Document:

PUBLIC HEALTH. SERVICE

EIGHTH AMENDMENT TO L-354-1998/0

 

This is the eighth amendment (“Eighth
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 agencies of the United States
Public Health Service (“PHS”) 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 Eighth Amendment, having NIH Reference Number L-354-1998/8, 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 Timberloch Place, Suite B-7, The Woodlands, Texas 77280, U.S.A. (“Licensee”).
This Eighth 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 an eighth time as set forth below in order to amend its Appendix A – Patent(s)
or Patent Applications(s).

 

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 A in the Agreement with Appendix A, as follows:

 

		I)	U.S. Patent(s) or Patent Application(s):

 

		(a)	U.S. Provisional Application No. 60/016,628, filed May 1, 1996, abandoned (HHS Ref.
No. E-016-1996/0-US-01),

 

		(b)	U.S. Patent No. 6,861,415, issued March 1, 1995 (HHS Ref. No. E-016-1996/0-US-24),

 

		(c)	U.S. Patent No. 7,087,591, issued August 8, 2006 (HHS Ref. No. E-016-1996/0-US-25),

 

		(d)	U.S. Application No. 11/500,627, filed August 7, 2006, allowed (HHS Ref. No. E-016-1996/0-US-26),

 

		(e)	U.S. Application No. 12/641,172, filed December 17, 2009, pending (HHS Ref. No. E-016-
1996/0-US-28),

 

		(f)	U.S. Patent No. 6,900,193, issued May 31, 2005 (HHS Ref. No. E-155-1999/0-US-01), and

 

		(g)	U.S. Application No. 11/069,817, filed February 28, 2005, pending (HHS Ref. No. E-155-1999/0-US-07);

 

		II)	International Patent(s) or Patent Application(s):

 

		(a)	PCT Application No. PCT/US97/07373, filed April 30, 1997, expired (HHS Ref. No. E-016-
1996/0-PCT-02),

 

		(b)	Australian Patent No 710139, granted January 20, 2000 (HHS Ref. No. E-016-1996/0-AU-03),

 

 

 

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		(c)	Canadian Patent No. 2253673, granted September 8, 2009 (HHS Ref. No. E-016-1996/0-CA-04),

 

		(d)	European Patent No. 0900234, granted July 5, 2000 (HHS Ref. No. E-016-1996/0-EP-05)
and validated in the following EPC member states: Germany, France, United Kingdom, Italy, Belgium, Denmark, Greece, Austria, Switzerland,
Spain, Netherlands, Sweden, Finland, Ireland, and Portugal,

 

		(e)	Hungarian Application No. P9903515, filed April 30, 1997, pending (HHS Ref. No. E-016-1996/0-HU-06),

 

		(f)	Japanese Patent No 4260886, granted February 20, 2009 (HHS Ref. No. E-016-1996/0-JP-07),

 

		(g)	Mexican Patent No. 213200, granted March 12, 2003 (HHS Ref. No. E-016-199610-MX-08),

 

		(h)	Canadian Application No. 2668824, filed June 4, 2009, pending (HHS Ref. No. E-016-1996/0-CA-27).

 

		(i)	PCT Application No. PCT/US2001/008681, filed March 16, 2001, expired (HHS Ref. No.
F-155-1999/0-PCT-02),

 

		(j)	Australian Patent No. 2001245849, granted April 19, 2007 (HHS Ref. No. E-155-1999/0-AU-03),

 

		(k)	Canadian Patent No. 2403756, granted February 9, 2010 (HHS Ref. No. E-155-1999/0-CA-04),

 

		(l)	European Patent No. 1265911, granted May 21, 2008 (HHS Ref. No. E-155-1999/0-EP-05)
and validated in the following EPC member states: Austria, Belgium, Switzerland, Cyprus, Germany, Spain, Finland, France, United
Kingdom, Greece, Monaco, Netherlands, Portugal, Sweden, Turkey, Denmark, Ireland, Italy, and Luxembourg,

 

		(m)	Japanese Application No. 2001-572529, filed March 16, 2001, pending (HHS Ref. No. E-155-199910-JP-06),
and

 

		(n)	European Application No. 8009259.6, filed May 20, 2008, pending (HHS Ref. No. E-155-199910-EP-27).

 

		2)	Within sixty (60) days of the execution of this Eighth Amendment, Licensee shall
pay PHS an amendment issue royalty in the sum of ten thousand U.S. dollars ($10,000), to be sent to the address specified
in Attachment 1.

 

		3)	PHS has agreed to allow Licensee to defer payment of the royalty due under Paragraph
6.02 of the Agreement for unreimbursed patent expenses incurred by PHS on or prior to the effective date of this Eighth
Amendment. Licensee shall pay PHS this royalty in four (4) installments, according to the following payment schedule:

 

		a)	A first installment of fifty thousand U.S. dollars ($50,000), payable six (6) months from the effective
date of this Eighth Amendment;

 

		b)	A second installment of fifty thousand U.S. dollars ($50,000), payable twelve (12) months from
the effective date of this Eighth Amendment;

 

 

 

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		c)	A third installment of fifty thousand U.S. dollars ($50,000), payable eighteen (18) months from
the effective date of this Eighth Amendment; and

 

		d)	A fourth installment equal to any remaining unreimbursed patent expenses incurred by PHS
on or prior to the effective date of this Eighth Amendment, payable two (2) years from the effective date of this Eighth
Amendment.

 

If the Agreement is terminated
before full payment of this royalty, the remaining unpaid amount shall become immediately due to PHS per the provisions
of Paragraph 13.09 of the Agreement. Royalties for patent expenses incurred by PHS after the effective date of this
Eighth Amendment shall be paid according to the terms of Paragraph 6.02 of the Agreement.

 

		4)	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.

 

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

 

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

 

		7)	This Eighth Amendment is effective upon execution by all parties.

 

SIGNATURES BEGIN ON NEXT PAGE

 

 

 

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EIGHTH
AMENDMENT TO -354-1998/0

 

SIGNATURE PAGE

 

In Witness Whereof, the parties have executed
this Eighth 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:

        

        

        

        
 

         
	 	

 
	Richard U. Rodriguez

        Director, Division of Technology Development and Transfer

        Office of Technology Transfer

        National Institutes of Health	 	Date
	 	 	 
	
        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:

 	 	

 
	Joseph S. Podolski	 	Date
	Chief Executive Officer	 	 
	 	 	 
	I.	
        Official and Mailing Address of Agreement notices:

Joseph S. Podolski

Chief Executive Officer

Repros Therapeutics, Inc.

2408 Timberloch Place, Suite B-7

The Woodlands, Texas 77380

E-mail Address:podolski@reprosrx.com

Telephone:281-719-3400

Fax:281-719-3446 
	 	 

 

 

 

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

         

	 	Louis Ploth

CFO and VP, Business Development

Repros Therapeutics, Inc.

2408 Timberloch Place, Suite B-7

The Woodlands, Texas  77380

E-mail Address:lploth@reprosrx.com 

Telephone:281-719-3454

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
ROYALTY PA TENT 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 NTH for
Royalty Payments

Bank Name: Federal Reserve Bank

ABA# 021030004

TREAS NYC

BNF=/AC-75080031

OBI=Licensee Name and OTT Reference Number

Dollar Amount Wired=$$

 

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.

 

Checks drawn on a U.S. bank account should be sent directly
to the following address:

National Institutes of Health (NIH)

P.O. Box 979071

St. Louis, MO 63197-9000

 

Overnight or carrier deliveries 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

Phone: 301-496-7057

 

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

 

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

 

 

 

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	9332353v.1 141540/00001NATIONAL 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.

 

		14.07	This 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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