EXHIBIT NO. 10.3
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
FIRST AMENDMENT TO COLLABORATION AND LICENSE AGREEMENT
This First Amendment to Collaboration and License Agreement (the "First
Amendment") dated as of June 29, 2001 (the "First Amendment Effective 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 00 Xxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000 ("Millennium") and Aventis
Pharmaceuticals Inc., a corporation organized and existing under the laws of the
State of Delaware and having its principal office at Xxxxx 000-000, X.X. Xxx
0000, Xxxxxxxxxxx, Xxx Xxxxxx 00000 ("Aventis").
INTRODUCTION
WHEREAS, Millennium and Aventis are Parties to a Collaboration and
License Agreement, having an Execution Date of June 22, 2000 (the "Collaboration
Agreement"); and
WHEREAS, Millennium and Aventis have determined that it is desirable to
amend and restate certain provisions of the Collaboration Agreement as set forth
herein, and incorporate additional provisions to the Collaboration Agreement as
set forth herein, to reflect further agreements between them.
NOW, THEREFORE, the Parties hereto, intending to be legally bound, and
for good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, hereby agree as follows:
The following definitions shall be added to the Collaboration Agreement or
amended, as the case may be. Capitalized terms used in this Amendment and not
defined herein shall have the meanings ascribed to them in the Collaboration
Agreement.
1. Section 1.1 of the Collaboration Agreement is hereby amended and
restated to read in its entirety as follows:
"ACTIVE". Active means, (a) with respect to a Small Molecule[**] of a
Scientifically-Qualified Target, that the Small Molecule [**] in the
case of [**] the Scientifically-Qualified Target with [**] and (b) with
respect to a Small Molecule[**] of a Program Target, that the Small
Molecule [**] in the case of [**] a Program Target with [**] set forth
in the applicable Lead Generation Plan.
2. Section 1.37 of the Collaboration Agreement is hereby amended and
restated to read in its entirety as follows:
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"LEAD COMPOUND FAMILY". Lead Compound Family means, with respect to a
Lead Compound, such Lead Compound and (i) [**] designated by the JRC
pursuant to the procedures set forth in the Section 7.1(a) of the
Chemistry SOP, and (ii) all Program Compounds that are [**] of such
Lead Compound in the conduct of the Research Program.
Article 1 of the Collaboration Agreement is hereby amended to add the
following additional defined terms:
"CHEMICAL LIBRARY". Chemical Library means those libraries of Small
Molecule compounds Controlled by a Party and made available for the
Research Program.
"CHEMISTRY SOP". Chemistry SOP means the guidelines and procedures set
forth in Exhibit A to this First Amendment, as amended from time to
time by the JRC.
"CORPORATE DATABASE". Corporate Database means the database of Small
Molecule compounds and other compounds maintained by each Party which
database records relevant information (such as, for example, structural
information) pertaining to such Small Molecules and other compounds,
including without limitation, Small Molecules identified during the
Research Program.
"CORPORATE IDENTIFICATION NUMBER". Corporate Identification Number
means the unique number used by a Party to identify a specific Small
Molecule or other compound within its Corporate Database.
"DATABASE FLAG". Database Flag means a descriptor identifying a
compound to be part of the Research Program and the status of that
Small Molecule in the Research Program, [**] in the Research Program.
As of the First Amendment Effective Date, the Database Flags in-use by
the Parties are:
DEDC: The Small Molecule is a Dropped EDC Compound.
EDC: The Small Molecule is an Early Development Candidate.
EDC BACK-UP: The Small Molecule is identified as a Back-Up
Compound in the EDC Data Package.
EDC FAMILY: The Small Molecule is identified as a member of an
EDC Family in the EDC Data Package.
HEP-ROOT: The Small Molecule is a [**] which is used as the
basis for the formulation of a HEP Research Plan (as defined
in the Chemistry SOP).
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JDC: The Small Molecule is a Joint Development Compound.
LC: The Small Molecule is a Lead Compound.
LCF: The Small Molecule is a member of the Lead Compound
Family.
PC: The Small Molecule is a Program Compound.
PCF: The Small Molecule is a member of the Program Compound
Family.
[**]UDC: The Small Molecule is a Unilateral Development
Compound.
Additional Database Flags may be designated from time-to-time
on an as-needed basis upon the approval of the JRC.
"EDC FAMILY". EDC Family means [**], which are selected by the JRC with
guidance from the Joint Research Project Team and the Joint Chemistry
Committee.
"INTERNAL CLEARANCE". Internal Clearance means the internal process
conducted by a Party to determine if a specific Small Molecule is
subject to an Internal Technology Obligation.
"INTERNAL TECHNOLOGY OBLIGATION". Internal Technology Obligation means,
with respect to a particular Small Molecule, that such Small Molecule
has been [**] wherein such [**] (a) [**] pursuant to [**], (b) [**],
and (c) as of [**] pursuant to the [**].
"LEAD GENERATION PLAN". Lead Generation Plan means the detailed
research plan approved by the JRC on a Program Target-by-Program Target
basis.
"POSITIVE(S)". Positive means a Small Molecule that is initially
identified pursuant to the screening of a Chemical Library and which
meets the criteria for a Positive set forth in the applicable Lead
Generation Plan.
"PROGRAM TARGET NOMINATION DATE" Program Target Nomination Date means
the first date a Party communicates to the JRC (or its designee), such
Party's interest in designating a particular target as a Program
Target.
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[**] means, with respect to a Small Molecule, that (i) it is subject to
[**], or (ii) in the case of a Small Molecule which is nominated for
Program Compound status, it is subject to a [**] that such [**] in the
Research Program.
3. Section 2.1.1(f) of the Collaboration Agreement is hereby amended to
read in its entirety as follows:
It is also intended, notwithstanding subsection (e) above, that during
the Research Program Term, the Parties shall collaborate in making
available for the Research Program Small Molecule Chemical Libraries as
set forth in the then current Annual Research Plan, with the global
objectives of maximizing the quantity and quality of the EDC Compounds
with potential utility in the Inflammation Field consistent with the
resources allocated to such activities under the Annual Research Plan.
Specific procedures [**] and the provision of information related to
[**], including, without limitation, [**], are set forth in the [**];
PROVIDED, THAT, except as otherwise provided in this Collaboration and
License Agreement, neither Party shall be obligated to disclose to the
other Party the chemical structure of any compound in any Chemical
Library Controlled by such Party unless and until such compound is
identified and confirmed by the Controlling Party to be Active against
a Program Target and such compound is not subject to [**] asserted by a
Party, or is otherwise designated a Program Compound by the Joint
Research Committee.
4. The second sentence of Section 2.4.1 of the Collaboration Agreement is
hereby amended to read in its entirety as follows:
The Parties shall conduct the Research Program in accordance with such
project progression guidelines, and in accordance with the procedures
set forth in the Chemistry SOP.
4. Section 2.4.5 of the Collaboration Agreement is hereby amended by
adding the following text at the end of Section 2.4.5:
The Parties shall establish a Joint Chemistry Committee, which shall be
a sub-committee of the JRC and which shall be responsible for
implementing the Chemistry SOP during the Research Program. The Joint
Chemistry Committee shall also be responsible for recommending to the
JRC revisions to the Chemistry SOP, on an as-needed basis. The Joint
Chemistry Committee shall be comprised of an equal number of
representatives from each Party. Each Party shall have one vote on the
Joint Chemistry Committee, and all decisions of the Joint Chemistry
Committee must be made by a vote in the affirmative from both Parties.
If the
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Joint Chemistry Committee is unable to agree on any decision or
recommendation before it, the issue shall be resolved by the JRC, and
if the JRC is unable to reach unanimous agreement on the matter it
shall be resolved pursuant to Article 12. Except as otherwise provided
in the immediately preceding five (5) sentences of this Section 2.4.5,
the Joint Chemistry Committee shall follow the procedures for formation
and membership, administrative matters, decision making and meetings
set forth in Section 2.2 hereof.
6. Section 2.5 of the Collaboration Agreement is hereby amended by adding
new Section 2.5.6, which shall read in its entirety as follows:
In the case of a Program Compound, prior to the designation of a Small
Molecule as a Program Compound by the Joint Research Committee, the
Parties shall conduct Internal Clearance with respect to such Program
Compound, as further described in the Chemistry SOP, in order to
identify any [**] with respect to such Small Molecule. The Parties
shall also determine if there are any Burdened Technology Obligations
with respect to the Small Molecule. A proposed Small Molecule will only
be permitted into the Research Program after it is determined that such
Small Molecule is not subject to [**] and the JRC has evaluated the
nature and scope of any Burdened Technology Obligation and accepted
such compound as a Program Compound.
7. Section 3.1.1 is hereby amended to read in its entirety as follows:
The Joint Research Committee shall notify the Joint Development
Committee in writing when a Joint Research Project Team has recommended
a Program Compound for EDC Status. Such notification shall (1) identify
the Program Compound with specificity, (2) identify the related Program
Target, if any, (3) identify [**] Small Molecules as members of the
corresponding EDC Family, and (4) identify any existing Back-Up
Compounds in accordance with Section 3.9. Such notification shall be
accompanied by any pertinent data, information, results and materials
relating to the foregoing available to the Joint Research Committee
(the "EDC Data Package"). In the case where Back-Up Compounds have not
been identified, the notification shall also include a proposed plan
for the identification of Back-Up Compounds. With respect to the
designated members of the EDC Family, such Small Molecules shall be
designated as members of an EDC Family for [**] such Small Molecules
[**]: (i) [**], or (ii) the date when [**], or (iii) with respect to a
particular member of an EDC Family, the Joint Research Committee (JRC)
determines that [**], it being understood that any such [**] shall only
occur as otherwise permitted under this Agreement.
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8. Section 3.9.1 is hereby amended and restated to read in its entirety
as follows:
When a Program Compound is nominated for EDC Status, the EDC Data
Package shall either: (a) identify other Program Compounds which shall
serve as Back-Up Compounds, or (b) in the case where Back-Up Compounds
have not been identified, include a proposed plan for the
identification of Back-Up Compounds. Back-Up Compounds identified or
to-be-identified shall be based on back-up selection criteria agreed
upon by the Joint Research Committee pursuant to 2.4.1.
9. Section 9.1.2(b) is hereby amended and restated to read in its
entirety as follows:
COMPOUND RELATED INVENTIONS. In the event a Party [**] in the conduct
of the Research Program [**], then the Party or Parties, as the case
may be, shall [**] to the Party or Parties, if any, [**].
10. The first sentence of Section 2.10.2 of the Collaboration Agreement
is hereby amended and restated to read in its entirety as follows:
Each GT Option and Vaccine Option will expire [**]after the
designation of the underlying target as a Program Target by
the Joint Research Committee.
11. The first sentence of Section 2.11.2 of the Collaboration Agreement is
hereby amended and restated to read in its entirety as follows:
Each Antibody Option and Diagnostic Option will expire [**]
after the designation of the underlying target as a Program
Target by the Joint Research Committee.
CONTINUING EFFECT. Except as specifically modified by this First Amendment, all
of the provisions of the Collaboration Agreement are hereby ratified and
confirmed to be in full force and effect, and shall remain in full force and
effect.
ENTIRE AGREEMENT; SUCCESSORS AND ASSIGNS. The Collaboration and License
Agreement, this First Amendment, and any written agreements executed by both
Parties pertaining to the subject matter therein, constitute the entire
agreement between the Parties hereto with respect to subject matter hereof and
thereof. Said documents supersede all other agreements and understandings
between the Parties with respect to the subject matter hereof and thereof,
whether written or oral. This First Amendment shall
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be binding upon and shall inure to the benefit of the Parties and their
respective heirs, administrators, executors, affiliates, successors and
permitted assigns.
HEADINGS. The section headings contained in this First Amendment are for
reference purposes only and shall not affect in any way the meaning or
interpretation of the First Amendment.
COUNTERPARTS. This First Amendment may be executed in one or more counterparts,
all of which shall be considered one and the same agreement, and shall become a
binding agreement when one or more counterparts have been signed by each Party
and delivered to the other Party.
MISCELLANEOUS. This First Amendment shall be governed by the laws of the State
of Delaware, without regard to its principles of conflicts of laws. This First
Amendment supercedes all prior understandings and agreements, whether written or
oral, among the Parties hereto relating to the essence of this First Amendment.
If there is a direct conflict between the provisions of the Collaboration and
License Agreement and this First Amendment, this First Amendment shall govern.
This First Amendment may be amended only by a written instrument executed by
each of the Parties.
[SIGNATURES APPEAR ON FOLLOWING PAGE]
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IN WITNESS WHEREOF, each of the Parties has caused this First Amendment
to be executed as of the date hereof by a duly authorized corporate officer.
AVENTIS PHARMACEUTICALS INC.
By: /s/XXXX XXXXX
Name: Xxxx Xxxxx
Title: Vice President
Technology Licensing & Alliances
Date: August 29, 2001
MILLENNIUM PHARMACEUTICALS,
INC.
By: /s/ XXXX XXXXX
Name:Xxxx Xxxxx
Title: SVP, Corporate Development
Date: September 4, 2001
