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Exhibit 10.2
Execution Copy
OPTION AND LICENSE AGREEMENT
This Option and License Agreement (this "Agreement") is made
effective as of December 21, 2006 (the "Effective Date") by and
between ImmunoGen, Inc., a Massachusetts corporation with a
principal place of business at 128 Sidney Street, Cambridge,
Massachusetts 02139 ("ImmunoGen"), and sanofi-aventis U.S. LLC, a
limited liability company organized and existing under the laws of
Delaware with offices at 1041 Rt. 202-206, Bridgewater, NJ 08807
("sanofi-aventis"). Each of sanofi-aventis and ImmunoGen is
sometimes referred to individually herein as a "Party" and
collectively as the "Parties."
WHEREAS, sanofi-aventis is the owner of or otherwise Controls
certain Patent Rights and Technology relating to certain
proprietary Antibodies; and
WHEREAS, ImmunoGen is the owner of or otherwise Controls certain
proprietary Patent Rights and Technology relating to or otherwise
useful in the conjugation of certain maytansine compounds to
Antibodies; and
WHEREAS, ImmunoGen has entered into agreements based on the
so-called "Revolving-Door" structure with a number of Third Parties
whereby such Third Parties are obligated to grant back to ImmunoGen
the right to such Third Parties’ improvements to Technology
and Patent Rights, and pursuant to which ImmunoGen has the right to
grant access to such Third Party Improvements to sanofi-aventis;
and
WHEREAS, sanofi-aventis desires to have access to such
Technology, Patent Rights and Improvements for research, discovery
and development of Ab-MAY Products (as defined below); and
WHEREAS, in connection therewith, sanofi-aventis desires to
receive, and ImmunoGen desires to grant, Options to obtain one or
more licenses to Licensed Technology having the terms set forth in
one or more License Agreements to be executed by the Parties.
NOW, THEREFORE, in consideration of the mutual covenants
contained herein, and for other good and valuable consideration,
the receipt and adequacy of which are hereby acknowledged, the
Parties hereby agree as follows:
1.
DEFINITIONS
Whenever used in this Agreement with an initial capital letter,
the terms defined in this Section 1 shall have the meanings
specified below.
1.1
" Ab-MAY Product " means any product
containing a conjugate of a Sanofi-aventis Antibody with a MAY
Compound in which the Sanofi-aventis Antibody is directed against a
Target that is not an Excluded Target.
1.2
" Affiliate " means, with respect to
any Party, any Person that, directly or through one or more
Affiliates, controls, or is controlled by, or is under common
control with, such Party. For purposes of this definition,
"control" means (a) ownership of more than fifty percent
(50%)
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.
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of the shares of stock entitled to vote for the
election of directors in the case of a corporation, or more than
fifty percent (50%) of the equity interests in the case of any
other type of legal entity, (b) status as a general partner in any
partnership, or (c) any other arrangement whereby a Person controls
or has the right to control the board of directors of a corporation
or equivalent governing body of an entity other than a
corporation.
1.3
" Antibody " means a polyclonal or
monoclonal antibody, whether multiple or single chain, recombinant
or naturally occurring, whole or fragment, and any variants,
derivatives or constructs thereof, including but not limited to,
antigen binding portions including Fab, Fab’, F(ab’)2,
Fv, dAb and CDR fragments, single chain antibodies (scFv), chimeric
antibodies, diabodies and polypeptides (including any humanized
versions thereof) that contain at least a portion of an
immunoglobulin that is sufficient to confer specific antigen
binding to the polypeptide.
1.4
" Antibody-MAY Compound Conjugate "
means any compound containing a conjugate of an Antibody with a MAY
Compound.
1.5
" Applicable Laws " means Federal,
state, local, national and supra-national laws, statutes, rules and
regulations, including any rules, regulations, guidance, guidelines
or requirements of Regulatory Authorities, national securities
exchanges or securities listing organizations, that may be in
effect from time to time during the Term and applicable to a
particular activity hereunder.
1.6
" Business Day " means a day on
which banking institutions in New York, New York are open for
business.
1.7
" Confidential Information " means
(a) with respect to ImmunoGen, all tangible embodiments of Licensed
Technology and Licensed Patent Rights; (b) with respect to
sanofi-aventis, the identification by sanofi-aventis of a Proposed
Target and the exercise by sanofi-aventis of any Option with
respect to an Optioned Target; and (c) with respect to each Party,
all information and Technology disclosed or provided by or on
behalf of such Party (the "disclosing Party") to the other Party
(the "receiving Party") or to any of the receiving Party’s
employees, consultants, Affiliates or sublicensees, provided, that,
none of the foregoing shall be Confidential Information if: (i) as
of the date of disclosure, it is known to the receiving Party or
its Affiliates as demonstrated by credible contemporaneous written
documentation, other than by virtue of a prior confidential
disclosure to such receiving Party; (ii) as of the date of
disclosure it is in the public domain, or it subsequently enters
the public domain through no fault of the receiving Party; (iii) it
is obtained by the receiving Party from a Third Party having a
lawful right to make such disclosure free from any obligation of
confidentiality to the disclosing Party; or (iv) it is
independently developed by or for the receiving Party without
reference to or use of any Confidential Information of the
disclosing Party as demonstrated by credible contemporaneous
written documentation. For purposes of clarity, the terms of
this Agreement shall constitute Confidential Information of each
Party.
1.8
" Control " or "
Controlled " means (a) with respect to Technology or Patent
Rights, the possession by a Party of the right to grant a license
or sublicense to such Technology or Patent Rights as provided
herein without the payment of additional consideration to, and
without violating the terms of any agreement or arrangement with,
any Third Party and (b) with
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respect to any Antibody, the possession by a
Party of the right to supply such Antibody to the other Party as
provided herein without the payment of additional consideration to,
and without violating the terms of any agreement or arrangement
with, any Third Party.
1.9
" Designated Senior Officer "
means, with respect to a Party, the senior officer of such Party or
an Affiliate designated by such Party to have final decision making
authority over disputed matters.
1.10
" Field " means all human therapeutic,
prophylactic and diagnostic uses.
1.11
" ImmunoGen Antibody " means any
Antibody Controlled, owned or made available by
ImmunoGen.
1.12
" Improvement " means any
enhancement, improvement or modification to the Licensed Technology
or the Licensed Patent Rights.
1.13
" License Agreement " means a written
license agreement executed by the Parties upon exercise of any
Option pursuant to Section 2.2.2 in substantially the form set
forth in Appendix A attached hereto.
1.14
" Licensed Patent Rights " means
any of the patents and patent applications described in Schedule
1 attached hereto, and any divisionals, continuations,
continuations-in-part (to the extent that any continuations-in-part
are entitled to the priority date of an initial patent or patent
application which is the subject of this Agreement), reissues,
reexaminations, confirmations, revalidations, registrations,
patents of addition, renewals, extensions or substitutes thereof,
or any patents issuing therefrom or any supplementary protection
certificates related thereto, including any Improvement related
thereto that is conceived or reduced to practice by ImmunoGen or
its Third Party collaborators, that are Controlled by ImmunoGen and
that include one or more claims that cover Licensed
Technology.
1.15
" Licensed Target " means an Optioned
Target following exercise of an Option as set forth in
Section 2.2.2 and which is the subject of a License Agreement
between the Parties.
1.16
" Licensed Technology " means any
Technology Controlled by ImmunoGen as of the Effective Dateorthat
is Controlled by ImmunoGen at any time during the Term including,
without limitation, any Improvement related thereto that is
conceived or reduced to practice by ImmunoGen or its Third Party
collaborators and that is, in any case, necessary or useful for
sanofi-aventis to practice the research licenses set forth in
Section 2.3.
1.17
" Manufacturing Cost " means, with
respect to any Preclinical Materials manufactured by ImmunoGen,
ImmunoGen’s fully-burdened costs (including the costs
associated with product testing and release activities) of
producing and packaging such Preclinical Materials, including the
sum of the following components: (a) direct costs, including (1)
materials directly used in producing and packaging such Preclinical
Materials and (2) with respect to any Preclinical Materials
obtained by ImmunoGen from a Third Party and supplied to
sanofi-aventis without modification, the amount paid by ImmunoGen
to such Third Party for the same; (b) manufacturing overhead costs
attributable to the cost of goods under the foregoing clause(a)(1),
including manufacturing and quality labor and manufacturing and
quality
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supervisory services, operating and
administrative costs of the manufacturing and quality departments
and occupancy costs which are allocable to company departments
based on space occupied or headcount or another reasonable
activity-based method; for the purpose of clarity, any cost
allocation shall be (i) in any case, applied in accordance with
GAAP, and (ii) applied consistently by ImmunoGen in relation to all
other Third Parties for which ImmunoGen manufactures comparable
materials; (c) any other reasonable and customary out-of-pocket
costs borne by ImmunoGen for the testing, transport, customs
clearance, duty, insurance and/or storage of such Preclinical
Materials; and (d) ImmunoGen’s general and administrative
costs, including purchasing, human resources, payroll, information
system and accounting, which are directly attributable or
reasonably allocable to company departments based on space occupied
or headcount.
1.18
" MAY Compound " means any and all
maytansinoid compounds (including, without limitation, maytansinol,
ansamitocins, DM1 and DM4), whether produced by a botanical source,
natural fermentation, chemical synthesis or otherwise, and shall
include, without limitation, all variants, fragments or derivatives
of any of the foregoing, in each case Controlled by
ImmunoGen.
1.19
" Option Agreement " means the
Option Agreement between the Parties dated as of August 31,
2006.
1.20
" Option Grant Date " means, with
respect to a Proposed Target that is not an Excluded Target, the
date of the Option Response provided by ImmunoGen.
1.21
" Optioned Target " means any
Proposed Target that is not an Excluded Target and becomes the
subject of an Option granted by ImmunoGen pursuant to Section
2.2.1.
1.22
" Patent Rights " means the rights and
interests in and to issued patents and pending patent applications
(including inventor’s certificates and utility models) in any
country or jurisdiction within the Territory, including all
provisionals, substitutions, continuations, continuations-in-part,
divisionals, supplementary protection certificates, renewals, all
letters patent granted thereon, and all reissues, reexaminations,
extensions, confirmations, revalidations, registrations, patents of
addition thereof, PCTs and foreign counterparts.
1.23
" Preclinical Materials " means any
materials (including without limitation any supplies of MAY
Compound or Ab-MAY Product) manufactured by ImmunoGen for
sanofi-aventis pursuant to this Agreement and in accordance with
Applicable Laws and all applicable specifications for use in
preclinical testing.
1.24
" Sanofi-aventis Antibody " means any
Antibody and other binding proteins Controlled by, owned by or made
available to sanofi-aventis.
1.25
" Sanofi-aventis Improvement "
means any Improvement that is conceived or first reduced to
practice by sanofi-aventis in connection with the exercise by
sanofi-aventis of the licenses set forth in Section 2.3.
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1.26
" Target " means any particular
antigen (whether a protein, carbohydrate, etc.) that is bound by a
particular Antibody used to create an Ab-MAY Product, and all
epitopes of such particular antigen.
1.27
" Technology " means, collectively,
all inventions, discoveries, improvements, trade secrets and
proprietary methods, whether or not patentable, including without
limitation, macromolecular sequences, data, formulations,
processes, techniques, know-how and results (including any negative
results).
1.28
" Territory " means all countries of
the world.
1.29
" Third Party " means any person or
entity other than ImmunoGen, sanofi-aventis and their respective
Affiliates.
Additional Definitions . In addition, each
of the following definitions shall have the respective meanings set
forth in the section of this Agreement indicated below:
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Definition
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Section
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Recitals
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4.3
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8.14.1
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2.2.1
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2.2.3
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2.2.3
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Recitals
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8.17.1
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8.18
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2.2.5
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2.2.5
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2.2.1
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2.2.2
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2.2.1
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2.2.1
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Recitals
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2.2.1
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2.3.5
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3.2
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Recitals
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8.17.2
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2.2.4
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7.1
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2.2.1
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2.
GRANT OF RIGHTS
2.1
Option to Initiate Research Term
. ImmunoGen hereby grants sanofi-aventis an option (the
"Research Term Option"), at sanofi-aventis’ sole discretion,
to initiate the Research
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Term by providing written notice of election to
ImmunoGen and paying the Research Term Exercise Fee on, or prior
to, August 31, 2008 (the date of such election, the "Research Term
Exercise Date").
2.2
Exclusive Target Options .
2.2.1
Option Request and Grant .
Sanofi-aventis may from time to time during the Research Term
provide written notice to ImmunoGen requesting the grant by
ImmunoGen of an exclusive option (each such option, an "Option")
(the "Option Request") to obtain an exclusive license in the
Territory under the Licensed Technology and Licensed Patent Rights,
with respect to any Target specified in the Option Request (each, a
"Proposed Target"), for the sole purpose of researching, making and
having made, Ab-MAY Products directed to such Proposed Target, for
any and all uses within the Field. ImmunoGen shall provide a
written response (the "Option Response") to sanofi-aventis within
[***] ([***]) Business Days of any Option Request specifying
whether or not the Proposed Target is available to be the subject
of an Option and, if unavailable, the reasons for such
unavailability as set forth in this Section 2.2.1 (it being
understood that the foregoing disclosure shall be subject to any
confidentiality obligations ImmunoGen may have with any Third
Party), provided, that, ImmunoGen hereby acknowledges and agrees
that it may only treat a Proposed Target that is identified in an
Option Request as unavailable (each, an "Excluded Target") if, on
the date of the Option Request, (a) ImmunoGen is pursuing an
internal development or commercialization program with a MAY
Compoundconjugated with an ImmunoGen Antibody that is directed
against such Proposed Target; (b) ImmunoGen has, with respect
to the Proposed Target, granted an exclusive option or license to a
Third Party under any Patent Rights Controlled by ImmunoGen that
are necessary or useful for the development, manufacture, use or
sale of Antibody-MAY Compound Conjugates (a "Third Party Right");
or (c) ImmunoGen is in discussions with a Third Party relating to a
potential grant of a Third Party Right. Upon the grant of an
Option to a Proposed Target to sanofi-aventis as provided in this
Section 2.2.1, the Proposed Target shall be deemed to be an
Optioned Target for purposes of this Agreement and, for the
duration of the Option Period, (i) sanofi-aventis shall have the
rights granted in Section 2.3.2 and (ii) ImmunoGen shall not
initiate or engage in discussions with any Third Party concerning a
Third Party Right with respect to the Optioned Target, or pursue
internally any development or commercialization program concerning
an Antibody-MAY Compound Conjugate directed against the Optioned
Target. Notwithstanding anything to the contrary set forth in
this Agreement, the Parties hereby agree that sanofi-aventis shall
have the right to select and maintain no more than [***] ([***])
Optioned Targets at any given time during the Term, provided, that,
Expired Options and Terminated Options shall not count as Optioned
Targets for purposes of this limitation.
2.2.2
Exercise of Options .
Sanofi-aventis shall have the right to exercise any Option at any
time during the period commencing on the Option Grant Date and
continuing for a period of [***] ([***]) months thereafter (as such
period may be extended as provided in Section 2.2.5 below, the
"Option Period"), by (a) delivering written notice of exercise
thereof, which notice shall specify the Optioned Target and (b)
executing a License Agreement in the form of Appendix A
attached hereto. Upon exercise of an Option covering an
Optioned Target as provided in this Section 2.2.2, such Optioned
Target shall become a Licensed Target and the Licensed Patent
Rights and Licensed Technology (as defined in the License
Agreement) shall be
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exclusively licensed with respect to such
Licensed Target to sanofi-aventis on the terms and subject to the
conditions set forth in the relevant License Agreement.
2.2.3
Option Expiration . In the
event that sanofi-aventis fails to exercise any Option during the
applicable Option Period (each, an "Expired Option"), all
rights granted by ImmunoGen to sanofi-aventis pursuant to Section
2.2.1 applicable to such Expired Option shall terminate as of such
expiration date; provided, that, if the Option becomes an Expired
Option prior to expiration of the Research Term, the non-exclusive
research license granted pursuant to Section 2.3.1 below for the
Optioned Target that is the subject of such Expired Option shall
again be in effect and shall survive, and such non-exclusive
license will continue until the date on which ImmunoGen provides
written notice to sanofi-aventis that such Target has become an
Excluded Target. Notwithstanding the foregoing, following the
expiration of any Option Period with respect to an Optioned Target,
(a) ImmunoGen shall have the right to initiate or engage in
discussions with any Third Party concerning a Third Party Right or
pursue internally any project concerning, any rights regarding an
Antibody-MAY Compound Conjugate directed to the Target covered by
such Expired Option; (b) during the period commencing on the date
of expiration of the Option Period and continuing for a period of
[***] ([***]) months (the "Expired Option Tail Period"),
sanofi-aventis may not provide an Option Request to ImmunoGen with
respect to the Target that is the subject of the Expired Option;
and (c) on and after the Expired Option Tail Period but prior to
the expiration of the Research Term, and subject to notice,
availability and limitations pursuant to this Section 2.2,
sanofi-aventis shall have the right, upon written request, to
provide an Option Request to ImmunoGen with respect to the Target
covered by such Expired Option.
2.2.4
Termination of Options .
Sanofi-aventis may terminate any Option that is not an
Expired Option at any time on and after [***] ([***]) months from
the Option Grant Date by providing written notice of termination to
ImmunoGen, which notice shall identify the Optioned Target to be
terminated (each, a "Terminated Option"). Upon termination of
an Option as provided in this Section 2.2.4, sanofi-aventis shall
have the rights set forth in Section 2.2.3 above, as if the
Terminated Option were an Expired Option (subject to notice,
availability and other limitations set forth in this Section 2.2),
and at such time or thereafter sanofi-aventis may select and be
granted another Option to replace the Terminated Option, subject to
limitations on the number of Options set forth in Section
2.2.1.
2.2.5
Non-Optioned Target: Request for Exclusive
License . Notwithstanding anything to the contrary
in this Agreement, sanofi-aventis may at any time during the
Research Term request the grant by ImmunoGen of an exclusive
license to any Target that is not an Optioned Target by giving
written notice to ImmunoGen (the "License Request"), which License
Request shall specify in reasonable detail the Target.
ImmunoGen shall provide a written response (the "License Response")
to sanofi-aventis within [***] ([***]) Business Days of any License
Request specifying whether or not the Target specified in the
License Request is available to be the subject of an exclusive
license and, if unavailable, the reasons for such unavailability as
set forth in Section 2.2.1. As promptly as possible following
the issuance by ImmunoGen of a License Response indicating that the
Target is available to be the subject of an exclusive license (a)
the Parties shall execute a License Agreement in the form of
Appendix A attached hereto. Upon execution of such
License Agreement, such Target shall become a Licensed Target and
the Licensed Patent Rights and Licensed Technology (as defined in
the
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License Agreement) shall be exclusively licensed
with respect to such Licensed Target to sanofi-aventis on the terms
and subject to the conditions set forth in the relevant License
Agreement.
2.2.6
Discussions Regarding Targets .
ImmunoGen agrees, upon the request of sanofi-aventis, to
confer with sanofi-aventis on whether ImmunoGen reasonably expects
any Target identified by sanofi-aventis will remain available to
become an Optioned Target and/or Licensed Target, provided, that
under no circumstances shall any such discussions be deemed by
sanofi-aventis to be a commitment by ImmunoGen with respect to any
such Target.
2.3
Non-Exclusive Research License; Option for
Exclusive Research License .
2.3.1
Non-Exclusive Research License .
ImmunoGen hereby grants sanofi-aventis a non-exclusive,
royalty-free license during the Research Term, without the right to
grant sublicenses, under the Licensed Technology and Licensed
Patent Rights with respect to any Target that is not an Optioned
Target or a Licensed Target (including any Optioned Target that is
the subject of an Expired Option and/or Terminated Option), to (a)
conduct safety and other preclinical studies in vitro and
toxicity studies in vivo in any non-human species with any
Ab-MAY Product directed at such Target, (b) to manufacture Ab-MAY
Product solely for use in such studies and (c) to manufacture and
conjugate MAY Compounds that do not comprise an Ab-MAY Product
solely for use as a control for any Ab-MAY Product that is directed
at an Optioned Target. For purposes of clarity,
sanofi-aventis shall have no right under the license described in
this Section 2.3.1 to conduct in vivo efficacy studies of
any Ab-MAY Product to any Target that is not an Optioned Target or
Licensed Target.
2.3.2
Exclusive Research License .
ImmunoGen hereby grants sanofi-aventis an exclusive, royalty-free
license during the Research Term, without the right to grant
sublicenses, with respect to any Optioned Target, to (a) conduct
any and all preclinical studies (including without limitation in
vivo efficacy studies) on any Ab-MAY Product directed at such
Optioned Target; and (b) manufacture Ab-MAY Product solely for use
in such studies.
2.3.3
Use of Subcontractors; bona fide
Collaborators . Sanofi-aventis shall have the
right to engage one or more Third Party subcontractors to perform
designated functions, or participate in bona fide
collaborations, related to the conduct of the activities described
in Section 2.3.1 and 2.3.2, provided , that (i) sanofi-aventis shall remain responsible for the
satisfactory accomplishment of such activities in accordance with
the terms and conditions of this Agreement; and (ii) each such
Third Party subcontractor or bona fide collaborator shall be
bound to the same extent that sanofi-aventis is obligated to
ImmunoGen under this Agreement.
2.3.4
Research Records .
Sanofi-aventis shall maintain records of access to and use of the
Licensed Technology and Licensed Patent Rights. Such records
shall be made available to ImmunoGen upon reasonable request during
business hours and provided that ImmunoGen shall make such request
no more than once per Calendar Year.
2.3.5
Research Term . Subject to
the payment of the Research Term Exercise Fee as provided in
Section 3.2 below and to the extension as provided in Section 2.3.6
below, the research term shall commence on the Research Term
Exercise Date and continue until August 31, 2011 (the "Research
Term"), unless this Agreement is earlier terminated by either
Party
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pursuant to the provisions of
Section 8. Unless otherwise provided in a License
Agreement or otherwise set forth in this Agreement, upon
termination or expiration of the Research Term, sanofi-aventis
shall discontinue use of the Licensed Technology and Licensed
Patent Rights and destroy all portions and copies of the Licensed
Technology and Licensed Patent Rights, provided, however, that
sanofi-aventis shall have the right to retain one (1) copy for its
legal files.
2.3.6
Extension of Research Term .
Sanofi-aventis may extend the Research Term for one additional
three (3) year period (ending on August 31, 2014) by providing
written notice and by paying ImmunoGen a non-refundable,
non-creditable fee in the amount of [***] [***] dollars (US $[***])
by wire transfer of immediately available funds at any time prior
to the expiration of the Research Term.
2.4
Grant of Improvement License to
ImmunoGen . Sanofi-aventis hereby grants ImmunoGen
a non-exclusive, worldwide, fully-paid, irrevocable, royalty-free
license of perpetual duration, with the right to grant sublicenses
as described below, under sanofi-aventis’ interest in any
Sanofi-aventis Improvements (a) to manufacture Preclinical
Materials pursuant to the terms of this Agreement; (b) to develop,
make, have made, use, sell, have sold, offer for sale, import, have
imported, export and have exported any product that is not
otherwise restricted by an agreement by and between sanofi-aventis
and ImmunoGen; and (c) to otherwise exploit such Sanofi-aventis
Improvements for all uses within the Field that are not otherwise
restricted by an agreement by and between sanofi-aventis and
ImmunoGen, provided, that, (i) any grant by ImmunoGen of a
sublicense is only made in connection with the grant of a license
to Technology and/or Patent Rights Controlled by ImmunoGen and used
in the conjugation of MAY Compounds to binding proteins; and (ii)
the right of ImmunoGen to grant any such sublicense is subject to
sanofi-aventis obtaining a grant back of a non-exclusive, fully
paid, irrevocable, royalty-free license, under that
sublicensee’s improvements, enhancements or modifications to
Technology Controlled by ImmunoGen to conduct research in the Field
and in the Territory in accordance with Sections 2.3.1 and/or 2.3.2
of this Agreement.
2.5
Notice of Improvements.
Sanofi-aventis shall promptly notify ImmunoGen of the
conception or reduction to practice of any such Sanofi-aventis
Improvement. ImmunoGen shall promptly notify sanofi-aventis of (a)
the conception or reduction to practice by ImmunoGen of any
Improvement or (b) its receipt of written notice from any of its
Third Party collaborators of its conception or reduction to
practice of any Improvement.
2.6
Manufacture of Research and/or Preclinical
Materials . Subject to this Section 2.6,
Sanofi-aventis shall have the sole right, at its sole cost and
discretion, for the manufacture of all materials (including without
limitation any Ab-MAY Products and/or MAY Compounds) necessary for
sanofi-aventis to practice the licenses granted to it under
Sections 2.3.1 and/or 2.3.2. In the event that, during the
Term, sanofi-aventis desires ImmunoGen to supply sanofi-aventis
with quantities of Preclinical Materials, sanofi-aventis shall
provide ImmunoGen with written notice of same. ImmunoGen
shall manufacture all ordered amounts of Preclinical Materials at
ImmunoGen’s Cambridge, Massachusetts facility or its Norwood,
Massachusetts facility and deliver such ordered amounts in
accordance with forecasting parameters, advance ordering timeframes
and delivery timeframes to be agreed upon by the Parties.
Sanofi-aventis may [***], at its sole discretion, the [***] [***]
[***] ImmunoGen will supply the requested
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Preclinical Materials. In connection with
any ordering of Preclinical Materials by sanofi-aventis, (a)
ImmunoGen shall provide sanofi-aventis with ImmunoGen’s good
faith estimate of the Manufacturing Cost for manufacture and supply
of such Preclinical Materials; (b) ImmunoGen’s price to
supply Preclinical Materials to sanofi-aventis manufactured at
ImmunoGen’s Cambridge, Massachusetts facility shall equal
[***]% of ImmunoGen’s Manufacturing Cost for such Preclinical
Materials; and (c) ImmunoGen’s price to supply Preclinical
Materials manufactured at ImmunoGen’s Norwood, Massachusetts
facility shall equal [***]% of ImmunoGen’s Manufacturing Cost
for such Preclinical Materials; provided, that, nothing in this
Section 2.6 shall preclude sanofi-aventis from making its own
arrangements for manufacture and supply of Preclinical Materials on
its own or with Third Parties, subject to the licenses granted
hereunder.
3.
FINANCIAL TERMS
3.1
Up-Front Fee . In
consideration of the rights granted to sanofi-aventis under this
Agreement, sanofi-aventis agrees to pay ImmunoGen a non-refundable,
non-creditable up-front fee in the amount of five hundred thousand
dollars ($500,000), payable in immediately available funds within
[***] ([***]) days of the Effective Date.
3.2
Research Term Exercise Fee In
consideration of the rights granted to sanofi-aventis under this
Agreement, sanofi-aventis agrees to pay ImmunoGen a non-refundable,
non-creditable exercise fee in the amount of [***] [***] [***]
[***] [***] dollars ($[***]) (the "Research Term Exercise Fee"),
payable in immediately available funds within [***] ([***])
Business Days of the Research Term Exercise Date.
4.
TREATMENT OF CONFIDENTIAL INFORMATION
4.1
Confidentiality .
4.1.1
Confidentiality Obligations .
ImmunoGen and sanofi-aventis each recognizes that the other
Party’s Confidential Information constitutes highly valuable
assets of such other Party. ImmunoGen and sanofi-aventis each
agrees that, subject to Section 4.1.2, (a) during the Term and for
an additional [***] ([***]) years thereafter it will not disclose,
and will cause its Affiliates and Sublicensees not to disclose, any
Confidential Information of the other Party and (b) during and
after the Term, it will not use, and will cause its Affiliates not
to use, any Confidential Information of the other Party, in either
case, except as expressly permitted hereunder. Without
limiting the generality of the foregoing, each Party shall take
such action, and shall cause its Affiliates and sublicensees to
take such action, to preserve the confidentiality of the other
Party’s Confidential Information as such Party would
customarily take to preserve the confidentiality of its own
Confidential Information and shall, in any event, use at least
reasonable care to preserve the confidentiality of the other
Party’s Confidential Information.
4.1.2
Limited Disclosure .
ImmunoGen and sanofi-aventis each agrees that disclosure of
its Confidential Information may be made by the other Party to any
employee, consultant or Affiliate of such other Party to enable
such other Party to exercise its rights or to carry out its
responsibilities under this Agreement, provided that any such
disclosure or transfer shall only be made to Persons who are bound
by written obligations as described in Section 4.1.3.
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In addition, ImmunoGen and sanofi-aventis each
agrees that the other Party may disclose its Confidential
Information (a) on a need-to-know basis to such other Party’s
legal and financial advisors and (b) as reasonably necessary
in connection with an actual or potential (i) permitted sublicense
of such other Party’s rights hereunder, (ii) debt or equity
financing of such other Party or (iii) purchase by any Third Party
of all of the capital stock or all or substantially all of the
assets of such other Party or any merger or consolidation involving
such other Party; if, in each case, the Person receiving such
Confidential Information of the other Party agrees in writing to
maintain the confidentiality of such Confidential Information of
the other Party with terms at least as restrictive as those
contained in Section 4.1.1. In addition, each Party agrees
that the other Party may disclose such Party’s Confidential
Information (A) as reasonably necessary to file, prosecute or
maintain patents or patent applications, or to file, prosecute or
defend litigation related to patents or patent applications, in
accordance with this Agreement; or (B) as required by
Applicable Laws, provided that, in the case of any disclosure under
this clause (B), the disclosing Party shall (1) if
practicable, provide the other Party with reasonable advance notice
of and an opportunity to comment on any such required disclosure,
(2) if requested by the other Party, cooperate in all
reasonable respects with the other Party’s efforts to obtain
confidential treatment or a protective order with respect to any
such disclosure, at the other Party’s expense and (3) use
good faith efforts to incorporate the comments of such other Party
in any such disclosure or request for confidential treatment or a
protective order.
4.1.3
Employees and Consultants .
ImmunoGen and sanofi-aventis each hereby represents that all of its
employees and consultants, and all of the employees and consultants
of its Affiliates, who participate in the activities contemplated
by this Agreement or have access to Confidential Information of the
other Party are or will, prior to their participation or access, be
bound by written obligations to maintain such Confidential
Information in confidence and not to use such information except as
expressly permitted hereunder. Each Party agrees to use, and
to cause its Affiliates to use, reasonable efforts to enforce such
obligations.
4.2
Publicity . The Parties
acknowledge that the terms of this Agreement constitute
Confidential Information of each Party and may not be disclosed
except as permitted by Section 4.1.2. Notwithstanding
anything to the contrary in Section 4.1, the Parties, upon the
execution of this Agreement, shall mutually agree to a press
release with respect to this Agreement and either Party may make
subsequent public disclosure of the contents of such press release
without further approval of the other Party. After issuance
of such press release, except as required by Applicable Laws,
neither Party shall issue a press or news release or make any
similar public announcement (other than publication in scientific
journals, in advertising materials and brochures, or presentation
at scientific conferences and meetings and the like that are
intended to be covered by, and are issued in compliance with,
Section 4.3) related to events arising under this Agreement without
the prior written consent of the other Party, provided that
notwithstanding the foregoing, ImmunoGen shall be expressly
permitted to publicly announce the exercise of an Option under
Section 2.1.3, provided, however, that the text of such
announcement shall be mutually agreed to by the Parties.
4.3
Publications and Presentations .
The Parties acknowledge that scientific publications and
presentations must be strictly monitored to prevent any adverse
effect from premature publication or dissemination of results of
the activities hereunder. Each Party agrees that, except as
required by Applicable Laws, it shall not publish or present, or
permit to be
11
published or presented, the results of the
research conducted by sanofi-aventis under or pursuant to this
Agreement to the extent such results refer to or otherwise relate
to the Licensed Technology or Licensed Patent Rights (the "Covered
Results") without the prior review by and approval of the other
Party. Each Party shall provide to the other Party the
opportunity to review each of the submitting Party’s proposed
abstracts, manuscripts or presentations (including, without
limitation, information to be presented verbally) that relate to
the Covered Results at least [***] ([***]) days prior to its
intended presentation or submission for publication, and such
submitting Party agrees, upon written request from the other Party
given within such [***]-[***] period, not to submit such abstract
or manuscript for publication or to make such presentation until
the other Party is given up to [***] ([***]) days from the date of
such written request to seek appropriate patent protection for any
Covered Rights in such publication or presentation that it
reasonably believes may be patentable. Once such abstracts,
manuscripts or presentations have been reviewed and approved by
each Party, the same abstracts, manuscripts or presentations do not
have to be provided again to the other Party for review for a later
submission for publication. Each Party also shall have the
right to require that any of its Confidential Information that is
disclosed in any such proposed publication or presentation be
deleted prior to such publication or presentation. In any
permitted publication or presentation by a Party, the other
Party’s contribution shall be duly recognized, and
co-authorship shall be determined in accordance with customary
industry standards.
5.
INTELLECTUAL PROPERTY RIGHTS
Except as otherwise expressly provided herein, all inventions
and discoveries governed by this Agreement shall be owned based on
inventorship, as inventorship is determined in accordance with
United States patent law. Notwithstanding anything to the
contrary in this Agreement, Sanofi-aventis Improvements shall be
solely owned by sanofi-aventis, and Licensed Technology and
Licensed Patent Rights shall be solely owned by ImmunoGen.
6.
PROVISIONS CONCERNING THE FILING, PROSECUTION AND
MAINTENANCE OF PATENT RIGHTS
6.1
Applicability . The
provisions of this Section 6 shall be applicable to all
patents covering Licensed Technology and Licensed Patent Rights
unless and until they become subject to a License Agreement,
whereupon the License Agreement will govern the rights of the
Parties with respect to the subject matter thereof.
6.2
Patent Filing .
6.2.1
Licensed Technology .
ImmunoGen, acting through patent counsel or agents of its choice,
shall be responsible, at its sole cost and expense, for the
preparation, filing, prosecution and maintenance of all Licensed
Patent Rights. All costs and expenses incurred by ImmunoGen
in connection with the preparation, filing, prosecution and
maintenance of Licensed Patent Rights shall be the sole
responsibility of ImmunoGen. At ImmunoGen’s request,
sanofi-aventis shall cooperate with ImmunoGen in all reasonable
respects in connection with such preparation, filing, prosecution
and maintenance of Licensed Patent Rights.
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6.2.2
Sanofi-aventis Improvements.
Sanofi-aventis, acting through patent counsel or agents of
its choice, shall be responsible, at its sole cost and expense, for
the preparation, filing, prosecution and maintenance of patent
applications and patents constituting Patent Rights claiming
Sanofi-aventis Improvements. Sanofi-aventis (i) will
provide ImmunoGen with a copy of any such proposed patent
application for review and comment reasonably in advance of filing,
and (ii) will keep ImmunoGen reasonably informed of the status
of such filing, prosecution and maintenance, including, without
limitation, (A) by providing ImmunoGen with copies of all
communications received from or filed in patent office(s) with
respect to such filing, and (B) by providing ImmunoGen a
reasonable time prior to taking or failing to take any action that
would affect the scope or validity of any such filing (including
the substantially narrowing, cancellation or abandonment of any
claim(s) without retaining the right to pursue such subject matter
in a separate application, or the failure to file or perfect the
filing of any claim(s) in any country), with prior written notice
of such proposed action or inaction so that ImmunoGen has a
reasonable opportunity to review and comment. If
sanofi-aventis fails to undertake the filing(s) of any such patent
application with respect to any such invention within [***] ([***])
days after receipt of written notice from ImmunoGen that ImmunoGen
believes filing(s) of such an application by sanofi-aventis is
appropriate, ImmunoGen may undertake such filing(s) at its own
expense, in which case sanofi-aventis will assign all of its rights
to such Improvements to ImmunoGen and any subsequently issued
patent thereon will be owned solely by ImmunoGen.
6.2.3
Cooperation . Each Party
agrees to cooperate reasonably with the other Party in the
preparation, filing, and prosecution of any patent applications
pursuant to this Section 6.2. Such cooperation includes,
but is not limited to, executing all papers and instruments, or
requiring its employees or agents to execute such papers and
instruments, so as to effectuate the ownership of such patent
applications and any patents thereon and to enable the filing and
prosecution of applications in any country.
6.3
Infringement .
6.3.1
Sanofi-aventis Improvements .
Sanofi-aventis shall have all rights, at its own expense, to
bring suit (or other appropriate legal action) against any actual
or suspected infringement of Patent Rights claiming Sanofi-aventis
Improvements.
6.3.2
ImmunoGen Technology .
ImmunoGen shall have all rights, at its own expense, to bring suit
(or other appropriate legal action) against any actual or suspected
infringement of the Licensed Patent Rights.
6.4
Cooperation . Each Party
shall give notice to the other Party of any potential infringement
or actual infringement by a Third Party of any Patents Rights
covering Licensed Technology and shall execute all papers and
perform such other acts (other than monetary) as may be reasonably
required to maintain any infringement suit brought in accordance
with Section 6.3 above (including giving legal consent for
bringing such suit, and agreeing to be named as a plaintiff or
otherwise joined in such suit), and at its option and expense, may
be represented in such suit by counsel of its choice. In
addition, the Parties shall reasonably cooperate with each other in
obtaining patent term restoration or supplemental
protection
13
certificates or their equivalents in any country
in the Territory where applicable to Licensed Patent
Rights.
6.5
No Obligation . No Party
shall have any obligation to the other Party under this Agreement
to pay any fees or costs: (i) for that Party’s bringing
a lawsuit or other action to enforce any Licensed Patent Rights, or
any other patent owned by a Party against an actual or suspected
infringement or (ii) for any other Party to obtain for its own
benefit independent business or legal advice concerning any of the
patent rights set forth in clause (i) hereof.
7.
TERM AND TERMINATION
7.1
Term . Unless earlier
terminated as provided in this Section 7, the term of this
Agreement shall expire upon the later of the expiration of the
Research Term or the last to expire of the Option Periods (the
"Term").
7.2
Termination . This Agreement
and the rights and options granted herein may be terminated by
either Party upon any material breach by the other Party of any
material obligation or condition, effective [***] ([***]) days
after giving written notice to the breaching Party of such
termination in the case of a payment breach and [***] ([***]) days
after giving written notice to the breaching Party of such
termination in the case of any other breach, which notice shall
describe such breach in reasonable detail. The foregoing
notwithstanding, if such default or breach is cured or shown to be
non-existent within the aforesaid [***] ([***]) or [***] ([***])
day period, the notice shall be automatically withdrawn and of no
effect. However, prior to giving any notice for breach, the
Parties shall first attempt to resolve any disputes as to the
existence of any breach as set forth in Section 8.14.
Additionally, until such time as sanofi-aventis has exercised the
Research Term Option, sanofi-aventis shall have the further right
to terminate this Agreement upon providing not less than [***]
([***]) days’ written notice to ImmunoGen of such
termination.
7.3
Remedies . If either Party
shall fail to perform or observe or otherwise breaches any of its
material obligations under this Agreement, in addition to any right
to terminate this Agreement, the non-defaulting Party may elect to
obtain other relief and remedies available under law.
7.4
Surviving Provisions .
Notwithstanding any provision herein to the contrary, the rights
and obligations set forth in Sections 2.3.6, 4, 5, 6.2, 7.4, 8.4,
8.5, 8.6, 8.16 and 8.17 hereof shall survive the expiration of the
Term or the termination of this Agreement. All other rights
and licenses of the Parties set forth in this Agreement shall
terminate.
8.
REPRESENTATIONS, WARRANTIES AND COVENANTS
8.1
Mutual Representations and Warranties
. ImmunoGen and sanofi-aventis each represents and
warrants to the other, as of the Effective Date, as
follows:
8.1.1
Organization . It is a
corporation duly organized, validly existing and in good standing
under the laws of the jurisdiction of its organization, and has all
requisite power and authority, corporate or otherwise, to execute,
deliver and perform this Agreement.
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8.1.2
Authorization . The execution
and delivery of this Agreement and the performance by it of the
transactionscontemplated hereby have been duly authorized by all
necessary corporate action and will not violate (a) such
Party’s certificate of incorporation or bylaws, (b) any
agreement, instrument or contractual obligation to which such Party
is bound in any material respect, (c) any requirement of any
Applicable Law, or (d) any order, writ, judgment, injunction,
decree, determination or award of any court or governmental agency
presently in effect applicable to such Party.
8.1.3
Binding Agreement . This
Agreement is a legal, valid and binding obligation of such Party
enforceable against it in accordance with its terms and
conditions.
8.1.4
No Inconsistent Obligation .
It is not under any obligation, contractual or otherwise, to any
Person that conflicts with or is inconsistent in any respect with
the terms of this Agreement or that would impede the diligent and
complete fulfillment of its obligations hereunder.
8.2
Additional Representations of ImmunoGen
. ImmunoGen further represents and warrants to
sanofi-aventis, as of the Effective Date, as follows:
8.2.1
Licensed Patent Rights . All
Licensed Patent Rights existing as of the Effective Date are
existing and, to ImmunoGen’s knowledge, no such Licensed
Patent Rights are invalid or unenforceable.
8.2.2
Claims or Judgments . There
are no claims, judgment or settlements against ImmunoGen pending,
or to ImmunoGen’s knowledge, threatened, that invalidate or
seek to invalidate the Licensed Patent Rights existing as of the
Effective Date.
8.2.3
Right to Technology .
ImmunoGen has the right to (a) use the Licensed Technology and
Licensed Patent Rights existing as of the Effective Date as is
necessary to fulfill its obligations under this Agreement; and (b)
grant the licenses under the Licensed Patent Rights granted
pursuant to this Agreement.
8.2.4
No Infringement . To
ImmunoGen’s knowledge, no Third Party is infringing, or
threatening to infringe, the Licensed Patent Rights.
8.2.5
No Litigation . To
ImmunoGen’s knowledge, there is no pending or threatened
litigation that alleges that ImmunoGen’s proposed activities
under this Agreement would infringe or misappropriate any
intellectual property rights of any Third Party.
8.3
Covenant . ImmunoGen agrees
to use commercially reasonable efforts to maintain the right, to
(a) use the Licensed Technology and Licensed Patent Rights existing
as of the Effective Date as is necessary to fulfill its obligations
under this Agreement; and (b) grant the licenses under the Licensed
Patent Rights granted pursuant to this Agreement.
9.
INDEMNIFICATION
9.1
Indemnification of sanofi-aventis by
ImmunoGen . ImmunoGen shall indemnify, defend and
hold harmless sanofi-aventis, its Affiliates, their respective
directors,
15
officers, employees and agents, and their
respective successors, heirs and assigns (collectively, the
"sanofi-aventis Indemnitees"), against all liabilities, damages,
losses and expenses (including, without limitation, reasonable
attorneys’ fees and expenses of litigation) (collectively,
"Losses") incurred by or imposed upon the sanofi-aventis
Indemnitees, or any one of them, as a direct result of claims,
suits, actions, demands or judgments of Third Parties, including
without limitation personal injury and product liability claims and
claims of suppliers and ImmunoGen employees (collectively,
"Claims"), arising out of the material breach by ImmunoGen of this
Agreement, except with respect to any Claim or Losses that result
from a material breach of this Agreement by, or the gross
negligence or willful misconduct of, sanofi-aventis, provided that,
with respect to any Claim for which ImmunoGen has an obligation to
any sanofi-aventis Indemnitee pursuant to this Section 9.1 and
sanofi-aventis has an obligation to any ImmunoGen Indemnitee
pursuant to Section 9.2, each Party shall indemnify each of the
other Party’s Indemnitees for its Losses to the extent of its
responsibility, relative to the other Party, for the facts
underlying the Claim.
9.2
Indemnification of ImmunoGen by
sanofi-aventis . Sanofi-aventis shall indemnify,
defend and hold harmless ImmunoGen, its Affiliates, their
respective directors, officers, employees and agents, and their
respective successors, heirs and assigns (the "ImmunoGen
Indemnitees"), against any Losses incurred by or imposed upon the
ImmunoGen Indemnitees, or any one of them, as a direct result of
Claims arising out of (a) the material breach by sanofi-aventis of
this Agreement; (b) the development or commercialization
(including, without limitation, the production, manufacture,
promotion, import, sale or use by any Person) of any MAY Compound
or Ab-MAY Product by sanofi-aventis or any of its Affiliates,
Sublicensees, distributors or agents, except with respect to any
Claim or Losses that result from a breach of this Agreement by, or
the gross negligence or willful misconduct of, ImmunoGen, provided
that with respect to any Claim for which ImmunoGen has an
obligation to any sanofi-aventis Indemnitee pursuant to Section 9.1
and sanofi-aventis has an obligation to any ImmunoGen Indemnitee
pursuant to this Section 9.2, each Party shall indemnify each of
the other Party’s Indemnitees for its Losses to the extent of
its responsibility, relative to the other Party, for the facts
underlying the Claim.
9.3
Conditions to Indemnification
. A Person seeking recovery under Sections 9.1 or 9.2(the
"Indemnified Party") in respect of a Claim shall give prompt notice
of such Claim to the Party from which recovery is sought (the
"Indemnifying Party") and, provided that the Indemnifying Party is
not contesting its obligation under Sections 9.1 or 9.2, shall
permit the Indemnifying Party to control any litigation relating to
such Claim and the disposition of such Claim, provided that the
Indemnifying Party shall (a) act reasonably and in good faith with
respect to all matters relating to the settlement or disposition of
such Claim as the settlement or disposition relates to such
Indemnified Party and (b) not settle or otherwise resolve such
claim without the prior written consent of such Indemnified Party
(which consent shall not be unreasonably withheld, conditioned or
delayed). Each Indemnified Party shall cooperate with the
Indemnifying Party in its defense of any such Claim in all
reasonable respectsand shall have the right to be present in person
or through counsel at all legal proceedings with respect to such
Claim.
9.4
Warranty Disclaimer . EXCEPT
AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY
MAKES ANY WARRANTY WITH RESPECT
16
TO ANY TECHNOLOGY, GOODS, SERVICES, RIGHTS OR
OTHER SUBJECT MATTER OF THIS AGREEMENT AND EACH PARTY HEREBY
DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE AND NONINFRINGEMENT.
9.5
Limited Liability .
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, NEITHER
PARTY SHALL BE LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES
FOR (I) ANY SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION LOST PROFITS OR
LOST REVENUES, OR (II) COST OF PROCUREMENT OF SUBSTITUTE GOODS,
TECHNOLOGY OR SERVICES, WHETHER UNDER ANY CONTRACT, WARRANTY,
NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE
THEORY.
10.
MISCELLANEOUS
10.1
Notices . Any notices,
requests, deliveries, approvals or consents required or permitted
to be given under this Agreement to sanofi-aventis or ImmunoGen
shall be in writing and shall be effective on receipt when
delivered to the applicable address specified below (or to such
other address as may be specified in writing to the other Party
hereto):
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If to ImmunoGen:
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ImmunoGen, Inc.
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128 Sidney Street
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Cambridge, MA 02139
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Attn: Chief Executive Officer
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With a copy to:
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Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
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One Financial Center
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Boston, MA 02111
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Attn: [***] [***] [***], Esq
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Telecopy: 617-542-2241
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If to sanofi-aventis:
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sanofi-aventis U.S. Inc.
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1041 Rt.202-206
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Bridgewater, NJ 08807
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Attn: Head, US Alliance &
Partnerships
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With a copy to:
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Attn: Head, US R&D Legal
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Except as otherwise expressly provided in this
Agreement or mutually agreed in writing, any notice, communication
or document (excluding payment) required to be given or made shall
be deemed given or made and effective upon actual receipt or, if
earlier, (a) three (3) business days after deposit with an
internationally-recognized overnight express courier with changes
prepaid, or (b) five (5) business days after mailed by certified,
registered or regular mail, postage prepaid, in each case addressed
to a Parties at its address stated above or to such other address
as such Party may designate by written notice given in accordance
with this Section 10.1.
17
10.2
Governing Law . This
Agreement will be construed, interpreted and applied in accordance
with the laws of the State of Delaware (excluding its body of law
controlling conflicts of law).
10.3
Limitations . Except as set
forth elsewhere in this Agreement, neither Party grants to the
other Party any right or license to any of its intellectual
property.
10.4
Entire Agreement . This is
the entire Agreement between the Parties with respect to the
subject matter hereof and supersedes all prior representations,
understandings and agreements between the Parties with respect to
the subject matter hereof, including without limitation the Option
Agreement. No modification shall be effective unless in
writing with specific reference to this Agreement and signed by the
Parties.
10.5
Waiver . The terms or
conditions of this Agreement may be waived only by a written
instrument executed by the Party waiving compliance. The
failure of either Party at any time or times to require performance
of any provision hereof shall in no manner affect its rights at a
later time to enforce the same. No waiver by either Party of
any condition or term shall be deemed as a continuing waiver of
such condition or term or of another condition or term.
10.6
Headings . Section and
subsection headings are inserted for convenience of reference only
and do not form part of this Agreement.
10.7
Assignment . Neither this
Agreement nor any obligation of a Party hereunder may be assigned
by either Party without the consent of the other which shall not be
unreasonably withheld, except that each Party may assign this
Agreement and the rights, obligations and interests of such Party,
in whole or in part, to any of its Affiliates, and to any Third
Party purchaser of all of the capital stock of such Party or all or
substantially all of its assets in the line of business to which
this Agreement pertains or to any successor corporation resulting
from any merger or consolidation of such Party with or into such
corporation.
10.8
Force Majeure . Neither Party
shall be liable for failure of or delay in performing obligations
set forth in this Agreement, and neither shall be deemed in breach
of its obligations, if such failure or delay is due to natural
disasters or any causes beyond the reasonable control of such
Party. In the event of such force majeure, the Party affected
thereby shall use reasonable efforts to cure or overcome the same
and resume performance of its obligations hereunder.
10.9
Construction . The Parties
hereto acknowledge and agree that each Party and its counsel
reviewed and negotiated the terms and provisions of this Agreement
and have contributed to its revision.
10.10
Severability . If any
provision(s) of this Agreement are or become invalid, are ruled
illegal by any court of competent jurisdiction or are deemed
unenforceable under then current applicable law from time to time
in effect during the Term hereof, it is the intention of the
Parties that the remainder of this Agreement shall not be affected
thereby provided that a Party’s rights under this Agreement
are not materially affected. The Parties hereto covenant and
agree to renegotiate any such term, covenant or application thereof
in good faith in order to provide a reasonably acceptable
alternative to the term, covenant or condition of this
Agreement
18
or the application thereof that is invalid,
illegal or unenforceable, it being the intent of the Parties that
the basic purposes of this Agreement are to be
effectuated.
10.11
Status . Nothing in this
Agreement is intended or shall be deemed to constitute a partner,
agency, employer-employee, or joint venture relationship between
the Parties.
10.12
Section 365(n) . All
licenses granted under this Agreement are deemed to be, for
purposes of Section 365(n) of the U.S. Bankruptcy Code,
licenses of right to "intellectual property" as defined in
Section 101 of such Code. The Parties agree that the
licensee may fully exercise all of its rights and elections under
the U.S. Bankruptcy Code, regardless of whether either Party files
for bankruptcy in the United States or other jurisdiction.
The Parties further agree that, in the event a licensee elects to
retain its rights as a licensee under such Code, the licensee shall
be entitled to complete access to any technology licensed to it
hereunder and all embodiments of such technology. Such
embodiments of the technology shall be delivered to the licensee
not later than (a) the commencement of bankruptcy proceedings
against the licensor, upon written request, unless the licensor
elects to perform its obligations under the Agreement, or (b) if
not delivered under Section 10.12(a) above, upon the rejection
of this Agreement by or on behalf of the licensor, upon written
request.
10.13
Further Assurances . Each
Party agrees to execute, acknowledge and deliver such further
instructions, and to do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this
Agreement.
10.14
Counterparts . This Agreement
may be executed simultaneously in one or more counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
[Remainder of page intentionally left
blank.]
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IN WITNESS WHEREOF, the Parties have caused this
Agreement to be executed by their duly authorized representative in
two (2) originals.
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IMMUNOGEN, INC.
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By:
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Name:
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Title:
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SANOFI-AVENTIS U.S. LLC
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By:
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Name:
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Title:
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SANOFI-AVENTIS U.S. LLC
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By:
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Name:
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20
APPENDIX A
FORM OF EXCLUSIVE LICENSE AGREEMENT
This EXCLUSIVE LICENSE AGREEMENT (this "Agreement") is entered
into as of
,
, by and between
ImmunoGen, Inc., a Massachusetts corporation having a principal
place of business at 128 Sidney Street, Cambridge, Massachusetts
02139 ("ImmunoGen"), and sanofi-aventis U.S. LLC, a limited
liability company organized and existing under the laws of Delaware
with offices at 1041 Rt.202-206, Bridgewater, NJ 08807
("sanofi-aventis"). Each of sanofi-aventis and ImmunoGen is
sometimes referred to individually herein as a "Party" and
collectively as the "Parties."
WHEREAS, the Parties executed an Option and License Agreement
(as hereinafter defined) pursuant to which ImmunoGen granted
sanofi-aventis certain options to license certain Technology
Controlled by ImmunoGen; and
WHEREAS, ImmunoGen has entered into agreements based on the
so-called "Revolving-Door" structure with a number of Third Parties
whereby such Third Parties are obligated to grant back to ImmunoGen
the right to such Third Parties’ improvements to Technology
and Patent Rights, and pursuant to which ImmunoGen has the right to
grant access to such Third Party Improvements to sanofi-aventis;
and
WHEREAS, sanofi-aventis exercised an Option (as hereinafter
defined) pursuant to the Option and License Agreement, pursuant to
which the Parties have agreed to enter into this Agreement in
accordance with the terms thereof.
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.
DEFINITIONS
Whenever used in this Agreement with an initial capital letter,
the terms defined in this Section 1 shall have the meanings
specified.
1.1
" Ab-MAY Product " means any
product containing a conjugate of a Sanofi-aventis Antibody with a
MAY Compound.
1.2
" Affiliate " means, with respect
to any Party, any Person that, directly or through one or more
Affiliates, controls, or is controlled by, or is under common
control with, such Party. For purposes of this definition,
"control" means (a) ownership of more than fifty percent (50%) of
the shares of stock entitled to vote for the election of directors
in the case of a corporation, or more than fifty percent (50%) of
the equity interests in the case of any other type of legal entity,
(b) status as a general partner in any partnership, or (c) any
other arrangement whereby a Person controls or has the right to
control the board of directors of a corporation or equivalent
governing body of an entity other than a corporation.
1.3
" Annual Net Sales " means the
aggregate Net Sales during a particular Calendar Year.
A-1
1.4
" Antibody " means a polyclonal or
monoclonal antibody, whether multiple or single chain, recombinant
or naturally occurring, whole or fragment, and any variants,
derivatives or constructs thereof, including but not limited to,
antigen binding portions including Fab, Fab’, F(ab’)2,
Fv, dAb and CDR fragments, single chain antibodies (scFv), chimeric
antibodies, diabodies and polypeptides (including any humanized
versions thereof) that contain at least a portion of an
immunoglobulin that is sufficient to confer specific antigen
binding to the polypeptide.
1.5
" Antibody-MAY Compound Conjugate "
means any compound containing a conjugate of an Antibody with a MAY
Compound.
1.6
" Applicable Laws " means Federal,
state, local, national and supra-national laws, statutes, rules and
regulations, including any rules, regulations, guidance, guidelines
or requirements of Regulatory Authorities, national securities
exchanges or securities listing organizations, that may be in
effect from time to time during the Term and applicable to a
particular activity hereunder.
1.7
" Business Day " means a day on
which banking institutions in New York, New York are open for
business.
1.8
" Calendar Quarter " means the
period beginning on the Effective Date and ending on the last day
of the calendar quarter in which the Effective Date falls, and
thereafter each successive period of three (3) consecutive calendar
months ending on March 31, June 30, September 30 or December
31.
1.9
" Calendar Year " means each
successive period of twelve (12) months commencing on January 1 and
ending on December 31.
1.10
" Clinical Materials " means any
supplies of MAY Compound or Licensed Product manufactured by
ImmunoGen in accordance with all Applicable Laws (including GMP)
and applicable Specifications for use in human clinical testing up
to and including non-pivotal Phase IIB Studies.
1.11
" Collaboration Agreement " means
that certain Collaboration and License Agreement dated as of July
30, 2003, as amended, by and between ImmunoGen and Aventis
Pharmaceuticals, Inc., the predecessor in interest to
sanofi-aventis.
1.12
" Commercialization " or "
Commercialize " means any and all activities directed to the
commercialization of a Licensed Product, including pre-launch and
launch activities, marketing, manufacturing for commercial sale,
promoting, detailing, distributing, offering to sell and selling a
Licensed Product, importing a Licensed Product for sale, conducting
additional human clinical trials and interacting with Regulatory
Authorities regarding the foregoing. When used as a verb,
"Commercializing" means to engage in Commercialization and
"Commercialized" has a corresponding meaning.
1.13
" Commercially Reasonable Efforts "
means, with respect to sanofi-aventis, the efforts at least equal
to those customarily used by sanofi-aventis with respect to a
product or potential product of similar nature at a similar stage
in its development or product life and of
A-2
similar market potential, in view of conditions
prevailing at the time, and evaluated taking into account all
relevant factors, including without limitation, the mechanism of
action, efficacy, safety, the anticipated regulatory authority
approved labeling, the competitiveness of alternative products that
are in the marketplace or under development, the patent and other
proprietary position of the product, the likelihood of Regulatory
Approval, the profitability of the product and other technical,
scientific, legal, medical, marketing and competitive
factors.
1.14
" Commercialization Regulatory Approval
" means, with respect to any Licensed Product, the granting
of approval by a Regulatory Authority of (a) an NDA in the United
States, or (b) the equivalent of an NDA required by Applicable Laws
in any country or region in the Territory outside of the United
States to sell such Licensed Product for use in the Field in such
country or region.
1.15
" Comparable Product " means a
product, other than any product being marketed and/or sold as of
the Effective Date, that (a) incorporates or is comprised of an
Antibody-drug conjugate, (b) is directed against the same Target as
a Licensed Product and (c) is marketed and sold by a Third Party
for use in the Field.
1.16
" Confidential Information " means
(a) with respect to ImmunoGen, all tangible embodiments of Licensed
Technology and Licensed Patent; (b) with respect to sanofi-aventis,
all information and Technology related to the sanofi-aventis
Antibody and otherwise included in any Regulatory Filings made, and
Regulatory Approvals received, by sanofi-aventis with respect to
Licensed Products; and (c) with respect to each Party, all
information and Technology disclosed or provided by or on behalf of
such Party (the "disclosing Party") to the other Party (the
"receiving Party") or to any of the receiving Party’s
employees, consultants, Affiliates or sublicensees, provided, that,
none of the foregoing shall be Confidential Information if: (i) as
of the date of disclosure, it is known to the receiving Party or
its Affiliates as demonstrated by credible contemporaneous written
documentation, other than by virtue of a prior confidential
disclosure to such receiving Party; (ii) as of the date of
disclosure it is in the public domain, or it subsequently enters
the public domain through no fault of the receiving Party; (iii) it
is obtained by the receiving Party from a Third Party having a
lawful right to make such disclosure free from any obligation of
confidentiality to the disclosing Party; or (iv) it is
independently developed by or for the receiving Party without
reference to or use of any Confidential Information of the
disclosing Party as demonstrated by credible contemporaneous
written documentation. For purposes of clarity, the terms of
this Agreement shall constitute Confidential Information of each
Party.
1.17
" Control " or "
Controlled " means with respect to Technology or Patent
Rights, the possession by a Party of the right to grant a license
or sublicense to such Technology or Patent Rights as provided
herein without the payment of additional consideration to, and
without violating the terms of any agreement or arrangement with,
any Third Party.
1.18
" Derived " means obtained,
developed, created, synthesized, designed, derived or resulting or
generated from, based upon, or otherwise containing (whether
directly or indirectly, or in whole or in part).
A-3
1.19 "
Designated Senior Officer " means, with respect to a
Party, the senior officer of such Party or its Affiliate designated
by such Party to have final decision making authority over Disputed
Matters.
1.20
" Development " or "
Develop " means, with respect to each Licensed Product, all
non-clinical and clinical activities required to obtain Regulatory
Approval of such Licensed Product. For purposes of clarity,
these activities include, without limitation, test method
development and stability testing, regulatory toxicology studies,
formulation, process development, manufacturing, manufacturing
scale-up, development-stage manufacturing, quality
assurance/quality control development, statistical analysis and
report writing, clinical trial design and operations, preparing and
filing Drug Approval Applications, and all regulatory affairs
related to the foregoing. When used as a verb, "Developing"
means to engage in Development and "Developed" has a corresponding
meaning.
1.21
" Drug Approval Application "
means, with respect to a Licensed Product in a particular country
or region, an application for Commercialization Regulatory Approval
for such Licensed Product in such country or region, including
without limitation: (a) an NDA or sNDA; (b) a counterpart of an NDA
or sNDA, including any MAA, in any country or region in the
Territory; and (c) all supplements and amendments to any of the
foregoing.
1.22
" Effective Date " means the date
first set forth above in the introductory paragraph to this
Agreement.
1.23
" FDA " means the United States Food
and Drug Administrati
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