CONFIDENTIAL TREATMENT
REQUESTED
FIFTH AMENDMENT TO
L-354-1998/0
This is the
fifth amendment (“ Fifth 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 (“ PHS ”), agencies of the United States
Public Health Service within the Department of Health and Human
Services (“ HHS ”), and Repros Therapeutics
Inc., formerly known as Zonagen having an effective date of
April 16, 1999 and having NIH Reference Number
L-354-1998/0 (“ Agreement ”). This Fifth
Amendment , having NIH Reference Number L-354-1998/5, 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 Timbeloch
Place, Suite B-7, The Woodlands, TX 77280 (“
Licensee ”). This Fifth 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 fifth time as set forth below.
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 E-BENCHMARKS AND
PERFORMANCE 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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1.
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Initiate Phase
III Clinical trials in U.S. for first indication
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[ **
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2.
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File NDA in the
U.S. for first indication
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[ **
]
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3.
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File for
approval Licensed Product in Europe for first
indication
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[ **
]
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4.
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File for
approval Licensed Product in Japan for first
indication
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[ **
]
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5.
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Initiate Phase
III Clinical trials in U.S. for second indication
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[ **
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6.
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File NDA in the
U.S. for second indication
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[ **
]
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7.
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File for
approval Licensed Product in Europe for second
indication
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[ **
]
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8.
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File for
approval Licensed Product in Japan for second
indication
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[ **
]
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2)
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Within thirty (30) days of the
execution of this Fifth Amendment , Licensee shall
pay PHS an amendment issue royalty in the sum of Five
Thousand US Dollars ($5,000), to be sent to the address specified
in Attachment 2.
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3)
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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 shipping and payment information in such
Attachment 1.
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A-382-2006
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CONFIDENTIAL
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Fifth
Am
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