Unassociated Document
October
15, 2010
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Alan
Gilbert
Direct
Phone: 612-672-8381
Direct
Fax: 612-642-8381
Alan.Gilbert@maslon.com
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SUBMITTED VIA
EDGAR
Jim B.
Rosenberg
Senior
Assistant Chief Accountant
Division
of Corporation Finance
United
States Securities and Exchange Commission
100 F
Street, N.E.
Washington,
D.C. 20549
Re:
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ZIOPHARM
Oncology, Inc. (the “Company”)
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Form
10-K for the Fiscal Year Ended December 31, 2009
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Filed
March 17, 2010
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Form
10-K/A for the Fiscal Year Ended December 31, 2009
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Filed
April 30, 2010
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File
Number 001-33038
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This
letter will respond on behalf of the Company to your comment letter dated
September 20, 2010 (the “Comment Letter”) with respect
to the above referenced documents filed by the Company with the Securities and
Exchange Commission (the “Commission”) (collectively,
the “Form
10-K”). To facilitate your review, we have included in this
letter your original comments (in bold) followed by our response, which has been
numbered to correspond to your letter.
Form 10-K for the Fiscal
Year Ended December 31, 2009
License Agreements and
Intellectual Property, page 5
1.
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With
respect to your agreements with each of The University of Texas M.D.
Anderson Cancer Center and the Texas A&M University System, DEKK-Tec
and Baxter, please provide proposed revised disclosure for inclusion in
future filings that expands your discussion to include a range of royalty
payments (e.g. low single digits or a range not to exceed ten percent) and
the term and termination provisions for each
agreement.
|
Jim B.
Rosenberg
Senior
Assistant Chief Accountant
United
States Securities and Exchange Commission
Page 2
of 13
Set forth
below is revised disclosure regarding the Company’s license agreements and
intellectual property that the Company proposes to include in its future
filings. The disclosure below has been expanded from that included in
the Form 10-K to include a range of royalty payments and the term and
termination provisions for each agreement. The proposed future disclosure is
marked below to show additions to the corresponding disclosure in the Form
10-K.
Patent
and Technology License Agreement — The University of Texas M. D. Anderson Cancer
Center and the Texas A&M University System.
On August
24, 2004, the Company entered into a patent and technology license agreement
with The Board of Regents of the University of Texas System, acting on behalf of
The University of Texas M. D. Anderson Cancer Center and the Texas A&M
University System (collectively, the “Licensors”). Under this agreement, the
Company was granted an exclusive, worldwide license to rights (including rights
to U.S. and foreign patent and patent applications and related improvements and
know-how) for the manufacture and commercialization of two classes of organic
arsenicals (water- and lipid-based) for human and animal use. The class of
water-based organic arsenicals includes darinaparsin.
As
partial consideration for the license rights obtained, the Company made an
upfront payment in 2004 of $125 thousand and granted the Licensors 250,487
shares of the Company’s common stock. In addition, the Company issued options to
purchase an additional 50,222 shares outside the 2003 Stock Option Plan for
$0.002 per share following the successful completion of certain clinical
milestones, which vested with respect to 12,555 shares upon the filing of an
Investigation New Drug application (“IND”) for darinaparsin in 2005 and vested
with respect to another 25,111 shares upon the completion of dosing of the last
patient for both Phase I clinical trials in 2007. The Company recorded $120
thousand of stock based compensation expense related to the vesting in 2007. The
remaining 12,556 shares will vest upon enrollment of the first patient in a
multi-center pivotal clinical trial, i.e., a human clinical trial intended to
provide the substantial evidence of efficacy necessary to support the filing of
an approvable New Drug Application (“NDA”). In addition, the Licensors are
entitled to receive certain milestone payments, including $100 thousand that was
paid in 2005 upon the commencement of Phase I clinical trial and $250 thousand
that was paid in 2006 upon the dosing of the first patient in the
Registrant-sponsored Phase II clinical trial for darinaparsin. The Company may
be required to make additional payments upon achievement of certain other
milestones, in varying amounts which on a cumulative basis could total up to
$4.85 million. In addition, the Licensors are entitled to receive single digit percentage
royalty payments on sales of a licensed product should such a product be
approved for commercial sale and sales of a licensed product be effected in the
United States, Canada, the European Union or Japan. The Licensors also will be
entitled to receive a portion of any fees that the Company may receive from a
possible sublicense under certain circumstances. The Company also paid the
Licensors $100 thousand in 2006 and 2007 to conduct scientific research with the
Company obtaining exclusive right to all resulting intellectual property rights.
The sponsored research agreements governing this research and any related
extensions expired in February 2008 with no payments being made in 2008 or
2009.
Jim B.
Rosenberg
Senior
Assistant Chief Accountant
United
States Securities and Exchange Commission
Page 3
of 13
The
license agreement also contains other provisions customary and common in similar
agreements within the industry, such as the right to sublicense the Company
rights under the agreement. However, if the Company sublicenses its rights prior
to the commencement of a pivotal study, i.e., a human clinical trial intended to
provide the substantial evidence of efficacy necessary to support the filing of
an approvable NDA, the Licensors will be entitled to receive a share of the
payments received by the Company in exchange for the sublicense (subject to
certain exceptions). The term
of the license agreement extends until the expiration of all claims under
patents and patent applications associated with the licensed technology, subject
to earlier termination in the event of defaults by the Company or the Licensors
under the license agreement, or if the Company becomes bankrupt or
insolvent.
License
Agreement with DEKK-Tec, Inc.
On
October 15, 2004, the Company entered into a license agreement with DEKK-Tec,
Inc., pursuant to which it was granted an exclusive, worldwide license for
palifosfamide. As part of the signing of license agreement with DEKK-Tec, the
Company expensed an upfront $50 thousand payment to DEKK-Tec in
2004.
In
consideration for the license rights, DEKK-Tec is entitled to receive milestone
payments upon the occurrence of certain achievements of certain milestones in
varying amounts which on a cumulative basis may total $3.9 million. Of the
aggregate milestone payments, most of the total amount will be creditable
against future royalty payments as referenced below. The Company expensed a $100
thousand milestone payment upon achieving Phase II milestones during the year
ended December 31, 2006. Additionally, in 2004 the Company issued DEKK-Tec an
option to purchase 27,616 shares of the Company’s common stock for $0.02 per
share. Upon the execution of the license agreement, 6,904 shares vested and were
subsequently exercised in 2005 and the remaining options will vest upon certain
milestone events, culminating with final FDA approval of the first NDA submitted
by the Company (or by its sublicensee) for palifosfamide. None of the remaining
options have vested as of December 31, 2009. DEKK-Tec is entitled to receive
single digit percentage
royalty payments on the sales of palifosfamide should it be approved for
commercial sale. There were no payments during 2008 or 2009. The Company’s obligation to pay
royalties will terminate on a country-by-country basis upon the expiration of
all valid claims of patents in such country covering licensed product, subject
to earlier termination in the event of defaults by the parties under the license
agreement.
Jim B.
Rosenberg
Senior
Assistant Chief Accountant
United
States Securities and Exchange Commission
Page 4
of 13
License
Agreement with Baxter Healthcare Corporation
On
November 3, 2006, the Company entered into a definitive Asset Purchase Agreement
(for indibulin) and License Agreement (to Baxter's proprietary nanosuspension
technology) with affiliates of Baxter. Indibulin is a novel anti-cancer agent
that binds to tubulin, one of the essential proteins for chromosomal
segregation, and targets mitosis like the taxanes and vinca alkaloids. It is
being developed as an oral form. Among the more well known antimitotic drugs are
the taxanes (paclitaxel, docetaxel) and the vinca alkaloids (vincristine,
vinblastine). The purchase included the entire indibulin intellectual property
portfolio as well as existing drug substance and capsule inventories. The terms
of the Asset Purchase Agreement included an upfront cash payment of
approximately $1.1 million and an additional $100 thousand payment for existing
inventory, both of which were expensed in 2006. In addition to the upfront
costs, the Asset Purchase Agreement includes additional milestone payments that
could amount to approximately $8 million in the aggregate and royalties on net
sales of products covered by a valid claim of a patent for the life of the
patent on a country-by-country basis. The Company expensed a $625 thousand
milestone payment upon the successful U.S. IND application for indibulin in
2007. The License Agreement requires payment of a $15 thousand annual patent and
license prosecution/maintenance fee through the expiration of the last to expire
of the licensed patents,
which is expected to expire in 2025, and single digit percentage
royalties on net sales of licensed products covered by a valid claim of a patent
for the life of the patent on a country-by-country basis. The term of the license agreement
extends until the expiration of the last to expire of the patents covering the
licensed products, subject to earlier termination in the event of defaults by
the parties under the license agreement.
In
October 2009, the Baxter License Agreement was amended to allow the Company to
manufacturer indibulin.
Jim B.
Rosenberg
Senior
Assistant Chief Accountant
United
States Securities and Exchange Commission
Page 5
of 13
2.
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We
note your disclosure on pages 25-27 that your product candidates are
covered by certain issued patents and patent applications in the U.S. and
foreign countries. Please provide proposed revised disclosure
for inclusion in future filings that expands your disclosure to identify
the number of material patents and patent applications for each of your
products, including the jurisdiction and, as applicable, the expiration of
such patents.
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Set forth
below is proposed disclosure regarding the issued patents and patent
applications in the U.S. and in foreign countries, which cover the Company’s
product candidates:
Patents
and Other Proprietary Rights
Our goal
is to obtain, maintain, and enforce patent protection for our products,
formulations, processes, methods, and other proprietary technologies in order to
preserve our trade secrets and to operate without infringing upon the
proprietary rights of other parties, both in the United States and in other
countries. Our policy is to actively seek the broadest possible intellectual
property protection for our product candidates through a combination of
contractual arrangements and patents, both in the United States and
abroad.
Patents
extend for varying periods according to the date of patent filing or grant and
the legal term of patents in the various countries where patent protection is
obtained. The actual protection offering by a patent, which can vary from
country to country, depends of the type of patent, the scope of its coverage and
the availability of legal remedies in the country.
We also
depend upon the skills, knowledge, and experience of our scientific and
technical personnel, as well as those of our advisors, consultants, and other
contractors, none of which is patentable. To help protect proprietary know-how,
which is not patentable, and for inventions for which patents may be difficult
to enforce, we currently rely, and in the future will continue to rely, on trade
secret protection and confidentiality agreements to protect our interests. To
this end, we generally require employees, consultants, advisors and other
contractors to enter into confidentiality agreements that prohibit the
disclosure of confidential information and, where applicable, require disclosure
and assignment to us of the ideas, developments, discoveries and inventions
important to our business.
Jim B.
Rosenberg
Senior
Assistant Chief Accountant
United
States Securities and Exchange Commission
Page 6
of 13
Our
patent position and proprietary rights are subject to certain risks and
uncertainties. Please read the “Risk Factors” section of this report for
information about certain risks and uncertainties that may affect our patent
position and proprietary rights.
Additional
information about material patents and other proprietary rights covering our
product candidates is set forth below.
Darinaparsin
The
patent estate covering darinaparsin compositions, methods of use and methods of
manufacture includes three issued United States patents, as well as issued
patents in certain foreign jurisdictions, all of which are scheduled to expire
in 2023. We license these patents, as well as pending applications in various
foreign jurisdictions, from The University of Texas M. D. Anderson Cancer Center
and the Texas A&M University System pursuant to an Agreement dated August
24, 2004. We have also filed pending applications in the United
States and various foreign jurisdictions.
Palifosfamide
The
patent estate covering palifosfamide compositions, methods of use and methods of
manufacture includes one issued United States patent that is scheduled to expire
in 2029, as well as pending applications in the United States and various
foreign jurisdictions. We license the issued patent and the patent applications
from DEKK-Tec, Inc. pursuant to an Agreement dated October 15,
2004. We have also filed pending applications in the United States
and various foreign jurisdictions.
Indibulin
The
patent estate covering indibulin compositions, methods of use and methods of
manufacture includes pending applications in the United States, and various
foreign jurisdictions, all of which we license from affiliates of Baxter
Healthcare Corporation pursuant to an agreement dated November 6, 2006. We also
have five issued United States patents that are scheduled to expire at varying
times between 2017 and 2019, as well as issued patents in various foreign
jurisdictions, and have filed pending applications in the United States and
various foreign jurisdictions.
Management Discussion and
Analysis of Financial Condition and Results of Operation
Results of Operations for
the Fiscal Year Ended December 31, 2009 versus December 31,
2008
Jim B.
Rosenberg
Senior
Assistant Chief Accountant
United
States Securities and Exchange Commission
Page 7
of 13
Research and Development
Expenses, page 30
3.
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Please
refer to the Division of Corporation Finance “Current Issues and
Rulemaking Projects Quarterly Update” under section VIII-Industry Specific
Issues – Accounting and Disclosure by Companies Engaged in Research and
Development Activities. You can find it at the following
website address: http://www.sec.gov/divisions/corpfin/cfcrq032001.htm#secviii.
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Please
provide us proposed disclosure to be included in your future filings beginning
with your September 30, 2010 Form 10-Q of the following information for each of
your major research and development projects:
a.
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The
costs incurred during each period presented and to date on the
project;
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b.
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The
nature, timing and estimated costs of the efforts necessary to complete
the project;
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c.
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The
anticipated completion dates;
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d.
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The
risks and uncertainties associated with completing development on
schedule, and the consequences to operations, financial position and
liquidity if the project is not completed timely; and
finally
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e.
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The
period in which material net cash inflows from significant projects are
expected to commence.
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Regarding
b., if you do not maintain any research and development costs by project,
disclose that fact and explain why management does not maintain and evaluate
research and development costs by project. Provide other quantitative
or qualitative disclosure that indicates the amount of the company’s resources
being used on the project.
Regarding
c. and d., disclose the amount or range of estimated costs and timing to
complete the phase in process and each future phase. To the extent
that information is not estimable , disclose those facts and circumstances
indicating the uncertainties that preclude you from making a reasonable
estimate.
Set forth
below is disclosure that the Company proposes to include in future filings,
beginning with its Form 10-Q for the quarter ended September 30, 2010, which
includes expanded information for each of the Company’s major research and
development projects.
Jim B.
Rosenberg
Senior
Assistant Chief Accountant
United
States Securities and Exchange Commission
Page 8
of 13
Overview
Our
research and development expense consists primarily of salaries and related
expenses for personnel, costs of contract manufacturing services, costs of
facilities and equipment, fees paid to professional service providers in
conjunction with our clinical trials, fees paid to research organizations in
conjunction with pre-clinical animal studies, costs of materials used in
research and development, consulting, license and milestone payments and
sponsored research fees paid to third parties.
We have
not accumulated and tracked our internal historical research and development
costs or our personnel and personnel-related costs on a program-by-program
basis. Our employee and infrastructure resources are allocated across
several projects, and many of our costs are directed to broadly applicable
research endeavors. As a result, we cannot state or accurately
estimate the costs incurred for each of our oncology programs on a
program-by-program basis.
In 2010,
our clinical projects consisted primarily of a Phase 3 project for our lead
product candidate palifosfamide. This project was initiated during
2010. The expenses incurred by us to third parties were $2.5 million
and $3.1 million for the three and nine months ended September 30, 2010,
respectively and $3.1 million for project to date.
Our
future research and development expenses in support of our current and future
programs will be subject to numerous uncertainties in timing and cost to
completion. We test potential products in numerous pre-clinical
studies for safety, toxicology and efficacy. We may conduct multiple
clinical trials for each product. As we obtain results from trials,
we may elect to discontinue or delay clinical trials for certain products in
order to focus our resources on more promising products or
indications. Completion of clinical trials may take several years or
more, and the length of time generally varies substantially according to the
type, complexity, novelty and intended use of a product. It is not
unusual for pre-clinical and clinical development of each of these types of
products to require the expenditure of substantial resources.
We
estimate that clinical trials of the type generally needed to secure a new drug
approval are typically completed over the following timelines:
Clinical
Phase
|
Estimated
Completion Period |
Phase 1 |
1 - 2
years |
Phase 2 |
2 - 3
years |
Phase 3 |
2-4
years |
|
|
Jim B.
Rosenberg
Senior
Assistant Chief Accountant
United
States Securities and Exchange Commission
Page 9
of 13
The
duration and the cost of clinical trials may vary significantly over the life of
a project as a result of differences arising during clinical development,
including, among others, the following:
·
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the
number of clinical sites included in the trials; |
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·
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the
length of time required to enroll suitable patents; |
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·
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the
number of patients that ultimately participate in the trials; |
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·
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the
duration of patient follow-up to ensure the absence of long-term
product-related adverse events; and
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·
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the
efficacy and safety profile of the product. |
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As a
result of the uncertainties discussed above, we are unable to determine or
accurately estimate the duration and completion costs of our programs or when
and to what extent we will receive cash inflows from the commercialization and
sale of a product. Our inability to complete our programs in a timely
manner or our failure to enter into appropriate collaborative agreements could
significantly increase our capital requirements and could inversely impact our
liquidity. These uncertainties could force us to seek additional,
external sources of financing from time-to-time in order to continue with our
product development strategy. Our ability to raise additional
capital, or to do so on terms reasonably acceptable to us, would jeopardize the
future success of our business.
Contractual Obligations,
page 33
4.
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Please
provide us proposed revised disclosure to be included in your future
filings beginning with your September 30, 2010 Form 10-Q of your table of
contractual obligations to include the annual patent and license
prosecution/maintenance fee due to Baxter Healthcare Corporation and any
other obligations resulting from your license
agreements.
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Set forth
below is proposed disclosure to be included in the Company’s future filings,
beginning with the September 30, 2010 Form 10-Q, of the Company’s table of
contractual obligations. As proposed, the table of contractual obligations
includes the annual patent and license prosecution/maintenance fee due to Baxter
Healthcare Corporation and any other obligations resulting from the Company’s
license agreements.
Jim B.
Rosenberg
Senior
Assistant Chief Accountant
United
States Securities and Exchange Commission
Page 10
of 13
Contractual
obligations
The
following table summarizes our outstanding obligations as of September 30, 2010
and the effect those obligations are expected to have on our liquidity and cash
flows in future periods:
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|
|
|
|
|
|
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Less
than
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|
|
|
|
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More
than
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($
in thousands)
|
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Total
|
|
|
1
year
|
|
|
2
- 3 years
|
|
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4
- 5 years
|
|
|
5
years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Operating
leases
|
|
$ |
1,051 |
|
|
$ |
410 |
|
|
$ |
536 |
|
|
$ |
105 |
|
|
$ |
- |
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Royalty
and license fees
|
|
|
1,625 |
|
|
|
25 |
|
|
|
300 |
|
|
|
800 |
|
|
|
500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Total
|
|
$ |
2,676 |
|
|
$ |
435 |
|
|
$ |
836 |
|
|
$ |
905 |
|
|
$ |
500 |
|
|
|
|
|
|
|
|
|
|
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Our
commitments for operating leases relate to the lease for our corporate
headquarters in New York, New York and our operations center in Boston,
Massachusetts. Our commitments for royalty and license fees relate to
our patent agreement with Baxter Healthcare Corporation and our royalty
agreements with Southern Research Institute and Baxter Healthcare
Corporation.
Notes to Financial
Statements
Note 8. Warrants, page
F-26
5.
|
With
regard to the warrants issued in connection with your December 2009 public
offering, you state that you classified these warrants as derivative
liabilities as they were not indexed to the Company’s own
stock. It appears in the agreement that this may be a result of
anti-dilution provisions. Please provide us proposed revised
disclosure to be included in future filings beginning with your September
30, 2010 Form 10-Q that discusses the key terms of the warrants that led
to the derivative classification. Regarding the valuation of
your warrants using the Black-Scholes model, this model does not appear to
take into account the warrants down-round protection. It
appears to us that the price adjustment feature would add value to the
warrant. Please explain to us why you use the Black-Scholes
option pricing model, instead of a binomial or lattice pricing model to
value your warrants. It appears that binomial or lattice models
are better suited to handle the potential changes to your warrant exercise
price.
|
The warrants issued in connection with the Company’s December 2009
public offering are classified as derivative liabilities not indexed to the
Company’s own stock. This classification is due to warrant provisions
that provide for anti-dilution protection. In its future filings,
beginning with its September 30, 2010 Form 10-Q, the Company will discuss the
key terms of the warrants that led to the derivative classification. In that
regard, proposed revised disclosure is set forth below:
Jim B.
Rosenberg
Senior
Assistant Chief Accountant
United
States Securities and Exchange Commission
Page 11
of 13
Also, in
connection with the December 2009 public offering, the Company issued warrants
to purchase an aggregate of 8,206,520 shares of common stock (including the
investor warrants and 464,520 warrants issued to the Underwriters). The investor
warrants are exercisable immediately and the underwriter warrants exercisable
six months after the date of issuance. The warrants have an exercise price of
$4.02 per share and have a five year term. Subject to certain exceptions, these
warrants provide for anti-dilution protection should common stock or common
stock equivalents be subsequently issued at a price less than the exercise price
of the warrants then in effect.
The
Company assessed whether the warrants require accounting as derivatives and,
based on the anti-dilution protection provided to the warrantholders, determined
that the warrants were not indexed to the Company’s own stock in accordance with
accounting standards codification Topic 815, Derivatives and Hedging. As such,
the Company has concluded the warrants did not meet the scope exception for
determining whether the instruments require accounting as derivatives and should
be classified in liabilities. The fair value of the warrants was
estimated at $22.9 million using a Black-Scholes model with the following
assumptions: expected volatility of 105%, risk free interest rate of 2.14%,
expected life of five years and no dividends.
The
Company believes that the “down-round” antidilution protection to which
warrantholders are entitled has a negligible effect on the valuation of the
warrants. The Company has therefore elected to use the Black-Scholes
option pricing model to value the warrants. However, the Company has undertaken
a valuation of the warrants using a binomial pricing model and will use such
pricing model to value the warrants going forward if the variance in warrant
value resulting from the two pricing models proves to be
significant.
Form 10-K/A for the Fiscal
Year Ended December 31, 2009
Item 11. Executive
Compensation
Summary Compensation Table, page
9
Jim B.
Rosenberg
Senior
Assistant Chief Accountant
United
States Securities and Exchange Commission
Page 12
of 13
6.
|
You
disclose that you are reporting the bonus amounts for your named executive
officers in 2007 and 2008 in the year in which such amounts were paid,
rather than in the year in which such bonus was earned. Your
summary compensation table should reflect in each year’s bonus column the
amount of year-end bonus earned during such year even if the payment was
made in the subsequent year. Please confirm that in future
filings you will report the year-end cash and equity bonuses as paid in
the year during which such bonuses were earned and that you will revise
the compensation for prior years
accordingly.
|
In its
future filings, the Company will report the year-end cash and equity bonuses as
paid in the year during which such bonuses were earned, rather than the year in
which such bonuses were paid (if different), and the Company will revise the
compensation for prior years accordingly.
Item 13. Certain
Relationships and Related Transactions, and Director Independence Related Party
Transactions, page 18
7.
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You
disclose that Riverbank may allocate or may have allocated to Mr.
McInerney a portion of the compensation that it received for serving as a
sub-placement agent. Please advise us whether Riverbank
directly allocated a portion of the consideration for service as a
sub-placement agent in connection with your September 15, 2009 private
placement and, if so, the amount allocated to Mr. McInerney. In
addition, please file a copy of the placement agent agreement as an
exhibit.
|
As set
forth in the 10-K, the Company paid Riverbank Capital Securities, Inc.
(“Riverbank”) approximately $185,000 and issued to Riverbank and its designees
warrants to purchase a total of 65,843 shares of the Company’s common stock, as
compensation for serving as a sub-placement agent in connection with the
Company’s September 15, 2009 private placement. Of such compensation,
Riverbank allocated warrants to purchase 40,298 shares of common stock to Mr.
McInerney.
In
connection with the private placement, the Company entered into a placement
agency agreement with Rodman & Renshaw, LLC, a subsidiary of Rodman &
Renshaw Capital Group, Inc. (“Rodman”), whereby Rodman agreed to serve as
placement agent. Rodman, in turn, engaged Riverbank to serve as a sub-agent
under an agreement to which the Company was not a party. The Company will file a
copy of the placement agency agreement with Rodman as an exhibit to its Form
10-Q for the quarter ending September 30, 2010.
Jim B.
Rosenberg
Senior
Assistant Chief Accountant
United
States Securities and Exchange Commission
Page 13
of 13
In
connection with this response, the Company hereby acknowledges
that:
|
·
|
that it is responsible for the
adequacy and accuracy of the disclosure in its filings with the
Commission;
|
|
·
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staff comments or changes to
disclosure in response to staff comments do not foreclose the Commission
from taking any action with respect to the filings;
and
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|
·
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The Company may not assert staff
comments as a defense in any proceeding initiated by the Commission or any
person under the federal securities laws of the United
States.
|
Should
you have any questions or comments regarding the foregoing, please direct them
to the undersigned by telephone at (612) 672-8381, or by facsimile at (612)
642-8381; or to Richard E. Bagley, the Company’s President, Chief Operating
Officer and Chief Financial Officer by telephone at (617) 259-1978, or by
facsimile at (617) 241-2855.
Regards,
/s/
Alan M. Gilbert
Alan M.
Gilbert, Esq.
cc: (via
email): |
Dr.
Jonathan Lewis
Richard
Bagley
Tyler
Cook
Kevin
Lafond
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