corresp
[GTx Letterhead]
December 21, 2010
Via EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: |
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Jeffrey Riedler
Johnny Gharib
Jennifer Riegel |
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Re: |
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GTx, Inc.
Form 10-K
Filed March 15, 2010
File No. 000-50549 |
Ladies and Gentlemen:
On behalf of GTx, Inc. (the Company), this letter is being transmitted in response to comments
received from the staff (the Staff) of the Securities and Exchange Commission (the Commission)
by letter dated December 15, 2010 (the Comment Letter) regarding (i) the Companys Annual Report
on Form 10-K for the fiscal year ended December 31, 2009, filed with the Commission on March 15,
2010 (the Form 10-K) and (ii) the Companys Definitive Proxy Statement on Schedule 14A, filed
with the Commission on March 18, 2010 (the Proxy Statement). The text of the Staffs comments has
been included in this response letter in italics for your convenience, and the numbering of the
paragraphs below correspond to the numbering of the Comment Letter.
Form 10-K, filed March 15, 2010
Licenses and Collaborative Relationships, page 14
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You disclose that you have upfront and milestone payments, annual license fees and/or
royalty payments in connection with your license and supply agreement with Orion and your
license agreements with UTRF. Although you have been granted confidential treatment for
certain provisions of these agreements, the material terms of these agreements should be
disclosed in your filing. Please provide draft disclosure to be in included in your 2010
Form 10-K describing the material terms of each agreement, including, but not limited to
the aggregate payments to date, a range of royalty rates not to exceed ten percent and the
remaining aggregate milestone payments. |
Securities and Exchange Commission
December 21, 2010
Page Two
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Response: |
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The Company respectfully submits that it has disclosed the material terms of its license and
supply agreement with Orion and its license agreements with UTRF beginning on page 14 of the
Form 10-K, including a description in each case of the aggregate upfront fees and payments
made to each of Orion and UTRF. The Company also advises the Staff that the Company does not
have any remaining milestone payments due to either Orion or UTRF under these agreements
(apart from its royalty payment obligations). In addition, while the Company continues to
pay royalties to Orion with respect to FARESTON® net sales, FARESTON®
revenue is not significant and therefore disclosure of aggregate royalty payments to Orion
with respect to FARESTON® net sales would not provide additional material
information relevant to an investors investment decision with respect to the Companys
securities. Likewise, the Companys annual license maintenance fees due to UTRF are not
material and disclosure of these amounts would therefore not provide additional material
information relevant to an investors investment decision with respect to the Companys
securities. In response to the Staffs comment, however, the Company will revise its
disclosure of the Orion and UTRF agreements to describe the royalty rate or range of royalty
rates, as applicable, that are payable pursuant to such agreements, as well as the aggregate
royalties paid to date on material sublicense revenue or material product revenue (to the
extent we have received any such amounts as of the applicable reporting period) in future
filings, as reflected in the updated proposed disclosure for the Companys 2010 Form 10-K
under the heading BusinessLicenses and Collaborative Relationships as set forth on
Exhibit A attached hereto. |
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The Company also respectfully notes that it may in the future determine that any of its
agreements with Orion or UTRF are no longer material to its business. To the extent that the
Company makes such a determination, the Company may determine that it is no longer
appropriate or necessary to include disclosure of the material terms of such agreements in
its annual reports on Form 10-K or other SEC filings. |
Intellectual Property, page 19
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We note that with respect to the method of use of toremifene 80 mg and the method of
use of toremifene 20 mg outside of the United States, you have some patents issued and
other pending patent applications. Please provide draft disclosure to be included in your
2010 Form 10-K stating the foreign countries where these patents are issued and where other
patent applications are pending and the expiration dates of the issued foreign patents in
regard to each product. |
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We note that for Ostarine and your other SARMs, you have an exclusive license from UTRF
for two sets of its issued patents and pending patent applications in the United States and
internationally. Please provide draft disclosure to be included in your 2010 Form 10-K
stating the expiration dates for the United States and foreign patents and the countries in
which the foreign patents have been issued or patent applications are pending. |
Securities and Exchange Commission
December 21, 2010
Page Three
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Response: |
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In response to the Staffs comment, commencing with the Companys 2010 Form 10-K, the
Company will enhance its disclosure under the heading BusinessIntellectual Property with
respect to toremifene and SARMs as reflected in the enhanced proposed disclosure as set
forth on Exhibit B attached hereto. |
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The Company also respectfully notes that it may in the future determine to discontinue its
development and any commercialization activities related to toremifene or SARMs and
therefore determine that such product candidates and the related patents and patent
applications are no longer material to its business. To the extent that the Company makes
such a determination, the Company may determine that it is no longer appropriate or
necessary to include disclosure related to such patents and patent applications in its
annual reports on Form 10-K or other SEC filings. |
Proxy Statement on Schedule 14A, filed March 18, 2010
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We note that you have not included any disclosure in response to Item 402(s) of
Regulation S-K. Please advise us of the basis for your conclusion that disclosure is not
necessary and describe the process you undertook to reach that conclusion. |
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Response: |
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The Company respectfully advises the Staff that the Company included disclosure in response
to Item 402(s) under the caption Compensation and Risk on page 46 of the Proxy Statement
to describe for investors why the Company believes that its compensation policies and
practices do not encourage excessive or inappropriate risk-taking by its employees and are
therefore not reasonably likely to have a material adverse effect on the Company. The
Company reached this disclosure conclusion in connection with the preparation of the Proxy
Statement after consideration of each element of its compensation program and an analysis of
whether that element (individually or collectively) would incent Company employees to
undertake excessive or inappropriate risk-taking. |
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Where applicable in future filings, the Company will provide appropriate disclosures
pursuant to Item 402(s) of Regulation S-K if the Company determines that the risks arising
from its compensation policies and practices for its employees are reasonably likely to have
a material adverse effect on the Company. |
* * * * *
The Company further acknowledges that:
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the Company is responsible for the adequacy and accuracy of the disclosure in the
filings; |
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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 |
Securities and Exchange Commission
December 21, 2010
Page Four
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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. |
Please do not hesitate to contact me at (901) 507-6916 or Chad Mills at (650) 843-5654 of Cooley
LLP, outside counsel to the Company, if you have any questions or would like additional information
regarding these matters.
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Sincerely,
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/s/ Henry P. Doggrell
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Henry P. Doggrell |
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Vice President and General Counsel
GTx, Inc. |
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cc: |
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Mitchell S. Steiner, Chief Executive Officer
Marc S. Hanover, President and Chief Operating Officer
Chadwick L. Mills, Cooley llp |
EXHIBIT A
Orion Corporation
In March 2000, we entered into a license and supply agreement with Orion to develop and
commercialize products containing toremifene. Our rights under the original license agreement were
limited to specific disease fields pertaining to prostate cancer. In December 2004, we entered into
an agreement with Orion to purchase specified FARESTON® related assets which Orion had
re-acquired from another licensee. We also entered into an amended and restated license and supply
agreement in January 2005 with Orion which replaced the original license agreement. We paid Orion
approximately $5.2 million under the 2004 agreements for the assets and related license rights.
Under the amended and restated license and supply agreement, we obtained an exclusive license
from Orion to develop and commercialize toremifene-based products for all human indications
worldwide, except breast cancer outside of the United States. We are required to pay Orion a
portion of certain types of upfront and milestone income that we receive from third-party
sublicensees, after we recover our clinical development costs, and a low double-digit royalty on
sales by us and our affiliates of FARESTON® for breast cancer in the United States. We are also
required to pay Orion a low double-digit royalty on sales by us, our affiliates and third-party
sublicensees of other toremifene-based products, including toremifene 80 mg and toremifene 20 mg if
approved for commercial sale. Our license and supply agreement with Orion requires that Orion will
manufacture and supply all of our and our sublicensees needs for clinical trial and commercial
grade material for toremifene-based products developed and marketed in the United States and
abroad, including toremifene globally and FARESTON® in the United States. Orion has the
right to terminate its supply obligations at its election at any time as a result of our failure to
obtain regulatory approval of one of our toremifene product candidates in the United States prior
to December 31, 2009, in which event we will have the right to enter into a contract manufacturing
agreement with another supplier for toremifene-based products. However, any arrangements we make
for an alternative supply would have to be made with a qualified alternative supplier with
appropriate FDA approval in order for us to obtain our supply requirements for toremifene. The term
of the amended and restated license and supply agreement lasts, on a country-by-country basis,
until the later of expiration of our own patents claiming the processes or the methods of use of
toremifene for prostate cancer or the end of all marketing or regulatory exclusivity which we may
obtain for toremifene-based products. The term of our method of use patents pertaining to
toremifene for prostate cancer extend from 2019 to 2022. Orion may terminate the amended and
restated license and supply agreement, on a country-by-country basis, as a result of our uncured
material breach, including under certain circumstances if we decided not to commercially launch
toremifene in any major country after we obtain regulatory approval in such country, or our
bankruptcy. Following the termination of the amended and restated license and supply agreement by
Orion for our material breach, we will grant a royalty-bearing license to Orion to enable Orion to
continue the development and commercialization of toremifene-based products in the countries in
which the agreement is terminated.
University of Tennessee Research Foundation
In July 2007, we and UTRF entered into a consolidated, amended and restated license agreement,
or the SARM License Agreement, to consolidate and replace our two previously existing SARM license
agreements with UTRF and to modify and expand certain rights and obligations of each of the parties
under both license agreements. Pursuant to the SARM License Agreement, we were granted exclusive
worldwide rights in all existing SARM technologies owned or controlled by UTRF, including all
improvements thereto, and exclusive rights to future SARM technology that may be developed by
certain scientists at the University of Tennessee or subsequently licensed to UTRF under certain
existing inter-institutional agreements with The Ohio State University. Unless terminated earlier,
the term of the SARM License Agreement will continue, on a country-by-country basis, for the longer
of 20 years or until the expiration of the last valid claim of any licensed patent in the
particular country in which a licensed product is being sold. UTRF may terminate the SARM License
Agreement for our uncured breach or upon our bankruptcy.
A-1
In September 2007, we and UTRF entered into an amended and restated license agreement, or the
SERM License Agreement, to replace our previously existing exclusive worldwide license agreement
for toremifene. Pursuant to the SERM License Agreement, we were granted exclusive worldwide rights
to UTRFs method of use patents relating to SERMs, including toremifene for chemoprevention of
prostate cancer as well as future related SERM technologies that may be developed by certain
scientists at the University of Tennessee. Unless terminated earlier, the term of the SERM License
Agreement will continue, on a country-by-country basis, in a particular country for the longer of
20 years from the effective date of our previously existing exclusive worldwide license agreement
with UTRF for toremifene or until the expiration of the last valid claim of any licensed patent in
such country. UTRF may terminate the SERM License Agreement for our uncured breach or upon our
bankruptcy.
Under the SARM License Agreement and the SERM License Agreement, or together, the UTRF License
Agreements, we paid UTRF a one-time, upfront fee of $290,000 per UTRF License Agreement as
consideration for entering into the UTRF License Agreements. We are also obligated to pay UTRF
annual license maintenance fees and low to mid single digit royalties on sublicense revenues and
net sales of products. During the year ended December 31, 2007, we paid UTRF a sublicense royalty
of approximately $1.9 million as a result of our previous collaboration with Merck. We also agreed
to pay all expenses to file, prosecute and maintain the patents relating to the licensed SARM and
SERM technologies, and are obligated to use commercially reasonable efforts to develop and
commercialize products based on the licensed SARM and SERM technologies.
In December 2008, we and UTRF amended the UTRF License Agreements, or together, the License
Amendments, to, among other things, clarify the treatment of certain payments that we may receive
from our current and future sublicensees for purposes of determining sublicense fees payable to
UTRF, including the treatment of payments made to us in exchange for the sale of our securities in
connection with sublicensing arrangements. In consideration for the execution of the License
Amendments, we paid UTRF an aggregate of $540,000.
A-2
EXHIBIT B
For toremifene in the United States and internationally, we have entered into an amended
and restated license and supply agreement with Orion Corporation granting us an exclusive license
under Orions patents covering the composition of matter of toremifene for all uses in humans in
the United States, and for all human uses outside the United States other than the treatment and
prevention of breast cancer. However, Orions patent for toremifene expired in the United States in
September 2009 and foreign counterparts of this patent also have expired. As a result, we will need
to rely primarily on the protection afforded by the method of use patents that either have been
already issued or may later issue from our owned or licensed patent applications.
We have licensed from UTRF method of use patents and pending patent applications for specific
disease indications and doses in the United States, and have licensed issued and pending patent
applications in a number of countries in Europe, Asia and in other jurisdictions internationally
related to the use of toremifene 20 mg for the reduction in the incidence of prostate cancer in
high risk men with high grade PIN. The method of use patents issued in the United States related to
the use of toremifene for this indication that we licensed from UTRF will expire between 2019 and
2022. The method of use patents that we licensed from UTRF related to the use of toremifene for
this indication and issued outside of the United States will expire between 2019 and 2020.
We have our own method of use patents and patent applications in the United States and in a
number of countries in Europe, Asia and in other jurisdictions internationally related to the use
of toremifene 80 mg for the treatment of osteoporosis and reduction of fractures in men with
prostate cancer treated by ADT, as well as other side effects from ADT such as gynecomastia and hot
flashes. Our method of use patent issued in the United States related to the use of toremifene for
the treatment of ADT-induced osteoporosis and fractures in men with prostate cancer will expire in
2022. Our method of use patents issued outside of the United States related to the use of
toremifene 80 mg for the treatment of osteoporosis and fractures and other side effects of ADT in
men with prostate cancer will also expire in 2022. We own pending patent applications in the United
States and a number of countries in Europe, Asia and in other jurisdictions internationally related
to the method of use of toremifene 80 mg for the treatment of ADT-induced osteoporosis and
fractures in men with prostate cancer that, if issued, would expire between 2022 and 2026.
Even though patents have issued in respect of our owned and licensed pending method of use
patent applications, since patents covering the composition of matter of toremifene have expired,
competitors could market and sell generic versions of toremifene at doses and in formulations that
are bioequivalent to FARESTON® (toremifene citrate 60 mg) for uses other than
the indications for toremifene covered by our issued and pending method of use patent applications,
and individual physicians would be permitted to prescribe generic versions of toremifene 60 mg for
indications that are protected by our or our licensors method of use patents and pending patent
applications. Assuming toremifene receives appropriate marketing approval, if patents do not issue
in a particular country on account of our pending method of use patent applications related to the
use of toremifene 80 mg for the treatment of osteoporosis and fractures and other side effects of
ADT in men with prostate cancer, and the use of toremifene 20 mg for the reduction in the incidence
of prostate cancer in high risk men with high grade PIN outside the United States, competitors may
be able to market and sell generic versions of toremifene tablets for these indications in that
country.
For Ostarine and our other SARMs, we have an exclusive license from UTRF under its issued
patents and pending patent applications in the United States and in a number of countries in
Europe, Asia and in other jurisdictions internationally covering the composition of matter of the
active pharmaceutical ingredient in these product indications, pharmaceutical compositions and
methods of synthesizing the active pharmaceutical ingredients. We have also exclusively licensed
from UTRF issued and pending patent applications in the United States and in a number of countries
in Europe, Asia and in other jurisdictions internationally related to methods for building muscle
mass and bone in patients, for treating bone related disorders including bone frailty and
osteoporosis, and for treating muscle wasting disorders, including cancer cachexia using Ostarine
and other SARMs. The patents we licensed from UTRF and issued in the United States for Ostarine and
our other SARMs expire between 2017 and 2030, and the patents we licensed from UTRF and issued
outside of the United States expire between 2017 and 2028.
B-1