Exhibit 10.11
EXECUTION COPY
December 21, 2005
Remi Barbier
President & CEO
Pain Therapeutics, Inc.
416 Browning Way
South San Francisco, CA
94080
Re: Amendment 1 to the Development and
License Agreement
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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***
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Confidential
treatment request pursuant to a request for confidential treatment
filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.
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[***]
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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 Parties) source or supply such Other
Ingredient absent such written agreement by the Parties. It is
further understood that in the event the Parties disagree over who
should have the right to source or to supply a particular Other
Ingredient based on the interpretation of the above, then upon
PTI’s request, DURECT shall assume responsibility to insure
continuous sourcing and supplying of such Other Ingredient on terms
and conditions substantially similar to [***] until DURECT and PTI
resolve such disagreement. [***]
(b) Subject to Sections 5.1 and
5.6(a), as between the Parties, PTI shall be solely responsible for
man
