exv10w3



 





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

Model 09-2006
	 	Draft Repros Therapeutics Inc

Page 1 of 5
	 	February 27, 2007

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

CONFIDENTIAL

Fifth Amendment of L-354-1998/0

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	 	Draft Repros Therapeutics Inc

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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



	 	 	 	 	 
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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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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

Fifth Amendment of L-354-1998/0

Model 09-2006
	 	Draft Repros Therapeutics Inc

Page 5 of 5
	 	February 27, 2007

L-354-1998/5