AMENDMENT NO. 1 TO THE COLLABORATION AND LICENSE AGREEMENT
Exhibit
10.1
Execution
Copy
AMENDMENT
NO. 1 TO
THE
This
Amendment No. 1 to
the Collaboration and License Agreement (this “Amendment”) is dated as of August
31, 2006 (the “Amendment Effective Date”) by and between ImmunoGen, Inc., a
Massachusetts corporation with a principal office at 000 Xxxxxx Xxxxxx,
Xxxxxxxxx, Xxxxxxxxxxxxx 00000 (“ImmunoGen”), and sanofi-aventis U. S. LLC, a
Delaware limited liability company with a offices at 1041 Xx. 000-000,
Xxxxxxxxxxx, XX 00000 (“sanofi-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. (“Aventis”).
WHEREAS,
on the Agreement
Effective Date, ImmunoGen and Aventis, the predecessor in interest to
sanofi-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 as set forth herein 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:
1. Amendments
to
Agreement.
(a) Section
1.20 of the
Agreement is hereby deleted in its entirety and replaced with the
following:
“1.20 “Collaboration
Product”
means any product, other than a Licensed Product, containing a Program
Antibody.”
b) A
new Section 2.14 is
hereby added to the Agreement which shall provide as follows:
“2.14 Collaboration
Portfolio.
For purposes of clarity
(a) Schedule
2.14
attached hereto lists all Antibody Targets, Program Targets, Program Targets
with Program Antibodies and Program Targets with Lead Antibodies that are
part
of the Research Program as of the Amendment Effective Date. The Joint Research
Committee shall update and amend, as appropriate, the then current Schedule
2.14
as
necessary during each Contract Year and on the expiration of the Research
Program Term in order to list all Antibody Targets, Program Targets, Program
Targets with Program Antibodies, Program Targets with Lead Antibody and Program
Targets with Lead Antibody in
Portions
of this
Exhibit were omitted 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.
Development
at that point
in time. In addition to those Program Targets for which Program Antibodies
have
already been generated, it is anticipated that Program Antibodies shall have
been generated prior to the expiration of the Research Program Term, for [***],
[***] and [***].”
(c) Section
2.8.1 of the
Agreement is hereby amended by adding the following sentence at the end of
such
provision:
“Notwithstanding
the
foregoing, the Parties hereby agree that during the period commencing on the
Amendment Effective Date and continuing until the expiration of the Research
Program Term, (a) neither Party shall have the obligation under this Agreement
to identify or provide Targets for use in the Research Program and the Parties
will focus on progressing the Targets and Antibodies listed in Schedule 2.14
as
more specifically described in the Research Plan for the remainder of the
Research Program Term and (b) Aventis shall have the right to identify and
provide new Targets for use in the Research Program pursuant to Section 2.8.2
below only to the extent that (i) the estimated number of FTEs to be provided
by
ImmunoGen under Section 2.5.1 for a particular Calendar Quarter is estimated
to
fall short of the number of FTEs set forth in the Annual Research Plan for
such
Calendar Quarter and (ii) ImmunoGen is not engaged in its own program outside
of
the collaboration on any such new Targets. Further, all Targets identified
pursuant to the [***] [***] [***] [***] with [***] [***] [***], including any
[***] [***] [***] [***] [***] during the Research Program Term, related to
development of murine monoclonal antibodies that selectively recognize novel
antigens in human tissues, shall be provided for use in the Research Program
and
shall be designated Program Targets pursuant to Section 2.8.2
below.”
(d) Section
7.1.2 of the
Agreement is hereby deleted in its entirety and replaced with the
following:
“7.1.2
Development
Licenses.
With respect to all Program Targets for which Program Antibodies have been
developed prior to the expiration of the Research Program Term, ImmunoGen hereby
grants to Aventis and its Affiliates, subject to Section 7.1.8 below, an
exclusive (even as to ImmunoGen and its Affiliates), worldwide, royalty-free
license, with the right to grant sublicenses to Approved Subcontractors, under
ImmunoGen Intellectual Property, to Develop Products.”
(e) Section
7.5.2 of the
Agreement is hereby deleted in its entirety.
2. Miscellaneous. The
Parties acknowledge
that in connection with the internal restructuring of the sanofi-aventis Group
in the United States, certain assets and liabilities of Aventis, including
its
rights and obligations under the Agreement, were contributed to,
and
2
Portions
of this
Exhibit were omitted 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.
assumed
by, sanofi-aventis
U.S. LLC, a limited liability company of which Aventis is a member. The Parties
hereby confirm and agree that, except as amended hereby, the Agreement remains
in full force and effect and is a binding obligation of the Parties hereto.
This
Amendment may be executed in counterparts, each of which shall be deemed
an
original, but all of which together shall constitute one and the same
instrument.
IN
WITNESS WHEREOF, the
Parties have caused this Amendment to be executed by their duly authorized
representatives.
| IMMUNOGEN, INC. | SANOFI-AVENTIS U.S. LLC | |||
| By: | By: | |||
| Name: | Name: | |||
| Title: | Title: | |||
| By: | ||||
| Name: | ||||
| Title: | ||||
3
Portions
of this
Exhibit were omitted 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.
Schedule
2.14
[COLLABORATION
PORTFOLIO AS OF AMENDMENT EFFECTIVE DATE
|
Antibody
Targets
|
Program
Target
|
Program
Targets
with
Program
Antibodies
|
Program
Targets
with
Lead
Antibody
|
Program
Targets
with
Lead
Antibody in Development
|
|
[***]
[***]
|
[***]
|
[***]
|
[***]
|
CD
33 (AVE9633)
|
|
[***]
|
[***]
|
[***]
|
[***]
|
CD
19 (SAR3419)
|
|
[***]
|
[***]
|
[***]
|
IGF-1R
(AVE1642)
|
|
|
[***]
|
[***]
|
|||
|
[***]
|
[***]
|
|||
|
[***]
|
[***]
|
|||
|
[***]
|
||||
|
[***]
|
||||
4
Portions
of this
Exhibit were omitted 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.
