provided by
financing activities was approximately $102,000 and consisted of private
placements of our common stock, through which we received net proceeds of
$102,000. For the year ended December 31, 2009, we incurred a net loss of
$122,857, and net cash used in operating activities was approximately $75,176.
During the year ended December 31, 2009, net cash provided by financing
activities was approximately $159,540, of which $154,540 was raised through
private placements of our common stock.
We expect
to incur substantial expenses and generate ongoing operating losses for the
foreseeable future as we prepare for the manufacturing and launch of the MASCT
System and build and operate our planned diagnostics laboratory. To fund our
operations for at least the next 12 months under our current business plan, we
estimate that we would need between $10 million and $12 million of additional
capital. If we are unable to raise this amount of capital, we could be forced to
curtail or cease operations. Our future capital uses and requirements depend on
numerous forward-looking factors. These factors include the following, among
others:
|
·
|
the
amount of capital raised in this offering and whether investors exercise
the Class B Warrants for cash, thereby providing additional
capital;
|
|
·
|
the
time and expense needed to complete the design and manufacturing of the
MASCT System and the design and build-out of our planned
laboratory;
|
|
·
|
the
expense associated with engaging one or more third-party contractors
to manufacture the MASCT System in commercial
quantities;
|
|
·
|
the
expense associated with building a sales force to market the MASCT System;
and
|
|
·
|
the
degree of patient and physician acceptance of the MASCT System and the
degree to which third-party payors approve the MASCT System and laboratory
analysis for
reimbursement.
|
To date,
we have not generated any revenues. We do not expect to generate revenue unless
or until we are able to manufacture and launch the MASCT System and build and
operate our planned laboratory. We expect our continuing operating losses to
result in increases in cash used in operations over at least the next year. We
expect the proceeds of this offering, together with our existing resources as of
the date of this prospectus, to be sufficient to fund our planned operations for
at least the next 12 months. However, we may require additional funds earlier
than we currently expect to successfully manufacture and commercialize the MASCT
System or build and operate our laboratory. Because of the numerous risks and
uncertainties associated with the development and commercialization of our
products and services, we are unable to estimate the amounts of increased
capital outlays and operating expenditures associated with our current and
anticipated research and development activities.
Additional
funding may not be available to us on acceptable terms or at all. In addition,
the terms of any financing may adversely affect the holdings or the rights of
our stockholders. For example, if we raise additional funds by issuing equity
securities or by selling debt securities, if convertible, further dilution to
our existing stockholders may result. To the extent our capital resources are
insufficient to meet our future capital requirements, we will need to finance
our future cash needs through public or private equity offerings, collaboration
agreements, debt financings or licensing arrangements.
If
adequate funds are not available, we may be required to terminate, significantly
modify or delay our development programs, reduce our planned commercialization
efforts, or obtain funds through collaborators that may require us to relinquish
rights to our technologies or product candidates that we might otherwise seek to
develop or commercialize independently. We may elect to raise additional funds
even before we need them if the conditions for raising capital are
favorable.
Off-Balance Sheet
Arrangements
We do not
currently have, nor have we ever had, any relationships with unconsolidated
entities or financial partnerships, such as entities often referred to as
structured finance or special purpose entities, established for the purpose of
facilitating off-balance sheet arrangements or other contractually narrow or
limited purposes. In addition, we do not engage in trading activities involving
non-exchange traded contracts.
Recent Accounting
Pronouncements
The
Company has adopted all recently issued accounting pronouncements that
management believes to be applicable to the Company. The adoption of these
accounting pronouncements, including those not yet effective, is not anticipated
to have a material effect on the financial position or results of operations of
the Company.
BUSINESS
Overview
The
Company is a development-stage healthcare company focused on the
commercialization of cellular and molecular diagnostic risk assessment products
and related services for the detection of pre-cancerous conditions that could
lead to breast cancer, and on the development of second-generation products and
services. The Company’s primary focus is the commercialization of the MASCT
System, a patented, FDA-cleared cellular and molecular diagnostic risk
assessment product and related testing and analysis services for the detection
of breast cancer. The Company owns all proprietary rights for the development,
manufacture, use and commercialization of the MASCT System, as well as all
related product rights, including the FDA marketing authorization.
The MASCT
System is a device and method for the collection, shipment and clinical analysis
of NAF. The clinical analysis of NAF, which contains cells and molecular
diagnostic biomarkers, is useful in detecting breast cancer and cellular changes
that may be precursors to breast cancer. The product component of the MASCT
System consists of a reusable hand-held pump for the collection of NAF, a
patient kit that includes two NAF sample vials, and a shipment kit for the
transportation of NAF samples to a specialized cytology and molecular
diagnostics laboratory that the Company intends to establish. Through this
laboratory, if successfully established, the Company intends to provide the
MASCT System services, which would consist of receiving and accessioning the two
NAF samples from each patient, preparing routine and IHC slides from the NAF
samples, and generating a report of the findings. The Company plans to establish
its laboratory in the fourth quarter of 2010 and commence its commercial launch
of the MASCT System in the first quarter of 2011.
Although
current mammography procedures can detect cancer already present in the breast,
the MASCT System has the ability to identify pre-cancerous changes in the breast
up to eight years in advance of mammography detection. This information allows
for the implementation of preventive measures such as lifestyle changes and
pharmaceutical interventions that may prevent breast cancer from developing or
treat breast cancer earlier, if it develops. The Company anticipates that the
MASCT System will initially be used in conjunction with standard mammography
exams and has the potential to become a critical assessment tool for identifying
women at risk for breast cancer. The MASCT System test is simple, quick
(approximately five minutes), convenient, painless and safe (no radiation). The
Company expects to price its NAF sample collection device at approximately $200
per device, its patient kits at approximately $50 per kit, and the cytology and
molecular diagnostics testing and analysis at between $106 and $1,202 per
patient, depending on the complexity of the analysis performed and without
taking into account any patient reimbursement from third-party
payors.
Effective
testing and analysis of the NAF samples collected using the MASCT System
requires both highly skilled pathologists and other medical personnel with
specialized expertise and laboratory facilities with the necessary testing
procedures and equipment. The Company intends to establish a so-called “complex
laboratory” certified under U.S. federal CLIA regulations, specializing in the
processing and analysis of NAF samples. Because NAF samples are among the
smallest medical samples handled by clinical laboratories, specialized
procedures, protocols and equipment will be required to maximize the diagnostic
value of each sample. The Company anticipates that it will use both conventional
cytology and advanced molecular diagnostic technologies in its laboratory and
engage a staff of professional medical personnel to deliver accurate and
comprehensive diagnostic reports. The Company intends to focus on
sample-handling efficiency and swift report turnaround times, providing
physicians with enhanced opportunities to maximize the quality of patient
care.
The MASCT
System requires no use of radiation. A study that analyzed the results of six
peer-reviewed medical research publications reported in December 2009 that low
dose radiation from mammograms can increase cancer incidence by 1.5 to 2.5 fold
in high-risk women, increasing the complexity of managing high-risk patients.
Unlike a biopsy, the MASCT System is a non-invasive and painless procedure. The
Company believes these aspects of the MASCT System may help to generate
acceptance of its use for NAF collection and testing.
The
Company estimates that there are over 8,600 mammography clinics, as well as
dedicated breast health clinics, and obstetrics/gynecology medical practices in
the United States that can utilize the MASCT System. The Company intends to
build an internal sales force to market the MASCT System to physicians and
clinics specializing in women’s health. The Company plans to hire a direct
sales force of approximately eight people initially to commercialize the MASCT
System in the Northwestern United States, where there are approximately 290
mammography clinics registered with the FDA. Following this regional
launch, the Company anticipates expanding nationally during the first half of
2012 and intends to grow its sales force to approximately 100 people in the
United States.
MASCT
System Development and Ownership History
Atossa
Healthcare, Inc. was incorporated in 1998 by Dr. Quay to conduct research on
breast cancer diagnostic tests, from which the MASCT System was
invented. Nastech Pharmaceutical Company, Inc., or Nastech, a company
developing nasal drug delivery products, acquired Atossa Healthcare, Inc. in
August 2000, and Dr. Quay became chairman, chief executive officer and president
of Nastech. In 2003, Nastech conducted clinical trials of the MASCT
System for the collection of NAF for cytological testing, and the product
received FDA clearance in May 2003.
After
receiving FDA clearance, Nastech, which changed its name to MDRNA, Inc., and
recently to Marina Biotech, Inc., did not engage in any further development of
the MASCT System. In January 2009, Ensisheim acquired from Nastech
five issued U.S. patents covering the MASCT System, as well as all related
product rights, including the FDA marketing authorization, for cash and the
assumption of debt related to unpaid patent expenses, in an amount of
approximately $50,000.
The
Company was incorporated in April 2009 as a Delaware corporation and
subsequently acquired from Ensisheim all ownership and commercialization rights
relating to the MASCT System, including the five issued U.S. patents, together
with foreign counterparts, covering the manufacture, use and sale of the MASCT
System, pending patent applications for improvements, and the FDA marketing
authorization for the MASCT System. The Company has no royalty or
other ongoing obligations to Ensisheim relating to the acquired
assets.
Design
of the MASCT System
The MASCT
System is a specially engineered, hand-held, manual breast pump with unique
features that include the ability to wick fluids out of the breast in a very
short period of time (approximately five minutes), as well as a proprietary
collection system that sanitarily captures NAF produced from the breast
ducts. The MASCT System is constructed from injection molded plastic
components with standard material gaskets and parts. The membrane
filter material that makes contact with the nipple is available from multiple
domestic suppliers. In July 2010, the Company entered into an
agreement with a leading medical device design company to produce 20 MASCT
System pumps and 10,000 patient kits for field testing by the Company during the
fourth quarter of 2010.
Breast
Anatomy and Nipple Aspirate Fluid Collection
The
female breast has two main components: glandular tissue (lobes and ducts) and
connective/fatty tissue. The breast is divided into 15 to 20 lobes
that radiate outward from the nipple and contain clusters of milk-producing
glands. The lobes are further divided into smaller compartments
called lobules. Each cluster drains into a duct, which connects the
lobules and the nipple. In the ducts, cells closest to the outer
portions of the lobules are called luminal cells and those deeper in the duct
wall are called basal cells. The molecular biology-based sub-typing
of pre-cancerous changes and cancers includes a molecular determination of
whether the cells are luminal or basal in origin. The breast is held
together by fatty connective tissue, which provides support and contains nerves
as well as blood and lymphatic vessels.
Since the
early studies conducted in the 1950s by Dr. George Papanicolaou, the inventor of
the “Pap smear” for cervical cancer, it has been understood that adult
non-pregnant, non-lactating women continuously secrete fluid into the milk ducts
of the breast. This fluid does not normally escape because the nipple
orifices are occluded by smooth muscle contraction, dried secretions, and
keratinized epithelium. This fluid contains several cell types,
including exfoliated breast epithelial cells, which may be normal, hyperplastic,
atypical, or even malignant. The fluid also contains molecular
diagnostic biomarkers, including associated proteins, complex lipids, RNA and
DNA.
A number
of medical devices have been designed over the years that apply negative
pressure to the nipple to induce the expression of NAF, which is then collected
by carefully touching a capillary tube to any apparent drops of
NAF. The Company believes that in general, these devices are
successful in obtaining NAF from 20% to 65% of all patients, and that this
sample collection variability has prevented the routine adoption of NAF cytology
for breast cancer screening.
The MASCT
System was designed to overcome this shortcoming by placing a hydrophilic, or
water seeking, membrane in contact with the nipple during the cycles of negative
pressure to “wick” fluid from the orifice of the ducts by capillary action,
thereby increasing the frequency of obtaining NAF in women.
Breast
Cancer and Atypical Ductal Hyperplasia
Adenocarcinoma
is a general term that refers to a cancer that starts in glandular tissues
anywhere in the body. Over 85% of breast cancers start in glandular
tissue and therefore are classified as adenocarcinomas. Those that
originate in lobules are known as lobular carcinoma and those that begin in
ducts are ductal carcinomas. The term “noninvasive breast cancer”
refers to adenocarcinomas that are confined to lobules or
ducts. Another term used to describe these cancers is in situ. Invasive
breast cancer refers to a carcinoma that has spread from lobules or ducts to
fatty connective tissue or beyond the breast, or is metastatic.
ADH is a
condition in which the cells lining the breast duct grow excessively and
abnormally. Without other risk factors, it produces a five-fold
increased risk of breast cancer. With a family history of breast
cancer, a diagnosis of ADH increases the risk of breast cancer 11 to 22-fold,
and in one study, one-third of the women with a biopsy of ADH had an occult
cancer growing nearby. Another study examined changes in chromosome
markers in ADH that are typical for invasive ductal cancer to determine if ADH
was monoclonal for these changes, as expected of cancer, or polyclonal, as
expected of hyperplasia, or excessive cell proliferation. The results
of this study showed that 50% of ADH was monoclonal and had the hallmarks of a
cancerous growth.
The
analysis of NAF for these chromosomal changes and the changes in expression of
related proteins may help determine the malignant or non-malignant properties of
ADH in a particular patient and thus provide information allowing a personalized
medicine therapeutic approach.
Clinical
Development of the MASCT System
Under the
direction of Dr. Quay, a clinical trial of the MASCT System was conducted at the
State University of New York, Stony Brook, New York in 2003 to test the
efficiency of NAF collection in normal women. Thirty-one healthy,
non-pregnant, pre-menopausal female volunteer subjects were tested with the
MASCT System device for the ability to collect NAF samples for cytological
examination, using the NAF cytology classification system of the College of
American Pathologists, or CAP, as described in the table below.
Category
|
|
Interpretation
|
|
Cytology Characteristics
|
Category
0
|
|
Scant
ductal epithelial cells and negative for atypical or malignant
cells
|
|
No
or <10 ductal cells. Foam cells, or acellular preparations in a
background of proteinaceous debris.
|
Category
I
|
|
Normal
ductal cytology
|
|
Normal
ductal epithelial cells, with or without foam cells. Some ductal cells
will display apocrine metaplasia
|
Category
II
|
|
Usual
ductal hyperplasia
|
|
Cell
distribution predominately in cohesive groups with >10-50 cells.
Minimal nuclear changes. Fine chromatin.
|
Category
III
|
|
Atypical
ductal hyperplasia
|
|
Distinct
nuclear enlargement, increasing N/C ratio, irregular nuclear borders and
nuclear variation. Coarse chromatin. Prominent
chromocenters.
|
Category
IV
|
|
Suspicious
for malignancy
|
|
Single
cells and groups of cells with nuclear features suspicious for
cancer.
|
Of the 31
subjects, 30, or 97%, had measurable NAF; 24 bilaterally and six
unilaterally. NAF samples ranged from one to 37 microliters, with an
average of seven microliters, and all samples collected were deemed to be
clinically useful. 58 of 60 NAF samples were reported as cytology
Category I, and two of 60 were reported as cytology Category II under the CAP’s
classification system for NAF cytology. No adverse events were
reported in the study. Based on the results of the study, a premarket
notification for the intended use of the MASCT System for the collection of NAF
for cytological testing was submitted to the FDA, indicating that the NAF
collected using the MASCT System can be used in the determination and/or
differentiation of normal versus premalignant versus malignant
cells.
The
Role of Immunohistochemistry (IHC) in the Molecular Classification of Breast
Cancer and Pre-Cancerous Lesions
Standard
pathology and cytology criteria to classify breast cancer and pre-cancerous
changes have limitations in predicting tumor behavior, sensitivity to molecular
targeted treatments, such as Herceptin (trastuzumab), or the development of drug
resistance. A method of predicting tumor behavior and treatment
response that involves identifying molecular biomarkers in breast tissue is
immunohistochemistry, or IHC. IHC is the process of localizing
antigens (e.g. proteins) in cells of a tissue section exploiting the principle
of antibodies binding specifically
to antigens in cells. Specific molecular markers are
characteristic of particular cellular events such as proliferation or cell
death. Visualizing an antibody-antigen interaction can be
accomplished in a number of ways. In the most common instance, an
antibody is conjugated to an enzyme, such as peroxidase, that can catalyze a
color-producing reaction. The use of IHC has become standard of care in many
clinical settings, for example, the measurement of estrogen or progesterone
receptors or HER2 antigens in breast cancer.
In May
2010, an international study from 21 academic institutions involving 42
investigators was published, describing the IHC-based molecular sub-typing of
breast cancers from 10,159 women and the correlation with survival over 15
years. Five IHC biomarkers were used to identify six molecular
sub-types. The five IHC markers were: the estrogen receptor and the
progesterone receptors (two hormone receptors expressed by luminal cells), the
human epidermal growth factors receptor-2 (HER2, a protein marker used to select
specific adjuvant therapies), and cytokeratin 5/6 (CK5/6) and EGFR (proteins
expressed by basal cells). The sub-types had IHC staining patterns,
incidences, and treatment options, as shown in the following table:
Molecular Subtype
|
|
ER/PR
|
|
HER2
|
|
EGFR or CK 5/6
|
|
Incidence
|
|
Treatment Options
|
Luminal
1, Basal Negative
|
|
Either
Positive
|
|
Negative
|
|
Negative
|
|
65%
|
|
Tamoxifen,
Raloxifene
|
Luminal
1, Basal Positive
|
|
Either
Positive
|
|
Negative
|
|
Positive
|
|
6%
|
|
Tamoxifen,
Raloxifene, EGFR inhibitors
|
Luminal
2, Basal Negative
|
|
Either
Positive
|
|
Positive
|
|
Negative
|
|
6%
|
|
Tamoxifen,
Raloxifene, Trastuzumab
|
Non-Luminal
HER2+
|
|
Both
Negative
|
|
Positive
|
|
Positive/Negative
|
|
6%
|
|
Trastuzumab
|
Core
Basal Subgroup
|
|
Both
Negative
|
|
Negative
|
|
Positive
|
|
9%
|
|
EGFR
inhibitors
|
Five
Negative Phenotype
|
|
Both
Negative
|
|
Negative
|
|
Negative
|
|
7%
|
|
Non-receptor
targeted chemotherapy
|
The six
IHC molecular subtypes had very different five and 15 year survival
rates.
These and
other findings indicate that the six subtypes of breast cancer defined by the
expression of five immunohistochemical markers have distinct biological
characteristics that are associated with important differences in short-term and
long-term outcomes. The application of these markers in the clinical
setting could improve the targeting of adjuvant therapies to those women most
likely to benefit.
These
same markers have been studied in pre-cancerous changes and have been found
useful in distinguishing future biological behavior of otherwise cytologically
indistinct samples. For example, CK5/6 expression in usual ductal
hyperplasia is associated with an increased risk of later development of
cancer. Similarly, estrogen or progesterone receptor, HER2, and EGFR
expression in a setting of hyperplasia are found in lesions that more frequently
progress to breast cancer. In fact, ADH and usual ductal hyperplasia
can be distinguished by IHC staining in cases where the cytology is
indistinguishable. Thus, IHC testing on NAF samples with
pre-cancerous changes can provide information about the possibility of future
progression to breast cancer.
The
Company’s issued patents cover the detection of estrogen and progesterone
receptors, CK 5/6, HER2, and EGFR in NAF. In addition to the MASCT
System, the Company intends to offer a panel of IHC markers for testing of all
cases in which ductal hyperplasia is seen. It is estimated that at
least 20% of all patient samples will be studied by IHC using this
panel. Following establishment of the Company’s cytology and
molecular diagnostics laboratory, the Company plans to validate these five IHC
tests for routine clinical use by standard methods and intends to begin offering
the tests as a panel in the first quarter of 2011.
The
Role of NAF Cytology in the Diagnosis and Treatment of Atypical Ductal
Hyperplasia
In a
study of women with normal mammograms who were undergoing breast reduction
surgery, which was conducted at the Virginia Mason Medical Center in Seattle,
Washington and published in Plastic and
Reconstructive Sugery in October 2009, the
incidence of ADH was found to be 4.4%. With approximately 94 million
women ages 30 and above in the United States, this suggests that more than four
million women in the United States may have ADH that remains undiagnosed by
mammography alone. ADH can be definitively diagnosed only by NAF
analysis or a breast tissue biopsy. In a study of approximately 2.5,
screening
mammograms done between 1996 and 2005 and collected from
mammography registries participating in the Breast Cancer Suveillance
Consortium Associations the
incidence of biopsy-proven ADH was 0.4%, suggesting that the use of biopsies in
conjunction with screening mammography fails to detect ADH in over 90% of
patients.
A
comprehensive study of the predictive value of NAF cytology for identifying
women at risk for breast cancer was conducted at the University of California at
San Francisco over a 19 year period. This study, conducted by
Margaret Wrensch and others at the University of California San Francisco,
showed in two studies, the first with a sample size of 4,040 women and the
second with a sample size of 3,627, that women with abnormal cytology in
breast fluid obtained by nipple aspiration had an increased relative
risk of breast cancer compared
with women from whom
fluid was not obtained and with women whose fluid had normal cytology. The
nipple aspirate fluids
were collected from women in the San Francisco Bay Area during the period from
1972 through 1991, classified the women according to the most
severe epithelial cytology
observed in fluid specimens, and
determined
breast cancer incidence
through March 1999. The groups were stratified
into women with acellular, normal, hyperplasia, or atypical NAF cytology and the
incidence of breast cancer determined in the two groups over an average of 21
and nine years follow-up, respectively. The incidence of hyperplasia
by NAF cytology was 13.6% and the incidence of ADH was 1.6%. Breast
cancer occurred in 3.7% of the women with acellular cytology and in 8.2% and
11.0% of the women with hyperplasia and atypia, respectively.
Drug
therapy clinical trials for preventing breast cancer in high risk women are
called chemoprevention trials. In a five year chemoprevention study
of over 19,700 women with ADH or other factors that placed them at a high risk
for invasive breast cancer, the use of either tamoxifen or raloxifene, drugs
that block or interfere with the actions of estrogen receptors, reduced the
incidence of breast cancer by approximately 50%. Side effects were
higher with tamoxifen compared to raloxifene. A separate study of
raloxifene vs. placebo showed a 72% reduction in cancer incidence at four years
and a 66% reduction at eight years.
In a
study of NAF specimens in 33 women at the start and six months after taking
either tamoxifen or raloxifene, NAF cytology was unchanged in 85%, worsened in
4%, and improved in 11% while the biomarker PSA, which has been shown to be
controlled by sex hormones and inversely associated with breast cancer,
increased from abnormally low (37 ng/L) to within the normal range (112 ng/L)
during treatment. United States patent 7,128,877, owned by the
Company, covers the testing of NAF for the biomarker PSA. Other
classes of drugs, including inhibitors of aromatase, an enzyme involved in
making estrogen, are being tested or considered for testing in breast cancer
chemoprevention trials. The Company believes that increased use of
pharmaceutical treatments with chemopreventive agents in high risk women will
lead to more NAF cytology studies to both diagnose ADH and follow the effects of
treatment.
Finally,
changes in diet and/or the use of dietary supplements are considered to have a
possible impact on breast cancer occurrence and can potentially change the
cytology or the presence of biomarkers in NAF. A study of the effect
of dietary intervention in 71 women over a one year period was
conducted. The probability of obtaining a cellular NAF cytology
increased with dietary fat intake, reaching over seven-fold increase for the
highest to lowest quartile of fat intake. Furthermore, cellular NAF
decreased with increasing plasma levels of dietary supplement antioxidants,
lutein and alpha-carotene. The National Cancer Institute, or NCI, is
currently sponsoring seven studies of the use of NAF sample collection and
analysis of cytology and molecular biomarkers as study endpoints to monitor the
efficacy of chemoprevention clinical trials using pharmaceuticals or dietary
supplements. The Company believes the successful outcome of one or
more of these studies could increase the use of NAF analysis.
The
Role of NAF Cytology and Molecular Diagnostic Biomarkers in Screening for Breast
Cancer
The
sensitivity of a test for detecting an abnormality is an important measure in
screening populations for the presence of occult disease. With
mammography as the well accepted standard for the detection of breast cancer, a
comparison of the sensitivity of NAF cytology and molecular diagnostic
biomarkers for detecting cancer against the sensitivity of mammography suggests
that the MASCT System could also serve as a screening tool for breast cancer, in
addition to ADH and other pre-cancerous conditions.
The
following table shows the relative sensitivity of mammography and NAF cytology
and biomarkers for detecting cancers, confirmed by needle biopsy.
Test
|
|
Sensitivity
|
|
Mammography:
40-64 years of age (1)
|
|
|
77-78%
|
|
NAF
biomarkers: DNA Methylation PCR (2)
|
|
|
82%
|
|
Mammography:
dense breasts (1)
|
|
|
68%
|
|
NAF
biomarker: SELDI-TOF Proteomics (3)
|
|
|
75-84%
|
|
Mammography:
under 40 years of age (1)
|
|
|
54%
|
|
NAF
cytology (4)
|
|
|
36%
|
|
(1)
|
Reflects sensitivity of
mammography for the detection of breast cancer in a review of 183,134
screening mammograms in Albuquerque, New
Mexico.
|
(2)
|
Reflects
sensitivity of DNA methylation-specific PCR for the detection of breast
cancer in NAF, in a study of specimens of tumor, normal tissue and NAF
collected from 22 breast cancer patients with ductal carcinomain
situ or stage I
cancer.
|
(3)
|
Reflects
sensitivity of proteomic analysis for the detection of breast cancer in
NAF, in a study of 20 subjects with breast
cancer.
|
(4)
|
Reflects
sensitivity of NAF cytology alone for the detection of residual breast
cancer, as reflected in the results of a study of 70 subjects with ductal
carcinomain
situ or stage I cancer published in the British Journal of Cancer
in 2001.
|
While NAF
cytology seems well suited to identifying ADH, the sensitivity of NAF cytology
alone for detecting cancer is not ideal. However, when its use
is combined with other scientific collection and biomarker methods, which
include DNA methylation and SELDI-TOF proteomics, sensitivity levels are
comparable to those found in mammography. This suggests that NAF
cytology, in combination with other biomarker tests, could serve as an
alternative testing and screening methodology which may be less painful and less
invasive to women than mammography and biopsy and require no exposure to
radiation. The Company intends to explore the development of such
biomarker tests beginning in 2011 (See “—Research and
Development”).
The
Market
United
States Laboratory Testing Market
Anatomic
Pathology. Anatomic pathology involves the diagnosis of cancer
and other medical conditions through the examination of tissues (biopsies) and
the analysis of cells (cytology) taken from patients. Generally, the
anatomic pathology process involves the preparation of slides by trained
histo-technologists or cytologists and the review of those slides by anatomic
pathologists. Although anatomic pathologists do not treat patients,
they establish a definitive diagnosis and may also consult with the referring
physician. As a result of the greater degree of complexity and
sophistication in anatomic pathology services, 2010 Medicare reimbursement rates
for the anatomic pathology services of the type that the Company expects to
perform are between $106 and $1,202 per patient. The patient fee
schedule for these tests can range from two to more than three times the
Medicare reimbursement rate.
Molecular
Diagnostics. Molecular diagnostics typically involve unique
and complex genetic and molecular tests performed by skilled personnel using
sophisticated instruments. As a result, molecular diagnostics are
typically offered by a limited number of commercial
laboratories. According to PriceWaterhouseCoopers, molecular
diagnostics represents one of the fastest growing segments of the $37 billion
market for in vitro
diagnostics, which includes test tube diagnostics such as glucose monitoring for
diabetes care but excludes diagnostics for research use. The Medicare
reimbursement rate in 2010 for microarray-based molecular diagnostics tests is
$1,250 while the reimbursement rate for fluorescent cellular probe-based tests
is $479 per probe. This market segment is expected to grow 14%
annually between 2007 and 2012, from $2.6 billion to $5.0 billion.
Clinical Pathology. The
clinical pathology market generally involves chemical testing and analysis of
body fluids using standardized laboratory tests. These tests
typically do not require the interpretive expertise of a pathologist and are
frequently routine, automated, and performed by large national or regional
clinical laboratory companies and hospital laboratories. The Company
currently does not intend to offer routine, automated, standardized laboratory
tests.
The
Company intends to develop and provide a range of molecular diagnostics to aid
in the management of breast health, premalignant conditions and
cancer.
United
States Market for MASCT System Procedures and Laboratory Tests
Testing
in Women at High Risk for Breast Cancer
The
Company expects that the MASCT System will initially be adopted by physicians
and other healthcare professionals for use in women at high risk for breast
cancer. The Company believes, based on the assumptions described
below, that up to approximately 52.6 million MASCT System studies could be
conducted annually in women at high risk for breast cancer in conjunction with
mammography under current American Cancer Society, or ACS, recommendations for
screening mammography.
Women Undergoing Diagnostic
Mammograms. Breast cancer screening by mammography involves
performing a screening mammogram and typically reviewing the mammogram while the
patient is still present in the clinic. If the screening mammogram
shows suspicious changes, a more extensive diagnostic mammogram is performed,
usually on the same day. In an audit of 46,857 consecutive mammograms
performed in the radiology department at the University of California, San
Francisco between 1997 and 2000, 10,007, or 21%, were diagnostic
mammograms. The audit also documented an increased incidence of
future cancer in those women who underwent a diagnostic mammogram, regardless of
the diagnosis at the time. Applying this frequency to the estimated
38.8 million total mammograms performed each year in the United States yields
approximately 8.1 million diagnostic mammograms. The Company believes
all women undergoing a diagnostic mammogram, who may be at higher risk of
developing breast cancer in the future, would be candidates for MASCT System
testing.
Breast Cancer
Survivors. Women who have had breast cancer are at a higher
risk for the recurrence of cancer or for a new malignancy. The ACS
has estimated that in 2010, there were more than 2.5 million breast cancer
survivors in the United States. The Company believes these women
would be candidates for regular MASCT System screening.
Post Menopausal Breast
Cancer. There is substantial evidence that post menopausal
breast cancer is linked to high levels of estrogen, which induces cancer related
biomarkers such as Cathepsin D. In December 2002, the National
Institute of Environmental Health Sciences added estrogen to its list of known
cancer-causing agents. The
Cathepsin D gene, coding for a ubiquitous Iysosomal aspartyl protease, is
overexpressed in aggressive human breast cancers, and its transcription is
induced by estrogens in hormone-responsive breast cancer cells. Since
the serum levels of estrogen drop significantly when the ovaries stop producing
it at menopause, the source of the hormone in breast cancer was not
understood. In 2006, investigators at Northwestern University
demonstrated that NAF contains estrogen and related sex hormones, that there is
no correlation between serum and the concentrations of these hormones in NAF,
preventing serum tests from identifying these high risk patients, and that the
likely source is synthesis within the breast itself. The authors
concluded that measuring female sex hormone biomarkers like Cathepsin D in NAF
may be useful in identifying post menopausal women at high risk for breast
cancer and in monitoring chemoprevention trials, since the mechanism of action
in these current therapies is interference with female sex hormone
activity. The Company has an issued U.S. patent covering the testing
of NAF for the biomarker Cathepsin D. There are approximately 52
million women age 50 and over, and therefore peri- or post-menopausal, in the
United States, and the Company believes NAF sex hormone screening could help
identify women who have high levels of these hormones in the breast and are thus
at high risk.
High Risk
Women. The Breast Cancer Risk Assessment Tool (based on the
Gail model) has been established by the NCI and the National Surgical Adjuvant
Breast and Bowel Project, or NSABP, to identify women with an increased risk of
breast cancer. The risk factors included in the test are: personal
history of breast abnormalities, age, age at first menarche, age at first live
birth, breast cancer among first-degree relatives (sisters, mother, or
daughters), breast biopsies, obesity and race. Approximately 10
million women in the United States are in the high risk group. A
study of 6,904 women for an average follow up of 14.6 years demonstrated that
NAF cytology may be most useful for women at highest absolute risk by the Risk
Assessment Tool because modest differences in relative risk are
amplified. In this group, the incidence of breast cancer by NAF
cytology ranged from 5.3 to 10.3 per 1,000 women (non-yielder to
hyperplasia/atypia).
Testing
in Normal Risk Women
The
Company believes that if it is able to develop, produce and successfully market
the MASCT System for use as an additional test in conjunction with all
mammography and all cervical cancer screenings (Pap smear), the potential annual
U.S. market size would be between 31.6 million and 55 million
women. This conclusion is based on the following assumptions and
scenarios:
MASCT System in conjunction with
cervical cancer screening (Pap smear), all ages. As indicated
by the National Cancer Institute in 2009, approximately 55 million Pap smear
examinations are performed annually, of which about 3.5 million, or 6%, are
abnormal.
MASCT System in conjunction with
mammography, all ages. According to the MQSA National
Statistics, 38.8 million mammograms have been performed in the United States in
2010.
MASCT System in conjunction with
mammography in women age 60-69. According to the U.S. Census
Bureau, as of July 1, 2009 there were approximately 14.5 million women age
60-69. The ACS’s current screening guidelines recommend annual
mammograms for women in this age group. According to the Centers for
Disease Control, 63.8% of women in this age group follow the guidelines. If the
MASCT System were used in conjunction with mammograms in this age group, there
would be approximately 9.3 million studies per year.
MASCT System in conjunction with
mammography in women age 50-59. According to the U.S. Census
Bureau, as of July 1, 2009 there were approximately 20.9 million women age
50-59. The ACS’s current screening guidelines recommend annual
mammograms for women in this age group. According to the Centers for
Disease Control, 71.8% of women in this age group follow the
guidelines. If the MASCT System were used in conjunction with
mammograms in this age group, there would be approximately 15 million studies
per year.
MASCT System in conjunction with
mammography in women age 40-49. According to the U.S. Census
Bureau, as of July 1, 2009 there were approximately 22 million women age
40-49. The ACS’s current screening guidelines recommend annual
mammograms for women in this age group. According to the Centers for
Disease Control, 63.5% of women in this age group follow the
guidelines. If the MASCT System were used in conjunction with
mammograms in this age group, there would be approximately 14 million studies
per year.
MASCT System in conjunction with
mammography in women age 30-39. On November 19, 2009, the U.S.
Preventive Services Task Force Recommendation, or USTFR, announced that, for normal
risk women, screening mammography should begin at age 50 and be biennial until
age 75. The ACS and other national groups strongly and publicly
objected to the lack of recommendations for women under the age of 50 and the
biennial interval for women over 50. If the USTRF guidelines were
adopted uniformly and the MASCT System were used in conjunction with
mammography, the Company believes that 21.5 million studies could be performed
annually and 10.1 million could be performed in 30-39 year old women in
conjunction with cervical Pap smears, or 31.6 million studies
total. It is also possible that adoption of the USTRF mammography
screening criteria could increase the utilization of the MASCT System as an
alternative to mammography, but the Company has not performed studies to try to
estimate this potential.
MASCT System in conjunction with
cervical screening in women age 30-39. According to the U.S.
Census Bureau, as of July 1, 2009 there were approximately 20 million women age
30-39. The ACS’s current screening guidelines recommend annual
mammograms for women in this age group. One survey indicated that
among women with no prior history of abnormal Pap smears, 55% had Pap smears
annually. If this percentage is representative of the frequency with
which women ages 30-39 have Pap smears, and the MASCT System were used in
conjunction with Pap smear testing in this age group, the Company believes that
there could be over 10 million studies per year in women ages
30-39.
International
Market for MASCT System Procedures and Laboratory Tests
An
article published in Breast Cancer: Basic and Clinical Research indicated that
in 2005, a total of 125.5 million mammograms were performed worldwide, with
approximately 50 million in North America, 50 million in Western Europe, 15
million in Japan, and 10 million in the rest of the world. In
addition, the Company believes that mammography is underutilized in some
international markets, including China and Greater Asia and that there is a
substantial market for its products and services outside the United States, but
has not further quantified the opportunity.
The
Company anticipates that if it is able to develop the MASCT System and
laboratory procedures in the United States, it will then proceed to develop and
market the MASCT System and the laboratory procedures to other
markets outside the United States.
Commercialization
Strategy
The
Company’s commercialization strategy is based on creating two main revenue
sources: (i) product sales-based revenue from the sale of the MASCT System
to physicians, breast health clinics, and mammography clinics and (ii) service-based revenue for
the preparation and interpretation of the NAF samples sent to the Company’s
laboratory. This is intended to result in revenues from both the sale
and the use of the MASCT System.
In order
to achieve its two-pronged revenue base, the Company will need to manufacture,
through medical device suppliers, the MASCT System components, i.e., the
collection device and patient NAF specimen kits and will need to establish a
direct sales force to call on physicians and breast health and mammography
clinics to market and sell the MASCT System. The collection device is
reusable when sanitized between patients. The kit contains the
patient contact materials, preservative fluid for the collected samples, and
bar-coded patient identification labeling. The kit components are
designed to work properly with the collection device and the Company is not
aware of any commercially available parts or components which could be
substituted for the Company’s kits.
The
Company intends to use funds raised from this offering to select and engage an
established medical device contract manufacturer to produce commercial
quantities of the MASCT System during the fourth quarter of 2010 and to commence
such commercial manufacture and production of the MASCT System during the first
quarter of 2011. The Company also plans to begin certification of its
laboratory facility for the analysis of NAF samples during the fourth quarter of
2010 and to begin developing an internal sales and marketing force by the first
quarter of 2011.
The
Company’s product- and service-based income plan is intended to provide revenues
from multiple, different sources with different timing in the procedure
cycle. The Company expects to generate product revenues from the sale
of kits in bulk to clinics and physicians for the testing of their patients, and
laboratory services revenues after its laboratory analyzes the results of these
tests and renders a diagnosis.
Manufacture
of MASCT System
In July
2010, the Company entered into an agreement with a contract manufacturer to
produce 20 MASCT System pumps and 10,000 patient kits for field testing by the
Company to confirm the proper operation of the MASCT System device and its
ability to collect adequate NAF samples during the fourth quarter of
2010. The Company has also received a proposal for completion of the
Computer Aided Design, or CAD, files that will permit high volume, low cost
manufacturing of the MASCT System. The Company plans to
select one or more established medical device contract manufacturers
and commence manufacturing of its MASCT System devices in commercial quantities
during the fourth quarter of 2010 following the completion of field
testing.
Specialty
Sales Team
To market
the MASCT System and its related laboratory diagnostic services, the Company
will need to hire sales representatives with technical knowledge in, for
example, molecular diagnostics, mammography, obstetrics/gynecology office
practices, and women’s health clinics. As a result, the Company will
expect its sales representatives to develop long-lasting, consultative
relationships with the referring physicians they serve. Similarly,
the Company anticipates that each of its client service associates will provide
dedicated support services to its physician clients. The Company
intends to hire representatives who will provide physician clients and their
office staff with a knowledgeable and consistent point of contact, thereby
strengthening the Company’s client relationships.
Once a
member of the Company’s sales team has developed a relationship with a referring
physician, retaining that salesperson will be significant to the Company’s
ability to capitalize on the client relationship. The Company intends
to offer its sales force the opportunity to earn higher compensation, primarily
through commissions on revenues earned over the duration of a physician client’s
account. The Company hopes that this structure will provide the sales
force with incentives to not only establish new clients but to maintain and
enhance relationships with existing clients.
The
specialization and focus of the sales team, including client service associates,
on breast health, disease prevention, and the diagnosis and treatment of cancer
allows them to develop significant expertise and hopefully will lead to strong
consultative relationships with referring physicians and their office
staff.
The
Company will focus its marketing and sales efforts on encouraging physicians and
breast health and mammography clinics to use the MASCT System in conjunction
with other health screening examinations, including annual physical examinations
and regularly scheduled cervical Pap smears and mammograms. The sales
representatives will concentrate on a geographic area based on the number of
physician clients and prospects, which will be identified using several national
physician databases that provide address information, patient demographic
information, and other data. The Company will also use the FDA
website containing contact information on the approximately 8,600 Mammography
Quality Standards Act (MQSA)-certified clinics to identify potential
clients.
Company
Laboratory
The
Company has entered into a lease for a laboratory facility and intends to
establish a clinical laboratory at this facility in the fourth quarter of 2010
for the cytology and molecular diagnostics testing and reading of results of
collected NAF samples. The Company believes that by maintaining its
own clinical laboratory, it will be able to generate substantial additional
service revenues through cytology and molecular diagnostic testing, in addition
to the sale of the MASCT System pumps and patient kits. The Company
has begun limited operations of the laboratory and anticipates that it will be
licensed under the Washington state Medical Tests Site (MTS) and federal CLIA
certification programs, as well as required state laboratory permits and
licenses.
The
Company intends to establish a comprehensive quality assurance program for its
laboratory, designed to drive accurate and timely test results and to ensure the
consistent high quality of its testing services. In addition to the
compulsory proficiency programs and external inspections required by CMS and
other regulatory agencies, the Company intends to develop a variety of internal
systems and procedures to emphasize, monitor, and continuously improve the
quality of its operations.
The
Company intends to participate in externally-administered quality surveillance
programs, and seek accreditation of its laboratory by the College of Anatomic
Pathology, or CAP. The CAP accreditation program involves both
unannounced on-site inspections of laboratories and participation in CAP’s
ongoing proficiency testing program. CAP is an independent, non-governmental
organization of board-certified pathologists that accredits laboratories
nationwide on a voluntary basis and that has been accredited by CMS to inspect
laboratories to determine adherence to the CLIA standards. A
laboratory’s receipt of accreditation by CAP satisfies the Medicare requirement
for participation in proficiency testing programs administered by an external
source, one of Medicare’s primary requirements for reimbursement
eligibility.
MASCT
System NAF Sample Collection and Testing Process
By
focusing on NAF samples and the cytology and molecular diagnostic technologies
utilizing NAF, the entire process from specimen collection to delivery of the
comprehensive patient diagnoses using the MASCT System will be tailored to the
specific needs of the Company’s referring physicians. When a nurse or
physician’s assistant uses the MASCT System to take a NAF specimen from a
patient for diagnostic testing, he or she will complete a requisition form
(either by hand or electronically, via electronic medical records, or EMR,
technology or via an EMR web interface), attach a bar-coded label to each NAF
specimen from the requisition, and package the specimen for shipment to the
Company.
The
Company will supply physicians with pre-addressed packaging for added
convenience. The Company intends to schedule daily specimen
collections from its referring physicians, which creates reliability and
convenience and relieves referring physicians of the administrative burden and
cost of handling logistical details. Once the specimen arrives in the
Company’s laboratory, the Company will scan the bar coded label on the
requisition and enter all pertinent information about the specimen, including
patient billing information, into a work-flow software system. A
cytotechnologist will then prepare the specimen for
interpretation. It is preferable to prepare NAF slides with
liquid-based cytology technique, using cellular concentration and monolayer
slide method. This approach aids interpretation, because it optimizes
cellularity. The prepared specimen will be delivered to one of the
Company’s pathologists for analysis. After diagnosis, the pathologist
will use a software system to prepare a comprehensive report, which might
include any relevant images from the NAF. The diagnostic report will
then be delivered to the physician via secure Internet software, remote printer,
fax or mail. Should the physician have questions, the Company’s
pathologists will be available for consultations.
The
practice of anatomic pathology requires a pathologist to make a specific
diagnosis, which referring physicians rely on to determine appropriate treatment
plans and monitor the effectiveness of treatment. In addition to Dr.
Quay, the Company intends to hire other board-certified pathologists and
cytotechnologists to assist in the interpretation of the NAF
samples.
International
Commercialization Strategy
Because
the Company holds foreign patents for the MASCT System and the laboratory
testing in Europe, Japan, Canada and Australia, it believes that it can find
local partners for marketing the MASCT System and for performing the clinical
laboratory testing in those countries. It also believes that it may
be able to license the MASCT System and laboratory technology to local
physicians, healthcare professionals and sales representatives in those
countries and will be able to enter into licensing agreements for sales- and
service-based royalties. The Company has pending patent applications in emerging
markets such as China and India and believes these will also represent a growth
opportunity.
Growth
Strategy
The
Company intends to launch the MASCT System in the first quarter of 2011 near its
headquarters in Seattle and initially to focus its sales and marketing efforts
in Washington, Oregon, and Idaho. This will allow the Company to test
different market approaches and to better understand the marketing and sales
process before committing the significant financial and human resources to a
national launch. These three states have approximately 290
mammography clinics registered with the FDA that perform approximately 1.2
million mammograms per year. The Company believes that this would
represent a total addressable market of over $100 million
annually.
The
Company plans to market the MASCT System nationally after its regional
marketing and selling effort, if successful, and after it has established
the operation of its clinical and diagnostic laboratory. This will
provide it with experience and knowledge of the issues and problems that may
arise as it markets the MASCT System and the facilities to provide the testing
and reading of the samples. Assuming a successful regional launch,
the Company intends to commence its national launch of the MASCT System during
the first quarter of 2012.
Research
and Development
Second
Generation Oxy-MASCT Product Development
Dr. Quay
also discovered that administration of a synthetic version of a natural hormone,
oxytocin, increases the production of NAF. The Company anticipates
that it will develop a second generation product, Oxy-MASCTÔ, based on this
research. The Oxy-MASCT technology is covered by three U.S. and nine
foreign patents owned by the Company. If the Company is successful in
developing and obtaining marketing approval for a product based on the Oxy-MASCT
technology, it may market the Oxy-MASCT product to the core of healthcare
professionals who use the MASCT System. The Company plans to initiate
clinical trials of the Oxy-MASCT System for the collection of NAF during the
fourth quarter of 2011, and, if the results of these trials are favorable, to
file with the FDA for market clearance of the Oxy-MASCT System as a Class III
medical device in 2013.
Second
Generation Biomarker Test Development
The
Company intends to engage in research activities relating to the study and
analysis of NAF samples to develop molecular diagnostic biomarkers for breast
health and disease. The Company believes that some of these tests may
be developed to serve the growing worldwide personalized medicine market, which
is estimated to reach $50 billion in 2012.
The
Company’s patents and patent applications provide the basis for its research
efforts. Specifically, its NAF biomarker patents are directed to the
general classes of biomarkers, that is, proteins, peptides, glycoproteins,
lipids, glycolipids, DNA polynucleotides, or RNA polynucleotides. The
patents are also directed to the following specific biomarkers in
NAF:
Alpha-Lactalbumin
|
|
EMS1
|
|
PAl-1
|
Actin
|
|
Epithelial
Membrane Antigen
|
|
PAl-2
|
bcl-2
|
|
Gal-GalNAC
|
|
PGE2
|
Beta-glucuronidase
|
|
GCDFP-15
|
|
Prolactin
|
blood
group antigens including ABH and MN
|
|
Heat
Shock Proteins
|
|
Proliferating
Cell Nuclear Antigen
|
BRCA1
|
|
HIVIFG
|
|
pS2
|
BRCA2
|
|
IL-10
|
|
PSA
|
CA
19-9
|
|
Insulin
Growth Factor Receptors
|
|
Ras
|
CA-125
|
|
Integrins
|
|
Rb
|
CA15-3
|
|
IR-14
|
|
S-100
protein
|
Cathepsin
D
|
|
KA
1
|
|
Tissue
Plasminogen Activator
|
CCND1
|
|
KA
14
|
|
Tn
Antigen
|
CD31
|
|
Ki67
Growth Factor
|
|
Transforming
Growth Factor alpha
|
CD44
splice variants
|
|
Laminin
Receptor
|
|
uPA
|
CEA
|
|
Laminins
|
|
uPA
Receptor
|
Cyclin
D1
|
|
LASA
|
|
uPA
related antigens and complexes
|
c-myb
|
|
Le(y)-Related
Carbohydrate Antigen
|
|
Vasopressin
|
c-myc
|
|
MCA
|
|
Vimentin
|
Collagenase
Type IV
|
|
Neuron-Specific
Enolase
|
|
p53
|
Cyclin
B1
|
|
nm23
|
|
blood
group antigens including Lewis
|
The
Company believes that each of the stages of breast cancer, from normal growth,
to hyperplasia, to ADH, to carcinoma in situ, and finally to invasive cancer is
associated with specific biomarker patterns. As a result, the Company
intends to develop second generation biomarker tests involving DNA methylation
patterns, mass spectrometry proteomics, and other microarray-based biomarker
panels using the following multi-phased clinical development platform, which it
intends to fund through additional equity and/or debt financings, as well as
revenue-based earnings from sales of the MASCT System:
Clinical Research
Phase. In this phase, the Company would establish a product
definition and research plan. The Company would initiate clinical
research with literature reviews of related biomarker expression patterns from
NAF studies, core and fine needle biopsy material, and cancer excisions, which
usually contain normal, hyperplastic, and carcinoma-in-situ changes in adjacent
anatomical locations. The Company would secure access to archival
tumor or pre-cancerous biopsy samples for feasibility studies as well as
archival tumor or pre-cancerous biopsy samples correlated with clinical data for
biomarker identification studies. The goal of these studies would be to identify
patterns of DNA sequences, DNA methylation changes, RNA microarrays, or protein
expression changes that occur in pre-cancerous hyperplasia compared to normal
tissue and that correlate with the later development of cancer.
Development Phase. The
Company would conduct additional clinical studies to refine the biomarker set in
the specific patient population of interest. The Company would select
the final biomarker panel through statistical modeling of the biomarker
correlation data to develop the best quantitative correlation to the target
clinical outcome. With a biomarker panel and quantitative methodology
established, the Company would then finalize all of the remaining assay
parameters. For example, the Company may test and verify protocols for DNA, RNA,
or protein extraction and amplification from archival tissue as well as NAF
samples, as appropriate, automated chemistry and reagent quality control and
handling to establish a reproducible, scalable process. Once the
biomarker panel, assay chemistry, automation and analysis specifications are
finalized, tested and verified, the Company would begin clinical
validation.
Validation Phase. In
this phase, the Company would conduct one or more validation studies with
prospectively designed endpoints to test its candidate biomarker panel and the
corresponding quantitative expression score. These studies would be conducted
with a different set of archival patient specimens to verify that the test
correlates with the predicted clinical outcome in an independent patient
population. Because the Company would control the quality and reproducibility of
its assays using formalin-fixed, paraffin embedded tissues, the Company would be
able to conduct large validation studies (approximately 700 patients) with
archived samples with years of clinical outcomes. This allows validation studies
to be performed more rapidly than would be the case with techniques that require
fresh tissue, which must be newly collected and need many years of follow up
before study results can be obtained.
Commercialization and Product
Expansion Phase. Once a test is commercialized, the Company may
perform additional studies designed to support the test’s clinical utility and
potentially to broaden its use in additional patient populations or for
additional indications. Such studies may include prospective studies to verify
that the Company’s test is changing physician behavior as well as testing a
commercial product in new populations. Multiple clinical studies are also useful
for driving adoption and reimbursement by physicians and payors.
Billing
and Reimbursement
Billing
for the MASCT System Medical Device and Patient Kits and the NAF Collection
Procedure
Currently
Medicare and certain insurance carriers do not cover the cost of collecting the
NAF sample. The Company intends to work with physicians and other
interest groups to obtain coverage for the procedures but this process can be
lengthy, costly, and might not be successful. Failure to receive
reimbursement could limit the adoption and utilization of the MASCT
System. Because the process can be done by a nurse or physician’s
assistant, takes less than five minutes, and the MASCT System supplies will
contain everything to obtain, label, and ship the NAF samples, the charge for
collecting NAF samples should be below the average cost of a
mammogram.
Billing
for Diagnostic Services
Billing
for diagnostic services is generally complex. As a result, the
Company intends to rely on a third-party billing company to perform most of its
billing and collection services. Laboratories must bill various payors, such as
private insurance companies, managed care companies, governmental payors such as
Medicare and Medicaid, physicians, hospitals, and employer groups, each of whom
may have different billing requirements. The Company expects to be obligated to
bill in the specific manner prescribed by the various payors. Additionally, the
audit requirements that must be met to ensure compliance with applicable laws
and regulations, as well as internal compliance policies and procedures, add
further complexity to the billing process. Other factors that complicate billing
include:
|
·
|
additional
billing procedures required by government payor
programs;
|
|
·
|
variability
in coverage and information requirements among various
payors;
|
|
·
|
missing,
incomplete or inaccurate billing information provided by referring
physicians;
|
|
·
|
billings
to payors with whom the Company does not have
contracts;
|
|
·
|
disputes
with payors as to who is responsible for
payment;
|
|
·
|
disputes
with payors as to the appropriate level of
reimbursement;
|
|
·
|
training
and education of employees and
clients;
|
|
·
|
compliance
and legal costs; and
|
|
·
|
cost
related to, among other factors, medical necessity denials and the absence
of advance beneficiaries’ notices.
|
In
general, the Company expects to perform the requested tests and report test
results even if the billing information is incorrect or missing. The Company
will subsequently attempt to obtain any missing information and correct
incomplete or erroneous billing information received from the healthcare
provider. Missing or incorrect information on requisitions adds complexity to
and slows the billing process, creates backlogs of unbilled requisitions, and
generally increases the aging of accounts receivable. When all issues relating
to the missing or incorrect information are not resolved in a timely manner, the
related receivables will be written off to the allowance for doubtful
accounts.
Reimbursement
Depending
on the billing arrangement and applicable law, the party that reimburses the
Company for its services will be (i) a third party who provides coverage to the
patient, such as an insurance company, managed care organization, or a
governmental payor program; (ii) the physician or other authorized party (such
as another laboratory) who ordered the test or otherwise referred the test to
us; or (iii) the patient. A large percentage of revenues are likely to be
derived from Medicare, so Medicare coverage and reimbursement rules will be
significant to the Company’s operations.
Reimbursement
for services under the Medicare program is based principally on two sets of fee
schedules. Generally, anatomic pathology services, including most of the
services the Company provides, are paid based on the Medicare physician fee
schedule. The physician fee schedule is designed to set compensation
rates for those medical services provided to Medicare beneficiaries that require
a degree of physician supervision. Clinical laboratory tests that are not
physician pathology services, such as most blood and urine tests, are paid by
Medicare based on the clinical laboratory fee schedule. Outpatient diagnostic
laboratory tests are typically paid according to the laboratory fee
schedule.
For the
anatomic pathology services that the Company will provide, it will be reimbursed
under the Medicare physician fee schedule, and beneficiaries are responsible for
applicable coinsurance and deductible amounts. The physician fee schedule is
based on assigned relative value units for each procedure or service, and an
annually determined conversion factor is applied to the relative value units to
calculate the reimbursement. The formula used to calculate the fee schedule
conversion factor has resulted in significant decreases in payment levels in
recent years, and for 2008, CMS generally provided for a 10.1% decrease in
physician fee schedule payments.
Future
decreases in the Medicare physician fee schedule are expected unless Congress
acts to change the fee schedule methodology or mandates freezes or increases
each year. Because the vast majority of the Company’s laboratory services will
be reimbursed based on the physician fee schedule, changes to the
physician fee schedule could result in a greater impact on the Company’s
revenues than changes to the Medicare laboratory fee schedule.
The
Company expects to bill the Medicare program directly. Generally, it
will be permitted to directly bill the Medicare beneficiary for clinical
laboratory tests only when the service is considered not medically necessary and
the patient has signed an Advanced Beneficiary Notice, or ABN, reflecting
acknowledgment that Medicare is likely to deny payment for the service. In most
situations, the Company is required to rely on physicians to obtain an ABN from
the patient. When the Company is not provided an ABN, it is generally
unable to recover payment for a service for which Medicare has denied payment
for lack of medical necessity.
In
billing Medicare, the Company is required to accept the lowest of: its actual
charge, the fee schedule amount for the state or local geographical area, or a
national limitation amount, as payment in full for covered tests performed on
behalf of Medicare beneficiaries. Payment under the laboratory fee
schedule has been limited by Congressional action such as freezes on the
otherwise applicable annual Consumer Price Index, or CPI, update to the fee
schedule amount. The CPI update of the laboratory fee schedule for
2004 through 2008 was frozen by the Medicare Prescription Drug, Improvement and
Modernization Act of 2003.
The
Medicare statute permits CMS to adjust statutorily prescribed fees for some
medical services, including clinical laboratory services, if the fees are
“grossly excessive.” Medicare regulations provide that if CMS or a
carrier determines that an overall payment adjustment of less than 15% is needed
to produce a realistic and equitable payment amount, then the payment amount is
not considered “grossly excessive or deficient.” However, if a determination is
made that a payment adjustment of 15% or more is justified, CMS could provide an
adjustment of 15% or less, but not more than 15%, in any given year. The Company
cannot provide any assurance that fees payable by Medicare for clinical
laboratory services could not be reduced as a result of the application of this
rule or that the government might not assert claims for recoupment of previously
paid amounts by retroactively applying these principles.
The
payment amounts under the Medicare fee schedules are important not only for
reimbursement under Medicare, but also because the schedule is often used as a
reference for the payment amounts set by other third-party
payors. For example, state Medicaid programs are prohibited from
paying more than the Medicare fee schedule limit for laboratory services
furnished to Medicaid recipients, and insurance companies and managed care
organizations typically reimburse at a percentage of the Medicare fee
schedule.
The
Company’s reimbursement rates will also vary depending on whether it is
considered an “in-network,” or participating, provider. If it enters
into a contract with an insurance company, the Company’s reimbursement will be
governed by its contractual relationship, and it will typically be reimbursed on
a fee-for-service basis at a discount from the patient fee
schedule. If the Company does not have a contract with an insurance
company, it will be classified as “out-of-network,” or as a non-participating
provider. In such instances, it would have no contractual right to
reimbursement for services. If it were to receive reimbursement, it would
generally be at a rate higher than reimbursement rates for participating
providers.
Reimbursement
Strategy
Significance
of CPT Codes
Reimbursement
for medical procedures and laboratory services is based on obtaining a Current
Procedural Terminology, or CPT, code from the AMA. CPT is a listing
of descriptive terms and identifying codes for reporting medical services and
procedures. The purpose of CPT is to provide a uniform and accurate
description of medical, surgical and diagnostic services, thereby serving as a
means for reliable nationwide communication among physicians and other
healthcare providers, patients and third parties.
CPT
descriptive terms and identifying codes currently serve a wide variety of
important functions. This system of terminology is the most widely
accepted medical nomenclature used to report medical procedures and services
under public and private health insurance programs. CPT is also used
for administrative management purposes such as claims processing and developing
guidelines for medical care review.
Category
I CPT Codes
Category
I CPT codes describe a procedure or service identified with a five-digit CPT
code and descriptor nomenclature. The inclusion of a descriptor and
its associated specific five-digit identifying code number in this category of
CPT codes is generally based upon the procedure being consistent with
contemporary medical practice and being performed by many physicians in clinical
practice in multiple locations.
In
developing new and revised regular CPT codes the Advisory Committees and the
Editorial Panel require:
|
·
|
that
the service/procedure has received approval from the FDA for the specific
use of devices or drugs;
|
|
·
|
that
the suggested procedure/service is a distinct service performed by many
physicians/practitioners across the United
States;
|
|
·
|
that
the clinical efficacy of the service/procedure is well established and
documented in U.S. peer review
literature;
|
|
·
|
that
the suggested service/procedure is neither a fragmentation of an existing
procedure/service nor currently reportable by one or more existing codes;
and
|
|
·
|
that
the suggested service/procedure is not requested as a means to report
extraordinary circumstances related to the performance of a
procedure/service already having a specific CPT
code.
|
Category
III CPT Codes – Emerging Technology
Category
III CPT codes are a temporary set of tracking codes for new and emerging
technologies. These codes are intended to facilitate data collection
on and assessment of new services and procedures. The Category III codes are
intended for data collection purposes in the FDA approval process or to
substantiate widespread usage. As such, the Category III codes may
not conform to the usual CPT code requirements for Category I. The
Panel has established the following criteria for evaluating Category III code
requests, any one of which is sufficient for consideration by the Editorial
Panel:
|
·
|
a
protocol for a study of procedures being
performed;
|
|
·
|
support
from the specialties who would use the
procedure;
|
|
·
|
availability
of U.S. peer-reviewed literature;
and
|
|
·
|
descriptions
of current United States trials outlining the efficacy of the
procedure.
|
In
general, these codes will be assigned a numeric-alpha identifier (eg,
1234T). These codes will be located in a separate section of CPT,
following the "Category II" section. Introductory language in this
code section explains the purpose of the Category III codes.
Since
Category III CPT codes are intended to be used for data collection purposes to
substantiate widespread usage or in the FDA approval process, they are not
intended for services/procedures that are not accepted by the Editorial Panel
because the proposal was incomplete, more information is needed, or the Advisory
Committee did not support the proposal.
Category
III CPT codes are not referred to the AMA / Specialty RVS Update Committee, or
RUC, for valuation because no relative value units, or RVUs, will be
assigned. Payment for these services/procedures is based on the
policies of payors and local Medicare carriers.
CPT
Code for MASCT System NAF Collection Procedure
The NAF
collection procedure of the MASCT System does not currently have a
procedure-specific Category I CPT code, which is important for reimbursement by
Medicare for eligible patients, and which is part of the basis by which
insurance companies make reimbursement decisions. A non-specific
Category I CPT code, 19499 (unlisted procedure, breast), can be used initially
by physicians and insurance carriers will often pay for such procedures with
proper documentation. Medicare does not currently reimburse for CPT
19499 procedures.
Beginning
in the first quarter of 2011, the Company expects to begin the process of
obtaining a Category III CPT code with which to collect clinical data to support
a Category I CPT code application for the use of NAF collection as an adjunct to
mammography. It is expected it may take 12 months to obtain the
Category III CPT code and up to two years to collect data to make an application
to the AMA for a Category I CPT code. The Company expects physicians
will be able to use either the non-specific Category I CPT code 19499 with
documentation or the MASCT System specific Category III code to obtain
reimbursement.
CPT
Code for Cytology and IHC Biomarker Testing
Category
I laboratory procedure codes for cytology, IHC biomarker tests, microarray-based
analysis of molecular probes, and in situ hybridization of DNA and RNA probes
currently exist and it is expected that reimbursement for these codes by
Medicare will be at the established rates shown in the following
table:
2010 CPT
Code
|
|
Description
|
|
2010 Medicare National
Reimbursement Rate (Per
Patient)
|
|
88161
|
|
Cytopathology,
smears; preparation, screening and interpretation
|
|
|
$106.20
|
|
88162
|
|
Cytopathology,
smears; extended study involving over 5 slides and/or multiple
stains
|
|
|
$151.18
|
|
88360
|
|
Morphometric
analysis, tumor immunohistochemistry (eg, Her-2/neu, estrogen
receptor/progesterone receptor), quantitative or semiquantitative, each
antibody; manual
|
|
|
$240.42
|
|
88360
(5)
|
|
Morphometric
analysis, tumor immunohistochemistry (eg, Her-2/neu, estrogen
receptor/progesterone receptor), quantitative or semiquantitative, five
antibody panel; manual
|
|
|
$1,202.10
|
|
88342
|
|
Immunohistochemistry
(including tissue immunoperoxidase), each antibody
|
|
|
$200.58
|
|
88342
(5)
|
|
Immunohistochemistry
(including tissue immunoperoxidase), five antibody panel
|
|
|
$1,002.50
|
|
88385
|
|
Array-based
evaluation of multiple molecular probes; 51 through 250
probes
|
|
|
$1,250.00
|
|
88367
|
|
Morphometric
analysis, in situ hybridization (quantitative or
semi-quantitative) each probe; using computer-assisted
technology
|
|
|
$479.34
|
|
Laboratories
typically set patient fee schedules at two to four times the Medicare
reimbursement rate for the same procedure.
Intellectual
Property
The
Company owns five issued U.S. patents and nine corresponding issued patents in
Australia, Canada, Europe, Hong Kong, and Japan as well as pending patent
applications in the U.S., Europe, and Japan. The patents encompass
the first and second generation product line for the company. The
first generation product and collection system encompasses the invention of a
proprietary, patented process for obtaining fluid and cells from within the
breast, in a reproducible and non-invasive method, through a device that
allows pressure to be applied to the nipple, thereby increasing the
amount of fluid that is extracted from the ducts and lobules of the
breast. A second generation
diagnostic product and testing service is derived from additional patented
technologies in which samples of breast fluid, containing cancer markers,
abnormal cells and malignant cells, are obtained from the breast nipple
following administration of oxytocin, a brain pituitary
hormone. Studies done by others in Europe have shown that oxytocin
administration increases NAF by as much as 10-fold. The Company has
also patented its test kit collection system, which will allow the company to
have the fluids processed exclusively by its own laboratory.
As of
June 30, 2010, the Company owned 13 issued patents (five U.S. and eight
foreign) and six pending applications (one U.S. and five foreign),
including one expired patent issued in the EU, now entering national
phase. The Company owns patents and patent applications covering the
development, manufacture, use and sale of the MASCT System and the Oxy-MASCT
System, as well as breast cancer biomarkers.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MASCT
System
|
|
|
5
|
|
|
|
2016-2020
|
|
|
|
4
|
|
|
|
8
|
|
|
|
2016-2020
|
|
|
|
5
|
|
Oxy-MASCT
System
|
|
|
3
|
|
|
|
2016-2020
|
|
|
|
3
|
|
|
|
8
|
|
|
|
2016-2020
|
|
|
|
5
|
|
Breast
cancer biomarkers
|
|
|
3
|
|
|
|
2016-2020
|
|
|
|
2
|
|
|
|
8
|
|
|
|
2016-2020
|
|
|
|
5
|
|
Total
(1)
|
|
|
5
|
|
|
|
2016-2020
|
|
|
|
4
|
|
|
|
8
|
|
|
|
2016-2020
|
|
|
|
5
|
|
(1) Certain of the Company’s patents and pending patent applications
contain claims covering one or more of the MASCT System, the Oxy-MASCT System
and breast cancer biomarkers. Some pending applications, if issued,
would expire in 2029.
The
Company has applied with the United States Patent and Trademark Office for
registration of the use of the marks Atossa (and design), MASCT, and
Oxy-MASCT.
The
technologies and products covered by the Company’s patents can be summarized
as:
|
·
|
MASCT
System collection device for NAF;
|
|
·
|
The
method of making a diagnosis from NAF, using “whole cells, cell fragments,
cell membranes, a protein, a peptide, a glycoprotein, a lipid, a
glycolipid, a DNA polynucleotide, an RNA polynucleotide, or a combination
thereof;” and
|
|
·
|
The
use of the drug oxytocin or oxytocin analogues to increase the amount of
NAF produced.
|
The
Company believes that its patents also provide protection against other uses for
the MASCT System and technology. Specifically, the MASCT System
collection kits to be provided by the Company are protected under an issued U.S.
patent owned by the Company and will be sold under a limited “collection only”
patent license, which will permit physicians to collect NAF samples but will not
allow for other uses of the vial. In addition, an issued U.S. patent
owned by the Company protects the processes of transferring and processing
samples to detect or quantify breast disease markers and the detection of these
biomarkers. The foreign patent counterparts contain similar
claims.
Competition
The
Company believes that the MASCT System for NAF collection will compete in the
medical device product industry with Neomatrix and with academic scientists and
physicians who use “homemade” NAF fluid collection systems for research
purposes. The Neomatrix device is automated and provides warmth and
nipple aspiration simultaneously.
The
Company believes it will compete in the anatomic pathology laboratory industry
based on the patent portfolio for the MASCT System, the technical expertise
provided by the Company’s focus on diagnoses utilizing NAF, service-focused
relationships with referring physicians, and its advanced
technology. The Company does not believe that its competitors can
transport or process NAF samples collected with the MASCT System without
infringing the Company’s patent estate.
Laboratories
that could process NAF samples not collected with the MASCT System include
thousands of local and regional pathology groups, national laboratories,
hospital pathologists, and academic laboratories. The largest such competitors
include Laboratory Corporation of America and Quest Diagnostics
Incorporated.
Characteristics
of each source of competition include:
Local and
Regional Pathology Groups. Local and
regional pathology groups focus on servicing hospitals, often maintaining a
staff of pathologists on site that can provide support in the interpretation of
certain results. The business models of these laboratories tend to be focused on
the efficient delivery of individual tests for a multitude of diseases rather
than the comprehensive assessment of only NAF samples, and their target groups
tend to be hospital pathologists as opposed to community
physicians.
National
Laboratories. National
laboratories typically offer a full suite of tests for a variety of medical
professionals, including general practitioners, hospitals, and pathologists.
Their emphasis on providing a broad product portfolio of commoditized tests at
the lowest possible price often limits such laboratories’ ability to handle
difficult or complex specimens requiring special attention, such as NAF samples.
In addition, national laboratories typically do not provide ready access to a
specialized pathologist for interpretation of test results.
Hospital
Pathologists. Pathologists
working in a hospital traditionally provide most of the diagnostic services
required for hospital patients and sometimes also serve non-hospital
patients. Hospital pathologists typically have close interaction with
treating physicians, including face-to-face contact. However,
hospital pathologists often do not have the depth of experience, specialization,
and expertise necessary to perform the specialized services needed for NAF
samples.
Academic
Laboratories.
Academic laboratories generally offer advanced technology and
know-how. In fact, the vast majority of NAF sample processing over
the last years has been in academic laboratories primarily for research
purposes. These laboratories typically pursue multiple activities and
goals, such as research and education, or are generally committed to their own
hospitals. Turn-around time for specimen results reporting from
academic laboratories is often slow. This limits the attractiveness of academic
laboratories to outside physicians who tend to have focused specialized needs
and require results to be reported in a timely manner.
The
Company also anticipates that the MASCT System will face competition from other
diagnostic tools for breast cancer, including mammograms, ultrasound
examinations, magnetic resonance imaging, fine needle aspiration and core
biopsies, among others. These methods are currently more widely used
and accepted by physicians, and may offer a competitive advantage over the
Company’s proposed products and services because they are currently reimbursed
by third-party payors.
Information
Systems
The
Company will need to acquire, develop and implement laboratory information
management systems, or LIMS, that support the Company’s operations and physician
services. There are a number of commercial vendors of LIMS for
anatomic pathology laboratories, and the Company intends initially to use such
third-party supplied products for its laboratory operations. Its
information systems, to the extent such systems hold or transmit patient medical
information, must be capable of being operated in compliance with state and
federal laws and regulations relating to the privacy and security of patient
medical information, including a comprehensive federal law and regulations
referred to as HIPAA. While the Company intends to establish its
information systems to be compliant with such laws, including HIPAA, such laws
are complex and subject to interpretation.
Government
Regulation
United
States Medical Device Regulation
The
Federal Food, Drug, and Cosmetic Act, or FDCA, and the FDA’s implementing
regulations, govern registration and listing, manufacturing, labeling, storage,
advertising and promotion, sales and distribution, and post-market surveillance.
Medical devices and their manufacturers are also subject to inspection by the
FDA. The FDCA, supplemented by other federal and state laws, also provides civil
and criminal penalties for violations of its provisions. We intend to
manufacture and market a medical device that is regulated by the FDA, comparable
state agencies and regulatory bodies in other countries. We also
intend to operate a clinical and diagnostic laboratory which will use reagents
and test kits some of which are regulated medical devices.
The FDA
classifies medical devices into one of three classes (Class I, II or III) based
on the degree of risk the FDA determines to be associated with a device and the
extent of control deemed necessary to ensure the device’s safety and
effectiveness. Devices requiring fewer controls because they are deemed to pose
lower risk are placed in Class I or II. Class I devices are deemed to pose the
least risk and are subject only to general controls applicable to all devices,
such as requirements for device labeling, premarket notification, and adherence
to the FDA’s current good manufacturing practice requirements, as reflected in
its QSR. Most pathology staining kits, reagents, and routine
antibody-based Immunohistochemistry protocols which the Company intends to use
initially are Class I devices. Class II devices are intermediate risk
devices that are subject to general controls and may also be subject to special
controls such as performance standards, product-specific guidance documents,
special labeling requirements, patient registries or postmarket surveillance.
The MASCT System device and certain advanced laboratory testing, such as
microarray multiplexed assays, where an algorithm is used to calculate a score
related to, for example, tumor aggression or sensitivity to chemotherapy from
dozens on individual expression data points, are Class II
devices. Class III devices are those for which insufficient
information exists to assure safety and effectiveness solely through general or
special controls, and include life-sustaining, life-supporting, or implantable
devices, and devices not “substantially equivalent” to a device that is already
legally marketed.
Most
Class I devices, including the laboratory staining kits and reagents the Company
intends to use, and some Class II devices are exempted by regulation from the
510(k) clearance requirement and can be marketed without prior authorization
from FDA. Class I and Class II devices that have not been so exempted are
eligible for marketing through the 510(k) clearance pathway. By contrast,
devices placed in Class III generally require premarket approval, or PMA,
approval prior to commercial marketing. To obtain 510(k) clearance
for a medical device, an applicant must submit a premarket notification to the
FDA demonstrating that the device is “substantially equivalent” to a predicate
device legally marketed in the United States. A device is
substantially equivalent if, with respect to the predicate device, it has the
same intended use and (i) the same technological characteristics, or (ii) has
different technological characteristics and the information submitted
demonstrates that the device is as safe and effective as a legally marketed
device and does not raise different questions of safety or effectiveness. A
showing of substantial equivalence sometimes, but not always, requires clinical
data. In the case of the MASCT System, a clinical trial was
conducted. Generally, the 510(k) clearance process can exceed 90 days
and may extend to a year or more. After a device has received 510(k)
clearance for a specific intended use, any modification that could significantly
affect its safety or effectiveness, such as a significant change in the design,
materials, method of manufacture or intended use, will require a new 510(k)
clearance or (if the device as modified is not substantially equivalent to a
legally marketed predicate device) PMA approval. While the determination as to
whether new authorization is needed is initially left to the manufacturer, the
FDA may review this determination and evaluate the regulatory status of the
modified product at any time and may require the manufacturer to cease marketing
and recall the modified device until 510(k) clearance or PMA approval is
obtained. The manufacturer may also be subject to significant regulatory fines
or penalties.
All
clinical trials must be conducted in accordance with regulations and
requirements collectively known as Good Clinical Practice, or
GCP. GCPs include the FDA’s Investigational Device Exemption, or IDE,
regulations, which describe the conduct of clinical trials with medical devices,
including the recordkeeping, reporting and monitoring responsibilities of
sponsors and investigators, and labeling of investigation devices. They also
prohibit promotion, test marketing, or commercialization of an investigational
device, and any representation that such a device is safe or effective for the
purposes being investigated. GCPs also include FDA’s regulations for
institutional review board approval and for protection of human subjects
(informed consent), as well as disclosure of financial interests by clinical
investigators.
Required
records and reports are subject to inspection by the FDA. The results of
clinical testing may be unfavorable or, even if the intended safety and
effectiveness success criteria are achieved, may not be considered sufficient
for the FDA to grant approval or clearance of a product. The commencement or
completion of clinical trials, if any, that the Company may sponsor,
may be delayed or halted, or be inadequate to support approval of a PMA
application or clearance of a premarket notification for numerous reasons,
including, but not limited to, the following:
|
·
|
the
FDA or other regulatory authorities do not approve a clinical trial
protocol or a clinical trial (or a change to a previously approved
protocol or trial that requires approval), or place a clinical trial on
hold;
|
|
·
|
patients
do not enroll in clinical trials or follow up at the rate
expected;
|
|
·
|
institutional
review boards and third-party clinical investigators may delay or reject
the Company’s trial protocol or changes to its trial
protocol;
|
|
·
|
third-party
clinical investigators decline to participate in a trial or do not perform
a trial on the Company’s anticipated schedule or consistent
with the clinical trial protocol, investigator agreements, good clinical
practices or other FDA
requirements;
|
|
·
|
third-party
organizations do not perform data collection and analysis in a timely or
accurate manner;
|
|
·
|
regulatory
inspections of clinical trials or manufacturing facilities, which may,
among other things, require the Company to undertake corrective action or
suspend or terminate its clinical
trials;
|
|
·
|
changes
in governmental regulations or administrative
actions;
|
|
·
|
the
interim or final results of the clinical trial are inconclusive or
unfavorable as to safety or effectiveness;
and
|
|
·
|
the
FDA concludes that the Company’s trial design is inadequate to demonstrate
safety and effectiveness.
|
After a
device is approved and placed in commercial distribution, numerous regulatory
requirements apply. These include:
|
·
|
establishment
registration and device listing;
|
|
·
|
the
QSR, which requires manufacturers to follow design, testing, control,
documentation and other quality assurance
procedures;
|
|
·
|
labeling
regulations, which prohibit the promotion of products for unapproved or
“off-label” uses and impose other restrictions on
labeling;
|
|
·
|
medical
device reporting regulations, which require that manufacturers report to
the FDA if a device may have caused or contributed to a death or serious
injury or malfunctioned in a way that would likely cause or contribute to
a death or serious injury if malfunctions were to recur;
and
|
|
·
|
corrections
and removal reporting regulations, which require that manufacturers report
to the FDA field corrections and product recalls or removals if undertaken
to reduce a risk to health posed by the device or to remedy a violation of
the FDCA caused by the device that may present a risk to
health.
|
The FDA
enforces regulatory requirements by conducting periodic, announced and
unannounced inspections and market surveillance. Inspections may include the
manufacturing facilities of our subcontractors. Failure to comply
with applicable regulatory requirements, including those applicable to the
conduct of our clinical trials, can result in enforcement action by the FDA,
which may lead to any of the following sanctions:
|
·
|
warning
letters or untitled letters;
|
|
·
|
fines
and civil penalties;
|
|
·
|
unanticipated
expenditures;
|
|
·
|
delays
in clearing or approving or refusal to clear or approve
products;
|
|
·
|
withdrawal
or suspension of FDA clearance;
|
|
·
|
product
recall or seizure;
|
|
·
|
orders
for physician notification or device repair, replacement, or
refund;
|
|
·
|
production
interruptions;
|
|
·
|
operating
restrictions;
|
The
Company and its contract manufacturers, specification developers and suppliers
are also required to manufacture the MASCT System in compliance with current
Good Manufacturing Practice requirements set forth in the QSR. The
QSR requires a quality system for the design, manufacture, packaging, labeling,
storage, installation and servicing of marketed devices, and includes extensive
requirements with respect to quality management and organization, device design,
buildings, equipment, purchase and handling of components, production and
process controls, packaging and labeling controls, device evaluation,
distribution, installation, complaint handling, servicing and record keeping.
The FDA enforces the QSR through periodic announced and unannounced inspections
that may include the manufacturing facilities of our subcontractors. If the FDA
believes the Company or any of its contract manufacturers or regulated suppliers
is not in compliance with these requirements, it can shut down the Company’s
manufacturing operations, require recall of the MASCT System, refuse to clear or
approve new marketing applications, institute legal proceedings to detain or
seize products, enjoin future violations, or assess civil and criminal penalties
against the Company or its officers or other employees. Any such
action by the FDA would have a material adverse effect on the Company’s
business.
European
Medical Device Regulation
The
European Union has adopted directives and numerous standards that govern and
harmonize the national laws and standards regulating the design, manufacture,
clinical trials, labeling, adverse event reporting and post-market surveillance
activities for medical devices that are marketed in member states.
Compliance
with voluntary harmonized standards including ISO 13845 issued by the
International Organization for Standards establishes the presumption of
conformity with the essential requirements for a CE Mark. The International
Organization for Standardization, or ISO, is a worldwide federation of national
standards bodies from some 130 countries, established in 1947. The mission of
the ISO is to promote the development of standardization and related activities
in the world with a view to facilitating the international exchange of goods and
services. ISO certification is commonly a prerequisite to use of the CE Mark and
indicates that a quality system complies with standards applicable to activities
ranging from initial product design and development through production and
distribution.
Devices
that comply with the requirements of a relevant directive will be entitled to
bear the CE Mark and, accordingly, can be commercially distributed throughout
the member states of the European Union, and other countries that comply with or
have adopted these directives. The method of assessing conformity
varies depending on the type and class of the product, but typically involves a
combination of self-assessment by the manufacturer and a third-party assessment
by a “Notified Body,” an independent and neutral institution appointed to
conduct conformity assessment. This third-party assessment consists of an audit
of the manufacturer’s quality system and technical review of the manufacturer’s
product. An assessment by a Notified Body residing within the European Union is
required in order for a manufacturer to commercially distribute the product
throughout the European Union. The manufacturer’s assessment will
include a clinical evaluation of the conformity of the device with applicable
regulatory requirements, which for the MASCT System will include clinical study
results. The clinical data presented by us must provide evidence that
the products meet the performance specifications claimed by the Company, provide
sufficient evidence of adequate assessment of unwanted side effects and
demonstrate that the benefits to the patient outweigh the risks associated with
the device. The Company is subject to continued surveillance by the
Notified Body and is required to report any serious adverse incidents to the
appropriate authorities of the European Union member states.
The
Medical Devices Directive, or MDD, covers the regulatory requirements of the
European Union for medical devices. Compliance with the requirements of the MDD
is declared by placing the CE Mark on the product and supplying the device with
a declaration of conformity, in which the manufacturer certifies that its
product complies with the MDD. Products intended for sale must bear
the CE mark to show compliance with the MDD. If a Notified Body is involved in
the approval, the number of the Notified Body must also appear adjacent to the
CE Mark. The routes to compliance under the MDD depend on the classification of
the product:
Class I
devices are low risk, such as pathology staining kits, stethoscopes, hospital
beds and wheelchairs. The manufacturer must produce a technical file, including
product test results compared to relevant standards. In addition, manufacturers
of sterile products and devices with a measuring function must apply to a
Notified Body for certification of the aspects of manufacture relating to
sterility or measurement.
Class IIa
devices are low to medium risk, such as hearing aids, electrocardiographs and
ultrasonic diagnostic equipment. The MASCT System is a Class IIa
device. As with Class I devices, the manufacturer produces a
technical file, but a conformity assessment must be carried out by a Notified
Body, according to one of the following routes, at the manufacturer’s
option:
|
·
|
examination
and testing of each product or homogenous batch of
products;
|
|
·
|
audit
of the full quality assurance
system;
|
|
·
|
audit
of the production quality assurance system;
or
|
|
·
|
audit
of final inspection and testing.
|
Class IIb
devices are medium-high risk devices, such as surgical lasers, infusion pumps,
ventilators, intensive care monitoring equipment and many implantable devices.
Routes to compliance are the same as for Class IIa devices, with the addition of
required examination and testing of the product by the Notified Body; however,
the full quality assurance route does not require type examination and
testing.
Class III
devices are high risk, such as balloon catheters and prosthetic heart valves.
Routes to compliance are:
|
·
|
audit
of the full quality assurance system and examination of a design dossier
by the Notified Body. A design dossier is a submission similar
to a PMA application with the FDA;
or
|
|
·
|
examination
and testing of the product, together with audit of the production quality
assurance system.
|
The
Company intends to seek approval to apply the CE Mark to the MASCT System as a
Class IIa device in order to market in the European Union and other countries
that accept the CE Mark.
CLIA
and State Regulation
As a
future provider of cytology and molecular diagnostic services, the Company is
required to hold certain federal, state and local licenses, certifications, and
permits. Under CLIA, it is required to hold a certificate applicable
to the type of work it performs and to comply with certain CLIA-imposed
standards. CLIA regulates all laboratories by requiring they be
certified by the federal government and comply with various operational,
personnel, facilities administration, quality, and proficiency requirements
intended to ensure that laboratory testing services are accurate, reliable, and
timely. CLIA does not preempt state laws that are more stringent than federal
law.
To obtain
and renew its CLIA certificates, which it is required to renew every two years,
the Company will be regularly subject to survey and inspection to assess
compliance with program standards and may be subject to additional random
inspections. Standards for testing under CLIA are based on the level of
complexity of the tests performed by the laboratory. Laboratories performing
high complexity testing are required to meet more stringent requirements than
laboratories performing less complex tests where a CLIA certificate is required.
Both NAF cytology and molecular diagnostic testing are high complexity tests.
CLIA certification is a prerequisite to be eligible for reimbursement under
Medicare and Medicaid.
The
Clinical Laboratory Improvement Amendments of 1988, or CLIA ’88, was passed to
improve quality control at cytology laboratories performing gynecological
diagnoses (Pap smears for cervical cancer). Under CLIA ‘88, the
number of slides a cytotechnologist may screen each day is regulated (no more
than 100 slides in any 24 hour period, and must have at least 8 hours to
complete the examination of 100 slides, which results in an average of 12.5
slides per hour) and quality control procedures require rescreening of a minimum
of 10% randomly selected within-normal-limits, or WNL, slides per
day. In addition, specialized proficiency testing requirements apply
not just to the laboratory, but to the individuals performing the test,
specialized personnel standards, and quality control procedures. The
Company will not be seeking certification to perform cervical Pap smears and
therefore does not believe these provisions of CLIA ‘88 apply to
it.
In
addition to CLIA requirements, the Company will be subject to various state
laws. CLIA provides that a state may adopt laboratory regulations that are more
stringent than those under federal law, and a number of states, including
Washington, where the Company is located, have done so. The
Washington state Medical Test Site, or MTS, Licensure law (Chapter 70.42 RCW)
was passed in May 1989 to allow the state to regulate clinical laboratory
testing. In October 1993, Washington became the first state to have its clinical
laboratory licensure program judged by the Federal Health and Human Services
Centers for Medicare and Medicaid Services, or CMS, as equivalent to CLIA and
was granted an exemption. In addition, New York, Maryland,
Pennsylvania, Rhode Island, and California, have implemented their own
laboratory regulatory schemes. State laws may require that laboratory personnel
meet certain qualifications, specify certain quality controls, or prescribe
record maintenance requirements.
Privacy
and Security of Health Information and Personal Information; Standard
Transactions
The
Company will be subject to state and federal laws and implementing regulations
relating to the privacy and security of the medical information of the patients
it treats. The principal federal legislation is part of
HIPAA. Pursuant to HIPAA, the Secretary of the Department of Health
and Human Services, or HHS, has issued final regulations designed to improve the
efficiency and effectiveness of the healthcare system by facilitating the
electronic exchange of information in certain financial and administrative
transactions, while protecting the privacy and security of the patient
information exchanged. These regulations also confer certain rights
on patients regarding their access to and control of their medical records in
the hands of healthcare providers such as the Company.
Four
principal regulations have been issued in final form: privacy regulations,
security regulations, standards for electronic transactions, and the National
Provider Identifier regulations. The HIPAA privacy regulations, which
fully came into effect in April, 2003, establish comprehensive federal standards
with respect to the uses and disclosures of an individual’s personal health
information, referred to in the privacy regulations as “protected health
information,” by health plans, healthcare providers, and healthcare
clearinghouses. The Company is a healthcare provider within the
meaning of HIPAA. The regulations establish a complex regulatory
framework on a variety of subjects, including:
|
·
|
the
circumstances under which uses and disclosures of protected health
information are permitted or required without a specific authorization by
the patient, including but not limited to treatment purposes, activities
to obtain payment for services, and healthcare operations
activities;
|
|
·
|
a
patient’s rights to access, amend, and receive an accounting of certain
disclosures of protected health
information;
|
|
·
|
the
content of notices of privacy practices for protected health information;
and
|
|
·
|
administrative,
technical and physical safeguards required of entities that use or receive
protected health information.
|
The
federal privacy regulations, among other things, restrict the Company’s ability
to use or disclose protected health information in the form of
patient-identifiable laboratory data, without written patient authorization, for
purposes other than payment, treatment, or healthcare operations (as defined by
HIPAA) except for disclosures for various public policy purposes and other
permitted purposes outlined in the privacy regulations. The privacy
regulations provide for significant fines and other penalties for wrongful use
or disclosure of protected health information, including potential civil and
criminal fines and penalties. Although the HIPAA statute and
regulations do not expressly provide for a private right of damages, the Company
could incur damages under state laws to private parties for the wrongful use or
disclosure of confidential health information or other private personal
information.
The
Company will implement policies and practices that it believes brings it into
compliance with the privacy regulations. However, the documentation and process
requirements of the privacy regulations are complex and subject to
interpretation. Failure to comply with the privacy regulations could subject the
Company to sanctions or penalties, loss of business, and negative
publicity.
The HIPAA
privacy regulations establish a “floor” of minimum protection for patients as to
their medical information and do not supersede state laws that are more
stringent. Therefore, the Company is required to comply with both
HIPAA privacy regulations and various state privacy laws. The failure to do so
could subject it to regulatory actions, including significant fines or
penalties, and to private actions by patients, as well as to adverse publicity
and possible loss of business. In addition, federal and state laws
and judicial decisions provide individuals with various rights for violation of
the privacy of their medical information by healthcare providers such as the
Company.
The final
HIPAA security regulations, which establish detailed requirements for physical,
administrative, and technical measures for safeguarding protected health
information in electronic form, became effective on April 21,
2003. The Company intends to employ what it considers to be a
reasonable and appropriate level of physical, administrative and technical
safeguards for patient information. Failure to comply with the
security regulations could subject the Company to sanctions or penalties and
negative publicity.
The final
HIPAA regulations for electronic transactions, referred to as the transaction
standards, establish uniform standards for certain specific electronic
transactions and code sets and mandatory requirements as to data form and data
content to be used in connection with common electronic transactions, such as
billing claims, remittance advices, enrollment, and eligibility. The
Company intends to outsource to a third-party vendor the handling of its billing
and collection transactions, to which the transaction standards apply. Failure
of the vendor to properly conform to the requirements of the transaction
standards could, in addition to possible sanctions and penalties, result in
payors not processing transactions submitted on our behalf, including claims for
payment.
The HIPAA
regulations on adoption of national provider identifiers, or NPI, required
healthcare providers to adopt new, unique identifiers for reporting on claims
transactions submitted after May 23, 2007. The Company intends to obtain NPIs
for its laboratory facilities and pathologists so that it can report NPIs to
Medicare, Medicaid, and other health plans.
The
healthcare information of the Company’s future patients will includes social
security numbers and other personal information that are not of an exclusively
medical nature. The consumer protection laws of a majority of states now require
organizations that maintain such personal information to notify each individual
if their personal information is accessed by unauthorized persons or
organizations, so that the individuals can, among other things, take steps to
protect themselves from identity theft. The costs of notification and the
adverse publicity can both be significant. Failure to comply with
these state consumer protection laws can subject a company to penalties that
vary from state to state, but may include significant civil monetary penalties,
as well as to private litigation and adverse publicity. California
recently enacted legislation that expanded its version of a notification law to
cover improper access to medical information generally, and other states may
follow suit.
Federal
and State Fraud and Abuse Laws
The
federal healthcare Anti-Kickback Statute prohibits, among other things,
knowingly and willfully offering, paying, soliciting, or receiving remuneration
to induce referrals or in return for purchasing, leasing, ordering, or arranging
for the purchase, lease, or order of any healthcare item or service reimbursable
under a governmental payor program. The definition of “remuneration” has been
broadly interpreted to include anything of value, including gifts, discounts,
the furnishing of supplies or equipment, credit arrangements, payments of cash,
waivers of payments, ownership interests, opportunity to earn income, and
providing anything at less than its fair market value. The Anti-Kickback Statute
is broad, and it prohibits many arrangements and practices that are lawful in
businesses outside of the healthcare industry. Recognizing that the
Anti-Kickback Statute is broad and may technically prohibit many innocuous or
beneficial arrangements within the healthcare industry, HHS has issued a series
of regulatory “safe harbors.” These safe harbor regulations set forth certain
provisions that, if met, will assure healthcare providers and other parties that
they will not be prosecuted under the federal Anti-Kickback Statute. Although
full compliance with these provisions ensures against prosecution under the
federal Anti-Kickback Statute, the failure of a transaction or arrangement to
fit within a specific safe harbor does not necessarily mean that the transaction
or arrangement is illegal or that prosecution under the federal Anti-Kickback
Statute will be pursued.
From time
to time, the Office of Inspector General, or OIG, issues alerts and other
guidance on certain practices in the healthcare industry. In October 1994, the
OIG issued a Special Fraud Alert on arrangements for the provision of clinical
laboratory services. The Fraud Alert set forth a number of practices allegedly
engaged in by some clinical laboratories and healthcare providers that raise
issues under the “fraud and abuse” laws, including the Anti-Kickback Statute.
These practices include: (i) laboratories providing employees to furnish
valuable services for physicians (other than collecting patient specimens for
testing for the laboratory) that are typically the responsibility of the
physicians’ staff; (ii) providing free testing to a physician’s managed care
patients in situations where the referring physicians benefit from such reduced
laboratory utilization; (iii) providing free pick-up and disposal of
bio-hazardous waste for physicians for items unrelated to a laboratory’s testing
services; (iv) providing general-use facsimile machines or computers to
physicians that are not exclusively used in connection with the laboratory
services; and (v) providing free testing for healthcare providers, their
families, and their employees (professional courtesy testing).
The OIG
emphasized in the Special Fraud Alert that when one purpose of an arrangement is
to induce referrals of program-reimbursed laboratory testing, both the clinical
laboratory and the healthcare provider, or physician, may be liable under the
Anti-Kickback Statute, and may be subject to criminal prosecution and exclusion
from participation in the Medicare and Medicaid programs.
Another
issue about which the OIG has expressed concern involves the provision of
discounts on laboratory services billed to customers in return for the referral
of more lucrative federal healthcare program business. In a 1999 Advisory
Opinion, the OIG concluded that a proposed arrangement whereby a laboratory
would offer physicians significant discounts on non-federal healthcare program
laboratory tests might violate the Anti-Kickback Statute. The OIG reasoned that
the laboratory could be viewed as providing such discounts to the physician in
exchange for referrals by the physician of business to be billed by the
laboratory to Medicare at non-discounted rates. The OIG indicated that the
arrangement would not qualify for protection under the discount safe harbor
because Medicare and Medicaid would not get the benefit of the discount.
Subsequently, in a year 2000 correspondence, the OIG stated that the
Anti-Kickback Statute may be violated if there were linkage between the discount
offered to the physician and the physician’s referrals of tests covered under a
federal healthcare program that would be billed by the laboratory directly.
Where there was evidence of such linkage, the arrangement would be considered
“suspect” if the charge to the physician was below the laboratory’s “average
fully loaded costs” of the test.
Generally,
arrangements that would be considered suspect, and possible violations under the
Anti-Kickback Statute, include arrangements between a clinical laboratory and a
physician (or related organizations or individuals) in which the laboratory
would (1) provide items or services to the physician or other referral source
without charge, or for amounts that are less than their fair market value; (2)
pay the physician or other referral source amounts that are in excess of the
fair market value of items or services that were provided; or (3) enter into an
arrangement with a physician or other entity because it is a current or
potential referral source. HIPAA also applies to fraud and false
statements. HIPAA created two new federal crimes: healthcare fraud and false
statements relating to healthcare matters. The healthcare fraud statute
prohibits knowingly and willfully executing a scheme to defraud any healthcare
benefit program, including private payors. A violation of this statute is a
felony and may result in fines, imprisonment, or exclusion from governmental
payor programs such as the Medicare and Medicaid programs. The false statements
statute prohibits knowingly and willfully falsifying, concealing, or covering up
a material fact or making any materially false, fictitious, or fraudulent
statement in connection with the delivery of or payment for healthcare benefits,
items, or services. A violation of this statute is a felony and may result in
fines or imprisonment or exclusion from governmental payor
programs.
Physician
Referral Prohibitions
Under a
federal law directed at “self-referral,” commonly known as the Stark Law,
prohibitions exist, with certain exceptions, on Medicare and Medicaid payments
for laboratory tests referred by physicians who personally, or through a family
member, have an investment interest in, or a compensation arrangement with, the
laboratory performing the tests. A person who engages in a scheme to circumvent
the Stark Law’s referral prohibition may be fined up to $100,000 for each such
arrangement or scheme. In addition, any person who presents or causes to be
presented a claim to the Medicare or Medicaid programs in violation of the Stark
Law is subject to civil monetary penalties of up to $15,000 per bill submission,
an assessment of up to three times the amount claimed, and possible exclusion
from participation in federal governmental payor programs. Bills submitted in
violation of the Stark Law may not be paid by Medicare or Medicaid, and any
person collecting any amounts with respect to any such prohibited bill is
obligated to refund such amounts.
Any
arrangement between a laboratory and a physician or physicians’ practice that
involves remuneration will prohibit the laboratory from obtaining payment for
services resulting from the physicians’ referrals, unless the arrangement is
protected by an exception to the self-referral prohibition or a provision
stating that the particular arrangement would not result in remuneration. Among
other things, a laboratory’s provision of any item, device, or supply to a
physician would result in a Stark Law violation unless it was used only to
collect, transport, process, or store specimens for the laboratory, or was used
only to order tests or procedures or communicate related results. This may
preclude a laboratory’s provision of fax machines and computers that may be used
for unrelated purposes. Most arrangements involving physicians that would
violate the Anti-Kickback Statute would also violate the Stark Law. Many states
also have “self-referral” and other laws that are not limited to Medicare and
Medicaid referrals. These laws may prohibit arrangements which are not
prohibited by the Stark Law, such as a laboratory’s placement of a phlebotomist
in a physician’s office to collect specimens for the laboratory.
Discriminatory
Billing Prohibition
In
response to competitive pressures, the Company will be increasingly required to
offer discounted pricing arrangements to managed care payers and physicians and
other referral services. Discounts to referral sources raise issues
under the Anti-Kickback Statute. Any discounted charge below the
amount that Medicare or Medicaid would pay for a service also raises issues
under Medicare’s discriminatory billing prohibition. The Medicare statute
permits the government to exclude a laboratory from participation in federal
healthcare programs if it charges Medicare or Medicaid “substantially in excess”
of its usual charges in the absence of “good cause.” In 2000, the OIG stated in
informal correspondence that the prohibition was violated only if the
laboratory’s charge to Medicare was substantially more than the “median
non-Medicare/–Medicaid charge.” On September 15, 2003, the OIG issued a notice
of proposed rulemaking addressing the statutory prohibition. Under the proposed
rule, a provider’s charge to Medicare or Medicaid would be considered
“substantially in excess of [its] usual charges” if it was more than 120% of the
provider’s mean or median charge for the service. The proposed rule was
withdrawn in June 2007. At that time, the OIG stated that it would continue to
evaluate billing patterns of individuals and entities on a case-by-case
basis.
Competitive
Bidding
The
Medicare Modernization Act of 2003 required CMS to conduct a demonstration
program on using competitive bidding for clinical lab tests that are furnished
without a face-to-face encounter between the individual and the entity
performing the test, to determine whether competitive bidding could be used to
provide lab services at reduced cost to Medicare, while continuing to maintain
quality and access to care. The Medicare Improvements for Patients
and Providers Act of 2008 repealed the Medicare Competitive Bidding
Demonstration Project for Clinical Laboratory
Services. Reintroduction by statute and widespread use of competitive
bidding, if implemented for clinical lab services, could have a significant
effect on the clinical laboratory industry and on us. The Company
could be precluded from furnishing certain clinical laboratory services to
Medicare beneficiaries if it is not the successful bidder or, as part of the
competitive bidding process, it could be required to offer reduced payment
amounts in order to participate in the arrangement. In addition,
states could initiate efforts to establish competitive bidding processes for the
provision of clinical laboratory services under the state Medicaid
program.
Corporate
Practice of Medicine
The
Company’s contractual relationships with the licensed healthcare providers are
subject to regulatory oversight, mainly by state licensing authorities. In
certain states, for example, limitations may apply to the relationship with the
pathologists that the Company intends to employ or engage, particularly in terms
of the degree of control that the Company exercises or has the power to exercise
over the practice of medicine by those pathologists. A number of states,
including New York, Texas, and California, have enacted laws prohibiting
business corporations, such as the Company, from practicing medicine and
employing or engaging physicians to practice medicine. These requirements are
generally imposed by state law in the states in which the Company operates, vary
from state to state, and are not always consistent among states. In addition,
these requirements are subject to broad powers of interpretation and enforcement
by state regulators. Some of these requirements may apply to the Company even if
it does not have a physical presence in the state, based solely on the
employment of a healthcare provider licensed in the state or the provision of
services to a resident of the state. The Company believes that it operates in
material compliance with these requirements. However, failure to comply can lead
to action against the Company and the licensed healthcare professionals that it
employs, fines or penalties, receipt of cease and desist orders from state
regulators, loss of healthcare professionals’ licenses or permits, the need to
make changes to the terms of engagement of those professionals that interfere
with the Company’s business, and other material adverse
consequences.
State
Laboratory Licensure
The
Company intends that its laboratory will be certified by CLIA and be licensed in
the state of Washington. However, many state licensure laws require a laboratory
that solicits or tests specimens from individuals within that state to hold a
license from that state, even if the testing occurs in another state. The
Company intends to accept testing from California, New York, Pennsylvania,
Maryland, New Jersey, and Rhode Island, which require out-of-state laboratories
to hold state licenses. The Company intends to apply for licenses in
these states. Similarly, many of the states from which it will
solicit specimens require that a physician interpreting specimens from that
state be licensed by that particular state, irrespective of where the services
are to be provided. In the absence of such a state license, the physician may be
considered to be engaged in the unlicensed practice of medicine.
The
Company may become aware from time to time of other states that require out of
state laboratories or physicians to obtain licensure in order to accept
specimens from the state, and it is possible that other states do have such
requirements or will have such requirements in the future. The Company intends
to follow instructions from the state regulators as how to comply with such
requirements.
Referrals
after Becoming a Public Company
Once the
Company’s stock is publicly traded, it will not be able to accept referrals from
physicians who own, directly or indirectly, shares of its stock unless it
complies with the Stark Law exception for publicly traded securities. This
requires, among other things, $75 million in stockholders’ equity (total assets
minus total liabilities). The parallel safe harbor requires, among other things,
$50 million in undepreciated net tangible assets, in order for any distributions
to such stockholders to be protected under the Anti-Kickback
Statute.
Other
Regulatory Requirements
The
Company’s laboratory will be subject to federal, state, and local regulations
relating to the handling and disposal of regulated medical waste, hazardous
waste, and biohazardous waste, including chemical, biological agents and
compounds, and human tissue. The Company intends to use outside vendors who are
contractually obligated to comply with applicable laws and regulations to
dispose of such waste. These vendors will be licensed or otherwise qualified to
handle and dispose of such waste.
The
Occupational Safety and Health Administration, or OSHA, has established
extensive requirements relating to workplace safety for healthcare employers,
including requirements mandating work practice controls, protective clothing and
equipment, training, medical follow-up, vaccinations, and other measures
designed to minimize exposure to, and transmission of, blood-borne pathogens.
Pursuant to its authority under the FDCA, the FDA has regulatory responsibility
over instruments, test kits, reagents, and other devices used to perform
diagnostic testing by laboratories such as ours. Specifically, the manufacturers
and suppliers of analyte specific reagents, or ASRs, which we will obtain for
use in diagnostic tests, are subject to regulation by the FDA and are required
to register their establishments with the FDA, to conform manufacturing
operations to the FDA’s Quality System Regulation and to comply with certain
reporting and other record keeping requirements. The FDA also regulates the sale
or distribution, in interstate commerce, of products classified as medical
devices under the FDCA, including in vitro diagnostic test
kits. Such devices must undergo premarket review by the FDA prior to
commercialization unless the device is of a type exempted from such review by
statute or pursuant to the FDA’s exercise of enforcement
discretion.
The FDA
maintains that it has authority to regulate the development and use of LDTs or
“home brews” as medical devices, but to date has not exercised its authority
with respect to “home brew” tests as a matter of enforcement discretion. The FDA
regularly considers the application of additional regulatory controls over the
sale of ASRs and the development and use of “home brews” by laboratories such as
the Company’s.
The FDA
has announced public hearings to discuss oversight of LDTs. While the
outcome of those hearings is unknown, it is probable that some form of
pre-market notification or approval process will become a requirement for
certain LDTs. Pre-market notification or approval of the Company’s
future LDTs would be costly and delay the ability of the Company to
commercialize such tests.
Compliance
Program
Compliance
with government rules and regulations is a significant concern throughout the
industry, in part due to evolving interpretations of these rules and
regulations. The Company will seek to conduct its business in
compliance with all statutes and regulations applicable to its
operations. To this end, it has determined that it will establish an
informal compliance program that reviews for regulatory compliance procedures,
policies, and facilities throughout its business. To better focus
compliance efforts, the Company intends to hire an experienced compliance
officer when appropriate and develop a formal compliance program. The
Company will endeavor to make all suitable adjustments or modifications as
become known or necessary in order to comply with these complex set of laws and
regulations.
Legal
Proceedings
The
Company is not a party to any material legal proceedings.
Employees
As of
September 1, 2010, the Company had three executive officers, one of whom serves
in such capacity as a consultant to the Company, and one other employee. The
Company expects that it will hire more employees as it expands.
Property
The
Company’s corporate headquarters are located at 4105 East Madison Street, Suite
320, Seattle, Washington 98112 where the Company occupies approximately 330
square feet of office space. The original term of the lease shall
terminate on December 31, 2010, with annual rent of $13,200 plus applicable
sales tax. From April 30, 2009 (inception) through June 30, 2010, the
Company incurred $6,848 of rent expense for the lease. As of June 30,
2010, security deposit for the lease amounted to $1,100. On July 15,
2010, the Company and Ensisheim terminated the lease, effective July 1, 2010 and
the Company began receiving free rent from Ensisheim. The Company
leases approximately 1,300 square feet of office and laboratory space in the
Seattle Life Sciences Center in Seattle, Washington, under a six-month lease
which will convert into a month-to-month lease starting in March,
2011. The Company believes that its current facilities will be
adequate to meet its needs for the next 12 months. The Company
intends to lease additional or alternative office and laboratory space in the
Greater Seattle area in the second half of 2011, if needed.
Insurance
The
Company currently maintains commercial general and office premises liability
insurance. At the time the Company establishes its laboratory and
launches the MASCT System, it expects to obtain liability insurance for its
products and services. As a general matter, providers of diagnostic
services may be subject to lawsuits alleging medical malpractice or other
similar legal claims. Some of these suits involve claims for
substantial damages. The Company believes that it will be able to
obtain adequate insurance coverage in the future at acceptable costs, but cannot
assure that it will be able to do so.
MANAGEMENT
The
following table sets forth information regarding the members of the board of
directors of the Company and its executive officers as of September 15,
2010:
Executive
Officers, Directors and Prospective Directors
|
|
|
|
|
Steven
C. Quay, M.D., Ph.D.
|
|
59
|
|
Chairman
of the Board of Directors, Chief Executive Officer and
President
|
Christopher
Benjamin
|
|
36
|
|
Chief
Financial Officer
|
Shu-Chih
Chen, Ph.D.
|
|
48
|
|
Director,
Chief Scientific Officer
|
John
Barnhart
|
|
53
|
|
Director
|
Mary
Tagliaferri, M.D.
|
|
44
|
|
Director
Nominee
|
Stephen
Galli, M.D.
|
|
60
|
|
Director
Nominee
|
Alexander
Cross, Ph.D.
|
|
78
|
|
Director
Nominee
|
Mary
Tagliaferri, M.D., Stephen Galli, M.D., and Alexander Cross, Ph.D., have agreed
to serve on the board of directors of the Company concurrent with the closing of
this offering.
The
Company’s bylaws provide that the number of directors authorized to serve on the
board of directors of the Company may be established, from time to time, by
action of the board of directors of the Company. Vacancies in the
existing board of directors of the Company are filled by a majority vote of the
remaining directors on the board of directors of the
Company. Directors serve for a one-year term until each subsequent
annual meeting of stockholders and until their respective successors have been
elected and qualified or until death, resignation or removal. The
Company’s executive officers are appointed by and serve at the discretion of the
board of directors of the Company.
Dr. Quay
is the Chief Executive Officer and Chairman of the board of directors of the
Company. Dr. Shu-Chih Chen is the Chief Scientific Officer and a
director. Drs. Quay and Chen are husband and wife. They currently
beneficially own a majority of the outstanding voting securities of the
Company. Following the completion of this offering and exercise of
the Class A Warrants, they will remain substantial minority
stockholders.
Steven C. Quay,
M.D., Ph.D. Dr. Quay has served as Chief Executive Officer and
Chairman of the board of directors of the Company since the Company was
incorporated in April 2009. Prior to his work at the Company, Dr.
Quay served as Chairman of the Board, President and Chief Executive Officer of
MDRNA, Inc. from August 2000 to May 2008, and as its Chief Scientific Officer
until November 31, 2008. Dr. Quay is certified in Anatomic Pathology
with the American Board of Pathology, with training at Massachusetts General
Hospital and Harvard Medical School, is a former faculty member of the
Department of Pathology, Stanford University School of Medicine, and is a named
inventor on 14 U.S. and foreign patents covering the MASCT System. He
oversaw the clinical testing and regulatory filing of the MASCT device with the
FDA that led to its ultimate marketing clearance. Including the
patents for the MASCT System, Dr. Quay has a total of 69 U.S. patents, 92
pending patent applications and is a named inventor on patents covering five
pharmaceutical products that have been approved by the FDA. Dr. Quay
received an M.D. in 1977 and a Ph.D. in 1975 from the University of Michigan
Medical School. He also received his B.A. degree in biology,
chemistry and mathematics from Western Michigan University in
1971. Dr. Quay is a member of the American Society of Investigative
Pathology, the Association of Molecular Pathology and the Association of
Pathology Informatics. He was selected to serve on the Company’s
board of directors because of his role as the founder of the Company and the
inventor of the MASCT System, as well as his qualifications as a physician and
the principal researcher overseeing the clinical and regulatory development of
the MASCT System.
Christopher
Benjamin. Mr. Benjamin has served as Chief Financial Officer
of the Company since July 2010. His experience includes both public
and private company financial reporting expertise. Based in Seattle,
Mr. Benjamin has served as President of Rogue CFO Consulting since November
2007, as well as serving as the Chief Financial Officer for NexTec and Redfin
Corporations and acting as the Accounting Manager and Assistant Controller for
the Bsquare Corporation. His responsibilities at these companies
included monthly financial reporting and analysis, audit and cash management,
forecasting, oversight of the General Ledger, as well as ensuring compliance
with GAAP, FASB and SEC reporting standards. From February 2003 to
November 2005, Mr. Benjamin worked at Cascade Natural Gas Corporation, where his
responsibilities included serving as Manager of Financial Reporting and Fixed
Assets, along with Sarbanes Oxley process documentation, process flow creation
and SEC reporting support. He received his M.B.A. from the University
of Washington in Seattle in 2007 and a B.A. in accounting from the University of
Fraser Valley in Abbotsford, British Columbia, Canada in 1997.
Shu Chih Chen,
Ph.D. Dr.
Chen has served as Chief Scientific Officer and director of the Company since
the Company was incorporated in April 2009. Prior to joining the
Company, Dr. Chen served as President of Ensisheim beginning in 2008, was
founder and President of SC2Q Consulting Company from 2006 to 2008, and served
as Head, Cell Biology, Nastech Pharmaceuticals Company, Inc. from 2002 to
2006. During 1995 and 1996, she was an Associate Professor at
National Yang Ming University, Taipei, Taiwan, and served as the principal
investigator of an NIH RO1 grant studying tumor suppression by gap junction
protein connexin 43 at the Department of Molecular Medicine at Northwest
Hospital before working in the research department at Nastech Pharmaceutical
Company. She is named as an inventor on four patent
applications related to cancer therapeutics. Dr. Chen received her
Ph.D. degree in microbiology and public health from Michigan State University in
1992 and has published extensively on Molecular Oncology. She received her B.S.
degree in medical technology from National Yang Ming University, Taipei, Taiwan
in 1984. Dr. Chen was selected to serve on the Company’s board of
directors because of her qualifications as a professor and researcher in the
field of cancer therapeutics.
John
Barnhart. Mr. Barnhart has served
as a director of the Company since July 2009. He is the founder and
has been the Managing Director of the Visconti Group, a management consulting
group in Seattle, Washington, since November 2003. He held prior
executive positions at The Walt Disney Company, Sony Pictures Entertainment, and
Walt Disney Imagineering. He received a B.S. degree in engineering
from California State University, Long Beach in 1974. Mr. Barnhart
was selected to serve on the Company’s board of directors because of his
understanding and experience with development and marketing of consumer products
and services.
Mary Tagliaferri,
M.D. Dr. Tagliaferri will become a member of the Company’s
board of directors upon the completion of this offering. Dr.
Tagliaferri is a co-founder of Bionovo Pharmaceuticals and has served in various
capacities there since February 2002. Most recently, in May 2007, she
was appointed as its President. She was appointed as a director of
Bionovo in May 2005 and as its Chief Medical Officer, Secretary and Treasurer in
April 2005, and continues to serve in these capacities. Bionovo is a
drug discovery and development company focused on developing safe and effective
drugs for the treatment of unmet medical needs in women’s health and cancer,
including a clinical-stage novel formulation for breast cancer. Dr.
Tagliaferri conducted translational research at the University of California,
San Francisco from 1996 to 2002 and has participated in the development of
ductal lavage, a method of obtaining NAF through cannulating the ducts. Dr.
Tagliaferri received her M.D. degree from University of California, San
Francisco and her B.S. from Cornell University. She also hold an M.S.
degree in traditional Chinese medicine from the American College of Traditional
Chinese Medicine. Dr. Tagliaferri has been selected as a director
nominee because of her experience as a founder, officer and director of a
biopharmaceutical company developing treatments for breast cancer, as well as
her qualifications as a physician and researcher in the area of breast health,
including NAF collection.
Stephen Galli,
M.D. Dr. Galli will become a member of the Company’s board of
directors upon the completion of this offering. Dr. Galli is Chair of
the Department of Pathology, Professor of Pathology and of Microbiology &
Immunology and the Mary Hewitt Loveless, M.D., Professor, Stanford University
School of Medicine, Stanford, California, and has served in these capacities
since February 1999. Before joining Stanford, he was on the faculty
of Harvard Medical School. He holds 13 U.S. patents and has over 340
publications. He is past president of the American Society for Investigative
Pathology and current president of the Collegium Internationale
Allergologicum. In addition to receiving awards for his research, he
was recently recognized with the 2010 Stanford University President’s Award for
Excellence Through Diversity for his recruitment and support of women and
underrepresented minorities at Stanford University. He received his
B.A. degree in biology, magna cum laude, from Harvard College in 1968 and his
M.D. degree from Harvard Medical School in 1973 and completed a residency in
anatomic pathology at the Massachusetts General Hospital in 1977. Dr.
Galli has been selected as a director nominee because of his qualifications as a
professor and physician, and his specialized expertise as a
pathologist.
Alexander D.
Cross, Ph.D. Dr. Cross will become a member of the Company’s
board of directors upon completion of this offering. Dr. Cross has
served on the board and as a member of the Audit, Compensation, and Nominating
and Governance Committees of a number of public companies, including MDRNA, Inc.
and Ligand Pharmaceuticals Inc. Dr. Cross also served as Chairman of
the Board and CEO of Cytopharm, Inc. until August 2006. Dr. Cross has
been a consultant in the fields of pharmaceuticals and biotechnology since
January 1986 and has served as a principal of NDA Partners, LLC since
2003. Previously, Dr. Cross served as President and CEO of Zoecon
Corporation, a biotechnology company, from April 1983 to December 1985, and
Executive Vice President and Chief Operating Officer from 1979 to
1983. Dr. Cross also previously held several corporate management
positions at Syntex Corporation from 1961 through 1979. Dr. Cross holds 109
issued United States patents and is the author of 90 peer-reviewed publications.
Dr. Cross received his B.Sc., Ph.D. and D.Sc. degrees from the University of
Nottingham, England, and is a Fellow of the Royal Society of
Chemistry. Dr. Cross has been selected as a director nominee because
of his qualifications as a scientist, business executive and audit committee
financial expert, and his prior experience as a director and committee member of
public companies.
Scientific
Advisory Board
The
Company has established a Scientific Advisory Board to provide strategic
resources to the Company’s management and its board of directors. It is intended
that the Company’s scientific advisory board will have knowledge in breast
cancer, NAF, and breast cancer biomarkers. The Company expects to
expand the board members in the future. The initial Scientific Advisory Board
currently consists of:
Dr. Edward
Sauter, M.D., Ph.D. Dr. Sauter is
the Associate Dean for Research and Professor of Surgery at the University of
North Dakota School of Medicine & Health Sciences. He received his M.D. from
the Louisiana State School of Medicine and his Ph.D. from the University of
Pennsylvania. He completed his general surgery residency at the Ochsner Clinic,
in New Orleans, Louisiana. Dr. Sauter also completed a Surgical
Oncology Fellowship at Fox Chase Cancer Center in Philadelphia, Pennsylvania.
Dr. Sauter was Vice-Chair for Research in the Department of Surgery and
Professor at the University of Missouri-Columbia. He also completed his MHA
while at the University of Missouri. Dr. Sauter is widely recognized for his
research and clinical experience in breast cancer. Among his many
accomplishments, Dr. Sauter and a team of researchers pioneered noninvasive and
minimally invasive techniques to predict breast cancer risk using NAF. Dr.
Sauter is the co-author of over 100 peer-reviewed publications on breast cancer,
the majority of which pertain to cytology and molecular diagnostic biomarkers in
NAF.
Dr.
Sauter and the Company entered into a consulting agreement on February 18, 2010
which provides a $5,000 signing fee and $1,000 per month for up to four hours
per month of Dr. Sauter’s time. The agreement also provides
reasonable travel expenses in connection with his work for the Company. The
agreement terminates on December 31, 2010 but can be renewed by agreement of the
parties.
Director
Compensation
Upon
completion of this offering, Mr. Barnhart and Drs. Tagliaferri, Galli and Cross,
as non-employee directors of the Company, will receive the
following:
|
·
|
an
initial director compensation fee of $50,000, paid in shares of the
Company’s common stock and that vests ratably over one year from the date
of grant;
|
|
·
|
an
annual director retainer of $50,000, paid in shares of the Company’s
common stock and that vests ratably over one year from the date of grant;
and
|
|
·
|
an
in-person meeting fee of $1,500 and a telephone meeting fee of
$1,000.
|
Compensation
for service on the Audit Committee will be $12,000 for the Chair and $8,000 for
each member, paid in fully vested shares of the Company’s common stock or
options, payable quarterly in arrears.
Compensation
for service on the Compensation Committee and Nominating/Governance Committee
will be $10,000 for the Chair and $6,000 for each member, paid in fully
vested shares of
the Company’s common stock or options, payable quarterly in
arrears.
All
committee members will also receive a cash payment of $2,000 per in-person
meeting for the Chair and $1,500 per in-person meeting for each member and
$1,500 per telephonic meeting for the Chair and $1,000 per telephonic meeting
for each member.
The
employee directors will receive no compensation for their board
service. All directors will receive reimbursement for reasonable
travel expenses.
Director
Independence
The board
of directors of the Company has reviewed the materiality of any relationship
that each of our directors and prospective directors has with the Company,
either directly or indirectly. Based on this review, the board of directors of
the Company has determined that John Barnhart, a current director, and the
following director nominees will be “independent directors” as
defined by Section 803(A)(2)(b) of the NYSE Amex LLC Company Guide at the time
they become directors (upon the completion of this offering): Mary Tagliaferri,
M.D., Stephen Galli, M.D. and Alexander Cross, Ph.D.
Committees
of the Board of Directors of the Company
The board
of directors of the Company has provided for the establishment of an audit
committee, a compensation committee and a nominating/governance committee
effective upon the completion of this offering. The composition and function of
each of these committees is described below.
Upon
completion of this offering, the audit committee will be comprised of Dr. Cross
(chair), Mr. Barnhart and Dr. Galli. The board of directors of the Company has
determined that Dr. Cross is an audit committee financial expert, as defined by
the rules of the SEC. The audit committee will be authorized to:
|
·
|
approve
and retain the independent registered public accounting firm to conduct
the annual audit of the Company’s financial
statements;
|
|
·
|
review
the proposed scope and results of the
audit;
|
|
·
|
review
and pre-approve audit and non-audit fees and
services;
|
|
·
|
review
accounting and financial controls with the independent auditors and the
Company’s financial and accounting
staff;
|
|
·
|
review
and approve transactions between the Company and its directors, officers
and affiliates;
|
|
·
|
recognize
and prevent prohibited non-audit services;
and
|
|
·
|
establish
procedures for complaints received by the Company regarding accounting
matters; oversee internal audit functions, if
any.
|
The
Company believes that the composition of its audit committee will meet the
independence requirements of the applicable rules of the SEC and NYSE Amex upon
completion of this offering.
Compensation
Committee
Upon the
completion of this offering, the compensation committee will be comprised of Dr.
Tagliaferri (chair), Mr. Barnhart and Dr. Cross. All members of the compensation
committee will qualify as independent directors under the current definition
promulgated by NYSE Amex. The compensation committee will be
authorized to:
|
·
|
review
and recommend the compensation arrangements for
management;
|
|
·
|
establish
and review general compensation policies with the objective to attract and
retain superior talent, to reward individual performance and to achieve
our financial goals;
|
|
·
|
administer
stock incentive and purchase plans;
and
|
|
·
|
oversee
the evaluation of the board of directors of the Company and
management.
|
Nominating and Governance
Committee
Upon the
completion of this offering, the nominating and governance committee will be
comprised of Mr. Barnhart (chair), Dr. Galli and Dr. Tagliaferri. All
members of the nominating and governance committee will qualify as independent
directors under the current definition promulgated by NYSE Amex. The
nominating and governance committee will be authorized to:
|
·
|
identify
and nominate candidates for election to the board of directors of the
Company; and
|
|
·
|
develop
and recommend to the board of directors of the Company a set of corporate
governance principles applicable to our
company.
|
Compensation
Committee Interlocks and Insider Participation
No
prospective member of our compensation committee has at any time been an
employee of ours. None of our executive officers serves as a member
of the board of directors or compensation committee of any other entity that has
one or more executive officers serving as a member of our board of directors or
compensation committee.
Code
of Business Conduct and Ethics
The
Company intends to adopt a code of business conduct and ethics that applies to
all its employees, officers and directors, including those officers responsible
for financial reporting. The code of business conduct and ethics will be
available on the Company’s website. The Company expects that any
amendments to the code, or any waivers of its requirements, will be disclosed on
its website.
Limitation
of Directors’ and Officers’ Liability and Indemnification
The
Delaware General Corporation Law authorizes corporations to limit or eliminate,
subject to specified conditions, the personal liability of directors to
corporations and their stockholders for monetary damages for breach of their
fiduciary duties. The Company’s certificate of incorporation and
amended and restated bylaws limit the liability of its directors to the fullest
extent permitted by Delaware law.
The
Company has obtained director and officer liability insurance to cover
liabilities the Company’s directors and officers may incur in connection with
their services to the Company. The Company’s certificate of
incorporation and amended and restated bylaws also provide that it will
indemnify and advance expenses to any of its directors and officers who, by
reason of the fact that he or she is an officer or director, is involved in a
legal proceeding of any nature. The Company will repay certain
expenses incurred by a director or officer in connection with any civil,
criminal, administrative or investigative action or proceeding, including
actions by the Company or in its name. Such indemnifiable expenses include, to
the maximum extent permitted by law, attorney’s fees, judgments, fines,
settlement amounts and other expenses reasonably incurred in connection with
legal proceedings. A director or officer will not receive indemnification if he
or she is found not to have acted in good faith and in a manner he or she
reasonably believed to be in, or not opposed to, the Company’s best
interest.
Such
limitation of liability and indemnification does not affect the availability of
equitable remedies. In addition, the Company has been advised that in the
opinion of the SEC, indemnification for liabilities arising under the Securities
Act of 1933, as amended, is against public policy as expressed in the Securities
Act and is therefore unenforceable.
There is
no pending litigation or proceeding involving any of the Company’s directors,
officers, employees or agents in which indemnification will be required or
permitted. The Company is not aware of any threatened litigation or proceeding
that may result in a claim for such indemnification.
EXECUTIVE
COMPENSATION
Remuneration
of Officers
The
Company did not accrue or pay any remuneration or compensation to any officer,
director or employee in 2009. In 2010, the Company has accrued salary
payments to Dr. Steven C. Quay and Dr. Shu-Chih Chen as of June 30, 2010 in the
amounts and on the terms as defined below. The monthly accruals are
approximately $20,833, and $16,667, respectively.
Upon the
completion of this offering, the Company’s compensation committee will be
responsible for reviewing and evaluating key executive employee base salaries,
setting goals and objectives for executive bonuses and administering benefit
plans. The compensation committee will provide advice and recommendations to the
board of directors of the Company on such matters. See “Committees of
the Board of Directors—Compensation Committee” for further details on the role
of the compensation committee.
Employment
Agreements
Employment
Agreement with Steven Quay, M.D. Ph.D.
The
Company has entered into an employment agreement with Dr. Quay to act as the
Company’s chief executive officer. The agreement will provide for an
initial base salary of $250,000 per year and an annual target bonus of up to 40%
of Dr. Quay’s then-current base salary, payable upon the achievement of
performance goals to be established annually by the compensation
committee.
Under the
employment agreement, Dr. Quay received an option to purchase 250,000 shares of
common stock at an exercise price of $5.00 per share, the fair market value of
the common stock on the date of grant, as determined by the Board of
Directors. 25% of the shares of common stock underlying the option,
or 62,500 shares, will vest on December 31, 2010, and the remaining 75%, or
187,500 shares, will vest in equal quarterly installments over the next three
years, so long as Dr. Quay remains employed with the Company.
During
the employment term, the Company will make available to Dr. Quay employee
benefits provided to other key employees and officers of the
Company. To the extent these benefits are based on length of service
with the Company, Dr. Quay will receive full credit for prior service with the
Company. Participation in health, hospitalization, disability, dental
and other insurance plans that the Company may have in effect for other
executives, all of which shall be paid for by the Company with contribution by
Dr. Quay as set for the other executives, as and if appropriate.
Dr. Quay
will be entitled to six weeks of paid vacation per year for each full year of
employment, pro rated for each partial year. Vacation time not taken
during a calendar year will not be accrued to the next calendar
year.
Dr. Quay
has also agreed that, for the period commencing on the date of his employment
agreement with the Company and during the term of his employment and for a
period of 12 months following voluntary termination of his employment with the
Company that he will not compete with the Company in the United
States. The employment agreement also contains provisions relating to
confidential information and assignment of inventions, which require Dr. Quay to
refrain from disclosing any proprietary information and to assign to the Company
any inventions which directly concern the MASCT System, Oxy-MASCT System, or
future products, research, or development, or which result from work they
perform for the Company or using its facilities.
Consulting
Agreement with Christopher Benjamin
The
Company has entered into an agreement with Christopher Benjamin to act as the
Company’s interim chief financial officer. The agreement provides a
monthly retainer fee of $2,250 for up to 25 hours of work per month and $100 per
hour beyond that level. The agreement may be terminated by the
Company upon 30 days written notice.
Employment
Agreement with Shu-Chih Chen
The
Company has entered into an amended and restated employment agreement with Dr.
Chen to act as the Company’s chief scientific officer. The agreement
will provide for an initial base salary of $200,000 per year and an annual
target bonus of up to 30% of Dr. Chen’s then-current base salary, payable upon
the achievement of performance goals to be established annually by the
compensation committee.
Under the
employment agreement, Dr. Chen received an option to purchase 100,000 shares of
common stock at an exercise price of $5.00 per share, the fair market value of
the common stock on the date of grant, as determined by the Board of
Directors. 25% of the shares of common stock underlying the option,
or 25,000 shares, will vest on December 31, 2010, and the remaining 75%, or
75,000 shares, will vest in equal quarterly installments over the next three
years, so long as Dr. Chen remains employed with the Company.
During
the employment term, the Company will make available to Dr. Chen employee
benefits provided to other key employees and officers of the
Company. To the extent these benefits are based on length of service
with the Company, Dr. Chen will receive full credit for prior service with the
Company. Participation in health, hospitalization, disability, dental
and other insurance plans that the Company may have in effect for other
executives, all of which shall be paid for by the Company with contribution by
Dr. Chen as set for the other executives, as and if appropriate.
Dr. Chen
will be entitled to six weeks of paid vacation per year for each full year of
employment, pro rated for each partial year. Vacation time not taken
during a calendar year will not be accrued to the next calendar
year.
Dr. Chen
has also agreed that, for the period commencing on the date of her employment
agreement with the Company and during the term of her employment and for a
period of 12 months following voluntary termination of her employment with the
Company that she will not compete with the Company in the United
States. The employment agreement also contains provisions relating to
confidential information and assignment of inventions, which require Dr. Chen to
refrain from disclosing any proprietary information and to assign to the Company
any inventions which directly concern the MASCT System, Oxy-MASCT System, or
future products, research, or development, or which result from work she
performs for the Company or using its facilities.
Severance
Benefits and Change in Control Arrangements
The
Company has agreed to provide the severance benefits and change in control
arrangements described below to its named executive officers.
Dr.
Steven Quay
Pursuant
to his employment agreement, if (i) the Company terminates the employment of Dr.
Quay without cause, or (ii) Dr. Quay terminates his employment for good reason,
then Dr. Quay will be entitled to receive all accrued but unpaid compensation,
plus a severance payment equal to twelve months of base salary. In
addition, upon such event, the vesting of all shares of common stock underlying
options then held by Dr. Quay will accelerate, and the options will remain
exercisable for the remainder of their terms. The cash severance
payment is required to be paid in substantially equal installments over a period
of six months beginning on the Company’s first payroll date that occurs
following the 30th day
after the effective date of termination of Dr. Quay’s employment, subject to
certain conditions. The Company will not be required, however, to pay
any severance pay for any period following the termination date if Dr. Quay
materially violates certain provisions of his employment agreement and the
violation is not cured within 30 days following receipt of written notice from
the Company containing a description of the violation and a demand for immediate
cure.
In
addition, under the terms of his employment agreement, in the event of a “change
in control” of the Company (as defined in the employment agreement) during Dr.
Quay’s employment term, Dr. Quay will be entitled to receive a one-time payment
equal to 2.9 times his base salary, and the vesting of all outstanding equity
awards then held by Dr. Quay will accelerate such that they are fully vested as
of the date of the change in control.
Dr.
Shu-Chih Chen
Pursuant
to her employment agreement, if (i) the Company terminates the employment of Dr.
Chen without cause, or (ii) Dr. Chen terminates her employment for good reason,
then Dr. Chen will be entitled to receive all accrued but unpaid compensation,
plus a severance payment equal to twelve months of base salary. In
addition, upon such event, the vesting of all shares of common stock underlying
options then held by Dr. Chen will accelerate, and the options will remain
exercisable for the remainder of their terms. The cash severance
payment is required to be paid in substantially equal installments over a period
of six months beginning on the Company’s first payroll date that occurs
following the 30th day
after the effective date of termination of Dr. Chen’s employment, subject to
certain conditions. The Company will not be required, however, to pay
any severance pay for any period following the termination date if Dr. Chen
materially violates certain provisions of her employment agreement and the
violation is not cured within 30 days following receipt of written notice from
the Company containing a description of the violation and a demand for immediate
cure.
In
addition, under the terms of her employment agreement, in the event of a “change
in control” of the Company (as defined in the employment agreement) during Dr.
Chen’s employment term, Dr. Chen will be entitled to receive a one-time payment
equal to 2.9 times her base salary, and the vesting of all outstanding equity
awards then held by Dr. Chen will accelerate such that they are fully vested as
of the date of the change in control.
2010
Stock Option and Incentive Plan
The
Company’s 2010 Stock Option and Incentive Plan, or the 2010 Plan, provides for
the grant of equity-based awards to employees, officers, non-employee directors
and other key persons providing services to the Company. Awards of
incentive options may be granted under the 2010 Plan until September
2020. No other awards may be granted under the 2010 Plan after the
date that is 10 years from the date of stockholder approval.
Plan
Administration. The 2010 Plan may be administered by the full
board or the compensation committee. It is the current intention of
the Company that the 2010 Plan be administered by the compensation
committee. The compensation committee has full power to select, from
among the individuals eligible for awards, the individuals to whom awards will
be granted, to make any combination of awards to participants, and to determine
the specific terms and conditions of each award, subject to the provisions of
the 2010 Plan. The compensation committee may delegate to our chief
executive officer the authority to grant stock options to employees who are not
subject to the reporting and other provisions of Section 16 of the Exchange
Act and not subject to Section 162(m) of the Code, subject to certain
limitations and guidelines.
Eligibility. Persons
eligible to participate in the 2010 Plan will be those full or part-time
officers, employees, non-employee directors and other key persons (including
consultants and prospective officers) of the Company and its subsidiaries as
selected from time to time by the compensation committee in its
discretion.
Plan Limits. Initially,
the total number of shares of common stock available for issuance under the 2010
Plan is 1,000,000 shares. On January 1, 2012 and each January 1
thereafter, the number of shares of common stock reserved and available for
issuance under the 2010 Plan will be cumulatively increased by 4% of the number
of shares of common stock issued and outstanding on the immediately preceding
December 31. Subject to these overall limitations, the maximum
aggregate number of shares of Stock that may be issued in the form of incentive
stock options or stock appreciation rights to any one individual will not exceed
the initial 2010 Plan limit of 1,000,000, cumulatively increased on January 1,
2012 and each January 1 thereafter by the lesser of (i) the 4% annual increase
applicable to the 2010 Plan for such year or (ii) 500,000
shares.
Stock Options. The
2010 Plan permits the granting of (i) options to purchase common stock
intended to qualify as incentive stock options under Section 422 of the
Code and (ii) options that do not so qualify. Options granted
under the 2010 Plan will be non-qualified options if they fail to qualify as
incentive options or exceed the annual limit on incentive stock
options. Incentive stock options may only be granted to employees of
the Company and its subsidiaries. Non-qualified options may be
granted to any persons eligible to receive incentive options and to non-employee
directors and key persons. The option exercise price of each option
will be determined by the compensation committee but may not be less than 100%
of the fair market value of the common stock on the date of
grant. Fair market value for this purpose will be the last reported
sale price of the shares of common stock on the NYSE Amex on the date of grant;
provided, that if the date of grant is the first day on which trading prices for
our common stock are reported on the NYSE Amex, the fair market value will be
the price to the public of shares of our common stock in this
offering. The exercise price of an option may not be reduced after
the date of the option grant, other than to appropriately reflect changes in our
capital structure.
The term
of each option will be fixed by the compensation committee and may not exceed 10
years from the date of grant. The compensation committee will
determine at what time or times each option may be exercised. Options
may be made exercisable in installments and the exercisability of options may be
accelerated by the compensation committee. In general, unless
otherwise permitted by the compensation committee, no option granted under the
2010 Plan is transferable by the optionee other than by will or by the laws of
descent and distribution, and options may be exercised during the optionee’s
lifetime only by the optionee, or by the optionee’s legal representative or
guardian in the case of the optionee’s incapacity.
Upon
exercise of options, the option exercise price must be paid in full either in
cash, by certified or bank check or other instrument acceptable to the
compensation committee or by delivery (or attestation to the ownership) of
shares of common stock that are beneficially owned by the optionee for at least
six months or were purchased in the open market. Subject to
applicable law, the exercise price may also be delivered to the Company by a
broker pursuant to irrevocable instructions to the broker from the
optionee. In addition, the compensation committee may permit
non-qualified options to be exercised using a net exercise feature which reduces
the number of shares issued to the optionee by the number of shares with a fair
market value equal to the exercise price.
To
qualify as incentive options, options must meet additional federal tax
requirements, including a $100,000 limit on the value of shares subject to
incentive options that first become exercisable by a participant in any one
calendar year.
Stock Appreciation
Rights. The compensation committee may award stock
appreciation rights subject to such conditions and restrictions as the
compensation committee may determine. Stock appreciation rights
entitle the recipient to shares of common stock equal to the value of the
appreciation in the stock price over the exercise price. The exercise
price is the fair market value of the common stock on the date of
grant. The term of a stock appreciation right will be fixed by the
compensation committee and may not exceed 10 years.
Restricted
Stock. The compensation committee may award shares of common
stock to participants subject to such conditions and restrictions as the
compensation committee may determine. These conditions and
restrictions may include the achievement of certain performance goals and/or
continued employment with us through a specified restricted period.
Restricted Stock
Units. The compensation committee may award restricted stock
units to any participants. Restricted stock units are generally
payable in the form of shares of common stock, although restricted stock units
granted to the chief executive officer may be settled in cash. These
units may be subject to such conditions and restrictions as the compensation
committee may determine. These conditions and restrictions may
include the achievement of certain performance goals (as summarized above)
and/or continued employment with the Company through a specified vesting
period. In the compensation committee’s sole discretion, it may
permit a participant to make an advance election to receive a portion of his or
her future cash compensation otherwise due in the form of a restricted stock
unit award, subject to the participant’s compliance with the procedures
established by the compensation committee and requirements of Section 409A
of the Code. During the deferral period, the deferred stock awards
may be credited with dividend equivalent rights.
Adjustments for Stock Dividends,
Stock Splits, Etc. The 2010 Plan requires the compensation
committee to make appropriate adjustments to the number of shares of common
stock that are subject to the 2010 Plan, to certain limits in the 2010 Plan, and
to any outstanding awards to reflect stock dividends, stock splits,
extraordinary cash dividends and similar events.
Tax
Withholding. Participants in the 2010 Plan are responsible for
the payment of any federal, state or local taxes that the Company is required by
law to withhold upon the exercise of options or stock appreciation rights or
vesting of other awards. Subject to approval by the compensation
committee, participants may elect to have the minimum tax withholding
obligations satisfied by authorizing the Company to withhold shares of common
stock to be issued pursuant to the exercise or vesting.
Amendments and
Termination. The board of directors of the Company may at any
time amend or discontinue the 2010 Plan and the compensation committee may at
any time amend or cancel any outstanding award for the purpose of satisfying
changes in the law or for any other lawful purpose. However, no such
action may adversely affect any rights under any outstanding award without the
holder’s consent. To the extent required under the NYSE Amex rules,
any amendments that materially change the terms of the 2010 Plan will be subject
to approval by our stockholders. Without approval by our
stockholders, the compensation committee may not reduce the exercise price of
options or stock appreciation rights or effect repricing through cancellation or
re-grants, including any cancellation in exchange for
cash. Amendments shall also be subject to approval by our
stockholders if and to the extent determined by the compensation committee to be
required by the Code to preserve the qualified status of incentive options or to
ensure that compensation earned under the 2010 Plan qualifies as
performance-based compensation under Section 162(m) of the
Code.
Retirement
Plan and Other Benefits
The
Company offers health, dental, disability, and life insurance to its full-time
employees.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
Dr. Quay
is the president, chief executive officer and chairman of the board of directors
of the Company. Dr. Chen is the chief scientific officer and a
director of the Company. Drs. Quay and Chen are husband and
wife. Prior to the completion of this offering, Drs. Quay and Chen
were the Company’s majority stockholders. After the completion of
this offering and exercise of the Class A Warrants, Drs. Quay and Chen will no
longer be majority stockholders but will remain substantial minority
stockholders. Ensisheim Partners, LLC, which holds 66.3% of the
outstanding common stock of the Company prior to this offering, is wholly owned
by Drs. Quay and Chen, and they are the beneficial owners of the shares of the
Company’s stock owned by that entity.
Ensisheim
was the original owner of the patents covering the MASCT System, which were
acquired by the Company in June 2010. Ensisheim has no further
interest or right to the U.S. patents and foreign counterparts that cover the
manufacture, use, and selling of the MASCT System, the pending patent
applications for improvements, or the FDA marketing authorization for the MASCT
System that was transferred to the Company. Ensisheim did not receive
any monetary compensation in connection with the transfer and assignment to the
Company of these patents and other assets.
On
December 24, 2009, the Company entered into a commercial lease agreement with
Ensisheim for office space located in Seattle, Washington, at an annual rent of
$13,200 plus applicable sales tax. The original term of the lease was
to expire on December 31, 2010. From April 30, 2009 (inception)
through June 30, 2010, the Company incurred $6,848 of rent expense for the
lease. As of June 30, 2010, security deposit for the lease amounted
to $1,100. On July 15, 2010, the Company and Ensisheim terminated the
lease, effective July 1, 2010 and the Company began occupying the facility on a
rent-free basis.
The
Company has borrowed an aggregate of $105,000 from Dr. Quay pursuant to
promissory notes that are due and payable in full on or before December 31,
2010. The notes bear an annual interest rate of 10% accruing from
June 30, 2010 and carry a pass-through loan origination fee of
$4,000.
In July
2010, in connection with the departure of Robert L. Kelly, a former officer, the
Company entered into a consulting agreement with a limited liability company
controlled by Mr. Kelly. Under the agreement, the Company was to
receive consulting services relating to capital raising and investor
relations. The agreement was terminated by the Company in September
2010, through which time a total of $30,000 had been
paid.
Indemnification
Agreements
Prior to
the completion of this offering, the Company intends to enter into
indemnification agreements with each of its directors and certain of its
executive officers. These agreements will require the Company to
indemnify these individuals to the fullest extent permitted under Delaware law
against liabilities that may arise by reason of their service to the Company,
and to advance expenses incurred as a result of any proceeding against them as
to which they could be indemnified.
Related
Party Transaction Policies
Related
party transactions to be entered into after the completion of this offering and
that the Company is required to disclose publicly under the federal securities
laws will require prior approval of the Company’s independent directors without
the participation of any director who may have a direct or indirect interest in
the transaction in question. Related parties include directors,
nominees for director, principal stockholders, executive officers and members of
their immediate families. For these purposes, a “transaction” will
include all financial transactions, arrangements or relationships, ranging from
extending credit to the provision of goods and services for value and will
include any transaction with a company in which a director, executive officer
immediate family member of a director or executive officer, or principal
stockholder (that is, any person who beneficially owns five percent or more of
any class of the Company’s voting securities) has an interest by virtue of a 10%
or greater equity interest. The Company’s policies and procedures
regarding related party transactions are not expected to be a part of a formal
written policy, but rather, will represent a course of practice determined to be
appropriate by the board of directors of the Company.
PRINCIPAL
STOCKHOLDERS
The
following table sets forth information as of September 30, 2010 regarding the
beneficial ownership of the Company’s common stock by each of its executive
officers and directors, individually and as a group and by each person who
beneficially owns in excess of five percent of the common stock after giving
effect to any exercise of warrants or options held by that person within 60 days
after September 30, 2010. Unless indicated otherwise, the address for
the beneficial holders is c/o Atossa Genetics Inc., 4105 E. Madison St., Suite
320, Seattle, Washington 98112.
|
|
|
|
|
Percentage of Common Stock
|
|
|
|
Shares
|
|
|
Beneficially Owned
|
|
Name of Beneficial Owner
|
|
Beneficially
|
|
|
Before
|
|
|
After
|
|
|
|
Owned
|
|
|
Offering (1)
|
|
|
Offering (2)
|
|
Directors
and Officers
|
|
|
|
|
|
|
|
|
|
Steven
C. Quay, M.D., Ph.D. (3)
|
|
|
4,293,252 |
|
|
|
71.6 |
% |
|
|
35.8 |
% |
Shu-Chih
Chen (4)
|
|
|
3,976,460 |
|
|
|
66.3 |
% |
|
|
33.1 |
% |
John
Barnhart
|
|
|
48,602 |
|
|
|
* |
|
|
|
* |
|
Christopher
Benjamin
|
|
|
0 |
|
|
|
— |
|
|
|
— |
|
All
Current Officers and Directors as a Group (4 persons)
|
|
|
4,341,854 |
|
|
|
72.4 |
% |
|
|
36.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Director
Nominees
|
|
|
|
|
|
|
|
|
|
|
|
|
Mary
Tagliaferri, M.D.
|
|
|
0 |
|
|
|
— |
|
|
|
— |
|
Stephen
Galli, M.D.
|
|
|
17,674 |
|
|
|
* |
|
|
|
* |
|
Alexander
D. Cross (5)
|
|
|
88,366 |
|
|
|
1.5 |
% |
|
|
* |
|
(1)
|
Based
on 6,000,063 shares of common stock issued and outstanding as of September
30, 2010 after giving effect to a one-for-2.26332 reverse split of our
common stock effected in September
2010.
|
(2)
|
Assumes
the sale of 9,000,000 shares of common stock, representing 3,000,000
shares underlying the Units and an additional 6,000,000 shares issuable
upon exercise of the Class A
Warrants.
|
(3)
|
Includes
(i) 316,792 shares of common stock directly owned by Dr. Quay and
(ii) 3,976,460 shares of common stock owned by
Ensisheim. Ensisheim is solely owned and controlled by Drs.
Quay and Chen, and, as a result, Drs. Quay and Chen are deemed to be
beneficial owners of the shares held by this
entity.
|
(4)
|
Consists
of 3,976,460 shares of common stock owned by
Ensisheim. Ensisheim is solely owned and controlled by Drs.
Quay and Chen, and, as a result, Drs. Quay and Chen are deemed to be
beneficial owners of the shares held by this
entity.
|
(5)
|
Represents
88,366 shares of common stock held by the Alexander D. Cross Family
Trust.
|
DESCRIPTION
OF SECURITIES
Capitalization
The
following description of the Company’s capital stock gives effect to an increase
in the authorized number of shares of common stock of the Company and a
one-for-2.26332 reverse stock split of the outstanding common stock of the
Company effected in September 2010.
The
Company is authorized to issue 75,000,000 shares of common stock, par value
$0.001 per share, of which 6,000,063 shares were outstanding as of the date of
this prospectus, and 10,000,000 shares of undesignated preferred stock, par
value $0.001 per share, none of which have been designated or
issued.
As of
September 30, 2010, there were 56 record holders of the Company’s common
stock.
Units
Unit
Composition. The Company is offering for sale 3,000,000 Units,
with each Unit consisting of (i) one share of common stock, (ii) two
Class A Warrants, and (iii) one Class B Warrant. A description
of the common stock, Class A Warrants and Class B Warrants is set forth
below. The securities underlying the Units will automatically
separate from the Units on the 90th day after the date of this prospectus,
unless Dawson James Securities, Inc., the representative of the underwriters,
determines that an earlier separation date is acceptable based on its assessment
of the relative strengths of the securities markets and small capitalization
companies in general, and the trading pattern of, and demand for, the Company’s
securities in particular. The Company will issue a press release
announcing when such separation will occur.
Rights as Stockholder. Unit
holders do not have any voting or other rights as a stockholder of the
Company. Upon the separation of the Units, a Unit holder will be
deemed to have become the holder of record of the underlying common stock as of
the date of separation. If the date of separation is a date upon
which the stock transfer books of the Company are closed, the Unit holder will
be deemed to have become the record holder of the underlying common stock the
next day on which the stock transfer books of the Company are open.
Listing of
Units. The Units are expected to be listed for trading on the
NYSE Amex under the symbol “ATOSU.” Once the securities comprising
the Units separate, the Units will cease trading and be cancelled and
terminated.
Common
Stock
Voting Rights. Holders of
shares of common stock are entitled to one vote for each share on all matters to
be voted on by the stockholders. Holders of common stock do not have cumulative
voting rights.
Dividend and Distribution
Rights. Holders of common stock are entitled to share ratably
in dividends, if any, as may be declared from time to time by the board of
directors of the Company in its discretion from funds legally available
therefore. In the event of a liquidation, dissolution or winding up, the holders
of common stock are entitled to share pro rata all assets remaining after
payment in full of all liabilities and all amounts due to holders of preferred
stock that may have a liquidation preference that is senior to the common
stock.
No Preemptive
Rights. Holders of common stock have no preemptive rights to
purchase additional shares of the Company’s common stock.
Other Rights. There are no
conversion or redemption rights or sinking fund provisions with respect to the
common stock.
Listing of Common
Stock. The common stock is expected to be listed for trading
on the NYSE Amex under the symbol “ATOS.” Trading of the common
stock will not commence until the Units are separated.
Class
A Warrants
Below is
a summary of the material terms of the Class A Warrants, including relevant
provisions of the Warrant Agent Agreement between the Company and Onyx Stock
Transfer, LLC, the Warrant Agent for the Class A Warrants and the Class B
Warrants, or Onyx Stock Transfer. This summary is qualified with
reference to the Warrant Agent Agreement and the Class A Warrant Certificate,
copies of which have been filed as exhibits to the Company’s registration
statement, of which this prospectus is a part. Investors are urged to
review the Warrant Agent Agreement and the form of Class A Warrant Certificate
for additional information regarding the Class A Warrants.
Purchase
Rights. Each Class A Warrant will entitle the holder to
acquire one share of common stock during the exercise period and subject to the
conditions set forth below.
Warrant Agent; Book Entry and
Certificated Warrants. Onyx Stock Transfer will serve as the
warrant agent for the Class A Warrants. Onyx Stock Transfer also
serves as the transfer agent and registrar for the Units, common stock, Class A
Warrants and Class B Warrants. Certificates representing Class A
Warrants are expected to be issued in “book entry” form, deposited with the
Depository Trust Company and registered in the name of Cede & Co., a nominee
of Depository Trust Company. If warrant certificates cannot be issued
in book entry form, or if a warrant holder requests in writing that a warrant
certificate be issued in physical form, then the warrant agent will issue a
Class A Warrant Certificate.
Listing of Class A
Warrants. The Class A Warrants will not be listed for trading
on any securities exchange.
Exercise
Period. The Class A Warrants will be exercisable at the option
of the holder for a period of 10 days, beginning the sixth trading day after
separation of the Units. The Company intends to issue a press release
announcing the separation of the securities and the commencement of the 10-day
exercise period. If any Class A Warrants are not exercised prior to
the expiration of this 10-day period, those warrants will expire.
Exercise
Price. Each Class A Warrant will have an exercise price of
$0.05 per share of common stock, which may only be paid on a cashless “net
exercise” basis. When exercising a Class A Warrant on a net exercise
basis, the holder will be entitled to receive a number of shares of common stock
for each Class A Warrant, rounded up to the nearest whole number, calculated
using the following formula:
X = (A -
$0.05)
A
Where:
|
X =
|
the
number of shares of common stock to be issued to the holder per Class A
Warrant
|
|
A
=
|
the
five trading-day average closing price of the Company’s common stock
immediately following separation of the
Units
|
Because
the number of shares of common stock to be issued upon exercise of the Class A
Warrant will be rounded up to the nearest whole share, each Class A Warrant will
represent the right to acquire one share of common stock irrespective of the
common stock value, unless the five-day average price of the common stock is
equal to or less than $0.05 per share, in which case the Class A Warrant would
have no value. The exercise price and the number of shares of common
stock purchasable upon the exercise of each warrant are subject to adjustment
upon the happening of certain events, such as stock dividends, distributions,
stock splits and recapitalizations, although the Company does not expect any
such events to occur prior to the expiration of the Class A
Warrants.
Rights as Stockholder.
Warrant holders do not have any voting or other rights as a stockholder
of the Company. Upon the exercise of the Class A Warrants, a holder
will be deemed to have become the holder of record of the underlying common
stock as of the date upon which the Class A Warrant Certificate (if issued) was
surrendered and the exercise notice was submitted. If the date of
such surrender (if applicable) and submission is a date upon which the stock
transfer books of the Company are closed, the holder will be deemed to have
become the record holder of the common stock the next day on which the stock
transfer books of the Company are open.
Limits on
Exercise. The Class A Warrants provide that no exercise will
be effected, and the holder of a warrant will not have the right to exercise a
warrant, if after giving effect to the exercise the holder, together with any
affiliates, would beneficially own in excess of 4.99% of the number of shares of
common stock of the Company outstanding immediately after giving effect to the
issuance of shares upon exercise. The holder may, upon 61 days prior
written notice, waive this 4.99% limit and thereby elect to increase the
exercise limit to 9.99% of the total shares outstanding. The holder
may not waive the 9.99% limit. To the extent that a warrant holder
cannot exercise a Class A Warrant due to this limitation, the unexercised
portion of the Class A Warrant will expire at the end of the 10-day exercise
period.
Amendment. With
the consent of holders of Class A Warrants representing a majority of the shares
issuable upon exercise of all outstanding Class A Warrants, the Company and Onyx
Stock Transfer, as the Warrant Agent, may modify the Warrant Agent Agreement or
modify the rights of the holders of the Class A Warrants; provided, however,
that no modifications made be made to the terms upon which the Class A Warrants
are exercisable without the consent of the holder of each outstanding Class A
Warrant that would be affected by the proposed amendment.
Fundamental
Transaction. The Class A Warrants will be exercisable for
securities, property or rights other than Company common stock if any of the
following transactions (each referred to below in this subsection as a
Fundamental Transaction) occur while Class A Warrants are issued and
outstanding:
|
·
|
the
Company, directly or indirectly, in one or more related transactions
effects any merger or consolidation of the Company with or into another
person;
|
|
·
|
the
Company, directly or indirectly, effects any sale, lease, license,
assignment, transfer, conveyance or other disposition of all or
substantially all of its assets in one or a series of related
transactions;
|
|
·
|
any,
direct or indirect, purchase offer, tender offer or exchange offer
(whether by the Company or another person) is completed pursuant to which
holders of Company common stock are permitted to sell, tender or exchange
their shares for other securities, cash or property and such offer has
been accepted by the holders of 50% or more of the outstanding Company
common stock;
|
|
·
|
the
Company, directly or indirectly, in one or more related transactions,
effects any reclassification, reorganization or recapitalization of the
common stock or any compulsory share exchange pursuant to which the common
stock is effectively converted into or exchanged for securities other than
the Company’s securities, cash or property;
or
|
|
·
|
the
Company, directly or indirectly, in one or more related transactions
consummates a stock or share purchase agreement or other business
combination (including, without limitation, a reorganization,
recapitalization, spin-off or scheme of arrangement) with another person
whereby such other person acquires more than 50% of the outstanding shares
of common stock (not including any shares of common stock held by the
other person or other persons making or party to, or associated or
affiliated with the other persons making or party to, such stock or share
purchase agreement or other business
combination).
|
Following
the occurrence of a Fundamental Transaction, upon any exercise of a Class A
Warrant, the holder will have the right to receive, for each share of common
stock that would have been issuable prior to the occurrence of the Fundamental
Transaction, securities of the successor or acquiring corporation or of the
Company, if it is the surviving corporation, and any additional consideration
(e.g., cash) payable in connection with the Fundamental Transaction on each
share of common stock that was outstanding immediately prior to the Fundamental
Transaction. For example, if the Company is acquired in a merger where each
share of Company common stock will receive upon closing one share of the
acquiring company, plus $1.00 per share, then the holders of Class A Warrants
would be entitled upon exercise to receive the same combination of cash and
stock. If holders of common stock are given any choice as to the type
of consideration they will receive in a Fundamental Transaction, then the
warrant holders will, upon exercise of the warrants, be given the same
choice.
Redemption
Rights. The Company will have no rights to call the Class A
Warrants for redemption.
Ranking. The Class
A Warrants are equal in seniority to the Class B warrants.
Class
B Warrants
Below is
a summary of the material terms of the Class B Warrants, including relevant
provisions of the Warrant Agent Agreement. This summary is qualified
with reference to the Warrant Agent Agreement and the Class B Warrant
Certificate, copies of which have been filed as exhibits to the Company’s
registration statement, of which this prospectus is a part. Investors
are urged to review the Warrant Agent Agreement and the form of Class B Warrant
Certificate for additional information regarding the Class B
Warrants.
Purchase
Rights. Each Class B Warrant will entitle the holder to
acquire one share of common stock during the exercise period and subject to the
conditions set forth below.
Warrant Agent; Book Entry and
Certificated Warrants. Onyx Stock Transfer will serve as the
warrant agent for the Class B Warrants. Onyx Stock Transfer also
serves as the transfer agent and registrar for the Units, common stock, Class A
Warrants and Class B Warrants. Certificates representing Class B
Warrants are expected to be issued in “book entry” form, deposited with the
Depository Trust Company and registered in the name of Cede & Co., a nominee
of Depository Trust Company. If warrant certificates cannot be issued
in book entry form, or if a warrant holder requests in writing that a warrant
certificate be issued in physical form, then the warrant agent will issue a
Class B Warrant Certificate.
Listing of Class B
Warrants. The Class B Warrants are expected to be listed for
trading on the NYSE Amex under the symbol “ATOSW.” Trading will
not commence until the Class B Warrants are separated from the
Units.
Exercise
Period. Subject to the redemption right described below, the
Class B Warrants will be exercisable at the option of the holder commencing
on the first anniversary of the date of this prospectus and continuing until the
fifth anniversary of the date of separation of the Units. The
Company intends to issue a press release announcing the separation of the
securities and the commencement of the exercise period. If any Class
B Warrants are not exercised prior to the expiration of this five-year exercise
period, those warrants will expire.
Exercise
Price. Each Class B Warrant will have an exercise price equal
to 55% of the Unit offering price. With an assumed Unit offering
price of $6.00 per Unit, which is the midpoint of the estimated price range on
the cover of this prospectus, the Class B Warrant exercise price would initially
be $3.30 per share. The Class B Warrants may be exercised only for
full shares of common stock.
The Class
B Warrants must be exercised for cash, unless the Company does not then have an
effective registration statement under the Securities Act of 1933 covering the
issuance of the shares underlying the Class B Warrants, in which case they may
only be exercised on a cashless, net exercise basis. When exercising
a Class B Warrant on a net exercise basis, the holder will be entitled to
receive a number of shares of common stock upon exercise calculated using the
following formula:
X = Y (A -
B)
A
Where:
|
X
=
|
the
number of shares of common stock to be issued to the holder under Class B
Warrants being exercised
|
Y
= the number of Class B
Warrants being exercised
|
A
=
|
the
ten trading-day average closing price of the Company’s common stock prior
to exercise
|
|
B
=
|
the
exercise price of the Class B Warrants (initially $3.30, based on an
assumed offering price of $6.00 per Unit), subject to any applicable
adjustments
|
The
exercise price and the number of shares of common stock purchasable upon the
exercise of each warrant are subject to adjustment upon the happening of certain
events, such as stock dividends, distributions, stock splits and
recapitalizations.
Rights as Stockholder.
Warrant holders do not have any voting or other rights as a stockholder
of the Company. Upon the exercise of the Class B Warrants, a holder
will be deemed to have become the holder of record of the underlying common
stock as of the date upon which the Class B Warrant Certificate (if issued) was
surrendered and the exercise notice was submitted. If the date of
such surrender (if applicable) and submission is a date upon which the stock
transfer books of the Company are closed, the holder will be deemed to have
become the record holder of the common stock the next day on which the stock
transfer books of the Company are open.
Limits on
Exercise. The Class B Warrants provide that no exercise will
be effected, and the holder of a warrant will not have the right to exercise a
warrant, if after giving effect to the exercise the holder, together with any
affiliates, would beneficially own in excess of 4.99% of the number of shares of
common stock of the Company outstanding immediately after giving effect to the
issuance of shares upon exercise. The holder may, upon 61 days prior
written notice, waive this 4.99% limit and thereby elect to increase the
exercise limit to 9.99% of the total shares outstanding. The holder
may not waive the 9.99% limit. To the extent that a warrant holder
cannot exercise a Class B Warrant due to this limitation, the unexercised
portion of the Class B Warrant will expire at the end of the exercise
period.
Amendment. With
the consent of holders of Class B Warrants representing a majority of the shares
issuable upon exercise of all outstanding Class B Warrants, the Company and Onyx
Stock Transfer, as the Warrant Agent, may modify the Warrant Agent Agreement or
modify the rights of the holders of the Class B Warrants; provided, however,
that no modifications made be made to the terms upon which the Class B Warrants
are exercisable without the consent of the holder of each outstanding Class B
Warrant that would be affected by the proposed amendment.
Fundamental
Transaction. The Class B Warrants will be exercisable for
securities, property or rights other than Company common stock if any of the
following transactions (each referred to below in this subsection as a
Fundamental Transaction) occur while Class B Warrants are issued and
outstanding:
|
·
|
the
Company, directly or indirectly, in one or more related transactions
effects any merger or consolidation of the Company with or into another
person;
|
|
·
|
the
Company, directly or indirectly, effects any sale, lease, license,
assignment, transfer, conveyance or other disposition of all or
substantially all of its assets in one or a series of related
transactions
|
|
·
|
any,
direct or indirect, purchase offer, tender offer or exchange offer
(whether by the Company or another person) is completed pursuant to which
holders of Company common stock are permitted to sell, tender or exchange
their shares for other securities, cash or property and such offer has
been accepted by the holders of 50% or more of the outstanding Company
common stock;
|
|
·
|
the
Company, directly or indirectly, in one or more related transactions,
effects any reclassification, reorganization or recapitalization of the
common stock or any compulsory share exchange pursuant to which the common
stock is effectively converted into or exchanged for securities other than
the Company’s securities, cash or property;
or
|
|
·
|
the
Company, directly or indirectly, in one or more related transactions
consummates a stock or share purchase agreement or other business
combination (including, without limitation, a reorganization,
recapitalization, spin-off or scheme of arrangement) with another person
whereby such other person acquires more than 50% of the outstanding shares
of common stock (not including any shares of common stock held by the
other person or other persons making or party to, or associated or
affiliated with the other persons making or party to, such stock or share
purchase agreement or other business
combination).
|
Following
the occurrence of a Fundamental Transaction, upon any exercise of a Class B
Warrant, the holder will have the right to receive, for each share of common
stock that would have been issuable prior to the occurrence of the Fundamental
Transaction, securities of the successor or acquiring corporation or of the
Company, if it is the surviving corporation, and any additional consideration
(e.g., cash) payable in connection with the Fundamental Transaction on each
share of common stock that was outstanding immediately prior to the Fundamental
Transaction. For example, if the Company is acquired in a merger where each
share of Company common stock will receive one share of the acquiring company’s
common stock, plus $1.00 per share, then the holders of Class B Warrants would
be entitled upon exercise to receive the same combination of stock and
cash. If holders of Company common stock are given any choice as to
the type of consideration they will receive in a Fundamental Transaction, then
the warrant holders will, upon exercise of the warrants, be given the same
choice.
Redemption
Rights. The Company will have the right to redeem the Class B
Warrants at $0.25 per share of common stock underlying the Class B Warrants in
the event (i) the average of the closing price of the common stock exceeds 200%
of the exercise price for 10 consecutive trading days while the warrants are
exercisable and (ii) there is then an effective registration statement with
a current prospectus on file with the SEC covering the exercise of the Class B
Warrants for cash. In the event that the Company wishes to call the
Class B Warrants for redemption, it will provide warrant holders with 30 days
prior notice of the redemption, during which time the holders of Class B
Warrants may continue to exercise the warrant. At the end of the
30-day period, and assuming the Company has complied with applicable redemption
requirements, the warrant holders will thereafter be entitled only to receive
the redemption value, subject to the surrender of warrant certificates, if
applicable.
Ranking. The Class
B Warrants are equal in seniority to the Class A warrants.
Preferred
Stock
The board
of directors of the Company is authorized to provide for the issuance of any or
all of the shares of preferred stock in series and, by filing a certificate
pursuant to the applicable law of the State of Delaware, to establish from time
to time the number of shares to be included in each such series, and to fix the
designation, powers, preferences and rights of the shares of each such series
and the qualifications, limitations or restrictions thereof.
The
authority of the board of directors of the Company with respect to each series
of preferred stock includes determination of the following
characteristics:
|
·
|
The
number of shares constituting that series and the distinctive designation
of that series;
|
|
·
|
The
dividend rate on the shares of that series, whether dividends shall be
cumulative, and, if so, from which date or dates, and the relative rights
of priority, if any, of payment of dividends on shares of that
series;
|
|
·
|
Whether
that series shall have voting rights, in addition to the voting rights
provided by law, and, if so, the terms of such voting
rights;
|
|
·
|
Whether
that series shall have conversion privileges, and, if so, the terms and
conditions of such conversion, including provision for adjustment of the
conversion rate in such events as the board of directors of the Company
shall determine;
|
|
·
|
Whether
or not the shares of that series shall be redeemable, and, if so, the
terms and conditions of such redemption, including the date or dates upon
or after which they shall be redeemable, and the amount per share payable
in case of redemption, which amount may vary under different conditions
and at different redemption dates;
|
|
·
|
Whether
that series shall have a sinking fund for the redemption or purchase of
shares of that series, and, if so, the terms and amount of such sinking
fund;
|
|
·
|
The
rights of the shares of that series in the event of voluntary or
involuntary liquidation, dissolution or winding up of the Company, and the
relative rights of priority, if any, of payment of shares of that series;
and
|
|
·
|
Any
other relative rights, preferences and limitations of that
series.
|
Anti-Takeover
Devices
The
Company’s certificate of incorporation authorizes “blank-check” preferred stock,
which means that the board of directors of the Company has the authority to
designate one or more series of preferred stock without stockholder
approval. These series of preferred stock may have superior rights,
preferences and privileges over our common stock, including dividend rights,
voting rights and liquidation preferences. The ability of the board
of directors of the Company to issue shares of the Company’s preferred stock
without stockholder approval could deter takeover offers and make it more
difficult or costly for a third party to acquire the Company without the consent
of the board of directors of the Company.
In
addition, the Company’s certificate of incorporation does not opt out of Section
203 of the Delaware General Corporation Law, which protects a corporation
against an unapproved takeover by basically prohibiting a company from engaging
in any business combination with any interested stockholder (defined as a
stockholder owning more than 15% of the outstanding shares) for a period of
three years from the time such stockholder became a 15% holder unless approved
by the board of directors of the Company. These antitakeover devices
will inhibit any attempt by stockholders to, for whatever reason, attempt a
takeover of the Company.
No
Trading Market
There is
currently no established public trading market for the Company’s
securities. A trading market in the securities may never
develop. The Company intends to apply for listing of the Units, its
common stock and the Class B Warrants on the NYSE Amex under the trading symbols
“ATOSU,” “ATOS” and “ATOSW,” respectively. If for any reason the
Units, the Company’s common stock or the Class B Warrants are not so listed or a
public trading market does not develop, purchasers of the Units may have
difficulty selling their securities. The Class A Warrants will not be
listed for trading on any exchange.
NYSE
Amex Listing Requirements
The NYSE
Amex has established quantitative standards for initial listing of companies as
well as continuation of listing standards. The NYSE Amex has four
differing listing standards applicable for initial listing. The
initial listing standard that most effectively applies to the Company consists
of a market capitalization of at least $50 million, a market value of the public
float of $15 million, a minimum per share price of $2.00, stockholders equity of
at least $4 million, and at least 400 public stockholders with at least 1.0
million shares. In addition, the NYSE Amex has qualitative standards
concerning corporate governance, director independence, and conflicts of
interest that must be met. The Company believes that following this
offering it will meet the requirements for initial listing.
Dividends
The
Company does not anticipate declaring dividends but anticipates that it will use
any funds for further development and growth of the Company.
Transfer
Agent
Onyx
Stock Transfer, LLC, 2672 Bayshore Parkway, Suite 1055, Mountain View,
California 94043 (telephone: (650) 215-4880; facsimile: (650) 215-4884) will
serve as transfer agent for the Units, Class A Warrants, Class B Warrants and
common stock of the Company.
SHARES
ELIGIBLE FOR FUTURE SALE
As of the
date of this prospectus, there are 6,000,063 shares of common stock
outstanding. Of such shares, approximately 4,340,000 are owned
directly and beneficially by affiliates of the Company, are not being registered
in this prospectus, are subject to the limitations of Rule 144 under the
Securities Act and may not be sold publicly unless they are registered under the
Securities Act or are sold pursuant to Rule 144. These shares are
subject to a lock-up agreement restricting the sale of such shares for one year
from the date of effectiveness of the registration statement of which this
prospectus forms a part. In the event shares not currently salable
become salable by means of registration or eligibility for sale under Rule 144
and the holders of such shares elect to sell such shares in the public market,
there is likely to be a negative effect on the market price of the Company’s
securities.
Lock-Up
Agreements
As of the
effective date of this prospectus, the holders of all the Company’s outstanding
shares of common stock have entered into lock-up agreements with the
underwriters restricting the sale of such shares, including all the shares owned
directly and beneficially by affiliates of the Company.
The
lock-up agreements restrict the sale of such shares from the effective date of
the registration statement of which this prospectus is a part for a period of 12
months, after which time the provisions of the lock-up agreement
expire. However, such shares cannot be sold publicly unless
registered under the Securities Act or sold pursuant to provisions of Rule 144
promulgated pursuant to the Securities Act.
CERTAIN
MATERIAL U.S. FEDERAL INCOME TAX CONSIDERATIONS
The
following discussion sets forth certain material U.S. federal income tax
considerations in connection with the purchase of the Units and of the ownership
and disposition of the common stock, Class A Warrants and Class B Warrants
underlying the Units and the exercise or expiration of the warrants, in each
case to U.S. Holders and Non-U.S. Holders (each as defined
below). This discussion is based upon the Internal Revenue Code of
1986, as amended, or the Code, Treasury Regulations promulgated thereunder,
judicial decisions, and the U.S. Internal Revenue Service’s, or IRS’s, current
administrative rules, practices and interpretations of law, all as in effect on
the date of this document, and all of which are subject to change, possibly with
retroactive effect, and to differing interpretations, which could result in U.S.
federal income tax consequences different from those described below. This
discussion applies only to holders that hold common stock and warrants as
capital assets, and does not address all aspects of U.S. federal income taxation
that may be important to particular holders in light of their individual
circumstances or to holders who may be subject to special tax rules, including,
without limitation, partnerships (including any entity or arrangement treated as
a partnership for U.S. federal income tax purposes), dealers in securities or
foreign currency, traders in securities that use a mark-to-market method of
accounting for securities holdings, U.S. expatriates, U.S. persons whose
functional currency is not the U.S. dollar, “controlled foreign corporations”,
“passive foreign investment companies”, insurance companies, tax-exempt
organizations, banks, financial institutions, broker-dealers, holders who hold
common stock as part of a hedge, straddle, conversion, constructive sale or
other integrated security transaction, or who acquired common stock pursuant to
the exercise of compensatory stock options or otherwise as compensation, all of
whom may be subject to tax rules that differ significantly from those summarized
below.
In
addition, newly enacted legislation imposes withholding taxes on certain types
of payments made to “foreign financial institutions” and certain other non-U.S.
entities unless additional certification, information reporting and other
specified requirements are satisfied. Failure to comply with the new
reporting requirements could result in withholding tax being imposed on payments
of dividends and sales proceeds to foreign intermediaries and certain non-U.S.
Holders. Prospective investors should consult their own tax advisers
regarding this new legislation.
We have
not sought, and will not seek, a ruling from the IRS regarding the U.S. federal
income tax consequences of this offering. The following discussion
does not address the tax consequences of this offering under foreign, state, or
local tax laws, or the alternative minimum tax provisions of the
Code. Accordingly, you are urged to consult your tax advisor with
respect to the particular tax consequences of this offering.
For
purposes of this description, a “U.S. Holder” is a beneficial owner of common
stock or a warrant that is:
|
·
|
An
individual citizen or resident of the United
States;
|
|
·
|
a
corporation or other entity taxable as a corporation that is created or
organized in or under the laws of the U.S., any state thereof or the
District of Columbia;
|
|
·
|
an
estate, the income of which is subject to U.S. federal income taxation,
regardless of its source; or
|
|
·
|
a
trust, if a U.S. court is able to exercise primary supervision over the
administration of the trust and one or more U.S. persons have the
authority to control all substantial decisions of the trust (or the trust
was in existence on August 20, 1996, and validly elected to continue to be
treated as a U.S. person).
|
For
purposes of this discussion, a Non-U.S. Holder is a beneficial owner of common
stock or a warrant that is not a U.S. Holder and is not a partnership for U.S.
federal income tax purposes. If an entity classified as a partnership
for U.S. federal income tax purposes holds common stock or a warrant, the tax
treatment of a partner will generally depend on the status of the partner and
the activities of the partnership. Any holder of common stock or a
warrant that is a partnership, or any partner in such a partnership, should
consult its tax advisors.
THIS
SUMMARY IS ONLY A GENERAL DISCUSSION AND IS NOT INTENDED TO BE, AND SHOULD NOT
BE CONSTRUED TO BE, LEGAL, OR TAX ADVICE. THE U.S. FEDERAL INCOME TAX
TREATMENT OF THE UNITS IS COMPLEX . EACH HOLDER WHO ACQUIRES UNITS IS
STRONGLY URGED TO CONSULT HIS, HER OR ITS OWN TAX ADVISER WITH RESPECT TO THE
U.S. FEDERAL, STATE, LOCAL AND FOREIGN INCOME, ESTATE AND OTHER TAX CONSEQUENCES
OF THE ACQUISITION OF THE UNITS, WITH SPECIFIC REFERENCE TO SUCH PERSON’S
PARTICULAR FACTS AND CIRCUMSTANCES.
U.S.
Holders
The
following is a summary of certain U.S. federal income tax considerations
applicable to a U.S. Holder:
Common
Stock
Distributions. Distributions
with respect to common stock, if any, will be includible in the gross income of
a U.S. Holder as ordinary dividend income to the extent paid out of current or
accumulated earnings and profits, as determined for U.S. federal income tax
purposes. Any portion of a distribution in excess of current or
accumulated earnings and profits would be treated as a return of the holder’s
tax basis in its common stock and then as gain from the sale or exchange of the
common stock. Under current law, if certain requirements are met, a maximum 15%
U.S. federal income tax rate will apply to any dividends paid to a holder of
common stock who is a U.S. individual and that is included in the U.S. Holder’s
income prior to January 1, 2011.
Distributions
to U.S. Holders that are corporate shareholders, constituting dividends for U.S.
federal income tax purposes, may qualify for the 70% dividends received
deduction, or DRD, which is generally available to corporate shareholders that
own less than 20% of the voting power or value of the outstanding stock of the
distributing corporation. A U.S. holder that is a corporate
shareholder holding 20% or more of the distributing corporation may be eligible
for an 80% DRD. No assurance can be given that we will have sufficient earnings
and profits (as determined for U.S. federal income tax purposes) to cause any
distributions to be eligible for a DRD. In addition, a DRD is
available only if certain holding periods and other taxable income requirements
are satisfied. The length of time that a U.S. Holder has held stock
is reduced by any period during which the U.S. Holder’s risk of loss with
respect to the stock is diminished by reason of the existence of certain
options, contracts to sell, short sales, or other similar transactions. Also, to
the extent that a corporation incurs indebtedness that is directly attributable
to an investment in the stock on which the dividend is paid, all or a portion of
the DRD may be disallowed. In addition, any dividend received by a corporation
may also be subject to the extraordinary distribution provisions of the Tax
Code.
Dispositions. If
you sell or otherwise dispose of any shares of common stock, you will generally
recognize capital gain or loss equal to the difference between your amount
realized and your adjusted tax basis of such shares of common
stock. The respective tax bases of the common stock, the Class A
Warrants and the Class B Warrants underlying the Units acquired in this offering
will be determined by first allocating the purchase price for each Unit among
the common stock, the Class A Warrants and the Class B Warrants in proportion to
their respective fair market values on the date the Unit is
purchased. (See “Warrants – Cashless Exercise” and “Warrants –
Exercise for Cash” below for a discussion of tax basis with respect to common
stock received upon exercise of a Class A Warrant or a Class B
Warrant). Such capital gain or loss will be long-term capital gain or
loss if your holding period for such shares of common stock is more than one
year. Long-term capital gain of a non-corporate U.S. Holder,
including an individual, that is recognized in taxable years beginning before
January 1, 2011 is generally taxed at a maximum rate of 15%. Your
holding period for the common stock underlying a Unit will begin on the date the
Unit is purchased. (See “Warrants – Cashless Exercise” and “Warrants
- - Exercise for Cash” below for a discussion of holding period with respect to
common stock received upon exercise of a Class A Warrant or a Class B
Warrant). The deductibility of capital losses is subject to
limitations.
Warrants
Dispositions. If
you sell or otherwise dispose of a warrant, you will generally recognize capital
gain or loss equal to the difference between the amount realized and your
adjusted tax basis of such warrant. The respective tax bases of the
common stock, the Class A Warrants and the Class B Warrants underlying the Units
acquired in this offering will be determined by first allocating the purchase
price for each Unit among the common stock, the Class A Warrants and the Class B
Warrants in proportion to their respective fair market values on the date of the
Unit is purchased. Such capital gain or loss will be long-term
capital gain or loss if your holding period for a warrant is more than one
year. Your holding period for the warrants underlying a Unit will
begin on the date the Unit is purchased. Long-term capital gain of a
non-corporate U.S. holder, including individuals, that is recognized in taxable
years beginning before January 1, 2011 is generally taxed at a maximum rate of
15%. In the event a warrant lapses unexercised, you will recognize a
capital loss in an amount equal to the adjusted tax basis of the
warrant. Such capital loss will be long-term if your holding period
of such warrant was more than one year at the time of lapse. The
deductibility of capital losses is subject to limitations.
Cashless
Exercise. The Class A Warrants maybe exercised only by way of
cashless exercise, while the Class B Warrants can be exercised in a cashless
manner only in certain limited circumstances. The tax consequences of
a cashless exercise of a warrant are not clear under current tax
law. It is possible that a cashless exercise may be treated as a
recapitalization for U.S. federal income tax purposes, in which case no gain or
loss would be recognized in connection with such exercise, other than with
respect to cash received in lieu of a fractional share. In this case,
a U.S. Holder’s tax basis in the common stock received would equal the holder’s
basis in the warrant (plus any gain recognized from the receipt of cash in lieu
of a fractional share minus the amount of cash received). If a
cashless exercise is treated as a recapitalization, the holding period of the
common stock will include the holding period of the warrant. The
Company intends to treat the Class A Warrants as equity for U.S. federal income
tax purposes and the cashless exercise of the Class A Warrants and the cashless
exercise of the Class B Warrants, if applicable, as a
recapitalization.
However,
it is also possible that a cashless exercise could be treated as a taxable
exchange in which gain or loss would be recognized. In such event, a
U.S. Holder could be deemed to have surrendered warrants equal to the number of
common shares having a value equal to the exercise price for the total number of
warrants to be exercised. The U.S. Holder would recognize capital
gain or loss in an amount equal to the difference between the fair market value
of the warrants deemed surrendered to pay the exercise price and the holder’s
tax basis in such warrants deemed surrendered. In this case, a U.S.
Holder’s tax basis in the common stock received would equal the sum of the fair
market value of the warrants deemed surrendered to pay the exercise price and
the holder’s tax basis in the warrants exercised. A U.S. Holder’s
holding period for the common stock would commence on the date following the
date of exercise of the warrant.
In
addition, upon a cashless exercise of a warrant, cash received in lieu of a
fractional share of common stock will be treated as a payment in a taxable
exchange for such fractional share of common stock, and gain or loss will be
recognized on the receipt of cash in an amount equal to the difference between
the amount of cash received and the amount of adjusted tax basis allocable to
the fractional share of common stock.
DUE TO
THE ABSENCE OF AUTHORITY ON THE U.S. FEDERAL INCOME TAX TREATMENT OF A CASHLESS
EXERCISE, THERE CAN BE NO ASSURANCE WHICH, IF ANY, OF THE ALTERNATIVE TAX
CONSEQUENCES AND HOLDING PERIODS DESCRIBED ABOVE WOULD BE ADOPTED BY THE IRS OR
A COURT OF LAW. ACCORDINGLY, HOLDERS SHOULD CONSULT THEIR TAX
ADVISORS REGARDING THE TAX CONSEQUENCES OF A CASHLESS EXERCISE.
Exercise for
Cash. Your tax basis in shares of common stock received upon
exercise of a Class B Warrant for cash generally will equal the tax basis of the
Class B Warrant, increased by the amount paid upon exercise of the
warrant. Your holding period of shares of common stock received upon
exercise of a warrant will begin on the day following the date on which the
warrant is exercised.
Constructive
Distributions. Upon the
occurrence of certain events, you may be deemed to receive a constructive
distribution pursuant to Section 305 of the Code. Such a constructive
distribution could occur upon the occurrence of certain adjustments, or failure
to make certain adjustments, to the number of shares of common stock to be
issued upon exercise of a warrant or to the warrant’s exercise
price. Any deemed distributions will be taxable as a dividend,
return of capital, or capital gain in accordance with the earnings and profits
rules under the Code. In addition, in certain situations, we may be
obligated to adjust the conversion rate of the warrants or, in lieu of such
adjustment, to provide for the conversion of warrants into warrants or shares of
an acquirer. Depending on the circumstances, such modification could result in a
deemed exchange of your warrant for a new warrant, potentially resulting in the
recognition of taxable gain or loss.
Information
Reporting and Backup Withholding
Information
reporting requirements generally will apply to payments of dividends on shares
of common stock or deemed dividends on a warrant and to the proceeds of a sale
of a warrant or shares of common stock paid to you unless you are an exempt
recipient such as a corporation or, in some circumstance, a tax-exempt
organization.
Backup
withholding will apply to those payments if you fail to provide your correct
taxpayer identification number, certify your exempt status, or report in full
interest and dividend income. Certain U.S. Holders, including, among
others, corporations, financial institutions and certain tax exempt
organizations, generally are not subject to backup withholding. Backup
withholding tax is not an additional tax, and you may use amounts withheld as
credit against your U.S. federal income tax liability or may claim a refund as
long as you timely provide certain information to the IRS. U.S. Holders
should consult their own tax advisors regarding the applicability of backup
withholding.
Non-U.S.
Holders
The
following is a summary of certain U.S. federal tax considerations
applicable to a Non-U.S. Holder:
Common
Stock
Distributions.
Dividends paid to a Non-U.S. Holder, if any, with respect to shares of
common stock will be subject to withholding tax at a 30% rate (or lower
applicable income tax treaty rate) unless the dividends are effectively
connected with the Non-U.S. Holder’s conduct of a trade or business in the
United States. If a Non-U.S. Holder is engaged in a trade or business in
the United States and dividends with respect to the common stock are effectively
connected with the conduct of that trade or business and, if required by an
applicable income tax treaty, are attributable to a U.S. permanent
establishment, then the Non-U.S. Holder will be subject to U.S. federal income
tax on those dividends on a net income basis (although the dividends will be
exempt from the 30% U.S. federal withholding tax, provided the certification
requirements are satisfied) in the same manner as if received by a U.S. person
as defined under the Code. Any such effectively connected income received by a
foreign corporation may, under certain circumstances, be subject to an
additional branch profits tax at a 30% rate (or lower applicable income tax
treaty rate).
Subject
to the discussion below under “— New Legislation Relating to Foreign Accounts,”
in order to obtain a reduced rate of withholding, you will be required to timely
provide a properly executed IRS Form W-8BEN (or other applicable IRS form)
certifying your entitlement to benefits under a treaty. If a Non-U.S. Holder is
eligible for a reduced rate of U.S. withholding tax pursuant to an income tax
treaty, it may obtain a refund of any excess amounts withheld by filing an
appropriate claim for refund with the Internal Revenue
Service.
Dispositions. A
Non-U.S. Holder may recognize gain upon the sale, exchange, redemption or other
taxable disposition of common stock. Subject to the discussion
below concerning backup withholding and the newly-enacted legislation relating
to foreign accounts, such gain generally will not be subject to U.S.
federal income tax unless: (i) that gain is effectively connected with conduct
of a trade or business in the United States (and, if required by an applicable
income tax treaty, is attributable to a U.S. permanent establishment) by a
Non-U.S. Holder; (ii) the Non-U.S. Holder is an individual who is present in the
United States for 183 days or more in the taxable year of that disposition, and
certain other conditions are met; or (iii) the Company is or has been a “U.S.
real property holding corporation” for U.S. federal income tax
purposes.
If a
Non-U.S. Holder is an individual described in clause (i) of the last sentence of
the preceding paragraph, the Non-U.S. Holder will generally be subject to tax on
the net gain at regular graduated U.S. federal income tax rates. If the
Non-U.S. holder is an individual described in clause (ii) of the preceding
paragraph, the Non-U.S. holder will generally be subject to a flat 30% tax on
the gain, which may be offset by U.S. source capital losses even though the
non-U.S. holder is not considered a resident of the United States. If a
Non-U.S. Holder is a foreign corporation that is described in clause (i) of the
last sentence of the preceding paragraph, it will be subject to tax on its net
gain in the same manner as if it were a U.S. person as defined under the Code
and, in addition, the Non-U.S. Holder may be subject to the branch profits tax
at a rate equal to 30% of its effectively connected earnings and profits or at
such lower rate as may be specified by an applicable income tax
treaty.
The Company believes that
it is not and does not anticipate becoming a “U.S. real property holding
corporation” for U.S. federal income tax purposes. However, because
the determination depends on the fair market value of our U.S. real property
interests and the fair market value of our other assets, no assurance can be
provided that we currently are not, or in the future will not become, a U.S.
real property holding corporation. The tax relating to stock in a “U.S. real
property holding corporation” generally will not apply to a Non-U.S. Holder
whose holdings (taking into account actual ownership and certain constructive
ownership rules) at all times during the applicable period, constituted 5% or
less of our common stock, provided that our common stock is regularly traded on
an established securities market. If we are a U.S. real property holding
corporation and our common stock is treated as a U.S. real property interest,
you will be subject to U.S. federal income tax on a net income basis on any gain
realized on a sale or other disposition of the common stock and a purchaser may
be required to withhold a portion of the proceeds payable to you from the
disposition.
Warrants
Dispositions.
A Non-U.S. Holder may recognize gain upon the sale, exchange, redemption,
exercise or other taxable disposition of a warrant. Subject to the discussion
below concerning backup withholding and the newly-enacted legislation relating
to foreign accounts, such gain generally will not be subject to U.S.
federal income tax unless: (i) that gain is effectively connected with conduct
of a trade or business in the United States (and, if required by an applicable
income tax treaty, is attributable to a U.S. permanent establishment) by a
Non-U.S. Holder; (ii) the Non-U.S. Holder is an individual who is present in the
United States for 183 days or more in the taxable year of that disposition, and
certain other conditions are met; or (iii) the Company is or has been a “U.S.
real property holding corporation” for U.S. federal income tax
purposes.
If a
Non-U.S. Holder is an individual described in clause (i) of the last sentence of
the preceding paragraph, the Non-U.S. Holder will generally be subject to tax on
the net gain at regular graduated U.S. federal income tax rates. If the
Non-U.S. holder is an individual described in clause (ii) of the preceding
paragraph, the Non-U.S. holder will generally be subject to a flat 30% tax on
the gain, which may be offset by U.S. source capital losses even though the
non-U.S. holder is not considered a resident of the United States. If a
Non-U.S. Holder is a foreign corporation that is described in clause (i) of the
last sentence of the preceding paragraph, it will be subject to tax on its net
gain in the same manner as if it were a U.S. person as defined under the Code
and, in addition, the Non-U.S. Holder may be subject to the branch profits tax
at a rate equal to 30% of its effectively connected earnings and profits or at
such lower rate as may be specified by an applicable income tax
treaty.
The Company believes that
it is not and does not anticipate becoming a “U.S. real property holding
corporation” for U.S. federal income tax purposes. However, because
the determination depends on the fair market value of our U.S. real property
interests and the fair market value of our other assets, no assurance can be
provided that we currently are not, or in the future will not become, a U.S.
real property holding corporation. If we are a U.S. real property holding
corporation and our warrants are treated as a U.S. real property interest, you
will be subject to U.S. federal income tax on a net income basis on any gain
realized on a sale or other disposition of the common stock and a purchaser may
be required to withhold a portion of the proceeds payable to you from the
disposition.
Constructive
Distributions. Upon the occurrence of
certain events, you may be deemed to receive a constructive distribution
pursuant to Section 305 of the Code. Such a constructive distribution
could occur upon the occurrence of certain adjustments, or failure to make
certain adjustments, to the number of shares of common stock to be issued upon
exercise of a warrant or to the warrant’s exercise price. Any
deemed dividends that are not effectively connected with the conduct of a trade
or business in the United States generally will be subject to withholding tax at
a 30% rate (or lower applicable income tax treaty rate). Subject to the
discussion below under “— New Legislation Relating to Foreign Accounts,” in
order to obtain a reduced rate of withholding, you will be required to timely
provide a properly executed IRS Form W-8BEN (or other applicable IRS form)
certifying your entitlement to benefits under a treaty. Because any
constructive dividend would not give rise to any cash from which any applicable
withholding tax could be satisfied, it is possible that this tax would be
withheld from any amount owed to you, including, but not limited to, cash or
shares of common stock otherwise due on exercise, dividends or sales proceeds
subsequently paid or credited to you.
Constructive
dividends that are effectively connected with the conduct of a trade or business
within the United States and, where a tax treaty applies, are attributable to a
U.S. permanent establishment, are not subject to withholding tax, but instead
are subject to U.S. federal income tax on a net income basis at applicable
graduated U.S. federal income tax rates in the same manner as if you were a
resident of the United States. In such cases, we generally will not be required
to withhold U.S. federal income tax if you comply with applicable certification
and disclosure requirements, generally on a properly executed IRS Form W-8ECI
(or other applicable IRS Form). Any such effectively connected income received
by a Non-U.S. Holder that is classified as corporation for U.S. tax purposes may
also be subject to an additional branch profits tax at a 30% rate (or lower
applicable income tax treaty rate).
A
Non-U.S. Holder of shares that wishes to claim the benefit of an applicable
treaty rate is required to satisfy applicable certification and other
requirements. If you are eligible for a reduced rate of U.S. withholding tax
pursuant to an income tax treaty, you may obtain a refund of any excess amounts
withheld by filing an appropriate claim for refund with the
IRS.
In
certain situations, we may be obligated to adjust the conversion rate of the
warrants or, in lieu of such adjustment, to provide for the conversion of
warrants into warrants or shares of an acquirer. Depending on the
circumstances, such modification could result in a deemed exchange of your
warrant for a new warrant, potentially resulting in the recognition of taxable
gain (See “Warrants – Dispositions” above).
New
Legislation Relating to Foreign Accounts
Newly
enacted legislation may impose withholding taxes on certain types of payments
made to “foreign financial institutions” and certain other non-U.S. entities.
The legislation imposes a 30% withholding tax on dividends on, and gross
proceeds from the sale or other disposition of, common stock or paid to a
foreign financial institution or to a foreign non-financial entity, unless (i)
the foreign financial institution undertakes certain diligence and reporting
obligations or (ii) the foreign non-financial entity either certifies it does
not have any substantial U.S. owners or furnishes identifying information
regarding each substantial U.S. owner. If the payee is a foreign financial
institution, it must enter into an agreement with the U.S. Treasury requiring,
among other things, that it undertake to identify accounts held by certain U.S.
persons or U.S.-owned foreign entities, annually report certain information
about such accounts, and withhold 30% on payments to account holders whose
actions prevent it from complying with these reporting and other requirements.
The legislation would apply to payments made after December 31, 2012.
Prospective investors should consult their tax advisors regarding this
legislation.
Information
Reporting and Backup Withholding
Generally,
we must report to the IRS and to you the amount of dividends paid (or deem paid)
to you and the amount of tax, if any, withheld with respect to those payments.
Copies of the information returns reporting such interest payments and any
withholding may also be made available to the tax authorities in the country in
which you reside under the provisions of an applicable income tax
treaty.
In
general, you will not be subject to backup withholding with respect to payments
of dividends (or deemed dividends) that we make to you provided that we do not
have actual knowledge or reason to know that you are a U.S. person, as defined
under the Code, and we have a properly executed IRS Form W-8BEN (or other
applicable IRS form) and certify, under penalties of perjury, that you are not a
U.S. person or (b) you hold your common stock or warrants through certain
foreign intermediaries and satisfy the certification requirements of applicable
U.S. Treasury regulations. Special rules apply to non-U.S. holders that
are pass-through entities rather than corporations or individuals.
In
addition, no information reporting or backup withholding will be required
regarding the proceeds of the sale of common stock or a warrant made within the
U.S. or conducted through certain U.S.-related financial intermediaries, if the
payor receives the statement described above and does not have actual knowledge
or reason to know that you are a U.S. person, as defined under the Code, or you
otherwise establish an exemption.
Any
amounts withheld under the backup withholding rules will be allowed as a refund
or a credit against your U.S. federal income tax liability provided the required
information is timely furnished to the IRS.
UNDERWRITING
Subject
to the terms and conditions of the underwriting agreement, the underwriters
named below, through their representative, Dawson James Securities, Inc., who is
acting as the sole book-running manager and sole representative of the
underwriters of this offering, each underwriter named below has severally agreed
to purchase from us on a firm commitment basis the following respective number
of Units at a public offering price less the underwriting discounts and
commissions set forth on the cover page of this prospectus:
|
|
|
Dawson
James Securities, Inc.
|
|
|
|
|
|
|
|
|
Total
|
|
|
The
underwriting agreement provides that the obligation of the underwriters to
purchase all of the 3,000,000 Units being offered to the public (assuming a
$6.00 per Unit public offering price) is subject to specific conditions,
including the absence of any material adverse change in our business or in the
financial markets and the receipt of certain legal opinions, certificates and
letters from us, our counsel and the independent auditors. Subject to the terms
of the underwriting agreement, the underwriters will purchase all of the
3,000,000 Units being offered to the public, other than those covered by the
over-allotment option described below, if any of these Units are
purchased.
Over-Allotment
Option
We have
granted to the underwriters an option, exercisable not later than 45 days after
the effective date of the registration statement, to purchase up to 450,000
additional Units at the public offering price less the underwriting discounts
and commissions set forth on the cover of this prospectus. The underwriters may
exercise this option only to cover over-allotments made in connection with the
sale of the Units offered by this prospectus. The over-allotment option will
only be used to cover the net syndicate short position resulting from the
initial distribution. To the extent that the underwriters exercise this option,
each of the underwriters will become obligated, subject to conditions, to
purchase approximately the same percentage of these additional Units as the
number of Units to be purchased by it in the above table bears to the total
number of Units offered by this prospectus. We will be obligated, pursuant to
the option, to sell these additional Units to the underwriters to the extent the
option is exercised. If any additional Units are purchased, the underwriters
will offer the additional Units on the same terms as those on which the other
Units are being offered hereunder.
Commissions
and Discounts
The
underwriting discounts and commissions are 7% of the initial public offering
price. We have agreed to pay the underwriters the discounts and commissions set
forth below, assuming either no exercise or full exercise by the underwriters of
the underwriters’ over-allotment option. In addition, we have agreed to pay to
the underwriters a non-accountable expense allowance of up to 3% of the gross
proceeds of this offering.
Additionally,
the underwriters will receive a warrant exercisable for the purchase of up to
15% of the aggregate number of Units sold in the public offering, exercisable
commencing one year from the effective date of the registration statement of
which this prospectus forms a part and expiring four years from such effective
date, at an exercise price of 110% of the public Unit offering price. The
underwriter warrant will contain a cashless, net exercise feature. The
Class A Warrants issuable upon exercise of the underwriter warrant will be
exercisable only on a cashless basis and will be exercisable for a period of 10
days from the date the underwriter Unit warrant is exercised; the Class B
Warrants issuable upon exercise of the underwriter warrant will be exercisable
for a period of five years following the exercise of the underwriter Unit
warrant. In compliance with the lock-up restrictions set forth in FINRA
Rule 5110(g)(1), neither the underwriter’s warrants nor the underlying
securities may be sold, transferred, assigned, pledged or hypothecated, or be
the subject of any hedging, short sale, derivative, put, or call transaction
that would result in the effective economic disposition of the securities by any
person for a period of at least 180 days immediately following the date of
effectiveness or commencement of sales of the offering, except to any member
participating in the offering and the officers or partners thereof, and only if
all securities so transferred remain subject to the one-year lock-up restriction
for the remainder of the lock-up period.
The
representative has advised us that the underwriters propose to offer the Units
directly to the public at the public offering price set forth on the cover of
this prospectus. In addition, the representative may offer some of the Units to
other securities dealers at such price less a concession of $___ per Unit.
The underwriters may also allow, and such dealers may reallow, a concession not
in excess of $___ per Unit to other dealers. After the common stock is
released for sale to the public, the representative may change the offering
price and other selling terms at various times.
The
following table summarizes the underwriting discounts and commissions we will
pay to the underwriters. The underwriting discounts and commissions are equal to
the public offering price per share less the amount per share the underwriters
pay us for the shares.
|
|
|
|
Total
without
Over-Allotment
|
|
Total
with
Over-Allotment
|
Public
offering price
|
|
|
|
|
|
|
Underwriting
discount (1)
|
|
|
|
|
|
|
Proceeds,
before expenses, to us
|
|
|
|
|
|
|
(1)
|
Does
not include the non-accountable expense reimbursement fee in the amount of
up to 3% of the gross proceeds of this
offering.
|
We
estimate that the total expenses of the offering, including registration, filing
and listing fees, printing fees and legal and accounting expenses, but excluding
underwriting discounts and commissions, will be approximately $_________, all of
which are payable by us.
Lock-Up
Agreements
We and
each of our officers, directors, and existing stockholders are bound by
agreements providing that, subject to certain exceptions, these stockholders may
not offer, issue, sell, contract to sell, encumber, grant any option for the
sale of or otherwise dispose of any shares of our common stock or other
securities convertible into or exercisable or exchangeable for shares of our
common stock for a period of 12 months from the effective date of the
registration statement of which this prospectus is a part without the prior
written consent of Dawson James.
Dawson
James may in its sole discretion and at any time without notice release some or
all of the shares subject to lock-up agreements prior to the expiration of the
lock-up period. When determining whether or not to release shares from the
lock-up agreements, the representative will consider, among other factors, the
securityholder’s reasons for requesting the release, the number of shares for
which the release is being requested and market conditions at the
time.
Pricing
of this Offering
Prior to
this offering there has been no public market for any of our securities. The
public offering price of the Units and the terms of the warrants, including the
exercise prices of the warrants, were negotiated between us and Dawson
James. Factors considered in determining the prices and terms of the
Units, including the common stock and warrants underlying the Units,
include:
|
·
|
the
history and prospects of companies in our
industry;
|
|
·
|
prior
offerings of those companies;
|
|
·
|
our
prospects for developing and commercializing our products; our capital
structure;
|
|
·
|
an
assessment of our management and their experience; general conditions of
the securities markets at the time of the offering;
and
|
|
·
|
other
factors as were deemed
relevant.
|
However,
although these factors were considered, the determination of our offering price
is more arbitrary than the pricing of securities for an operating company in a
particular industry since the underwriters are unable to compare our financial
results and prospects with those of public companies operating in the same
industry.
Price
Stabilization, Short Positions and Penalty Bids
The
underwriters may engage in over-allotment, stabilizing transactions, syndicate
covering transactions, and penalty bids or purchasers for the purpose of
pegging, fixing or maintaining the price of the common stock, in accordance with
Regulation M under the Exchange Act:
|
·
|
Over-allotment
involves sales by the underwriters of shares in excess of the number of
shares the underwriters are obligated to purchase, which creates a
syndicate short position. The short position may be either a covered short
position or a naked short position. In a covered short position, the
number of shares over-allotted by the underwriters is not greater than the
number of shares that they may purchase in the over-allotment option. In a
naked short position, the number of shares involved is greater than the
number of shares in the over-allotment option. The underwriters may close
out any short position by either exercising their over-allotment option
and/or purchasing shares in the open
market.
|
|
·
|
Stabilizing
transactions permit bids to purchase the underlying security so long as
the stabilizing bids do not exceed a specified
maximum.
|
|
·
|
Syndicate
covering transactions involve purchases of the common stock in the open
market after the distribution has been completed in order to cover
syndicate short positions. In determining the source of shares to close
out the short position, the underwriters will consider, among other
things, the price of shares available for purchase in the open market as
compared to the price at which they may purchase shares through the
over-allotment option. If the underwriters sell more shares than could be
covered by the over-allotment option, a naked short position, the position
can only be closed out by buying shares in the open market. A naked short
position is more likely to be created if the underwriters are concerned
that there could be downward pressure on the price of the shares in the
open market after pricing that could adversely affect investors who
purchase in the offering.
|
|
·
|
Penalty
bids permit the underwriters to reclaim a selling concession from a
syndicate member when the common stock originally sold by the syndicate
member is purchased in a stabilizing or syndicate covering transaction to
cover syndicate short positions.
|
These
stabilizing transactions, syndicate covering transactions and penalty bids may
have the effect of raising or maintaining the market price of our common stock
or preventing or retarding a decline in the market price of the common stock. As
a result, the price of the common stock may be higher than the price that might
otherwise exist in the open market. These transactions may be effected in the
over-the-counter market or otherwise and, if commenced, may be discontinued at
any time.
Neither
we nor any of the underwriters make any representation or prediction as to the
direction or magnitude of any effect that the transactions described above may
have on the price of the common stock. In addition, neither we nor any of the
underwriters make representation that the underwriters will engage in these
stabilizing transactions or that any transaction, once commenced, will not be
discontinued without notice.
Other
Terms
For a
period of 24 months from the consummation of this offering, we have granted
Dawson James, on any transaction where we elect to employ a banker, the right of
first refusal to act as a co-lead manager and book runner, for any and all
future public and private equity offerings by us or any of our successors or
subsidiaries. We have engaged Dawson James, on a non-exclusive basis, as
our agent for the solicitation of the exercise of the Class B Warrants. To
the extent not inconsistent with the guidelines of the Financial Industry
Regulatory Authority, or FINRA, and the rules and regulations of the SEC, we
have agreed to pay the underwriter for bona fide services rendered a commission
equal to 5% of the exercise price for each warrant exercised more than one year
after the date of this prospectus if the exercise was solicited by Dawson James.
No compensation will be paid to the underwriter upon the exercise of the
warrants if:
|
·
|
the
market price of the underlying shares of common stock is lower than the
exercise price;
|
|
·
|
the
holder of the warrants has not confirmed in writing that the underwriter
solicited his, her or its exercise;
|
|
·
|
the
warrants are held in a discretionary account, unless prior specific
written approval for the exercise is received from the
holder;
|
|
·
|
the
warrants are exercised in an unsolicited transaction;
or
|
|
·
|
the
arrangement to pay the commission is not disclosed in the prospectus
provided to warrant holders at the time of
exercise.
|
In
addition, we have agreed to reimburse the underwriters for up to $150,000 of the
legal fees incurred by the underwriters in connection with the offering, plus up
to an additional $25,000 in legal fees for blue sky matters and up to $15,000
for legal fees related to filings with FINRA.
Indemnification
We have
agreed to indemnify the underwriters against liabilities relating to the
offering arising under the Securities Act, liabilities arising from breaches of
some or all of the representations and warranties contained in the underwriting
agreement, and to contribute to payments that the underwriters may be required
to make for these liabilities.
Electronic
Distribution
A
prospectus in electronic format may be made available on a website maintained by
the representatives of the underwriters and may also be made available on a
website maintained by other underwriters. The underwriters may agree to allocate
a number of shares to underwriters for sale to their online brokerage account
holders. Internet distributions will be allocated by the representatives of the
underwriters to underwriters that may make Internet distributions on the same
basis as other allocations. In connection with the offering, the underwriters or
syndicate members may distribute prospectuses electronically. No forms of
electronic prospectus other than prospectuses that are printable as Adobe® PDF
will be used in connection with this offering.
The
underwriters have informed us that they do not expect to confirm sales of Units
offered by this prospectus to accounts over which they exercise discretionary
authority.
Other
than the prospectus in electronic format, the information on any underwriter’s
website and any information contained in any other website maintained by an
underwriter is not part of the prospectus or the registration statement of which
this prospectus forms a part, has not been approved and/or endorsed by us or any
underwriter in its capacity as underwriter and should not be relied upon by
investors.
Relationships
Certain
of the underwriters or their affiliates have provided from time to time and may
in the future provide investment banking, lending, financial advisory and other
related services to us and our affiliates for which they have received and may
continue to receive customary fees and commissions.
Foreign
Regulatory Restrictions on Purchase of Units
We have
not taken any action to permit a public offering of the Units outside the United
States or to permit the possession or distribution of this prospectus outside
the United States. Persons outside the United States who come into possession of
this prospectus must inform themselves about and observe any restrictions
relating to this offering of Units and the distribution of the prospectus
outside the United States.
LEGAL
MATTERS
The
validity of the securities offered by this prospectus will be passed upon for us
by Goodwin Procter LLP, San Francisco, California. Certain legal matters
relating to this offering will be passed upon for the underwriter by McDermott
Will & Emery LLP, Menlo Park, California.
EXPERTS
KCCW
Accountancy Corp., an independent PCAOB registered public accounting firm, has
audited the Company’s balance sheets as of December 31, 2009 and the related
statements of operations, stockholders’ equity, and cash flows, which are
included in this prospectus. The financial statements are included in
reliance on the report of KCCW Accountancy Corp., given their authority as
experts in accounting and auditing.
ADDITIONAL
INFORMATION
We have
filed with the SEC a registration statement on Form S-1 under the Securities Act
of 1933 with respect to the Units offered by this prospectus. This
prospectus does not contain all of the information included in the registration
statement, portions of which are omitted as permitted by the rules and
regulations of the SEC. For further information pertaining to us and the Units
to be sold in this offering, you should refer to the registration statement and
its exhibits.
In this
prospectus, whenever reference is made to contracts, agreements or other
documents, the references are not necessarily complete, and you should refer to
the exhibits attached to the registration statement for copies of the actual
contract, agreement or other document filed as an exhibit to the registration
statement or such other document, each such statement being qualified in all
respects by such reference.
Upon the
completion of this offering, we will be subject to the informational
requirements of the Securities Exchange Act of 1934 and will be required to file
annual, quarterly and current reports, proxy statements and other information
with the SEC. We anticipate making these documents publicly available, free of
charge, on its website as soon as reasonably practicable after filing such
documents with the SEC. The information contained in, or that can be accessed
through, our website is not part of this prospectus.
You can
read the registration statement and future filings, as they are filed with the
SEC, over the Internet at the SEC’s website at www.sec.gov. Copies of
filings may be requested, at no cost, from us. You may also read and copy
any document filed with the SEC at its public reference facility at 100 F
Street, N.E., Washington, D.C. 20549 and copies may be requested at prescribed
rates at such address or at 1-800-SEC-0330.
ATOSSA
GENETICS, INC.
(A
Development Stage Company)
INDEX
TO FINANCIAL STATEMENTS
|
|
Page
|
|
|
|
Unaudited
Financial Statements |
|
|
|
|
|
Balance
Sheet as of June 30, 2010 (unaudited)
|
|
F-1
|
|
|
|
Statements
of Operations through the Period Ended June 30, 2010
(unaudited)
|
|
F-2
|
|
|
|
Statements
of Cash Flows through the Period Ended June 30, 2010
(unaudited)
|
|
F-3
|
|
|
|
Notes
to Financial Statements as of June 30, 2010 (unaudited)
|
|
F-4
|
|
|
|
Audited Financial
Statements |
|
|
|
|
|
Report
of Independent Registered Public Accounting Firm
|
|
F-11
|
|
|
|
Balance
Sheet as of December 31, 2009
|
|
F-12
|
|
|
|
Statements
of Operations through the Period Ended December 31, 2009
|
|
F-13
|
|
|
|
Statements
of Changes in Stockholders’ Deficit through the Period Ended December 31,
2009
|
|
F-14
|
|
|
|
Statements
of Cash Flows through the Period Ended December 31, 2009
|
|
F-15
|
|
|
|
Notes
to Financial Statements as of December 31, 2009
|
|
F-16
|
|
|
|
ATOSSA
GENETICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
BALANCE
SHEETS
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
(Unaudited)
|
|
|
(Audited)
|
|
Assets
|
|
|
|
|
|
|
Current
Assets
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
32,098 |
|
|
$ |
84,364 |
|
Prepaid
expenses
|
|
|
8,000 |
|
|
|
- |
|
Total
Current Assets
|
|
|
40,098 |
|
|
|
84,364 |
|
|
|
|
|
|
|
|
|
|
Other
Assets
|
|
|
|
|
|
|
|
|
Security
deposit - related parties
|
|
|
1,100 |
|
|
|
1,100 |
|
Total
Other Assets
|
|
|
1,100 |
|
|
|
1,100 |
|
|
|
|
|
|
|
|
|
|
Total
Assets
|
|
$ |
41,198 |
|
|
$ |
85,464 |
|
|
|
|
|
|
|
|
|
|
Liabilities
and Stockholders' (Deficit) Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
|
|
|
|
Accrued
payroll
|
|
$ |
53,571 |
|
|
$ |
- |
|
Accrued
expenses
|
|
|
39,864 |
|
|
|
36,281 |
|
Note
payable - related party
|
|
|
5,000 |
|
|
|
5,000 |
|
Accrued
royalty payable - related party
|
|
|
- |
|
|
|
12,500 |
|
Total
Current Liabilities
|
|
|
98,436 |
|
|
|
53,781 |
|
|
|
|
|
|
|
|
|
|
Stockholders'
(Deficit) Equity
|
|
|
|
|
|
|
|
|
Preferred
stock - $.001 par value; 10,000,000 shares authorized,
|
|
|
|
|
|
|
|
|
0
shares issued and outstanding
|
|
|
- |
|
|
|
- |
|
Common
stock - $.001 par value; 50,000,000 shares authorized,
|
|
|
|
|
|
|
|
|
6,000,063
and 4,899,882 shares issued and
|
|
|
|
|
|
|
|
|
outstanding,
respectively
|
|
|
6,000 |
|
|
|
4,900 |
|
Additional
paid-in capital
|
|
|
321,540 |
|
|
|
149,640 |
|
Accumulated
deficit
|
|
|
(384,778 |
) |
|
|
(122,857 |
) |
Total
Stockholders' (Deficit) Equity
|
|
|
(57,238 |
) |
|
|
31,683 |
|
|
|
|
|
|
|
|
|
|
Total
Liabilities and Stockholders' (Deficit) Equity
|
|
$ |
41,198 |
|
|
$ |
85,464 |
|
The
accompanying notes are an integral part of these financial
statements.
ATOSSA
GENETICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF OPERATIONS
(UNAUDITED)
|
|
|
|
|
From April 30,
|
|
|
|
|
|
From April 30,
|
|
|
|
For The Three
|
|
|
2009 (Inception)
|
|
|
For The Six
|
|
|
2009 (Inception)
|
|
|
|
Months Ended
|
|
|
Through June 30,
|
|
|
Months Ended
|
|
|
Through June 30,
|
|
|
|
June 30, 2010
|
|
|
2009
|
|
|
June 30, 2010
|
|
|
2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Revenue
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Executive
compensation
|
|
|
53,571 |
|
|
|
- |
|
|
|
53,571 |
|
|
|
53,571 |
|
Website
and internet expenses
|
|
|
52,508 |
|
|
|
- |
|
|
|
52,538 |
|
|
|
55,538 |
|
Consulting
expenses
|
|
|
39,165 |
|
|
|
- |
|
|
|
44,165 |
|
|
|
44,165 |
|
Legal
and professional expenses
|
|
|
26,125 |
|
|
|
- |
|
|
|
90,709 |
|
|
|
179,231 |
|
Advertising
and promotion expenses
|
|
|
- |
|
|
|
- |
|
|
|
12,204 |
|
|
|
12,204 |
|
Research
and development expenses
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
21,250 |
|
Other
operating expenses
|
|
|
25,859 |
|
|
|
524 |
|
|
|
21,561 |
|
|
|
31,646 |
|
Total
operating expenses
|
|
|
197,228 |
|
|
|
524 |
|
|
|
274,747 |
|
|
|
397,605 |
|
Other
Operating Income
|
|
|
- |
|
|
|
- |
|
|
|
12,500 |
|
|
|
12,500 |
|
Operating
Loss
|
|
|
(197,228 |
) |
|
|
(524 |
) |
|
|
(262,247 |
) |
|
|
(385,105 |
) |
Interest
Income
|
|
|
128 |
|
|
|
- |
|
|
|
453 |
|
|
|
453 |
|
Net
Loss before Income Taxes
|
|
|
(197,101 |
) |
|
|
(524 |
) |
|
|
(261,795 |
) |
|
|
(384,653 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
Taxes
|
|
|
- |
|
|
|
- |
|
|
|
125 |
|
|
|
125 |
|
Net
Loss
|
|
$ |
(197,101 |
) |
|
$ |
(524 |
) |
|
$ |
(261,920 |
) |
|
$ |
(384,778 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
per common share - basic and diluted
|
|
$ |
(0.03 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.08 |
) |
Weighted
average shares outstanding, basic and diluted
|
|
|
5,996,206 |
|
|
|
3,976,459 |
|
|
|
5,870,334 |
|
|
|
4,814,161 |
|
The
accompanying notes are an integral part of these financial
statements.
ATOSSA
GENETICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF CASH FLOWS
(UNAUDITED)
|
|
|
|
|
From April 30,
|
|
|
From
April 30,
|
|
|
|
For The Six
|
|
|
2009 (Inception)
|
|
|
2009 (Inception)
|
|
|
|
Months Ended
|
|
|
Through June 30,
|
|
|
Through June 30,
|
|
|
|
June 30, 2010
|
|
|
2009
|
|
|
2010
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(261,920 |
) |
|
$ |
(524 |
) |
|
$ |
(384,778 |
) |
Common
shares issued for services
|
|
|
71,000 |
|
|
|
- |
|
|
|
71,000 |
|
Adjustments
to reconcile net loss to net cash
|
|
|
|
|
|
|
|
|
|
|
|
|
provided
by operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase
in prepaid expenses
|
|
|
(8,000 |
) |
|
|
- |
|
|
|
(8,000 |
) |
Increase
in security deposits
|
|
|
- |
|
|
|
- |
|
|
|
(1,100 |
) |
Increase
in accrued payroll
|
|
|
53,571 |
|
|
|
- |
|
|
|
53,571 |
|
(Decrease)
Increase in accrued expenses
|
|
|
(8,917 |
) |
|
|
- |
|
|
|
39,864 |
|
Net
cash used in operating activities
|
|
|
(154,266 |
) |
|
|
(524 |
) |
|
|
(229,442 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from issuance of common stocks
|
|
|
102,000 |
|
|
|
- |
|
|
|
256,540 |
|
Proceeds
from loans from related parties
|
|
|
- |
|
|
|
5,000 |
|
|
|
5,000 |
|
Net
cash provided by financing activities
|
|
|
102,000 |
|
|
|
5,000 |
|
|
|
261,540 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
(DECREASE) INCREASE IN CASH & CASH EQUIVALENTS
|
|
|
(52,266 |
) |
|
|
4,476 |
|
|
|
32,098 |
|
CASH
& CASH EQUIVALENTS, BEGINNING BALANCE
|
|
|
84,364 |
|
|
|
- |
|
|
|
- |
|
CASH
& CASH EQUIVALENTS, ENDING BALANCE
|
|
$ |
32,098 |
|
|
$ |
4,476 |
|
|
$ |
32,098 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL
DISCLOSURES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
paid
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
Income
taxes paid
|
|
$ |
125 |
|
|
$ |
- |
|
|
$ |
125 |
|
The
accompanying notes are an integral part of these financial
statements.
ATOSSA
GENETICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO UNAUDITED FINANCIAL STATEMENTS
NOTE
1: NATURE OF OPERATIONS
Atossa
Genetics, Inc., (the “Company”) was incorporated on April 30, 2009 in the State
of Delaware. The Company was formed to develop and market the Mammary
Aspirate Specimen Cytology Test, or the MASCT System, a cellular and molecular
diagnostic risk assessment product for the detection of pre-cancerous changes
that could lead to breast cancer. The Company’s fiscal year ends on
December 31st.
Development Stage
Risk
To date,
the Company has not earned any revenues from operations. Accordingly,
the Company’s activities have been accounted for as those of a “Development
Stage Enterprise” as set forth in Accounting Standards Codification (“ASC”) 915
“Development Stage Entities”, which was previously Statement of Financial
Accounting Standards No. 7 (“SFAS 7”). Among the disclosures required
by ASC 915 are that the Company’s financial statements be identified as those of
a development stage company, and that the statements of operations,
stockholders’ equity and cash flows disclose activity since the date of the
Company’s inception.
Since its
inception, the Company has been dependent upon the receipt of capital investment
to fund its continuing activities. In addition to the normal risks
associated with a new business venture, there can be no assurance that the
Company’s business plan will be successfully executed. The Company’s
ability to execute its business plan will depend on its ability to obtain
additional financing and achieve a profitable level of
operations. There can be no assurance that sufficient financing will
be obtained. Further, the Company cannot give any assurance that it
will generate substantial revenues or that its business operations will prove to
be profitable.
NOTE
2: GOING CONCERN
The
Company’s financial statements are prepared using generally accepted accounting
principles in the United States of America applicable to a going concern, which
contemplates the realization of assets and the satisfaction of liabilities in
the normal course of business. The Company has not yet established an
ongoing source of revenues sufficient to cover its operating costs and allow it
to continue as a going concern. The ability of the Company to
continue as a going concern is dependent on the Company obtaining adequate
capital to fund operating losses until it becomes profitable. If the
Company is unable to obtain adequate capital, it could be forced to cease
operations. The accompanying financial statements do not include any
adjustments that might be necessary if the Company is unable to continue as a
going concern.
Management’s Plan to
Continue as a Going Concern
In order
to continue as a going concern, the Company will need, among other things,
additional capital resources. Management’s plans to obtain such resources for
the Company include (1) obtaining capital from the sale of its securities, (2)
sales of the MASCT System and (3) short-term borrowings from stockholders or
other related party(ies) when needed. However, management cannot provide any
assurance that the Company will be successful in accomplishing any of its
plans.
ATOSSA
GENETICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO UNAUDITED FINANCIAL STATEMENTS
The
ability of the Company to continue as a going concern is dependent upon its
ability to successfully accomplish the plans described in the preceding
paragraph and eventually to secure other sources of financing and attain
profitable operations.
NOTE
3: SUMMARY OF ACCOUNTING POLICIES
Revenue
Recognition:
Although
the Company has yet to generate any revenues, it expects that it will recognize
product and service revenue when the following fundamental criteria are met: (i)
persuasive evidence of an arrangement exists, (ii) delivery has occurred or the
service has been performed, (iii) the Company’s price to the customer is fixed
or determinable and (iv) collection of the resulting accounts receivable is
reasonably assured. The Company will recognize revenue for product
sales upon transfer of title to the customer. The Company will
recognize revenue for services upon performance of the
service. Customer purchase orders and/or contracts will generally be
used to determine the existence of an arrangement. Shipping documents
and the completion of any customer acceptance requirements, when applicable,
will be used to verify product delivery or that services have been
rendered. The Company will assess whether a price is fixed or
determinable based upon the payment terms associated with the transaction and
whether the sales price is subject to refund or adjustment. The Company will
record reductions to revenue for estimated product returns and pricing
adjustments in the same period that the related revenue is
recorded. These estimates will be based on industry-based historical
data, historical sales returns, if any, analysis of credit memo data, and other
factors known at the time.
Interim
Financial Statements:
The
unaudited financial statements of the Company have been prepared in accordance
with U.S. generally accepted accounting principles for interim financial
information. Accordingly, they do not include all the information
and footnotes
required by accounting principles generally accepted in the United States of
America for annual audited financial statements. However, the
information included in these interim financial statements reflects all
adjustments (consisting solely of normal recurring adjustments) which are, in
the opinion of management, necessary for the fair presentation of the financial
position and the results of operations of the Company. Results shown
for interim periods are not necessarily indicative of the results to be obtained
for a full year. These interim financial statements should be read in
conjunction with the Company’s audited financial statements as of December 31,
2009 and related notes included therein.
Cash
and Cash Equivalents:
Cash and
cash equivalents include cash and all highly liquid instruments with original
maturities of three months or less.
Use
of Estimates:
The
preparation of financial statements in conformity with generally accepted
accounting principles in the United States of America requires management to
make estimates and assumptions that affect the reported amounts of assets and
liabilities and the disclosure of contingent assets and liabilities at the date
of the financial statements and the reported amounts of revenues and expenses
during the reporting period. Accordingly, actual results could differ
from those estimates.
ATOSSA
GENETICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO UNAUDITED FINANCIAL STATEMENTS
Research
and Development Expenses:
Research
and development costs are generally expensed as incurred. The
Company’s research and development expenses consist of costs incurred for
internal and external research and development.
Share
Based Payments:
In
December 2004, the Financial Accounting Standard Board, or the FASB, issued the
Statement of Financial Accounting Standards, or SFAS, No. 123(R), “Share-Based
Payment”, which replaces SFAS No. 123 and supersedes APB Opinion No.
25. SFAS No. 123(R) is now included in the FASB’s ASC Topic 718,
“Compensation – Stock Compensation.” Under SFAS No. 123(R), companies
are required to measure the compensation costs of share-based compensation
arrangements based on the grant-date fair value and recognize the costs in the
financial statements over the period during which employees or independent
contractors are required to provide services. Share-based
compensation arrangements include stock options and warrants, restricted share
plans, performance-based awards, share appreciation rights and employee share
purchase plans. In March 2005, the SEC issued Staff Accounting
Bulletin No. 107, or SAB 107, which expresses views of the staff regarding the
interaction between SFAS No. 123(R) and certain SEC rules and regulations and
provides the staff’s views regarding the valuation of share-based payment
arrangements for public companies. SFAS No. 123(R) permits public
companies to adopt its requirements using one of two methods. On
April 14, 2005, the SEC adopted a new rule amending the compliance dates for
SFAS No. 123(R). Companies may elect to apply this statement either
prospectively, or on a modified version of retrospective application under which
financial statements for prior periods are adjusted on a basis consistent with
the pro forma disclosures required for those periods under SFAS No.
123.
The
Company has fully adopted the provisions of FASB ASC 718 and related
interpretations as provided by SAB 107. As such, compensation cost is
measured on the date of grant as the fair value of the share-based
payments. Such compensation amounts, if any, are amortized over the
respective vesting periods of the option grant.
Recently
Issued Accounting Pronouncements:
The
Company has adopted all recently issued accounting pronouncements that
management believes to be applicable to the Company. The adoption of
these accounting pronouncements, including those not yet effective, is not
anticipated to have a material effect on the financial position or results of
operations of the Company.
NOTE
4: STOCKHOLDERS’ EQUITY
The
Company is authorized to issue a total of 85,000,000 shares of stock consisting
of 75,000,000 shares of Common Stock, par value $.001 per share, and 10,000,000
shares of Preferred Stock, par value $.001 per share.
ATOSSA
GENETICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO UNAUDITED FINANCIAL STATEMENTS
Prior Issuances of Common
Stock
On April
30, 2009 (inception), the Company issued 1,767,315 shares (or 4,000,000 shares
before giving effect to the September 2010 reverse stock split) to Ensisheim
Partners LLC, a party related to the Company through common ownership by two of
the Company’s officers, for cash in the amount of $24,000, or $.014 per share
(or $.006 per share before giving effect to the September 2010 reverse stock
split); 1,325,487 shares (3,000,000 shares before giving effect to the September
2010 reverse stock split) to Manistee Ventures LLC, a party related to the
Company through common ownership by two of the Company’s officers, for cash in
the amount of $18,000, or $.014 per share (or $.006 per share before giving
effect to the September 2010 reverse stock split); and 883,658 shares (or
2,000,000 shares before giving effect to the September 2010 reverse stock split)
to the Chairman, Chief Executive Officer and President of the Company at that
time for cash in the amount of $12,000, or $.014 per share (or $.006 per share
before giving effect to the September 2010 reverse stock split).
On July
28, 2009, the Company issued 39,765 shares (or 90,000 shares before giving
effect to the September 2010 reverse stock split) to a director of the Company
for cash in the amount of $540, or $.014 per share (or $.006 per share before
giving effect to the September 2010 reverse stock split).
On
December 28, 2009, the Company issued 883,658 shares (or 2,000,000 shares before
giving effect to the September 2010 reverse stock split) to Ensisheim Partners
LLC for cash in the amount of $100,000, or $0.11 per share (or $.05 per share
before giving effect to the September 2010 reverse stock split).
On
January 21, 2010, the Company issued 865,984 shares (or 1,960,000 shares before
giving effect to the September 2010 reverse stock split) to forty-four (44)
investors for cash in the amount of $98,000, or $0.11 per share (or
$.05 per share before giving effect to the September 2010 reverse stock
split).
On
January 21, 2010, the Company issued 132,549 shares (or 300,000 shares before
giving effect to the September 2010 reverse stock split) to a service provider
for effecting transactions intended to cause the Company to become a public
company and to have its securities traded on a national exchange in the United
States. The shares were issued at a value of $15,000, or $0.11 per
share (or $.05 per share before giving effect to the September 2010 reverse
stock split), the same price as the 865,984 shares (or 1,960,000 shares before
giving effect to the September 2010 reverse stock split) issued for cash on the
same date.
On
January 21, 2010, the Company issued an additional 53,019 shares (or 120,000
shares before giving effect to the September 2010 reverse stock split) to a
shareholder who acquired 13,255 shares (or 30,000 shares before giving effect to
the September 2010 reverse stock split) for cash on the same date as one of the
forty-four (44) investors. Those shares were issued to the
shareholder for services to be performed, including investor relations, media
relations, and corporate communications. Those shares were issued at
a value of $6,000, or $0.11 per share (or $.05 per share before giving effect to
the September 2010 reverse stock split), the same price as the issuance of the
865,984 shares (or 1,960,000 shares before giving effect to the September 2010
reverse stock split) for cash on the same date.
On
January 23, 2010, the Company issued 35,346 shares (or 80,000 shares before
giving effect to the September 2010 reverse stock split) to an investor for cash
in the amount of $4,000, or $0.11 per share (or $.05 per share before giving
effect to the September 2010 reverse stock split).
On April
27, 2010, the Company issued 13,255 shares (or 30,000 shares before giving
effect to the September 2010 reverse stock split) to a service provider for
website development services pursuant to an original agreement between the
Company and the website developer executed on December 14, 2009, where it was
agreed at that time the shares of common stock would be issued to the developer
in exchange for his services invoiced for $50,000, which would have valued the
shares on December 14, 2009 at $3.77 per share (or $1.67 per share before giving
effect to the September 2010 reverse stock split).
ATOSSA
GENETICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO UNAUDITED FINANCIAL STATEMENTS
Letter of Intent for
Proposed Initial Public Offering
On May
25, 2010, the Company executed a Letter of Intent with Dawson James Securities,
Inc. relating to a proposed public initial public offering of the Company’s
securities (the “Letter Agreement”). Pursuant to the Letter
Agreement, the Company paid a $25,000 deposit upon signing for out-of-pocket
expenses and will reimburse Dawson James for up to $150,000 in expenses incurred
in connection with the offering. If the offering is successful,
Dawson James will receive compensation in an amount equal to 7% of the gross
proceeds received by the Company in the offering, plus an expense allowance of
3% of the gross proceeds. Dawson James will also receive a warrant to
purchase Units equal to 15% of the total Units sold in the offering, exercisable
at 110% of the public offering price of the Units.
NOTE
5: INCOME TAXES
The
Company accounts for income taxes as outlined in ASC 740, “Income Taxes”, which
was previously Statement of Financial Accounting Standards No. 109, “Accounting
for Income Taxes” (“SFAS 109”). Under the asset and liability method
of SFAS 109, deferred income tax assets and liabilities are recognized for the
estimated future tax consequences attributable to differences between the
financial reporting and tax bases of assets and liabilities and are measured
using enacted tax rates in effect for the year in which those temporary
differences are expected to be recovered or settled. A valuation
allowance is provided for the amount of deferred tax assets that, based on
available evidence, are not expected to be realized.
The
provision for income taxes differs from the amounts which would be provided by
applying the statutory federal income tax rate of 34% to the net loss before
provision for income taxes for the following reasons:
|
|
Six
Month
Period
Ended
June
30, 2010
|
|
|
From
April 30,
2009
(Inception)
Through
June
30,
2009
|
|
|
From
April 30,
2009
(Inception)
Through
June 30,
2010
|
|
Income
tax benefit at statutory rate (34%)
|
|
$ |
(89,002 |
) |
|
$ |
(178 |
) |
|
$ |
(130,662 |
) |
Valuation
allowance
|
|
|
89,002 |
|
|
|
178 |
|
|
|
130,662 |
|
Delaware
state tax
|
|
|
125 |
|
|
|
- |
|
|
|
125 |
|
Income
taxes
|
|
$ |
125 |
|
|
$ |
- |
|
|
$ |
125 |
|
The tax
effect of temporary difference that gave rise to the Company’s deferred tax
asset as of June 30, 2010 and December 31, 2009 is as follows:
|
|
|
|
|
|
|
NOL
carryover
|
|
$ |
130,662 |
|
|
$ |
46,871 |
|
Valuation
allowance
|
|
|
(130,662 |
) |
|
|
(46,871 |
) |
Net
deferred tax asset
|
|
$ |
- |
|
|
$ |
- |
|
ATOSSA
GENETICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO UNAUDITED FINANCIAL STATEMENTS
NOTE
6: CONCENTRATION OF CREDIT RISK
Financial
instruments that potentially subject the Company to concentration of credit risk
consist principally of cash deposits. Accounts at each institution
are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to
$250,000. At June 30, 2010 and December 31, 2009, the Company had no
amounts in excess of the FDIC insured limit.
NOTE
7: RELATED PARTY TRANSACTIONS
Loans from
Officer
The
Company had borrowed $5,000 as of June 30, 2010 and December 31, 2009 from its
Chairman of the Board and Chief Executive Officer. This amount was
borrowed on May 26, 2009 as a short-term, unsecured loan via verbal agreement
and did not bear any interest. Commencing June 30, 2010, the loan was
converted into a written Promissory Note bearing an annual interest rate of 10%,
with a maturity date of December 31, 2010.
On June
30, 2010, the Company borrowed an additional $100,000 from its Chairman of the
Board and Chief Executive Officer pursuant to a promissory note. The
note bears a 10% interest rate per annum and carries a $4,000 loan origination
fee. The note is payable in full on or before December 31,
2010. The loan under the note was funded to the Company on July 12,
2010.
Exclusive License
Agreement
On July
27, 2009, the Company entered into an exclusive license agreement with Ensisheim
Partners LLC (“Ensisheim”), an entity solely owned by the Chairman and Chief
Executive Officer of the Company and the Chief Scientific Officer of the
Company, who is also the Company’s Chairman and CEO’s wife. Pursuant
to that agreement, Ensisheim granted the Company an exclusive, worldwide,
perpetual, irrevocable, royalty-bearing, license to the MASCT System, with the
right to grant and authorize sublicenses. The license agreement
provided that the Company would pay Ensisheim a royalty equal to 2% of net sales
revenues, with a minimum royalty of $12,500 per fiscal quarter during the term
of the agreement, which would have increased to a minimum royalty of $25,000 per
fiscal quarter beginning in the quarter in which the first commercial sale of a
licensed product would have taken place. As of December 31, 2009, a
total of $12,500 was payable to Ensisheim under the minimum royalty
provisions. From inception through June 30, 2010, the Company had
incurred $16,250 in patent-related expenses under the license agreement with
Ensisheim, which was recorded as accrued expense, whereas $4,000 was paid during
the period from inception through December 31, 2009.
On June
17, 2010, the Company and Ensisheim entered into an Assignment Agreement,
whereby Ensisheim assigned to the Company all rights to the patents and patent
applications underlying the MASCT System. Pursuant to the assignment,
the Company will have all responsibility for prosecution, maintenance, and
enforcement and will indemnify Ensisheim from any and all claims against the
patent estate. Ensisheim retained no residual rights with respect to
the patents and patent applications. In conjunction with the
assignment, the Company terminated the exclusive license agreement between the
Company and Ensisheim dated July 27, 2009. As a result of the
termination, the Company has no further obligations with respect to royalty
payments to Ensisheim due under the old licensing agreement. As a
result, the $12,500 of patent royalty payable to Ensisheim recorded as accrued
royalty payable at December 31, 2009 has been removed and recorded as other
operating income during the second quarter of 2010.
ATOSSA
GENETICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO UNAUDITED FINANCIAL STATEMENTS
Commercial Lease
Agreement
On
December 24, 2009, the Company entered into a commercial lease agreement with
Ensisheim for office space located in Seattle, Washington. The lease
provided for annual rent of $13,200, plus applicable sales tax. From
inception through December 31, 2009, the Company incurred $248 of rent expense
for the lease. As of December 31, 2009, security deposit for the
lease amounted to $1,100. For the period of January 1, 2010 through
June 30, 2010, the Company incurred $6,600 of rent expense for the
lease. On July 15, 2010 the Company and Ensisheim terminated the
lease, effective July 1, 2010 and the Company commenced use of the facility rent
free.
Executive
Compensation
On May
19, 2010, the Company entered into employment agreements with three executives,
including its Chief Executive Officer, its former President, and its Chief
Scientific Officer. The annual base salaries under each agreement
were calculated based on combined consideration of the success of capital raise
and the operating results of the Company, and capped at $360,000, $350,000, and
$250,000, respectively for the three executives.
In July
2010, the employment agreement with the former President was terminated with no
salary paid or payable.
NOTE
8: SUBSEQUENT EVENTS
On July
22, 2010, the Company restated and amended the employment agreements with its
Chief Executive Officer and Chief Scientific Officer. The agreements
modified the base annual salary amounts to $250,000 and $200,000, respectively,
effective retroactively to May 19, 2010. These salaries were accrued
and amounted to $53,571 as of June 30, 2010. No stock options or
warrants were issued or effective as of June 30, 2010 under the revised
agreements.
On July
22, 2010, in connection with the resignation and departure of Robert L. Kelly,
the President and a director, the Company entered into a consulting agreement
with a limited liability company controlled by Mr. Kelly. Under the
agreement, the Company was to receive consulting services relating to capital
raising and investor relations. The agreement was terminated by the
Company in September 2010, through which time a total of $30,000 had been
paid.
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the
Board of Directors and Stockholders of
Atossa
Genetics, Inc.:
We have
audited the accompanying balance sheet of Atossa Genetics, Inc. (a development
stage company) (the “Company”) as of December 31, 2009, and the related
statement of operations, changes in stockholders' equity, and cash flows for the
period from April 30, 2009 (inception) through December 31,
2009. These financial statements are the responsibility of the
Company's management. Our responsibility is to express an opinion on these
financial statements based on our audits.
We
conducted our audits in accordance with standards of the Public Company
Accounting Oversight Board (United States). Those standards require
that we plan and perform the audits to obtain reasonable assurance about whether
the financial statements are free of material misstatement. The
Company is not required to have, nor were we engaged to perform, an audit of its
internal control over financial reporting. Our audits included
consideration of internal control over financial reporting as a basis for
designing audit procedures that are appropriate in the circumstances, but not
for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no
such opinion. An audit includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting
principles used and significant estimates made by management, as well as
evaluating the overall financial statement presentation. We believe
that our audits provide a reasonable basis for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of Atossa Genetics, Inc. (a
development stage company) as of December 31, 2009 and the results of their
operations and their cash flows for the period from April 30, 2009 (inception)
through December 31, 2009 in conformity with accounting principles generally
accepted in the United States of America.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As described in Note 2 of the
financial statements, the Company has been in the development stage since its
inception (April 30, 2009) and continues to incur expenses. The
Company’s viability is dependent upon its ability to obtain future financing and
the success of its future operations. These matters raise substantial
doubt about the Company’s ability to continue as a going
concern. Management’s plan in regard to these matters is also
described in Note 2 to the financial statements. The financial
statements do not include any adjustments that might result from the outcome of
this uncertainty.
/s/ KCCW
Accountancy Corp.
Diamond
Bar, California
February
20, 2010
ATOSSA
GENETICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
BALANCE
SHEET
December
31, 2009
Assets
|
|
|
|
|
|
|
|
Current
Assets
|
|
|
|
Cash
and cash equivalents
|
|
$ |
84,364 |
|
Total
Current Assets
|
|
|
84,364 |
|
|
|
|
|
|
Other
Assets
|
|
|
|
|
Security
deposit - related parties
|
|
|
1,100 |
|
Total
Other Assets
|
|
|
1,100 |
|
|
|
|
|
|
Total
Assets
|
|
$ |
85,464 |
|
|
|
|
|
|
Liabilities and Stockholders'
Equity
|
|
|
|
|
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
Accrued
expenses
|
|
$ |
36,281 |
|
Accrued
expenses - related parties
|
|
|
12,500 |
|
Loan
from officer
|
|
|
5,000 |
|
Total
Current Liabilities
|
|
|
53,781 |
|
|
|
|
|
|
Stockholders'
Equity
|
|
|
|
|
Preferred
stock - $.001 par value; 10,000,000 shares authorized, 0
shares
|
|
|
|
|
issued
and outstanding
|
|
|
- |
|
Common
stock - $.001 par value; 50,000,000 shares authorized,
|
|
|
|
|
4,899,882
shares issued and outstanding
|
|
|
4,900 |
|
Additional
paid-in capital
|
|
|
149,640 |
|
Accumulated
deficit
|
|
|
(122,857 |
) |
Total
Stockholders' Equity
|
|
|
31,683 |
|
|
|
|
|
|
Total
Liabilities and Stockholders' Equity
|
|
$ |
85,464 |
|
The
accompanying notes are an integral part of financial
statements.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENT
OF OPERATIONS
From
April 30, 2009 (Inception) through December 31, 2009
Net
Revenue
|
|
$ |
- |
|
|
|
|
|
|
General
and Administrative Expenses
|
|
|
|
|
Legal
and professional expenses
|
|
|
88,522 |
|
Other
general and administrative expenses
|
|
|
13,085 |
|
Total
general, selling and administrative expenses
|
|
|
101,607 |
|
|
|
|
|
|
Research
and Development Expenses
|
|
|
21,250 |
|
|
|
|
|
|
Net
Loss before Income Taxes
|
|
|
(122,857 |
) |
|
|
|
|
|
Income
Tax Expense
|
|
|
- |
|
|
|
|
|
|
Net
Loss
|
|
$ |
(122,857 |
) |
|
|
|
|
|
Loss
per common share - basic and diluted
|
|
$ |
(0.03 |
) |
Weighted
average shares outstanding, basic and diluted
|
|
|
4,037,847 |
|
The
accompanying notes are an integral part of financial
statements.
ATOSSA
GENETICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENT
OF STOCKHOLDERS' EQUITY
|
|
Common Stock
|
|
|
Additional
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
Paid-in
|
|
|
Accumulated
|
|
|
Stockholders'
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at April 30, 2009, Founders' shares
|
|
|
3,976,459 |
|
|
$ |
3,976 |
|
|
$ |
50,024 |
|
|
$ |
- |
|
|
$ |
54,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of shares for cash, July 28, 2009
|
|
|
39,765 |
|
|
|
40 |
|
|
|
500 |
|
|
|
- |
|
|
|
540 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of shares for cash, December 28, 2009
|
|
|
883,658 |
|
|
|
884 |
|
|
|
99,116 |
|
|
|
- |
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss for the period ended December 31, 2009
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(122,857 |
) |
|
|
(122,857 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at December 31, 2009
|
|
|
4,899,882 |
|
|
$ |
4,900 |
|
|
$ |
149,640 |
|
|
$ |
(122,857 |
) |
|
$ |
31,683 |
|
The
accompanying notes are an integral part of financial
statements.
ATOSSA
GENETICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENT
OF CASH FLOWS
From
April 30, 2009 (Inception) through December 31, 2009
CASH
FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
Net
loss
|
|
$ |
(122,857 |
) |
Adjustments
to reconcile net loss to net cash provided by operating
activities:
|
|
|
|
|
Increase
in security deposits
|
|
|
(1,100 |
) |
Increase
in accrued expenses
|
|
|
48,781 |
|
|
|
|
|
|
Net
cash used in operating activities
|
|
|
(75,176 |
) |
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
|
Proceeds
from issuance of common stocks
|
|
|
154,540 |
|
Proceeds
from loans from related parties
|
|
|
5,000 |
|
|
|
|
|
|
Net
cash provided by financing activities
|
|
|
159,540 |
|
|
|
|
|
|
NET
DECREASE IN CASH & CASH EQUIVALENTS
|
|
|
84,364 |
|
|
|
|
|
|
CASH
& CASH EQUIVALENTS, BEGINNING BALANCE
|
|
|
- |
|
|
|
|
|
|
CASH
& CASH EQUIVALENTS, ENDING BALANCE
|
|
$ |
84,364 |
|
|
|
|
|
|
SUPPLEMENTAL
DISCLOSURES:
|
|
|
|
|
Interest
paid
|
|
$ |
- |
|
Income
taxes paid
|
|
$ |
- |
|
The
accompanying notes are an integral part of financial
statements.
NOTE
1: NATURE OF OPERATIONS
Atossa
Genetics, Inc., (the “Company”) was incorporated on April 30, 2009 in the State
of Delaware. The Company specializes in the molecular diagnostic
industry to develop and market a patented, FDA-approved cellular and molecular
diagnostic risk assessment product for breast cancer, the Mammary Aspirate
Cytology Specimen Test (MASCT) system. The Company’s fiscal
year ends on December 31st.
Development Stage
Risk
The
Company has not earned revenues from operations. Accordingly, the
Company’s activities have been accounted for as those of a “Development Stage
Enterprise” as set forth in Accounting Standards Codification (“ASC”) 915
“Development Stage Entities”, which was previously Statement of Financial
Accounting Standards No. 7 (“SFAS 7”). Among the disclosures required
by ASC 915 are that the Company’s financial statements be identified as those of
a development stage company, and that the statements of operations,
stockholders’ equity and cash flows disclose activity since the date of the
Company’s inception.
Since its
inception, the Company has been dependent upon the receipt of capital investment
to fund its continuing activities. In addition to the normal risks
associated with a new business venture, there can be no assurance that the
Company’s business plan will be successfully executed. Our ability to
execute our business plan will depend on our ability to obtain additional
financing and achieve a profitable level of operations. There can be
no assurance that sufficient financing will be obtained. Further, we
cannot give any assurance that we will generate substantial revenues or that our
business operations will prove to be profitable.
NOTE
2: GOING CONCERN
The
Company’s financial statements are prepared using generally accepted accounting
principles in the United States of America applicable to a going concern, which
contemplates the realization of assets and the satisfaction of liabilities in
the normal course of business. The Company has not yet established an
ongoing source of revenues sufficient to cover its operating costs and allow it
to continue as a going concern. The ability of the Company to
continue as a going concern is dependent on the Company obtaining adequate
capital to fund operating losses until it becomes profitable. If the
Company is unable to obtain adequate capital, it could be forced to cease
operations. The accompanying financial statements do not include any
adjustments that might be necessary if the Company is unable to continue as a
going concern.
Management’s Plan to
Continue as a Going Concern
In order
to continue as a going concern, the Company will need, among other things,
additional capital resources. Management’s plans to obtain such
resources for the Company include (1) obtaining capital from the sale of its
securities, (2) the sale of the MASCT Systems, and (3) short-term borrowings
from shareholders or related party when needed. However, management
cannot provide any assurance that the Company will be successful in
accomplishing any of its plans.
The
ability of the Company to continue as a going concern is dependent upon its
ability to successfully accomplish the plans described in the preceding
paragraph and eventually secure other sources of financing and attain profitable
operations.
NOTE
3: SUMMARY OF ACCOUNTING POLICIES
Basis
of Presentation:
The
accompanying financial statements have been prepared by the
Company. The Company’s financial statements are prepared in
accordance with generally accepted accounting principles in the United States of
America (“US GAAP”).
Cash
and Cash Equivalents:
Cash and
cash equivalents include cash and all highly liquid instruments with original
maturities of three months or less.
Use
of Estimates:
The
preparation of financial statements in conformity with generally accepted
accounting principles in the Unites States of America requires management to
make estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenue and expenses during
the reporting period. Accordingly, actual results could differ from
those estimates.
Research
and Development Expenses:
Research
and Development costs are generally expensed as incurred. The
Company’s Research and Development expenses consist of costs incurred for
internal and external research and development.
Share
Based Payments:
In
December, 2004, the FASB issued SFAS No. 123(R), “Share-Based Payment”, which
replaces SFAS No. 123 and supersedes APB Opinion No. 25. SFAS No.
123(R) is now included in ASC 718 “Compensation – Stock
Compensation”. Under SFAS No. 123(R), companies are required to
measure the compensation costs of share-based compensation arrangements based on
the grant-date fair value and recognize the costs in the financial statements
over the period during which employees or independent contractors are required
to provide services. Share-based compensation arrangements include
stock options and warrants, restricted share plans, performance-based awards,
share appreciation rights and employee share purchase plans. In
March, 2005, the SEC issued Staff Accounting Bulletin No. 107 (“SAB 107”) which
expresses views of the staff regarding the interaction between SFAS No. 123(R)
and certain SEC rules and regulations and provides the staff’s views regarding
the valuation of share-based payment arrangements for public
companies. SFAS No. 123(R) permits public companies to adopt its
requirements using one of two methods. On April 14, 2005, the SEC
adopted a new rule amending the compliance dates for SFAS No.
123(R). Companies may elect to apply this statement either
prospectively, or on a modified version of retrospective application under which
financial statements for prior periods are adjusted on a basis consistent with
the pro forma disclosures required for those periods under SFAS No.
123.
The
Company has fully adopted the provisions of SFAS No. 123(R) and related
interpretations as provided by SAB 107. As such, compensation cost is
measured on the date of grant as the fair value of the share-based
payments. Such compensation amounts, if any, are amortized over the
respective vesting periods of the option grant.
Recently
Issued Accounting Pronouncements:
The
Company has adopted all recently issued accounting
pronouncements. The adoption of the accounting pronouncements,
including those not yet effective, is not anticipated to have a material effect
on the financial position or results of operations of the
Company.
NOTE
4: STOCKHOLDERS’ EQUITY
As of
June 30, 2010, the Company was authorized to issue a total of 60,000,000 shares
of stock consisting of 50,000,000 shares of Common Stock with par value of $.001
per share and 10,000,000 shares of Preferred Stock, par value of
$.001.
On April
30, 2009 (inception), the Company issued 1,767,315 shares (or 4,000,000 before
giving effect to the September 2010 reverse stock split) to Ensisheim Partners
LLC, a related party to the Company through common ownership, for cash in the
amount of $24,000, or $.014 per share (or $.006 per share before giving effect
to the September 2010 reverse stock split); 1,325,487 shares (or 3,000,000
shares before giving effect to the September 2010 reverse stock split) to
Manistee Ventures LLC, a related party to the Company through common ownership,
for cash in the amount of $18,000, or $.014 per share (or $.006 per share before
giving effect to the September 2010 reverse stock split); and 883,658 shares (or
2,000,000 shares before giving effect to the September 2010 reverse stock split)
to the Chairman, CEO and President of the Company at that time for cash in the
amount of $12,000, or $.014 per share (or $.006 per share before giving effect
to the September 2010 reverse stock split).
On July
28, 2009, the Company issued 39,765 shares (or 90,000 shares before giving
effect to the September 2010 reverse stock split) to a director of the Company
for cash in the amount of $540, or $.014 per share (or $.006 per share before
giving effect to the September 2010 reverse stock split).
On
December 28, 2009, the Company issued 883,658 shares (or 2,000,000 shares before
giving effect to the September 2010 reverse stock split) to Ensisheim Partners
LLC for cash in the amount of $100,000, or $.11 per share (or $.05 per share
before giving effect to the September 2010 reverse stock
split).
NOTE
5: INCOME TAXES
The
Company accounts for income taxes as outlined in ASC 740, “Income Taxes”, which
was previously Statement of Financial Accounting Standards No. 109, “Accounting
for Income Taxes” (“SFAS 109”). Under the asset and liability method
of SFAS 109, deferred income tax assets and liabilities are recognized for the
estimated future tax consequences attributable to differences between the
financial reporting and tax bases of assets and liabilities and are measured
using enacted tax rates in effect for the year in which those temporary
differences are expected to be recovered or settled. A valuation
allowance is provided for the amount of deferred tax assets that, based on
available evidence, are not expected to be realized.
The
provision for income taxes differs from the amounts which would be provided by
applying the statutory federal income tax rate of 34% to the net loss before
provision for income taxes for the following reasons:
|
|
December 31,
2009
|
|
Income
tax benefit at statutory rate (34%)
|
|
$ |
(46,871 |
) |
Valuation
allowance
|
|
|
46,871 |
|
Net
income tax benefit
|
|
$ |
- |
|
The tax
effect of temporary difference that gave rise to the Company’s deferred tax
asset as of December 31, 2009 is as follows:
|
|
December 31,
2009
|
|
NOL
carryover
|
|
$ |
46,871 |
|
Valuation
allowance
|
|
|
(46,871 |
) |
Net
deferred tax asset
|
|
$ |
- |
|
NOTE
6: CONCENTRATION OF CREDIT RISK
Financial
instruments that potentially subject the Company to concentration of credit risk
consist principally of cash deposits. Accounts at each institution
are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to
$250,000. At December 31, 2009, the Company had no amounts in excess
of FDIC insured limit.
NOTE
7: RELATED PARTY TRANSACTIONS
The
parties primarily refer to the shareholders and officers of the Company and
corporate entities related to the Company through common
ownership.
Loan from
Officer
Loan from
officer amounted to $5,000 as of December 31, 2009. The loan was
borrowed from the CEO and President of the Company on May 26, 2009 for
short-term with verbal agreement, unsecured, and bearing no
interest.
Exclusive License
Agreement
On July
27, 2009, the Company entered into an exclusive license agreement with Ensisheim
Partners LLC (“Ensisheim”), solely owned by the CEO and President of the Company
and the COO of the Company, the Company’s CEO’s
wife. Pursuant to the agreement, Ensisheim grants to the Company an
exclusive, worldwide, perpetual, irrevocable, royalty-bearing, license, with the
right to grant and authorize sublicenses. The Company will pay
Ensisheim a royalty equal to two percent (2%) of net sales revenues derived from
such licensing, with a minimum royalty of $12,500 per fiscal quarter during the
term of this agreement, which will increase to a minimum royalty of $25,000 per
fiscal quarter beginning in the quarter in which the first commercial sale of a
licensed product takes place. This agreement will continue in effect,
on a country-by-country basis, until the date on which no further licensing
royalty would be due in such country, unless terminated earlier in accordance
with the terms of this agreement. From inception through December 31,
2009, the Company incurred $16,250 of patent royalty with Ensisheim which was
recorded as research and development expense. As of December 31,
2009, $12,500 of patent royalty payable to Ensisheim was recorded as accrued
expense whereas $4,000 was paid during the period from inception through
December 31, 2009.
Commercial Lease
Agreement
On
December 24, 2009, the Company entered into a commercial lease agreement with
Ensisheim for an office space located in Seattle, Washington. The
term of the lease shall terminate on December 31, 2010, with annual rent of
$13,200 plus applicable sales tax. From inception through December
31, 2009, the Company incurred $248 of rent expense for the lease. As
of December 31, 2009, security deposit for the lease amounted to
$1,100.
NOTE
8: SUBSEQUENT EVENTS
On
January 21, 2010, the Company issued 865,984 shares (or 1,960,000 shares before
giving effect to the September 2010 reverse stock split) to forty-four (44)
investors for cash in the amount of $98,000, or $0.11 per share (or
$.05 per share before giving effect to the September 2010 reverse stock
split).
On
January 21, 2010, the Company issued 132,549 shares (or 300,000 shares before
giving effect to the September 2010 reverse stock split) to a service provider
for effecting transactions intended to cause the Company to become a public
company and to have its securities traded on a national exchange in the United
States. The shares were issued at a value of $15,000, or $0.11 per
share (or $.05 per share before giving effect to the September 2010 reverse
stock split), the same price as the 865,984 shares (or 1,960,000 shares before
giving effect to the September 2010 reverse stock split) issued for cash on the
same date.
On
January 21, 2010, the Company issued an additional 53,019 shares (or 120,000
shares before giving effect to the September 2010 reverse stock split) to a
shareholder who acquired 13,255 shares (or 30,000 shares before giving effect to
the September 2010 reverse stock split) for cash on the same date as one of the
forty-four (44) investors. Those shares were issued to the
shareholder for services to be performed, including investor relations, media
relations, and corporate communications. Those shares were issued at
a value of $6,000, or $0.11 per share (or $.05 per share before giving effect to
the September 2010 reverse stock split), the same price as the issuance of the
865,984 shares (or 1,960,000 shares before giving effect to the September 2010
reverse stock split) for cash on the same date.
On
January 23, 2010, the Company issued 35,346 shares (or 80,000 shares before
giving effect to the September 2010 reverse stock split) to an investor for cash
in the amount of $4,000, or $0.11 per share (or $.05 per share before giving
effect to the September 2010 reverse stock split).
3,000,000
Units
PROSPECTUS
DAWSON
JAMES SECURITIES, INC.
______________________,
2010
Until
_______________, all dealers that effect transactions in these securities,
whether or not participating in this offering, may be required to deliver a
prospectus. This is in addition to the dealers’ obligation to deliver a
prospectus when acting as underwriters and with respect to their unsold
allotments or subscriptions.
PART
II
Item
13. Other Expenses of Issuance and Distribution
The
expenses (other than underwriting discounts and commissions) payable by us in
connection with this offering are as follows:
|
|
|
|
SEC
registration fee
|
|
$ |
1,255 |
|
Financial
Industry Regulatory Authority, Inc. fee
|
|
|
3,000 |
|
NYSE
Amex listing fee
|
|
|
* |
|
Accountants’
fees and expenses
|
|
|
* |
|
Legal
fees and expenses
|
|
|
* |
|
Transfer
Agent’s fees and expenses
|
|
|
* |
|
Printing
and engraving expenses
|
|
|
* |
|
Miscellaneous
|
|
|
* |
|
Total
Expenses
|
|
$ |
* |
|
|
*
|
to
be completed by amendment
|
All
expenses are estimated except for the SEC registration fee and the Financial
Industry Regulatory Authority, Inc. fee.
Item
14. Indemnification of Directors and Officers
Section
145 of the Delaware General Corporation Law, or the DGCL, authorizes a
corporation to indemnify its directors and officers against liabilities arising
out of actions, suits and proceedings to which they are made or threatened to be
made a party by reason of the fact that they have served or are currently
serving as a director or officer to a corporation. The indemnity may cover
expenses (including attorneys’ fees) judgments, fines and amounts paid in
settlement actually and reasonably incurred by the director or officer in
connection with any such action, suit or proceeding. Section 145 permits
corporations to pay expenses (including attorneys’ fees) incurred by directors
and officers in advance of the final disposition of such action, suit or
proceeding. In addition, Section 145 provides that a corporation has the power
to purchase and maintain insurance on behalf of its directors and officers
against any liability asserted against them and incurred by them in their
capacity as a director or officer, or arising out of their status as such,
whether or not the corporation would have the power to indemnify the director or
officer against such liability under Section 145.
We have
adopted provisions in our certificate of incorporation and bylaws to be in
effect at the completion of this offering that limit or eliminate the personal
liability of our directors to the fullest extent permitted by the DGCL, as it
now exists or may in the future be amended. Consequently, a director will not be
personally liable to us or our stockholders for monetary damages or breach of
fiduciary duty as a director, except for liability for:
|
·
|
any
breach of the director’s duty of loyalty to us or our
stockholders;
|
|
·
|
any
act or omission not in good faith or that involves intentional misconduct
or a knowing violation of law;
|
|
·
|
any
unlawful payments related to dividends or unlawful stock purchases,
redemptions or other distributions;
or
|
|
·
|
any
transaction from which the director derived an improper personal
benefit.
|
These
limitations of liability do not alter director liability under the federal
securities laws and do not affect the availability of equitable remedies such as
an injunction or rescission.
In
addition, our bylaws to be in effect at the completion of this offering will
provide that:
|
·
|
we
will indemnify our directors, officers and, in the discretion of our board
of directors, certain employees to the fullest extent permitted by the
DGCL, as it now exists or may in the future be amended;
and
|
|
·
|
we
will advance reasonable expenses, including attorneys’ fees, to our
directors and, in the discretion of our board of directors, to our
officers and certain employees, in connection with legal proceedings
relating to their service for or on behalf of us, subject to limited
exceptions.
|
We will
enter into indemnification agreements with each of our directors and certain of
our executive officers. These agreements provide that we will indemnify each of
these directors and executive officers to the fullest extent permitted by
Delaware law. We will advance expenses, including attorneys’ fees, judgments,
fines and settlement amounts, to each indemnified director, executive officer or
affiliate in connection with any proceeding in which indemnification is
available and we will indemnify our directors and officers for any action or
proceeding arising out of that person’s services as an officer or director
brought on behalf of the Company or in furtherance of our rights.
We also
expect to maintain general liability insurance that covers certain liabilities
of our directors and officers arising out of claims based on acts or omissions
in their capacities as directors or officers, including liabilities under the
Securities Act.
The
underwriting agreement filed as Exhibit 1.1 to this registration statement
provides for indemnification of us and our directors and officers by the
underwriters against certain liabilities under the Securities Act and the
Exchange Act.
Item
15. Recent Sales of Unregistered Securities
The
Company has sold the following securities within the past three years which were
not registered under the Securities Act of 1933:
Pursuant
to an exemption from registration under Section 4(2) of the Securities Act of
1933, as amended, as a transaction by an issuer not involving any public
offering as founder shares in connection with the formation of the Company, the
Company issued 4,899,884 shares of its common stock as follows:
|
|
|
|
|
|
|
|
Steven
Quay
|
|
|
883,658 |
|
April
30, 2009
|
|
$ |
12,000 |
|
Ensisheim
Partners LLC
|
|
|
1,767,316 |
|
April
30, 2009
|
|
$ |
24,000 |
|
Ensisheim
Partners LLC
|
|
|
883,658 |
|
December
28, 2009
|
|
$ |
100,000 |
|
Manistee
Ventures, Inc.
|
|
|
1,325,487 |
|
April
30, 2009
|
|
$ |
18,000 |
|
John
Barnhart
|
|
|
39,765 |
|
July
28, 2009
|
|
$ |
540 |
|
In
January 2010, pursuant to an exemption from registration under Rule 504 pursuant
to the Securities Act of 1933 (the “Securities Act”), the Company issued an
aggregate of 901,354 shares of its common stock to 45 investors for aggregate
cash proceeds of $102,000. Of these 45 investors, 13 are accredited
investors and 4 are citizens and residents of Taiwan, Republic of
China.
In
January 2010, the Company issued 185,569 shares in consideration for services
performed by two consultants, with an aggregate value of $21,000. This
offering was exempt from registration under Rule 504 under the Securities
Act.
On April
23, 2010, the Company issued 13,256 shares of common stock for services
performed by a consultant with an aggregate value of $50,000. This
offering was exempt from registration under Section 4(2) of the Securities Act,
as a transaction by an issuer not involving any public
offering.
Item
16. Exhibits and Financial Statement Schedules.
EXHIBITS
1.1*
|
|
Form
of Underwriting Agreement
|
3.1
|
|
Certificate
of Incorporation, as currently in effect
|
3.2*
|
|
Certificate
of Incorporation (to be effective immediately prior to
completion of this offering)
|
3.3
|
|
By-laws,
as currently in effect
|
3.4*
|
|
By-laws
(to be effective immediately prior to completion of this
offering)
|
4.1*
|
|
Specimen
common stock certificate
|
4.2*
|
|
Form
of Warrant Agent Agreement
|
4.3*
|
|
Form
of Class A Warrant Certificate
|
4.4*
|
|
Form
of Class B Warrant Certificate
|
4.5*
|
|
Form
of Unit Certificate
|
5.1*
|
|
Opinion
of Goodwin Procter LLP
|
10.1
|
|
License
Agreement with Ensisheim Partners, LLC
|
10.2
|
|
Termination
of Exclusive Patent License Agreement, dated June 17,
2010
|
10.3#
|
|
Amended
and Restated Employment Agreement with Steven Quay
|
10.4#
|
|
Amended
and Restated Employment Agreement with Shu-Chih Chen
|
10.5*
|
|
Form
of Indemnification Agreement
|
10.6#
|
|
2010
Stock Option and Incentive Plan
|
10.7*#
|
|
Form
of Stock Option Agreement
|
10.8*#
|
|
Form
of Stock Award Agreement
|
10.9*
|
|
Form
of Lock-Up Agreement
|
10.10
|
|
Form
of Subscription Agreement
|
10.11
|
|
Promissory
Note issued by the Company to Steven Quay on January 2,
2010.
|
10.12
|
|
Promissory
Note issued by the Company to Steven Quay on June 30,
2010.
|
10.13 |
|
Sublease
Agreement with CompleGen, Inc, dated September 29,
2010 |
10.14* |
|
Patent
Assignment Agreement by and between Atossa Genetics, Inc. and Ensisheim
Partners, LLC |
23.1
|
|
Consent
of KCCW Accountancy Corp.
|
23.2*
|
|
Consent
of Goodwin Procter LLP (filed as part of Exhibit 5.1)
|
24.1
|
|
Power
of Attorney (contained on signature page)
|
99.1
|
|
Consent
of Prospective Director Mary Tagliaferri, M.D.
|
99.2
|
|
Consent
of Prospective Director Stephen Galli, M.D.
|
99.3
|
|
Consent
of Prospective Director Alexander Cross,
Ph.D.
|
*
|
To
be filed by amendment.
|
#
|
Indicates
management contract or compensatory plan, contract or
agreement.
|
Item
17. Undertakings
Undertaking Pursuant to Rule
415 Under the Securities Act of 1933
The
undersigned registrant hereby undertakes:
(1).
|
To
file, during any period in which it offers or sales securities, a
post-effective amendment to this registration
statement:
|
(i) To
include any prospectus required by Section 10(a)(3) of the Securities Act of
1933;
(ii) To
reflect in the prospectus any facts or events which, individually or in the
aggregate, represent a fundamental change in the information in the registration
statement. Notwithstanding the foregoing, any increase or decrease in volume of
securities offered (if the total dollar value of securities offered would not
exceed that which was registered) any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form of prospectus
filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the
changes in volume and price represent no more than a 20% change in the maximum
aggregate offering price set forth in the “Calculation of Registration Fee”
table in the effective registration statement; and
(iii) To
include any additional material information with respect to the plan of
distribution not previously disclosed in the registration statement or any
material change to such information in the registration statement.
(2).
|
That,
for the purpose of determining any liability under the Securities Act of
1933, each such post-effective amendment shall be deemed to be a new
registration statement relating to the securities offered therein, and the
offering of the securities at that time to be the initial bona fide
offering thereof.
|
(3).
|
To
remove from registration by means of a post-effective amendment any of the
securities that remain unsold at the termination of the
offering.
|
(4).
|
That,
for the purpose of determining liability under the Securities Act of 1933
to any purchaser in the initial distribution of
securities:
|
Each
prospectus filed pursuant to Rule 424(b) as part of a registration statement
relating to this offering, other than registration statements relying on Rule
403B or other than prospectuses filed in reliance on Rule 430A, shall be deemed
to be part of and included in the registration statement as of the date it is
first used after effectiveness. Provided, however, that no statement made
in a registration statement or prospectus that is part of the registration
statement or made in a document incorporated or deemed incorporated by reference
into the registration statement or prospectus that is part of the registration
statement will, as to a purchaser with a time of contract of sale prior to such
first use, supersede or modify any statement that was made in the registration
statement or prospectus that was part of the registration statement or made in
any such document immediately prior to such date of first use.
(5).
|
That,
for the purpose of determining liability under the Securities Act of 1933
to any purchaser in the initial distribution of
securities:
|
The
undersigned registrant undertakes that in a primary offering of securities of
the undersigned registrant pursuant to this registration statement, regardless
of the underwriting method used to sell the securities to the purchaser, if the
securities are offered or sold to such purchaser by means of any of the
following communications, the undersigned registrant will be a seller to the
purchaser and will be considered to offer or sell such securities to such
purchaser.:
|
i
|
Any
preliminary prospectus or prospectus of the undersigned registrant
relating to this offering required to be filed pursuant to Rule
424;
|
|
ii.
|
Any
free writing prospectus relating to this offering prepared by or on behalf
of the undersigned registrant or used or referred to by the undersigned
registrant;
|
|
iii.
|
The
portion of any other free writing prospectus relating to the offering
containing material information about the undersigned registrant or its
securities provided by or on behalf of the undersigned registrant;
and
|
|
iv.
|
Any
other communication that is an offer in the offering made by the
undersigned registrant to the
purchaser.
|
Undertaking Request for
acceleration of effective date or filing of registration statement becoming
effective upon filing.
The
undersigned registrant hereby undertakes:
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may
be permitted to directors, officers and controlling persons of the registrant
pursuant to the foregoing provisions, or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Act and is,
therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the registrant of expenses incurred
or paid by a director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Act and will be governed by the final adjudication of
such issue.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant has duly
caused this Registration Statement on Form S-1 to be signed on its behalf by the
undersigned, thereunto duly authorized in the City of Seattle, State of
Washington, on September 30, 2010.
|
ATOSSA
GENETICS INC.
|
|
|
|
By:
|
/s/
Steven C. Quay |
|
Name:
Steven C. Quay, M.D., Ph.D.
|
|
Title:
President and Chief Executive
Officer
|
SIGNATURES
AND POWER OF ATTORNEY
We, the
undersigned officers and directors of Atossa Genetics Inc., hereby severally
constitute and appoint Steven C. Quay, M.D., Ph.D. our true and lawful
attorney-in-fact and agent, with full power of substitution and resubstitution
for him and in his name, place and stead, and in any and all capacities, to sign
for us and in our names in the capacities indicated below any and all amendments
(including post-effective amendments) to this registration statement (or any
other registration statement for the same offering that is to be effective upon
filing pursuant to Rule 462(b) under the Securities Act of 1933, as amended),
and to file the same, with all exhibits thereto and other documents in
connection therewith, with the Securities and Exchange Commission, granting unto
said attorneys-in-fact and agents, and each of them, full power and authority to
do and perform each and every act and thing requisite or necessary to be done in
and about the premises, as full to all intents and purposes as he might or could
do in person, hereby ratifying and confirming all that said attorneys-in-fact
and agents or any of them, or their or his substitute or substitutes, may
lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Act of 1933, as amended, this Registration
Statement on Form S-1 has been signed by the following persons in the capacities
and on the dates indicated.
|
|
|
|
|
|
|
|
|
|
/s/ Steven
C. Quay
|
|
President,
Chief Executive Officer and
Chairman
of the Board of Directors
|
|
September
30, 2010
|
Steven
C. Quay, M.D., Ph.D.
|
|
(Principal
Executive Officer)
|
|
|
|
|
|
|
|
/s/ Christopher
Benjamin
|
|
Chief
Financial Officer
|
|
September
30, 2010
|
Christopher
Benjamin
|
|
(Principal
Financial Officer and
Principal
Accounting Officer)
|
|
|
|
|
|
|
|
/s/
Shu-Chih Chen
|
|
Director
|
|
September
30, 2010
|
Shu-Chih
Chen
|
|
|
|
|
|
|
|
|
|
/s/
John
Barnhart
|
|
Director
|
|
September
30, 2010
|
John
Barnhart
|
|
|
|
|
EXHIBIT
3.1
AMENDED
AND RESTATED
CERTIFICATE
OF INCORPORATION OF
ATOSSA
GENETICS INC.
Atossa
Genetics Inc., a corporation organized and existing under the laws of the State
of Delaware (the “Company”), certifies
that:
A. The
name of the Company is Atossa Genetics Inc. The Company’s original
Certificate of Incorporation was filed with the Secretary of State of the State
of Delaware on April 30, 2009.
B. This
Amended and Restated Certificate of Incorporation was duly adopted in accordance
with Sections 242 and 245 of the General Corporation Law of the State of
Delaware, and has been duly approved by the written consent of the stockholders
of the Company in accordance with Section 228 of the General Corporation
Law of the State of Delaware.
C. The
text of the Certificate of Incorporation is amended and restated to read as set
forth in EXHIBIT A attached hereto.
IN
WITNESS WHEREOF, the Company has caused this Amended and Restated Certificate of
Incorporation to be signed by Steven C. Quay, a duly authorized officer of the
Company, on September 28, 2010.
|
/s/
Steven C. Quay
|
|
Steven
C. Quay
|
|
Chief
Executive Officer
|
EXHIBIT A
AMENDED
AND RESTATED CERTIFICATE OF INCORPORATION OF
ATOSSA
GENETICS INC.
ARTICLE
I
The name
of the corporation is Atossa Genetics Inc. (the “Company”).
ARTICLE
II
The
address of the Company’s registered office in the State of Delaware is 2711
Centerville Road, Suite 400, in the City of Wilmington, County of New Castle.
The name of the registered agent at such address is Corporation Service
Company.
ARTICLE
III
The
purpose of the Company is to engage in any lawful act or activity for which
corporations may be organized under the Delaware General Corporation Law, as the
same exists or as may hereafter be amended from time to time.
ARTICLE
IV
A. Upon
the filing and effectiveness of this Amended and Restated Certificate of
Incorporation of the Company pursuant to the General Corporation Law of the
State of Delaware (the “Effective Time”), one
share of Common Stock, par value $0.001 per share (the “New Common Stock”),
will be issued in exchange for each 2.26332 shares of Common Stock, par value
$0.001 per share, of the Company (the “Old Common Stock”),
outstanding and held by each record holder of Old Common Stock immediately prior
to the Effective Time. Any fractional share that would otherwise be
issued as a result of the exchange will be rounded up to the nearest whole share
of Common Stock. Each stock certificate that, immediately prior to
the Effective Time, represented shares of the Old Common Stock will, from and
after the Effective time, automatically and without the necessity of presenting
the same for exchange, represent the number of shares of the New Common Stock as
equals the number obtained by dividing the number of shares of Old Common Stock
represented by such certificate immediately prior to the Effective Time by
2.26332, with any remaining fractional share interest rounded up to the nearest
whole share of New Common Stock. The New Common Stock issued in this
exchange shall have the same rights, preferences and privileges as the Common
Stock (as defined below).
B. This
Company is authorized to issue a total of 85,000,000 shares of stock, consisting
of 75,000,000 shares of Common Stock, par value of $0.001 per share (the “Common Stock”), and
10,000,000 shares of preferred stock, par value of $0.001 (the “Preferred
Stock”).
ARTICLE
V
In
furtherance and not in limitation of the powers conferred by statute, the board
of directors of the Company is expressly authorized to make, alter, amend or
repeal the bylaws of the Company.
ARTICLE
VI
Elections
of directors need not be by written ballot unless otherwise provided in the
bylaws of the Company.
ARTICLE
VII
To the
fullest extent permitted by the Delaware General Corporation Law, as the same
exists or as may hereafter be amended from time to time, a director of the
Company shall not be personally liable to the Company or its stockholders for
monetary damages for breach of fiduciary duty as a director. If the
Delaware General Corporation Law is amended to authorize corporate action
further eliminating or limiting the personal liability of directors, then the
liability of a director of the Company shall be eliminated or limited to the
fullest extent permitted by the Delaware General Corporation Law, as so
amended.
The
Company shall indemnify, to the fullest extent permitted by applicable law, any
director or officer of the Company who was or is a party or is threatened to be
made a party to any threatened, pending or completed action, suit or proceeding,
whether civil, criminal, administrative or investigative (a “Proceeding”) by
reason of the fact that he or she is or was a director, officer, employee or
agent of the Company or is or was serving at the request of the Company as a
director, officer, employee or agent of another corporation, partnership, joint
venture, trust or other enterprise, including service with respect to employee
benefit plans, against expenses (including attorneys’ fees), judgments, fines
and amounts paid in settlement actually and reasonably incurred by such person
in connection with any such Proceeding. The Company shall be required
to indemnify a person in connection with a Proceeding initiated by such person
only if the Proceeding was authorized by the Board.
The
Company shall have the power to indemnify, to the extent permitted by the
Delaware General Corporation Law, as it presently exists or may hereafter be
amended from time to time, any employee or agent of the Company who was or is a
party or is threatened to be made a party to any Proceeding by reason of the
fact that he or she is or was a director, officer, employee or agent of the
Company or is or was serving at the request of the Company as a director,
officer, employee or agent of another corporation, partnership, joint venture,
trust or other enterprise, including service with respect to employee benefit
plans, against expenses (including attorneys’ fees), judgments, fines and
amounts paid in settlement actually and reasonably incurred by such person in
connection with any such Proceeding.
Neither
any amendment nor repeal of this Article, nor the adoption of any provision of
this Certificate of Incorporation inconsistent with this Article, shall
eliminate or reduce the effect of this Article in respect of any matter
occurring, or any cause of action, suit or claim accruing or arising or that,
but for this Article, would accrue or arise, prior to such amendment, repeal or
adoption of an inconsistent provision.
ARTICLE
VIII
Except as
provided in ARTICLE VII above, the Company reserves the right to amend, alter,
change or repeal any provision contained in this Certificate of Incorporation,
in the manner now or hereafter prescribed by statute, and all rights conferred
upon stockholders herein are granted subject to this
reservation.
Unassociated Document
AMENDED
AND RESTATED
BYLAWS
OF
ATOSSA
GENETICS INC.
Adopted
June 10, 2009
TABLE
OF CONTENTS
Page
|
|
|
|
ARTICLE I
— MEETINGS OF STOCKHOLDERS |
1
|
|
1.1
|
Place
of Meetings
|
1
|
|
1.2
|
Annual
Meeting
|
1
|
|
1.3
|
Special
Meeting
|
1
|
|
1.4
|
Notice
of Stockholders’ Meetings
|
2
|
|
1.5
|
Quorum
|
2
|
|
1.6
|
Adjourned
Meeting; Notice
|
2
|
|
1.7
|
Conduct
of Business
|
2
|
|
1.8
|
Voting
|
2
|
|
1.9
|
Stockholder
Action by Written Consent Without a Meeting
|
3
|
|
1.10
|
Record
Date for Stockholder Notice; Voting; Giving Consents
|
4
|
|
1.11
|
Proxies
|
5
|
|
1.12
|
List
of Stockholders Entitled to Vote
|
5
|
ARTICLE II
— DIRECTORS |
5
|
|
2.1
|
Powers
|
5
|
|
2.2
|
Number
of Directors
|
5
|
|
2.3
|
Election,
Qualification and Term of Office of Directors
|
5
|
|
2.4
|
Resignation
and Vacancies
|
6
|
|
2.5
|
Place
of Meetings; Meetings by Telephone
|
6
|
|
2.6
|
Conduct
of Business
|
7
|
|
2.7
|
Regular
Meetings
|
7
|
|
2.8
|
Special
Meetings; Notice
|
7
|
|
2.9
|
Quorum;
Voting
|
7
|
|
2.10
|
Board
Action by Written Consent Without a Meeting
|
8
|
|
2.11
|
Fees
and Compensation of Directors
|
8
|
|
2.12
|
Removal
of Directors
|
8
|
ARTICLE III
— COMMITTEES |
8
|
|
3.1
|
Committees
of Directors
|
8
|
|
3.2
|
Committee
Minutes
|
9
|
|
3.3
|
Meetings
and Actions of Committees
|
9
|
|
3.4
|
Subcommittees
|
9
|
ARTICLE IV
— OFFICERS |
10
|
|
4.1
|
Officers
|
10
|
|
4.2
|
Appointment
of Officers
|
10
|
|
4.3
|
Subordinate
Officers
|
10
|
|
4.4
|
Removal
and Resignation of Officers
|
10
|
|
4.5
|
Vacancies
in Offices
|
10
|
|
4.6
|
Representation
of Shares of Other Corporations
|
10
|
|
4.7
|
Authority
and Duties of Officers
|
11
|
ARTICLE V
— INDEMNIFICATION |
11
|
|
5.1
|
Indemnification
of Directors and Officers in Third Party Proceedings
|
11
|
TABLE
OF CONTENTS
(Continued)
Page
|
5.2
|
Indemnification
of Directors and Officers in Actions by or in the Right of the
Company
|
11
|
|
5.3
|
Successful
Defense
|
11
|
|
5.4
|
Indemnification
of Others
|
12
|
|
5.5
|
Advanced
Payment of Expenses
|
12
|
|
5.6
|
Limitation
on Indemnification
|
12
|
|
5.7
|
Determination;
Claim
|
13
|
|
5.8
|
Non-Exclusivity
of Rights
|
13
|
|
5.9
|
Insurance
|
13
|
|
5.10
|
Survival
|
13
|
|
5.11
|
Effect
of Repeal or Modification
|
13
|
|
5.12
|
Certain
Definitions
|
14
|
ARTICLE VI
— STOCK |
14
|
|
6.1
|
Stock
Certificates; Partly Paid Shares
|
14
|
|
6.2
|
Special
Designation on Certificates
|
14
|
|
6.3
|
Lost
Certificates
|
15
|
|
6.4
|
Dividends
|
15
|
|
6.5
|
Stock
Transfer Agreements
|
15
|
|
6.6
|
Registered
Stockholders
|
15
|
|
6.7
|
Transfers
|
16
|
ARTICLE VII
— MANNER OF GIVING NOTICE AND WAIVER |
16
|
|
7.1
|
Notice
of Stockholder Meetings
|
16
|
|
7.2
|
Notice
by Electronic Transmission
|
16
|
|
7.3
|
Notice
to Stockholders Sharing an Address
|
17
|
|
7.4
|
Notice
to Person with Whom Communication is Unlawful
|
17
|
|
7.5
|
Waiver
of Notice
|
17
|
ARTICLE VIII
— GENERAL MATTERS |
18
|
|
8.1
|
Fiscal
Year
|
18
|
|
8.2
|
Seal
|
18
|
|
8.3
|
Annual
Report
|
18
|
|
8.4
|
Construction;
Definitions
|
18
|
ARTICLE IX
— AMENDMENTS |
18
|
BYLAWS
ARTICLE I
— MEETINGS OF STOCKHOLDERS
1.1 Place of Meetings.
Meetings of stockholders of Atossa Genetics Inc. (the “Company”) shall be held at any
place, within or outside the State of Delaware, determined by the Company’s
board of directors (the “Board”). The Board may, in its
sole discretion, determine that a meeting of stockholders shall not be held at
any place, but may instead be held solely by means of remote communication as
authorized by Section 211(a)(2) of the Delaware General Corporation Law
(the “DGCL”). In the
absence of any such designation or determination, stockholders’ meetings shall
be held at the Company’s principal executive office.
1.2 Annual Meeting.
An annual meeting of stockholders shall be held for the election of directors at
such date and time as may be designated by resolution of the Board from time to
time. Any other proper business may be transacted at the annual meeting. The
Company shall not be required to hold an annual meeting of stockholders, provided that (i) the
stockholders are permitted to act by written consent under the Company’s
certificate of incorporation and these bylaws, (ii) the stockholders take
action by written consent to elect directors and (iii) the stockholders
unanimously consent to such action or, if such consent is less than unanimous,
all of the directorships to which directors could be elected at an annual
meeting held at the effective time of such action are vacant and are filled by
such action.
1.3 Special Meeting. A
special meeting of the stockholders may be called at any time by the Board,
Chairperson of the Board, Chief Executive Officer or President (in the absence
of a Chief Executive Officer) or by one or more stockholders holding shares in
the aggregate entitled to cast not less than 10% of the votes at that
meeting.
If any
person(s) other than the Board calls a special meeting, the request
shall:
(i) be
in writing;
(ii) specify
the time of such meeting and the general nature of the business proposed to be
transacted; and
(iii) be
delivered personally or sent by registered mail or by facsimile transmission to
the Chairperson of the Board, the Chief Executive Officer, the President (in the
absence of a Chief Executive Officer) or the Secretary of the
Company.
The
officer(s) receiving the request shall cause notice to be promptly given to the
stockholders entitled to vote at such meeting, in accordance with these bylaws,
that a meeting will be held at the time requested by the person or persons
calling the meeting. No business may be transacted at such special meeting other
than the business specified in such notice to stockholders. Nothing contained in
this paragraph of this section 1.3 shall be
construed as limiting, fixing, or affecting the time when a meeting of
stockholders called by action of the Board may be held.
1.4 Notice of Stockholders’
Meetings.
Whenever stockholders are required or permitted to take any action at a meeting,
a written notice of the meeting shall be given which shall state the place, if
any, date and hour of the meeting, the means of remote communication, if any, by
which stockholders and proxy holders may be deemed to be present in person and
vote at such meeting, and, in the case of a special meeting, the purpose or
purposes for which the meeting is called. Except as otherwise provided in the
DGCL, the certificate of incorporation or these bylaws, the written notice of
any meeting of stockholders shall be given not less than 10 nor more than 60
days before the date of the meeting to each stockholder entitled to vote at such
meeting.
1.5 Quorum.
Except as otherwise provided by law, the certificate of incorporation or these
bylaws, at each meeting of stockholders the presence in person or by proxy of
the holders of shares of stock having a majority of the votes which could be
cast by the holders of all outstanding shares of stock entitled to vote at the
meeting shall be necessary and sufficient to constitute a quorum. Where a
separate vote by a class or series or classes or series is required, a majority
of the outstanding shares of such class or series or classes or series, present
in person or represented by proxy, shall constitute a quorum entitled to take
action with respect to that vote on that matter, except as otherwise provided by
law, the certificate of incorporation or these bylaws.
If,
however, such quorum is not present or represented at any meeting of the
stockholders, then either (i) the chairperson of the meeting, or
(ii) the stockholders entitled to vote at the meeting, present in person or
represented by proxy, shall have the power to adjourn the meeting from time to
time, in the manner provided in section 1.6, until a
quorum is present or represented.
1.6 Adjourned Meeting;
Notice.
Any meeting of stockholders, annual or special, may adjourn from time to time to
reconvene at the same or some other place, and notice need not be given of the
adjourned meeting if the time, place, if any, thereof, and the means of remote
communications, if any, by which stockholders and proxy holders may be deemed to
be present in person and vote at such adjourned meeting are announced at the
meeting at which the adjournment is taken. At the adjourned meeting, the Company
may transact any business which might have been transacted at the original
meeting. If the adjournment is for more than 30 days, or if after the
adjournment a new record date is fixed for the adjourned meeting, a notice of
the adjourned meeting shall be given to each stockholder of record entitled to
vote at the meeting.
1.7 Conduct of
Business.
Meetings of stockholders shall be presided over by the Chairperson of the Board,
if any, or in his or her absence by the Vice Chairperson of the Board, if any,
or in the absence of the foregoing persons by the Chief Executive Officer, or in
the absence of the foregoing persons by the President, or in the absence of the
foregoing persons by a Vice President, or in the absence of the foregoing
persons by a chairperson designated by the Board, or in the absence of such
designation by a chairperson chosen at the meeting. The Secretary shall act as
secretary of the meeting, but in his or her absence the chairperson of the
meeting may appoint any person to act as secretary of the meeting. The
chairperson of any meeting of stockholders shall determine the order of business
and the procedure at the meeting, including such regulation of the manner of
voting and the conduct of business.
1.8 Voting.
The stockholders entitled to vote at any meeting of stockholders shall be
determined in accordance with the provisions of section 1.10 of these
bylaws, subject to Section 217 (relating to voting rights of fiduciaries,
pledgors and joint owners of stock) and Section 218 (relating to voting
trusts and other voting agreements) of the DGCL.
Except as
may be otherwise provided in the certificate of incorporation, each stockholder
entitled to vote at any meeting of stockholders shall be entitled to one vote
for each share of capital stock held by such stockholder which has voting power
upon the matter in question. Voting at meetings of stockholders need not be by
written ballot and, unless otherwise required by law, need not be conducted by
inspectors of election unless so determined by the holders of shares of stock
having a majority of the votes which could be cast by the holders of all
outstanding shares of stock entitled to vote thereon which are present in person
or by proxy at such meeting. If authorized by the Board, such requirement of a
written ballot shall be satisfied by a ballot submitted by electronic
transmission (as defined in section 7.2 of these
bylaws), provided that
any such electronic transmission must either set forth or be submitted with
information from which it can be determined that the electronic transmission was
authorized by the stockholder or proxy holder.
Except as
otherwise required by law, the certificate of incorporation or these bylaws, in
all matters other than the election of directors, the affirmative vote of a
majority of the voting power of the shares present in person or represented by
proxy at the meeting and entitled to vote on the subject matter shall be the act
of the stockholders. Except as otherwise required by law, the certificate of
incorporation or these bylaws, directors shall be elected by a plurality of the
voting power of the shares present in person or represented by proxy at the
meeting and entitled to vote on the election of directors. Where a separate vote
by a class or series or classes or series is required, in all matters other than
the election of directors, the affirmative vote of the majority of shares of
such class or series or classes or series present in person or represented by
proxy at the meeting shall be the act of such class or series or classes or
series, except as otherwise provided by law, the certificate of incorporation or
these bylaws.
1.9 Stockholder Action by Written
Consent Without a Meeting.
Unless otherwise provided in the certificate of incorporation, any action
required by the DGCL to be taken at any annual or special meeting of
stockholders of a corporation, or any action which may be taken at any annual or
special meeting of such stockholders, may be taken without a meeting, without
prior notice, and without a vote, if a consent or consents in writing, setting
forth the action so taken, shall be signed by the holders of outstanding stock
having not less than the minimum number of votes that would be necessary to
authorize or take such action at a meeting at which all shares entitled to vote
thereon were present and voted.
An
electronic transmission (as defined in section 7.2) consenting
to an action to be taken and transmitted by a stockholder or proxy holder, or by
a person or persons authorized to act for a stockholder or proxy holder, shall
be deemed to be written, signed and dated for purposes of this section, provided that any such
electronic transmission sets forth or is delivered with information from which
the Company can determine (i) that the electronic transmission was
transmitted by the stockholder or proxy holder or by a person or persons
authorized to act for the stockholder or proxy holder and (ii) the date on
which such stockholder or proxy holder or authorized person or persons
transmitted such electronic transmission.
In the
event that the Board shall have instructed the officers of the Company to
solicit the vote or written consent of the stockholders of the Company, an
electronic transmission of a stockholder written consent given pursuant to such
solicitation may be delivered to the Secretary or the President of the Company
or to a person designated by the Secretary or the President. The Secretary or
the President of the Company or a designee of the Secretary or the President
shall cause any such written consent by electronic transmission to be reproduced
in paper form and inserted into the corporate records.
Prompt
notice of the taking of the corporate action without a meeting by less than
unanimous written consent shall be given to those stockholders who have not
consented in writing and who, if the action had been taken at a meeting, would
have been entitled to notice of the meeting if the record date for such meeting
had been the date that written consents signed by a sufficient number of holders
to take the action were delivered to the Company as provided in Section 228
of the DGCL. In the event that the action which is consented to is such as would
have required the filing of a certificate under any provision of the DGCL, if
such action had been voted on by stockholders at a meeting thereof, the
certificate filed under such provision shall state, in lieu of any statement
required by such provision concerning any vote of stockholders, that written
consent has been given in accordance with Section 228 of the
DGCL.
1.10 Record Date for Stockholder Notice;
Voting; Giving Consents.
In order that the Company may determine the stockholders entitled to notice of
or to vote at any meeting of stockholders or any adjournment thereof, or
entitled to express consent to corporate action in writing without a meeting, or
entitled to receive payment of any dividend or other distribution or allotment
of any rights, or entitled to exercise any rights in respect of any change,
conversion or exchange of stock or for the purpose of any other lawful action,
the Board may fix a record date, which record date shall not precede the date
upon which the resolution fixing the record date is adopted by the Board and
which record date:
(i) in
the case of determination of stockholders entitled to notice of or to vote at
any meeting of stockholders or adjournment thereof, shall, unless otherwise
required by law, not be more than sixty nor less than ten days before the date
of such meeting;
(ii) in
the case of determination of stockholders entitled to express consent to
corporate action in writing without a meeting, shall not be more than ten days
after the date upon which the resolution fixing the record date is adopted by
the Board; and
(iii) in
the case of determination of stockholders for any other action, shall not be
more than 60 days prior to such other action.
If no
record date is fixed by the Board:
(i) the
record date for determining stockholders entitled to notice of or to vote at a
meeting of stockholders shall be at the close of business on the day next
preceding the day on which notice is given, or, if notice is waived, at the
close of business on the day next preceding the day on which the meeting is
held;
(ii) the
record date for determining stockholders entitled to express consent to
corporate action in writing without a meeting when no prior action of the Board
is required by law, shall be the first date on which a signed written consent
setting forth the action taken or proposed to be taken is delivered to the
Company in accordance with applicable law, or, if prior action by the Board is
required by law, shall be at the close of business on the day on which the Board
adopts the resolution taking such prior action; and
(iii) the
record date for determining stockholders for any other purpose shall be at the
close of business on the day on which the Board adopts the resolution relating
thereto.
A
determination of stockholders of record entitled to notice of or to vote at a
meeting of stockholders shall apply to any adjournment of the meeting, provided that the Board may
fix a new record date for the adjourned meeting.
1.11 Proxies.
Each stockholder entitled to vote at a meeting of stockholders or to express
consent or dissent to corporate action in writing without a meeting may
authorize another person or persons to act for such stockholder by proxy
authorized by an instrument in writing or by a transmission permitted by law
filed in accordance with the procedure established for the meeting, but no such
proxy shall be voted or acted upon after three years from its date, unless the
proxy provides for a longer period. The revocability of a proxy that states on
its face that it is irrevocable shall be governed by the provisions of
Section 212 of the DGCL.
1.12 List of Stockholders Entitled to
Vote.
The officer who has charge of the stock ledger of the Company shall prepare and
make, at least ten days before every meeting of stockholders, a complete list of
the stockholders entitled to vote at the meeting, arranged in alphabetical
order, and showing the address of each stockholder and the number of shares
registered in the name of each stockholder. The Company shall not be required to
include electronic mail addresses or other electronic contact information on
such list. Such list shall be open to the examination of any stockholder, for
any purpose germane to the meeting for a period of at least ten days prior to
the meeting: (i) on a reasonably accessible electronic network, provided that the information
required to gain access to such list is provided with the notice of the meeting,
or (ii) during ordinary business hours, at the Company’s principal place of
business. In the event that the Company determines to make the list available on
an electronic network, the Company may take reasonable steps to ensure that such
information is available only to stockholders of the Company. If the meeting is
to be held at a place, then the list shall be produced and kept at the time and
place of the meeting during the whole time thereof, and may be examined by any
stockholder who is present. If the meeting is to be held solely by means of
remote communication, then the list shall also be open to the examination of any
stockholder during the whole time of the meeting on a reasonably accessible
electronic network, and the information required to access such list shall be
provided with the notice of the meeting.
ARTICLE II
— DIRECTORS
2.1 Powers.
The business and affairs of the Company shall be managed by or under the
direction of the Board, except as may be otherwise provided in the DGCL or the
certificate of incorporation.
2.2 Number of
Directors.
The Board shall consist of one or more members, each of whom shall be a natural
person. Unless the certificate of incorporation fixes the number of directors,
the number of directors shall be determined from time to time by resolution of
the Board. No reduction of the authorized number of directors shall have the
effect of removing any director before that director’s term of office
expires.
2.3 Election, Qualification and Term of
Office of Directors.
Except as provided in section 2.4 of these
bylaws, and subject to sections 1.2 and 1.9 of these bylaws, directors
shall be elected at each annual meeting of stockholders. Directors need not be
stockholders unless so required by the certificate of incorporation or these
bylaws. The certificate of incorporation or these bylaws may prescribe other
qualifications for directors. Each director shall hold office until such
director’s successor is elected and qualified or until such director’s earlier
death, resignation or removal.
2.4 Resignation and
Vacancies.
Any director may resign at any time upon notice given in writing or by
electronic transmission to the Company. A resignation is effective when the
resignation is delivered unless the resignation specifies a later effective date
or an effective date determined upon the happening of an event or events. A
resignation which is conditioned upon the director failing to receive a
specified vote for reelection as a director may provide that it is irrevocable.
Unless otherwise provided in the certificate of incorporation or these bylaws,
when one or more directors resign from the Board, effective at a future date, a
majority of the directors then in office, including those who have so resigned,
shall have power to fill such vacancy or vacancies, the vote thereon to take
effect when such resignation or resignations shall become
effective.
Unless
otherwise provided in the certificate of incorporation or these
bylaws:
(i) Vacancies
and newly created directorships resulting from any increase in the authorized
number of directors elected by all of the stockholders having the right to vote
as a single class may be filled by a majority of the directors then in office,
although less than a quorum, or by a sole remaining director.
(ii) Whenever
the holders of any class or classes of stock or series thereof are entitled to
elect one or more directors by the provisions of the certificate of
incorporation, vacancies and newly created directorships of such class or
classes or series may be filled by a majority of the directors elected by such
class or classes or series thereof then in office, or by a sole remaining
director so elected.
If at any
time, by reason of death or resignation or other cause, the Company should have
no directors in office, then any officer or any stockholder or an executor,
administrator, trustee or guardian of a stockholder, or other fiduciary
entrusted with like responsibility for the person or estate of a stockholder,
may call a special meeting of stockholders in accordance with the provisions of
the certificate of incorporation or these bylaws, or may apply to the Court of
Chancery for a decree summarily ordering an election as provided in
Section 211 of the DGCL.
If, at
the time of filling any vacancy or any newly created directorship, the directors
then in office constitute less than a majority of the whole Board (as
constituted immediately prior to any such increase), the Court of Chancery may,
upon application of any stockholder or stockholders holding at least 10% of the
voting stock at the time outstanding having the right to vote for such
directors, summarily order an election to be held to fill any such vacancies or
newly created directorships, or to replace the directors chosen by the directors
then in office as aforesaid, which election shall be governed by the provisions
of Section 211 of the DGCL as far as applicable.
A
director elected to fill a vacancy shall be elected for the unexpired term of
his or her predecessor in office and until such director’s successor is elected
and qualified, or until such director’s earlier death, resignation or
removal.
2.5 Place of Meetings; Meetings by
Telephone.
The Board may hold meetings, both regular and special, either within or outside
the State of Delaware.
Unless
otherwise restricted by the certificate of incorporation or these bylaws,
members of the Board, or any committee designated by the Board, may participate
in a meeting of the Board, or any committee, by means of conference telephone or
other communications equipment by means of which all persons participating in
the meeting can hear each other, and such participation in a meeting shall
constitute presence in person at the meeting.
2.6 Conduct of
Business.
Meetings of the Board shall be presided over by the Chairperson of the Board, if
any, or in his or her absence by the Vice Chairperson of the Board, if any, or
in the absence of the foregoing persons by a chairperson designated by the
Board, or in the absence of such designation by a chairperson chosen at the
meeting. The Secretary shall act as secretary of the meeting, but in his or her
absence the chairperson of the meeting may appoint any person to act as
secretary of the meeting.
2.7 Regular Meetings.
Regular meetings of the Board may be held without notice at such time and at
such place as shall from time to time be determined by the Board.
2.8 Special Meetings;
Notice.
Special meetings of the Board for any purpose or purposes may be called at any
time by the Chairperson of the Board, the Chief Executive Officer, the
President, the Secretary or any two directors.
Notice of
the time and place of special meetings shall be:
(i) delivered
personally by hand, by courier or by telephone;
(ii) sent
by United States first-class mail, postage prepaid;
(iii) sent
by facsimile; or
(iv) sent
by electronic mail,
directed
to each director at that director’s address, telephone number, facsimile number
or electronic mail address, as the case may be, as shown on the Company’s
records.
If the
notice is (i) delivered personally by hand, by courier or by telephone, (ii)
sent by facsimile or (iii) sent by electronic mail, it shall be delivered
or sent at least 24 hours before the time of the holding of the meeting. If the
notice is sent by United States mail, it shall be deposited in the United States
mail at least four days before the time of the holding of the meeting. Any oral
notice may be communicated to the director. The notice need not specify the
place of the meeting (if the meeting is to be held at the Company’s principal
executive office) nor the purpose of the meeting.
2.9 Quorum; Voting.
At all meetings of the Board, a majority of the total authorized number of
directors shall constitute a quorum for the transaction of business. If a quorum
is not present at any meeting of the Board, then the directors present thereat
may adjourn the meeting from time to time, without notice other than
announcement at the meeting, until a quorum is present. A meeting at which a
quorum is initially present may continue to transact business notwithstanding
the withdrawal of directors, if any action taken is approved by at least a
majority of the required quorum for that meeting.
The vote
of a majority of the directors present at any meeting at which a quorum is
present shall be the act of the Board, except as may be otherwise specifically
provided by statute, the certificate of incorporation or these
bylaws.
If the
certificate of incorporation provides that one or more directors shall have more
or less than one vote per director on any matter, every reference in these
bylaws to a majority or other proportion of directors shall refer to a majority
or other proportion of the votes of the directors.
2.10 Board Action by Written Consent
Without a Meeting.
Unless otherwise restricted by the certificate of incorporation or these bylaws,
any action required or permitted to be taken at any meeting of the Board, or of
any committee thereof, may be taken without a meeting if all members of the
Board or committee, as the case may be, consent thereto in writing or by
electronic transmission and the writing or writings or electronic transmission
or transmissions are filed with the minutes of proceedings of the Board or
committee. Such filing shall be in paper form if the minutes are maintained in
paper form and shall be in electronic form if the minutes are maintained in
electronic form.
2.11 Fees and Compensation of
Directors.
Unless otherwise restricted by the certificate of incorporation or these bylaws,
the Board shall have the authority to fix the compensation of
directors.
2.12 Removal of Directors.
Unless otherwise restricted by statute, the certificate of incorporation or
these bylaws, any director or the entire Board may be removed, with or without
cause, by the holders of a majority of the shares then entitled to vote at an
election of directors.
No
reduction of the authorized number of directors shall have the effect of
removing any director prior to the expiration of such director’s term of
office.
ARTICLE III
— COMMITTEES
3.1 Committees of
Directors.
The Board may designate one or more committees, each committee to consist of one
or more of the directors of the Company. The Board may designate one or more
directors as alternate members of any committee, who may replace any absent or
disqualified member at any meeting of the committee. In the absence or
disqualification of a member of a committee, the member or members thereof
present at any meeting and not disqualified from voting, whether or not such
member or members constitute a quorum, may unanimously appoint another member of
the Board to act at the meeting in the place of any such absent or disqualified
member. Any such committee, to the extent provided in the resolution of the
Board or in these bylaws, shall have and may exercise all the powers and
authority of the Board in the management of the business and affairs of the
Company, and may authorize the seal of the Company to be affixed to all papers
that may require it; but no such committee shall have the power or authority to
(i) approve or adopt, or recommend to the stockholders, any action or
matter (other than the election or removal of directors) expressly required by
the DGCL to be submitted to stockholders for approval, or (ii) adopt, amend
or repeal any bylaw of the Company.
3.2 Committee Minutes.
Each committee shall keep regular minutes of its meetings and report the same to
the Board when required.
3.3 Meetings and Actions of
Committees.
Meetings and actions of committees shall be governed by, and held and taken in
accordance with, the provisions of:
(i) section 2.5 (Place of
Meetings; Meetings by Telephone);
(ii) section 2.7 (Regular
Meetings);
(iii) section 2.8 (Special
Meetings; Notice);
(iv) section 2.9 (Quorum;
Voting);
(v) section 2.10 (Board
Action by Written Consent Without a Meeting); and
(vi) section 7.5 (Waiver of
Notice)
with such
changes in the context of those bylaws as are necessary to substitute the
committee and its members for the Board and its members. However:
(i) the
time of regular meetings of committees may be determined either by resolution of
the Board or by resolution of the committee;
(ii) special
meetings of committees may also be called by resolution of the Board;
and
(iii) notice
of special meetings of committees shall also be given to all alternate members,
who shall have the right to attend all meetings of the committee. The Board may
adopt rules for the government of any committee not inconsistent with the
provisions of these bylaws.
Any
provision in the certificate of incorporation providing that one or more
directors shall have more or less than one vote per director on any matter shall
apply to voting in any committee or subcommittee, unless otherwise provided in
the certificate of incorporation or these bylaws.
3.4 Subcommittees.
Unless otherwise provided in the certificate of incorporation, these bylaws or
the resolutions of the Board designating the committee, a committee may create
one or more subcommittees, each subcommittee to consist of one or more members
of the committee, and delegate to a subcommittee any or all of the powers and
authority of the committee.
ARTICLE IV
— OFFICERS
4.1 Officers.
The officers of the Company shall be a President and a Secretary. The Company
may also have, at the discretion of the Board, a Chairperson of the Board, a
Vice Chairperson of the Board, a Chief Executive Officer, one or more Vice
Presidents, a Chief Financial Officer, a Treasurer, one or more Assistant
Treasurers, one or more Assistant Secretaries, and any such other officers as
may be appointed in accordance with the provisions of these bylaws. Any number
of offices may be held by the same person.
4.2 Appointment of
Officers.
The Board shall appoint the officers of the Company, except such officers as may
be appointed in accordance with the provisions of section 4.3 of these
bylaws.
4.3 Subordinate
Officers.
The Board may appoint, or empower the Chief Executive Officer or, in the absence
of a Chief Executive Officer, the President, to appoint, such other officers and
agents as the business of the Company may require. Each of such officers and
agents shall hold office for such period, have such authority, and perform such
duties as are provided in these bylaws or as the Board may from time to time
determine.
4.4 Removal and Resignation of
Officers.
Any officer may be removed, either with or without cause, by an affirmative vote
of the majority of the Board at any regular or special meeting of the Board or,
except in the case of an officer chosen by the Board, by any officer upon whom
such power of removal may be conferred by the Board.
Any
officer may resign at any time by giving written notice to the Company. Any
resignation shall take effect at the date of the receipt of that notice or at
any later time specified in that notice. Unless otherwise specified in the
notice of resignation, the acceptance of the resignation shall not be necessary
to make it effective. Any resignation is without prejudice to the rights, if
any, of the Company under any contract to which the officer is a
party.
4.5 Vacancies in Offices.
Any vacancy occurring in any office of the Company shall be filled by the Board
or as provided in section 4.3.
4.6 Representation of Shares of Other
Corporations.
Unless otherwise directed by the Board, the President or any other person
authorized by the Board or the President is authorized to vote, represent and
exercise on behalf of the Company all rights incident to any and all shares of
any other corporation or corporations standing in the name of the Company. The
authority granted herein may be exercised either by such person directly or by
any other person authorized to do so by proxy or power of attorney duly executed
by such person having the authority.
4.7 Authority and Duties of
Officers.
Except as otherwise provided in these bylaws, the officers of the Company shall
have such powers and duties in the management of the Company as may be
designated from time to time by the Board and, to the extent not so provided, as
generally pertain to their respective offices, subject to the control of the
Board.
ARTICLE V
— INDEMNIFICATION
5.1 Indemnification of Directors and
Officers in Third Party
Proceedings.
Subject to the other provisions of this Article V, the Company
shall indemnify, to the fullest extent permitted by the DGCL, as now or
hereinafter in effect, any person who was or is a party or is threatened to be
made a party to any threatened, pending or completed action, suit or proceeding,
whether civil, criminal, administrative or investigative (a “Proceeding”) (other than an
action by or in the right of the Company) by reason of the fact that such person
is or was a director or officer of the Company, or is or was a director or
officer of the Company serving at the request of the Company as a director,
officer, employee or agent of another corporation, partnership, joint venture,
trust or other enterprise, against expenses (including attorneys’ fees),
judgments, fines and amounts paid in settlement actually and reasonably incurred
by such person in connection with such Proceeding if such person acted in good
faith and in a manner such person reasonably believed to be in or not opposed to
the best interests of the Company, and, with respect to any criminal action or
proceeding, had no reasonable cause to believe such person’s conduct was
unlawful. The termination of any Proceeding by judgment, order, settlement,
conviction, or upon a plea of nolo contendere or its
equivalent, shall not, of itself, create a presumption that the person did not
act in good faith and in a manner which such person reasonably believed to be in
or not opposed to the best interests of the Company, and, with respect to any
criminal action or proceeding, had reasonable cause to believe that such
person’s conduct was unlawful.
5.2 Indemnification of Directors and
Officers in Actions by or in the Right of the Company.
Subject to the other provisions of this Article V, the Company
shall indemnify, to the fullest extent permitted by the DGCL, as now or
hereinafter in effect, any person who was or is a party or is threatened to be
made a party to any threatened, pending or completed action or suit by or in the
right of the Company to procure a judgment in its favor by reason of the fact
that such person is or was a director or officer of the Company, or is or was a
director or officer of the Company serving at the request of the Company as a
director, officer, employee or agent of another corporation, partnership, joint
venture, trust or other enterprise against expenses (including attorneys’ fees)
actually and reasonably incurred by such person in connection with the defense
or settlement of such action or suit if such person acted in good faith and in a
manner such person reasonably believed to be in or not opposed to the best
interests of the Company; except that no indemnification shall be made in
respect of any claim, issue or matter as to which such person shall have been
adjudged to be liable to the Company unless and only to the extent that the
Court of Chancery or the court in which such action or suit was brought shall
determine upon application that, despite the adjudication of liability but in
view of all the circumstances of the case, such person is fairly and reasonably
entitled to indemnity for such expenses which the Court of Chancery or such
other court shall deem proper.
5.3 Successful
Defense.
To the extent that a present or former director or officer of the Company has
been successful on the merits or otherwise in defense of any action, suit or
proceeding described in section 5.1 or section 5.2, or in defense of any
claim, issue or matter therein, such person shall be indemnified against
expenses (including attorneys’ fees) actually and reasonably incurred by such
person in connection therewith.
5.4 Indemnification of
Others.
Subject to the other provisions of this Article V, the Company
shall have power to indemnify its employees and agents to the extent not
prohibited by the DGCL or other applicable law. The Board shall have the power
to delegate to such person or persons the determination of whether employees or
agents shall be indemnified.
5.5 Advanced Payment of
Expenses.
Expenses (including attorneys’ fees) incurred by an officer or director of the
Company in defending any Proceeding shall be paid by the Company in advance of
the final disposition of such Proceeding upon receipt of a written request
therefor (together with documentation reasonably evidencing such expenses) and
an undertaking by or on behalf of the person to repay such amounts if it shall
ultimately be determined that the person is not entitled to be indemnified under
this Article V or
the DGCL. Such expenses (including attorneys’ fees) incurred by former directors
and officers or other employees and agents may be so paid upon such terms and
conditions, if any, as the Company deems appropriate. The right to advancement
of expenses shall not apply to any Proceeding for which indemnity is excluded
pursuant to these bylaws.
5.6 Limitation on
Indemnification.
Subject to the requirements in section 5.3 and the DGCL,
the Company shall not be obligated to indemnify any person pursuant to this
Article V in
connection with any Proceeding (or any part of any Proceeding):
(i) for
which payment has actually been made to or on behalf of such person under any
statute, insurance policy, indemnity provision, vote or otherwise, except with
respect to any excess beyond the amount paid;
(ii) for
an accounting or disgorgement of profits pursuant to Section 16(b) of the
Securities Exchange Act of 1934, as amended, or similar provisions of federal,
state or local statutory law or common law, if such person is held liable
therefor (including pursuant to any settlement arrangements);
(iii) for
any reimbursement of the Company by such person of any bonus or other
incentive-based or equity-based compensation or of any profits realized by such
person from the sale of securities of the Company, as required in each case
under the Securities Exchange Act of 1934, as amended (including any such
reimbursements that arise from an accounting restatement of the Company pursuant
to Section 304 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), or the
payment to the Company of profits arising from the purchase and sale by such
person of securities in violation of Section 306 of the Sarbanes-Oxley
Act), if such person is held liable therefor (including pursuant to any
settlement arrangements);
(iv) initiated
by such person, including any Proceeding (or any part of any Proceeding)
initiated by such person against the Company or its directors, officers,
employees, agents or other indemnitees, unless (a) the Board authorized the
Proceeding (or the relevant part of the Proceeding) prior to its initiation,
(b) the Company provides the indemnification, in its sole discretion,
pursuant to the powers vested in the Company under applicable law,
(c) otherwise required to be made under section 5.7 or
(d) otherwise required by applicable law; or
(v) if
prohibited by applicable law.
5.7 Determination;
Claim.
If a claim for indemnification or advancement of expenses under this Article V is not paid by
the Company or on its behalf within 90 days after receipt by the Company of a
written request therefor, the claimant shall be entitled to an adjudication by a
court of competent jurisdiction of his or her entitlement to such
indemnification or advancement of expenses. To the extent not prohibited by law,
the Company shall indemnify such person against all expenses actually and
reasonably incurred by such person in connection with any action for
indemnification or advancement of expenses from the Company under this Article V, to the extent
such person is successful in such action. In any such suit, the Company shall,
to the fullest extent not prohibited by law, have the burden of proving that the
claimant is not entitled to the requested indemnification or advancement of
expenses.
5.8 Non-Exclusivity of
Rights.
The indemnification and advancement of expenses provided by, or granted pursuant
to, this Article V
shall not be deemed exclusive of any other rights to which those seeking
indemnification or advancement of expenses may be entitled under the certificate
of incorporation or any statute, bylaw, agreement, vote of stockholders or
disinterested directors or otherwise, both as to action in such person’s
official capacity and as to action in another capacity while holding such
office. The Company is specifically authorized to enter into individual
contracts with any or all of its directors, officers, employees or agents
respecting indemnification and advancement of expenses, to the fullest extent
not prohibited by the DGCL or other applicable law.
5.9 Insurance.
The Company may purchase and maintain insurance on behalf of any person who is
or was a director, officer, employee or agent of the Company, or is or was
serving at the request of the Company as a director, officer, employee or agent
of another corporation, partnership, joint venture, trust or other enterprise
against any liability asserted against such person and incurred by such person
in any such capacity, or arising out of such person’s status as such, whether or
not the Company would have the power to indemnify such person against such
liability under the provisions of the DGCL.
5.10 Survival.
The rights to indemnification and advancement of expenses conferred by this
Article V shall
continue as to a person who has ceased to be a director, officer, employee or
agent and shall inure to the benefit of the heirs, executors and administrators
of such a person.
5.11 Effect of Repeal or Modification.
Any amendment, alteration or repeal of this Article V shall not
adversely affect any right or protection hereunder of any person in respect of
any act or omission occurring prior to such amendment, alteration or
repeal.
5.12 Certain
Definitions.
For purposes of this Article V, references to
the “Company” shall
include, in addition to the resulting corporation, any constituent corporation
(including any constituent of a constituent) absorbed in a consolidation or
merger which, if its separate existence had continued, would have had power and
authority to indemnify its directors, officers, employees or agents, so that any
person who is or was a director, officer, employee or agent of such constituent
corporation, or is or was serving at the request of such constituent corporation
as a director, officer, employee or agent of another corporation, partnership,
joint venture, trust or other enterprise, shall stand in the same position under
the provisions of this Article V with respect to
the resulting or surviving corporation as such person would have with respect to
such constituent corporation if its separate existence had continued. For
purposes of this Article V, references to
“other enterprises”
shall include employee benefit plans; references to “fines” shall include any
excise taxes assessed on a person with respect to an employee benefit plan; and
references to “serving at the
request of the Company” shall include any service as a director, officer,
employee or agent of the Company which imposes duties on, or involves services
by, such director, officer, employee or agent with respect to an employee
benefit plan, its participants or beneficiaries; and a person who acted in good
faith and in a manner such person reasonably believed to be in the interest of
the participants and beneficiaries of an employee benefit plan shall be deemed
to have acted in a manner “not
opposed to the best interests of the Company” as referred to in this
Article V.
ARTICLE VI
— STOCK
6.1 Stock Certificates; Partly Paid
Shares.
The shares of the Company shall be represented by certificates, provided that the Board may
provide by resolution or resolutions that some or all of any or all classes or
series of its stock shall be uncertificated shares. Any such resolution shall
not apply to shares represented by a certificate until such certificate is
surrendered to the Company. Every holder of stock represented by certificates
shall be entitled to have a certificate signed by, or in the name of the Company
by the Chairperson of the Board or Vice-Chairperson of the Board, or the
President or a Vice-President, and by the Treasurer or an Assistant Treasurer,
or the Secretary or an Assistant Secretary of the Company representing the
number of shares registered in certificate form. Any or all of the signatures on
the certificate may be a facsimile. In case any officer, transfer agent or
registrar who has signed or whose facsimile signature has been placed upon a
certificate has ceased to be such officer, transfer agent or registrar before
such certificate is issued, it may be issued by the Company with the same effect
as if such person were such officer, transfer agent or registrar at the date of
issue. The Company shall not have power to issue a certificate in bearer
form.
The
Company may issue the whole or any part of its shares as partly paid and subject
to call for the remainder of the consideration to be paid therefor. Upon the
face or back of each stock certificate issued to represent any such partly paid
shares, or upon the books and records of the Company in the case of
uncertificated partly paid shares, the total amount of the consideration to be
paid therefor and the amount paid thereon shall be stated. Upon the declaration
of any dividend on fully paid shares, the Company shall declare a dividend upon
partly paid shares of the same class, but only upon the basis of the percentage
of the consideration actually paid thereon.
6.2 Special Designation on
Certificates.
If the Company is authorized to issue more than one class of stock or more than
one series of any class, then the powers, the designations, the preferences, and
the relative, participating, optional or other special rights of each class of
stock or series thereof and the qualifications, limitations or restrictions of
such preferences and/or rights shall be set forth in full or summarized on the
face or back of the certificate that the Company shall issue to represent such
class or series of stock; provided that, except as
otherwise provided in Section 202 of the DGCL, in lieu of the foregoing
requirements there may be set forth on the face or back of the certificate that
the Company shall issue to represent such class or series of stock, a statement
that the Company will furnish without charge to each stockholder who so requests
the powers, designations, preferences and relative, participating, optional or
other special rights of each class of stock or series thereof and the
qualifications, limitations or restrictions of such preferences and/or rights.
Within a reasonable time after the issuance or transfer of uncertificated stock,
the Company shall send to the registered owner thereof a written notice
containing the information required to be set forth or stated on certificates
pursuant to this section 6.2 or
Sections 156, 202(a) or 218(a) of the DGCL or with respect to this section 6.2 a statement
that the Company will furnish without charge to each stockholder who so requests
the powers, designations, preferences and relative, participating, optional or
other special rights of each class of stock or series thereof and the
qualifications, limitations or restrictions of such preferences and/or rights.
Except as otherwise expressly provided by law, the rights and obligations of the
holders of uncertificated stock and the rights and obligations of the holders of
certificates representing stock of the same class and series shall be
identical.
6.3 Lost Certificates.
Except as provided in this section 6.3, no new
certificates for shares shall be issued to replace a previously issued
certificate unless the latter is surrendered to the Company and cancelled at the
same time. The Company may issue a new certificate of stock or uncertificated
shares in the place of any certificate theretofore issued by it, alleged to have
been lost, stolen or destroyed, and the Company may require the owner of the
lost, stolen or destroyed certificate, or such owner’s legal representative, to
give the Company a bond sufficient to indemnify it against any claim that may be
made against it on account of the alleged loss, theft or destruction of any such
certificate or the issuance of such new certificate or uncertificated
shares.
6.4 Dividends.
The Board, subject to any restrictions contained in the certificate of
incorporation or applicable law, may declare and pay dividends upon the shares
of the Company’s capital stock. Dividends may be paid in cash, in property, or
in shares of the Company’s capital stock, subject to the provisions of the
certificate of incorporation.
The Board
may set apart out of any of the funds of the Company available for dividends a
reserve or reserves for any proper purpose and may abolish any such
reserve.
6.5 Stock Transfer Agreements.
The Company shall have power to enter into and perform any agreement with any
number of stockholders of any one or more classes of stock of the Company to
restrict the transfer of shares of stock of the Company of any one or more
classes owned by such stockholders in any manner not prohibited by the
DGCL.
6.6 Registered
Stockholders.
The Company:
(i) shall
be entitled to recognize the exclusive right of a person registered on its books
as the owner of shares to receive dividends and to vote as such
owner;
(ii) shall
be entitled to hold liable for calls and assessments the person registered on
its books as the owner of shares; and
(iii) shall
not be bound to recognize any equitable or other claim to or interest in such
share or shares on the part of another person, whether or not it shall have
express or other notice thereof, except as otherwise provided by the laws of
Delaware.
6.7 Transfers.
Transfers of record of shares of stock of the Company shall be made only upon
its books by the holders thereof, in person or by an attorney duly authorized,
and, if such stock is certificated, upon the surrender of a certificate or
certificates for a like number of shares, properly endorsed or accompanied by
proper evidence of succession, assignation or authority to
transfer.
ARTICLE VII
— MANNER OF GIVING NOTICE AND WAIVER
7.1 Notice of Stockholder
Meetings.
Notice of any meeting of stockholders, if mailed, is given when deposited in the
United States mail, postage prepaid, directed to the stockholder at such
stockholder’s address as it appears on the Company’s records. An affidavit of
the Secretary or an Assistant Secretary of the Company or of the transfer agent
or other agent of the Company that the notice has been given shall, in the
absence of fraud, be prima
facie evidence of the facts stated therein.
7.2 Notice by Electronic
Transmission.
Without limiting the manner by which notice otherwise may be given effectively
to stockholders pursuant to the DGCL, the certificate of incorporation or these
bylaws, any notice to stockholders given by the Company under any provision of
the DGCL, the certificate of incorporation or these bylaws shall be effective if
given by a form of electronic transmission consented to by the stockholder to
whom the notice is given. Any such consent shall be revocable by the stockholder
by written notice to the Company. Any such consent shall be deemed revoked
if:
(i) the
Company is unable to deliver by electronic transmission two consecutive notices
given by the Company in accordance with such consent; and
(ii) such
inability becomes known to the Secretary or an Assistant Secretary of the
Company or to the transfer agent, or other person responsible for the giving of
notice.
However,
the inadvertent failure to treat such inability as a revocation shall not
invalidate any meeting or other action.
Any
notice given pursuant to the preceding paragraph shall be deemed
given:
(i) if
by facsimile telecommunication, when directed to a number at which the
stockholder has consented to receive notice;
(ii) if
by electronic mail, when directed to an electronic mail address at which the
stockholder has consented to receive notice;
(iii) if
by a posting on an electronic network together with separate notice to the
stockholder of such specific posting, upon the later of (A) such posting
and (B) the giving of such separate notice; and
(iv) if
by any other form of electronic transmission, when directed to the
stockholder.
An
affidavit of the Secretary or an Assistant Secretary or of the transfer agent or
other agent of the Company that the notice has been given by a form of
electronic transmission shall, in the absence of fraud, be prima facie evidence of the
facts stated therein.
An “electronic transmission” means
any form of communication, not directly involving the physical transmission of
paper, that creates a record that may be retained, retrieved, and reviewed by a
recipient thereof, and that may be directly reproduced in paper form by such a
recipient through an automated process.
Notice by
a form of electronic transmission shall not apply to Sections 164, 296,
311, 312 or 324 of the DGCL.
7.3 Notice to Stockholders Sharing an
Address.
Except as otherwise prohibited under the DGCL, without limiting the manner by
which notice otherwise may be given effectively to stockholders, any notice to
stockholders given by the Company under the provisions of the DGCL, the
certificate of incorporation or these bylaws shall be effective if given by a
single written notice to stockholders who share an address if consented to by
the stockholders at that address to whom such notice is given. Any such consent
shall be revocable by the stockholder by written notice to the Company. Any
stockholder who fails to object in writing to the Company, within 60 days of
having been given written notice by the Company of its intention to send the
single notice, shall be deemed to have consented to receiving such single
written notice.
7.4 Notice to Person with Whom
Communication is Unlawful.
Whenever notice is required to be given, under the DGCL, the certificate of
incorporation or these bylaws, to any person with whom communication is
unlawful, the giving of such notice to such person shall not be required and
there shall be no duty to apply to any governmental authority or agency for a
license or permit to give such notice to such person. Any action or meeting
which shall be taken or held without notice to any such person with whom
communication is unlawful shall have the same force and effect as if such notice
had been duly given. In the event that the action taken by the Company is such
as to require the filing of a certificate under the DGCL, the certificate shall
state, if such is the fact and if notice is required, that notice was given to
all persons entitled to receive notice except such persons with whom
communication is unlawful.
7.5 Waiver of Notice.
Whenever notice is required to be given under any provision of the DGCL, the
certificate of incorporation or these bylaws, a written waiver, signed by the
person entitled to notice, or a waiver by electronic transmission by the person
entitled to notice, whether before or after the time of the event for which
notice is to be given, shall be deemed equivalent to notice. Attendance of a
person at a meeting shall constitute a waiver of notice of such meeting, except
when the person attends a meeting for the express purpose of objecting at the
beginning of the meeting, to the transaction of any business because the meeting
is not lawfully called or convened. Neither the business to be transacted at,
nor the purpose of, any regular or special meeting of the stockholders need be
specified in any written waiver of notice or any waiver by electronic
transmission unless so required by the certificate of incorporation or these
bylaws.
ARTICLE VIII
— GENERAL MATTERS
8.1 Fiscal Year.
The fiscal year of the Company shall be fixed by resolution of the Board and may
be changed by the Board.
8.2 Seal.
The Company may adopt a corporate seal, which shall be in such form as may be
approved from time to time by the Board. The Company may use the corporate seal
by causing it or a facsimile thereof to be impressed or affixed or in any other
manner reproduced.
8.3 Annual Report.
The Company shall cause an annual report to be sent to the stockholders of the
Company to the extent required by applicable law. If and so long as there are
fewer than 100 holders of record of the Company’s shares, the requirement of
sending an annual report to the stockholders of the Company is expressly waived
(to the extent permitted under applicable law).
8.4 Construction; Definitions.
Unless the context requires otherwise, the general provisions, rules of
construction, and definitions in the DGCL shall govern the construction of these
bylaws. Without limiting the generality of this provision, the singular number
includes the plural, the plural number includes the singular, and the term
“person” includes both a corporation and a natural person.
ARTICLE IX
— AMENDMENTS
These
bylaws may be adopted, amended or repealed by the stockholders entitled to vote.
However, the Company may, in its certificate of incorporation, confer the power
to adopt, amend or repeal bylaws upon the directors. The fact that such power
has been so conferred upon the directors shall not divest the stockholders of
the power, nor limit their power to adopt, amend or repeal bylaws.
A bylaw
amendment adopted by stockholders which specifies the votes that shall be
necessary for the election of directors shall not be further amended or repealed
by the Board.
Unassociated Document
EXCLUSIVE
PATENT LICENSE AGREEMENT
This
Exclusive Patent License Agreement is made as of July 27, 2009 (“Effective Date”) between
Ensisheim Partners, LLC, a Washington limited liability company (“Licensor”), and Atossa
Genetics, Inc., a Delaware corporation (“Atossa”). The parties agree as
follows:
1. DEFINITIONS
1.1 “First Commercial Sale” means
the initial transfer of a Licensed Product by Atossa, an affiliate or a
sublicensee to a third party in exchange for cash or some equivalent to which
value can be assigned in any country after all required marketing and pricing
approvals have been granted, or otherwise permitted, by the authorities of such
country, in each case for use or consumption of such Licensed Product in such
country by the general public. Sales for test marketing, sampling and
promotional uses, clinical trial purposes, or compassionate or similar use will
not be considered a First Commercial Sale.
1.2 “Licensed Patents” means: (a)
all patents and patent applications set forth in Exhibit A; (b) all
divisions, substitutions, continuations, continuation-in-parts, reissues,
reexaminations, and extensions of the patents and patent applications described
in Section 1.1(a); (c) all foreign and
international counterparts of the patents and patent applications described in
Sections 1.1(a) and 1.1(b); and (d) all patents issuing from patent
applications described in Sections 1.1(a), 1.1(b), and 1.1(c).
1.3 “Licensed Product” means any
product the manufacture, use, or sale of which would, in the absence of the
licenses granted in this Agreement, infringe a Valid Claim of a Licensed Patent
in the country in which that product is made, used, or sold.
1.4 “Net Sales Revenues” means the
gross amount collected by Atossa for the sale of a Licensed Product, less all:
(a) normal and customary cash and trade discounts and rebates (including prompt
payment and volume discounts); (b) duties and taxes (including excise, sales,
use, and value added taxes); (c) insurance, freight, packaging, handling,
shipment, and transportation expenses (including associated insurance costs);
(d) amounts allowed or credited due to returns, rejections, recalls, rebates,
charge backs, billing errors, or retroactive price reductions; and (e) sales
commissions or fees paid. Net Sales Revenues excludes amounts collected by
Atossa: (i) that are not directly related to sale of a Licensed Product,
including amounts paid for support, maintenance, development, research, clinical
trials, training, and products bundled with a Licensed Product; (ii) for
transfers made to a third party for resale by the third party or to an
affiliate; and (iii) for Licensed Products used for research and development or
other non-commercial uses, supplied as commercial samples, or supplied as
charitable donations.
1.5 “Valid Claim” means a pending
or issued and unexpired claim of a Licensed Patent so long as that claim has not
been: (a) irrevocably abandoned, withdrawn, or declared to be unpatentable,
invalid, or unenforceable in an unappealable decision of a court or other
authority of competent jurisdiction; or (b) found or admitted to be invalid or
unenforceable through no fault or cause of Atossa, whether through reissue,
re-examination, disclaimer or otherwise.
2. GRANT
OF RIGHTS
2.1 Licensed Patents.
Licensor hereby grants to Atossa and its affiliates an exclusive, worldwide,
perpetual, irrevocable, royalty-bearing (as set forth in Section 3), license, with the right to grant and authorize
sublicenses, under the Licensed Patents to do the following: (a) make, have
made, use, sell, offer to sell, export, import, and otherwise distribute
Licensed Products; (b) practice and perform any processes, methods, and
procedures described in or that would infringe a Valid Claim of a Licensed
Patent; and (c) otherwise exploit the Licensed Patents.
2.2 Exclusivity. The
license granted in Section 2.1 is exclusive in that
Licensor must not, directly or indirectly: (a) exercise or grant to any third
party any license or other right under a Licensed Patent; or (b) develop or sell
any products or services in the Exclusive Field that would infringe a Licensed
Patent. Without limiting Atossa’s rights or remedies at law, and without regard
to whether Atossa has an adequate remedy at law, Atossa will have the right to
seek equitable relief to prevent any breach or threatened breach of this
Section 2.2.
2.3 Ownership of Licensed
Patents. Licensor will at all times be the sole owner of all right,
title, and interest (including intellectual property rights) in and to the
Licensed Patents.
2.4 No Requirements.
Atossa is not required to: (a) develop Licensed Products; (b) receive Licensor’s
or a third party’s approval for any use of any Licensed Products; (c) attribute
creation or development of any Licensed Product to Licensor; or (d) take action
against any third party relating to the third party’s use or exploitation of any
Licensed Product.
2.5 Rights in Bankruptcy.
All rights and licenses granted under or pursuant to this Agreement by Licensor
to Atossa are, and will otherwise be deemed to be, for purposes of Section
365(n) of the United States Bankruptcy Code, licenses of rights to “intellectual
property” as defined under Section 101(56) of the Bankruptcy Code. Atossa, as a
licensee of the rights under this Agreement, will retain and may fully exercise
all of its rights and elections under the Bankruptcy Code.
3. ROYALTY
3.1 Royalty Rate. Subject
to Section 3.2, Atossa will pay Licensor a royalty
equal to two percent (2%) of Net Sales Revenues (“Licensing Royalty”). No more
than one royalty payment will be due under this Agreement with respect to a sale
of a particular Licensed Product, even if that Licensed Product is covered by
multiple Valid Claims.
3.2 Minimum
Royalty. Atossa will pay Licensor, in accordance with this
Section, a minimum royalty of $12,500 per fiscal quarter during the term of this
Agreement, which will increase to a minimum royalty of $25,000 per fiscal
quarter beginning in the quarter in which the First Commercial Sale of a
Licensed Product takes place (each, a “Minimum Royalty”). Atossa will
pay Licensor a pro-rata portion of the first Minimum Royalty within 30 days of
the Effective Date, and the Minimum Royalty for each subsequent fiscal quarter
will be due upon the first day of that fiscal quarter. The Minimum Royalty for
any given fiscal quarter is creditable against any Licensing Royalties due in
that fiscal quarter.
3.3 Reduction for Third Party
Payments. If Atossa’s manufacture, sale, use, importation, or other
exploitation of a Licensed Product is subject to one or more patents owned,
controlled, or licensable by a third party and Atossa pays the third party to
license such patents, then the Licensing Royalty will be reduced by the amount
paid to the third party for such license, except that the Licensing Royalty
payable to Licensor will not fall below 1% of Net Sales Revenues during any
fiscal quarter.
3.4 Reporting and
Payment. No later than 60 days after the end of each fiscal quarter
during the term of this Agreement, Atossa will deliver to Licensor a written
report of the Net Sales Revenues collected during the fiscal quarter. With each
report submitted by Atossa, Atossa will deliver payment of the Licensing Royalty
due for the applicable fiscal quarter to the extent not covered by any other
payments made by Atossa that are creditable against Licensing Royalty payments,
e.g., the applicable Minimum Royalty payment.
4. PROSECUTION
AND MAINTENANCE OF THE LICENSED PATENTS
4.1 Atossa’s Rights.
Licensor grants to Atossa: (a) the right to prepare, file, prosecute, and
maintain, in its own name and at its own expense, the Licensed Patents in any
country; and (b) an irrevocable power of attorney to act on Licensor’s behalf
and to execute and file documents on Licensor’s behalf to prepare, file,
prosecute, and maintain these rights.
4.2 Licensor’s
Obligations. Licensor will consult with Atossa regarding the preparation,
filing, prosecution, and maintenance of the Licensed Patents. Licensor will not
prepare, file, prosecute, or maintain the Licensed Patents without Atossa’s
prior written consent. Licensor will have the right to prepare, file, prosecute,
and maintain, in its own name and at its own expense, the Licensed Patents in
any country where Atossa fails or declines to prosecute or maintain those
rights. Licensor may exercise this right only if it notifies Atossa of its
intent in writing and Atossa does not proceed to prosecute or maintain those
rights within 60 days after the notice. Licensor will keep Atossa reasonably
informed regarding Licensor’s prosecution and maintenance of the Licensed
Patents in accordance with this Section (e.g., status of patent filings and
registrations).
5. ENFORCEMENT
OF LICENSED PATENTS
5.1 Atossa’s Rights.
Licensor grants to Atossa the right to bring and prosecute lawsuits against
third parties, in Atossa’s own name or jointly with Licensor if required by law,
for infringement of a Licensed Patent. This right includes bringing any legal
action for infringement, defending any counter claim of invalidity or action of
a third party for declaratory judgment for non-infringement or non-interference,
and settling a suit. Atossa will be entitled to all of the damages, profits, and
awards of whatever nature recoverable from the suit. Licensor will fully
cooperate with Atossa in the prosecution of any such lawsuit at Atossa’s
expense.
5.2 Licensor’s
Obligations. Licensor will not bring or prosecute a lawsuit against any
third party for infringement of a Licensed Patent without Atossa’s prior written
consent. In addition, if Atossa does not institute a lawsuit (including, but not
limited to, temporary and permanent injunctive actions) within a reasonable
period, but no more than 60 days following Licensor’s written request to do so,
Licensor will have the right to institute and
prosecute
the lawsuit in its own name or jointly with Atossa if required by law. Atossa
will fully cooperate with Licensor in the prosecution of any such lawsuit at
Licensor’s expense.
6. TERM
AND TERMINATION
6.1 Term. This Agreement
will take effect on the Effective Date and will continue in effect, on a
country-by-country basis, until the date on which no further Licensing Royalty
would be due in such country, unless terminated earlier in accordance with the
terms of this Agreement.
6.2 Termination by Atossa for
Convenience. Atossa may terminate this Agreement, in whole or as to any
particular Licensed Patent or Licensed Product, for any reason or for no reason
by notifying Licensor in writing. Termination in accordance with this Section 6.2 will take effect five days after Licensor receives
Atossa’s written notice of termination.
6.3 Effects of Termination or
Expiration
(a) Payment or Refund.
Within 60 days after termination or expiration of the Agreement, Atossa will pay
to Licensor all Licensing Royalties that it owes for sale of Licensed Products
prior to the date of termination or expiration.
(b) Survival. All rights
and duties of the parties under this Agreement will terminate upon termination
or expiration of this Agreement for any reason except that: (i) all sublicenses
granted by Atossa prior to termination or expiration will survive termination;
and (ii) Sections 6.3 and 8 will survive termination or expiration of this
Agreement.
7. REPRESENTATIONS
AND WARRANTIES
7.1 Authorization.
Licensor represents and warrants that: (a) it is duly organized, validly
existing, and in good standing in the jurisdiction stated in the preamble to
this Agreement; (b) the execution and delivery of this Agreement by Licensor has
been duly and validly authorized; and (c) this Agreement constitutes a valid,
binding, and enforceable obligation of Licensor.
7.2 No Conflict. Licensor
represents and warrants that: (a) the execution of this Agreement and Licensor’s
performance under this Agreement does not and will not violate, conflict with,
or result in a material default under any other agreement, indenture, decree,
judgment, lien, or encumbrance to which Licensor is a party or by which any of
the Licensed Patents are or may become subject or bound; (b) Licensor has not
granted any other rights under the Licensed Patents; and (c) Licensor will not
grant any rights under any future agreement, nor will it permit or suffer any
lien, obligation, or encumbrances, that will conflict with the full enjoyment by
Atossa of its rights under this Agreement.
7.3 Validity and
Enforceability. Licensor represents and warrants that: (a) to Licensor’s
knowledge, Licensor’s rights to the Licensed Patents are valid and enforceable;
and (b) Licensor does not know of any facts or circumstances that could impair
the validity or enforceability of any of its rights to the Licensed
Patents.
7.4 Legal Proceedings.
Licensor represents and warrants that: (a) Licensor is not involved in any legal
proceeding (litigation, arbitration, mediation, or otherwise) relating to the
Licensed Patents; (b) Licensor has not received notice of a claim relating to
the Licensed Patents; and (c) Licensor is not aware of any facts or
circumstances that might lead to a legal proceeding relating to the Licensed
Patents.
8. GENERAL
8.1 Remedies
(a) No Consequential
Damages. IN NO EVENT WILL EITHER PARTY HAVE LIABILITY TO THE OTHER PARTY
FOR ANY INDIRECT, INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES, EVEN IF ADVISED
OF THE POSSIBILITY OF THESE DAMAGES. THESE LIMITATIONS WILL APPLY
NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY
IN THIS AGREEMENT.
(b) Limitation to
Damages. Licensor’s sole remedy, if any, in the event of a breach will be
an action for monetary damages. Licensor will not be entitled to injunctive or
other equitable relief or to terminate or rescind this Agreement or the licenses
granted in this Agreement.
8.2 Relationship. Nothing
in this Agreement may be construed as creating an employer-employee
relationship, agency relationship, joint venture, or partnership between the
parties.
8.3 Assignability.
Neither this Agreement nor any rights or obligations under this Agreement may be
assigned or otherwise transferred by Licensor, in whole or in part, whether
voluntarily or by operation of law, without the prior written consent of Atossa.
Atossa may assign this Agreement or any rights and obligations under this
Agreement freely. Subject to the foregoing, this Agreement will be binding upon
and will inure to the benefit of the parties and their respective successors and
assigns. Any assignment in violation of the foregoing will be null and
void.
8.4 Further Assurances.
Each party agrees that it will execute and deliver such documents as may be
required to implement any of the provisions of this Agreement.
8.5 Governing Law. This
Agreement is governed by the laws of the State of Washington, without giving
effect to provisions related to choice of laws or conflict of laws.
8.6 Venue and
Jurisdiction. Venue and jurisdiction of any lawsuit involving this
Agreement exists exclusively in the state and federal courts in King County,
Washington, unless Atossa seeks injunctive relief that, in Atossa’s judgment,
would not be effective unless obtained in some other venue.
8.7 Waiver. The waiver by
either party of any breach of any provision of this Agreement does not waive any
other breach. The failure of any party to insist on strict performance of any
covenant or obligation under this Agreement will not be a waiver of such
party’s
right to demand strict compliance in the future, nor will the same be construed
as a novation of this Agreement.
8.8 Severability. If any
part of this Agreement is found to be unenforceable, the remaining portions of
this Agreement will remain in full force and effect.
8.9 Drafting. The parties
have had an equal opportunity to participate in the drafting of this Agreement
and the attached exhibits. No ambiguity will be construed against any party
based upon a claim that that party drafted the ambiguous
language.
8.10 Headings. The
headings appearing at the beginning of several sections contained in this
Agreement have been inserted for identification and reference purposes only and
must not be used to construe or interpret this Agreement.
8.11 Notices. Any notice
required or permitted to be given under this Agreement will be effective if it
is in writing and sent by certified or registered mail, or insured courier,
return receipt requested, to the appropriate party at the address set forth
below and with the appropriate postage affixed. Either party may change its
address for receipt of notice by notice to the other party in accordance with
this Section. Notices will be deemed given two business days following the date
of mailing or one business day following delivery to a courier.
To Licensor:
|
To Atossa:
|
Shu-Chih
Chen Quay
|
Dr.
Steven Quay
|
Ensisheim
Partners, LLC
4105
E Madison St, Suite 320
|
Atossa
Genetics, Inc.
4105 E. Madison St., Suite 320
Seattle, WA 98112
|
Seattle,
WA 98112
|
|
With
a copy to:
Ms.
Effie Toshav, Esq.
Wilson
Sonsini Goodrich & Rosati, PC
701
Fifth Ave., Suite 5100
Seatlle,
WA 98104
|
|
8.12 Counterparts. This
Agreement may be executed in any number of identical counterparts,
notwithstanding that the parties have not signed the same counterpart, with the
same effect as if the parties had signed the same document. All counterparts
will be construed as and constitute the same agreement.
8.13 Entire Agreement.
This Agreement, including any exhibits, is the final and complete expression of
all agreements between these parties and supersedes all previous oral and
written agreements regarding these matters. It may be changed only by a written
agreement signed by the party against whom enforcement is sought.
|
|
“Licensor”
|
“Atossa”
|
Ensisheim
Partners, LLC
|
Atossa
Genetics, Inc.
|
Name:
Shu-Chih Chen Quay
|
Name:
Dr. Steven Quay
|
Title:
Principal
|
Title:
President
|
Signature: /s/
Shu-Chih Chen Quay
|
Signature:
/s/ Steven
Quay
|
Date:
27 July,
2009
|
Date:
27 July,
2009
|
EXHIBIT
A
LICENSED
PATENTS
WWKMN
Ref.
(TTC
Ref. No.)
Country
|
Title
|
Inventor(s)
Priority
|
Application
Number
Filing
Date
|
Patent
Number
Issue
Date
Due:
|
ATOS-0003
US
(020424-000100US)
|
Methods
and Kits for Obtaining and Assaying Mammary Fluid Samples for Breast
Diseases, Including Cancer
|
Steven
C. Quay
Debra
L. Quay
|
08/709,207
08/27/96
|
5,798,266
08/25/98
11.5
Yr MF-February 25, 2010
|
ATOS-0005
Australia
(020424-000100AU)
|
Methods
and Kits for Obtaining and Assaying Mammary Fluid Samples for Breast
Diseases, Including Cancer
|
Steven
C. Quay
Debra
L. Quay
(claims
priority to ATOS-0004 and ATOS-00003)
|
40850/97
08/22/97
|
740,160
13th
Yr MF-August 22, 2009
|
ATOS-0006
Canada
(020424-000100CA)
|
Methods
and Kits for Obtaining and Assaying Mammary Fluid Samples for Breast
Diseases, Including Cancer
|
Steven
C. Quay
Debra
L. Quay
(claims
priority to ATOS-0004 and ATOS-00003)
|
2,264,277
08/22/97
|
2,264,277
04/15/2008
13th
Yr MF-August 22, 2009
|
WWKMN
Ref.
(TTC
Ref. No.)
Country
|
Title
|
Inventor(s)
Priority
|
Application
Number
Filing
Date
|
Patent
Number
Issue
Date
Due:
|
PCT
ATOS-0004?
|
Methods
and Kits for Obtaining and Assaying Mammary Fluid Samples for Breast
Diseases, Including Cancer
|
Steven
C. Quay
Debra
L. Quay
(claims
priority to ATOS-0004 and ATOS-00003)
Foreign
filing of ATOS-0003
|
PCT/US97/14863
filed
08/22/97
WO
98/08976 published 03/05/1998
|
NATIONAL
|
ATOS-0007
European
(020424-000100EP)
|
Kits
for Obtaining and Assaying Mammary Fluid Samples for Breast Diseases,
Including Cancer
|
Steven
C. Quay
Debra
L. Quay
(claims
priority to ATOS-0004 and ATOS-00003)
|
97938551.5
08/22/97
Notice
of Intent to Grant
EU
Validation-November 8, 2008
|
EP
0932699 - withdrawn
January
8, 2009-2 Month Further Processing Request
|
ATOS-0025
Hong
Kong
(020424-000100HK)
|
Kits
for Obtaining and Assaying Mammary Fluid Samples for Breast Diseases,
Including Cancer
|
Steven
C. Quay
Debra
L. Quay
(claims
priority to ATOS-0004 and ATOS-00003)
|
00100654.7
08/22/97
|
13th
Yr MF-August 22, 2009
|
WWKMN
Ref.
(TTC
Ref. No.)
Country
|
Title
|
Inventor(s)
Priority
|
Application
Number
Filing
Date
|
Patent
Number
Issue
Date
Due:
|
ATOS-0026
Japan
(020424-000100JP)
|
Methods
and Kits for Obtaining and Assaying Mammary Fluid Samples for Breast
Diseases, Including Cancer
|
Steven
C. Quay
Debra
L. Quay
(claims
priority to ATOS-0004 and ATOS-00003)
|
10-511772
03/01/99
08/22/97
|
Abandoned
in Favor of CYTC-11-0407
|
ATOS-0027
US
(020424-000110US)
|
Methods
and Devices for Obtaining and Assaying Mammary Fluid Samples for
Evaluating Breast Diseases, Including Cancer
|
Steven
C. Quay
Debra
L. Quay
(CIP
of ATOS-0003)
|
09/027,362
02/20/98
|
6,287,521
B1
09/11/01
7.5
Yr MF-March 11, 2009
|
ATOS-0028
US
(020424-000120US)
|
Methods
and Devices for Obtaining and Assaying Mammary Fluid Samples for
Evaluating Breast Diseases, Including Cancer
|
Steven
C. Quay
Debra
L. Quay
(Cont.
of ATOS-0027 which is a CIP of ATOS-0003)
|
09/435,131
11/05/99
|
Abandoned
|
WWKMN
Ref.
(TTC
Ref. No.)
Country
|
Title
|
Inventor(s)
Priority
|
Application
Number
Filing
Date
|
Patent
Number
Issue
Date
Due:
|
ATOS-0040
US
|
Devices
and Methods for Obtaining Mammary Fluid Samples for Evaluating Breast
Diseases, Including Cancer
|
Steven
C. Quay
(Utility
filing of ATOS-0030 and ATOS-0033
|
10/002,540
11/13/01
|
6,887,210
05/03/2005
|
ATOS-0041
US
|
Methods
and Devices for Collecting, Handling and Processing Mammary Fluid Samples
for Evaluating Breast Diseases, Including Cancer
|
Steven
C. Quay
(Utility
filing of ATOS-0030 and ATOS-0033
|
10/001,041
11/13/01
|
6,689,073
02/10/2004
|
US
|
Methods
and Devices for Collecting, Handling and Processing Mammary Fluid Samples
for Evaluating Breast Diseases, Including Cancer
|
Steven
C. Quay
|
60/248,134
11/13/00
|
EXPIRED
|
WWKMN
Ref.
(TTC
Ref. No.)
Country
|
Title
|
Inventor(s)
Priority
|
Application
Number
Filing
Date
|
Patent
Number
Issue
Date
Due:
|
US
|
Methods
and Devices for Collecting, Handling and Processing Mammary Fluid Samples
for Evaluating Breast Diseases, Including Cancer
|
Steven
C. Quay
|
60/248,136
11/13/00
|
EXPIRED
|
ATOS-0042
PCT
|
Methods
and Devices for Collecting, Handling and Processing Mammary Fluid Samples
for Evaluating Breast Diseases, Including Cancer
|
Steven
C. Quay
(foreign
filing of ATOS-0030 and ATOS -0033 both filed 11/13/00)
|
PCT/US01/46032
11/13/01
Publication
No.
WO
02/38032 A2 on May 16, 2002
|
NATIONAL
|
ATOS-0043
Australia
|
Methods
and Kits for Obtaining and Assaying Mammary Fluid Samples for Breast
Diseases, Including Cancer
|
Steven
C. Quay
Debra
L. Quay
(Divisional
of ATOS-0005 which claims priority to ATOS-0004 and
ATOS-0003)
|
14725/02
01/31/02
|
781,187
13th
Yr MF- August 22, 2009
|
WWKMN
Ref.
(TTC
Ref. No.)
Country
|
Title
|
Inventor(s)
Priority
|
Application
Number
Filing
Date
|
Patent
Number
Issue
Date
Due:
|
ATOS-0070
U.S.
Utility
|
Methods
and Devices for Obtaining and Assaying Mammary Fluid Samples for
Evaluating Breast Diseases, Including Cancer
|
Steven
C. Quay
Debra
L. Quay
(Cont.
of ATOS-0028, which is a cont. of ATOS-0027, which is a CIP of
ATOS-0003)
|
10/404,866
Filed
3/31/03
|
7,128,877
10/31/2006
|
US
|
Methods
and Devices for Obtaining and Assaying Mammary Fluid Samples for
Evaluating Breast Diseases, Including Cancer
|
Steven
C. Quay
|
11/116,961
04/27/2005
|
Abandoned
|
JP
|
Methods
and Devices for Obtaining and Assaying Mammary Fluid Samples for
Evaluating Breast Diseases, Including Cancer
|
Steven
C. Quay
(claims
priority to ATOS-0042, 60/248,134 & 60/248,136)
|
2003-343663
03/24/2004
11/13/2001
|
|
WWKMN
Ref.
(TTC
Ref. No.)
Country
|
Title
|
Inventor(s)
Priority
|
Application
Number
Filing
Date
|
Patent
Number
Issue
Date
Due:
|
CA
|
Methods
and Devices for Obtaining and Assaying Mammary Fluid Samples for
Evaluating Breast Diseases, Including Cancer
|
Steven
C. Quay
(claims
priority to ATOS-0042, 60/248,134 & 60/248,136)
|
2,427,967
08/22/1997
11/13/2001
|
2,427,967
8th
Yr MF – November 13, 2008
|
EP
|
Methods
and Devices for Obtaining and Assaying Mammary Fluid Samples for
Evaluating Breast Diseases, Including Cancer
|
Steven
C. Quay
(claims
priority to ATOS-0042, 60/248,134 & 60/248,136)
|
01993422.3
11/13/2001
|
|
JP
|
Methods
and Devices for Obtaining and Assaying Mammary Fluid Samples for
Evaluating Breast Diseases, Including Cancer
|
Steven
C. Quay
(claims
priority to ATOS-0042, 60/248,134 & 60/248,136)
|
11/13/2001
4,050,612
|
4,050,612
10th
Yr MF – November 13, 2008
|
WWKMN
Ref.
(TTC
Ref. No.)
Country
|
Title
|
Inventor(s)
Priority
|
Application
Number
Filing
Date
|
Patent
Number
Issue
Date
Due:
|
AU
|
Methods
and Devices for Obtaining and Assaying Mammary Fluid Samples for
Evaluating Breast Diseases, Including Cancer
|
Steven
C. Quay
(claims
priority to ATOS-0042, 60/248,134 & 60/248,136)
|
2002-227163
11/13/2001
|
8th
Yr MF – November 13, 2008
|
HK
|
Methods
and Devices for Obtaining and Assaying Mammary Fluid Samples for
Evaluating Breast Diseases, Including Cancer
|
Steven
C. Quay
(claims
priority to ATOS-0042, 60/248,134 & 60/248,136)
|
03105927.4
11/13/2001
|
9th
Yr MF – August 19, 2009
|
EXHIBIT
10.2
June 17,
2010
Robert
Kelly, President
Atossa
Genetics, Inc.
4105 E
Madison St, Suite 320
Seattle,
WA 98112
OBJECT: TERMINATION
OF EXCLUSIVE PATENT LICENSE AGREEMENT
Dear
Robert,
With this
letter, we hereby terminate the Exclusive Patent License Agreement between
Ensisheim Partners LLC (“Ensisheim”) and Atossa Genetics, Inc. (“Atossa”) dated
July 27, 2009. The reason for this termination is that we have agreed
that an assignment of all patent rights rather than a license is a better
business arrangement.
Upon
acceptance of this letter, Atossa will have no further obligation with respect
to royalty payments to Ensisheim. Any accrued but unpaid royalties
are immediately forgiven. Upon assignment, Atossa will have all
responsibility for prosecution, maintenance, and enforcement and will indemnify
Ensisheim from any and all claims against the patent
estate. Ensisheim will retain no residual rights with respect to the
patents and patent applications.
Thank you
for your immediate attention to this matter.
Sincerely
STEVEN
C. QUAY, M.D., PH.D.
|
|
|
|
/s/ Steven C.
Quay
|
|
|
|
Chairman
and CEO
|
|
Atossa
Genetics, Inc.
|
|
4105
E. Madison St, Suite 320
|
|
Seattle,
WA 98112
|
|
|
|
Accepted
on behalf of Atossa Genetics, Inc.
|
|
|
|
/s/ Robert Kelly
|
|
Robert
Kelly, President
|
|
RESTATED
AND AMENDED EMPLOYMENT AGREEMENT
THIS
RESTATED AND AMENDED EMPLOYMENT AGREEMENT (this “Agreement”) is made
and entered into as of September 27, 2010 and restates and amends the Restated
and Amended Employment Agreement made as of July 22, 2010 (the “Prior Agreement”) by
and between Steven C. Quay, M.D., Ph.D., an individual (“Employee”), and
Atossa Genetics, Inc. a Delaware corporation, having its principal office at
4105 E. Madison Street, Suite 320, Seattle, WA 98112 (the “Company”, and
collectively with Employee referred to herein as the “Parties,” and
individually, as a “Party”).
RECITALS
Whereas,
the Company is engaged in the commercialization of a patented, FDA approved
non-invasive test for the detection of pre-cancerous conditions that may lead to
breast cancer;
Whereas,
the Company has not yet completed development of its infrastructure and is in
need of capital, management, infrastructure, accounting and various other
critical elements including management and negotiations with sophisticated
corporate entities and organizations;
Whereas,
Employee is a founder of the Company;
Whereas,
Employee desires to be employed by Company and Company desires to employ the
Employee on the terms provided herein;
Whereas,
the Employee and the Company desire to amend and restate the
Prior Agreement and to accept the terms and conditions hereof in lieu
of the terms and conditions provided under the Prior Agreement.
AGREEMENT
1. Employment. The
Company hereby hires and employs Employee as Chief Executive Officer of the
Company and Employee hereby accepts such employment with the Company on the
terms and conditions set forth herein.
2. Term &
Position.
(a) Employment
Term. Subject to the terms and conditions set forth in Section
7 of this Agreement, the Employee and the Company
shall each have the right to terminate Employee’s employment
hereunder. The term of Employee’s employment hereunder is referred to
herein as the “Employment
Term.”
(b) Position. During
the Employment Term, Employee shall be the Chief Executive Officer of the
Company and shall be appointed Chairman of the Board of Directors.
3. Duties and
Responsibilities. Employee shall serve the Company diligently
and faithfully in the performance of his duties on the Company’s behalf, which
shall include duties and responsibilities as the Company may from time to time
reasonably prescribe consistent with the duties and responsibilities of the
Chief Executive Officer of the Company. Employee and the Board of
Directors shall be responsible for strategy and tactics and for setting
corporate goals during the Employment Term, as and if appropriate.
4. Compensation. For
services rendered to the Company pursuant to this Agreement, Employee shall be
entitled to receive the following cash and equity compensation:
(a) Base
Salary. Employee shall be entitled to an initial base salary
of $250,000.00 per year, payable biweekly. The Company may elect to accrue
payment of such base salary until the completion of a financing.
(b) Bonus. Employee
shall be eligible to receive an annual cash performance bonus in an amount of up
to 40% of his then-current base salary, subject to the achievement of goals
established prospectively by the Compensation Committee of the board. The
performance goals for 2010 will be set at the first board meeting following the
completion of the Company’s initial public offering.
(c) Equity. The
Company will grant to Employee an option (the “Option”) to purchase
565,833 shares of common stock at an exercise price per share equal to the fair
market value per share on the date the option is granted, as determined by the
Board of Directors. The Option will be subject to the terms and conditions
applicable to options granted under an equity incentive plan to be adopted by
the Board of Directors and stockholders of the Company (the “Plan”), and the
applicable stock option agreement pursuant to the Plan, which will include the
appropriate provisions contained in this Agreement. 25% of the shares of
common stock underlying the option, or 141,458 shares, will vest on December 31,
2010, and the remaining 75%, or 424,375 shares, will vest in equal quarterly
installments over the next three years, so long as Employee remains employed
with the Company.
(d) Change in
Control. In the event of a Change in Control (as defined
below) during the Employment Term, Employee shall be entitled to receive a
one-time bonus equal to 2.9 (two and nine-tenths) times his then-current base
salary as set forth and determined above, or on any amendment to this Agreement,
and all then-unvested shares of restricted stock, warrants and/or employee stock
options, if any, then held by Employee shall accelerate and become fully vested
as of immediately prior to the completion of the Change in Control. For
purposes hereof, a “Change in Control” shall mean:
(i) merger
or consolidation in which (A) the Company is a constituent party or (B) a
Subsidiary of the Company is a constituent party and the Company issues shares
of its capital stock pursuant to such merger or consolidation, in each case
except any such merger or consolidation involving the Company or a Subsidiary in
which the shares of capital stock of the Company outstanding immediately prior
to such merger or consolidation continue to represent, or are converted into or
exchanged for shares of capital stock that represent, immediately following such
merger or consolidation, at least a majority, by voting power, of the capital
stock of (1) the surviving or resulting corporation or (2) if the surviving or
resulting corporation is a wholly owned subsidiary of another corporation
immediately following such merger or consolidation, the parent corporation of
such surviving or resulting corporation; or
(ii) the
sale, lease, transfer, exclusive license or other disposition, in a single
transaction or series of related transactions, by the Company or any Subsidiary
of all or substantially all the assets of the Company and its Subsidiaries taken
as a whole, except where such sale, lease, transfer, exclusive license or other
disposition is to a wholly-owned subsidiary of the Company.
5. Fringe
Benefits. During the Employment Term, the Company agrees to
make available the following fringe benefits to Employee in accordance with the
policies and plans adopted by the Company; said fringe benefits shall be no less
favorable to the Employee than those provided to other key employees and
officers of the Company. To the extent such benefits are based on length
of service with the Company, Employee shall receive full credit for prior
service with the Company.
(a) Expenses. Employee
shall be expected to incur various business expenses and other out-of-pocket
expenses customarily incurred by persons holding like positions, including but
not limited to traveling, entertainment and similar expenses incurred by
Employee in the performance of Employee’s services for the benefit of the
Company. Company shall reimburse Employee for all reasonable business
expenses incurred or paid by Employee upon presentation of documentation
reasonably acceptable to the Company and subject to any reimbursement policy
adopted by the Company.
(b) Health
Insurance. Participation in health, hospitalization,
disability, dental and other insurance plans that the Company may have in effect
for other executives, all of which shall be paid for by the Company with
contribution by the Employee as set for the other executives, as and if
appropriate.
(c) Vacation. Employee
shall be entitled to six weeks of paid vacation per year for each full year of
employment and pro rata for each partial year. Vacation time not taken during a
calendar year is not accrued to the next calendar year.
6. Termination. Either
the Company or Employee may terminate Employee’s employment by the Company at
the end of any calendar month, with or without “Cause” or “Good Reason” (as such
terms are defined below), in its or his sole discretion, upon thirty (30) days’
prior written notice of termination. In addition, Employee’s employment by
the Company shall terminate upon the death or Disability (as defined below) of
Employee. Termination of Executive’s employment as provided for
herein shall terminate the Employment Term. For purposes of this
Agreement, in the case of a termination of Employee’s employment hereunder, the
following terms shall have the following meanings:
(a) “Good Reason” shall
mean the Employee has complied with the Good Reason Process (as defined below)
following the occurrence of any of the following events: (i) a material
diminution in Employee’s responsibilities, authority or duties at the Company
that constitutes a demotion or (ii) a material diminution in Employee’s base
salary (other than a general reduction applicable to all executive employees of
the Company) (each, a “Good Reason
Condition”).
(b) “Good Reason Process”
means that (i) Employee reasonably determines in good faith that a Good Reason
Condition has occurred, (ii) Employee notifies the Company in writing of the
occurrence of the Good Reason Condition within 60 days after the first
occurrence of such condition; (iii) Employee cooperates in good faith with the
Company’s efforts, for a period not less than 30 days following such notice (the
“Cure Period”),
to remedy the Good Reason Condition; (iv) notwithstanding such efforts, the Good
Reason Condition continues to exist; and (v) Employee terminates his employment
within 60 days after the end of the Cure Period. If the Company cures the
Good Reason Condition during the Cure Period, Good Reason will be deemed not to
have occurred.
(c) “Cause” shall mean:
(i) Employee’s willful and repeated failure reasonably to perform his duties
hereunder or to comply with any reasonable and proper direction given by the
Board if such failure of performance or compliance is not cured within thirty
(30) days following receipt by Employee of written notice from the Company
containing a description of such failures and non-compliance and a demand for
immediate cure thereof; (B) Employee being found guilty in a criminal court
of an offense involving moral turpitude; (C) Employee’s commission of any
material act of fraud or theft against the Company; or (D) Employee’s
material violation of any of the material terms, covenants, representations or
warranties contained in this Agreement if such violation is not cured within
thirty (30) days following receipt by Employee of written notice from the
Company containing a description of the violation and a demand for immediate
cure thereof.
(d) “Disability” shall
mean total and permanent disability as defined in Section 22(e)(3) of the
Internal Revenue Code of 1986, as amended.
7. Severance. Subject
to Section 6 hereof, if (i) the Company terminates
the employment of Employee without Cause, or (ii) Employee terminates his
employment for Good Reason, then Employee shall be entitled to receive all of
his accrued and then-unpaid base salary, any bonus cash compensation earned by
Employee through the effective date of termination (determined at the maximum
annual rate for bonus cash compensation provided for above but on a pro-rated
basis for the portion of the fiscal year that shall have elapsed when the
termination occurs). In addition, subject to Employee’s execution and
non-revocation of an agreement containing a release of any and all legal claims
and other termination-related provisions in a form acceptable to the Company
(the “Separation
Agreement”), Employee shall be entitled to receive upon such
termination an additional cash payment in the amount of twelve (12) months
of such base salary (the “Severance Payment”),
and notwithstanding the vesting and exercisability provisions otherwise
applicable to the options issued to Employee under prior agreements, the vesting
of all shares of common stock underlying such options shall accelerate as of the
effective date of such termination, and such options shall remain exercisable
for the remainder of their terms. The Company shall pay the Severance
Payment in substantially equal installments over six (6) months (the “Severance Benefits
Period”) in accordance with the Company’s standard payroll practice, in
arrears beginning on the first payroll date that occurs following the thirtieth
(30th) day after the date on which Employee’s employment with the Company
terminates; provided,
that prior to such date, the Separation Agreement becomes effective.
Solely for purposes of Section 409A of the Internal Revenue Code of 1986, as
amended (the “Code”), each
installment of the Severance Payment will be considered a separate
payment. Notwithstanding the foregoing, the Company shall not be required
to pay any severance pay for any period following the effective date of
termination of Employee’s employment hereunder if Employee shall have materially
violated the provisions of Sections 3, 8, 10 or 11 of this Agreement and such violation is not cured
within thirty (30) days following receipt of written notice from the Company
containing a description of the violation and a demand for immediate
cure.
8. Noncompetition and
Non-Solicitation Commitment. Employee hereby agrees as
follows:
(a) Agreement Not to
Compete. Employee hereby covenants, and agrees that, during
the Employment Term and for a period of twelve (12) months thereafter, he shall
not within the United States directly or indirectly in any manner or capacity
(whether alone or as a partner, joint venturer, stockholder or investor,
creditor, principal, agent, advisor, employee, officer, director, licensor,
licensee, salesman, broker or representative, for any “Person” (defined as any
individual, corporation (including any non-profit corporation), general, limited
or limited liability partnership, limited liability company, joint venture,
estate, trust, association, organization, or other entity or governmental body),
or through any agency or by any other means whatsoever) engage in the Business
of the Company or any Subsidiary, except for on behalf of the Company or its
affiliates. For purposes of the foregoing, the “Business of the Company,”
from time to time means the Company’s business as is described in Part I, Item 1
(“Description of Business”) of the Company’s then most recent Annual Report on
Form 10-K filed with the United States Securities and Exchange Commission, and
the term “Subsidiary” means a corporation or other entity that is at least
majority owned, directly or indirectly, by the Company.
(b) No
Interference. Employee shall not take any action to interfere
with the relationships between the Company and its Affiliates, on the one hand,
and their customers on the other, during the Non-Compete Period.
(c) Indirect
Competition. Employee further agrees that, during the
Non-Compete Period, he shall not, directly or indirectly, assist or encourage
any other Person in carrying out, directly or indirectly, any activity that
would be prohibited by the foregoing provisions of this Section 8 if such activity were carried out by
Employee.
(d) No
Solicitation. Employee agrees that during the Non-Compete
Period, he will not, directly or indirectly, on behalf of himself or any other
Person, solicit the hiring of or hire, on any basis, any Person employed by the
Company or its Affiliates at the time of such solicitation.
9. Reasonable Restriction;
Limits on Enforcement.
(a) The
parties hereto agree that the restrictions on the activities and business of
Employee provided for in this Agreement, and the duration and territorial scope
thereof, are, under all circumstances, reasonable and necessary to safeguard the
interests of the Company and its Affiliates and to protect the goodwill acquired
pursuant thereto.
(b) If
any court of competent jurisdiction shall refuse to enforce any or all of the
provisions hereof because the time limit applicable thereto is deemed
unreasonable, it is expressly understood and agreed that such provisions shall
not be void, but that for the purpose of such proceedings and in such
jurisdiction such time limitation shall be deemed to be reduced to the extent
necessary to permit enforcement of such provisions.
(c) If
any court of competent jurisdiction shall refuse to enforce any or all of the
provisions hereof because they are more extensive (whether as to geographical
area, scope of business or otherwise) than is deemed reasonable, it is expressly
understood and agreed that such provisions shall not be void, but that for the
purpose of such proceedings and in such jurisdiction, the restrictions contained
herein (whether as to geographic area, scope of business or otherwise) shall be
deemed to be reduced to the extent necessary to permit enforcement of such
provisions.
(d) The
existence of any claim or cause of action by Employee or any other Person
against the Company or its Affiliates shall not constitute a defense to the
enforcement of any provision hereof.
(e) Employee
expressly stipulates and agrees that this Agreement shall be construed in a
manner which renders its provisions valid and enforceable to the maximum extent
(not exceeding its express terms) permissible under applicable law.
10. Confidential
Information.
(a) For
purposes of this Section 10, the term “Confidential
Information” means, in addition to its meaning under applicable law,
information which is not generally known in the Company’s industry and which is
proprietary to the Company and which is subject to efforts by the Company to
maintain its confidentiality, including (i) trade secret information about
the Company, its customers and its products, and (ii) information relating
to the business of the Company as conducted at any time within the previous five
(5) years or anticipated to be conducted by the Company, and to any of its past,
current or anticipated products, including, without limitation, information
about the Company’s purchasing, accounting, marketing, selling, or
servicing. “Confidential
Information” shall not include information that is, or thereafter by
legal means becomes, lawfully available from public sources or any information
that is required by a law or any competent administrative agency or judicial
authority to be disclosed, or the disclosure of which is otherwise reasonably
necessary or appropriate in connection with performance by Employee of his
duties under this Agreement.
(b) Employee
shall not, either during the term of this Agreement or for a period one (1) year
following the expiration or termination of this Agreement, use Confidential
Information for any purpose other than the performance of his duties and
responsibilities under this Agreement or disclose any Confidential Information
to any Person not employed by the Company except with the prior written
authorization of the Company or as may be necessary for Employee to perform his
duties hereunder and shall exercise prudence and the same degree of care taken
by the Company to safeguard and protect, and to prevent the unauthorized
disclosure of, all such Confidential Information.
(c) Upon
expiration or termination of this Agreement, Employee shall turn over to a
designated representative of the Company all property in Employee’s possession
and custody and belonging to the Company and all tangible embodiments of
Confidential Information. Employee shall not retain any copies or
reproductions of correspondence, memoranda, reports, notebooks, drawings,
photographs or other documents relating in any way to the affairs of the Company
and containing Confidential Information which came into Employee’s possession at
any time during the term of this Agreement.
11. Inventions and
Innovations. Employee agrees to communicate to the Company,
promptly and fully, and to assign to the Company, all inventions, trade secrets,
and technical or business innovations, and all worldwide intellectual property
rights therein, developed or conceived solely by Employee, or jointly with
others, while employed by the Company, which were developed on the time of the
Company or in reliance on Confidential Information. Employee further
agrees to execute all necessary papers and otherwise to assist the Company, at
the Company’s sole expense, to obtain patents or other legal protection as the
Company deems fit, and to assist in perfecting in the Company all rights granted
to it hereunder. Both the Company and Employee intend that all original
works of authorship created by Employee while working in the employ of the
Company will be works for hire within the meaning of applicable copyright laws
and will be the sole and exclusive property of the Company.
12. Third Party
Beneficiaries. Employee acknowledges and agrees that the
covenants contained in Sections 8 through 11 hereof are expressly intended to benefit the
Company and all of its Affiliates, and that for purposes of such sections the
term “Company” shall include all of Company’s Affiliates.
13. Survival. The
covenants and agreements of the Employee set forth in Sections 8 through 12 shall remain
in effect and survive the termination of this Agreement for the respective
periods set forth therein.
14. Waiver. No
waiver of any term, condition or covenant of this Agreement shall be deemed to
be a waiver of subsequent breaches of the same or other terms, covenants or
conditions hereof.
15. Amendment. This
Agreement may not be amended, altered or modified except by a written agreement
between the parties hereto.
16. Assignability. Employee
may not assign this Agreement to any third party for whatever purpose without
the express written consent of the Company, other than as specifically
authorized herein. The Company may not assign this Agreement to any third
party without the express written consent of Employee except by operation of
law, or through merger, liquidation, recapitalization or sale of all or
substantially all of the assets of the Company, provided that the Company may
assign this Agreement at any time to an Affiliate of the Company.
17. Invalidity. In
the event part or any portion of this Agreement is determined in a legally
binding manner to be invalid and unenforceable, the parties agree that this
Agreement as so construed shall remain in force and effect between them and
applied as if the offending part or portion did not comprise an element
hereof.
18. Severability. If
any particular provision of this Agreement shall be determined to be invalid or
unenforceable, the parties expressly authorize the court or other tribunal
making such a determination to edit the invalid or unenforceable provision to
allow this Agreement, and the provisions thereof, to be valid and enforceable to
the fullest extent allowed by applicable law.
19. Entire
Agreement. This Agreement contains the entire agreement of the
parties relative to the subject matter of this Agreement and there is no
provision, condition or understanding relative to the employment of Employee
outside this Agreement.
20. Notices. Any
notice required to be given hereunder shall be duly and properly given,
effective as of the date of mailing, if mailed postage prepaid to either party
at the addresses set forth below, or to such other address as such party may
subsequently notify to the other.
If
to Employee:
|
Steven
C. Quay, MD, PhD
|
|
4105
E. Madison Street, Suite 320
|
|
Seattle,
WA 98112
|
|
|
If
to Company:
|
Atossa
Genetics, Inc.
|
|
Attn: Directors
|
|
4105
E. Madison Street, Suite 320
|
|
Seattle,
WA 98112
|
21. Governing
Law. This Agreement shall be governed by and construed under
the internal laws of the State of Washington, without regard to the principles
of comity and/or the applicable conflicts of laws of any state that would result
in the application of any laws other than the State of Washington.
22. Jurisdiction &
Arbitration. The validity, performance and interpretation of
the Agreement shall be governed by the laws of the State Washington, without
regard to its conflicts of law rules. Any dispute or claim arising under or with
respect to this Agreement, which is incapable of resolution, will be resolved by
arbitration before one (1) arbitrator in Seattle, Washington, in accordance with
the Rules for Commercial Arbitration of the American Arbitration Association
("AAA"). The
appointing agency shall be the AAA and the arbitrator shall apply Washington
State law to both interpret this Agreement and fashion an
award.
23. Tax
Matters.
(a) The
parties intend that this Agreement be administered in accordance with Section
409A of the Code. To the extent that any provision of this Agreement is
ambiguous as to its compliance with, or exemption from, Section 409A of the
Code, the provision will be read in such a manner so that all payments hereunder
either comply with, or are exempt from, Section 409A of the Code. The
Parties agree that this Agreement may be amended as reasonably requested by
either Party, and as may be necessary to fully comply with Section 409A of the
Code and all related rules and regulations in order to preserve the payments and
benefits provided hereunder without additional cost to either party. The
Company makes no representation or warranty and will have no liability to
Employee or any other person if any provisions of this Agreement are determined
to constitute deferred compensation subject to Section 409A of the Code but do
not satisfy an exemption from, or the conditions of, such Section.
(b) Anything
in this Agreement to the contrary notwithstanding, if at the time of Employee’s
“separation from service” within the meaning of Section 409A of the Code, the
Company determines that Employee is a “specified employee” within the meaning of
Section 409A(a)(2)(B)(i) of the Code, then to the extent any payment or benefit
that Employee becomes entitled to under this Agreement on account of his
separation from service would be considered deferred compensation subject to the
20 percent additional tax imposed pursuant to Section 409A(a) of the Code as a
result of the application of Section 409A(a)(2)(B)(i) of the Code, such payment
shall not be payable and such benefit shall not be provided until the date that
is the earlier of (A) six months and one day after Employee’s separation from
service or (B) Employee’s death. If any such delayed cash payment is
otherwise payable on an installment basis, the first payment shall include a
catch-up payment covering amounts that would otherwise have been paid during the
six-month period but for the application of this provision, and the balance of
the installments will be payable in accordance with their original
schedule.
(c) To
the extent that any payment or benefit described in this Agreement constitutes
“non-qualified deferred compensation” under Section 409A of the Code, and to the
extent that such payment or benefit is payable upon Employee’s termination of
employment, then such payments or benefits shall be payable only upon Employee’s
“separation from service.” The determination of whether and when a
separation from service has occurred shall be made in accordance with the
presumptions set forth in Treasury Regulation Section 1.409A 1(h).
(d) All
in-kind benefits provided and expenses eligible for reimbursement under this
Agreement shall be provided by the Company or incurred by Employee during the
time periods set forth in this Agreement. All reimbursements shall be paid
as soon as administratively practicable, but in no event shall any reimbursement
be paid after the last day of the taxable year following the taxable year in
which the expense was incurred. The amount of in-kind benefits
provided or reimbursable expenses incurred in one taxable year shall not affect
the in-kind benefits to be provided or the expenses eligible for reimbursement
in any other taxable year. Such right to reimbursement or in-kind
benefits is not subject to liquidation or exchange for another
benefit.
24. Counterparts and Electronic
Signatures. This Agreement may be executed in two or more
counterparts and by facsimile or any electronic means, each of which shall be
deemed an original but all of which together shall constitute one and the same
Agreement.
[SIGNATURE
PAGE FOLLOWS]
IN
WITNESS WHEREOF, the parties have executed this Agreement as of September 27,
2010.
COMPANY:
|
|
EMPLOYEE:
|
|
|
|
Atossa
Genetics, Inc.
|
|
|
|
|
|
By:
|
/s/ John Barnhart
|
|
By:
|
/s/ Steven C. Quay
|
|
John
Barnhart
|
|
|
Steven
C. Quay, M.D., Ph.D.
|
|
Director,
Board of Directors
|
|
|
[SIGNATURE
PAGE TO EMPLOYMENT AGREEMENT]
EXHIBIT
10.4
RESTATED
AND AMENDED EMPLOYMENT AGREEMENT
THIS
RESTATED AND AMENDED EMPLOYMENT AGREEMENT (this “Agreement”) is made
and entered into as of September 27, 2010 and restates and amends the Restated
and Amended Employment Agreement made as of July 22, 2010 (the “Prior Agreement”) by
and between Shu-Chih Chen, Ph.D., an individual (“Employee”), and
Atossa Genetics, Inc. a Delaware corporation, having its principal office at
4105 E. Madison Street, Suite 320, Seattle, WA 98112 (the “Company”, and
collectively with Employee referred to herein as the “Parties,” and
individually, as a “Party”).
RECITALS
Whereas,
the Company is engaged in the commercialization of a patented, FDA approved
non-invasive test for the detection of pre-cancerous conditions that may lead to
breast cancer;
Whereas,
the Company has not yet completed development of its infrastructure and is in
need of capital, management, infrastructure, accounting and various other
critical elements including management and negotiations with sophisticated
corporate entities and organizations;
Whereas,
Employee is a founder of the Company;
Whereas,
Employee desires to be employed by Company and Company desires to employ the
Employee on the terms provided herein;
Whereas,
the Employee and the Company desire to amend and restate the
Prior Agreement and to accept the terms and conditions hereof in lieu
of the terms and conditions provided under the Prior Agreement.
AGREEMENT
1. Employment. The
Company hereby hires and employs Employee as Chief Scientific Officer of the
Company and Employee hereby accepts such employment with the Company on the
terms and conditions set forth herein.
2. Term &
Position.
(a) Employment
Term. Subject to the terms and conditions set forth in Section
7 of this Agreement, the Employee and the Company shall each have the right to
terminate Employee’s employment hereunder. The term of Employee’s
employment hereunder is referred to herein as the “Employment
Term.”
(b) Position. During
the Employment Term, Employee shall be the Chief Scientific Officer of the
Company and shall be appointed as a member of the Board of
Directors.
3. Duties and
Responsibilities. Employee shall serve the Company diligently
and faithfully in the performance of her duties on the Company’s behalf, which
shall include duties and responsibilities as the Company may from time to time
reasonably prescribe consistent with the duties and responsibilities of the
Chief Scientific Officer of the Company, including establishing the Company’s
laboratory, and managing the Company’s biomarker research and development
efforts.
4. Compensation. For
services rendered to the Company pursuant to this Agreement, Employee shall be
entitled to receive the following cash and equity compensation:
(a) Base
Salary. Employee shall be entitled to an initial base salary
of $200,000.00 per year, payable biweekly. The Company may elect to
accrue payment of such base salary until the completion of a
financing.
(b) Bonus. Employee
shall be eligible to receive an annual cash performance bonus in an amount of up
to 30% of her then-current base salary, subject to the achievement of goals
established prospectively by the Compensation Committee of the
board. The performance goals for 2010 will be set at the first board
meeting following the completion of the Company’s initial public
offering.
(c) Equity. The
Company will grant to Employee an option (the “Option”) to purchase
226,333 shares of common stock at an exercise price per share equal to the fair
market value per share on the date the option is granted, as determined by the
Board of Directors. The Option will be subject to the terms and
conditions applicable to options granted under an equity incentive plan to be
adopted by the Board of Directors and stockholders of the Company (the “Plan”), and the
applicable stock option agreement pursuant to the Plan, which will include the
appropriate provisions contained in this Agreement. 25% of the shares
of common stock underlying the option, or 56,583 shares, will vest on December
31, 2010, and the remaining 75%, or 169,750 shares, will vest in equal quarterly
installments over the next three years, so long as Employee remains employed
with the Company.
(d) Change in
Control. In the event of a Change in Control (as defined
below) during the Employment Term, Employee shall be entitled to receive a
one-time bonus equal to 2.9 (two and nine-tenths) times her then-current base
salary as set forth and determined above, or on any amendment to this Agreement,
and all then-unvested shares of restricted stock, warrants and/or employee stock
options, if any, then held by Employee shall accelerate and become fully vested
as of immediately prior to the completion of the Change in
Control. For purposes hereof, a “Change in Control”
shall mean:
(i) merger
or consolidation in which (A) the Company is a constituent party or (B) a
Subsidiary of the Company is a constituent party and the Company issues shares
of its capital stock pursuant to such merger or consolidation, in each case
except any such merger or consolidation involving the Company or a Subsidiary in
which the shares of capital stock of the Company outstanding immediately prior
to such merger or consolidation continue to represent, or are converted into or
exchanged for shares of capital stock that represent, immediately following such
merger or consolidation, at least a majority, by voting power, of the capital
stock of (1) the surviving or resulting corporation or (2) if the surviving or
resulting corporation is a wholly owned subsidiary of another corporation
immediately following such merger or consolidation, the parent corporation of
such surviving or resulting corporation; or
(ii) the
sale, lease, transfer, exclusive license or other disposition, in a single
transaction or series of related transactions, by the Company or any Subsidiary
of all or substantially all the assets of the Company and its Subsidiaries taken
as a whole, except where such sale, lease, transfer, exclusive license or other
disposition is to a wholly-owned subsidiary of the Company.
5. Fringe
Benefits. During the Employment Term, the Company agrees to
make available the following fringe benefits to Employee in accordance with the
policies and plans adopted by the Company; said fringe benefits shall be no less
favorable to the Employee than those provided to other key employees and
officers of the Company. To the extent such benefits are based on
length of service with the Company, Employee shall receive full credit for prior
service with the Company.
(a) Expenses. Employee
shall be expected to incur various business expenses and other out-of-pocket
expenses customarily incurred by persons holding like positions, including but
not limited to traveling, entertainment and similar expenses incurred by
Employee in the performance of Employee’s services for the benefit of the
Company. Company shall reimburse Employee for all reasonable business
expenses incurred or paid by Employee upon presentation of documentation
reasonably acceptable to the Company and subject to any reimbursement policy
adopted by the Company.
(b) Health
Insurance. Participation in health, hospitalization,
disability, dental and other insurance plans that the Company may have in effect
for other executives, all of which shall be paid for by the Company with
contribution by the Employee as set for the other executives, as and if
appropriate.
(c) Vacation. Employee
shall be entitled to six weeks of paid vacation per year for each full year of
employment and pro rata for each partial year. Vacation time not taken during a
calendar year is not accrued to the next calendar year.
6. Termination. Either
the Company or Employee may terminate Employee’s employment by the Company at
the end of any calendar month, with or without “Cause” or “Good Reason” (as such
terms are defined below), in its or her sole discretion, upon thirty (30) days’
prior written notice of termination. In addition, Employee’s
employment by the Company shall terminate upon the death or Disability (as
defined below) of Employee. Termination of Executive’s employment as
provided for herein shall terminate the Employment Term. For purposes
of this Agreement, in the case of a termination of Employee’s employment
hereunder, the following terms shall have the following
meanings:
(a) “Good Reason” shall
mean the Employee has complied with the Good Reason Process (as defined below)
following the occurrence of any of the following events: (i) a material
diminution in Employee’s responsibilities, authority or duties at the Company
that constitutes a demotion or (ii) a material diminution in Employee’s base
salary (other than a general reduction applicable to all executive employees of
the Company) (each, a “Good Reason
Condition”).
(b) “Good Reason Process”
means that (i) Employee reasonably determines in good faith that a Good Reason
Condition has occurred, (ii) Employee notifies the Company in writing of the
occurrence of the Good Reason Condition within 60 days after the first
occurrence of such condition; (iii) Employee cooperates in good faith with the
Company’s efforts, for a period not less than 30 days following such notice (the
“Cure Period”),
to remedy the Good Reason Condition; (iv) notwithstanding such efforts, the Good
Reason Condition continues to exist; and (v) Employee terminates her employment
within 60 days after the end of the Cure Period. If the Company cures
the Good Reason Condition during the Cure Period, Good Reason will be deemed not
to have occurred.
(c) “Cause” shall mean:
(i) Employee’s willful and repeated failure reasonably to perform her duties
hereunder or to comply with any reasonable and proper direction given by the
Board if such failure of performance or compliance is not cured within thirty
(30) days following receipt by Employee of written notice from the Company
containing a description of such failures and non-compliance and a demand for
immediate cure thereof; (B) Employee being found guilty in a criminal court
of an offense involving moral turpitude; (C) Employee’s commission of any
material act of fraud or theft against the Company; or (D) Employee’s
material violation of any of the material terms, covenants, representations or
warranties contained in this Agreement if such violation is not cured within
thirty (30) days following receipt by Employee of written notice from the
Company containing a description of the violation and a demand for immediate
cure thereof.
(d) “Disability” shall
mean total and permanent disability as defined in Section 22(e)(3) of the
Internal Revenue Code of 1986, as amended.
7. Severance. Subject
to Section 6 hereof, if (i) the Company terminates the employment of Employee
without Cause, or (ii) Employee terminates her employment for Good Reason, then
Employee shall be entitled to receive all of her accrued and then-unpaid base
salary, any bonus cash compensation earned by Employee through the effective
date of termination (determined at the maximum annual rate for bonus cash
compensation provided for above but on a pro-rated basis for the portion of the
fiscal year that shall have elapsed when the termination occurs). In
addition, subject to Employee’s execution and non-revocation of an agreement
containing a release of any and all legal claims and other termination-related
provisions in a form acceptable to the Company (the “Separation
Agreement”), Employee shall be entitled to receive upon such
termination an additional cash payment in the amount of twelve (12) months
of such base salary (the “Severance Payment”),
and notwithstanding the vesting and exercisability provisions otherwise
applicable to the options issued to Employee under prior agreements, the vesting
of all shares of common stock underlying such options shall accelerate as of the
effective date of such termination, and such options shall remain exercisable
for the remainder of their terms. The Company shall pay the Severance
Payment in substantially equal installments over six (6) months (the “Severance Benefits
Period”) in accordance with the Company’s standard payroll practice, in
arrears beginning on the first payroll date that occurs following the thirtieth
(30th) day after the date on which Employee’s employment with the Company
terminates; provided,
that prior to such date, the Separation Agreement becomes
effective. Solely for purposes of Section 409A of the Internal
Revenue Code of 1986, as amended (the “Code”), each
installment of the Severance Payment will be considered a separate
payment. Notwithstanding the foregoing, the Company shall not be
required to pay any severance pay for any period following the effective date of
termination of Employee’s employment hereunder if Employee shall have materially
violated the provisions of Sections 3, 8, 10 or 11 of this Agreement and such
violation is not cured within thirty (30) days following receipt of written
notice from the Company containing a description of the violation and a demand
for immediate cure.
8. Noncompetition and
Non-Solicitation Commitment. Employee hereby agrees as
follows:
(a) Agreement Not to
Compete. Employee hereby covenants, and agrees that, during
the Employment Term and for a period of twelve (12) months thereafter, she shall
not within the United States directly or indirectly in any manner or capacity
(whether alone or as a partner, joint venturer, stockholder or investor,
creditor, principal, agent, advisor, employee, officer, director, licensor,
licensee, salesman, broker or representative, for any “Person” (defined as any
individual, corporation (including any non-profit corporation), general, limited
or limited liability partnership, limited liability company, joint venture,
estate, trust, association, organization, or other entity or governmental body),
or through any agency or by any other means whatsoever) engage in the Business
of the Company or any Subsidiary, except for on behalf of the Company or its
affiliates. For purposes of the foregoing, the “Business of the
Company,” from time to time means the Company’s business as is described in Part
I, Item 1 (“Description of Business”) of the Company’s then most recent Annual
Report on Form 10-K filed with the United States Securities and Exchange
Commission, and the term “Subsidiary” means a corporation or other entity that
is at least majority owned, directly or indirectly, by the Company.
(b) No
Interference. Employee shall not take any action to interfere
with the relationships between the Company and its Affiliates, on the one hand,
and their customers on the other, during the Non-Compete Period.
(c) Indirect
Competition. Employee further agrees that, during the
Non-Compete Period, she shall not, directly or indirectly, assist or encourage
any other Person in carrying out, directly or indirectly, any activity that
would be prohibited by the foregoing provisions of this Section 8 if such
activity were carried out by Employee.
(d) No
Solicitation. Employee agrees that during the Non-Compete
Period, she will not, directly or indirectly, on behalf of himself or any other
Person, solicit the hiring of or hire, on any basis, any Person employed by the
Company or its Affiliates at the time of such solicitation.
9. Reasonable Restriction;
Limits on Enforcement.
(a) The
parties hereto agree that the restrictions on the activities and business of
Employee provided for in this Agreement, and the duration and territorial scope
thereof, are, under all circumstances, reasonable and necessary to safeguard the
interests of the Company and its Affiliates and to protect the goodwill acquired
pursuant thereto.
(b) If
any court of competent jurisdiction shall refuse to enforce any or all of the
provisions hereof because the time limit applicable thereto is deemed
unreasonable, it is expressly understood and agreed that such provisions shall
not be void, but that for the purpose of such proceedings and in such
jurisdiction such time limitation shall be deemed to be reduced to the extent
necessary to permit enforcement of such provisions.
(c) If
any court of competent jurisdiction shall refuse to enforce any or all of the
provisions hereof because they are more extensive (whether as to geographical
area, scope of business or otherwise) than is deemed reasonable, it is expressly
understood and agreed that such provisions shall not be void, but that for the
purpose of such proceedings and in such jurisdiction, the restrictions contained
herein (whether as to geographic area, scope of business or otherwise) shall be
deemed to be reduced to the extent necessary to permit enforcement of such
provisions.
(d) The
existence of any claim or cause of action by Employee or any other Person
against the Company or its Affiliates shall not constitute a defense to the
enforcement of any provision hereof.
(e) Employee
expressly stipulates and agrees that this Agreement shall be construed in a
manner which renders its provisions valid and enforceable to the maximum extent
(not exceeding its express terms) permissible under applicable law.
10. Confidential
Information.
(a) For
purposes of this Section 10, the term “Confidential
Information” means, in addition to its meaning under applicable law,
information which is not generally known in the Company’s industry and which is
proprietary to the Company and which is subject to efforts by the Company to
maintain its confidentiality, including (i) trade secret information about
the Company, its customers and its products, and (ii) information relating
to the business of the Company as conducted at any time within the previous five
(5) years or anticipated to be conducted by the Company, and to any of its past,
current or anticipated products, including, without limitation, information
about the Company’s purchasing, accounting, marketing, selling, or
servicing. “Confidential
Information” shall not include information that is, or thereafter by
legal means becomes, lawfully available from public sources or any information
that is required by a law or any competent administrative agency or judicial
authority to be disclosed, or the disclosure of which is otherwise reasonably
necessary or appropriate in connection with performance by Employee of her
duties under this Agreement.
(b) Employee
shall not, either during the term of this Agreement or for a period one (1) year
following the expiration or termination of this Agreement, use Confidential
Information for any purpose other than the performance of her duties and
responsibilities under this Agreement or disclose any Confidential Information
to any Person not employed by the Company except with the prior written
authorization of the Company or as may be necessary for Employee to perform her
duties hereunder and shall exercise prudence and the same degree of care taken
by the Company to safeguard and protect, and to prevent the unauthorized
disclosure of, all such Confidential Information.
(c) Upon
expiration or termination of this Agreement, Employee shall turn over to a
designated representative of the Company all property in Employee’s possession
and custody and belonging to the Company and all tangible embodiments of
Confidential Information. Employee shall not retain any copies or
reproductions of correspondence, memoranda, reports, notebooks, drawings,
photographs or other documents relating in any way to the affairs of the Company
and containing Confidential Information which came into Employee’s possession at
any time during the term of this Agreement.
11. Inventions and
Innovations. Employee agrees to communicate to the Company,
promptly and fully, and to assign to the Company, all inventions, trade secrets,
and technical or business innovations, and all worldwide intellectual property
rights therein, developed or conceived solely by Employee, or jointly with
others, while employed by the Company, which were developed on the time of the
Company or in reliance on Confidential Information. Employee further
agrees to execute all necessary papers and otherwise to assist the Company, at
the Company’s sole expense, to obtain patents or other legal protection as the
Company deems fit, and to assist in perfecting in the Company all rights granted
to it hereunder. Both the Company and Employee intend that all
original works of authorship created by Employee while working in the employ of
the Company will be works for hire within the meaning of applicable copyright
laws and will be the sole and exclusive property of the Company.
12. Third Party
Beneficiaries. Employee acknowledges and agrees that the
covenants contained in Sections 8 through 11 hereof are expressly intended
to benefit the Company and all of its Affiliates, and that for purposes of such
sections the term “Company” shall include all of Company’s
Affiliates.
13. Survival. The
covenants and agreements of the Employee set forth in Sections 8 through 12
shall remain in effect and survive the termination of this Agreement for the
respective periods set forth therein.
14. Waiver. No
waiver of any term, condition or covenant of this Agreement shall be deemed to
be a waiver of subsequent breaches of the same or other terms, covenants or
conditions hereof.
15. Amendment. This
Agreement may not be amended, altered or modified except by a written agreement
between the parties hereto.
16. Assignability. Employee
may not assign this Agreement to any third party for whatever purpose without
the express written consent of the Company, other than as specifically
authorized herein. The Company may not assign this Agreement to any
third party without the express written consent of Employee except by operation
of law, or through merger, liquidation, recapitalization or sale of all or
substantially all of the assets of the Company, provided that the Company may
assign this Agreement at any time to an Affiliate of the Company.
17. Invalidity. In
the event part or any portion of this Agreement is determined in a legally
binding manner to be invalid and unenforceable, the parties agree that this
Agreement as so construed shall remain in force and effect between them and
applied as if the offending part or portion did not comprise an element
hereof.
18. Severability. If
any particular provision of this Agreement shall be determined to be invalid or
unenforceable, the parties expressly authorize the court or other tribunal
making such a determination to edit the invalid or unenforceable provision to
allow this Agreement, and the provisions thereof, to be valid and enforceable to
the fullest extent allowed by applicable law.
19. Entire
Agreement. This Agreement contains the entire agreement of the
parties relative to the subject matter of this Agreement and there is no
provision, condition or understanding relative to the employment of Employee
outside this Agreement.
20. Notices. Any
notice required to be given hereunder shall be duly and properly given,
effective as of the date of mailing, if mailed postage prepaid to either party
at the addresses set forth below, or to such other address as such party may
subsequently notify to the other.
If
to Employee:
|
Shu-Chih
Chen, PhD
|
|
4105
E. Madison Street, Suite 320
|
|
Seattle,
WA 98112
|
|
|
If
to Company:
|
Atossa
Genetics, Inc.
|
|
Attn: President
|
|
4105
E. Madison Street, Suite 320
|
|
Seattle,
WA 98112
|
21. Governing
Law. This Agreement shall be governed by and construed under
the internal laws of the State of Washington, without regard to the principles
of comity and/or the applicable conflicts of laws of any state that would result
in the application of any laws other than the State of
Washington.
22. Jurisdiction &
Arbitration. The validity, performance and interpretation of
the Agreement shall be governed by the laws of the State Washington, without
regard to its conflicts of law rules. Any dispute or claim arising under or with
respect to this Agreement, which is incapable of resolution, will be resolved by
arbitration before one (1) arbitrator in Seattle, Washington, in accordance with
the Rules for Commercial Arbitration of the American Arbitration Association
("AAA"). The
appointing agency shall be the AAA and the arbitrator shall apply Washington
State law to both interpret this Agreement and fashion an award.
23. Tax
Matters.
(a) The
parties intend that this Agreement be administered in accordance with Section
409A of the Code. To the extent that any provision of this Agreement
is ambiguous as to its compliance with, or exemption from, Section 409A of the
Code, the provision will be read in such a manner so that all payments hereunder
either comply with, or are exempt from, Section 409A of the Code. The
Parties agree that this Agreement may be amended as reasonably requested by
either Party, and as may be necessary to fully comply with Section 409A of the
Code and all related rules and regulations in order to preserve the payments and
benefits provided hereunder without additional cost to either
party. The Company makes no representation or warranty and will have
no liability to Employee or any other person if any provisions of this Agreement
are determined to constitute deferred compensation subject to Section 409A of
the Code but do not satisfy an exemption from, or the conditions of, such
Section.
(b) Anything
in this Agreement to the contrary notwithstanding, if at the time of Employee’s
“separation from service” within the meaning of Section 409A of the Code, the
Company determines that Employee is a “specified employee” within the meaning of
Section 409A(a)(2)(B)(i) of the Code, then to the extent any payment or benefit
that Employee becomes entitled to under this Agreement on account of her
separation from service would be considered deferred compensation subject to the
20 percent additional tax imposed pursuant to Section 409A(a) of the Code as a
result of the application of Section 409A(a)(2)(B)(i) of the Code, such payment
shall not be payable and such benefit shall not be provided until the date that
is the earlier of (A) six months and one day after Employee’s separation from
service or (B) Employee’s death. If any such delayed cash payment is
otherwise payable on an installment basis, the first payment shall include a
catch-up payment covering amounts that would otherwise have been paid during the
six-month period but for the application of this provision, and the balance of
the installments will be payable in accordance with their original
schedule.
(c) To
the extent that any payment or benefit described in this Agreement constitutes
“non-qualified deferred compensation” under Section 409A of the Code, and to the
extent that such payment or benefit is payable upon Employee’s termination of
employment, then such payments or benefits shall be payable only upon Employee’s
“separation from service.” The determination of whether and when a
separation from service has occurred shall be made in accordance with the
presumptions set forth in Treasury Regulation Section 1.409A
1(h).
(d) All
in-kind benefits provided and expenses eligible for reimbursement under this
Agreement shall be provided by the Company or incurred by Employee during the
time periods set forth in this Agreement. All reimbursements shall be
paid as soon as administratively practicable, but in no event shall any
reimbursement be paid after the last day of the taxable year following the
taxable year in which the expense was incurred. The amount of in-kind
benefits provided or reimbursable expenses incurred in one taxable year shall
not affect the in-kind benefits to be provided or the expenses eligible for
reimbursement in any other taxable year. Such right to reimbursement
or in-kind benefits is not subject to liquidation or exchange for another
benefit.
24. Counterparts and Electronic
Signatures. This Agreement may be executed in two or more
counterparts and by facsimile or any electronic means, each of which shall be
deemed an original but all of which together shall constitute one and the same
Agreement.
[SIGNATURE
PAGE FOLLOWS]
IN
WITNESS WHEREOF, the parties have executed this Agreement as of September 27,
2010.
COMPANY:
|
|
EMPLOYEE:
|
|
|
|
Atossa
Genetics, Inc.
|
|
|
|
|
|
By:
|
/s/ John Barnhart
|
|
By:
|
/s/ Shu-Chih Chen
|
|
John
Barnhart
|
|
|
Shu-Chih
Chen, Ph.D.
|
|
Director,
Board of Directors
|
|
|
|
[SIGNATURE
PAGE TO EMPLOYMENT AGREEMENT]
ATOSSA
GENETICS INC.
2010
STOCK OPTION AND INCENTIVE PLAN
SECTION
1.
|
GENERAL PURPOSE OF THE
PLAN; DEFINITIONS
|
The name
of the plan is the Atossa Genetics Inc. 2010 Stock Option and Incentive Plan
(the “Plan”). The purpose of the Plan is to encourage and enable the
officers, employees, Non-Employee Directors and other key persons (including
Consultants and prospective employees) of Atossa Genetics Inc. (the “Company”)
and its Subsidiaries upon whose judgment, initiative and efforts the Company
largely depends for the successful conduct of its business to acquire a
proprietary interest in the Company. It is anticipated that providing such
persons with a direct stake in the Company’s welfare will assure a closer
identification of their interests with those of the Company and its
stockholders, thereby stimulating their efforts on the Company’s behalf and
strengthening their desire to remain with the Company.
The
following terms shall be defined as set forth below:
“Act” means the Securities
Act of 1933, as amended, and the rules and regulations thereunder.
“Administrator” means either
the Board or the compensation committee of the Board or a similar committee
performing the functions of the compensation committee and which is comprised of
not less than two Non-Employee Directors who are independent.
“Award” or “Awards,” except where
referring to a particular category of grant under the Plan, shall include
Incentive Stock Options, Non-Qualified Stock Options, Stock Appreciation Rights,
Restricted Stock Units, Restricted Stock Awards, Unrestricted Stock Awards,
Cash-Based Awards, Performance Share Awards and Dividend Equivalent
Rights.
“Award Certificate” means a
written or electronic document setting forth the terms and provisions applicable
to an Award granted under the Plan. Each Award Certificate is subject to
the terms and conditions of the Plan.
“Board” means the Board of
Directors of the Company.
“Cash-Based Award” means an
Award entitling the recipient to receive a cash-denominated
payment.
“Code” means the Internal
Revenue Code of 1986, as amended, and any successor Code, and related rules,
regulations and interpretations.
“Consultant” means any
natural person that provides bona fide services to the Company, and such
services are not in connection with the offer or sale of securities in a
capital-raising transaction and do not directly or indirectly promote or
maintain a market for the Company’s securities.
“Covered Employee” means an
employee who is a “Covered Employee” within the meaning of Section 162(m)
of the Code.
“Dividend Equivalent Right”
means an Award entitling the grantee to receive credits based on cash dividends
that would have been paid on the shares of Stock specified in the Dividend
Equivalent Right (or other award to which it relates) if such shares had been
issued to and held by the grantee.
“Effective Date” means the
date on which the Plan is approved by stockholders as set forth in
Section 21.
“Exchange Act” means the
Securities Exchange Act of 1934, as amended, and the rules and regulations
thereunder.
“Fair Market Value” of the
Stock on any given date means the fair market value of the Stock determined in
good faith by the Administrator; provided, however, that if the Stock is
admitted to quotation on the National Association of Securities Dealers
Automated Quotation System (“NASDAQ”), NASDAQ Global Market or another national
securities exchange, the determination shall be made by reference to market
quotations. If there are no market quotations for such date, the
determination shall be made by reference to the last date preceding such date
for which there are market quotations; provided further, however, that if the
date for which Fair Market Value is determined is the first day when trading
prices for the Stock are reported on a national securities exchange, the Fair
Market Value shall be the “Price to the Public” (or equivalent) set forth on the
cover page for the final prospectus relating to the Company’s Initial Public
Offering.
“Incentive Stock Option”
means any Stock Option designated and qualified as an “incentive stock option”
as defined in Section 422 of the Code.
“Initial Public Offering”
means the consummation of the first fully underwritten, firm commitment public
offering pursuant to an effective registration statement under the Act covering
the offer and sale by the Company of its equity securities, or such other event
as a result of or following which the Stock shall be publicly held.
“Non-Employee Director” means
a member of the Board who is not also an employee of the Company or any
Subsidiary.
“Non-Qualified Stock Option”
means any Stock Option that is not an Incentive Stock Option.
“Option” or “Stock Option” means any
option to purchase shares of Stock granted pursuant to
Section 5.
“Performance-Based Award”
means any Restricted Stock Award, Restricted Stock Units, Performance Share
Award or Cash-Based Award granted to a Covered Employee that is intended to
qualify as “performance-based compensation” under Section 162(m) of the Code and
the regulations promulgated thereunder.
“Performance Criteria” means
the criteria that the Administrator selects for purposes of establishing the
Performance Goal or Performance Goals for an individual for a Performance
Cycle. The Performance Criteria (which shall be applicable to the
organizational level specified by the Administrator, including, but not limited
to, the Company or a unit, division, group, or Subsidiary of the Company) that
will be used to establish Performance Goals are limited to the
following: earnings before interest, taxes, depreciation and
amortization, net income (loss) (either before or after interest, taxes,
depreciation and/or amortization), changes in the market price of the Stock,
economic value-added, funds from operations or similar measure, sales or
revenue, acquisitions or strategic transactions, operating income (loss), cash
flow (including, but not limited to, operating cash flow and free cash flow),
return on capital, assets, equity, or investment, stockholder returns, return on
sales, gross or net profit levels, productivity, expense, margins, operating
efficiency, customer satisfaction, working capital, earnings (loss) per share of
Stock, sales or market shares and number of customers, any of which may be
measured either in absolute terms or as compared to any incremental increase or
as compared to results of a peer group.
“Performance Cycle” means one
or more periods of time, which may be of varying and overlapping durations, as
the Administrator may select, over which the attainment of one or more
Performance Criteria will be measured for the purpose of determining a grantee’s
right to and the payment of a Restricted Stock Award, Restricted Stock Units,
Performance Share Award or Cash-Based Award. Each such period shall not be
less than 12 months.
“Performance Goals” means,
for a Performance Cycle, the specific goals established in writing by the
Administrator for a Performance Cycle based upon the Performance
Criteria.
“Performance Share Award”
means an Award entitling the recipient to acquire shares of Stock upon the
attainment of specified Performance Goals.
“Restricted Stock Award”
means an Award entitling the recipient to acquire, at such purchase price (which
may be zero) as determined by the Administrator, shares of Stock subject to such
restrictions and conditions as the Administrator may determine at the time of
grant.
“Restricted Stock Units”
means an Award of phantom stock units to a grantee.
“Sale Event” shall mean (i)
the sale of all or substantially all of the assets of the Company on a
consolidated basis to an unrelated person or entity, (ii) a merger,
reorganization or consolidation pursuant to which the holders of the Company’s
outstanding voting power immediately prior to such transaction do not own a
majority of the outstanding voting power of the resulting or successor entity
(or its ultimate parent, if applicable) immediately upon completion of such
transaction, (iii) the sale of all of the Stock of the Company to an unrelated
person or entity, or (iv) any other transaction in which the owners of the
Company’s outstanding voting power prior to such transaction do not own at least
a majority of the outstanding voting power of the Company or any successor
entity immediately upon completion of the transaction other than as a result of
the acquisition of securities directly from the Company.
“Sale Price” means the value
as determined by the Administrator of the consideration payable, or otherwise to
be received by stockholders, per share of Stock pursuant to a Sale
Event.
“Section 409A” means Section
409A of the Code and the regulations and other guidance promulgated
thereunder.
“Stock” means the Common
Stock, par value $0.001 per share, of the Company, subject to adjustments
pursuant to Section 3.
“Stock Appreciation Right”
means an Award entitling the recipient to receive shares of Stock having a value
equal to the excess of the Fair Market Value of the Stock on the date of
exercise over the exercise price of the Stock Appreciation Right multiplied by
the number of shares of Stock with respect to which the Stock Appreciation Right
shall have been exercised.
“Subsidiary” means any
corporation or other entity (other than the Company) in which the Company has at
least a 50 percent interest, either directly or indirectly.
“Ten Percent Owner” means an
employee who owns or is deemed to own (by reason of the attribution rules of
Section 424(d) of the Code) more than 10 percent of the combined voting power of
all classes of stock of the Company or any parent or subsidiary
corporation.
“Unrestricted Stock Award”
means an Award of shares of Stock free of any restrictions.
SECTION
2.
|
ADMINISTRATION OF
PLAN; ADMINISTRATOR AUTHORITY TO SELECT GRANTEES AND DETERMINE
AWARDS
|
(a) Administration of
Plan. The Plan shall be administered by the
Administrator.
(b) Powers of
Administrator. The Administrator shall have the power and authority
to grant Awards consistent with the terms of the Plan, including the power and
authority:
(i) to
select the individuals to whom Awards may from time to time be
granted;
(ii) to
determine the time or times of grant, and the extent, if any, of Incentive Stock
Options, Non-Qualified Stock Options, Stock Appreciation Rights, Restricted
Stock Awards, Restricted Stock Units, Unrestricted Stock Awards, Cash-Based
Awards, Performance Share Awards and Dividend Equivalent Rights, or any
combination of the foregoing, granted to any one or more grantees;
(iii) to
determine the number of shares of Stock to be covered by any Award;
(iv) to
determine and modify from time to time the terms and conditions, including
restrictions, not inconsistent with the terms of the Plan, of any Award, which
terms and conditions may differ among individual Awards and grantees, and to
approve the forms of Award Certificates;
(v) to
accelerate at any time the exercisability or vesting of all or any portion of
any Award;
(vi) subject
to the provisions of Section 5(b), to extend at any time the period in
which Stock Options may be exercised; and
(vii) at
any time to adopt, alter and repeal such rules, guidelines and practices for
administration of the Plan and for its own acts and proceedings as it shall deem
advisable; to interpret the terms and provisions of the Plan and any Award
(including related written instruments); to make all determinations it deems
advisable for the administration of the Plan; to decide all disputes arising in
connection with the Plan; and to otherwise supervise the administration of the
Plan.
All
decisions and interpretations of the Administrator shall be binding on all
persons, including the Company and Plan grantees.
(c) Award
Certificate. Awards under the Plan shall be evidenced by Award
Certificates that set forth the terms, conditions and limitations for each Award
which may include, without limitation, the term of an Award and the provisions
applicable in the event employment or service terminates.
(d) Indemnification.
Neither the Board nor the Administrator, nor any member of either or any
delegate thereof, shall be liable for any act, omission, interpretation,
construction or determination made in good faith in connection with the Plan,
and the members of the Board and the Administrator (and any delegate thereof)
shall be entitled in all cases to indemnification and reimbursement by the
Company in respect of any claim, loss, damage or expense (including, without
limitation, reasonable attorneys’ fees) arising or resulting therefrom to the
fullest extent permitted by law and/or under the Company’s articles or bylaws or
any directors’ and officers’ liability insurance coverage which may be in effect
from time to time and/or any indemnification agreement between such individual
and the Company.
(e) Foreign Award
Recipients. Notwithstanding any provision of the Plan to the
contrary, in order to comply with the laws in other countries in which the
Company and its Subsidiaries operate or have employees or other individuals
eligible for Awards, the Administrator, in its sole discretion, shall have the
power and authority to: (i) determine which Subsidiaries shall be
covered by the Plan; (ii) determine which individuals outside the United States
are eligible to participate in the Plan; (iii) modify the terms and conditions
of any Award granted to individuals outside the United States to comply with
applicable foreign laws; (iv) establish subplans and modify exercise procedures
and other terms and procedures, to the extent the Administrator determines such
actions to be necessary or advisable (and such subplans and/or modifications
shall be attached to this Plan as appendices); provided, however, that no such
subplans and/or modifications shall increase the share limitations contained in
Section 3(a) hereof; and (v) take any action, before or after an Award is made, that
the Administrator determines to be necessary or advisable to obtain approval or
comply with any local governmental regulatory exemptions or approvals.
Notwithstanding the foregoing, the Administrator may not take any actions
hereunder, and no Awards shall be granted, that would violate the Exchange Act
or any other applicable United States securities law, the Code, or any other
applicable United States governing statute or law.
SECTION
3.
|
STOCK ISSUABLE UNDER
THE PLAN; MERGERS;
SUBSTITUTION
|
(a) Stock Issuable.
The maximum number of shares of Stock reserved and available for issuance under
the Plan shall be 2,263,320 shares (the “Initial Limit”), subject to adjustment
as provided in Section 3(b), plus on January 1, 2012 and each January 1
thereafter, the number of shares of Stock reserved and available for issuance
under the Plan shall be cumulatively increased by 4 percent (4%) of the number
of shares of Stock issued and outstanding on the immediately preceding December
31 (the “Annual Increase”). Subject to such overall limitation, the
maximum aggregate number of shares of Stock that may be issued in the form of
Incentive Stock Options shall not exceed the Initial Limit cumulatively
increased on January 1, 2012 and on each January 1 thereafter by the lesser of
the Annual Increase for such year or 50% of the Initial Limit, subject in all
cases to adjustment as provided in Section 3(b). For purposes of this
limitation, the shares of Stock underlying any Awards that are forfeited,
canceled, held back upon exercise of an Option or settlement of an Award to
cover the exercise price or tax withholding, reacquired by the Company prior to
vesting, satisfied without the issuance of Stock or otherwise terminated (other
than by exercise) shall be added back to the shares of Stock available for
issuance under the Plan. In the event the Company repurchases shares of
Stock on the open market, such shares shall not be added to the shares of Stock
available for issuance under the Plan. Subject to such overall
limitations, shares of Stock may be issued up to such maximum number pursuant to
any type or types of Award; provided, however, that Stock Options or Stock
Appreciation Rights with respect to no more than 50% of the Initial Limit may be
granted to any one individual grantee during any one calendar year period.
The shares available for issuance under the Plan may be authorized but unissued
shares of Stock or shares of Stock reacquired by the Company.
(b) Changes in
Stock. Subject to Section 3(c) hereof, if, as a result of any
reorganization, recapitalization, reclassification, stock dividend, stock split,
reverse stock split or other similar change in the Company’s capital stock, the
outstanding shares of Stock are increased or decreased or are exchanged for a
different number or kind of shares or other securities of the Company, or
additional shares or new or different shares or other securities of the Company
or other non-cash assets are distributed with respect to such shares of Stock or
other securities, or, if, as a result of any merger or consolidation, sale of
all or substantially all of the assets of the Company, the outstanding shares of
Stock are converted into or exchanged for securities of the Company or any
successor entity (or a parent or subsidiary thereof), the Administrator shall
make an appropriate or proportionate adjustment in (i) the maximum number of
shares reserved for issuance under the Plan, including the maximum number of
shares that may be issued in the form of Incentive Stock Options, (ii) the
number of Stock Options or Stock Appreciation Rights that can be granted to any
one individual grantee and the maximum number of shares that may be granted
under a Performance-Based Award, (iii) the number and kind of shares or other
securities subject to any then outstanding Awards under the Plan, (iv) the
repurchase price, if any, per share subject to each outstanding Restricted Stock
Award, and (v) the exercise price for each share subject to any then
outstanding Stock Options and Stock Appreciation Rights under the Plan, without
changing the aggregate exercise price (i.e., the exercise price multiplied by
the number of Stock Options and Stock Appreciation Rights) as to which such
Stock Options and Stock Appreciation Rights remain exercisable. The
Administrator shall also make equitable or proportionate adjustments in the
number of shares subject to outstanding Awards and the exercise price and the
terms of outstanding Awards to take into consideration cash dividends paid other
than in the ordinary course or any other extraordinary corporate event.
The adjustment by the Administrator shall be final, binding and
conclusive. No fractional shares of Stock shall be issued under the Plan
resulting from any such adjustment, but the Administrator in its discretion may
make a cash payment in lieu of fractional shares.
(c) Mergers and Other
Transactions. Except as the Administrator may otherwise specify
with respect to particular Awards in the relevant Award Certificate, in the case
of and subject to the consummation of a Sale Event, the Plan and all outstanding
Awards granted hereunder shall terminate, unless provision is made in connection
with the Sale Event in the sole discretion of the parties thereto for the
assumption or continuation of Awards theretofore granted by the successor
entity, or the substitution of such Awards with new Awards of the successor
entity or parent thereof, with appropriate adjustment as to the number and kind
of shares and, if appropriate, the per share exercise prices, as such parties
shall agree (after taking into account any acceleration hereunder). In the
event of such termination, (i) the Company shall have the option (in its sole
discretion) to make or provide for a cash payment to the grantees holding
Options and Stock Appreciation Rights, in exchange for the cancellation thereof,
in an amount equal to the difference between (A) the Sale Price multiplied by
the number of shares of Stock subject to outstanding Options and Stock
Appreciation Rights (to the extent then exercisable (after taking into account
any acceleration hereunder) at prices not in excess of the Sale Price) and (B)
the aggregate exercise price of all such outstanding Options and Stock
Appreciation Rights; or (ii) each grantee shall be permitted, within a specified
period of time prior to the consummation of the Sale Event as determined by the
Administrator, to exercise all outstanding Options and Stock Appreciation Rights
held by such grantee. The Administrator shall also have the discretion to
accelerate the vesting of all other Awards.
(d) Substitute
Awards. The Administrator may grant Awards under the Plan in
substitution for stock and stock based awards held by employees, directors or
other key persons of another corporation in connection with the merger or
consolidation of the employing corporation with the Company or a Subsidiary or
the acquisition by the Company or a Subsidiary of property or stock of the
employing corporation. The Administrator may direct that the substitute
awards be granted on such terms and conditions as the Administrator considers
appropriate in the circumstances. Any substitute Awards granted under the
Plan shall not count against the share limitation set forth in
Section 3(a).
Grantees
under the Plan will be such full or part-time officers and other employees,
Non-Employee Directors and key persons (including Consultants and prospective
employees) of the Company and its Subsidiaries as are selected from time to time
by the Administrator in its sole discretion.
Any Stock
Option granted under the Plan shall be in such form as the Administrator may
from time to time approve.
Stock
Options granted under the Plan may be either Incentive Stock Options or
Non-Qualified Stock Options. Incentive Stock Options may be granted only
to employees of the Company or any Subsidiary that is a “subsidiary corporation”
within the meaning of Section 424(f) of the Code. To the extent that
any Option does not qualify as an Incentive Stock Option, it shall be deemed a
Non-Qualified Stock Option.
Stock
Options granted pursuant to this Section 5 shall be subject to the
following terms and conditions and shall contain such additional terms and
conditions, not inconsistent with the terms of the Plan, as the Administrator
shall deem desirable. If the Administrator so determines, Stock Options
may be granted in lieu of cash compensation at the optionee’s election, subject
to such terms and conditions as the Administrator may establish.
(a) Exercise Price.
The exercise price per share for the Stock covered by a Stock Option granted
pursuant to this Section 5 shall be determined by the Administrator at the
time of grant but shall not be less than 100 percent of the Fair Market Value on
the date of grant. In the case of an Incentive Stock Option that is
granted to a Ten Percent Owner, the option price of such Incentive Stock Option
shall be not less than 110 percent of the Fair Market Value on the grant
date.
(b) Option Term.
The term of each Stock Option shall be fixed by the Administrator, but no Stock
Option shall be exercisable more than ten years after the date the Stock Option
is granted. In the case of an Incentive Stock Option that is granted to a
Ten Percent Owner, the term of such Stock Option shall be no more than five
years from the date of grant.
(c) Exercisability; Rights of a
Stockholder. Stock Options shall become exercisable at such time or
times, whether or not in installments, as shall be determined by the
Administrator at or after the grant date. The Administrator may at any
time accelerate the exercisability of all or any portion of any Stock
Option. An optionee shall have the rights of a stockholder only as to
shares acquired upon the exercise of a Stock Option and not as to unexercised
Stock Options.
(d) Method of
Exercise. Stock Options may be exercised in whole or in part, by
giving written or electronic notice of exercise to the Company, specifying the
number of shares to be purchased. Payment of the purchase price may be
made by one or more of the following methods to the extent provided in the
Option Award Certificate:
(i) In
cash, by certified or bank check or other instrument acceptable to the
Administrator;
(ii) Through
the delivery (or attestation to the ownership) of shares of Stock that have been
purchased by the optionee on the open market or that have been beneficially
owned by the optionee for at least six months and that are not then subject to
restrictions under any Company plan. Such surrendered shares shall be
valued at Fair Market Value on the exercise date;
(iii) By
the optionee delivering to the Company a properly executed exercise notice
together with irrevocable instructions to a broker to promptly deliver to the
Company cash or a check payable and acceptable to the Company for the purchase
price; provided that in the event the optionee chooses to pay the purchase price
as so provided, the optionee and the broker shall comply with such procedures
and enter into such agreements of indemnity and other agreements as the
Administrator shall prescribe as a condition of such payment procedure;
or
(iv) With
respect to Stock Options that are not Incentive Stock Options, by a “net
exercise” arrangement pursuant to which the Company will reduce the number of
shares of Stock issuable upon exercise by the largest whole number of shares
with a Fair Market Value that does not exceed the aggregate exercise
price.
Payment
instruments will be received subject to collection. The transfer to the
optionee on the records of the Company or of the transfer agent of the shares of
Stock to be purchased pursuant to the exercise of a Stock Option will be
contingent upon receipt from the optionee (or a purchaser acting in his stead in
accordance with the provisions of the Stock Option) by the Company of the full
purchase price for such shares and the fulfillment of any other requirements
contained in the Option Award Certificate or applicable provisions of laws
(including the satisfaction of any withholding taxes that the Company is
obligated to withhold with respect to the optionee). In the event an
optionee chooses to pay the purchase price by previously-owned shares of Stock
through the attestation method, the number of shares of Stock transferred to the
optionee upon the exercise of the Stock Option shall be net of the number of
attested shares. In the event that the Company establishes, for itself or
using the services of a third party, an automated system for the exercise of
Stock Options, such as a system using an internet website or interactive voice
response, then the paperless exercise of Stock Options may be permitted through
the use of such an automated system.
(e) Annual Limit on Incentive
Stock Options. To the extent required for “incentive stock option”
treatment under Section 422 of the Code, the aggregate Fair Market Value
(determined as of the time of grant) of the shares of Stock with respect to
which Incentive Stock Options granted under this Plan and any other plan of the
Company or its parent and subsidiary corporations become exercisable for the
first time by an optionee during any calendar year shall not exceed
$100,000. To the extent that any Stock Option exceeds this limit, it shall
constitute a Non-Qualified Stock Option.
SECTION
6.
|
STOCK APPRECIATION
RIGHTS
|
(a) Exercise Price of Stock
Appreciation Rights. The exercise price of a Stock Appreciation
Right shall not be less than 100 percent of the Fair Market Value of the Stock
on the date of grant.
(b) Grant and Exercise of Stock
Appreciation Rights. Stock Appreciation Rights may be granted by
the Administrator independently of any Stock Option granted pursuant to
Section 5 of the Plan.
(c) Terms and Conditions of
Stock Appreciation Rights. Stock Appreciation Rights shall be
subject to such terms and conditions as shall be determined from time to time by
the Administrator. The term of a Stock Appreciation Right may not exceed
ten years.
SECTION
7.
|
RESTRICTED STOCK
AWARDS
|
(a) Nature of Restricted Stock
Awards. The Administrator shall determine the restrictions and
conditions applicable to each Restricted Stock Award at the time of grant.
Conditions may be based on continuing employment (or other service relationship)
and/or achievement of pre-established performance goals and objectives.
The terms and conditions of each such Award Certificate shall be determined by
the Administrator, and such terms and conditions may differ among individual
Awards and grantees.
(b) Rights as a
Stockholder. Upon the grant of the Restricted Stock Award and
payment of any applicable purchase price, a grantee shall have the rights of a
stockholder with respect to the voting of the Restricted Stock, subject to such
conditions contained in the Restricted Stock Award Certificate. Unless the
Administrator shall otherwise determine, (i) uncertificated Restricted Stock
shall be accompanied by a notation on the records of the Company or the transfer
agent to the effect that they are subject to forfeiture until such Restricted
Stock are vested as provided in Section 7(d) below, and (ii) certificated
Restricted Stock shall remain in the possession of the Company until such
Restricted Stock is vested as provided in Section 7(d) below, and the
grantee shall be required, as a condition of the grant, to deliver to the
Company such instruments of transfer as the Administrator may
prescribe.
(c) Restrictions.
Restricted Stock may not be sold, assigned, transferred, pledged or otherwise
encumbered or disposed of except as specifically provided herein or in the
Restricted Stock Award Certificate. Except as may otherwise be provided by
the Administrator either in the Award Certificate or, subject to Section 18
below, in writing after the Award is issued, if a grantee’s employment (or other
service relationship) with the Company and its Subsidiaries terminates for any
reason, any Restricted Stock that has not vested at the time of termination
shall automatically and without any requirement of notice to such grantee from
or other action by or on behalf of, the Company be deemed to have been
reacquired by the Company at its original purchase price (if any) from such
grantee or such grantee’s legal representative simultaneously with such
termination of employment (or other service relationship), and thereafter shall
cease to represent any ownership of the Company by the grantee or rights of the
grantee as a stockholder. Following such deemed reacquisition of unvested
Restricted Stock that are represented by physical certificates, a grantee shall
surrender such certificates to the Company upon request without
consideration.
(d) Vesting of Restricted
Stock. The Administrator at the time of grant shall specify the
date or dates and/or the attainment of pre-established performance goals,
objectives and other conditions on which the non-transferability of the
Restricted Stock and the Company’s right of repurchase or forfeiture shall
lapse. Subsequent to such date or dates and/or the attainment of such
pre-established performance goals, objectives and other conditions, the shares
on which all restrictions have lapsed shall no longer be Restricted Stock and
shall be deemed “vested.” Except as may otherwise be provided by the
Administrator either in the Award Certificate or, subject to Section 18
below, in writing after the Award is issued, a grantee’s rights in any shares of
Restricted Stock that have not vested shall automatically terminate upon the
grantee’s termination of employment (or other service relationship) with the
Company and its Subsidiaries and such shares shall be subject to the provisions
of Section 7(c) above.
SECTION
8.
|
RESTRICTED STOCK
UNITS
|
(a) Nature of Restricted Stock
Units. The Administrator shall determine the restrictions and
conditions applicable to each Restricted Stock Unit at the time of grant.
Conditions may be based on continuing employment (or other service relationship)
and/or achievement of pre-established performance goals and objectives.
The terms and conditions of each such Award Certificate shall be determined by
the Administrator, and such terms and conditions may differ among individual
Awards and grantees. At the end of the deferral period, the Restricted
Stock Units, to the extent vested, shall be settled in the form of shares of
Stock. To the extent that an award of Restricted Stock Units is subject to
Section 409A, it may contain such additional terms and conditions as the
Administrator shall determine in its sole discretion in order for such Award to
comply with the requirements of Section 409A.
(b) Election to Receive
Restricted Stock Units in Lieu of Compensation. The Administrator
may, in its sole discretion, permit a grantee to elect to receive a portion of
future cash compensation otherwise due to such grantee in the form of an award
of Restricted Stock Units. Any such election shall be made in writing and
shall be delivered to the Company no later than the date specified by the
Administrator and in accordance with Section 409A and such other rules and
procedures established by the Administrator. Any such future cash
compensation that the grantee elects to defer shall be converted to a fixed
number of Restricted Stock Units based on the Fair Market Value of Stock on the
date the compensation would otherwise have been paid to the grantee if such
payment had not been deferred as provided herein. The Administrator shall
have the sole right to determine whether and under what circumstances to permit
such elections and to impose such limitations and other terms and conditions
thereon as the Administrator deems appropriate. Any Restricted Stock Units
that are elected to be received in lieu of cash compensation shall be fully
vested, unless otherwise provided in the Award Certificate.
(c) Rights as a
Stockholder. A grantee shall have the rights as a stockholder only
as to shares of Stock acquired by the grantee upon settlement of Restricted
Stock Units; provided, however, that the grantee may be credited with Dividend
Equivalent Rights with respect to the phantom stock units underlying his
Restricted Stock Units, subject to such terms and conditions as the
Administrator may determine.
(d) Termination.
Except as may otherwise be provided by the Administrator either in the Award
Certificate or, subject to Section 18 below, in writing after the Award is
issued, a grantee’s right in all Restricted Stock Units that have not vested
shall automatically terminate upon the grantee’s termination of employment (or
cessation of service relationship) with the Company and its Subsidiaries for any
reason.
SECTION
9.
|
UNRESTRICTED STOCK
AWARDS
|
Grant or Sale of
Unrestricted Stock. The Administrator may, in its sole discretion,
grant (or sell at par value or such higher purchase price determined by the
Administrator) an Unrestricted Stock Award under the Plan. Unrestricted
Stock Awards may be granted in respect of past services or other valid
consideration, or in lieu of cash compensation due to such
grantee.
SECTION
10.
|
CASH-BASED
AWARDS
|
Grant of Cash-Based
Awards. The Administrator may, in its sole discretion, grant
Cash-Based Awards to any grantee in such number or amount and upon such terms,
and subject to such conditions, as the Administrator shall determine at the time
of grant. The Administrator shall determine the maximum duration of the
Cash-Based Award, the amount of cash to which the Cash-Based Award pertains, the
conditions upon which the Cash-Based Award shall become vested or payable, and
such other provisions as the Administrator shall determine. Each
Cash-Based Award shall specify a cash-denominated payment amount, formula or
payment ranges as determined by the Administrator. Payment, if any, with
respect to a Cash-Based Award shall be made in accordance with the terms of the
Award and may be made in cash or in shares of Stock, as the Administrator
determines.
SECTION
11.
|
PERFORMANCE SHARE
AWARDS
|
(a) Nature of Performance Share
Awards. The Administrator may, in its sole discretion, grant
Performance Share Awards independent of, or in connection with, the granting of
any other Award under the Plan. The Administrator shall determine whether
and to whom Performance Share Awards shall be granted, the Performance Goals,
the periods during which performance is to be measured, and such other
limitations and conditions as the Administrator shall determine.
(b) Rights as a
Stockholder. A grantee receiving a Performance Share Award shall
have the rights of a stockholder only as to shares actually received by the
grantee under the Plan and not with respect to shares subject to the Award but
not actually received by the grantee. A grantee shall be entitled to
receive shares of Stock under a Performance Share Award only upon satisfaction
of all conditions specified in the Performance Share Award Certificate (or in a
performance plan adopted by the Administrator).
(c) Termination.
Except as may otherwise be provided by the Administrator either in the Award
agreement or, subject to Section 18 below, in writing after the Award is
issued, a grantee’s rights in all Performance Share Awards shall automatically
terminate upon the grantee’s termination of employment (or cessation of service
relationship) with the Company and its Subsidiaries for any reason.
SECTION
12.
|
PERFORMANCE-BASED
AWARDS TO COVERED EMPLOYEES
|
(a) Performance-Based
Awards. Any employee or other key person providing services to the
Company and who is selected by the Administrator may be granted one or more
Performance-Based Awards in the form of a Restricted Stock Award, Restricted
Stock Units, Performance Share Awards or Cash-Based Award payable upon the
attainment of Performance Goals that are established by the Administrator and
relate to one or more of the Performance Criteria, in each case on a specified
date or dates or over any period or periods determined by the
Administrator. The Administrator shall define in an objective fashion the
manner of calculating the Performance Criteria it selects to use for any
Performance Cycle. Depending on the Performance Criteria used to establish
such Performance Goals, the Performance Goals may be expressed in terms of
overall Company performance or the performance of a division, business unit, or
an individual. The Administrator, in its discretion, may adjust or modify
the calculation of Performance Goals for such Performance Cycle in order to
prevent the dilution or enlargement of the rights of an individual (i) in the
event of, or in anticipation of, any unusual or extraordinary corporate item,
transaction, event or development, (ii) in recognition of, or in anticipation
of, any other unusual or nonrecurring events affecting the Company, or the
financial statements of the Company, or (iii) in response to, or in anticipation
of, changes in applicable laws, regulations, accounting principles, or business
conditions provided however, that the Administrator may not exercise such
discretion in a manner that would increase the Performance-Based Award granted
to a Covered Employee. Each Performance-Based Award shall comply with the
provisions set forth below.
(b) Grant of Performance-Based
Awards. With respect to each Performance-Based Award granted to a
Covered Employee, the Administrator shall select, within the first 90 days of a
Performance Cycle (or, if shorter, within the maximum period allowed under
Section 162(m) of the Code) the Performance Criteria for such grant, and
the Performance Goals with respect to each Performance Criterion (including a
threshold level of performance below which no amount will become payable with
respect to such Award). Each Performance-Based Award will specify the
amount payable, or the formula for determining the amount payable, upon
achievement of the various applicable performance targets. The Performance
Criteria established by the Administrator may be (but need not be) different for
each Performance Cycle and different Performance Goals may be applicable to
Performance-Based Awards to different Covered Employees.
(c) Payment of Performance-Based
Awards. Following the completion of a Performance Cycle, the
Administrator shall meet to review and certify in writing whether, and to what
extent, the Performance Goals for the Performance Cycle have been achieved and,
if so, to also calculate and certify in writing the amount of the
Performance-Based Awards earned for the Performance Cycle. The
Administrator shall then determine the actual size of each Covered Employee’s
Performance-Based Award, and, in doing so, may reduce or eliminate the amount of
the Performance-Based Award for a Covered Employee if, in its sole judgment,
such reduction or elimination is appropriate.
(d) Maximum Award
Payable. The maximum Performance-Based Award payable to any one
Covered Employee under the Plan for a Performance Cycle is up to 50% of the
Initial Limit (subject to adjustment as provided in Section 3(b) hereof) or
$500,000 in the case of a Performance-Based Award that is a Cash-Based
Award.
SECTION
13.
|
DIVIDEND EQUIVALENT
RIGHTS
|
(a) Dividend Equivalent
Rights. A Dividend Equivalent Right may be granted hereunder to any
grantee as a component of an award of Restricted Stock Units, Restricted Stock
Award or Performance Share Award or as a freestanding award. The terms and
conditions of Dividend Equivalent Rights shall be specified in the Award
Certificate. Dividend equivalents credited to the holder of a Dividend
Equivalent Right may be paid currently or may be deemed to be reinvested in
additional shares of Stock, which may thereafter accrue additional
equivalents. Any such reinvestment shall be at Fair Market Value on the
date of reinvestment or such other price as may then apply under a dividend
reinvestment plan sponsored by the Company, if any. Dividend Equivalent
Rights may be settled in cash or shares of Stock or a combination thereof, in a
single installment or installments. A Dividend Equivalent Right granted as
a component of an award of Restricted Stock Units, Restricted Stock Award or
Performance Share Award may provide that such Dividend Equivalent Right shall be
settled upon settlement or payment of, or lapse of restrictions on, such other
Award, and that such Dividend Equivalent Right shall expire or be forfeited or
annulled under the same conditions as such other Award. A Dividend
Equivalent Right granted as a component of a Restricted Stock Units, Restricted
Stock Award or Performance Share Award may also contain terms and conditions
different from such other Award.
(b) Interest
Equivalents. Any Award under this Plan that is settled in whole or
in part in cash on a deferred basis may provide in the grant for interest
equivalents to be credited with respect to such cash payment. Interest
equivalents may be compounded and shall be paid upon such terms and conditions
as may be specified by the grant.
(c) Termination.
Except as may otherwise be provided by the Administrator either in the Award
Certificate or, subject to Section 18 below, in writing after the Award is
issued, a grantee’s rights in all Dividend Equivalent Rights or interest
equivalents granted as a component of an award of Restricted Stock Units,
Restricted Stock Award or Performance Share Award that has not vested shall
automatically terminate upon the grantee’s termination of employment (or
cessation of service relationship) with the Company and its Subsidiaries for any
reason.
SECTION
14.
|
TRANSFERABILITY OF
AWARDS
|
(a) Transferability.
Except as provided in Section 14(b) below, during a grantee’s lifetime, his
or her Awards shall be exercisable only by the grantee, or by the grantee’s
legal representative or guardian in the event of the grantee’s incapacity.
No Awards shall be sold, assigned, transferred or otherwise encumbered or
disposed of by a grantee other than by will or by the laws of descent and
distribution or pursuant to a domestic relations order. No Awards shall be
subject, in whole or in part, to attachment, execution, or levy of any kind, and
any purported transfer in violation hereof shall be null and void.
(b) Administrator
Action. Notwithstanding Section 14(a), the Administrator, in
its discretion, may provide either in the Award Certificate regarding a given
Award or by subsequent written approval that the grantee (who is an employee or
director) may transfer his or her Awards (other than any Incentive Stock Options
or Restricted Stock Units) to his or her immediate family members, to trusts for
the benefit of such family members, or to partnerships in which such family
members are the only partners, provided that the transferee agrees in writing
with the Company to be bound by all of the terms and conditions of this Plan and
the applicable Award. In no event may an Award be transferred by a grantee
for value.
(c) Family Member.
For purposes of Section 14(b), “family member” shall mean a grantee’s
child, stepchild, grandchild, parent, stepparent, grandparent, spouse, former
spouse, sibling, niece, nephew, mother-in-law, father-in-law, son-in-law,
daughter-in-law, brother-in-law, or sister-in-law, including adoptive
relationships, any person sharing the grantee’s household (other than a tenant
of the grantee), a trust in which these persons (or the grantee) have more than
50 percent of the beneficial interest, a foundation in which these persons (or
the grantee) control the management of assets, and any other entity in which
these persons (or the grantee) own more than 50 percent of the voting
interests.
(d) Designation of
Beneficiary. Each grantee to whom an Award has been made under the
Plan may designate a beneficiary or beneficiaries to exercise any Award or
receive any payment under any Award payable on or after the grantee’s
death. Any such designation shall be on a form provided for that purpose
by the Administrator and shall not be effective until received by the
Administrator. If no beneficiary has been designated by a deceased
grantee, or if the designated beneficiaries have predeceased the grantee, the
beneficiary shall be the grantee’s estate.
SECTION
15.
|
TAX
WITHHOLDING
|
(a) Payment by
Grantee. Each grantee shall, no later than the date as of which the
value of an Award or of any Stock or other amounts received thereunder first
becomes includable in the gross income of the grantee for Federal income tax
purposes, pay to the Company, or make arrangements satisfactory to the
Administrator regarding payment of, any Federal, state, or local taxes of any
kind required by law to be withheld by the Company with respect to such
income. The Company and its Subsidiaries shall, to the extent permitted by
law, have the right to deduct any such taxes from any payment of any kind
otherwise due to the grantee. The Company’s obligation to deliver evidence
of book entry (or stock certificates) to any grantee is subject to and
conditioned on tax withholding obligations being satisfied by the
grantee.
(b) Payment in
Stock. Subject to approval by the Administrator, a grantee may
elect to have the Company’s minimum required tax withholding obligation
satisfied, in whole or in part, by authorizing the Company to withhold from
shares of Stock to be issued pursuant to any Award a number of shares with an
aggregate Fair Market Value (as of the date the withholding is effected) that
would satisfy the withholding amount due.
SECTION
16.
|
SECTION 409A
AWARDS
|
To the
extent that any Award is determined to constitute “nonqualified deferred
compensation” within the meaning of Section 409A (a “409A Award”), the Award
shall be subject to such additional rules and requirements as specified by the
Administrator from time to time in order to comply with Section 409A. In
this regard, if any amount under a 409A Award is payable upon a “separation from
service” (within the meaning of Section 409A) to a grantee who is then
considered a “specified employee” (within the meaning of Section 409A), then no
such payment shall be made prior to the date that is the earlier of (i) six
months and one day after the grantee’s separation from service, or (ii) the
grantee’s death, but only to the extent such delay is necessary to prevent such
payment from being subject to interest, penalties and/or additional tax imposed
pursuant to Section 409A. Further, the settlement of any such Award may
not be accelerated except to the extent permitted by Section
409A.
SECTION
17.
|
TRANSFER, LEAVE OF
ABSENCE, ETC.
|
For
purposes of the Plan, the following events shall not be deemed a termination of
employment:
(a) a
transfer to the employment of the Company from a Subsidiary or from the Company
to a Subsidiary, or from one Subsidiary to another; or
(b) an
approved leave of absence for military service or sickness, or for any other
purpose approved by the Company, if the employee’s right to re-employment is
guaranteed either by a statute or by contract or under the policy pursuant to
which the leave of absence was granted or if the Administrator otherwise so
provides in writing.
SECTION
18.
|
AMENDMENTS AND
TERMINATION
|
The Board
may, at any time, amend or discontinue the Plan and the Administrator may, at
any time, amend or cancel any outstanding Award for the purpose of satisfying
changes in law or for any other lawful purpose, but no such action shall
adversely affect rights under any outstanding Award without the holder’s
consent. The Administrator is specifically authorized to exercise its
discretion to reduce the exercise price of outstanding Stock Options or Stock
Appreciation Rights or effect the repricing through cancellation and
re-grants. To the extent required under the rules of any securities
exchange or market system on which the Stock is listed, to the extent determined
by the Administrator to be required by the Code to ensure that Incentive Stock
Options granted under the Plan are qualified under Section 422 of the Code,
or to ensure that compensation earned under Awards qualifies as
performance-based compensation under Section 162(m) of the Code, Plan
amendments shall be subject to approval by the Company stockholders entitled to
vote at a meeting of stockholders. Nothing in this Section 18 shall
limit the Administrator’s authority to take any action permitted pursuant to
Section 3(b) or 3(c).
SECTION
19.
|
STATUS OF
PLAN
|
With
respect to the portion of any Award that has not been exercised and any payments
in cash, Stock or other consideration not received by a grantee, a grantee shall
have no rights greater than those of a general creditor of the Company unless
the Administrator shall otherwise expressly determine in connection with any
Award or Awards. In its sole discretion, the Administrator may authorize
the creation of trusts or other arrangements to meet the Company’s obligations
to deliver Stock or make payments with respect to Awards hereunder, provided
that the existence of such trusts or other arrangements is consistent with the
foregoing sentence.
SECTION
20.
|
GENERAL
PROVISIONS
|
(a) No
Distribution. The Administrator may require each person acquiring
Stock pursuant to an Award to represent to and agree with the Company in writing
that such person is acquiring the shares without a view to distribution
thereof.
(b) Delivery of Stock
Certificates. Stock certificates to grantees under this Plan shall
be deemed delivered for all purposes when the Company or a stock transfer agent
of the Company shall have mailed such certificates in the United States mail,
addressed to the grantee, at the grantee’s last known address on file with the
Company. Uncertificated Stock shall be deemed delivered for all purposes
when the Company or a Stock transfer agent of the Company shall have given to
the grantee by electronic mail (with proof of receipt) or by United States mail,
addressed to the grantee, at the grantee’s last known address on file with the
Company, notice of issuance and recorded the issuance in its records (which may
include electronic “book entry” records). Notwithstanding anything herein
to the contrary, the Company shall not be required to issue or deliver any
certificates evidencing shares of Stock pursuant to the exercise of any Award,
unless and until the Administrator has determined, with advice of counsel (to
the extent the Administrator deems such advice necessary or advisable), that the
issuance and delivery of such certificates is in compliance with all applicable
laws, regulations of governmental authorities and, if applicable, the
requirements of any exchange on which the shares of Stock are listed, quoted or
traded. All Stock certificates delivered pursuant to the Plan shall be
subject to any stop-transfer orders and other restrictions as the Administrator
deems necessary or advisable to comply with federal, state or foreign
jurisdiction, securities or other laws, rules and quotation system on which the
Stock is listed, quoted or traded. The Administrator may place legends on
any Stock certificate to reference restrictions applicable to the Stock.
In addition to the terms and conditions provided herein, the Administrator may
require that an individual make such reasonable covenants, agreements, and
representations as the Administrator, in its discretion, deems necessary or
advisable in order to comply with any such laws, regulations, or
requirements. The Administrator shall have the right to require any
individual to comply with any timing or other restrictions with respect to the
settlement or exercise of any Award, including a window-period limitation, as
may be imposed in the discretion of the Administrator.
(c) Stockholder
Rights. Until Stock is deemed delivered in accordance with Section
20(b), no right to vote or receive dividends or any other rights of a
stockholder will exist with respect to shares of Stock to be issued in
connection with an Award, notwithstanding the exercise of a Stock Option or any
other action by the grantee with respect to an Award.
(d) Other Compensation
Arrangements; No Employment Rights. Nothing contained in this Plan
shall prevent the Board from adopting other or additional compensation
arrangements, including trusts, and such arrangements may be either generally
applicable or applicable only in specific cases. The adoption of this Plan
and the grant of Awards do not confer upon any employee any right to continued
employment with the Company or any Subsidiary.
(e) Trading Policy
Restrictions. Option exercises and other Awards under the Plan
shall be subject to the Company’s insider trading policies and procedures, as in
effect from time to time.
(f)
Forfeiture of Awards
under Sarbanes-Oxley Act. If the Company is required to prepare an
accounting restatement due to the material noncompliance of the Company, as a
result of misconduct, with any financial reporting requirement under the
securities laws, then any grantee who is one of the individuals subject to
automatic forfeiture under Section 304 of the Sarbanes-Oxley Act of 2002 shall
reimburse the Company for the amount of any Award received by such individual
under the Plan during the 12-month period following the first public issuance or
filing with the United States Securities and Exchange Commission, as the case
may be, of the financial document embodying such financial reporting
requirement.
SECTION
21.
|
EFFECTIVE DATE OF
PLAN
|
This Plan
shall become effective upon stockholder approval in accordance with applicable
state law, the Company’s bylaws and articles of incorporation, and applicable
stock exchange rules or pursuant to written consent. No grants of Stock
Options and other Awards may be made hereunder after the tenth anniversary of
the Effective Date and no grants of Incentive Stock Options may be made
hereunder after the tenth anniversary of the date the Plan is approved by the
Board.
SECTION
22.
|
GOVERNING
LAW
|
This Plan
and all Awards and actions taken thereunder shall be governed by, and construed
in accordance with, the laws of the State of Delaware, applied without regard to
conflict of law principles.
DATE
APPROVED BY BOARD OF DIRECTORS: September 28, 2010
DATE
APPROVED BY STOCKHOLDERS: September 28, 2010
EXHIBIT
10.10
ATOSSA
GENETICS, INC.
Subscription
Agreement
Name
of
Subscriber:_______________________________________________________
Number
of Shares Purchased (______) share
minimum):_________________________
Subscription
Amount ($_______ per share):____________________________________
State
of
Residence:_________________________________________________________
1. Subscription. The undersigned
hereby subscribes to the number of shares set forth above of the common stock of
Atossa Genetics, Inc. (the “Investment Securities”) a corporation organized and
existing under the laws of the State of Delaware (the “Company”), and agrees to
pay for such Investment Securities the amount set forth above in cash or by
check subject to collection upon execution of this subscription
agreement.
2. Agreements and Understandings of the
Undersigned. The undersigned agrees and understands that:
2.1. The
undersigned is entitled to full information about the Company and its
principals. Written materials describing the Company and the Investment
Securities (the “Investment Documents”) have been furnished to the undersigned
prior to execution of this subscription agreement and the undersigned has been
given the time required to read such materials, alone or with the undersigned’s
advisor(s).
2.2. If
the undersigned has made any deposit, escrow or other payment in whole or in
part toward the purchase of the Investment Securities offered hereby before
executing this subscription agreement, the undersigned may elect to either: (i)
ratify the undersigned’s investment and receive a credit in full for such
payment by execution of this subscription agreement; or (ii) have returned on
demand the full amount of such payment, less distributions received by the
undersigned, if any, plus lawful interest, at which time the undersigned will
have no interest in or further obligation in regard to the Investment Securities
offered hereby.
2.3. The
undersigned (or the entity for which the undersigned is acting, if any) will not
offer or sell all or any part of the undersigned’s Investment Securities until
and unless the Investment Securities are registered under the Securities Act of
1933, as amended and under applicable state laws or unless the undersigned has
delivered to the Company an opinion of counsel satisfactory to it that such
registration is not required.
2.4. No
Federal or state agency has made any finding or determination as to the fairness
for investment, nor recommendation or endorsement, of the Investment
Securities.
2.5. If
the undersigned is neither a United States citizen nor a resident of the United
States, then the undersigned agrees: (a) to supply the Company with any and all
information necessary so that the Company may satisfy any and all United States
legal reporting requirements; and (b) to indemnify the Company for any liability
incurred by the Company as a result of its failure to withhold any taxes or
comply with any reporting requirements because
the undersigned did not provide the necessary information to the Company to
enable it to withhold the necessary taxes or fully comply with such
requirements. Furthermore, if the undersigned is a foreign investor who fails to
timely file U.S. Internal Revenue Service Form 4224 with the Company (the first
such Form must be filed in duplicate with the Company prior to the acceptance of
this subscription), the undersigned agrees, at the request of the Company, to
execute any and all documents and instruments requested by the Company in order
to consummate a sale or disposition of the Investment Securities as required to
comply with law.
2.6. If
the undersigned is an organization (other than a cooperative described in
Section 521 of the Internal Revenue Code of 1986, as amended) whose income from
the Company will be exempt from United States income tax, the undersigned shall
so advise the Company.
2.7. THE OFFERING OF THESE SECURITIES IS
NOT REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. AS SUCH THE
UNDERSIGNED MUST BEAR THE ECONOMIC RISK OF THE INVESTMENT FOR AN INDEFINITE
PERIOD OF TIME BECAUSE THE SECURITIES CANNOT BE SOLD UNLESS THEY ARE
SUBSEQUENTLY REGISTERED UNDER THE SECURITIES ACT OR AN EXEMPTION FROM SUCH
REGISTRATION IS AVAILABLE. RESTRICTIONS WILL BE PLACED ON THE TRANSFERABILITY OF
THE SECURITIES.
2.8. THESE SECURITIES HAVE NOT BEEN
APPROVED OR DISAPPROVED BY THE STATE OR JURISDICTION OF THE UNDERSIGNED’S
RESIDENCE NOR HAS THE STATE OR JURISDICTION OF THE UNDERSIGNED’S RESIDENCE
PASSED UPON THE ACCURACY OR ADEQUACY OF ANY INFORMATIONAL
MATERIALS.
2.9. THESE SECURITIES HAVE NOT BEEN
APPROVED OR DISAPPROVED BY THE SECURITIES AND EXCHANGE COMMISSION NOR HAS THE
COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF ANY INFORMATIONAL MATERIALS.
ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
3. Warranties of the
Undersigned. The undersigned represents and warrants
that:
3.1. The
undersigned has reached the age of majority in the state or country in which the
undersigned resides.
3.2. The
undersigned (or the entity for which the undersigned is acting, if any) intends
to retain indefinitely, and has no present arrangement, understanding or
agreement for disposing of the Investment Securities and takes such Investment
Securities solely for the account of the name(s) which appear
below.
3.3. If
a trust, corporation, partnership, or other entity, the undersigned: (i) is duly
organized and validly existing under the laws of the state of formation; (ii) is
duly authorized and empowered to purchase the Investment Securities; (iii) was
not organized exclusively for the purpose of acquiring the Investment Securities
and has an independent reason for existence beyond such investment; (iv) has
duly authorized the signatory hereto to execute this subscription agreement on
behalf of the undersigned, and, upon such execution, the subscription agreement
and any related documents shall be a binding obligation of the undersigned; and
(v) will, upon request of counsel to the Company, furnish evidence of the
representations and warranties of this subparagraph, including certified copies
of the certificate (articles) of incorporation, articles of (limited)
partnership, or other creating or implementing documents.
3.4. If
the undersigned is not an Accredited Investor (described hereinafter) under
Regulation D of the General Rules and Regulations of the Securities and Exchange
Commission, the undersigned, either alone or with an advisor(s), has such
knowledge and experience in financial and business matters that the undersigned
is capable of evaluating the merits and risks of the prospective
investment.
3.5. It
has been called to the undersigned’s attention that this investment involves a
high degree of risk, and no assurances are or have been made regarding the
economic advantages, if any, which may inure to the benefit of investors. The
economic benefit from an investment in the Investment Securities depends on the
ability of the Company to successfully conduct its business activities. The
accomplishment of such goals in turn depends on many factors beyond the control
of the Company or its management. Accordingly, the suitability for any
particular investor of a purchase of the Investment Securities will depend upon,
among other things, such investor’s investment objectives and such investor’s
ability to accept speculative risks, including the risk of a total loss of
investment in the Investment Securities. The undersigned and the undersigned’s
advisor(s), if any, have carefully reviewed and understand the risk of, and
other considerations relating to, a purchase of the Investment
Securities.
3.6. The
undersigned is able to bear the economic risks of this investment, is able to
hold the Investment Securities for an indefinite period of time, and has
sufficient net worth to sustain a loss of the entire investment in the Company
in the event such loss should occur.
3.7. The
undersigned and the undersigned’s advisor(s), if any, have relied only upon the
information contained in the Investment Documents made available to the
undersigned and the undersigned’s advisor(s). Any other information concerning
this offering, whether oral or written, may be incomplete or inaccurate. Only
the Investment Documents are intended to be an accurate description of the
offering and its terms.
3.8. The
Company has answered all inquiries that the undersigned and the undersigned’s
advisor(s), if any, have made of it concerning the Company or any other matters
relating to the business and proposed operation of the Company and the offer and
sale of the Investment Securities. No oral statement, printed material, or
inducement which is contrary to the information contained in the Investment
Documents has been given or made by or on behalf of the Company to the
undersigned or the undersigned’s advisor(s), if any.
3.9. All
of the representations and information provided by the undersigned in this
subscription agreement and any additional information which the undersigned has
furnished to the Company with respect to the undersigned’s financial position
and business experience is accurate and complete as of the date that this
subscription agreement was executed by the undersigned. If there should be any
material adverse change in such representations or information prior to the sale
of the Investment Securities subscribed for herein to the undersigned, the
undersigned will immediately furnish accurate and complete information
concerning any such material change to the Company.
3.10. The
undersigned represents, if the undersigned is subject to the Employee Retirement
Income Security Act of 1974 (“ERISA”), that in making the proposed investment
the undersigned is aware of and has taken into consideration the diversification
requirements of Section 404(a)(1)(C) of ERISA, and has concluded that the
proposed investment is a prudent one.
4. “Non-Resident Alien” Status (if
applicable). By indication below, the undersigned represents and warrants
that the undersigned (or the entity for which the undersigned is acting, if any)
is not a citizen of the United States or Canada and is not, and has no present
intention of becoming, a resident of the United States (defined as being any
natural person physically present within the United States for at least 183 days
in a 12-month consecutive period or any entity who maintained an office in the
United States at any time during a 12-month consecutive period). The undersigned
understands that the Company may rely upon the representations and warranty of
this paragraph as a basis for an exemption from registration of the Investment
Securities under the Securities Act of 1933, as amended, and the provisions of
relevant state securities laws.
_____
CHECK HERE IF NOT A CITIZEN/RESIDENT OF THE UNITED
STATES OR CANADA.
5. “Accredited Investor”
Status. Unless indicated otherwise herein, the undersigned
falls within one of the following definitions of Accredited
Investor:
For
individuals:
○
|
The
undersigned is a natural person whose individual net worth, or joint net
worth with spouse, exceeds $1,000,000 at the time of purchase of the
Investment Securities.
|
○
|
The
undersigned is a natural person who had an individual income in excess of
$200,000 in each of the last two years or joint income with spouse in
excess of $300,000 in each of those years and reasonably expects to reach
the same income level in the current
year.
|
○
|
The
undersigned is either a director, executive officer or general partner of
the Company, or adirector,
executive officer or general partner of a general partner of the
Company.
|
If an
Accredited Investor, the undersigned further certifies that: (i) the undersigned
(or the undersigned’s professional advisor(s)) has the capacity to protect the
undersigned’s interests in this investment; (ii) the undersigned is able to bear
the economic risks of this investment; and (iii) the amount of the investment
does not exceed 10% of the undersigned’s net worth or joint net worth with
spouse.
For
entities:
○
|
The
undersigned is an institutional investor as provided in Regulation Section
230.501(a)(1) under the Securities Act of
1933.
|
○
|
The
undersigned is a private business development company within the meaning
of Section 202(a)(22) of the Investment Advisers Act of
1940.
|
○
|
The
undersigned is any organization described in Section 501©(3) of the
Internal Revenue Code, not formed for the specific purpose of acquiring
the Investment Securities, with total assets in excess of
$5,000,000.
|
○
|
The
undersigned is a trust with total assets in excess of $5,000,000, not
formed for the special purpose of acquiring the Investment Securities,
whose investment is directed by a person described in Regulation Section
230.506(b)(2)(ii) under the Securities Act of
1933.
|
○
|
The
undersigned is an entity owned entirely by any of the persons described
above.
|
6. Suitability Information for Investors
who are not Accredited Investors. If the undersigned does
not meet the definition
above of an Accredited Investor, the undersigned must be able to check the
following category as applicable.
IF
NOT AN ACCREDITED INVESTOR YOU MUST BE ABLE TO CHECK THIS CATEGORY:
_____
|
I
have such knowledge and experience in financial and business matters that
I (alone or together with a Purchaser Representative) am capable of
evaluating the merits and risks of this
investment.
|
If the
undersigned is not an Accredited Investor, the Company may require that the
undersigned utilize the services of a Purchaser Representative or equivalent
advisor who may be required to complete a Purchaser Representative
Questionnaire.
7. Acceptance and Conditions of
Investment.
The
undersigned agrees and is aware that:
7.1. The
Company reserves the unrestricted right to reject any subscription, and no
subscription will be
binding unless and until accepted by it. A subscription from a
non-accredited investor will not be accepted if the maximum limitation on the
number of non-accredited investors has already been reached.
7.2. A
legend in substantially the following form will be placed on any certificate(s)
evidencing the Investment Securities:
THESE
SECURITIES CANNOT BE SOLD, TRANSFERRED OR OTHERWISE DISPOSED OF BY ANY INVESTOR
TO ANY OTHER PERSON OR ENTITY UNLESS SUBSEQUENTLY REGISTERED UNDER THE
SECURITIES ACT OF 1933, AS AMENDED, AND UNDER APPLICABLE LAW OF THE STATE OR
JURISDICTION WHERE SOLD, TRANSFERRED OR DISPOSED OF, UNLESS SUCH SALE, TRANSFER
OR DISPOSITION SHALL QUALIFY UNDER AN ALLOWED EXEMPTION TO SUCH
REGISTRATION.
7.3. Stop
transfer instructions will be placed with respect to the Investment Securities
so as to restrict resale or other transfer thereof subject to further items
hereof, including the provisions of the legend set forth above.
7.4. Unless
otherwise provided by law, the legend and stop transfer instructions described
above will be placed with respect to any new certificate(s) or other document(s)
issued upon presentment by the undersigned of certificate(s) or other
document(s) for transfer.
8. Registration
Rights. The undersigned, or subsequent holder of the
Investment Securities, shall have the right to have the Investment Securities
included in the first registration statement effected by the Company for any of
its stock or other securities under the Securities Act of 1933, as amended,
(other than a registration statement relating solely to the sale of securities
to participants in a Company stock plan, a Form S-4 registration statement, or a
registration on any other form which does not include substantially the same
information as would be required to be included in a registration statement
covering the sale of the Investment Securities). Holders who wish their
Investment Securities included in such registration statement shall comply with
reasonable conditions imposed by the Company, including the furnishing of
certain information required to be included in the registration statement. The
expenses of the registration statement will be borne by the Company except for
expenses (such as the advice of an attorney, accountant or financial advisor)
incurred by the holder individually.
9. Accuracy of Information
Given. The undersigned certifies that the undersigned has
given the information contained herein to the best of the undersigned’s
knowledge and answers thereto are complete and accurate. The undersigned agrees
that the foregoing representations and warranties shall survive the purchase of
the Investment Securities as well as any acceptance of this subscription for the
Investment Securities.
10. Election of Purchaser
Representative. The undersigned understands that the
undersigned is entitled to be advised by a Purchaser Representative or an
equivalent advisor in making a decision to invest and that (unless the
undersigned is an Accredited Investor) the undersigned must be so advised if the
undersigned does not have sufficient knowledge and experience in financial and
business matters to evaluate the merits and risks of this
investment.
11. Indemnification. The
undersigned acknowledges that the undersigned understands the meaning and legal
consequences of the representations and warranties hereof, and hereby agrees to
indemnify and hold harmless the Company, its affiliates, attorneys, accountants,
agents, employees and any selling securityholder from and against any and all
loss, damage or liability, including, without limitation, reasonable attorneys
fees incurred as a result of such breach, due to or arising out of a breach of
any such representations or warranties. This indemnification shall not require
that the Company shall have been determined by any Federal, state or other
authority or person to have qualified for any exemption from the registration
provisions of Federal or state securities laws, rules or
regulations.
12. Arbitration. The
undersigned hereby agrees that any and all claims (other than claims for
injunctive or other equitable relief) now or at any time hereafter as to which
the Company, its affiliates, attorneys, accountants, agents or employees and the
undersigned, the undersigned’s successors or assigns may be adverse parties,
whether arising out of this agreement or from any other cause, will be resolved
by arbitration before the American Arbitration Association. Each
party irrevocably consents to subject matter and personal jurisdiction before
the American Arbitration Association. The parties covenant that under
no conditions will any of them file any action at law against any other or bring
any claim in any forum other than before the American Arbitration Association,
and they agree that any litigation, if filed, shall be immediately dismissed
upon application and shall be referred for arbitration hereunder with costs and
attorneys’ fees to the prevailing party. The situs of arbitration and
any counterclaims shall be selected by the person against whom arbitration is
sought provided that such situs is within the United States and is the situs of
such person’s principal residence or place of business. Any dispute
concerning situs shall be determined by the American Arbitration
Association.
The
parties shall restrict themselves to claims for compensatory
damages. No claims shall be made by any party for lost profits,
punitive or similar damages. The parties agree that any award or
decision by the American Arbitration Association shall be final and
non-appealable except as to errors of law. Any appeal from an award
of the arbitrator shall be taken to the appropriate court having jurisdiction
over the situs of the arbitration. No bond shall be required of any
party on appeal, and no enforcement of the award shall be granted until a
determination of the appeal is final or until time to take an appeal has
expired. Each party shall pay their own attorneys fees and costs of
the arbitration and any appeal.
It is the
intent of the parties and their affiliates to deal with all disputes between
them by arbitration to the maximum degree allowed by law (including claims
against any party’s current or former attorneys, accountants, agents, employees,
successors or assigns), and if any claim or claims should be held not subject to
arbitration, only such claim or claims shall be excluded from this
paragraph.
PLEASE
EXECUTE THE ATTACHED SIGNATURE PAGE
ATOSSA
GENETICS, INC.
Signature
Page to Subscription Agreement
____________________________________________________________________________
Name of
Subscriber
____________________________________________________________________________
Street
____________________________________________________________________________
City,
State, Zip Code
$___________________________________________________________________________
Amount of
Subscription
By__________________________________________________________________________
Signature
Date_________________________________________________________________________
Taxpayer
Identification
Number___________________________________________________
(Social
Security number for individuals)
Status (if not
individual):
( ) Trust
|
( ) Corporation
|
( ) Partnership
|
( ) Other_________________
|
( ) IRA
|
(describe)
|
Title to be Taken By (if not
individual):
( ) Joint
Tenant with ________________________________
( ) Other
(describe):_________________________________
By:_________________________________________
Date:
EXHIBIT
10.11
PROMISSORY
NOTE & AGREEMENT
$5,000.00
|
Date:
January 2,
2010
|
For value
received, the undersigned Atossa Genetics, Inc. (the “Borrower”), at 4105 E
Madison St, Suite
320 Seattle, WA 98112, promises to pay to the order of Steven Quay, (the
“Lender”), at 4105 E
Madison St, Suite 320, Seattle WA 98112 (or at such other place as the Lender
may designate
in writing) the sum of Five Thousand Dollars ($5,000.00) with interest from June
30, 2010, on
the unpaid principal at the rate of 10.00% per annum, as the loan was “interest
free” prior to
the date of the execution of this Agreement.
The
unpaid principal and accrued interest shall be payable in full on, or before,
December 30, 2010.
All
payments on this Note shall be applied first in payment of accrued interest and
any remainder in payment of principal.
If any
payment obligation under this Note is not paid when due, the remaining unpaid
principal balance
and any accrued interest shall become due immediately at the option of the
Lender.
The
Borrower reserves the right to prepay this Note (in whole or in part) prior to
the Due Date with no
prepayment penalty.
If any
payment obligation under this Note is not paid when due, the Borrower promises
to pay all costs of
collection, including reasonable attorney fees, whether or not a lawsuit is
commenced as part of
the collection process.
If any of
the following events of default occur, this Note and any other obligations of
the Borrower to the Lender shall become due immediately, without demand or
notice:
1) the
failure of the Borrower to pay the principal and any accrued interest in full on
or before the Due Date;
2) the
filing of bankruptcy proceedings involving the Borrower as a
debtor;
3) the
application for the appointment of a receiver for the Borrower;
4) the
making of a general assignment for the benefit of the Borrower’s
creditors;
5) the
insolvency of the Borrower;
If any
one or more of the provisions of this Note are determined to be unenforceable,
in whole or in part, for any reason, the remaining provisions shall remain fully
operative.
All
payments of principal and interest on this Note shall be paid in the legal
currency of the United States. The Borrower waives presentment for
payment, protest, and notice of protest and nonpayment
of this Note.
No
renewal or extension of this Note, delay in enforcing any right of the Lender
under this Note, or
assignment by Lender of this Note shall affect the liability or the obligations
of the Borrower. All
rights of the Lender under this Note are cumulative and may be exercised
concurrently or consecutively
at the Lender’s option.
This Note
shall be construed in accordance with the laws of the State of
Washington.
Signed
this 30th day of June,
2010,
Borrower:
|
|
ATOSSA
GENETICS Inc.
|
|
|
|
/s/ Robert L. Kelly
|
|
By:
Robert L. Kelly
|
|
Its:
President
|
|
|
|
STEVEN
C. QUAY, M.D., PH.D.
|
|
|
|
/s/ Steven C. Quay
|
|
EXHIBIT
10.12
PROMISSORY
NOTE & AGREEMENT
$100,000.00
|
Date:
June 30, 2010
|
For value
received, the undersigned Atossa Genetics, Inc. (the “Borrower”), at 4105 E
Madison St, Suite
320 Seattle, WA 98112, promises to pay to the order of Steven Quay, (the
“Lender”), at 4105 E
Madison St, Suite 320, Seattle WA 98112or at such other place as the Lender may
designate
in writing) the sum of One Hundred Thousand Dollars ($100,000.00) with interest
from June
30, 2010, on the unpaid principal at the rate of 10.00% per
annum.
A loan
initiation fee of $4,000.00 is charged.
The
unpaid principal, initiation fee, and accrued interest shall be payable in full
on, or before, December
30, 2010.
All
payments on this Note shall be applied first in payment of initiation fee, then
to accrued interest
and any remainder in payment of principal.
If any
payment obligation under this Note is not paid when due, the remaining unpaid
principal balance
and any accrued interest and fee shall become due immediately at the option of
the Lender.
The
Borrower reserves the right to prepay this Note (in whole or in part) prior to
the Due Date with no
prepayment penalty.
If any
payment obligation under this Note is not paid when due, the Borrower promises
to pay all costs of
collection, including reasonable attorney fees, whether or not a lawsuit is
commenced as part of
the collection process.
If any of
the following events of default occur, this Note and any other obligations of
the Borrower to the Lender shall become due immediately, without demand or
notice:
1) the
failure of the Borrower to pay the principal and any accrued interest in full on
or before the Due Date;
2) the
filing of bankruptcy proceedings involving the Borrower as a
debtor;
3) the
application for the appointment of a receiver for the Borrower;
4) the
making of a general assignment for the benefit of the Borrower’s
creditors;
5) the
insolvency of the Borrower;
If any
one or more of the provisions of this Note are determined to be unenforceable,
in whole or in part,
for any reason, the remaining provisions shall remain fully
operative.
All
payments of principal and interest on this Note shall be paid in the legal
currency of the United
States. The Borrower waives presentment for payment, protest, and notice of
protest and nonpayment
of this Note.
No
renewal or extension of this Note, delay in enforcing any right of the Lender
under this Note, or
assignment by Lender of this Note shall affect the liability or the obligations
of the Borrower. All
rights of the Lender under this Note are cumulative and may be exercised
concurrently or consecutively
at the Lender’s option.
This Note
shall be construed in accordance with the laws of the State of
Washington.
Signed
this 30th day of June,
2010,
Borrower:
|
|
ATOSSA
GENETICS Inc.
|
|
|
|
/s/ Robert L. Kelly
|
|
By:
Robert L. Kelly
|
|
Its:
President
|
|
|
|
STEVEN
C. QUAY, M.D., PH.D.
|
|
|
|
/s/ Steven C. Quay
|
|
Unassociated Document
SUBLEASE
AGREEMENT
This
Sublease Agreement (this "Sublease") is made effective as of September 29, 2010,
by and between CompleGen, Inc. ("Tenant"), and Atossa Genetics, Inc.
("Subtenant"). The Tenant has previously entered into a lease
agreement with Alexandria Real Estate Equities, Inc. (the "Landlord"), said
lease agreement dated June 26, 2006 (the "Prime Lease") with a First amendment
dated October 1, 2009, which is incorporated by reference and has been provided
to Subtenant. Tenant now desires to sublet the leased property to the
Subtenant and the Subtenant desires to sublet the leased property from the
Tenant. Therefore, the parties agree as follows:
PREMISES. Tenant,
in consideration of the payments provided in the Sublease, subleases to the
Subtenant laboratory rooms 622 and 621, located on the 6th floor
of the Seattle Life Sciences Building, at 1124 Columbia Street, Seattle, WA
98104-2050 (the "Premises"). Subtenant shall share CompleGen’s leased
cold room (laboratory room 647), lunch room (Room 644) and conference room (Room
644A). A sketch of the Premises subject to this Sublease is attached
as Exhibit A.
TERM AND
POSSESSION. The term of this Sublease shall commence on
September 30, 2010, and unless terminated sooner pursuant to the terms of this
Sublease, it shall terminate in six months on March 31,
2011. Sublease will continue on a month to month basis at the
expiration of the original sublease term provided that either party may
terminate the option by giving two (2) months written notice. The
Subtenant shall be entitled to possession on the first day of the term of this
Sublease, and shall yield possession to the Tenant on the last day of the term
of this Sublease, unless otherwise agreed by both parties in writing, or sooner
if this Sublease is terminated pursuant to the terms of the Sublease by either
party.
SUBLEASE
PAYMENTS. The Subtenant shall pay to the Tenant monthly
payments of $3,657.05 per month, payable in advance on the first day of each
month. Sublease payments shall be made to the Tenant at 1124 Columbia
Street, Suite 662, Seattle, WA 98104-2050, which may be changed from time to
time by the Tenant upon providing written notice.
ADDITIONAL RENT. In
addition to Sublease payments, Subtenant agrees to pay to Tenant as additional
rent: (i) Subtenant’s share, equal to 13.25%, of “Net Operating
Expenses” as defined in the Prime Lease, which share is based on a formula of
1,296 square feet divided by 9,778 square feet, and (ii) any and all other
amounts Subtenant expressly assumes or agrees to pay under the provisions of
this Sublease, including, without limitation, any and all other sums that may
become due by reason of any default of Subtenant or failure to comply with the
agreements, terms, covenants and conditions of this Sublease to be performed by
Subtenant, after any applicable notice and cure period.
DCN
SERVICES. The
Subtenant will arrange and pay separately to third parties for all Subtenant’s
communication needs, including but not limited to telephone, facsimile, copier
and internet access expenses. Charges for janitorial service will be
the responsibility of Subtenant.
SECURITY DEPOSIT. A
security deposit of $3,657.05 is due on signing of this agreement, provided that
this amount shall be refunded in full within 2 business days if the Tenant does
not obtain Landlord approval for this Sublease as contemplated below under the
caption “Landlord’s Consent.”
TENANT
IMPROVEMENTS. The passage way in the northwest corner of Room
622 to 625 shall be closed by a wall or other substantial structure to prevent
unauthorized access to 622 at a cost of up to $200.00 to the
Subtenant. Otherwise, the Subtenant shall accept the space in “as is”
condition. Subtenant shall be permitted to install security keypads,
at Subtenant’s expense, on its dedicated space in laboratory rooms 622 and
625. Upon request the Subtenant shall return the premises to its
original condition and configuration.
NOTICE. Notices
under this Sublease shall not be deemed valid unless given or served in writing
and forwarded by mail, postage prepaid, addressed as follows and sent to every
interested party:
TENANT:
Name: CompleGen,
Inc.
Address:
1124 Columbia Street, Suite 600
Seattle, WA 98104
Attention: John Swindle, PhD,
President & CEO
SUBTENANT:
Name: Atossa
Genetics, Inc.
Address: 4105
E Madison St, Ste 320
Seattle, WA 98112
Attention: Steven Quay, MD, PhD,
Chairman, President & CEO
LANDLORD:
Name: Alexandria
Real Estate Equities, Inc.
Address: 385
East Colorado Blvd, Suite #229
Pasadena, CA 91101
Attention: General
Counsel
DCN
Such
addresses may be changed from time to time by any party by providing notice to
the other interested party(ies) as described above.
GOVERNING LAW. This
Lease shall be construed in accordance with the laws of the State of
Washington.
LANDLORD'S
CONSENT. The Prime Lease requires the prior written consent of
the Landlord to any sublease of the Premises. The terms and
conditions of this Sublease are conditional upon the Landlord's written consent
to this Sublease. The Tenant agrees to use the Tenant's best efforts
to obtain such consent within 20 days of signing of the sublease, however this
must be obtained before the Subtenant may take possession. Should the
Landlord refuse to consent to this Sublease, this Sublease shall be null and
void and neither party shall have any further obligations or liabilities under
its terms.
INCORPORATION OF PRIME
LEASE. This Sublease Agreement is subject to all of the terms
of the Prime Lease with the same force and effect as if each provision of the
Prime Lease were included in this Sublease, excepting as otherwise provided
herein. Tenant covenants that it has provided Subtenant a full and complete copy
of the Prime Lease. All of the terms which Tenant is bound to comply
with under the Prime Lease shall, to the extent only that they apply to the
Premises and except as otherwise provided herein, be binding upon
Subtenant. All of the obligations of Landlord set forth in the Prime
Lease shall, to the extent that they apply to the Premises, inure to Subtenant's
benefit provided, however, that this shall not be construed to establish any
direct obligations on the part of the Landlord to Subtenant under the terms of
the Prime Lease, nor any direct obligation on the part of Subtenant to
Landlord. It is the intention of the parties that, except as
otherwise provided in this Sublease, the relationship between Tenant and
Subtenant shall be governed by the language of the various sections and the
covenants of the Prime Lease as if those sections were included in this Sublease
in full, and the words "Landlord", "Tenant" and "Lease" as used in the Prime
Lease, shall refer to, respectively, "Tenant", "Subtenant" and
"Sublease". To the extent that action is required by the Landlord to
effect the terms of the Prime Lease or Sublease, Tenant agrees to assist
Subtenant and use its best efforts to effect such action on the part of Landlord
in a commercially reasonable manner.
REPRESENTATION. Tenant
hereby represents to Subtenant that Tenant is using commercially reasonable best
efforts to comply with the terms of the Prime Lease and covenants that it will
use commercially reasonable best efforts to continue to comply with the terms of
the Prime Lease during the term of this Sublease.
DCN
INDEMNIFICATION. (a)
Except to the extent caused by the negligence or willful misconduct of Tenant,
its agents, employees, contractors or invitees, Subtenant shall indemnify,
defend with counsel reasonably acceptable to Tenant and hold Tenant harmless
from and against any and all claims, liabilities, judgments, causes of action,
damages, costs and expenses (including reasonable attorneys' and experts' fees)
caused by or arising in connection with: (i) the use, occupancy or condition of
the Premises by Subtenant; (ii) the negligence or willful misconduct of
Subtenant or its agents, employees, contractors, or invitees; or (iii) a breach
of Subtenant's obligations under this Sublease or the provisions of the Prime
Lease assumed by Subtenant hereunder. Subtenant's indemnification of
Tenant shall survive termination of this Sublease. (b) Except to the
extent caused by the negligence or willful misconduct of Subtenant, its agents,
employees, contractors or invitees, Tenant shall indemnify, defend with counsel
reasonably
acceptable to Subtenant and hold Subtenant harmless from and against any and all
claims, liabilities, judgments, causes of action, damages, costs and expenses
(including reasonable attorneys' and experts' fees) caused by or arising in
connection with: (i) a breach of Tenant's representations or
obligations under this Sublease; (ii) a breach of Tenant's representations or
obligations under the Prime Lease to the extent
those obligations are not assumed by Subtenant under this Sublease; or (iii) the
negligence or willful misconduct of Tenant, its agents, employees, contractors
or invitees occurring on the Subleased Premises. Tenant's
indemnification of Subtenant shall survive termination of this
Sublease.
INSURANCE. The
Subtenant, at its sole cost and expense shall maintain during the Term of the
Sublease, risk property insurance in an amount reasonably expected to cover the
full replacement cost of all property and improvements installed or placed in
the Premises by the Subtenant at the Subtenant’s expense. The
Subtenant must have workers’ compensation insurance with no less than the
minimum limits required by law, employer’s liability insurance with such limits
as required by law and commercial general liability insurance with a minimum
limit of $2,000,000 per occurrence for bodily injury and property damage with
respect to the Premises. The commercial general liability insurance
policy shall name CompleGen and the Landlord Parties, Alexandria Real Estate
Equities, Inc., including its employees and agents as additional
insureds. A Certificate of Insurance consistent with the foregoing
terms must be submitted to the Landlord before taking possession of the
premises.
Dated: September
29, 2010
TENANT
|
|
SUBTENANT
|
|
|
|
/s/ John Swindle
|
|
/s/ Steven C. Quay
|
CompleGen,
Inc.
|
|
Atossa
Genetics, Inc.
|
President
& CEO
|
|
Chairman,
President & CEO
|
DCN
Exhibit
A:
v197816_ex23-1 -- Converted by SECPublisher 2.1.1.8, created by BCL Technologies Inc., for SEC Filing
EXHIBIT
99.1
ATOSSA
GENETICS INC.
CONSENT
OF PROSPECTIVE DIRECTOR
I, Mary
Tagliaferri, hereby consent to be named as a prospective director of
Atossa Genetics Inc. (the “Company”) in the Registration Statement on
Form S-1 of the Company to be filed in connection with the initial public
offering of the Company’s securities, and in any amendments
thereto.
|
Mary
Tagliaferri, M.D.
|
|
Dated: September
28, 2010
|
EXHIBIT
99.2
ATOSSA
GENETICS INC.
CONSENT
OF PROSPECTIVE DIRECTOR
I,
Stephen Galli, hereby consent to be named as a prospective director of
Atossa Genetics Inc. (the “Company”) in the Registration Statement on
Form S-1 of the Company to be filed in connection with the initial public
offering of the Company’s securities, and in any amendments
thereto.
/s/ Stephen Galli
|
Stephen
Galli, M.D.
|
|
Dated: September
27, 2010
|
EXHIBIT
99.3
ATOSSA
GENETICS INC.
CONSENT
OF PROSPECTIVE DIRECTOR
I,
Alexander Cross, Ph.D., hereby consent to be named as a prospective director of
Atossa Genetics Inc. (the “Company”) in the Registration Statement on
Form S-1 of the Company to be filed in connection with the initial public
offering of the Company’s securities, and in any amendments
thereto.
|
Alexander
Cross, Ph.D.
|
|
Dated: September
28, 2010
|