Exhibit No. 10.7(g)
Millennium/Aventis
Third Amendment to Collaboration and License
Agreement
Execution
Version
Confidential Materials omitted
and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
THIRD AMENDMENT TO COLLABORATION
AND LICENSE AGREEMENT
This Third Amendment to
Collaboration and License Agreement (this “Third
Amendment”) effective as of October 31, 2005 (the
“Third Amendment Date”) is by and between Millennium
Pharmaceuticals, Inc., a corporation organized and existing under
the laws of the State of Delaware and having its principal office
at 75 Sidney Street, Cambridge, Massachusetts 02139
(“Millennium”) and Aventis Pharmaceuticals Inc., a
member of the sanofi-aventis Group and a corporation organized and
existing under the laws of the State of Delaware and having its
principal office at Route 202-206, P.O. Box 6800, Bridgewater, New
Jersey 08807 (“Aventis”). All capitalized terms used in
this Third Amendment and not otherwise defined in this Third
Amendment have the meanings assigned them in the Collaboration
Agreement (as that term is defined in the first recital paragraph,
below).
RECITALS
WHEREAS, Millennium and Aventis
entered into a Collaboration and License Agreement dated as of June
22, 2000 (as previously amended, the “Collaboration
Agreement”);
WHEREAS, in general, the Research
Program Term under the Collaboration Agreement expired on July 21,
2005, but the Parties entered into a letter agreement dated July
20, 2005 extending certain aspects of the Research Program
for a limited time to permit the Parties to discuss further
collaborative activities (the “Extension Letter”);
and
WHEREAS, Millennium and Aventis have
agreed to the following changes to the Collaboration Agreement to
facilitate the Parties’ continued work together.
AGREEMENT
NOW, THEREFORE, Millennium and
Aventis hereby agree as follows:
1.
End of Research Program
Term . Effective as of
the Third Amendment Date, the Research Program and the Research
Program Term have expired for all matters for which the Research
Program Term was extended under the Extension Letter. The Parties
acknowledge the Research Program Term expired on July 21, 2005 for
all other matters.
2.
Interim Research
Period . After the
expiration of the Research Program Term, the Parties will continue
to conduct Pre-EDC Research Evaluation solely on the Program
Compounds identified in this Section 2 and for the specific period
(the “Interim Research Period”) applicable to that
Program Compound. The sole purpose of this continued Pre-EDC
Research Evaluation will be to determine whether one or more of the
listed compounds qualifies
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as an EDC pursuant to the terms of the
Collaboration Agreement as amended by this Third Amendment. For
this purpose, the Parties will apply the same EDC qualification
criteria, governing structures and decision-making processes as if
the Research Program Term had not expired and the Parties will have
the same “opt-in” and “opt-out” rights for
any resulting EDCs as for EDCs identified prior to the expiration
of the Research Program Term. The research licenses granted by each
Party to the other Party pursuant to Sections 7.1.1(a) and 7.2.1(a)
of the Collaboration Agreement will be extended during the
applicable Interim Research Period solely to permit the work
contemplated under this Section 2.
a.
[**] and [**]. The Parties
acknowledge that the only data remaining to determine whether the
Program Compounds known as [**] and/or [**], both of which are
aimed at the Program Target known as [**], meet the requirements to
be classified as an EDC is data for each compound [**] at Aventis
as of the date of signature of this Third Amendment. The Interim
Research Period will end as to each of [**] and [**] upon the
earliest to occur of (a) a determination that such Program Compound
meets the requirements for EDC, (b) a determination that such
Program Compound does not meet the requirements for EDC, or (c) 30
days or the next meeting of the Joint Development Committee,
whichever is later, after receipt of the [**] Program
Compound.
b.
[**]. Millennium will conduct
additional Pre-EDC Research Evaluation of the Program Compound
known as [**], which is aimed at the Program Target known as [**],
to determine whether [**] meets the requirements to be classified
as an EDC. Aventis will reimburse Millennium [**]percent ([**]%) of
the FTE Costs and other costs incurred by Millennium in the course
of conducting this Pre-EDC Research Evaluation during the extended
Research Program Term and the Interim Research Period for [**] up
to a maximum of $[**] U.S. The Interim Research Period will end as
to [**] upon the earliest to occur of (a) a determination that [**]
meets the requirements for EDC, or (b) a determination that [**]
does not meet the requirements for EDC. If [**] does not meet the
requirements to become an EDC, [**] will be distributed to
Millennium as a Millennium Single-Party Research Target, effective
as of the end of the Interim Research Period for [**]. If [**] is
so distributed, then Millennium will have the same rights and
obligations with regard to [**] and the Small Molecules related to
[**] as if [**] was a Pre-EDC Exempt Target distributed to
Millennium upon expiration of the Research Program through the
selection process described in Section 2.7.5(c)(ii) of the
Collaboration Agreement. For clarity, and subject to the
exclusivity period regarding SPRT Compounds specified in Section
2.7.3(b) of the Collaboration Agreement, Aventis retains the right
at any time to use [**] for further validation and drug discovery
activities, [**]. For further clarity, this Section 2(b) provides
the final disposition of [**] made during the Research Program Term
and such research assets shall not be further subject to Section
2.7.5 of the Collaboration Agreement.
c.
[**]. Aventis will, at its sole
cost, conduct additional Pre-EDC Research Evaluation of the Program
Compound known as [**], which is aimed at the Program Target known
as [**], to determine whether [**] meets the requirements to be
classified as an EDC. The Interim Research Period will end as to
[**] upon the earliest to occur of (a) a determination that [**]
meets the requirements for EDC, or (b) a determination
that
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[**] does not meet the requirements
for EDC. If [**] does not meet the requirements to become an EDC,
[**] will be distributed to Aventis as an Aventis Single-Party
Research Target, effective as of the end of the Interim Research
Period for [**]. If [**] is so distributed, then Aventis will have
the same rights and obligations with regard to [**] related to [**]
as if [**] was a Pre-EDC Exempt Target distributed to Aventis upon
expiration of the Research Program through the selection process
described in Section 2.7.5(c)(ii) of the Collaboration Agreement.
For clarity, and subject to the exclusivity period regarding SPRT
Compounds specified in Section 2.7.3(b) of the Collaboration
Agreement, Millennium retains the right at any time to use [**] for
further validation and drug discovery activities, [**]. For further
clarity, this Section 2(c) provides the final disposition of [**]
made during the Research Program Term and such research assets
shall not be further subject to Section 2.7.5 of the Collaboration
Agreement.
3.
[**]. Effective as of the Third
Amendment Date, the Program Target known as [**] will become an
Aventis Single-Party Research Target. Aventis will have the same
rights and obligations with regard to [**] related to [**] as if
[**] was a Pre-EDC Exempt Target distributed to Aventis upon
expiration of the Research Program through the selection process
described in Section 2.7.5(c)(ii) of the Collaboration Agreement.
For clarity, and subject to the exclusivity period regarding SPRT
Compounds specified in Section 2.7.3(b) of the Collaboration
Agreement, Millennium retains the right at any time to use [**] for
further validation and drug discovery activities, [**]. For further
clarity, this Section 3 provides the final disposition of [**] made
during the Research Program Term and such research assets shall not
be further subject to Section 2.7.5 of the Collaboration
Agreement.
4.
Additional Indications for
Current JDCs . The
Parties agree to cooperate in investigating additional indications,
[**], for all JDCs in the interest of maximizing the value of those
assets. Decisions regarding new indications will be made jointly by
the Parties in accordance with the procedures in the Collaboration
Agreement as amended by this Third Amendment, including, but not
limited to, the governing structures, decision-making processes,
cost sharing and profit sharing provisions.
5.
“Second Generation”
Programs for [**]. A new
Section 3.13 is added to the Collaboration Agreement to read as
follows:
3.13
“Second Generation”
Programs
3.13.1
Programs . Aventis may , at its sole cost but in its
discretion, make efforts to identify, test and qualify Small
Molecules to serve as back-up or follow-on compounds for any EDCs
approved by the Parties aimed at [**].
(a)
The Joint Research Committee will
meet no less frequently than [**] to discuss Aventis’s
activities and progress in identifying, testing and qualifying such
Small Molecules or, if the Parties agree in a particular instance,
Aventis may provide to
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Millennium a written report of its
activities and progress in lieu of a meeting.
(b)
Millennium will cooperate reasonably
with Aventis in transferring any Program Technology or Program
Materials necessary for Aventis to fulfill its obligations under
this Section 3.13.1.
(c)
Any decision whether any Small
Molecule identified by Aventis in accordance with this Section
3.13.1 qualifies as an EDC will be made jointly by the Parties
using the same EDC qualification criteria, governing structures and
decision-making processes as if the Research Program Term had not
expired and the Parties will have the same “opt-in” and
“opt-out” rights for any resulting EDCs as for EDCs
identified prior to the expiration of the Research Program
Term.
(d)
In addition to the above, Aventis
will provide to Millennium a research plan describing the
activities that Aventis intends to undertake to identify, test and
qualify such Small Molecules aimed at [**] within [**] days after
signature of the Third Amendment to this Agreement. If at any time
Aventis fails to pursue the activities described in the research
plan for a consecutive [**] period, Aventis will, at
Millennium’s request, transfer the program back to Millennium
at no cost to Millennium, and Millennium will have the right, in
its discretion, to continue to identify, test and qualify such
Small Molecules. If Millennium decides to continue to identify,
test and qualify such Small Molecules, then the provisions of
Section 3.13.1(c) shall apply to any Small Molecules identified by
Millennium.
3.13.2
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