Exhibit 10.4
SANOFI-AVENTIS AND IMMUNOGEN
CONFIDENTIAL
Execution Copy
AMENDMENT NO. 2 TO THE
COLLABORATION AND LICENSE AGREEMENT
This Amendment
No. 2 to the Collaboration and License Agreement (this
“Amendment”) is dated as of December 7, 2007 (the
“Amendment Effective Date”) by and between
ImmunoGen, Inc., a Massachusetts corporation with a principal
office at 128 Sidney Street, Cambridge, MA 02139
(“ImmunoGen”), and sanofi-aventis U.S. LLC, a Delaware
limited liability company with offices at 1041 Rte. 202-206,
Bridgewater, NJ 08807 (“Aventis”). Capitalized
terms used but not otherwise defined herein shall have the meanings
ascribed to such terms in the Collaboration and License Agreement
(the “Agreement”) dated as of July 30, 2003 (the
“Agreement Effective Date”) by and between ImmunoGen
and Aventis Pharmaceuticals, Inc. (predecessor in interest to
Aventis), as amended August 31, 2006.
WHEREAS, on the
Agreement Effective Date, ImmunoGen and Aventis entered into the
Agreement for the purpose of collaborating on the identification
and validation of targets for use in the discovery of antibodies
and antibody-drug conjugates in the Collaborative Focus Area (as
defined in the Agreement) and in the development and
commercialization of such antibodies and antibody-drug conjugates;
and
WHEREAS, the
Parties hereto desire to amend the Agreement to provide that
ImmunoGen will develop a Phase IIb/III scale process for
manufacturing SAR3419 and Aventis will assist and compensate
ImmunoGen, all as set forth in this Amendment, and to set forth
certain additional terms applicable to the Agreement, as so
amended.
NOW, THEREFORE, in
consideration of the mutual covenants contained herein, and for
other good and valuable consideration, the Parties hereto,
intending to be legally bound, hereby agree as follows:
In consideration
of the mutual promises and covenants hereinafter set forth herein,
and other consideration, the Parties agree as follows:
1.
Amendments to Agreement
.
(a)
The following new definitions are hereby added to Article 1 of
the Collaboration Agreement:
“1.25A
“Conjugation Process” means a process for
manufacturing SAR3419 by conjugating its component parts, which is
to be developed as part of the Services under this
Agreement.”
“1.82A
“Project Plan” means the project plan attached
hereto as Exhibit C, which describes the Services, sets forth
the Requirements, and includes other information, terms and
conditions relevant to performance of the Services, as amended and
updated by mutual agreement of the Parties.”
“1.82B
“Project Materials” means any materials, other
than Aventis Materials, used by ImmunoGen in the conduct of the
Services.”
“1.82C
“Project Technology” means any Technology that
is developed or conceived by employees of, or consultants to,
ImmunoGen in the conduct of the Services.”
“1.85D
“SAR3419” means huB4 antibody conjugated to DM4
through the SPDB linker.”
“1.85E
“Requirements” means any specifications or
requirements applicable to the Services set forth in the Project
Plan.”
Portions of this Exhibit were
omitted, as indicated by [***], and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
“1.86A
“Services” means the process development work to
be performed by ImmunoGen, as described in the Project
Plan.”
(b)
The definition of Aventis Materials set forth in Section 1.10
of the Agreement is hereby amended by adding the following sentence
at the end of the definition:
“For
purposes of clarity, Aventis Materials includes
SAR3419.”
(c)
The definition of ImmunoGen Materials set forth in
Section 1.49 of the Agreement is hereby amended by adding the
following sentence at the end of the definition:
“For
purposes of clarity, ImmunoGen Materials includes all Project
Materials.”
(d)
The definition of “ImmunoGen Technology Improvements”
is hereby deleted in its entirety and replaced with the
following:
“ ImmunoGen
Technology Improvements ” means (a) any
Technology which (i) is developed or conceived by employees
of, or consultant to, either Party or jointly by both Parties,
under this Agreement and (ii) (A) is Covered by the
ImmunoGen Patent Rights or (B) is a maytansinoid that is
substantially equivalent to a maytansinoid Covered by an ImmunoGen
Patent Right listed on Schedule 1.50 or (C) is a method of
manufacture or use with respect to a maytansinoid that is
substantially equivalent to a method of manufacture or use,
respectively, with respect to a maytansinoid and Covered by an
ImmunoGen Patent right listed on Schedule 1.50 and (b) any
Project Technology.”
(e)
A new Section 4.5 is hereby added to the Agreement which shall
provide as follows:
“4.5
“Process Development Services.”
4.5.1
Project Plan Document. The Project Plan describes the
Services, and the terms and conditions applicable to the conduct by
ImmunoGen of the Services, under this Agreement. The Project
Plan may be amended by mutual agreement of the Parties and any
updated or amended Project Plan will become part of this Agreement
upon execution by both Parties. In the event of a conflict
between the terms of this Agreement and any terms of the Project
Plan, the terms of this Agreement shall control.
4.5.2
Performance of Services. ImmunoGen shall use
Commercially Reasonable Efforts to perform the Services in
accordance with this Agreement, the Project Plan and the
Requirements. Without limiting the foregoing, ImmunoGen shall
(a) make available facilities, utilities, equipment and
computerized systems that are adequate to perform the Services in
accordance with the Project Plan; and (b) provide an adequate
number of personnel to perform the Services, all of whom have
appropriate education, training and experience to do so. At
Aventis’ request, ImmunoGen shall provide Aventis with
resumes or CVs for personnel assigned to perform the
Services. ImmunoGen shall be responsible for procuring any
and all Project Materials, for ensuring that such Project Materials
are suitable for the intended purposes, and for inspecting,
testing, as appropriate, storing and maintaining Project
Materials. Other than payment of fees under
Section 8.47(a), (b) and (c) and reimbursement of
certain out-of-pocket costs under Section 8.4.7(d), ImmunoGen
shall be responsible for all costs and expenses incurred in
providing the Services.
Portions of this Exhibit were
omitted, as indicated by [***], and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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4.5.3
Schedule and Adjustments. If ImmunoGen proposes to
make any proposed changes to its personnel, facilities, utilities
or equipment that are reasonably likely to affect the quality or
timing of its performance of the Services, ImmunoGen shall promptly
notify Aventis in writing of such proposed changes. If
Aventis reasonably determines that any such proposed changes are
likely to materially affect the development and/or
commercialization by Aventis of SAR3419, the implementation of
those changes will be subject to Aventis’ approval, which
will not be unreasonably withheld. If any delay in completing
the Services is due to Aventis’ failure to perform its
obligations under this Agreement, including but not limited to
delay in providing Aventis Materials under Section 4.5.6, then
the Project Plan and the Milestone-Based Fees in
Section 8.4.7(c) will be adjusted accordingly to
reasonably account for such delay.
4.5.4
Project Management and Aventis Assistance. Each Party
shall appoint designees to coordinate the conduct of the Services
as appropriate (the “Project Managers”). Project
Managers will meet on a bi-weekly basis (more or less frequently if
mutually agreed) to assess the progress of the Services.
Decisions by Project Managers are not binding except to the extent
consistent with the Project Plan or agreed in writing by the
Parties. Aventis shall provide ImmunoGen with guidance,
information and assistance as reasonably necessary for ImmunoGen to
perform the Services, and shall use Commercially Reasonable Efforts
to perform any obligations under any Project Plan related to such
guidance and assistance.
4.5.5
Modifications of Services, Requirements or Project Plan
Document. If Aventis reasonably determines that
modifications to the Services or any Requirements are necessary,
Aventis shall communicate such proposed modifications in writing to
ImmunoGen (the “Proposed Modifications”). If
ImmunoGen reasonably believes that any such proposed modifications
would be a material change to the Services or the Requirements,
then ImmunoGen shall so inform Aventis, and shall include
(a) an estimate of the length of time of any delay in the
schedule as a result of the Proposed Modifications, and/or
(b) an estimate of any revisions to the fees or costs as a
result of the Proposed Modifications. Subject to the
foregoing, (a) ImmunoGen shall use Commercially Reasonable
Efforts to assist Aventis in implementing the Proposed
Modifications, (b) the Parties shall update the schedule in
the Project Plan (including the applicable milestones), and
(c) the Parties shall mutually agree on the fees and/or costs
required to implement the Proposed Modifications. Aventis
shall be responsible for the payment of all such agreed fees and/or
costs, as reflected in the updated schedule in accordance with this
Agreement.
4.5.6
Aventis Materials. Unless otherwise specified in the
Project Plan, Aventis shall deliver to ImmunoGen, at its own
expense, the Aventis Materials in the form and amounts identified
in the Project Plan. For any Aventis Materials to be procured
by ImmunoGen, ImmunoGen shall procure those Aventis Materials in
the form and in amounts identified in the Project Plan and Aventis
shall reimburse ImmunoGen for its costs incurred in making such
procurement under Section 8.4.7(d).
4.5.7
Termination of Services. The obligation of ImmunoGen
to conduct all or any part of the Services may, subject to
Section 4.5.8 below, be terminated (a) by Aventis, at any
time, and for any reason or no reason, by providing written notice
of termination to ImmunoGen at least [***] prior to the date of
termination, which notice shall specify the scope of the terminated
Services; and (b) by either Party, by providing written notice
of termination to the other Party at least [***] after having
provided to the other Party notice of such Party’s material
breach of this Agreement, unless such material breach has been
cured within the [***] period after the initial notice of breach;
provided, however, that when a Party allegedly in breach disputes
in good faith that a breach has occurred, then both Parties shall
continue performance during the pendency of any dispute resolution
procedure for up to a maximum of [***] after notice of an alleged
material breach.
Portions of this Exhibit were
omitted, as indicated by [***], and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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4.5.8
Obligations Upon Termination or Expiration of Services.
(a)
Payment by Aventis : Except with regard to termination
by Aventis as a result of the uncured material breach of ImmunoGen,
upon termination of the Services as provided in Section 4.5.7,
Aventis shall pay ImmunoGen: (i) the Service Fees described in
Section 8.4.7(a) that were authorized to be incurred and
were actually incurred prior to termination; (ii) reimbursable
costs not already paid, to the extent such costs already have been
incurred and (iii) any early termination fee as calculated
under subsection (b) below.
(b)
Early Terminatio
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