-----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, Dzf68AfvNvRqqf3m1O+Ny7x3agvMZ2Jw8WiVa6c2/GEDFzu4Am20IzXXMU5o9qbM kfWYVj5OnVXQEP3HsgZgMg== 0001144204-09-056277.txt : 20091103 0001144204-09-056277.hdr.sgml : 20091103 20091103165801 ACCESSION NUMBER: 0001144204-09-056277 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20091028 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Unregistered Sales of Equity Securities ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20091103 DATE AS OF CHANGE: 20091103 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: 091155125 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 v164475_8k.htm
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): October 28, 2009
 
Repros Therapeutics Inc.
(Exact name of registrant as specified in its charter)

Delaware
001-15281
76-0233274
(State or other jurisdiction of incorporation or organization)
(Commission File Number)
(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.
 
Seventh Amendment to NIH Agreement

On October 28, 2009, Repros Therapeutics Inc., a Delaware corporation (the “Company”), entered into the Seventh Amendment (the “Amendment”) to the Agreement by and between the Company and National Institutes of Health of the Food and Drug Administration agencies of the United States Public Health Service within the Department of Health and Human Services (as previously amended, the “Agreement”).

The Amendment revises the existing milestones and dates for performance to provide additional time to lift the current clinical hold on Proellex® or select a second generation molecule for further development from the family of anti-progestational agents covered by the Agreement.  If the hold on the active ingredient of Proellex® cannot be lifted, the Company can satisfy the diligence portion of the Agreement by selecting a second molecule from the family of anti-progestational agents covered by the Agreement and, after sufficient pre-clinical work, submit a pre-clinical package for opening an Investigational New Drug Application to the FDA to commence human clinical testing of this new agent.

A copy of the Company’s press release announcing entry into the Amendment is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
 
Settlement Agreement with Creditors
 
On October 29, 2009, the Company entered into a Master Settlement Agreement and Releases (the “Settlement Agreement”) with its major creditors (the “Creditors”).  Pursuant to the Settlement Agreement, the Company agreed to issue an aggregate of up to 5,503,843 shares of its common stock and pay an aggregate of approximately $2.8 million to such Creditors as payment in full for then-outstanding liabilities to such Creditors and in exchange for the release of the claims held by and the dismissal of the litigation commenced by the Creditors against the Company.  Under the Settlement Agreement, the Company agreed to use its best efforts to prepare and file a registration statement to register such shares issued to the Creditors, to use its best efforts to have such registration statement declared effective as soon as possible, and to maintain such registration statement until all such shares registered thereunder to the Creditors have been sold or for a period of one year, whichever comes first.  The Company  also agreed to refrain from (i) filing any other registration statement for any primary public offering or other offering of its equity securities prior to filing such registration statement with the Securities and Exchange Commission and (ii) selling any shares for any primary public offering or other offering of its equity securities during the ten business days immediately following the effective date of such registration statement, in order to provide such Creditors an opportunity to sell their shares issued under the Settlement Agreement.
 
A copy of the Company’s press release announcing entry into the Settlement Agreement and a copy of the Settlement Agreement are attached as Exhibit 99.2 and Exhibit 10.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.
 

 
Item 3.02  Unregistered Sales of Equity Securities.
 
The information set forth under the heading titled “Settlement Agreement with Creditors” in Item 1.01 of this Current Report on Form 8-K is hereby incorporated into this Item 3.02 by reference.
 
Item 5.02  Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
 
On October 29, 2009, Katherine Anderson was engaged as the Chief Accounting Officer of the Company.  Ms. Anderson, 51, is a certified public accountant and has served as the Company’s Controller for the previous 8 years.

In connection with her appointment as Chief Accounting Officer, the Company and Ms. Anderson entered into a consulting agreement.  Pursuant to the terms and conditions of the Consulting Agreement, Ms. Anderson will receive $10,500 per month as compensation for service as the Chief Accounting Officer.  The foregoing description is qualified in its entirety by reference to the Consulting Agreement, a copy of which is attached hereto as Exhibit 10.2 and is incorporated herein by reference.

As of October 29, 2009, Dr. Paul Lammers resigned his positions as the Company’s President and Secretary to become the Chief Executive Officer of Mirna Therapeutics, a private biotechnology company.  Dr. Lammers’ resignation was not a result of any disagreements relating to the Company’s operations, policies or practices.
 
On October 30, 2009, John C. Reed, MD, Ph.D. resigned his position as a member of the Company’s board of directors effective November 1, 2009.  Dr. Reed’s resignation was not a result of any disagreements relating to the Company’s operations, policies or practices.
 
Item 9.01  Financial Statements and Exhibits.
 
(d)  Exhibits.
 
  Exhibit  
  Number Description
     
 
10.1
Master Settlement Agreement and Releases dated October 29, 2009 by and among the Company and its creditors signatory thereto

 
10.2
Consulting Agreement dated October 29, 2009 by and between the Company and Katherine Anderson

 
99.1
Press Release dated October 28, 2009

99.2 
Press Release dated October 30, 2009
 

 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
  Repros Therapeutics Inc.  
       
Date:  November 2, 2009      
 
By:
/s/ Joseph S. Podolski  
    Joseph S. Podolski  
    Chief Executive Officer  
 

 
EXHIBIT INDEX
 
  Exhibit  
  Number Description
     
 
10.1
Master Settlement Agreement and Releases dated October 29, 2009 by and among the Company and its creditors signatory thereto

 
10.2
Consulting Agreement dated October 29, 2009 by and between the Company and Katherine Anderson

 
99.1
Press Release dated October 28, 2009

99.2 
Press Release dated October 30, 2009
 

EX-10.1 2 v164475_ex10-1.htm
MASTER SETTLEMENT AGREEMENT AND RELEASES

This Master Settlement Agreement and Releases (“Agreement”) is entered into as of the Effective Date by and between the Creditors and Repros.1
 
WHEREAS, the Creditors entered into various agreements with Repros to provide goods and/or services relative to a clinical trial of the drug known as Proellex; and
 
WHEREAS, on August 3, 2009 (the “Close Out Date”), Repros announced it was voluntarily suspending dosing in all of its clinical trials with Proellex (the “Studies”), which decision was based on available information regarding the occurrence of clinically significant increases of liver enzymes at the 50 mg and 25 mg doses, coupled with input from a consulting panel of liver experts. Following this decision, Repros was notified the next day, August 4, 2009, by the US Food and Drug Administration  that its Investigational New Drug Applications for Proellex had been put on clinical hold for safety reasons; and
 
WHEREAS, due to the foregoing, Repros was unable to raise funds in the equity markets or otherwise sufficient to pay the Creditors for goods and/or services provided with respect to Proellex; and
 
WHEREAS, several Creditors commenced lawsuits to collect amounts owed by Repros and other creditors threatened such actions; and
 
WHEREAS, Repros asserted various defenses and/or disputed the Creditors’ claims;
 
WHEREAS, the Creditors and Repros have agreed to settle the Litigation, and all causes of action, known or unknown, that could be asserted;
 
NOW, THEREFORE, in consideration of the mutual promises and covenants contained herein, and for other good and valuable consideration, the sufficiency and receipt of which is hereby acknowledged, the Parties agree to compromise and settle all disputes existing or alleged to exist between or among them as follows:
1 Capitalized terms are defined in Section 1, below.

 
1

 


1.           Definitions.  For purposes of this Agreement , the following terms shall have the following meanings:
 
“Creditors” shall mean any and all of the following, including but not limited to, their respective agents, officers, directors, employees, shareholders, partners, associates, consultants, insurers, attorneys, assigns, successors-in-interest, related entities, parent companies, subsidiary companies, owners, divisions, and/or representatives:

AAIPharma, Inc.
ACM Medical Laboratory, Inc.
Advances in Health, Inc.
Compleware Corporation
Comprehensive Clinical Trials, LLC
Impact Clinical Trials
IntegReview, Ltd.
inVentiv Clinical Solutions, LLC
Pharm-Olam International Ltd.
PharmaForm, LLC

“Effective Date” shall mean the last date when this Master Settlement Agreement is executed by all Parties with claims equal to no less than 95% of the total amount due all Creditors as set forth in Section 3.

“Event of Default” shall have the meaning set forth in Section 5.

 “Litigation” shall mean the following lawsuits:

Advances in Health, Inc. vs. Repros Therapeutics, Inc.; In the 295th Judicial District Court of Harris County, Texas; Case No. 2009-53475

Compleware Corporation v. Repros Therapeutics, Inc.; In the United States District Court for the Southern District of Iowa; Civil Action No. 3:09-CV-00115

“Party” and/or “Parties” shall mean Creditors and Repros, either individually and/or collectively as a whole.

 
2

 


 
Repros” shall mean Repros Therapeutics, Inc.

2.           Consideration to be paid by Repros. In full and final satisfaction of all claims and causes of action Repros shall:
 
 
a.
Pay each Creditor in cash thirty-two percent of the amount shown next to such Creditor’s name in Section 3 hereof.  The payment shall be made within two business days of the Effective Date.
 
 
b.
The Company represents and warrants that is has not less than 6.2 million available authorized and unissued and treasury shares of its common stock, not including any shares reserved for outstanding options and other convertible securities.  Immediately following the Effective Date, issue to Computershare, Repros’ transfer agent, an irrevocable instruction letter to issues and deliver to each Creditor that number of shares of common stock of Repros equal to the greater of (i) the result obtained by subtracting (x) the cash payment specified in subparagraph (a) above from (y) the total amount due to each Creditor as reflected next to such Creditor’s name in Section 3 hereof, and dividing such result by the closing price for Repros’ common stock on the Nasdaq Global Market on the Effective Date (the “Effective Date Price”),2 or (ii) subject to approval of NASDAQ, 4,000,000 shares, issued pro rata to the Creditors in Section 3. If the Company fails to cause shares of its common stock to be issued in accordance with the foregoing sentence or fails to deliver the payment in accordance with Sec 2(a) above, or if the representation and warranty set forth in the first sentence of this Section 2(b) shall not be true and correct on the Effective Date, then this Agreement shall be null and void and of no force or effect.  The Creditors acknowledge that these shares will be unregistered shares subject to Rule 144 which requires a waiting period prior to sale of six months; however, Repros agrees that it will use its best efforts to prepare and file a registration statement (“Creditors’ Registration Statement’) on the applicable form with the U.S. Securities and Exchange Commission (the “SEC”) to register the shares issued to the Creditors as soon as possible following the Effective Date, to use its best efforts to have such registration statement declared effective as soon as possible, and to maintain such registration statement until all shares registered thereunder to the Creditors have been sold or for a period of one year, whichever comes first.  Repros also agrees that it will as promptly as possible, and in any event within ten business days following the Effective Date, deliver the draft registration statement to its independent auditors, PricewaterhouseCoopers (“PwC”), for their review, and file such registration statement with the SEC within three business days following the completion of such review by PwC.  Repros further agrees that it will refrain from (i) filing any other registration statement for any primary public offering, PIPE or other offering of its equity securities prior to filing the Creditor’s Registration Statement with the SEC, and (ii) selling any shares for any primary public offering, PIPE or other offering of its equity securities during the ten business days immediately following the effective date of the Creditors’ Registration Statement, in order to provide the Creditors an opportunity to sell their shares.



 
3

 

3.           Agreed Claim Amounts. For purposes of the payments referred to herein, the Creditors and Repros agree to the following amounts which result in the Pro Rata Share shown:

NAME
 
AMOUNT
   
32% PAYMENT
 
             
AAIPharm, Inc.
  $ 2,982,036.50     $ 954,251.68  
ACM Medical Laboratory, Inc
  $ 468,162.63     $ 149,812.04  
Advances in Health, Inc.
  $ 371,827.48     $ 118,984.79  
Compleware Corp.
  $ 1,256,334.92     $ 402,027.17  
Comprehensive Clinical Trials LLC
  $ 129,289.75     $ 41,372.72  
Impact Clinical Trials, INC
  $ 191,113.00     $ 61,156.16  
IntegReview, Ltd
  $ 177,067.48     $ 56,661.59  
inventive Clinical Solutions, LLC
  $ 2,478,361.80     $ 793,075.78  
Pharm-Olam International, Ltd
  $ 618,334.42     $ 197,867.01  
PharmaForm, LLC
  $ 230,756.27     $ 73,842.01  
Total
  $ 8,903,284     $ 2,849,051  

 
4

 

4.           Mutual Releases.  The Parties agree to the following mutual releases:
 
 
a.
Release of Repros.  Except for the obligations created by this Agreement, Creditors, for themselves, their agents, employees, legal representatives, heirs, attorneys, successors and assigns, officers directors and all persons, natural or corporate, in privity with all or any of them, do hereby fully and forever RELEASE, ACQUIT, DISCHARGE and DISMISS: any and all claims, demands, damages, actions, causes of action, costs, attorneys’ fees and liabilities, known or unknown, whether based in contract, tort, equity or otherwise arising out of allegations which have been or could have been asserted by them against Repros, its agents, employees, legal representatives, heirs, attorneys, successors and assigns, officers directors and all persons, natural or corporate, in privity with all or any of them.  In addition, the Litigation shall be dismissed with prejudice.  Provided, however, that this release shall not release Repros from liability under any new contracts entered into after the Effective Date or, if applicable to any particular Creditor, from any legitimate costs or expenses incurred by a Creditor following the Close Out Date, in connection with the Studies.

 
b.
Release of Creditors.  Except for the obligations created by this Agreement, Repros it agents, employees, legal representatives, heirs, attorneys, successors and assigns, officers directors and all persons, natural or corporate, in privity with all or any of them, do hereby fully and forever RELEASE, ACQUIT, DISCHARGE and DISMISS: any and all claims, demands, damages, actions, causes of action, costs, attorneys’ fees and liabilities, known or unknown, whether based in contract, tort, equity or otherwise against the Creditors, their agents, employees, legal representatives, heirs, attorneys, successors and assigns, officers directors and all persons, natural or corporate, in privity with all or any of them.

 
c.
Exclusion.  Except for the release granted by Repros to the Creditors set forth in paragraph 4b, this agreement shall not in any way be deemed to operate as a release of any entity engaged by Repros to conduct and manage any of the Studies on behalf of Repros from any claims held by the Creditors against such entity.

 
d.
Clinical Trial Indemnity Claims.  Notwithstanding anything hereinabove to the contrary, nothing herein is intended to alter or affect, in any way, any indemnification obligation, if any, of Repros or the Creditors in respect of liabilities relating to Third Party Claims (as defined below) under and pursuant to any existing clinical trial agreement previously entered into between them, to the extent any such obligation applies thereto.  Third Party Claims is hereby defined as including any claims from patients involved in the Studies, or from any regulatory body or governmental agencies relating to the Studies, and the like, but shall not include any third parties which were contracted for by the Creditors to participate in the Studies such as clinical trial sites or physicians.

 
5

 

 
5.           No Additional Consideration; Entire Agreement.  The Parties hereby agree that no additional consideration of any kind will be paid or given or has been promised for the execution of this Agreement, and that no further recovery on account of the matters stated herein, or in any way related thereto, may hereafter be had from any of them or their respective agents, employees, heirs, successors and assigns for any damages or wrongful conduct which has occurred.  Each Party acknowledges that they have carefully read this instrument and that this instrument expresses the final and entire agreement between the Parties, and that each Party has executed this Agreement freely and of its own accord.  The Parties hereto acknowledge and agree that there are no oral agreements between them and, specifically, there are no agreements of indemnity between them (except as otherwise referenced in Section 4(c) above).  The Parties acknowledge that the terms and conditions of this Agreement have been voluntarily agreed upon, that each has consulted counsel, that no one is under any disadvantage and that no representations have been made other than those set forth herein.
 
6.           Financial Information.  Prior to the execution of this Agreement, Repros provided the Creditors with certain financial information.   Creditors represent and warrant that they have become  Parties hereto solely in reliance upon their own independent investigation, examination, due diligence, evaluation, or have otherwise satisfied themselves thereto as they deem necessary and appropriate to make a complete and accurate analysis and decision so as to enter into this transaction, and that Creditors are not relying upon any representation, warranty or statement of Repros, other than as set forth herein, for entering into this Agreement.

 
6

 

7.           No Admission of Liability.  All Parties understand, acknowledge and agree that this Agreement constitutes a compromise of disputed claims, and is not to be construed as an admission of liability on the part of any Party(ies), collectively or individually, any and all such liability(ies) being expressly denied.
 
8.           Representation of Ownership of Claims.  All Parties represent and warrant (which representations and warranties are in part consideration of the execution of this Agreement), that they own all and each of the claims, rights, demands and causes of action which they are hereby settling or releasing, and that they have not assigned to any other person or entity all or any part of said claims, rights, demands or causes of action.
 
9.           Assignment.  The Creditors may not assign their rights under this Agreement absent the consent of Repros.
 
10.         Agreement to Execute Necessary Documents.  The Parties further agree, upon demand, to execute, acknowledge and deliver any and all documents, in addition to the documents set forth herein, and to do such other acts and things which are reasonably necessary to accomplish the purpose and terms of this Agreement.
 
11.         Governing Law.  This Agreement shall be construed and enforced in accordance with the laws of the State of Delaware.
 
12.         Binding Effect.  This Agreement shall inure to the benefit of and be binding upon Repros and each of the other Parties hereto who execute this Agreement, together with their respective officers, directors, shareholders, employees, agents, attorneys, heirs, successors and assigns.

13.         Costs and Expenses.  The Parties expressly agree that each shall bear its own respective attorneys’ fees, costs and related expenses incurred to date.

 
7

 

14.         Contractual Terms.  The Parties agree and acknowledge that the terms of this Agreement are contractual and not merely recitals and that the agreements contained herein and the consideration transferred are to compromise disputed claims, to avoid litigation or other similar proceedings and to buy full and final peace.
 
15.         Modification.  No provision of this Agreement may be modified, waived or terminated except by instrument in writing (specifically referring to this Agreement) executed by the Party against whom the modification, waiver or termination is sought to be enforced.
 
16.         Voluntary Execution.  Each Party to this Agreement represents that this Agreement is entered voluntarily and without coercion, and that no signatory is relying upon any representation made by any other Party in electing to execute this Agreement.
 
17.         Multiple Originals.  It is understood and agreed that this Agreement may be executed in a number of identical counterparts, each of which shall be deemed an original for all purposes.
 
18.         Shared Drafting.  The Parties acknowledge that they have shared in the drafting of this Agreement and, therefore, that it shall not be construed in favor of one or the other.

 
8

 

IN WITNESS WHEREOF, the Parties hereto have executed this Agreement in multiple originals as of the dates of their respective acknowledgments.

REPROS THERAPEUTICS, INC.
   
By:
/s/ Joseph Podolski
   
Name:
Joseph Podolski
   
Title:
Chief Executive Officer
   
Dated:
10/28/2009
   
AAIPHARMA, INC.
   
By:
/s/ Lyle Lohmeyer
   
Name:
 Lyle Lohmeyer
   
Title:
Chief Financial Officer
   
Dated:
October 29, 2009
   
ACM MEDICAL LABORATORY, INC.
   
By:
/s/ Arthur E. Glenz
   
Name:
 Arthur E. Glenz
   
Title:
President/CEO
   
Dated:
10/29/08


 
9

 

ADVANCES, IN HEALTH, INC.
   
By:
/s/ Melissa Poindexter
   
Name:
Melissa Poindexter
   
Title:
President
   
Dated:
10/29/2009
   
COMPLEWARE CORPORATION.
 
 
By:
/s/ Kay Weiler
   
Name:
Kay Weiler
   
Title:
Vice President
   
Dated:
October 29, 2009
   
COMPREHENISVE CLINICAL TRIAL, LLC
   
By:
/s/ Ronald T. Ackerman, MD, FACOG
   
Name:
 Ronald T. Ackerman, MD, FACOG
   
Title:
CEO/Medical Director
   
Dated:
10/29/09
   
IMPACT CLINICAL TRIALS
   
By:
/s/ Lydie Hazan, M.D.
 
Lydie Hazan, M.D.
Name:
 
   
Title:
CEO/President
   
Dated:
10/29/09

 
10

 
 
INTEGREVIEW, LTD
 
By:
/s/ Lynn Meyer
   
Name:
Lynn Meyer
   
Title:
President
   
Dated:
10/29/09
   
INVENTIVE CLINICAL SOLUTIONS, LLC
   
By:
/s/ Gerald Kappes
   
Name:
Gerald Kappes
   
Title:
CFO
   
Dated:
10/29/2009
   
PHARM-OLAM INTERNATIONAL, LTD
   
By:
/s/ James W. Clark, Jr.
   
Name:
James W. Clark, Jr.
   
Title:
CFO
   
Dated:
10/29/2009
   
PHARMAFORM, LLC
 
By:
 
   
Name:
 
   
Title:
 
   
Dated:
 
 
 
11

 
EX-10.2 3 v164475_ex10-2.htm

Repros Therapeutics Inc.

Consulting Agreement
 
Repros Therapeutics Inc., a Delaware corporation (the “Company”), and the undersigned consultant whose name and address appear below (“Consultant”) hereby agree as follows:

1.           Consulting Services.  Consultant is hereby engaged by the Company as an independent contractor, and not as an employee, to carry out the project(s) specified in the Description of Work attached hereto as Exhibit A, on the terms and conditions set forth in such Description of Work.

2.           Term. This Agreement shall commence on the Start Date specified on the Description of Work attached hereto as Exhibit A and continue until the Completion Date specified therein, unless earlier terminated by the Company or Consultant.  This Agreement may be terminated by Consultant or Company, with or without “cause” (as defined below), by giving 15 days’ advance written notice thereof to the other party hereto.  In addition, this Agreement may be terminated by the Company immediately for “cause.”  For purposes of this Agreement, “cause” shall be deemed to exist for termination of this Agreement by the Company in the event (i) Consultant is not performing in compliance with the Description of Work, (ii) Consultant has engaged in personal conduct which (in the good faith determination of the Company) would materially injure the goodwill or reputation of the Company or otherwise materially adversely affect the interests of the Company or (iii) of any breach by Consultant of the obligations contained in this Agreement or any other agreement between the Company and Consultant.

In the event of any termination of this Agreement prior to completion of the term of this Agreement pursuant to the foregoing provisions (whether with or without “cause”), the Company’s sole liability thereupon will be to pay Consultant any unpaid balance due for work performed up to and including the date of termination, if applicable.

3.           Independent Contractor.  It is agreed that Consultant’s services are made available to the Company on the basis that Consultant will retain Consultant’s individual professional status and that Consultant’s relationship with the Company is that of an independent consultant and not that of an employee.  Consultant will not be eligible for any employee benefits, nor will the Company make deductions from its fees to Consultant for taxes, insurance, bonds or any other subscription of any kind.  Consultant will use Consultant’s own discretion in performing the tasks assigned, within the scope of work specified by the Company.  Consultant agrees to indemnify and hold the Company harmless from and against any claim made by any third party against the Company based in whole or in part upon any action by Consultant or any of Consultant’s employees, associates, consultants, agents, representatives, assignees or successors in interest (collectively, “Consultant’s Associates”), which occurs pursuant to or in connection with this Agreement or the relationship or relationships contemplated by this Agreement.
 
 
 
Consulting Agreement

 
 

 

4.           Confidential Information.  Consultant agrees that Consultant, and all of Consultant’s Associates, shall keep in strictest confidence all information relating to the products, programs, algorithms, designs, trade secrets, secret processes, customers and markets of the Company and all other confidential knowledge, data and information related to the business or affairs of the Company (collectively, “Confidential Information”) that may be acquired pursuant to or in connection with this Agreement or the relationship or relationships contemplated by this Agreement.  During and after the term of this Agreement, neither Consultant nor any of Consultant’s Associates will, without the prior written consent of an officer of the Company, publish, communicate, disclose or use for any purpose any of such Confidential Information.  Upon termination of this Agreement, Consultant will return to the Company all records, data, notes, reports, printouts, sketches, material, equipment and other documents or property, and all reproductions of any of the foregoing, furnished by the Company or developed or prepared pursuant to the relationship hereunder.

Notwithstanding the foregoing, it is agreed that Confidential Information shall not include any (i) information which is or becomes through no fault of Consultant or any of Consultant’s Associates generally known to the public, and (ii) Consultant’s and Consultant’s Associates’ skill, knowledge, know-how and experience.

5.           Assignment of Intellectual Property.  Consultant agrees to transfer and assign and hereby does transfer and assign to the Company the entire right, title and interest for the entire world in and to all data, software, designs, models, algorithms, writings, drawings, notebooks, documents, photographs, inventions and discoveries (collectively, “Inventions”) made or conceived or reduced to practice by Consultant or any of Consultant’s Associates, (i) in the course of accomplishing the work described on the Description of Work attached as Exhibit A hereto, (ii) in the course of accomplishing other work performed pursuant to the relationship established by this Agreement, or (iii) with the use of materials or facilities of the Company.

Consultant agrees that Consultant and each of Consultant’s Associates will sign, execute and acknowledge, or cause to be signed, executed and acknowledged, at the expense of the Company, any and all documents, and will perform any and all acts, as may be necessary, useful or convenient for the purpose of securing to the Company or its nominee patent, trademark or copyright protection throughout the world upon all such Inventions.  At the request of the Company, Consultant will have each of Consultant’s Associates with access to Confidential Information of the Company or who performs work pursuant to this Agreement to sign an agreement in form substantially identical to this Agreement.

6.           License Rights.  In the event that Consultant recommends to the Company that the Company make use of devices and/or processes covered by patents and/or patent applications which Consultant may own or control, Consultant will then so inform the Company, and in the event that the Company shall follow Consultant’s recommendation and Consultant has the right to grant a license under such patents and/or patent applications, then Consultant will grant to the Company a license on reasonable terms which are no less favorable than those granted by Consultant to any other licensee.
 
 
 
Consulting Agreement
 


7.           Representations and Warranties.

(a)           Representations of Consultant.  Consultant represents and warrants to the Company that (i) this Agreement is a valid and binding obligation of Consultant, enforceable against Consultant in accordance with its terms, and (ii) his execution and delivery of, and performance of his services and other obligations under, this Agreement will not result in the breach or violation of applicable law or any agreement to which he is a party.

(b)           Representations of the Company.  The Company represents and warrants to Consultant that (i) this Agreement has been duly and validly authorized by the Company and is a valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, and (ii) its execution and delivery of, and performance of its obligations under, this Agreement will not result in the breach or violation of applicable law or any agreement to which it is a party.

8.           Miscellaneous.

(a)          Effective Date.  This Agreement shall be effective as of the effective date specified below, and it is expressly agreed to by Consultant and the Company that all the provisions hereof shall apply as if this Agreement had been entered into on such date.

(b)          Survival of Terms.  The provisions of paragraphs 4, 5 and 6 hereof shall survive termination of this Agreement.

(c)          Successors and Assigns.  This Agreement may not be assigned by Consultant without the written consent of the Company.  This Agreement shall be binding on all of Consultant’s Associates, all of Consultant’s heirs, executors, administrators and legal representatives, and all of Consultant’s successors in interest and assigns, and shall be for the benefit of the Company, its successors and its assigns.

(d)          Governing Law.  This Agreement shall be governed by and construed and enforced in accordance with the laws of the State of Texas as they apply to contracts entered into and wholly to be performed in Texas.

(e)          Severability.  If one or more of the provisions in this Agreement are deemed void by law, then the remaining provisions will continue in full force and effect.

(f)          Amendment.  Neither this Agreement nor the Description of Work may be amended except by a written agreement modifying the appropriate document duly executed by Consultant and an officer of the Company.
 
 
-3-
Consulting Agreement
 

 
(g)           Entire Agreement.  This Agreement, together with the Description of Work attached hereto and any other confidentiality agreement previously or subsequently entered into by the Company and Consultant, constitutes the sole and complete agreement of the parties with respect to the matters included herein, and supersedes any previous oral or written agreement, if any, relating to the subject matters included herein.

(h)           No Conflict.  Consultant represents and warrants that this Agreement does not conflict with any other agreement or term of employment applicable to or binding upon the Consultant as of the date hereof and that Consultant will promptly notify the Company in the event that any such conflict does arise during the term hereof.

(i)           Construction.  Each party to this Agreement has had the opportunity to review this Agreement with legal counsel.  This Agreement shall not be construed or interpreted against any party on the basis that such party drafted or authored a particular provision, parts of or the entirety of this Agreement.

This Agreement is executed on the date set forth below, and shall be effective as of the date specified.

CONSULTANT:
 
COMPANY:
     
/s/ Kathi Anderson
 
/s/ Joseph S. Podolski
(Signature)
 
(Signature)
     
Name:  Kathi Anderson
 
Name:  Joseph S. Podolski
     
 
 
Chief Executive Officer
         
Date:
10/30/2009
 
Date:
10/30/2009
 
 
-4-
Consulting Agreement

 
 

 

EXHIBIT A

Repros Therapeutics Inc.

Description of Work
(Consulting Agreement Dated October 1, 2009)

1.
DETAILED DESCRIPTION OF WORK:  To perform all functions as Chief Accounting Officer including but not limited to assisting on the preparation of quarterly and annual financial statements for reporting purposes, and signing as Chief Accounting Officer on behalf of Repros.  Consultant shall report to the Chief Executive Officer of the Company and perform such other tasks as are requested of her by the CEO from time to time that are consistent with such position.  Such efforts shall be on a part time basis, but no less than 24 hours per week.  It is understood that consultant may maintain other clients as part of her consulting business and this does not present a conflict of interest related to the duties to be performed for Repros Therapeutics Inc. as the consultant is governed under the Rules of Professional Conduct administered by the Texas State Board of Public Accountancy.

2.
START DATE:  October 1, 2009, provided for sake of clarity that Consultant’s appointment as Chief Accounting Officer shall become effective upon the filing of the Form 10Q for the Third Quarter of 2009.

COMPLETION DATE: Either party may terminate the Agreement on written notice to the other party.

3. 
PERSON (S) WHO ARE TO PERFORM THE WORK:  Kathi Anderson

4. 
AUTHORIZED REPRESENTATIVE OF THE COMPANY: Joseph Podolski

PAYMENT:  $10,500 per month billed semimonthly
 
 
-5-
Consulting Agreement
 
 
 

 
EX-99.1 4 v164475_ex99-1.htm
Contact: 
Joseph S. Podolski
Chief Executive Officer
(281) 719-3447

Repros Therapeutics Announces Amendment of NIH Proellex® License

THE WOODLANDS, Texas, October 28, 2009 – Repros Therapeutics (NasdaqGM:RPRX) today announced that the Company has entered into an amendment with the National Institutes of Health (NIH) to its existing exclusive license for Proellex® that revises the existing milestones and dates for performance to provide additional time to lift the current clinical hold on Proellex or select a second generation molecule for further development from the family of anti-progestational agents covered by the  license.
 
Previously the Company announced in early August 2009 that it had voluntarily suspended dosing of all patients in its Proellex clinical trials. The FDA subsequently notified Repros that the Proellex program was placed on full clinical hold due to the observation of increased liver enzymes in a number of patients treated with Proellex.
 
The clinical hold on Proellex affected a variety of benchmark milestones used by the NIH to enforce its license. The Company believes the new agreed amendment between Repros and the NIH allows Repros sufficient time to determine whether it is possible to lift the clinical hold on Proellex. The Company is addressing the deficiencies noted by the FDA and hopes to submit pharmacokinetic data as soon as possible to the Agency that would be supportive of the safety of lower doses that could be tested in short duration trials that would be suggestive of clinical efficacy. However, there can be no assurances that the FDA will view such data as sufficient for lifting the current full clinical hold.
 
If the hold on the active ingredient of Proellex cannot be lifted, the Company can satisfy the diligence portion of the NIH license by selecting a second molecule from the family of anti-progestational agents covered by the license and, after sufficient pre-clinical work, submit a pre-clinical package for opening an Investigational New Drug Application to the FDA to commence human clinical testing of this new agent. The Company believes the time allowed in the amendment for this determination and resultant activity is reasonable.
 
The NIH license allows for Repros to sub-license the technology pending NIH approval.
 
The Company also reported that Dr. Paul Lammers has resigned his position as President to become the CEO of Mirna Therapeutics, a private biotechnology company. In an unrelated move the Company has further reduced its headcount by eliminating the full time position of Sr. VP of Regulatory and Clinical Affairs held by Dr. Andre van As. Dr. Jean Fourcroy, member of the Company’s Board of Directors, and former Medical Officer at the FDA’s Division of Reproductive and Urological Products, the Division where both of the Company’s drug development programs are being evaluated, has agreed to serve as the Company’s Chief Medical Officer on an as needed basis.
 
 
 

 
 
About Repros Therapeutics Inc.

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

Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Repros' ability to raise needed additional capital in the immediate future in order for it to continue its operations on acceptable terms or at all, to settle or otherwise resolve its outstanding liabilities resulting from the Proellex clinical trials recently put on clinical hold,  to successfully defend itself against the recently-filed class action complaints, to continue to maintain its listing on any Nasdaq trading market, whether a clear clinical path for Androxal® can be realized, the eventual outcome of the recent discussions and correspondence with the FDA regarding the Proellex clinical trials currently on clinical hold and  whether clinical trials of Proellex may be resumed, whether any safe and effective dose for Proellex can be determined, whether the NIH license for Proellex can be maintained, 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 Therapeutics 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.

 
 

 
EX-99.2 5 v164475_ex99-2.htm
Contact: 
Joseph S. Podolski
Chief Executive Officer
(281) 719-3447

Repros Therapeutics Announces Settlement with Major Creditors

THE WOODLANDS, Texas, October 30, 2009 – Repros Therapeutics (NasdaqGM:RPRX) today announced that the Company has entered into a settlement agreement with its major creditors for the large majority of the debt incurred associated with the recently suspended Proellex® clinical program.

Previously the Company announced in early August 2009 that it had voluntarily suspended dosing of all patients in its Proellex clinical trials.  The FDA subsequently notified Repros that the Proellex program was placed on full clinical hold due to the observation of increased liver enzymes in a number of patients treated with Proellex.  These elevated liver enzyme observations occurred during the time that the Company was attempting to raise additional capital to fund its continued operations and the Proellex program in particular.  The liver enzyme issue resulted in a failure of the fund raising activity and led to a situation where the Company had more debt than cash.  If this situation were to remain unresolved, Repros would face bankruptcy.

The creditor settlement allows for Repros to repay ten of its major creditors a total of nearly $9 million of debt incurred during the execution of the Proellex clinical studies.  The creditors include clinical research organizations, clinical investigator sites, clinical laboratories and a manufacturer of clinical supplies.  Repros will repay the debt with a mixture of cash and unregistered stock.  The unregistered stock is priced at $1.10 which is the last transaction price of Repros stock at the close of regular trading on Thursday, October 29, 2009.  The settlement calls for $2,849,051 to be paid in cash and $6,054,233 to be paid in unregistered stock.  Repros will use its reasonable best efforts to register the stock in a timely fashion.  The settlement also provides for the dismissal with prejudice of pending lawsuits brought against Repros by creditors participating in the agreement.  In addition the Company is concurrently attempting to resolve claims from approximately another 60 smaller creditors that are owed a total of about $1.6 million.

Joseph Podolski, Repros CEO, commented, “The last few months have clearly been difficult times, not only for the Company and its shareholders, but also the Company’s creditors.  The creditor settlement and the recently announced NIH amendment provide us with the opportunity to seek to obtain value from the Proellex program.”  He further noted, “The creditor settlement is an important first step in addressing our balance sheet issues and allows us to continue our Androxal® program for the immediate future while we pursue additional financing and strategic options.  We have recently submitted a request for a Type C meeting with the FDA to discuss our latest findings for Androxal.”

Mr. Podolski continued: “We hope to determine with the FDA whether the previously reported preservation of fertility while being treated for secondary hypogonadism is a clinically relevant outcome which would allow for a clear clinical path for Androxal, an oral treatment that restores testicular function.  There can be no assurances that the FDA will deem fertility preservation during treatment as clinically relevant and sufficient to support efficacy of the drug.  Previously Repros showed Androxal to be non inferior to Androgel when comparing circulating testosterone levels.  Androgel is a topical testosterone gel and the leading testosterone treatment with reported US sales of over $400 million.  Unlike Androgel or exogenous testosterone treatments in general, Androxal does not suppress the hypothalamic-pituitary-testes axis as evidenced by secretion of normal pituitary hormones as well as normalization of testicular production of testosterone and sperm when hypogonadal men are administered Androxal.”
 
 
 

 

About Repros Therapeutics Inc.

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

Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Repros' ability to raise needed additional capital in the immediate future in order for it to continue its operations on acceptable terms or at all, to settle or otherwise resolve its outstanding liabilities resulting from the Proellex clinical trials recently put on clinical hold,  to successfully defend itself against the recently-filed class action complaints, to continue to maintain its listing on any Nasdaq trading market, whether a clear clinical path for Androxal can be realized, the eventual outcome of the recent discussions and correspondence with the FDA regarding the Proellex clinical trials currently on clinical hold and  whether clinical trials of Proellex may be resumed, whether any safe and effective dose for Proellex can be determined, whether the NIH license for Proellex can be maintained, 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 Therapeutics 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.

 
 

 
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