8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 7, 2009

Repros Therapeutics Inc.

(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction
of incorporation) 001-15281
(Commission
File Number) 76-0233274
(I.R.S. Employer
Identification No.)

2408 Timberloch Place, Suite B-7
The Woodlands, Texas 77380
(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (281) 719-3400

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 1.01. Entry into a Material Definitive Agreement.

     On July 7, 2009, Repros Therapeutics Inc., a Delaware corporation (the “Company”), entered into the Sixth Amendment (the “Amendment”) to the Agreement by and between the National Institutes of Health or the Food and Drug Administration agencies of the United States Public Health Service within the Department of Health and Human Services (collectively, the “Public Health Service” or “PHS”) and the Company (as previously amended, the “Agreement”).

     The Amendment clarified that certain cancers related to the human reproductive system are within the scope of the licensed field, amended the development and commercialization benchmarks to be met and added or modified certain milestone payments due to NIH on the achievement of certain benchmarks. In particular, the Amendment revised the dates by which certain development and commercialization benchmarks must be met. These revisions include an extension of the date by which the Company is required to file an NDA covering a licensed product in the United States for a first indication from June 30, 2009 to June 30, 2011. In addition, under the amended Agreement, the Company is required to obtain financing, upfront licensing consideration, or any combination thereof, of no less than a combined total of $6,000,000 by September 30, 2009. The Amendment also (1) extended the dates by which certain other benchmarks must be met, including benchmarks relating to filing for approval of a licensed product in Europe and Japan, the filing of an NDA for a licensed product in a second indication in the United States, and the application for regulatory approval of a licensed product in a second indication in Europe and Japan, and (2) added benchmarks relating to initiation of Phase 3 clinical trials in Europe and Japan for licensed product in a second indication. Failure to meet these benchmarks could result in modification or termination of the Agreement. The Company paid PHS an amendment issue royalty in the amount of $100,000 in connection with entering into the Amendment.

     The foregoing description of the Amendment is qualified in its entirety by reference to the actual amendment filed herewith as Exhibit 10.1 which exhibit is incorporated herein by reference.

Item 8.01. Other Events.

     On July 8, 2009, the Company issued a press release titled “Repros Therapeutics Inc. Announces Amendment to NIH License Agreement,” a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) The following exhibit is furnished with this report:

Exhibit Number	Description
10.1	Sixth Amendment to PHS Patent License Agreement, as amended, dated July 7, 2009 between the Company and certain agencies of the United States Public Health Service within the Department of Health and Human Services. *
99.1	Press Release dated July 8, 2009

* Portions omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

SIGNATURES

     Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

REPROS THERAPEUTICS INC.
By:	/s/ Louis Ploth, Jr.
	Louis Ploth, Jr.
	Chief Financial Officer

Date: July 9, 2009

EXHIBIT INDEX

Exhibit Number	Description
10.1	Sixth Amendment to PHS Patent License Agreement, as amended, dated July 7, 2009 between the Company and certain agencies of the United States Public Health Service within the Department of Health and Human Services. *
99.1	Press Release dated July 8, 2009

* Portions omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

EX-10.1

Exhibit 10.1

Confidential Treatment Requested

PUBLIC HEALTH SERVICE

SIXTH AMENDMENT TO L-354-1998/0

This is the sixth amendment (“Sixth Amendment”) of the agreement by and between the National Institutes of Health (“NIH”) or the Food and Drug Administration (“FDA”), hereinafter singly or collectively referred to as agencies of the United States Public Health Service (“PHS”) within the Department of Health and Human Services (“HHS”), and Zonagen, Inc. having an effective date of April 16,1999, and having NIH Reference Number L-354-1998/0 (“Agreement”). This Sixth Amendment, having NIH Reference Number L-354-1998/6, is made between the PHS through the Office of Technology Transfer, NIH, having an address at 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804, U.S.A., and Repros Therapeutics, Inc., having an office at 2408 Timberloch Place, Suite B-7, The Woodlands, Texas 77280 (“Licensee”). This Sixth Amendment includes, in addition to the amendments made below, 1) a Signature Page and 2) Attachment 1 (Royalty Payment Information).

WHEREAS, PHS and Licensee desire that the Agreement be amended a sixth time as set forth below in order to change its Appendix B-Licensed Fields-of-Use and Licensed Territory, Appendix C—Royalties, and Appendix E-Benchmarks and Performance.

NOW, THEREFORE, in consideration of the mutual covenants and promises contained herein, PHS and Licensee, intending to be bound, hereby mutually agree to the following:

1) Replace Appendix B in the Agreement, as amended, with Appendix B as follows:

Licensed Fields-of-Use: Treatment of human endocrinologic pathologies or conditions in steroid-sensitive tissues, including cancers related to the human reproductive system.

Licensed Territory: Worldwide.

2) Replace Appendix C, I.) (ii) c through g with the following:

c.	[**] within thirty(30) days of filing the first New Drug Application for a Licensed Product with the United States FDA.
d.	[**] within thirty(30) days of filing the first new drug application for a Licensed Product with the appropriate agency or regulatory body of any European country.
e.	[**] within thirty(30) days of filing the first new drug application for a Licensed Product with the appropriate Agency or regulatory body in Japan.
f.	[**] within thirty (30) days of receipt of the first marketing approval for a Licensed Product from the United States FDA.
g.	[**] within thirty (30) days of receipt of the first marketing approval for a Licensed Product from the appropriate agency or regulatory body of any European country.
h.	[**] within thirty (30) days of receipt of the first marketing approval for a Licensed Product from the appropriate agency or regulatory body in Japan.

A-285-2009		CONFIDENTIAL
Sixth Amendment of L-354-1998/0	Final REPROS THERAPEUTICS, INC.	July 7, 2009
Model 09-2006 (updated 3-2009)	Page 1 of 5	L-354-1998/6

Portions of this Exhibit have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, and Rule 406 under the Securities Act of 1933, as amended. These omitted portions have been marked with “**” and have been filed separately with the Securities and Exchange Commission.

SIXTH AMENDMENT TO L-354-1998/0

3) Replace Appendix E in the Agreement, as amended, with Appendix E as follows:

Licensee agrees to the following Benchmarks for the purpose of measuring its performance under this Agreement. Licensee shall notify PHS in writing within thirty (30) days of achieving all such Benchmarks. They are as follows:

	Benchmark	Date
1.	Obtain financing, upfront licensing consideration, or any combination thereof (all of which are subject to section 1(vi) of Appendix C of this Agreement) of no less than a combined total of Six Million Dollars ($6,000,000)		9/30/2009
2.	File NDA in U.S. for first indication		06/30/2011
3.	File for approval of Licensed Product in Europe for first indication		[**]
4.	File for approval of Licensed Product in Japan for first indication		[**]
5.	Initiate Phase III clinical trial in U.S. for second indication	Completed
6.	Initiate Phase III clinical trial in Europe for second indication		[**]
7.	Initiate Phase III clinical trial in Japan for second indication		[**]
8.	File NDA in U.S. for second indication		[**]
9.	File for approval of Licensed Product in Europe for second indication		[**]
10.	File for approval of Licensed Product in Japan for second indication		[**]

4)	Within thirty (30) days of the execution of this Sixth Amendment, Licensee shall pay PHS an amendment issue royalty in the sum of One Hundred Thousand US Dollars ($100,000), to be sent to the address specified in Attachment 1.
5)	In the event any provision(s) of the Agreement is/are inconsistent with Attachment 1, such provision(s) is/are hereby amended to the extent required to avoid such inconsistency and to give effect to the shipping and payment information in such Attachment 1.
6)	All terms and conditions of the Agreement not herein amended remain binding and in effect.
7)	The terms and conditions of this Amendment shall, at PHS’ sole option, be considered by PHS to be withdrawn from Licensee’s consideration and the terms and conditions of this Amendment, and the Amendment itself to be null and void, unless this Amendment is executed by the Licensee and a fully executed original is received by PHS within sixty (60) days from the date of PHS signature found at the Signature Page.
8)	This Sixth Amendment is effective upon execution by all parties.

SIGNATURES BEGIN ON NEXT PAGE

A-285-2009		CONFIDENTIAL
Sixth Amendment of L-354-1998/0	Final REPROS THERAPEUTICS, INC.	July 7, 2009
Model 09-2006 (updated 3-2009)	Page 2 of 5	L-354-1998/6

Portions of this Exhibit have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, and Rule 406 under the Securities Act of 1933, as amended. These omitted portions have been marked with “**” and have been filed separately with the Securities and Exchange Commission.

SIXTH AMENDMENT TO L-354-1998/0

SIGNATURE PAGE

In Witness Whereof, the parties have executed this Sixth Amendment on the dates set forth, below. Any communication or notice to be given shall be forwarded to the respective addresses listed below.

For PHS:
/s/ Mark L. Rohrbaugh	7/7/09
Mark L. Rohrbaugh, Ph.D., J.D.	Date
Director
Office of Technology Transfer
National Institutes of Health

Mailing Address for Agreement notices:

Chief, Monitoring & Enforcement Branch, DTDT
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, Maryland 20852-3804 U.S.A.

For Licensee (Upon, information and belief, the undersigned expressly certifies or affirms that the contents of any statements of Licensee made or referred to in this document are truthful and accurate.):

by:
/s/ Joseph S. Podolski	7/7/09
Joseph S. Podolski	Date
Chief Executive Officer

Official and Mailing Address for Agreement notices:

Joseph S. Podolski
Chief Executive Officer
Repros Therapeutics, Inc.
2408 Timberloch Place
Suite B-7
The Woodlands, Texas 77380

Email Address:
Telephone:
Fax:

A-285-2009		CONFIDENTIAL
Sixth Amendment of L-354-1998/0	Final REPROS THERAPEUTICS, INC.	July 7, 2009
Model 09-2006 (updated 3-2009)	Page 3 of 5	L-354-1998/6

Portions of this Exhibit have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, and Rule 406 under the Securities Act of 1933, as amended. These omitted portions have been marked with “**” and have been filed separately with the Securities and Exchange Commission.

Official and Mailing Address for Financial notices (Licensee’s contact person for royalty payments):

Louis Ploth
CFO and VP, Business Development
Repros Therapeutics, Inc.
2408 Timberloch Place
Suite B-7
The Woodlands, Texas 77380

Email Address:
Telephone:
Fax:

Any false or misleading statements made, presented, or submitted to the Government, including any relevant omissions, under this Agreement and during the course of negotiation of this Agreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. §§3801-3812 (civil liability) and 18 U.S.C. §1001 (criminal liability including fine(s) or imprisonment).

A-285-2009		CONFIDENTIAL
Sixth Amendment of L-354-1998/0	Final REPROS THERAPEUTICS, INC.	July 7, 2009
Model 09-2006 (updated 3-2009)	Page 4 of 5	L-354-1998/6

Portions of this Exhibit have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, and Rule 406 under the Securities Act of 1933, as amended. These omitted portions have been marked with “**” and have been filed separately with the Securities and Exchange Commission.

ATTACHMENT 1 — ROYALTY PAYMENT OPTIONS

NIH/PHS License Agreements

*In order to process payment via Electronic Funds Transfer sender MUST supply the following information:

Procedure for Transfer of Electronic Funds to NIH for Royalty Payments

Bank Name:

NOTE: Only U.S. banks can wire directly to the Federal Reserve Bank, Foreign banks cannot wire directly to the Federal Reserve Bank, but must go through an intermediary U.S. bank. Foreign banks may send the wire transfer to the U.S. bank of their choice, who, in turn forwards the wire transfer tothe Federal Reserve Bank.

Checks drawn on a U.S. bank account should be sent directly to the following address:

National Institutes of Health (NIH)

Overnight or courier deliveries should be sent to the following address:

Checks drawn on a foreign bank account should be sent directly to the following address:

National Institutes of Health (NIH)
Office of Technology Transfer
Royalties Administration Unit

All checks should be made payable to “NIH Patent Licensing”.

The OTT Reference Number MUST appear on checks, reports and correspondence

A-285-2009		CONFIDENTIAL
Sixth Amendment of L-354-1998/0	Final REPROS THERAPEUTICS, INC.	July 7, 2009
Model 09-2006 (updated 3-2009)	Page 5 of 5	L-354-1998/6

Portions of this Exhibit have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, and Rule 406 under the Securities Act of 1933, as amended. These omitted portions have been marked with “**” and have been filed separately with the Securities and Exchange Commission.

EX-99.1

Exhibit 99.1

Repros Therapeutics Inc. Announces Amendment to NIH License Agreement

The Woodlands, Texas — July 8, 2009. Repros Therapeutics, Inc. (Nasdaq Global Market: RPRX) (“Repros” or the “Company”) today announced that it entered into the Sixth Amendment to its Agreement (the “Agreement”) with the National Institutes of Health (“NIH”) (the “Amendment”) relating to the Company’s lead product Proellex. The Amendment clarified that certain cancers related to the human reproductive system are within the scope of the licensed field, amended the development and commercialization benchmarks that the Company is required to meet under the Agreement and added or modified certain milestone payments due to NIH on the achievement of certain benchmarks.

Most significantly, the Amendment revised the dates by which certain development and commercialization benchmarks must be met. These revisions include an extension of the date by which the Company is required to submit to the Food and Drug Administration a new drug application (“NDA”) covering a licensed product in the United States for a first indication from June 30, 2009 to June 30, 2011. Notwithstanding this extension, as previously reported, Repros remains committed to its target date for an initial submission of an NDA for Proellex in the second half of 2010.

In addition, under the Amendment, the Company is required to obtain financing, upfront licensing consideration, or any combination thereof, of no less than a combined total of $6,000,000 by September 30, 2009. The Amendment also (1) extended the dates by which certain other benchmarks must be met, including benchmarks relating to filing for approval of a licensed product in Europe and Japan, the filing of an NDA for a licensed product in a second indication in the United States, and the application for regulatory approval for a licensed product in a second indication in Europe and Japan, and (2) added benchmarks relating to initiation of Phase 3 clinical trials in Europe and Japan for a licensed product in a second indication. Failure to meet these benchmarks could result in modification or termination of the Agreement. The Company is obligated to pay NIH an amendment issue royalty in the amount of $100,000 in connection with the Amendment.

A copy of the Amendment will be filed as an Exhibit to a Current Report on Form 8-K to be filed by the Company with the Securities and Exchange Commission and the foregoing summary of certain terms of the Amendment is qualified in its entirety by reference to the actual Amendment.

About Repros Therapeutics

Repros focuses on the development of oral small molecule drugs for major unmet medical needs associated with male and female reproductive disorders.

Our lead drug, Proellex®, is a selective blocker of the progesterone receptor and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. We are also developing Proellex as a short course pre-surgical treatment for anemia associated with excessive menstrual bleeding related to uterine

- more -

fibroids. There is no currently approved orally administered drug for the long-term treatment of uterine fibroids or endometriosis. In the United States alone, 300,000 women per year undergo a hysterectomy as a result of severe uterine fibroids.

Our second product candidate, Androxal®, is a single isomer of clomiphene citrate and is an orally active proprietary small molecule compound. We are developing Androxal for men of reproductive age with low testosterone levels who want to improve or maintain their fertility and/or sperm function while being treated for low testosterone. In November 2008, we received guidance from the FDA related to the submission of a new investigational new drug application (“IND”) to the Division of Metabolic and Endocrine Products (“DMEP”) for the investigation of Androxal as a potential treatment for type 2 diabetes. We plan to submit a new IND for this indication to the DMEP as soon as practicable.

Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Repros’ ability to achieve any of the benchmarks contained in the Agreement or the Amendment, Repros’ ability to have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical trials and the accuracy or results of such trials, the timing of submission of NDAs, limited patient populations of clinical trials to date and the possibility that final data may not be consistent with interim data, Repros’ ability to raise additional capital in a timely manner and on acceptable terms or at all and such other risks which are identified in the Company’s most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

For more information, please visit the Company’s website at http://www.reprosrx.com.

Contact:	Dr. Paul Lammers
	President
	(713) 294-2380