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): June 14, 2013
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):
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ 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 Agreement. |
On June 14, 2013, Repros Therapeutics Inc., a Delaware corporation (the “Company”), entered into the Ninth Amendment (the “Ninth Amendment”) to the PHS Patent License Agreement dated April 16, 1999, by and between the National Institutes of Health, the Centers for Disease Control 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 Ninth Amendment substitutes and amends the development benchmarks that the Company is required to meet under the Agreement. The Company is also filing herewith the Eighth Amendment to the Agreement (the “Eighth Amendment”) dated April 20, 2010, which added additional molecules licensed to the Company from PHS under the Agreement.
The foregoing descriptions of the Eighth and Ninth Amendments are qualified in their entirety by reference to the actual amendments filed herewith as Exhibits 10.1 and 10.2, which exhibits are incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
Exhibit
| Number | Description |
| 10.1 | Eighth Amendment to PHS Patent License Agreement, as amended, dated April 20, 2010 between the Company and certain agencies of the United States Public Health Service within the Department of Health and Human Services. |
| 10.2 | Ninth Amendment to PHS Patent License Agreement, as amended, dated June 14, 2013 between the Company and certain agencies of the United States Public Health Service within the Department of Health and Human Services. |
_________________
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: June 17, 2013 | ||
| By: | /s/ Kathi Anderson | |
| Kathi Anderson | ||
| Chief Financial Officer | ||
EXHIBIT INDEX
| Exhibit | ||
| Number | Description | |
| 10.1 | Eighth Amendment to PHS Patent License Agreement, as amended, dated April 20, 2010 between the Company and certain agencies of the United States Public Health Service within the Department of Health and Human Services. | |
| 10.2 | Ninth Amendment to PHS Patent License Agreement, as amended, dated June 14, 2013 between the Company and certain agencies of the United States Public Health Service within the Department of Health and Human Services. |
_________________
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), |
| CONFIDENTIAL | ||
| Eighth Amendment of L-354-1998/0 | Final Repros Therapeutics, Inc. | April 19, 2010 |
| Model 09-2006 (updated 3-2009) | Page 1 of 6 | L-354-1998/8 |
| 9332353v.1 141540/00001 |
| (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; |
| CONFIDENTIAL | ||
| Eighth Amendment of L-354-1998/0 | Final Repros Therapeutics, Inc. | April 19, 2010 |
| Model 09-2006 (updated 3-2009) | Page 2 of 6 | L-354-1998/8 |
| 9332353v.1 141540/00001 |
| 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
| CONFIDENTIAL | ||
| Eighth Amendment of L-354-1998/0 | Final Repros Therapeutics, Inc. | April 19, 2010 |
| Model 09-2006 (updated 3-2009) | Page 3 of 6 | L-354-1998/8 |
| 9332353v.1 141540/00001 |
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:
|
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| Richard U. Rodriguez Director, Division of Technology Development and Transfer Office of Technology Transfer National Institutes of Health |
Date | ||
|
Mailing Address for Agreement notices:
|
|||
| 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: |
||
| CONFIDENTIAL | ||
| Eighth Amendment of L-354-1998/0 | Final Repros Therapeutics, Inc. | April 19, 2010 |
| Model 09-2006 (updated 3-2009) | Page 4 of 6 | L-354-1998/8 |
| 9332353v.1 141540/00001 |
| 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).
| CONFIDENTIAL | ||
| Eighth Amendment of L-354-1998/0 | Final Repros Therapeutics, Inc. | April 19, 2010 |
| Model 09-2006 (updated 3-2009) | Page 5 of 6 | L-354-1998/8 |
| 9332353v.1 141540/00001 |
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
| CONFIDENTIAL | ||
| Eighth Amendment of L-354-1998/0 | Final Repros Therapeutics, Inc. | April 19, 2010 |
| Model 09-2006 (updated 3-2009) | Page 6 of 6 | L-354-1998/8 |
| 9332353v.1 141540/00001 |
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. |
| 14.07 | 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.
| CONFIDENTIAL - NIH | ||
| Ninth Amendment of L-354-199/0 | Final Repros | June 14, 2013 |
| Model 09-2006 (updated 8-2012) | Page 1 of 8 | |
| 9332721v.1 141540/00001 |
| 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
| CONFIDENTIAL - NIH | ||
| Ninth Amendment of L-354-199/0 | Final Repros | June 14, 2013 |
| Model 09-2006 (updated 8-2012) | Page 2 of 8 | |
| 9332721v.1 141540/00001 |
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 | ||
| CONFIDENTIAL - NIH | ||
| Ninth Amendment of L-354-199/0 | Final Repros | June 14, 2013 |
| Model 09-2006 (updated 8-2012) | Page 3 of 8 | |
| 9332721v.1 141540/00001 |
| I. |
Official and Mailing Address of Agreement notices:
|
| CONFIDENTIAL - NIH | ||
| Ninth Amendment of L-354-199/0 | Final Repros | June 14, 2013 |
| Model 09-2006 (updated 8-2012) | Page 4 of 8 | |
| 9332721v.1 141540/00001 |
| 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).
| CONFIDENTIAL - NIH | ||
| Ninth Amendment of L-354-199/0 | Final Repros | June 14, 2013 |
| Model 09-2006 (updated 8-2012) | Page 5 of 8 | |
| 9332721v.1 141540/00001 |
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 |
| CONFIDENTIAL - NIH | ||
| Ninth Amendment of L-354-199/0 | Final Repros | June 14, 2013 |
| Model 09-2006 (updated 8-2012) | Page 6 of 8 | |
| 9332721v.1 141540/00001 |
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
| CONFIDENTIAL - NIH | ||
| Ninth Amendment of L-354-199/0 | Final Repros | June 14, 2013 |
| Model 09-2006 (updated 8-2012) | Page 7 of 8 | |
| 9332721v.1 141540/00001 |
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 |
| CONFIDENTIAL - NIH | ||
| Ninth Amendment of L-354-199/0 | Final Repros | June 14, 2013 |
| Model 09-2006 (updated 8-2012) | Page 8 of 8 | |
| 9332721v.1 141540/00001 |