Document:

exv10w1

 

Exhibit 10.1

L-354-98/4

FOURTH AMENDMENT TO PATENT LICENSE AGREEMENT

     Effective the date of signature of the last party to sign this fourth amendment to license
L-354-98/0 (“Fourth Amendment”), the Public Health Service (“PHS”), through the Office of
Technology Transfer of the National Institutes of Health, having its principal office at 6011
Executive Boulevard, Suite 325, Rockville, Maryland 20852, U.S.A., and Zonagen, Inc. (“Licensee”),
a Delaware corporation, having its principal office at 2408 Timberloch Place, Suite B-4, The
Woodlands, Texas 77280, agree as follows:

W H E R E A S:

     PHS and Licensee entered into a license agreement (L-354-98/0) on April 16, 1999 (hereinafter
referred to as “Agreement”), which was amended June 25, 1999, August 7, 2000, and July 11, 2002.

     The Agreement by and between PHS and Licensee granted Licensee an exclusive license under the
Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to
sell and have sold, to offer to sell, and to import Licensed Products in the Licensed Fields-of-Use
and to practice and have practiced any Licensed Processes in the Licensed Field-of-Use.

     The Licensee and PHS now wish to amend the Agreement a fourth time to facilitate the
development of Licensed Products under the Licensed Patent Rights.

NOW THEREFORE:

	 	1.	 	Insert a new paragraph 14.18 as follows:

“Upon receipt of a one hundred twelve thousand and five dollar ($112,005) royalty,
PHS agrees to supply Licensee with eighty-five (85) grams of material produced under
the Licensed Patent Rights, for Licensee use, under the terms and conditions of the
Agreement. For purposes of this Fourth Amendment, such material shall mean
eighty-five (85) grams of 17a-Acetoxy- 1113-(4-N, N dimethylaminophenyl)-2
I-methoxy- 19-norpregna-4, 9-diene-3, 20-dione (also known as “CDB-4124B”), as
supplied by the National Institute of Child Health and Human Development at the
National Institutes of Health”;

	 	2.	 	This Amendment shall become effective immediately upon execution by all
Parties;
	 
	 	3.	 	Except as set forth herein and the previous three amendments, the Agreement
shall continue unchanged and in full force and effect; and
	 
	 	4.	 	This Amendment may be executed in multiple counterparts, each of which so
executed shall be deemed to be an original, but all such counterparts shall together
constitute but one and the same Amendment.

 

 

     Unless otherwise defined in this Fourth Amendment, terms in bold print shall have meaning as
defined in the Agreement. In all other respects, the Agreement is confirmed and ratified.

SIGNATURES BEGIN ON NEXT PAGE

2

 

SIGNATURE PAGE

     IN WITNESS WHEREOF, the parties hereto have caused this Fourth Amendment to be executed by
their duly authorized representatives as of the last signature date below.

	 	 	 	 	 	 	 
	 	 	FOR PUBLIC HEALTH SERVICE:
	 
	 	 	 	 	 	 
	 

	 	By:
	 	/s/ Steven M. Ferguson	 	 
	 

	 	 	 	 	 	 
	 

	 	 	 	Steven M. Ferguson	 	 
	 

	 	 	 	Director, Division of Technology	 	 
	 

	 	 	 	Development and Transfer	 	 
	 

	 	 	 	National Institutes of Health	 	 
	 
	 	 	 	 	 	 
	 

	 	Date:
	 	    12/5/03	 	 
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	Mailing Address for Notices:
	 
	 	 	 	 	 	 
	 	 	Office of Technology Transfer
	 	 	National Institutes of Health
	 	 	6011 Executive Boulevard
	 	 	Rockville, Maryland 20852-3804
	 
	 	 	 	 	 	 
	 	 	FOR LICENSEE:
	 
	 	 	 	 	 	 
	 

	 	By:
	 	/s/ Joseph S. Podolski	 	 
	 

	 	 	 	 	 	 
	 

	 	Name:

Title:
	 	Joseph S. Podolski
President	 	 
	 
	 	 	 	 	 	 
	 

	 	Date:
	 	    12/9/03	 	 
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	Mailing Address for Notices:
	 
	 	 	 	 	 	 
	 	 	Zonagen, Inc.
	 	 	2408 Timberloch Place
	 	 	Suite B-10
	 	 	The Woodlands, Texas 77380

3exv10w2

 

Exhibit 10.2

[LETTERHEAD FOR NIH OFFICE OF TECHNOLOGY TRANSFER]

March 8, 2007

Dr. Ronald D. Wiehle, Ph.D.

Vice President of Research and Development

Repros Therapeutics, Inc.

2408 Timberloch Place, B-7

The Woodlands, Texas 77380

			
	Subject:	 	Waiver of United States Manufacturing Requirement
under PHS License L-354-1998/0 
to Repros
Therapeutic, Inc. for E-016-1996/0 “21-Substituted
Progesterone Derivatives as 
New Antiprogestational
Agents” developed by Hyun K. Kim et al at NICHD.

Dear Dr. Wiehle:

     Your request for a waiver of the U.S. manufacturing requirement for the above-captioned
technology, as presented to this office in your January 18, 2007 letter to PHS has been evaluated.
The determination is to grant this waiver, based on the assertions made by Repros Therapuetics,
Inc. (Repros) that it would be expensive and difficult to set up and arrange production in the
United States of the ProllexTM CDB4124 derived from the above referenced technology and
that product quality would be adversely affected.

     Thus, in accordance with and relying on representations made by Repros, OTT grants a waiver of
the U.S. manufacturing requirement (35 U.S.C. § 204) to Repros. Repros shall be permitted to make,
produce or otherwise manufacture the ProllexTM CDB4124 using the above referenced
technology outside the United States (U.S.) and to sell inside the U.S.

     This waiver shall be in full force and effect as of the date of this letter, and shall remain
in effect for the term of PHS license L-354-1998/0, unless license L-354-1998/0 is sooner
terminated.

     If I may be of further assistance, please contact me.

	 	 	 	 	 
	 	Sincerely yours, 

 	 
	 	/s/ Steven M. Ferguson
 	 
	 	Steven M. Ferguson, M.B.A. 	 
	 	Director, Division of Technology Development
and Transferexv10w3

 

Exhibit 10.3

CONFIDENTIAL TREATMENT REQUESTED

PUBLIC HEALTH SERVICE

FIFTH AMENDMENT TO L-354-1998/0

This is the fifth amendment (“Fifth 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 (“PHS”), agencies of the United States Public Health Service within the
Department of Health and Human Services (“HHS”), and Repros Therapeutics Inc., formerly known as
Zonagen having an effective date of April 16, 1999 and having NIH Reference Number L-354-1998/0
(“Agreement”). This Fifth Amendment, having NIH Reference Number L-354-1998/5, 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 Timbeloch Place, Suite B-7, The Woodlands, TX 77280 (“Licensee”). This Fifth 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 fifth time as set forth below.

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 E-BENCHMARKS AND PERFORMANCE 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. 	 	 	Initiate Phase III Clinical trials in U.S. for first indication

	 	[ ** ]
	 	 	 	2. 	 	 	File NDA in the U.S. for first indication

	 	[ ** ]
	 	 	 	3. 	 	 	File for approval Licensed Product in Europe for first indication

	 	[ ** ]
	 	 	 	4. 	 	 	File for approval Licensed Product in Japan for first indication

	 	[ ** ]
	 	 	 	5. 	 	 	Initiate Phase III Clinical trials in U.S. for second indication

	 	[ ** ]
	 	 	 	6. 	 	 	File NDA in the U.S. for second indication

	 	[ ** ]
	 	 	 	7. 	 	 	File for approval Licensed Product in Europe for second indication

	 	[ ** ]
	 	 	 	8. 	 	 	File for approval Licensed Product in Japan for second indication

	 	[ ** ]

	 	2)	 	Within thirty (30) days of the execution of this Fifth Amendment, Licensee shall pay PHS an
amendment issue royalty in the sum of Five Thousand US Dollars ($5,000), to be sent to the
address specified in Attachment 2.

	 	3)	 	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.

	 	 	 	 	 
	A-382-2006	 	 	 	 
	CONFIDENTIAL	 	 	 	 
	Fifth Amendment of L-354-1998/0

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L-354-1998/5

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.

 

 

	 	4)	 	All terms and conditions of the Agreement not herein amended remain binding and in effect.

	 	5)	 	This Fifth Amendment is effective on upon execution by all parties.

SIGNATURES BEGIN ON NEXT PAGE

	 	 	 	 	 
	A-382-2006

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L-354-1998/5

 

 

FIFTH AMENDMENTTO L-354-1998/0

SIGNATURE PAGE

In Witness Whereof, the parties have executed this Fifth 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/ Steven M. Ferguson
 

	 	3/13/07
 

	Steven M. Ferguson

	 	Date
	Director, Division of Technology Development and Transfer
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/ Ronald Wiehle

 

	 	3/15/07

 

	Signature of Authorized Official

	 	Date

Name: Ronald Wiehle

Title:

	 	I.	 	Official and Mailing Address for Agreement notices:

Repros Therapeutics Inc.

2408 Timberloch Place, B-7

The Woodlands, TX 77380

281-719-3400

	 	 	 	 	 
	A-382-2006

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

	 	 	 	 	 
	 

	 	Louis Ploth, Jr.
	 	 
	 

	 	 	 	 
	 

	 	Name	 	 
	 
	 	 	 	 
	 

	 	VP, Business Development & CFO
	 	 
	 

	 	 	 	 
	 

	 	Title	 	 
	 
	 	 	 	 
	 

	 	Mailing Address:
	 	 
	 
	 	 	 	 
	 

	 	Repros Therapeutics Inc.	 	 
	 

	 	 	 	 
	  
	 	 	 	 
	 

	 	2408 Timberloch Place, B-7	 	 
	 
	 	 
	 
	 	 	 	 
	 
	 	 	 	 
	 

	 	The Woodlands, TX 77380	 	 
	 

	 	 	 	 
	 
	 	 	 	 
	 
	 	 	 	 
	 

	 	 
	 	 

	 	 	 	 	 
	 

	 	Email Address:
	 	Omitted.
	 
	 	 	 	 
	 

	 	Phone:
	 	Omitted.
	 
	 	 	 	 
	 

	 	Fax:
	 	Omitted.

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-382-2006

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L-354-1998/5

 

 

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: This has been omitted from this copy.

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 to the Federal Reserve Bank.

Mailing Address for Royalty Payments:

National Institutes of Health

Omitted from this copy.

Overnight Mail for Royalty Payments only:

Omitted from this copy.

Please make checks payable to: NIH/Patent Licensing.

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

	 	 	 	 	 
	A-382-2006

CONFIDENTIAL

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L-354-1998/5

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