NATIONAL INSTITUTES OF HEALTH

NINTH AMENDMENT TO L-354-1998/0

 

This is the ninth amendment (“Ninth Amendment”) of the agreement by and between
the National Institutes of Health (“NIH”) 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 Ninth
Amendment, having NIH Reference Number L-354-1998/9, is made between the NIH
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, U.S.A. the (“Licensee”). This Ninth Amendment
includes, in addition to the amendments made below, 1) a Signature Page, 2)
Attachment 1 (Royalty Payment Information), and 3) Appendix E — Benchmarks and
Performance.

 

WHEREAS, Licensee has requested that the benchmark dates be amended to simplify
negotiations with perspective partners.

 

WHEREAS, Licensee represents that it is no longer planning development of a
second generation compound, and would like to amend the agreement to remove
those milestones.

 

WHEREAS, the NIH will accept, in lieu of a greater amendment issue royalty, a
fixed royalty upon assignment of the Agreement, either individually, as part of
the sale or transfer of substantially the entire business of Licensee relating
to operations which concern this Agreement, or acquisition of the company.

 

WHEREAS, the NIH and the Licensee desire that the Agreement be amended a ninth
time as set forth below in order to amend the benchmarks and assignment
provision.

 

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

 

1)The following modifications shall be made to the Agreement:

 

a.Paragraph 14.07 shall be deleted and replaced with the following Paragraph
14.07.

 

14.07This Agreement shall not be assigned by Licensee except: a) with the prior
written consent of PHS, such consent not to be withheld unreasonably; or b) as
part of a sale or transfer of substantially the entire business of Licensee
relating to operations which concern this Agreement. Licensee shall notify PHS
prior to any assignment of this Agreement by Licensee, sale or transfer of
substantially the entire business of Licensee relating to operations which
concern this Agreement, or acquisition of Licensee.

 

Licensee shall pay PHS a One Hundred Thousand Dollar ($100,000) assignment
royalty upon assignment of the Agreement, sale or transfer of substantially the
entire business of Licensee relating to operations which concern this Agreement,
or acquisition of Licensee.

 

 

 

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b.Appendix E — Benchmarks and Performance shall be deleted and replaced with the
attached Appendix E — Benchmarks and Performance.

 

2)Within sixty (60) days of the execution of this Ninth Amendment, the Licensee
shall pay the NIH an amendment issue royalty in the sum of Five Thousand US
Dollars ($5,000), and payment options may be found in Attachment 1.

 

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 payment information in such
Attachment 1.

 

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

 

5)The terms and conditions of this Ninth Amendment shall, at the NIH’s sole
option, be considered by the NIH to be withdrawn from the Licensee’s
consideration and the terms and conditions of this Ninth Amendment, and the
Ninth Amendment itself, to be null and void, unless this Ninth Amendment is
executed by the Licensee and a fully executed original is received by the NIH
within sixty (60) days from the date of the NIH’s signature found at the
Signature Page.

 

6)This Ninth Amendment is effective on the date both parties sign this Ninth
Amendment.

 

SIGNATURES BEGIN ON NEXT PAGE

 

 

 

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NINTH AMENDMENT TO L-354-1998/0

 

SIGNATURE PAGE

 

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

 

For NIH:                       Richard U. Rodriguez   Date Director, Division of
Technology Development and Transfer     Office of Technology Transfer    
National Institutes of Health           Mailing Address or E-mail Address for
Agreement notices and reports:           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.  
        E-mail: LicenseNotices_Reports@mail.nih.gov           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:                 Signature of
Authorized Official   Date       Name: Kathi Anderson     Title: Chief Financial
Officer    

 

 

 

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I.

Official and Mailing Address of Agreement notices:

Kathi Anderson
Name

Chief Financial Officer
Title

Mailing Address:

     2408 Timberloch Place
     Suite B-7
     The Woodlands, Texas 77380

E-mail Address: anderson@reprosrx.com
Telephone: 281-719-3447
Fax: 281-719-3446

Jeff Harder
Name

Partner, Jackson Walker
Title

Mailing Address:
     1401 McKinney, Suite 1900
     Houston, TX 77010

E-Mail Address: jharder@jw.com

Phone: (713) 752-4346

Fax: (713) 308-4146

 

 

 

 

 

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II.

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

 

  Kathi Anderson
Name

Chief Financial Officer
Title

Mailing Address:

     2408 Timberloch Place
     Suite B-7
     The Woodlands, Texas  77380

E-mail Address: anderson@reprosrx.com

Telephone: 281-719-3447

Fax: 281-719-3446        

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).

 

 

 

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ATTACHMENT I — ROYALTY PAYMENT OPTIONS

 

The OTT License Number MUST appear on payments, reports and correspondence.

 

Automated Clearing House (ACH) for payments through U.S. banks only

 

The NIH encourages its licensees to submit electronic funds transfer payments
through the Automated Clearing House (ACH). Submit your ACH payment through the
U.S. Treasury web site located at: https://www.pay.gov. Locate the “NIH Agency
Form” through the Pay.gov “Agency List”.

 

Electronic Funds Wire Transfers

 

The following account information is provided for wire payments. In order to
process payment via Electronic Funds Wire Transfer sender MUST supply the
following information within the transmission:

 

Drawn on a U.S. bank account via FEDWIRE should be sent directly to the
following account:

 

Beneficiary Account: Federal Reserve Bank of New York or TREAS NYC Bank: Federal
Reserve Bank of New York ABA# 021030004 Account Number: 75080031 Bank Address:
33 Liberty Street, New York, NY 10045 Payment Details: License Number
(L-XXX-XXXX)
Name of the Licensee

 

Drawn on a foreign bank account should be sent directly to the following
account. Payment must be sent in U.S. Dollars (USD) using the following
instructions:

 

Beneficiary Account: Federal Reserve Bank of New York/ITS or FRBNY/ITS Bank:
Citibank N.A. (New York) SWIFT Code: CITIUS33 Account Number: 36838868 Bank
Address: 388 Greenwich Street, New York, NY 10013 Payment Details (Line 70): NIH
75080031
License Number (L-XXX-XXXX)
Name of the Licensee Detail of Charges (line 71a): Charge Our    

 

 

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Checks

 

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

 

Checks drawn on a U.S. bank account and sent by US Postal Service should be sent
directly to the following address:

 

National Institutes of Health (NIH)
P.O. Box 979071
St. Louis, MO 63197-9000

 

Checks drawn on a U.S. bank account and sent by overnight or courier should be
sent to the following address:

 

US Bank
Government Lockbox SL-MO-C2GL
1005 Convention Plaza
St. Louis, MO 63101
Phone: 314-418-4087

 

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
6011 Executive Boulevard
Suite 325, MSC 7660
Rockville, Maryland 20852

 

 

 

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APPENDIX E-Benchmarks and Performance

 

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:

 

Benchmark Date Initiate a Phase III trial June 30, 2015 File a New Drug
Application December 31, 2016 Approval of the New Drug Application December 31,
2017

 

 

 

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