Confidential Treatment
Requested
SIXTH AMENDMENT TO
L-354-1998/0
This is the
sixth amendment (“ Sixth 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 Sixth Amendment , having NIH Reference Number
L-354-1998/6, 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 (“ Licensee ”). This Sixth
Amendment includes, in addition to the amendments made below,
1) a Signature Page and 2) Attachment 1 (Royalty Payment
Information).
WHEREAS,
PHS and Licensee desire that the Agreement be
amended a sixth time as set forth below in order to change its
Appendix B-Licensed Fields-of-Use and Licensed Territory,
Appendix C—Royalties, and Appendix E-Benchmarks and
Performance.
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:
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1)
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Replace Appendix B in the
Agreement , as amended, with Appendix B as
follows:
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Licensed
Fields-of-Use: Treatment
of human endocrinologic pathologies or conditions in
steroid-sensitive tissues, including cancers related to the human
reproductive system.
Licensed
Territory: Worldwide.
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2)
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Replace Appendix C, I.)
(ii) c through g with the following:
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c.
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[**] within thirty(30) days of
filing the first New Drug Application for a Licensed Product
with the United States FDA.
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d.
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[**] within thirty(30) days of
filing the first new drug application for a Licensed Product
with the appropriate agency or regulatory body of any European
country.
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e.
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[**] within thirty(30) days of
filing the first new drug application for a Licensed Product
with the appropriate Agency or regulatory body in Japan.
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f.
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[**] within thirty (30) days of
receipt of the first marketing approval for a Licensed
Product from the United States FDA.
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g.
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[**] within thirty (30) days of
receipt of the first marketing approval for a Licensed
Product from the appropriate agency or regulatory body of any
European country.
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h.
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[**] within thirty (30) days of
receipt of the first marketing approval for a Licensed
Product from the appropriate agency or regulatory body in
Japan.
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CONFIDENTIAL
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Sixth Amendment
of L-354-1998/0
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Final REPROS THERAPEUTICS,
INC.
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July 7, 2009
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Model 09-2006
(updated 3-2009)
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Page 1 of 5
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L-354-1998/6
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Portions of
this Exhibit have been omitted pursuant to a request for
confidential treatment pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended, and Rule 406
under the Securities Act of 1933, as amended. These omitted
portions have been marked with “**” and have been filed
separately with the Securities and Exchange Commission.
SIXTH AMENDMENT TO
L-354-1998/0
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3)
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Replace Appendix E in the
Agreement, as amended, with Appendix E as
follows:
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Licensee agrees to the following Benchmarks for
the purpose of measuring its performance under this Agreement.
Licensee shall notify PHS in writing within thirty
(30) days of achieving all such Benchmarks. They are as
follows:
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Benchmark
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Date
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1.
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Obtain financing, upfront licensing
consideration, or any combination thereof (all of which are subject
to section 1(vi) of Appendix C of this Agreement ) of
no less than a combined total of Six Million Dollars
($6,000,000)
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9/30/2009
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2.
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File NDA in U.S. for first indication
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06/30/2011
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3.
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File for approval of Licensed Product in
Europe for first indication
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[**]
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4.
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