Exhibit 10.4
AMENDMENT #2 TO
PATHEON MANUFACTURING SERVICES
AGREEMENT
This Amendment #2 (hereinafter
referred to as this “ Amendment ”), dated as of
the 29th day of July, 2009 (the “ Amendment Date
”), is made by and between Patheon Inc., a corporation
existing under the laws of Canada (“ Patheon Canada
”), Patheon Pharmaceuticals Inc., a corporation existing
under the laws of Delaware (hereinafter referred to as “
Patheon ”), and Pivot Acquisition, Inc., a Delaware
corporation formerly known as Transcept Pharmaceuticals, Inc.
(hereinafter referred to as “ Client ”) and a
wholly-owned subsidiary of Transcept Pharmaceuticals, Inc. (a
publicly-traded Delaware corporation hereinafter referred to as
“ Transcept ”). Patheon Canada, Patheon and
Client are sometimes referred to herein individually as a “
Party ” or collectively as the “ Parties
”.
WHEREAS, the Parties have entered
into that certain Manufacturing Services Agreement dated
October 6, 2006, as amended on January 1, 2008, pursuant
to which Patheon agreed to supply quantities of Products to Client
in the Territory (the “ MSA ”);
WHEREAS, Transcept has entered into
that certain United States License and Collaboration Agreement
dated as of the date hereof with Purdue Pharma L.P., a Delaware
limited partnership having a place of business at One Stamford
Forum, 201 Tresser Boulevard, Stamford, Connecticut 06901-3431
(hereinafter referred to as “ Purdue ” and such
agreement the “ Collaboration Agreement ”),
pursuant to which, among other matters, Transcept has granted
Purdue exclusive rights with respect to the commercialization of
Products solely in the United States;
WHEREAS, Patheon and Purdue desire
to enter into an agreement setting forth the terms and conditions
of Patheon’s manufacture and supply of a Product for Purdue
solely with respect to the United States (the “ Purdue
MSA ”);
WHEREAS, Patheon and Transcept
desire to amend the MSA so that Purdue may enter into such
agreement with Patheon solely with respect to the United
States;
WHEREAS, Patheon and Transcept
desire for Client to retain all rights under the MSA with respect
to the Territory excluding the United States and its territories
and possessions; and
WHEREAS, the rights granted by
Transcept to Purdue under the Collaboration Agreement do not come
into effect until such time as the approved NDA for a Product is
transferred to Purdue pursuant to Section 4.2(c) of the
Collaboration Agreement (hereinafter referred to as the “
NDA Transfer ”).
NOW, THEREFORE, the Parties agree as
follows:
1. Capitalized Terms . All
capitalized terms used in this Amendment and not otherwise defined
herein shall have the meanings given to them in the MSA.
2. Effective Date . This
Amendment shall be effective as of the Effective Date. As used
herein, “ Effective Date ” means the date of
Patheon’s deemed receipt (in accordance with
Section 13.9 of the MSA) of the written notice from Transcept
to Patheon pursuant to which Transcept notifies Patheon that the
NDA Transfer has occurred, such notice to be substantially in the
form attached hereto as Exhibit A .
3. Territory . Effective as
of the Effective Date, the defined term “Territory” in
Section 1.1 of the MSA shall be deleted in its entirety and
amended as follows:
“ Territory ”
means worldwide, except for the United States and its territories
and possessions.
Notwithstanding the foregoing,
effective upon any termination of the Purdue MSA, any and all
rights with respect to the United States and its territories and
possessions shall revert to Client and the United States and its
territories and possessions shall be included in the Territory
under the MSA. Client and Transcept shall not be liable for any
acts or omissions of Purdue under any such Purdue MSA or
otherwise.
4. Miscellaneous .
(a) Entire Agreement . This
Amendment constitutes the entire agreement among the Parties with
respect to the amendment of the MSA, and supersedes all prior
agreeme
