Amendment to License Agreement for Anti-HER2 Antibodies
Amendment
to License Agreement for Anti-HER2
Antibodies
Genentech, Inc.
(“GENENTECH”) and ImmunoGen, Inc.
(“IMMUNOGEN”) are entering into this Amendment to License
Agreement for Anti-HER2 Antibodies (“Amendment”) as of May 3,
2006 (the “Amendment Effective Date”).
Background
Genentech and ImmunoGen
are parties to the following agreements: that certain
License Agreement dated as of May 2, 2000, and amendments thereto (the
“License Agreement”); that certain Heads of Agreement, dated as
of May 2, 2000, as amended (as so amended, the “Heads of
Agreement”); that certain Process Development Heads of Agreement, dated
as of June 29, 2001, and amendments thereto, including that certain Amendment
No.1 dated November 15, 2002 (the “PD Heads of Agreement”);
that certain Manufacturing and Supply Agreement dated as of January 11, 2005,
and amendments thereto (the “Clinical Supply Agreement”); that
certain Development Agreement dated as of June 1, 2004, and amendments thereto
(the “Development Agreement”); and the Quality Services
Agreement dated as of June 30, 2005 (the “Quality Services
Agreement”) (the License Agreement, the Heads of Agreement, the PD
Heads of Agreement, the Clinical Supply Agreement, the Development Agreement
and
the Quality Services Agreement, collectively the “Existing
Agreements”).
GENENTECH and IMMUNOGEN
are, as of the Amendment Effective Date, entering into a
Process Development Agreement (the “Process Development
Agreement”), under which IMMUNOGEN will develop a commercial-scale
conjugation process for certain products that are “Licensed Products” under the
License Agreement.
In connection with entering
into the Process Development Agreement, GENENTECH
has agreed to increase the milestones and royalties for Licensed Products in
certain circumstances, as set forth in this Amendment.
GENENTECH and IMMUNOGEN
also have agreed to modify the terms of the license
granted, specifically by revising the definition of “Improvements” and expanding
IMMUNOGEN’s rights to Improvements.
In
consideration of the mutual promises and covenants contained in this Amendment,
the sufficiency of which consideration is hereby mutually acknowledged, the
Parties have agreed as follows:
Agreement
1. Definitions.
In the License Agreement, the following definitions are modified or added,
effective as of the Amendment Effective Date.
(a)
Definition of “Improvement.” Section 1.27 (definition
of “Improvement”) of the License Agreement is hereby deleted in its entirety and
replaced with the following:
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.
1.27
“Improvement” means: (a) improvements to any MAY Compound,
(b) improvements to methods of making any MAY Compound, and
(c) improvements to the conjugation process for making antibody-drug
conjugates that include any MAY Compound (including, for example, reaction
conditions or changes in process that create improvements in the yield of such
conjugate). “Improvement” excludes any and all of the following items
(“GNE Exclusions”): (w) any improvement that is specific to any
antibody-drug conjugates that bind to an antigen that is subject to an exclusive
license from ImmunoGen under, or arising from, the Heads of Agreement or is
subject to an Exclusive Target Option under the Heads of Agreement during the
period that such exclusive license or Exclusive Target Option remains in effect;
(x) improvements to [***] [***] [***] or [***] [***], or the [***] of [***]
or [***] [***] of the foregoing; (y) improvements arising out of Genentech
[***] or [***] activities (whether or not the associated [***] is licensed
to
Genentech by ImmunoGen); or (z) the [***] or [***] of [***] [***] [***]
(i.e., the [***] or [***] of such [***] [***] (e.g., the [***] of
[***] or the [***] of [***] to [***]) and [***] the manner of [***] such [***]
[***]) that binds to an antigen that is subject to an exclusive license from
ImmunoGen under, or arising from, the Heads of Agreement or an antigen that
is
subject to an Exclusive Target Option under the Heads of Agreement, during
the
period that such exclusive license or Exclusive Target Option remains in
effect.
(b)
Definition of “ImmunoGen
Field.” A new Section 1.26A is added as follows:
1.26A “ImmunoGen
Field” means any and all uses other than any use that involves
an antibody that binds to an antigen that is subject to an exclusive license
from ImmunoGen under, or arising from, the Heads of Agreement or an antigen
that
is subject to an Exclusive Target Option under the Heads of Agreement, during
the period that such exclusive license or Exclusive Target Option remains in
effect.
2. License
to ImmunoGen. Section 2.1(b) of the License Agreement is hereby
deleted in its entirety and the following is inserted in lieu thereof:
(b)
License to IMMUNOGEN. GENENTECH hereby grants to IMMUNOGEN a
non-exclusive, royalty-free license (i) under GENENTECH’s
intellectual
property interest in Improvements, to develop, make, use, sell, offer for sale,
import, and export any product that is not a Licensed Product, subject to
Section 2.3(b) below and the remaining terms of this Section 2.1(b); and (ii)
to
otherwise exploit Improvements for all uses within the ImmunoGen Field, subject
to Section 2.3(b) below and the remaining terms of this Section 2.1(b).
The foregoing license includes the right to sublicense the rights granted under
this Section 2.1(b) on and after the Amendment Effective Date
only if all of the following three conditions (i), (ii) and (iii) are met:
(i)
the sublicense is limited to the ImmunoGen Field;
(ii)
the sublicense is granted only in connection with a license to ImmunoGen MAY
Technology (where “ImmunoGen MAY Technology” means Technology
Controlled by ImmunoGen and used in the conjugation of MAY Compounds to binding
proteins), and the rights granted for ImmunoGen MAY Technology are of the same
scope (e.g., for the same product or technology and within the same field and
the same territory) as the rights granted for Genentech’s Improvements;
and
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.
(iii)
GENENTECH obtains Substantially Similar Grant Back Rights without incurring
an
obligation to pay any additional consideration (either to IMMUNOGEN or to the
sublicensee). “Substantially Similar Grant Back Rights” means
non-exclusive rights in and to that sublicensee’s “improvements” (improvements
to MAY Compounds, methods of making MAY Compounds, and methods of making
antibody-drug conjugates) that are of substantially the same scope (e.g., within
the same field and the same territory) as the rights granted in and to
Improvements under this Agreement. (GENENTECH may obtain such rights
directly from IMMUNOGEN’s sublicensee or indirectly through IMMUNOGEN; if
GENENTECH obtains such rights from IMMUNOGEN, IMMUNOGEN may have obtained such
rights under license or by transfer of ownership).
Nothing
in this Agreement or the course of dealings between the Parties or usage or
custom in the industry or trade shall be construed to confer any other rights
or
licenses to any other intellectual property Controlled by either Party or its
Affiliates by implication, estoppel or otherwise. GENENTECH has no
obligation to [***] in any [***] [***] or [***] of [***] [***] to [***] or
a
[***] of [***] with respect to [***]. During the term of the Process Development
Agreement, IMMUNOGEN may inquire of GENENTECH as to Improvements Controlled
by
GENENTECH, and GENENTECH shall respond by disclosing any such Improvements
within the ImmunoGen Field.
3. Milestone
Payments. Section 4.1.1 of the License Agreement is replaced in
its entirety by the following:
4.1.1
In consideration of the grant of the license by IMMUNOGEN hereunder, and subject
to the other terms of this Agreement, GENENTECH will pay IMMUNOGEN the amounts
in the column titled “milestone payment” within thirty (30) days after the first
achievement of each of the milestones set forth in the table below.
Further, if IMMUNOGEN successfully meets the milestones set forth in the Process
Development Agreement and if the [***] of the Conjugation Process (as defined
in
the Process Development Agreement) to a [***] is [***] by the end of the first
[***] [***] of [***] (as the foregoing timeline will be adjusted in accordance
with the Process Development Agreement), then GENENTECH shall pay IMMUNOGEN
the
amounts in the column titled “additional payment” within thirty (30) days after
the first achievement of the milestones for which an additional payment applies.
Milestone payments and additional payments under this Section are
nonrefundable and noncreditable, except as expressly provided in Section 4.1.2
below.
|
Milestone
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Milestone
Payment
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Additional
Payment
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Effective
Date (of License Agreement)
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$2
Million*
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IND
Acceptance for a Licensed Product
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$2
Million*
|
|
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[***]
of [***] [***] [***] [***] [***] [***] [***] for a [***] [***]
|
$[***]
[***]
|
$[***]
[***]
|
|
[***]
of [***] [***] [***] [***] in the [***] [***] for a [***] [***] or
[***]
[***] [***] [***] for a [***] [***] ([***] is [***])
|
$[***]
[***]
|
$[***]
[***]
|
|
[***]
of [***] or [***] by the [***] for a [***] [***] for [***] of [***]
[***]
[***]
|
$[***]
[***]
|
$[***]
[***]
|
|
[***]
of an [***] or other [***] [***] [***] in the [***] [***] for a [***]
[***] for [***] of [***] [***] [***]
|
$[***]
[***]
|
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[***]
of a [***] [***] for a [***] [***] in [***] for treatment of [***]
[***]
[***]
|
$[***]
[***]
|
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[***]
of [***] or [***] by the [***] for a [***] [***] [***]
|
$[***]
[***]
|
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[***]
of [***] or [***] by the [***] for [***] [***] [***].
|
$[***]
[***]
|
|
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.
It
is hereby acknowledged and agreed that those milestone payments and
additional payments identified with a * in the table above already have been
paid by GENENTECH. It is also hereby acknowledged and agreed that any
milestone payment shall be made only once, with respect to the first achievement
of the relevant milestone for the first Licensed Product, regardless of how
many
times a particular Licensed Product achieves such milestones. GENENTECH
shall notify IMMUNOGEN of the achievement of milestones hereunder as provided
in
Section 3.2(a) above.
4. Royalties.
Section 4.2.3 ([***] [***] [***]) of the License Agreement is replaced with
the
following:
4.2.3
[***]
[***] [***]. In
consideration of the grant of the license by IMMUNOGEN hereunder, and subject
to
the other terms of this Agreement (including the other terms of this Section
4):
(a)
[***] [***] [***]. Notwithstanding anything set forth in [***]
above, the [***] [***] set forth therein shall apply, on a [***] and [***]
[***], to [***] [***] of [***] [***] [***] [***] [***] [***] [***] or its [***],
[***] or [***] in [***] [***] would, [***] for the [***] under this Agreement,
[***] a [***] [***] [***] the [***] [***] [***] (excluding any [***] [***]
[***]
[***] by [***] and [***] and further excluding any [***] [***] in or to [***]
for which [***] is the [***] or [***] [***]).Subject to the other
terms of this Agreement (except for Section 4.2.2 above, which shall not apply),
on a [***] and [***] [***] where and as of when the [***] [***] under Section
4.2.1 [***] [***] [***] as a [***] of this Section 4.2.3 (a), GENENTECH shall
[***] to IMMUNOGEN a [***] [***] to [***]:
(i) if the [***] [***] has been [***] [***], in [***] or in [***] [***], the
[***] [***] (as defined in the Process Development Agreement) following the
[***] of the [***] [***] the [***] [***] as contemplated by Section 3.2 of
the
Process Development Agreement, then [***] [***] ([***]) of [***] [***] of [***]
[***] [***] [***] by [***] and/or its [***] in [***] [***];
or
(ii)
if
the [***] [***] has not been [***] [***],
in [***] or in [***] [***], the [***] [***] (as defined in the Process
Development Agreement) following the [***] of the [***] [***] the [***] [***]
as
contemplated by Section 3.2 of the Process Development Agreement, then [***]
[***] ([***]) of [***] [***] of [***] [***] [***] [***] by [***] and/or its
[***] in [***] [***].
5.
Miscellaneous. This Amendment is governed by the
substantive rules of the state of California. Capitalized terms used and
not otherwise defined herein shall have the respective meanings ascribed to
them
in the respective Existing Agreement that is being amended hereby.
The Existing Agreements remain in full force and effect, as amended by this
Amendment. References in the Existing Agreements to “Agreement” mean those
Existing Agreements as amended by the Amendment.
[Signature
page follows.]
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.
IN WITNESS WHEREOF,
the
Parties have caused this AMENDMENT TO LICENSE AGREEMENT to be duly executed,
effective as of the Amendment Effective Date, by their respective duly
authorized officers.
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GENENTECH, INC.
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IMMUNOGEN, INC.
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By:
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By:
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Name:
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Name:
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Xxxxxxx Xxx Xxxx
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Title:
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Title:
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Senior Vice President
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Corporate Development and
Operations
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Date:
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Date:
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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.
