Exhibit 10.45
Confidential treatment has been
requested for portions of this exhibit. The copy filed herewith
omits the information subject to the confidentiality request.
Omissions are designated as ***. A complete version of this exhibit
has been filed separately with the Securities and Exchange
Commission.
December 21, 2005
Remi Barbier
President & CEO
Pain Therapeutics, Inc.
416 Browning Way
South San Francisco, CA
94080
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Re:
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Amendment 1
to the Development and License Agreement
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Dear Remi:
The following sets forth amendments
to the Development and License Agreement entered into by Pain
Therapeutics, Inc. and DURECT Corporation effective
December 19, 2002 (the “Agreement”), as agreed to
by the Parties. Unless otherwise defined in this letter, all terms
shall have the meaning given to such terms in the License
Agreement.
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PTI and DURECT
agree that DURECT shall not be obligated to supply to PTI, and PTI
shall not be obligated to purchase from DURECT, SABER™
Ingredients. Accordingly, Section 5.1(a) of the Agreement
shall be amended to read as follows:
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“5.1(a) Subject to the terms
and conditions set forth herein, DURECT shall supply to PTI, and
PTI shall purchase from DURECT: (i) [* * *] (collectively, the
‘Excipient Ingredients’) for manufacture of Licensed
Products used in the conduct of the Clinical Program and
(ii) Licensed Products used in the Pre-Clinical Program and
the initial pharmacokinetic studies in humans under the Clinical
Program (the ‘Bulk Dosage Form’).”
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The terms and
conditions of Article V of the Agreement shall govern the supply of
[* * *] by DURECT to PTI under Section 5.1(a), with
“Excipient Ingredients” substituted for
“SABER™ Ingredients” throughout the Agreement
except with respect to Sections 11.2(iv) and 12.4(b). For clarity,
Excipient Ingredients shall be supplied by DURECT to PTI in their
neat form according to specifications mutually agreed upon by PTI
and DURECT.
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Exhibit 5.1 of
the Agreement is amended to read as follows:
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“The Transfer Price for [* *
*]
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Section 5.6 shall be amended to read as
follows:
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“(a) Subject to
Section 5.1(a), PTI or its agents shall be solely responsible
for all aspects of sourcing, supplying, formulating or
manufacturing any excipient, additive, solvent or ingredient other
than the Excipient Ingredients for manufacture of Licensed Products
(each an ‘Other Ingredient’ and collectively
‘Other Ingredients’); provided, however,
notwithstanding the foregoing, in the event the Other Ingredient is
[* * *], then PTI and DURECT shall determine, by mutual agreement
in writing, which Party shall have the responsibility for sourcing
and supplying such Other Ingredient, and the terms and conditions
therefor, and neither Party may directly or indirectly (e.g.,
through agents or other Third Par
