WYETH ACTING THROUGH ITS WYETH PHARMACEUTICALS DIVISION 500 Arcola Road Collegeville, Pennsylvania 19426 USA
Exhibit 10.12
CONFIDENTIAL
WYETH
ACTING THROUGH ITS
WYETH PHARMACEUTICALS DIVISION
000 Xxxxxx Xxxx
Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000 XXX
ACTING THROUGH ITS
WYETH PHARMACEUTICALS DIVISION
000 Xxxxxx Xxxx
Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000 XXX
November 30, 2006
Re: Amendment No. 1 to the Collaboration and License Agreement dated as of
December 19, 2005 (the “Agreement”) by and between Trubion Pharmaceuticals,
Inc. (“Trubion”) and Wyeth, acting through its Wyeth Pharmaceuticals Division
(“Wyeth”)
Ladies and Gentlemen:
This letter agreement (the “Letter Agreement”) constitutes Amendment No. 1 to the
Agreement referred to above. Capitalized terms used but not defined herein shall have
the meanings set forth in the Agreement. Trubion and Wyeth desire to amend the
Agreement as set forth herein, for purposes that pertain to, among other things, the
transfer of proprietary materials from Wyeth to Trubion for use in connection with the
Research Program, activities related to process development and manufacturing in
connection with the Agreement, and other activities mutually agreed upon in writing by
the Parties. This Letter Agreement sets forth the agreement of Trubion and Wyeth with
respect to such amendment.
1.
Section 3.2.2. Each of Trubion and Wyeth agrees that the Agreement hereby is
amended by deleting the phrase “On or before *** appearing in the first sentence of Section
3.2.2 and replacing it with the following phrase: “On or before
***
2.
Section 3.7. Each of Trubion and Wyeth agrees that the Agreement hereby is
amended by the following restatement of the first sentence of Section 3.7 appearing
therein, which amended sentence shall read as follows:
“Data and Deliverables. Each Party will use Commercially Reasonable Efforts to promptly provide to
the other Party the data or desired deliverables specified in the Research Plan and such other
data, deliverables and materials as the Parties may deem desirable in furtherance of the
Agreement, including, without limitation, (a) SMIPs, Recombinant DNA, and Cell Lines, to the
extent related to Licensed Targets and/or Licensed Products, (b) activity evaluation of the items
listed in (a) obtained from in vitro or in vivo assays, and (c) pharmacology studies, process
development and manufacturing
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CONFIDENTIAL
data, drug product formulation data, toxicology and safety studies, and evaluation of chemotherapy
conjugates.”
The other sentences in Section 3.7 of the Agreement remain unchanged.
3. New
Section 6.4. Each of Trubion and Wyeth agrees that the Agreement hereby is
further amended by inserting the following new Section 6.4 after Section 6.3 therein:
“6.4 Transfer of Materials by Wyeth.
6.4.1. Transfer. From time to time Wyeth may provide Trubion with proprietary Wyeth
materials (the “Wyeth Materials”). Wyeth represents and warrants to Trubion that Wyeth has
the right to provide the Wyeth Materials to Trubion for the uses authorized herein. Except
as set forth in the preceding sentence, the Wyeth Materials are provided by Wyeth on an
“as-is” basis without representation or warranty of any type, express or implied,
including any representation or warranty of merchantability, non-infringement, title or
fitness for a particular purpose, each of which is hereby disclaimed by Wyeth.
6.4.2. Use of Wyeth Materials. Trubion shall use the Wyeth Materials, and shall be
permitted to make modifications to the Wyeth Materials, solely in connection with
conducting the specific activities under this Agreement, including without limitation
activities under the Research Plan, for which such Wyeth Materials are provided to Trubion
and for no other purpose. Trubion shall not use the Wyeth Materials for the benefit of any
Third Party. Trubion shall not administer any of the Wyeth Materials to any human. Trubion
shall comply with all applicable laws, rules and regulations regarding the handling and
use of the Wyeth Materials. Trubion agrees to retain possession over the Wyeth Materials
and not to provide the Wyeth Materials to any Third Parties without Wyeth’s prior written
consent, except to contract employees and consultants working at Trubion’s facilities as
may be reasonably required pursuant to this Agreement, provided that in each such case
Trubion shall ensure that the Third Party is subject to contractual obligations of
confidentiality and non-use with respect to the Wyeth Materials that are consistent with
those set forth in this Agreement.
6.4.3. Unauthorized Use of Materials. In the event that Trubion uses the Wyeth Materials
for any purpose other than the purposes authorized herein, the results of such unauthorized
use, and any discoveries or inventions that arise from any such unauthorized use, whether
patentable or not, shall belong solely and exclusively to Wyeth. If required in order to
perfect or enforce Wyeth’s rights to such discoveries or inventions, Trubion hereby assigns
and agrees to assign to Wyeth all of its right, title and interest in and to all such
discoveries or inventions. Trubion agrees to cooperate with Wyeth to execute and deliver
any and all documents that Wyeth deems reasonably necessary to perfect and enforce its
right hereunder.
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CONFIDENTIAL
6.4.4.
Title to Wyeth Materials. All rights, title, and interest in the Wyeth
Materials shall remain the sole property of Wyeth notwithstanding the transfer to
and use by Trubion of the same.
6.4.5. Return of Wyeth Materials. Upon completion of the activities for which
the Wyeth Materials have been provided, or upon expiration or termination of this
Agreement, if earlier, Trubion shall, at Wyeth’s option, either destroy or return to
Wyeth all unused Wyeth Materials.
6.4.6. License. The Parties acknowledge that certain Materials Inventions (as
defined below) constitute Trubion Technology and are within the scope of the
licenses granted to Wyeth under Section 2.1.1, subject to the other terms and
conditions of this Agreement. To the extent not covered by the licenses granted
to Wyeth under Section 2.1.1, Trubion hereby grants to Wyeth a perpetual,
worldwide, royalty-free, non-exclusive license, with the right to grant sublicenses,
to make, use, practice, offer for sale, sell, import and exploit Materials Inventions.
As used herein, the term “Materials Invention” means any
invention or Know - How made by employees of Trubion that would not have been invented or made
at the time of invention or making but for the use of the Wyeth Materials pursuant
to this Agreement. The Joint Patent Committee shall determine whether any
potentially relevant inventions and Know-How are Materials Inventions, and
whether such Materials Inventions are covered by the licenses granted to Wyeth
under Section 2.1.1.
6.4.7. Survival. Notwithstanding anything in this Agreement to the contrary,
Sections 6.4.3, 6.4.4, 6.4.5 and 6.4.6 shall survive the expiration or termination of
this Agreement.”
Article 6 of the Agreement otherwise remains unchanged.
This Amendment No. 1 shall have retroactive effect to December 22, 2005, and shall apply to any
Wyeth Materials provided by Wyeth to Trubion on or after that date. As of that date, the term
“Agreement” (as used herein and in the original Agreement) shall mean the Collaboration and License
Agreement as modified by this Amendment No. 1. The Parties confirm that the Agreement is in full
force and effect.
[signature page follows]
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CONFIDENTIAL
Please indicate your acknowledgement of and agreement with the foregoing by having each counterpart
of this Letter Agreement executed on behalf of Trubion.
Very truly yours,
WYETH, acting through its
WYETH PHARMACEUTICALS DIVISION
WYETH PHARMACEUTICALS DIVISION
By:
|
/s/ Xxxxxx X. Xxxxx | |||
Name: Xxxxxx X. Xxxxx | ||||
Title: Senior Vice President | ||||
ACKNOWLEDGED AND AGREED: | ||||
TRUBION PHARMACEUTICALS, INC. | ||||
By:
|
/s/ Xxxxx Xxxxxxxx | |||
Name: Xxxxx X. Xxxxxxxx, M.D. | ||||
Title: President and Chief Executive Officer | ||||
Date: 12/4/2006 |
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