-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, NrMuADHzn8MMmkY6cu5XTMG/VnvUZ+aY6WgrwbGKCTYOdg2w4Q1QZVyGW1lTinv4 T8vE4s7Z0mVHqtmcS2sCHQ== 0000950129-07-001468.txt : 20070320 0000950129-07-001468.hdr.sgml : 20070320 20070320155716 ACCESSION NUMBER: 0000950129-07-001468 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20070315 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070320 DATE AS OF CHANGE: 20070320 FILER: COMPANY DATA: COMPANY CONFORMED NAME: REPROS THERAPEUTICS INC. CENTRAL INDEX KEY: 0000897075 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 760233274 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-15281 FILM NUMBER: 07706465 BUSINESS ADDRESS: STREET 1: 2408 TIMBERLOCH PL STREET 2: SUITE B-7 CITY: WOODLANDS STATE: TX ZIP: 77380 BUSINESS PHONE: 2817193400 MAIL ADDRESS: STREET 1: 2408 TIMBERLOCH PLACE B-7 CITY: THE WOODLANDS STATE: TX ZIP: 77380 FORMER COMPANY: FORMER CONFORMED NAME: REPROS THERAPEUTICS INC DATE OF NAME CHANGE: 20060503 FORMER COMPANY: FORMER CONFORMED NAME: ZONAGEN INC DATE OF NAME CHANGE: 19930208 8-K 1 h44708e8vk.htm FORM 8-K - CURRENT REPORT e8vk
 

 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report Filed Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report
(Date of earliest event reported): March 15, 2007
Repros Therapeutics Inc.
(Exact name of registrant as specified in its charter)
         
Delaware
(State or other jurisdiction of
incorporation or organization)
  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)
(281) 719-3400
(Registrant’s telephone number, including area code)
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 March 15, 2007, Repros Therapeutics Inc., a Delaware corporation (the “Company”), entered into the Fifth Amendment (the “Fifth Amendment”) to the Agreement by and between the National Institutes of Health or the Food and Drug Administration (collectively, the Public Health Service or PHS), agencies of the United States Public Health Service within the Department of Health and Human Services and the Company (as amended, the “Agreement”). The Fifth Amendment amended the benchmarks that the Company is required to meet under the Agreement. On March 8, 2007, in connection with the Fifth Amendment, PHS granted to the Company a waiver of the requirement under the Agreement that the Company have Proellex manufactured in the United States. For clarity, the Company is also filing the Fourth Amendment to the Agreement (the “Fourth Amendment”) dated December 9, 2003 which was an amendment relating to the purchase from the PHS of an immaterial amount of Proellex for use in the Company’s clinical trials at such time. The Fourth Amendment did not change any other provisions of the Agreement.
     The foregoing descriptions of the Fourth and Fifth Amendments and the waiver to the Agreement are qualified in their entirety by reference to the actual amendments and waiver filed herewith as Exhibits 10.1, 10.2 and 10.3, which exhibits are incorporated herein by reference.
Item 9.01.   Financial Statements and Exhibits
     c.  Exhibits
     
Exhibit
Number
   
Description
 
 
 
 
   
10.1  
  Fourth Amendment to PHS Patent License Agreement, as amended, dated December 9, 2003 between the Company and certain agencies of the United States Public Health Service within the Department of Health and Human Services.
 
   
10.2  
  Waiver to PHS Patent License Agreement, as amended, dated March 8, 2007 between the Company and certain agencies of the United States Public Health Service within the Department of Health and Human Services.
 
   
10.3*
  Fifth Amendment to PHS Patent License Agreement, as amended, dated March 15, 2007 between the Company and certain agencies of the United States Public Health Service within the Department of Health and Human Services.
  *   Portions of this exhibit have been omitted based on a request for confidential treatment pursuant to Rule 24b-2 of the Exchange Act. Such omitted portions have been filed separately with the Commission.

 


 

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  Repros Therapeutics Inc.
 
 
Date: March 19, 2007  By:   /s/ Louis Ploth, Jr.    
    Louis Ploth, Jr.   
    Vice President, Business Development and
Chief Financial Officer 
 

 


 

         
EXHIBIT INDEX
     
Exhibit
Number
   
Description
 
 
 
 
   
10.1  
  Fourth Amendment to PHS Patent License Agreement, as amended, dated December 9, 2003 between the Company and certain agencies of the United States Public Health Service within the Department of Health and Human Services.
 
   
10.2  
  Waiver to PHS Patent License Agreement, as amended, dated March 8, 2007 between the Company and certain agencies of the United States Public Health Service within the Department of Health and Human Services.
 
   
10.3*
  Fifth Amendment to PHS Patent License Agreement, as amended, dated March 15, 2007 between the Company and certain agencies of the United States Public Health Service within the Department of Health and Human Services.
  *   Portions of this exhibit have been omitted based on a request for confidential treatment pursuant to Rule 24b-2 of the Exchange Act. Such omitted portions have been filed separately with the Commission.

 

EX-10.1 2 h44708exv10w1.htm FOURTH AMENDMENT TO PHS PATENT LICENSE AGREEMENT 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

3

EX-10.2 3 h44708exv10w2.htm WAIVER TO PHS PATENT LICENSE AGREEMENT exv10w2
 

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 Transfer   
 

EX-10.3 4 h44708exv10w3.htm FIFTH AMENDMENT TO PHS PATENT LICENSE AGREEMENT 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
Model 09-2006
  Draft Repros Therapeutics Inc
Page 2 of 5
  February 27, 2007
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
CONFIDENTIAL
Fifth Amendment of L-354-1998/0
Model 09-2006
  Draft Repros Therapeutics Inc
Page 3 of 5
  February 27, 2007
L-354-1998/5

 


 

  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
CONFIDENTIAL
Fifth Amendment of L-354-1998/0
Model 09-2006
  Draft Repros Therapeutics Inc
Page 4 of 5
  February 27, 2007
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
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

 

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