CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
Exhibit 10.12
THIRD AMENDMENT TO
COLLABORATION AGREEMENT
This Third Amendment To Collaboration Agreement (this "Collaboration Third
Amendment") is made and entered into as of this 14th day of February, 2001 by
and between Sanwa Kagaku Kenkyusho Co., Ltd., a Japanese corporation ("Sanwa")
and Telik, Inc., a Delaware corporation ("Telik").
Recitals
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A. Sanwa and Telik are parties to that Collaboration Agreement dated as of
December 20, 1996 as amended by that certain First Amendment to Collaboration
Agreement dated September 24, 1997 and that Second Amendment to Collaboration
Agreement dated October 29, 1998 (the "Collaboration Agreement") pursuant to
which the Parties have jointly engaged in research to identify one or more
compounds which activate the insulin signal transduction pathway and appear to
be useful for treatment of diabetes mellitus or insulin resistance in humans.
B. Sanwa and Telik are entering into a Master Amendment Agreement of even
date herewith in connection with which, as one of the conditions to Sanwa paying
Telik the amount set forth therein, the parties have agreed to execute and
deliver this Collaboration Third Amendment.
NOW, THEREFORE, in consideration of the above recitals and for other good
and valuable consideration, the adequacy and receipt of which are hereby
acknowledged, the parties hereby agree as follows:
1. Amendments. The Collaboration Agreement is hereby amended as follows:
-----------
A. Section 2.1 is amended in its entirety as follows:
"The Parties will participate in a program (the "Research Program")
to research and discover novel compounds in the Field. The Research
Program shall commence on the Effective Date and continue until the
fifth anniversary of the Effective Date, unless (i) terminated
pursuant to Sections 9.2 or 9.3 or (ii) extended by mutual written
agreement of the Parties. The period of time during which the
Research Program is in effect shall be the "Research Term." The
Research Term shall be conducted pursuant to a detailed research
plan attached hereto as Exhibit A, which may be modified from time
to time by the RMC (the "Research Plan"). Telik shall commence the
Research Program promptly upon execution of this Agreement. Telik
shall devote commercially reasonable efforts to its obligations
under the Research Program, consistent with the efforts Telik
devotes to Telik's own research programs of comparable market
potential."
1.
B. Section 2.5.1 is amended in its entirety as follows:
"Telik will be responsible for providing [*] (the [*] all
infrastructure [*] necessary for conducting [*] Phase 1 of the
Research Plan, relating to identification and selection of advanced
lead compounds and Phase 2 of the Research Plan, relating to
identification and selection of Clinical Candidates. Telik will
also use commercially reasonable efforts to undertake the US FDA
Phase 1 clinical studies or European equivalent with respect to or
based on any compounds discovered as a result of the Research Plan.
Telik, [*], will also be responsible for providing all
infrastructure [*] necessary for and conducting [*], Phase 3 of the
Research Plan, relating to all IND enabling work for Clinical
Candidates, except that portion of Phase 3 work identified in the
Research Plan as uniquely required for an IND application in Japan,
for:
(i) The first Clinical Candidate; and
(ii) Subsequent Clinical Candidates if Telik shall choose by
written notice to Sanwa, to develop or have developed the
same Clinical Candidate(s) outside the Sanwa Territory.
If, as of the date Telik provides notice to Sanwa pursuant to
Section 2.5.1 (ii), Sanwa has commenced work on that portion of
Phase 3 of the Research Plan for which Telik would be responsible
as a result of providing such notice using protocols for such Phase
3 work as may be recommended by the RMC, then Telik shall promptly
[*] such portion of Phase 3 of the Research Plan and Telik shall
take over and complete or have such work completed."
C. Section 2.7 is amended in its entirety to read as follows:
"Sanwa will have the right, but no obligation, to provide
infrastructure [*] necessary for and to conduct [*] that portion of
Phase 3 of the Research Plan identified therein as uniquely
required for an IND application in Japan with respect to Clinical
Candidates."
D. Section 2.8.3 is revised to read in its entirety as follows:
"2.8.3 Telik shall make available and disclose to Sanwa, on a
quarterly basis, all work related to Phase 3 of the Research
Program for which Telik is responsible pursuant to Section 2.5.
Telik shall also make available to Sanwa all work related to and
all results of any FDA, European or other clinical studies
conducted based on any compounds discovered as a result of the
Research Program, including, without limitation, any US FDA Phase 1
clinical studies or equivalent foreign studies conducted by Telik.
Telik shall also make available to Sanwa data within the Field
relevant to
2.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
the Research Program arising from arrangements between Telik and
third parties similar to this Agreement but only to the extent, and
upon such terms, as such third party shall agree including, if
necessary, an agreement by Sanwa to provide similar information to
such third party upon a reciprocal basis. Without limiting the
generality of the foregoing, Telik agrees to use its reasonable
efforts in good faith to cause any third party having rights to
Clinical Candidates outside the Sanwa Territory to provide the
results of tests and other work corresponding to Phase 3 of the
Research Plan to Sanwa for such Clinical Candidates. The
obligations of Telik set forth in this Section 2.8.3 shall
terminate upon Telik's receipt of written notice from Sanwa
pursuant to Section 4.4."
E. Section 2.8.4 is revised to read in its entirety as follows:
"To the extent that Sanwa performs any Phase 3 work relating to
Clinical Candidates, Sanwa shall disclose the results of such work
to Telik. Telik may use such information solely for the purposes of
the Research Program and shall not use it for any other purpose or
disclose it to any third party unless Sanwa agrees to the terms of
such use or disclosure (which may include [*] for all or a portion
of the Phase 3 work conducted by Sanwa or on Sanwa's behalf by a
third party)."
F. Sections 2.10(b) and 2.10(c) are deleted in their entirety and
Section 2.10(d) is renumbered as Section 2.10 (b) and revised in
its entirety to read as follows:
"(b) During the Research Term, Telik shall be fully responsible for
performing all work [*] (the [*] and ensuring that at all times
Telik has [*] to fulfill all of its obligations in accordance with
the Research Plan."
G. Section 4.4 is amended in its entirety to read as follows:
4.4 Exclusive Collaboration. Each party to this Agreement covenants
and agrees that the Research Program shall be its sole and
exclusive activity within the Field in the Sanwa Territory during
the term of this Agreement. Telik covenants and agrees that during
the term of this Agreement, Telik will not license compounds to
third parties in the Sanwa Territory where the development of such
compounds is directed toward the Field. Notwithstanding the
foregoing, if (a) Telik has not developed a detailed clinical plan
in form and content reasonably satisfactory to the parties for
clinical studies to be carried out with respect to [*] compounds
discovered as a result of the Research Program by [*], (b) Telik
has not commenced clinical studies in accordance with such clinical
plan by [*], or (c) Telik fails to use commercially reasonable
efforts to diligently develop compounds discovered as a result of
the Research Program or abandons development of such compounds,
then upon written notice from
3.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
Sanwa to Telik, all of Sanwa's duties and obligations pursuant to
this Section 4.4 shall immediately terminate.
H. Section 9.4 is amended in its entirety to read as follows:
9.4 Accrued Rights; Surviving Obligations. Termination of this
Agreement shall not affect any accrued rights of either Party. The
terms of Section 2.8.3, Articles 3, 6, 8 and 10 of this Agreement
shall survive termination of this Agreement. Except as set forth in
the License Agreement, promptly after termination of this Agreement
each Party shall return or dispose of any know-how of the other in
accordance with the instructions of the other, including without
limitation any compounds, assays or other biological or chemical
materials.
2. Defined Terms; Incorporation. Unless otherwise expressly provided
----------------------------
herein, defined terms used in this Third Amendment shall have the same meaning
as set forth in the Collaboration Agreement, and all terms herein shall be
incorporated into the Collaboration Agreement. From and after the Third
Amendment Effective Date, all references to the "Collaboration Agreement" in all
other documents delivered in connection with the Collaboration Agreement shall
refer to the Collaboration Agreement, as amended hereby.
3. Counterparts: Facsimile. This Third Amendment may be executed in
-----------------------
counterparts and by facsimile.
4. Effective Date. This Third Amendment shall be effective as of
--------------
February 14, 2001 (the "Third Amendment Effective Date").
IN WITNESS WHEREOF, the parties have executed this Collaboration Third
Amendment as of the date first set forth above.
TELIK, INC. SANWA KAGAKU KENKYUSHO CO., LTD.
/s/ Xxxxxxx X. Xxxx /s/ Xxxxx Xxxxxxxx
--------------------------------- -----------------------------------
By: Xxxxxxx X. Xxxx, M.D., Ph.D. By: Xxxxx Xxxxxxxx
Its: Chairman and CEO Its: President
4.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
