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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Agreement
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Recitals
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Covered Results
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4.3
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Disputed Matter
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8.14.1
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Excluded Target
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2.2.1
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Expired Option
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2.2.3
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Expired Option Tail
Period
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2.2.3
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ImmunoGen
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Recitals
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ImmunoGen Indemnitees
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8.17.1
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Indemnifying Party
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8.18
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License Response
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2.2.5
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License Request
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2.2.5
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Option
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2.2.1
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Option Period
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2.2.2
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Option Request
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2.2.1
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Option Response
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2.2.1
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Party/Parties
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Recitals
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Proposed Target
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2.2.1
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Research Term
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2.3.5
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Research Term Exercise
Fee
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3.2
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sanofi-aventis
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Recitals
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sanofi-aventis
Indemnitees
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8.17.2
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Terminated Option
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2.2.4
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Term
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7.1
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Third Party Right
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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
9
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.
10
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.
12
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.
14
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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|
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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.]
19
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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SANOFI-AVENTIS U.S. LLC
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By:
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SANOFI-AVENTIS U.S. LLC
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By:
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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 Ter
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