Exhibit 10.1
LICENSE AGREEMENT
between
IMMUNOGEN, INC.
and
SANOFI-AVENTIS U.S.
LLC
October 5, 2006
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.
TABLE OF CONTENTS
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Page
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1.
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DEFINITIONS
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1
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2.
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LICENSE GRANTS; TECHNOLOGY TRANSFER
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8
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2.1
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License Grants
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8
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2.2
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Right to Sublicense
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8
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2.3
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Retained Rights of ImmunoGen
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9
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2.4
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No Other Rights
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9
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2.5
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Technology Transfer; ImmunoGen
Activities
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9
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2.6
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Compliance
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10
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2.7
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Manufacture of Licensed Products for
Development
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10
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3.
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DEVELOPMENT AND COMMERCIALIZATION OF LICENSED
PRODUCTS
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10
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3.1
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Responsibility for Development and
Commercialization
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10
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3.2
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Diligence
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10
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3.3
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Reportable Events
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10
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3.4
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Manufacture of Licensed Products for Commercial
Sale
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11
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3.5
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Product Recalls
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11
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4.
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PAYMENTS
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11
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4.1
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Upfront Fee
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11
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4.2
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Research License Term Extension Fee
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11
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4.3
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ImmunoGen Activity Payments
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11
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4.4
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Milestone Payments
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11
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4.5
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Payment of Royalties; Royalty Rates; Accounting
and Records
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12
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5.
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TREATMENT OF CONFIDENTIAL
INFORMATION;
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16
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PUBLICITY
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16
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5.1
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Confidentiality
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16
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5.2
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Publicity
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5.3
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Publications and Presentations
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17
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6.
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FILING, PROSECUTION AND MAINTENANCE OF PATENT
RIGHTS
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18
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6.1
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Patent Filing, Prosecution and
Maintenance
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18
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6.2
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Abandonment
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18
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6.3
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Legal Actions
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18
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7.
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TERM AND TERMINATION
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19
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7.1
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Term
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7.2
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Termination
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7.3
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Consequences of Termination of
Agreement
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7.4
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Surviving Provisions
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i
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8.
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REPRESENTATIONS AND WARRANTIES
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8.1
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Mutual Representations and Warranties
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8.2
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Additional Representations of
ImmunoGen
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9.
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INDEMNIFICATION
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9.1
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Indemnification of sanofi-aventis by
ImmunoGen
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9.2
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Indemnification of ImmunoGen by
sanofi-aventis
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23
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9.3
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Conditions to Indemnification
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23
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9.4
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Warranty Disclaimer
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24
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9.5
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Limited Liability
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24
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10.
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MISCELLANEOUS
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10.1
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Notices
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10.2
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Governing Law
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10.3
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Binding Effect
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25
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10.4
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Headings
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10.5
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Counterparts
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10.6
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Amendment; Waiver
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10.7
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No Third Party Beneficiaries
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10.8
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Purposes and Scope
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10.9
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Assignment and Successors
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26
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10.10
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Force Majeure
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10.11
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Interpretation
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26
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10.12
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Integration; Severability
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10.13
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Further Assurances
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Schedules
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Schedule 1
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Licensed Patent Rights
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ii
LICENSE AGREEMENT
This LICENSE AGREEMENT (this
“Agreement”) is entered into as of October 5, 2006, 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, ImmunoGen and Aventis
Pharmaceuticals, Inc., sanofi-aventis’ predecessor in
interest (“Aventis”), entered into that certain
Collaboration and License Agreement dated as of July 30, 2003 (the
“Collaboration Agreement”) pursuant to which ImmunoGen
and Aventis agreed to collaborate in the identification and
validation of targets for use in the discovery of antibodies and
antibody drug conjugates for the prevention, control and/or
treatment in humans of precancerous and/or cancerous conditions;
and
WHEREAS, ImmunoGen has developed
certain proprietary technology related to antibody humanization;
and
WHEREAS, sanofi-aventis desires to
obtain from ImmunoGen, and ImmunoGen desires to grant to
sanofi-aventis, a non-exclusive license to use such proprietary
technology in the development of its proprietary Antibodies and the
commercialization of Licensed Products resulting
therefrom.
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
Any reference to a defined term not
specifically defined in this Agreement shall have the meaning set
forth in the Collaboration Agreement. Whenever used in this
Agreement with an initial capital letter, the terms defined in this
Section 1 shall have the meanings specified.
1.1
“ 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.
1.2
“ Annual Net Sales
” means the aggregate Net Sales
during a particular Calendar Year.
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
“ 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.
1.5
“ 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.
1.6
“ Calendar Year
” means each successive period
of twelve (12) months commencing on January 1 and ending on
December 31.
1.7
“ Collaboration
Exclusions ” means any research activities
directed towards Targets or Antibodies being actively pursued in
the Research Program pursuant to the Collaboration
Agreement.
1.8
“ 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.
1.9
“ Commercially Reasonable
Efforts ” means, with respect
to sanofi-aventis, the efforts at least equal to those normally
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 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.
1.10
“ 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.
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1.11
“ Confidential
Information ” means (a) with respect to
ImmunoGen, all tangible embodiments of Licensed Technology and
Licensed Patents and (b) 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.
1.12
“ 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.
1.13
“ Designated Senior
Officer ” means, with respect to a
Party, the senior officer designated by such Party to have final
decision making authority over disputed matters.
1.14
“ 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.
1.15
“ Discover ” or
“ Discovered ” means, with respect to any
Licensed Product (a) the invention, discovery or identification of
such Licensed Product; (b) the identification of the function,
utility or mode of action of such Licensed Product in the Field; or
(c) the identification of a new method of synthesizing such
Licensed Product.
1.16
“ 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.
1.17
“ Effective Date
” means the date first set
forth above in the introductory paragraph to this
Agreement.
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1.18
“
FDA ” means the United
States Food and Drug Administration or any successor agency or
authority thereto.
1.19
“ FDCA
”means the
United States Federal Food, Drug, and Cosmetic Act, as
amended.
1.20
“ Field ”
means all human
therapeutic and diagnostic uses of Licensed Products, provided,
however, that during the Research Program Term the Field shall not
include the Collaboration Exclusions.
1.21
“ First Commercial Sale
” means, with respect to a
Licensed Product in any country in the Territory, the first sale,
transfer or disposition for value or for end use or consumption of
such Licensed Product in such country; provided, that, any sale to
an Affiliate or Sublicensee will not constitute a First Commercial
Sale unless the Affiliate or Sublicensee is the last entity in the
distribution chain of the Licensed Product.
1.22
“ Force Majeure
” means any occurrence beyond
the reasonable control of a Party that (a) prevents or
substantially interferes with the performance by such Party of any
of its obligations hereunder and (b) occurs by reason of any act of
God, flood, fire, explosion, earthquake, strike, lockout, labor
dispute, casualty or accident, or war, revolution, civil commotion,
act of terrorism, blockage or embargo, or any injunction, law,
order, proclamation, regulation, ordinance, demand or requirement
of any government or of any subdivision, authority or
representative of any such government.
1.23
“ Hatch-Waxman Act
” means the Drug Price
Competition and Patent Term Restoration Act of 1984, as
amended.
1.24
“ IND ”
means: (a) an
Investigational New Drug Application (as defined in the FDCA and
regulations promulgated thereunder) or any successor application or
procedure required to initiate clinical testing of a Licensed
Product in humans in the United States; (b) a counterpart of an
Investigational New Drug Application that is required in any other
country or region in the Territory before beginning clinical
testing of a Licensed Product in humans in such country or region;
and (c) all supplements and amendments to any of the
foregoing.
1.25
“ Initiation
” means, with respect to any
Pivotal Clinical Trial, the first date that a human subject is
dosed in such Pivotal Clinical Trial.
1.26
“ Licensed Patent
Rights ” means any of the patents and
patent applications described in Schedule 1 attached hereto,
and any divisional, continuation, continuation-in-part (to the
extent that the continuation-in-part is entitled to the priority
date of an initial patent or patent application which is the
subject of this Agreement), reissue, reexamination, confirmation,
revalidation, registration, patent of addition, renewal, extension
or substitute thereof, or any patent issuing therefrom or any
supplementary protection certificates related thereto.
1.27
“ Licensed
Product ” means any product
(including any product that incorporates an Antibody) (a) the
manufacture, use or sale of which would, absent the license granted
to sanofi-aventis hereunder, infringe any Valid Claim included in
the Licensed Patent Rights,
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(b) that is
Discovered and/or Developed in whole or in part through the use of
a process which is covered by a Valid Claim included in the
Licensed Patent Rights, or (c) that is not covered by (a) or (b)
but that is Discovered, Developed and/or manufactured as a result
of the use of the Licensed Technology.
1.28
“ Licensed Technology
” means any Technology
Controlled by ImmunoGen as of the Effective Dateorthat is
Controlled by ImmunoGen at any time during the Term that is related
to any patent or patent application included in the Licensed Patent
Rights and is necessary for sanofi-aventis to exercise the license
granted to it pursuant to Section 2.1.
1.29
“ MAA ”
means any
application filed with the relevant Regulatory Authority seeking
Regulatory Approval to market and sell a Licensed Product outside
the United States for a particular indication in the
Field.
1.30
“ NDA ”
means a New Drug
Application, as defined in the FDCA and regulations promulgated
thereunder, or any successor application or procedure required to
sell a Licensed Product in the United States for a particular
indication in the Field.
1.32
“ Net Sales
” means the gross amount
invoiced by sanofi-aventis or its Affiliates or Sublicensees to
Third Parties in each country in the Territory for sales of each
Licensed Product in such country during the period in which
royalties are payable hereunder with respect to sales of such
Licensed Product in such country, less the following deductions
from such gross amounts absorbed or accrued with respect to such
gross amounts: (a) trade, cash and/or quantity discounts allowed
and taken directly with respect to such sales, or reflected in the
invoiced amount; (b) excise, sales and other consumption taxes
(including VAT on the sale of Licensed Products and excluding taxes
based on income) and custom duties imposed upon and paid directly
by sanofi-aventis with respect to the Licensed Products, to the
extent included in the invoice price; (c) freight, insurance and
other transportation charges, to the extent included in the invoice
price; (d) amounts repaid or credited by reason of returns,
rejections, defects or recalls, chargebacks, retroactive price
reductions, refunds and billing errors; and (e) compulsory payments
and rebates directly related to the sale of Licensed Products,
accrued, paid or deducted, pursuant to agreements (including, but
not limited to, managed care agreements) or governmental
regulations.
Use of Licensed Products for
promotional or sampling purposes and for use in clinical trials
contemplated under this Agreement shall not be considered in
determining Net Sales. In the case of any sale of a Licensed
Products between or among sanofi-aventis and its Affiliates or
Sublicensees for resale, Net Sales shall be calculated as above
only on the first arm’s length sale thereafter to a Third
Party.
In the event a Licensed Product is
sold as a component of a combination or bundledproduct that
consists of a Licensed Product together with another
therapeutically active product for the same indication (a
“Combination Product”), the Net Sales from the
Combination Product, for the purposes of determining royalty
payments, shall be determined by multiplying the Net Sales of the
Combination Product (as defined in the standard Net Sales
definition above), during the applicable royalty reporting period,
by the fraction, A/A+B, where A is the average per unit sale price
of the active ingredient contained in Licensed Product when sold
separately in finished
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form in the country in which the
Combination Product is sold during the same royalty reporting
period in similar volumes and of the same class, purity and potency
and B is the average per unit sale price of the active ingredient
contained in other product(s) included in the Combination Product
when sold separately in finished form in the country during the
same royalty reporting period in similar volumes and of the same
class, purity and potency in which the Combination Product is sold,
in each case during the applicable royalty reporting period or, if
sales of the Licensed Product alone did not occur in such period,
then in the most recent royalty reporting period in which arms
length fair market sales of such Licensed Product occurred.
In the event that such average sale price cannot be determined for
the Licensed Product, on the one hand, and all other product(s)
included in the Combination Product, on the other, Net Sales for
the purposes of determining royalty payments shall be mutually
agreed upon by the Parties based on the relative value contributed
by each component, such agreement to be negotiated in good
faith.
1.33
“ Person ”
means an
individual, sole proprietorship, partnership, limited partnership,
limited liability partnership, corporation, limited liability
company, business trust, joint stock company, trust, incorporated
association, joint venture or similar entity or organization,
including a government or political subdivision, department or
agency of a government.
1.34
“ Pivotal Clinical
Trial ” means, as to a particular
Licensed Product for a particular indication, a controlled and
lawful study in humans of the safety and efficacy of such Licensed
Product for such indication, which is prospectively designed to
demonstrate statistically whether such Licensed Product is safe and
effective for use in such indication in a manner sufficient to file
a Drug Approval Application for the indication under investigation
in such study.
1.35
“ Regulatory Approval
” means, with respect to any
country or region in the Territory, any approval, product and
establishment license, registration or authorization of any
Regulatory Authority required for the manufacture, use, storage,
importation, exportation, transport or sale of a Licensed Product
for use in the Field in such country or region.
1.36
“ Regulatory Authority
” means the FDA or any
counterpart of the FDA outside the United States, or other
national, supra-national, regional, state or local regulatory
agency, department, bureau, commission, council or other
governmental entity with authority over the distribution,
importation, exportation, manufacture, production, use, storage,
transport, clinical testing or sale of a Licensed
Product.
1.37
“ Regulatory Filings
” means, collectively: (a) all
INDs, NDAs, establishment license applications, drug master files,
applications for designation as an “Orphan Product”
under the Orphan Drug Act, for “Fast Track” status
under Section 506 of the FDCA (21 U.S.C. § 356) or for a
Special Protocol Assessment under Section 505(b)(4)(B) and (C) of
the FDCA (21 U.S.C. § 355(b)(4)(B)) or all other similar
filings (including CTNs, MAAs and, counterparts of any of the
foregoing in any country or region in the Territory) as may be
required by any Regulatory Authority for the Development or
Commercialization of a Licensed Product in the Territory; (b) all
supplements and amendments to any of the foregoing; and (c) all
data and other information contained in, and correspondence
relating to, any of the foregoing.
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1.38
“ Reportable Event
” means any occurrence in a
patient or subject who is administered a Licensed Product to the
extent attributable to a [***] [***] [***] [***].
1.39
“
Research License Term
” means the
period beginning on the Effective Date and ending on the third
anniversary of the termination or expiration of the Research
Program Term, as such period may be extended pursuant to Section
2.1.2.
1.40
“ Research Program Term
” means the Research Program
Term as defined pursuant to Section 2.1.2 of the Collaboration
Agreement.
1.41
“ Resurfaced Antibody
” means any Antibody Controlled
by sanofi-aventis that is resurfaced by ImmunoGen using the
Licensed Patent Rights and/or Licensed Technology as part of its
conduct of ImmunoGen activities pursuant to Section
2.5.4.
1.42
“ Royalty Term
” means, with respect to each
Licensed Product in each country in the Territory, the period
beginning on the date of First Commercial Sale of such Licensed
Product in such country and continuing until the later of (a) the
expiration of the last to expire Valid Claim in such country within
the Licensed Patent Rights or (b) [***] ([***]) years from the date
of the First Commercial Sale of such Licensed Product in such
country.
1.43
“ sNDA ”
means a
Supplemental New Drug Application, as defined in the FDCA and
applicable regulations promulgated thereunder.
1.44
“ Sublicensee
” means any Third Party (other
than an Affiliate) to which sanofi-aventis grants a license or
sublicense pursuant to Section 2.2.
1.45
“ 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).
1.46
“ Territory
” meansall countries of the
world.
1.47
“ Third Party
” means any Person other than
sanofi-aventis and ImmunoGen and their respective
Affiliates.
1.48
“ Valid Claim
” means any claim of a pending
patent application or an issued unexpired patent within the
Licensed Patent Rights that (a) has not been finally cancelled,
withdrawn, abandoned or rejected by any administrative agency or
other body of competent jurisdiction, (b) has not been permanently
revoked, held invalid, or declared unpatentable or unenforceable in
a decision of a court or other body of competent jurisdiction that
is unappealable or unappealed within the time allowed for appeal,
(c) has not been rendered unenforceable through disclaimer or
otherwise, and (d) is not lost through an interference
proceeding.
7
Additional Definitions
. In addition, each of the
following definitions shall have the respective meanings set forth
in the section of this Agreement indicated below or in the section
of the Collaboration 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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Claims
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9.1
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Collaboration Agreement
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Recitals
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Covered Results
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5.3
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ImmunoGen Indemnitees
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9.2
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Indemnified Party
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9.3
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Indemnifying Party
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9.3
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Infringement
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6.3.1(a)
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Infringement Notice
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6.3.1(a)
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Losses
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9.1
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Research License Term Extension
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2.1.2
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Research License Term Extension Fee
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4.2
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sanofi-aventis Indemnitees
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9.1
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Term
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7.1
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Third Party Payments
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4.5.3
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Withholding Taxes
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4.5.7
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2.
LICENSE GRANTS; TECHNOLOGY
TRANSFER
2.1
License Grants
.
2.1.1
License to
sanofi-aventis . Subject to the other terms
of this Agreement, ImmunoGen hereby grants to sanofi-aventis and
its Affiliates (a) a non-exclusive, royalty-free, license during
the Research License Term, without right to grant sublicenses, to
use Licensed Technology and Licensed Patent Rights with Antibodies
Controlled by sanofi-aventis to Develop Licensed Products in the
Field and in the Territory and (b) a non-exclusive, royalty-bearing
license during the Term, including the right to grant sublicenses
as provided in Section 2.2, under the Licensed Technology and
Licensed Patent Rights, to Develop, have Developed, Commercialize
and have Commercialized Licensed Products in the Field and in the
Territory.
2.1.2
Extension of Research License
Term .
Notwithstanding anything
to the contrary in Section 2.1.1, sanofi-aventis shall have
the right to extend the Research License Term for one or
more additional periods of three (3) years each by
providing ImmunoGen with written notice in accordance with
Section 4.2 at any time on or before expiration of the
then-current Research License Term (each such extension, a
“Research License Term Extension”). The Research
License Term Extension Fee shall be paid as set forth in Section
4.2.
2.2
Right to
Sublicense .
Sanofi-aventis and its Affiliates shall have the right to grant
sublicenses under the license granted to it under Section
2.1.1(b)with respect to any Licensed Product to any Third Party;
provided, that: (a) it shall be a condition of any such sublicense
that such Sublicensee agrees to be bound by all terms of this
Agreement applicable to the
8
Development and
Commercialization of Licensed Products in the Field in the
Territory (including, without limitation, Sections 3.2, 3.3 and
3.4); (b) sanofi-aventis shall provide written notice to ImmunoGen
of any such proposed sublicense at least [***] ([***]) days prior
to such execution and provide redacted copies to ImmunoGen of each
such sublicense within [***] ([***]) days of such execution; (c)
sanofi-aventis shall be deemed to have guaranteed that each such
Sublicensee will fulfill all of sanofi-aventis’ obligations
under this Agreement applicable to the subject matter of such
sublicense; and (d) sanofi-aventis shall not be relieved of its
obligations pursuant to this Agreement as a result of any such
sublicense.
2.3
Retained Rights of
ImmunoGen Subject to the other
terms of this Agreement, ImmunoGen retains the right to use the
Licensed Technology and practice the Licensed Patent Rights (a) to
perform its obligations under this Agreement (including without
limitation its obligation to perform ImmunoGen Activities in
accordance with Section 2.6.4 of this Agreement), (b) to develop,
have developed, make, have made, use, have used, sell, have sold,
offer for sale, import, have imported, export and have exported any
product that is not a Licensed Product, and (c) for any and all
uses outside of the Field.
2.4
No Other Rights
. Sanofi-aventis shall
have no rights to use or otherwise exploit any Technology
Controlled by ImmunoGen except as expressly set forth
herein.
2.5
Technology Transfer; ImmunoGen
Activities .
2.5.1
Transfer of Licensed
Technology .
ImmunoGen shall
(a) as soon as practicable after the Effective Date, transfer to
sanofi-aventis all Licensed Technology (including any protocols)
comprising and/or otherwise applicable to the Licensed Patent
Rights not previously transferred to sanofi-aventis pursuant to the
Collaboration Agreement and necessary for sanofi-aventis to perform
in silico resurfacing as contemplated by this Agreement; and
(b) during the Research License Term, provide updates to
sanofi-aventis of any improvements and/or updates to the Licensed
Technology or Licensed Patent Rights that are Controlled by
ImmunoGen.
2.5.2
Use of Licensed
Technology .
In
connection with the transfer of the Licensed Technology
contemplated by Section 2.5.1, sanofi-aventis hereby agrees that
(a) it shall not use such Licensed Technology for any purpose other
than exercising its rights or performing its obligations hereunder;
(b) it shall use such Licensed Technology only in compliance with
all Applicable Laws; (c) it shall not transfer any such Licensed
Technology to any Third Party without the prior written consent of
ImmunoGen, except as expressly permitted hereby; and (d) except for
the rights expressly set forth herein, sanofi-aventis shall not
acquire any other rights, title or interest in or to such Licensed
Technology as a result of such transfer by ImmunoGen.
2.5.3
Training . ImmunoGen shall use
commercially reasonable efforts to provide sanofi-aventis with such
training as may be reasonably necessary to enable sanofi-aventis to
practice the Licensed Technology and Licensed Patent Rights to
humanize Antibodies through conference calls [***] [***] [***]
[***] to the [***] of sanofi-aventis or its Affiliates in the
United States and Europe. All such training calls [***] [***]
shall be requested in advance
9
in writing by
sanofi-aventis and shall be scheduled by ImmunoGen at times
mutually convenient to the Parties.
2.5.4
Additional Obligations of
ImmunoGen .
Subject to
the other terms of this Agreement (including without limitation
Section 4.3), ImmunoGen shall use commercially reasonable efforts
to conduct such activities in connection with a Resurfaced Antibody
as sanofi-aventis may request in writing at any time during the
Research License Term.
2.6
Compliance
. Sanofi-aventis shall
perform its obligations to Develop Licensed Products in good
scientific manner and in compliance in all material respects with
all Applicable Laws; provided that, with respect to each activity
so performed that will or would reasonably be expected to be
submitted to a Regulatory Authority in support of a Regulatory
Filing or Drug Approval Application, sanofi-aventis shall comply in
all material respects with the regulations and guidance of the FDA
that constitute Good Laboratory Practice or Good Manufacturing
Practice (or, if and as appropriate under the circumstances, or
other comparable regulation and guidance of any applicable
Regulatory Authority in any country or region in the
Territory).
2.7
Manufacture of Licensed Products
for Development .
Sanofi-aventis shall have the sole responsibility and obligation,
at its sole cost and expense, to manufacture all Licensed Products
required for the conduct of Development activities under this
Agreement (including without limitation the conduct of all
necessary Clinical Trials in the Territory) and/or the making of
all Regulatory Filings and obtaining of all Regulatory
Approvals.
3.
DEVELOPMENT AND COMMERCIALIZATION
OF LICENSED PRODUCTS
3.1
Responsibility for Development
and Commercialization . Except for the
activities conducted by ImmunoGen in accordance with Section 2.5.4,
sanofi-aventis shall have the sole right, at its sole expense, for
all aspects of the Development and Commercialization of Licensed
Products in the Field in the Territory, including, without
limitation, the conduct of: (a) all IND-enabling non-clinical
studies; (b) all activities related to human clinical trials; (c)
all activities relating to the manufacture and supply of Licensed
Products (including all required process development and scale up
work with respect thereto); and (d) all pre-marketing, marketing,
promotion, sales, distribution, import and export activities
(including securing reimbursement, sales and marketing and
conducting any post-marketing trials or databases and
post-marketing safety surveillance). Without limiting the
generality of the foregoing, sanofi-aventis shall have the sole
right, at its sole expense, for (i) making all Regulatory Filings
for Licensed Products and filing all Drug Approval Applications and
otherwise seeking all Regulatory Approvals for Licensed Products,
as well as all correspondence and communications with Regulatory
Authorities regarding such matters, and (ii) reporting of all
adverse events to Regulatory Authorities if and to the extent
required by Applicable Laws.
3.2
Diligence . Sanofi-aventis shall use
Commercially Reasonable Efforts in the conduct of all
Commercialization activities it undertakes related to Licensed
Products in the Field in the Territory. For the purpose of
clarity, sanofi-aventis shall have no diligence obligations of any
kind related to the research and Development of Licensed
Products.
10
3.3
Reportable Events
. Sanofi-aventis shall
promptly provide ImmunoGen with all information related to any
Reportable Event as such information is compiled or prepared by
sanofi-aventis in the normal course of business in connection with
the Development and Commercialization of any Licensed Product and,
in any event, within time frames consistent with any reporting
obligations under Applicable Laws.
3.4
Manufacture of Licensed Products
for Commercial Sale . Unless otherwise
agreed to by the Parties, sanofi-aventis shall have the sole
obligation and responsibility, at its sole cost and expense, for
the manufacture of all Licensed Products (including without
limitation the active pharmaceutical ingredient in any Licensed
Product) for commercial sale.
3.5
Product Recalls
. &
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