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.
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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
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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.
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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. In the event
that any Regulatory Authority issues or requests a recall or takes similar
action in connection with a Licensed
Product that sanofi-aventis reasonably believes is attributable to or otherwise
relates to the Licensed Technology or Licensed Patent Rights, or in the event a
Party reasonably believes that an event, incident or circumstance has occurred
that may result in the need for such a recall, such Party shall promptly advise
the other Party thereof by telephone or facsimile. Following such notification, sanofi-aventis
shall decide and have control of whether to conduct a recall or market
withdrawal (except in the event of a recall or market withdrawal mandated by a
Regulatory Authority, in which case it shall be required) or to take other
corrective action in any country and the manner in which any such recall,
market withdrawal or corrective action shall be conducted; provided that
sanofi-aventis shall keep ImmunoGen regularly informed regarding any such
recall, market withdrawal or corrective action.
sanofi-aventis shall bear all expenses of any such recall, market
withdrawal or corrective action (including, without limitation, expenses for
notification, destruction and return of the affected Licensed Product and any refund to customers of amounts paid for
such Licensed Product).
4. PAYMENTS
4.1 Upfront Fee. Sanofi-aventis shall pay ImmunoGen an upfront
fee in the amount of One Million Dollars (US $1,000,000), which amount shall be
non-refundable and non-creditable, fifty percent (50%) of which shall be
payable in immediately available funds within thirty (30) days of the Effective
Date and fifty percent (50%) of which shall be payable in immediately available
funds on the date of [***] or [***] of the [***] [***] [***].
4.2 Research
License Term Extension Fee.
Upon the exercise by sanofi-aventis of each [***] ([***]) year Research
License Term Extension as described in Section 2.1.2, sanofi-aventis shall pay
ImmunoGen an extension fee (the “Research License Term Extension Fee”) in the
amount of [***] [***] [***] Dollars (US $[***]) in immediately available funds
within seven (7) days of the start of each such Research License Term
Extension.
4.3 ImmunoGen Activity Payments. In consideration of the conduct by
ImmunoGen of the activities, if any, contemplated by Section 2.5.4, sanofi-aventis
shall pay ImmunoGen [***] [***] [***] Dollars (US $[***]) upon delivery by
ImmunoGen of each Resurfaced Antibody.
ImmunoGen shall provide sanofi-aventis with an invoice promptly upon
delivery to sanofi-aventis of each Resurfaced Antibody and sanofi-aventis shall
pay each such invoice within thirty (30) days of receipt.
11
4.4 Milestone Payments.
4.4.1 Milestones.
Sanofi-aventis shall make the following
nonrefundable, non-creditable milestone payments to ImmunoGen within [***] ([***])
days after the achievement by sanofi-aventis and/or sanofi-aventis’ Affiliates
and Sublicensees of each event for each Licensed Product as set forth below:
|
Milestone Event
|
|
Milestone Payment
|
|
|
[***] of [***]
[***] for a [***] [***]
|
|
$
|
[***]
|
|
|
[***] of [***] [***] [***] [***] for a [***] [***]
|
|
$
|
[***]
|
|
|
[***] of [***]
[***] [***] [***] for a [***] [***]
|
|
$
|
[***]
|
|
|
[***] of [***]
[***] [***] [***] in the [***] [***] for a [***] [***]
|
|
$
|
[***]
|
|
|
[***] of [***]
[***] [***] [***] in [***] [***] or [***] for a [***] [***]
|
|
$
|
[***]
|
|
For purposes of clarity, sanofi-aventis shall make a payment
corresponding to each of the foregoing milestone events for each Licensed Product that achieves such
milestone event; provided, however, that after the last to expire of the
Licensed Patent Rights, any milestone event achieved by sanofi-aventis shall
result in a milestone payment to ImmunoGen in an amount equal to [***] percent
([***]%) of the corresponding milestone payment amount listed above.
4.4.2 Milestone Notices. Sanofi-aventis shall provide ImmunoGen with
prompt written notice upon each occurrence of a milestone event set forth in
Section 4.4.1. In the event that,
notwithstanding the fact that sanofi-aventis has not given such a notice,
ImmunoGen believes any such milestone event has occurred, it shall so notify
sanofi-aventis in writing and shall provide to sanofi-aventis data,
documentation or other information that supports its belief.
4.5 Payment of Royalties; Royalty Rates; Accounting and Records.
4.5.1 Payment of Royalties.
(a) Patent Coverage. For each Licensed Product covered by a Valid Claim in any country in the
Territory in which it is sold, sanofi-aventis shall pay ImmunoGen a royalty
based on Annual Net Sales of such Licensed
Product in each Calendar Year (or partial Calendar Year) commencing with the
First Commercial Sale of such Licensed
Product in such country and ending upon the expiration of the Royalty Term for
such Licensed Product, at the
following rates:
|
Annual Net Sales
|
|
Royalty Rate (%)
|
|
|
Up to and
including $[***] [***]
|
|
[***]
|
%
|
|
Above $[***] [***]
and up to and including $[***] [***]
|
|
[***]
|
%
|
|
Above $[***] [***]
|
|
[***]
|
%
|
12
(b) No
Patent Coverage. For each Licensed
Product that is not covered by a Valid Claim in any country in the Territory in
which it is sold, sanofi-aventis shall pay ImmunoGen a royalty based on Annual
Net Sales of such Licensed Product in each Calendar Year (or partial Calendar
Year) commencing with the First Commercial Sale of such Licensed Product in
such country (including without
limitation the First Commercial Sale following the termination or expiration of
any Valid Claim in such country covering such Licensed Product)and ending on the
expiration of the Royalty Term for such Licensed Product at the following
rates:
|
Annual Net Sales
|
|
Royalty Rate (%)
|
|
|
Up to and including
$[***] [***]
|
|
[***]
|
%
|
|
Above $[***] [***] and
up to and including $[***] [***]
|
|
[***]
|
%
|
|
Above $[***] [***]
|
|
[***]
|
%
|
(c) Applicability
of Royalty Rates. For purposes of clarity, (i) if a Licensed Product is
covered by a Valid Claim in a country within the Territory such that royalties
are paid by sanofi-aventis pursuant to Section 4.5.1(a) and, prior to the [***]
([***]) anniversary of the date of First Commercial Sale of such Licensed
Product in such country, the Licensed Product is no longer covered by a Valid
Claim in such country, sanofi-aventis shall pay ImmunoGen a royalty at the
rates set forth in Section 4.5.1(b) for that portion of the Royalty Term during
which no such Valid Claim exists in such country; and (ii) if a Licensed
Product is not covered by a Valid Claim in a country within the Territory such
that royalties are paid by sanofi-aventis pursuant to Section 4.5.1(b) and,
prior to the [***] ([***]) anniversary of the date of First Commercial Sale of
such Licensed Product, the Licensed Product becomes covered by a Valid Claim in
such country, sanofi-aventis shall pay ImmunoGen a royalty at the rates set
forth in Section 4.5.1(a) for that portion of the Royalty Term during which
such Valid Claim exists in such country.
4.5.2 Royalty
Term. Sanofi-aventis
shall pay the royalties set forth in Section 4.5.1 with respect to each
Licensed Product on a country-by-country and product-by-product basis until
expiration of the Royalty Term with respect thereto. Upon the expiration of the Royalty Term for
each Licensed Product in each country in the Territory, sanofi-aventis shall
have a worldwide, perpetual, fully paid-up license, with the right to
sublicense, under any and all Licensed Patents covering such Licensed Product
to develop, make, have made, use, import, offer for sale, distribute and sell
such Licensed Product in the Field and in such country.
13
4.5.3 Payments
to Third Parties. If,
during any Calendar Quarter, sanofi-aventis actually makes pursuant to a
legally binding obligation any royalty payments to one or more Third Parties in
consideration for a license, in the absence of which sanofi-aventis could not
practice the Licensed Patent Rights to produce a Licensed Product without
infringing an issued patent or patents owned by such Third Party in any country
(collectively, “Third Party Payments”), then sanofi-aventis shall have the
right to reduce the royalties otherwise due to ImmunoGen pursuant to Section
4.5.1 hereof with respect to sales in such country of such Licensed Product in
such Calendar Quarter or any subsequent Calendar Quarter by an amount equal to
up to [***] percent ([***]%) of the amount of such Third Party Payments. Notwithstanding the foregoing, such
reductions shall in no event be greater than the royalties otherwise due to
ImmunoGen pursuant to Section 4.5.1 hereof with respect to the sales of such
Licensed Product in such country by more than [***] percent ([***]%).
4.5.4 Payment
Dates and Reports. Royalty payments shall be made by
sanofi-aventis within [***] ([***]) days after the end of each Calendar Quarter
commencing with the Calendar Quarter in which the First Commercial Sale of a Licensed Product occurs. All payments shall be made by wire transfer
in accordance with instructions given in writing from time to time by
ImmunoGen. Sanofi-aventis shall also
provide, at the same time each such payment is made, a report showing: (a) the Net Sales of each Licensed Product by country in the
Territory;(b) the basis for any
deductions from gross amounts billed or invoiced to determine Net Sales; (c)
the applicable royalty rates for such Licensed
Product; (d) the exchange rates used in calculating any of the foregoing; and
(e) a calculation of the amount of royalty due to ImmunoGen.
4.5.5 Records;
Audit Rights. For a period of [***] ([***]) years,
sanofi-aventis shall keep and maintain, and shall require its respective
Affiliates and Sublicensees to keep and maintain, such accurate and complete
books and records in connection with the sale of Licensed Products hereunder,
as are necessary to allow the accurate calculation consistent with generally
accepted accounting principles of the royalties due to ImmunoGen, including any
records required to calculate any royalty adjustments hereunder. Once per
Calendar Year, ImmunoGen shall have the right to engage an independent certified
public accounting firm of nationally recognized standing and reasonably
acceptable to sanofi-aventis, which shall have the right to examine in
confidence the relevant books and records of sanofi-aventis and its respective
Affiliates and Sublicensees as may be reasonably necessary to determine and/or
verify the amount of royalty payments due hereunder. Such examination
shall be conducted, and sanofi-aventis shall make its records available, during
normal business hours, after at least [***] ([***]) days prior written notice
to sanofi-aventis, as applicable, and shall take place at the facility(ies)
where such records are maintained. Each such examination shall be limited
to pertinent books and records for any year ending not more than [***] ([***])
months prior to the date of request;provided, that, ImmunoGen shall not
be permitted to audit the same period of time more than once. Before
permitting such independent accounting firm to have access to such books and
records, sanofi-aventis may require such independent accounting firm and its
personnel involved in such audit, to sign a confidentiality agreement (in form
and substance reasonably acceptable to each of the Parties) as to any
Confidential Information which is to be provided to such accounting firm or to which
such accounting firm will have access, while conducting the audit under this
paragraph. The ImmunoGen independent accounting firm will prepare and
provide to
14
each Party a written report stating whether
the royalty reports submitted and royalties paid are correct or incorrect and
the specific details concerning any discrepancies. Such accounting firm
may not reveal to ImmunoGen any information learned in the course of such audit
other than the amount of any such discrepancies. ImmunoGen agrees to hold
in strict confidence all information disclosed to it, except to the extent
necessary for ImmunoGen to enforce its rights under this Agreement or if
disclosure is required by law. In the event there was an underpayment by
sanofi-aventis hereunder, sanofi-aventis shall promptly (but in no event later
than [***] ([***]) days after such Party’s receipt of the independent auditor’s
report so correctly concluding) make payment to ImmunoGen of any
shortfall. In the event that there was an overpayment by sanofi-aventis
hereunder, ImmunoGen shall promptly (but in no event later than [***] ([***])
days after ImmunoGen’s receipt of the independent auditor’s report so correctly
concluding) refund to sanofi-aventis the excess amount. ImmunoGen shall
bear the full cost of such audit unless such audit discloses an underreporting
by sanofi-aventis of more than [***] percent ([***]%) of the aggregate amount
of royalties in any twelve (12) month period, in which case, sanofi-aventis
shall reimburse ImmunoGen for all costs incurred by ImmunoGen in connection
with such examination and audit.
4.5.6 Overdue
Payments. All royalty payments not made within the time
period set forth in Section 4.5.4, and all milestone payments not made within
the time period specified in Section 4.4.1, shall bear interest at a rate of
one percent (1%) per month from the due date until paid in full or, if less,
the maximum interest rate permitted by Applicable Laws. Any such overdue royalty or milestone payment
shall, when made, be accompanied by, and credited first to, all interest so
accrued.
4.5.7 Withholding
Taxes. Any payments made by sanofi-aventis to
ImmunoGen under this Agreement shall be free and clear of any taxes, duties,
levies, fees or charges, and such amounts shall be reduced by the amount
required to be paid or withheld pursuant to any applicable law, including, but
not limited to, United States federal, state or local tax law (“Withholding
Taxes”). Any such Withholding Taxes required by law to be paid or
withheld shall be an expense of, and borne solely by, ImmunoGen.
Sanofi-aventis, as applicable, shall submit to ImmunoGen reasonable proof of
payment of the Withholding Taxes, together with an accounting of the
calculations of such taxes, within thirty (30) days after such Withholding
Taxes are remitted to the proper authority. The Parties will cooperate
reasonably in completing and filing documents required under the provisions of
any applicable tax laws or under any other applicable law in connection with
the making of any required tax payment or withholding payment, or in connection
with any claim to a refund of or credit for any such payment.
4.5.8 Foreign Currency
Exchange. With
respect to Net Sales invoiced or expenses incurred in U.S. dollars, the Net
Sales or expense amounts and the amounts due to ImmunoGen hereunder shall be
expressed in U.S. dollars. With respect to Net Sales invoiced or expenses
incurred in a currency other than U.S. dollars, the Net Sales or expense shall
be expressed in the domestic currency of the entity making the sale or
incurring the expense, together with the U.S. dollar equivalent, calculated
using the arithmetic average of the spot rates on the last Business Day of each
month of the Calendar Quarter in which the Net Sales were made or the expense
was incurred. The “closing mid-point rates” found in the “Dollar spot
15
forward against the Dollar” table published
by The Financial Times, or any
other publication as agreed to by the Parties, shall be used as the source of
spot rates to calculate the average as defined in the preceding sentence.
All payments shall be made by wire transfer in U.S. dollars to the credit of
such bank account as shall be designated at least [***] ([***]) business days
in advance by ImmunoGen in writing to sanofi-aventis.
5. TREATMENT OF CONFIDENTIAL INFORMATION;
PUBLICITY
5.1 Confidentiality
5.1.1 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 5.1.2, (a) during the
Research License 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.
5.1.2 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 5.1.3. 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 5.1.1. 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
16
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.
5.1.3 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.
5.2 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 5.1.2. Notwithstanding anything
to the contrary in Section 5.1, 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 5.3) related to the Development or Commercialization
of a Licensed Product without the prior written consent of the other Party;
provided that notwithstanding the foregoing, ImmunoGen shall be expressly
permitted to publicly announce the occurrence of any milestone event under
Section 4.4.1; provided, however, that the text of such announcement shall be
mutually agreed to by the Parties.
5.3 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 published or presented, the results of the Development
or Commercialization of a Licensed Product 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
17
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.
6. FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS
6.1 Patent Filing, Prosecution
and Maintenance. 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.
6.2 Abandonment. If
ImmunoGen decides to abandon or to allow to lapse any of the Licensed Patent
Rights in any country or region in the Territory, ImmunoGen shall inform
sanofi-aventis of such decision promptly and, in any event, so as to provide
sanofi-aventis a reasonable amount of time to meet any applicable deadline to
establish or preserve such Licensed Patent Rights in such country or
region. Sanofi-aventis shall have the
right to assume responsibility for continuing the prosecution of such Licensed
Patent Rights in such country or region and paying any required fees to
maintain such Licensed Patent Rights in such country or region or defending
such Licensed Patent Rights, in each case at sanofi-aventis’s sole expense and
through patent counsel or agents of its choice.
Sanofi-aventis shall not become an assignee of such Licensed Patent
Rights as a result of its assumption of any such responsibility. Upon transfer of ImmunoGen’s responsibility
for prosecuting, maintaining and defending any of the Licensed Patent Rights to
sanofi-aventis under this Section 6.2, ImmunoGen shall promptly deliver to
sanofi-aventis copies of all necessary files related to the Licensed Patent
Rights with respect to which responsibility has been transferred and shall take
all actions and execute all documents reasonably necessary for sanofi-aventis
to assume such prosecution, maintenance and defense.
6.3 Legal
Actions.
6.3.1 Third Party Infringement.
(a) In the event either Party becomes aware of any possible
infringement of, or the submission by any Third Party of an abbreviated new
drug application under the Hatch-Waxman Act that is covered by, any Licensed
Patent Rights that cover a Licensed Product (an “Infringement”), that Party
shall promptly notify the other Party and provide it with all details of such
Infringement of which it is aware (each, an “Infringement Notice”). ImmunoGenshall have the first right and option to
eliminate such Infringement by reasonable steps, which may include the institution of legal proceedings or other
action. All costs, including without
limitation attorneys’ fees, relating to such legal proceedings or other action
shall be borne by ImmunoGen. If ImmunoGen does not take commercially reasonable steps to eliminate
the Infringement within [***] [***] [***] ([***]) days from any Infringement
18
Notice (or [***]-[***] ([***]) days in the case of
an Infringement under the Hatch-Waxman Act), then sanofi-aventis shall have the
right and option to do so at its expense; provided that if ImmunoGen has
commenced negotiations with an alleged infringer for elimination of such
Infringement within such [***]-[***] (or, if applicable [***]-[***]) period,
ImmunoGen shall have an additional [***] ([***]) days (or in the case of an
Infringement under the Hatch-Waxman Act, [***] ([***]) days) to conclude its
negotiations before sanofi-aventis may take steps to eliminate such
Infringement. Neither Party shall settle
any Infringement claim or proceeding under this Section 6.3.1 without the prior
written consent of the other Party, which consent shall not be unreasonably
withheld, conditioned or delayed.
(b) Each Party shall have the right to participate, and be
represented by counsel that it selects, in any legal proceedings or other
action instituted under this Section 6.3.1 by the other Party. If a Party with the right to initiate legal
proceedings under Section 6.3.1 to eliminate an Infringement lacks standing to
do so and the other Party has standing to initiate such legal proceedings, then
the Party with standing shall initiate such legal proceedings at the request
and expense of the other Party.
(c) In any action, suit or proceeding instituted
under this Section 6.3.1, the Parties shall cooperate with and assist each other in all reasonable
respects. Upon the reasonable request of
the Party instituting such action, suit or legal proceeding, the other Party
shall join such action, suit or legal proceeding and shall be represented using
counsel of its own choice, at the requesting Party’s expense.
(d) Any amounts recovered by either Party
pursuant to Section 6.3.1(a), whether by settlement or judgment, shall be allocated in the
following order: (i) first, to reimburse ImmunoGen and sanofi-aventis for their
reasonable out-of-pocket
expenses in making such recovery (which amounts shall be allocated pro rata according to such expenses if insufficient
to cover the totality of such expenses); and (ii) then, one hundred percent
(100%) to ImmunoGen.
6.3.2 Defense of Claims. In the event that any action, suit or
proceeding is brought against either Party or any Affiliate or Sublicensee of
either Party alleging the infringement of the Technology or Patent Rights of a
Third Party by reason of the use by sanofi-aventis of the Licensed Technology
or Licensed Patent Rights to Develop or Commercialize any Licensed Product: (a)[***] shall have the obligation to defend
such action, suit or proceeding at its sole expense; (b) [***] shall have the
right to separate counsel at its own expense in any such action, suit or
proceeding; and (c) the Parties shall cooperate with each other in all
reasonable respects in any such action, suit or proceeding. Each Party shall provide the other Party with
prompt written notice of the commencement of any such suit, action or
proceeding, or of any allegation of infringement of which such Party becomes
aware, and shall promptly furnish the other Party with a copy of each
communication relating to the alleged infringement that is received by such
Party. For purposes of clarity, nothing
in this Section 6.3.2 shall affect the right of ImmunoGen to defend itself in
any action suit or proceeding.
7. TERM AND TERMINATION
7.1 Term. This Agreement shall
commence on the Effective Date and shall continue
19
in full force and effect until the end of the
Research License Term, and, if sanofi-aventis is Developing or Commercializing
a Licensed Product as of the end of the Research License Term, thereafter until
(a) such time as sanofi-aventis is no longer Developing at least one (1)
Licensed Product for use in the Field and in the Territory or (b) if, as of the
time sanofi-aventis is no longer Developing at least one (1) Licensed Product
for use in the Field and in the Territory, the first Commercialization
Regulatory Approval of any Licensed Product has been obtained, then such time
as the Royalty Term for the final Licensed Product has ended, unless earlier
terminated in accordance with the provisions of this Article 7 (the “Term”).
7.2 Termination. This Agreement may be terminated at any time
by either Party as follows:
7.2.1 Termination
for Breach.
Except as set forth herein, either Party may terminate this Agreement,
effective immediately upon written notice to the other Party, for a breach by
the other Party of any material
term of this Agreement that remains uncured [***] ([***]) days ([***] ([***])
days in the event that the breach is a failure of sanofi-aventis to make any
payment required hereunder) after the non-breaching Party first gives written
notice of such breach to the other Party.
Notwithstanding anything to the contrary set forth herein, (a) if the
asserted breach is cured or shown to be non-existent within the applicable cure
period, the notice of breach hereunder shall be deemed automatically withdrawn;
and (b) a material breach by a party shall not give rise to the termination
right under this Section 7.2.1 to the extent such material breach arises from a
Force Majeure event as described in Section 10.11; provided, that the Party breaching
this Agreement shall have the burden of demonstrating the occurrence of a Force
Majeure. Notwithstanding the foregoing,
a Party may not terminate this Agreement pursuant to this Section 7.2.1 at a
time when such Party has committed a breach of a material term of this
Agreement which remains uncured.
7.2.2 Termination
for Insolvency. In the event that either Party files for
protection under bankruptcy laws, makes an assignment for the benefit of
creditors, appoints or suffers appointment of a receiver or trustee over its
property, files a petition under any bankruptcy or insolvency act or has any
such petition filed against it which is not discharged within [***] ([***])
days of the filing thereof, then the other Party may terminate this Agreement
effective immediately upon written notice to such Party. In connection therewith, all rights
and licenses granted under this Agreement are, and shall be deemed to be, for
purposes of Section 365(n) of the United States Bankruptcy Code, licenses
of rights to “intellectual property” as defined under Section 101(56) of
the United States Bankruptcy Code. In
the event that either Party undergoes a voluntary dissolution or winding-up of
its affairs, then the other Party may terminate this Agreement effective immediately
upon written notice to such Party.
7.3 Consequences of Termination of Agreement. In
the event of the termination of this Agreement pursuant to Section 7.2, the
following provisions shall apply, as applicable.
7.3.1 Termination by ImmunoGen under Section 7.2.1. If this Agreement is terminated by
ImmunoGen pursuant to Section 7.2.1:
(a) all of the licenses granted by ImmunoGen to
sanofi-aventis pursuant to Section 2.1.1 shall immediately terminate; and
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(b) each Party shall promptly return or
destroy all Confidential Information of the other Party that are not subject to a
continuing license hereunder; provided that each Party may retain one copy of
the Confidential Information of the
other Party in its archives solely for the purpose of establishing the contents
thereof and ensuring compliance with its obligations hereunder.
7.3.2 Termination by sanofi-aventis Pursuant to Section 7.2.1. If this Agreement is terminated by
sanofi-aventis pursuant to Section 7.2.1:
(a) the license granted by ImmunoGen to
sanofi-aventis pursuant to Section 7.2.1(b) shall survive solely as applied to Licensed Products being Developed or
Commercialized by sanofi-aventis as of the
effective date of termination, subject to sanofi-aventis’s continued payment of
all milestone, royalty and other payments under and in accordance with this
Agreement with respect thereto;
(b) all
other licenses granted by ImmunoGen to sanofi-aventis pursuant to Section 2.1.1
shall immediately terminate; and
(c) each Party shall promptly return or
destroy all Confidential Information of the other Party that are not subject to
a continuing license hereunder; provided that each Party may retain one copy of
the Confidential
Information of the other Party in its archives solely for the purpose of establishing the contents thereof and
ensuring compliance with its obligations hereunder.
7.3.3 Termination
Pursuant to Section 7.2.2.
If this Agreement is terminated by sanofi-aventis or ImmunoGen pursuant to Section 7.2.2,
unless prohibited by Applicable Laws:
(a) the license set forth in Section
7.2.1(b) shall survive solely as applied to Licensed Products being Developed or
Commercialized by sanofi-aventis as of the effective date of termination,
subject to sanofi-aventis’
continued payment of all milestone, royalty and other payments under and in
accordance with this Agreement with respect thereto;
(b) all
other licenses granted by ImmunoGen to sanofi-aventis pursuant to Section 2.1.1
shall immediately terminate; and
(c) each Party shall promptly return all
Confidential Information of the other Party that are not subject to a
continuing license hereunder; provided that each Party may retain one copy of
the Confidential
Information of the other Party in its archives solely for the purpose of
establishing the contents thereof and ensuring compliance with its obligations
hereunder.
7.4 Surviving Provisions.
Termination or expiration of this Agreement for any reason shall be
without prejudice to:
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(a) the
rights and obligations of the Parties provided in Sections 7.4 and Articles 5,
9 and 10 (including all other Sections or Articles referenced in any such Section or Article
and including Article 1), all of which shall survive such termination;
(b) ImmunoGen’s
rights to receive royalties and milestone payments for the duration of any
applicable Royalty Term, if any;
(c) any
other rights or remedies
provided at law or equity which either Party may otherwise have; and
(d) with
respect to expiration of this Agreement, any licenses granted in
accordance with Section 4.5.2 at the expiration of the Royalty Term for each
Licensed Product in each country in the Territory.
8. REPRESENTATIONS AND WARRANTIES
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.
8.1.2 Authorization. The
execution and delivery of this Agreement and the performance by it of the transactions contemplated 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. ImmunoGen has the right
to enforce the Licensed Patent Rights existing as of the Effective Date.
8.2.2 Claims or Judgments. There are no claims, judgment or
settlements
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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 full right, power and authority to grant the licenses
under the Licensed Technology and the Licensed Patent Rights existing as of the Effective Date granted pursuant to
this Agreement. ImmunoGen is the sole
and exclusive owner or the exclusive licensee of the right, title, and interest
in and to the Licensed Technology and the Licensed Patent Rights, free and clear of any liens,
charges or encumbrances, including, without limitation, all patent rights
included therein, and no third party has any right, title or interest in or to
the Licensed Technology and the Licensed Patent Rights.
8.2.4 No Infringement. To ImmunoGen’s knowledge, no Third
Party is infringing, or threatening to infringe,
the Licensed Patent Rights existing as of the Effective Date nor does ImmunoGen
have any knowledge of any patent, patent application or other intellectual
property right of any Third Party which could materially and adversely affect
the ability of sanofi-aventis to exercise or exploit any of the rights or
licenses granted to it pursuant to this Agreement.
8.2.5 No Litigation. There is no pending or, to ImmunoGen’s
knowledge, threatened, litigation
that alleges that the proposed activities of sanofi-aventis under this
Agreement would infringe or misappropriate any intellectual property rights of
any Third Party.
9. INDEMNIFICATION
9.1 Indemnification
of sanofi-aventis by ImmunoGen. ImmunoGen shall indemnify,
defend and hold harmless sanofi-aventis, its Affiliates, their respective
directors, 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,
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without limitation, the production, manufacture, promotion, import,
sale or use by any Person) of any Licensed 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 this Article 9(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 this Article
9, 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 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. All
notices and communications shall be in writing and delivered personally or by
courier or mailed via certified mail, return receipt requested, addressed as
follows, or to such other address as may be designated from time to time:
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If to sanofi-aventis:
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If to ImmunoGen:
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sanofi-aventis
U.S. LLC
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ImmunoGen, Inc.
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1041 Rt. 202-206
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128 Sidney Street
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Bridgewater, NJ
08807
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Cambridge, Massachusetts 02139
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Attn: Head, US
Alliances & Partnerships
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Attn: Chief Executive Officer
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With a copy to:
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With a copy to:
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Head, US R&D
Legal
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Mintz, Levin, Cohn, Ferris, Glovsky
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and Popeo, PC
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One Financial
Center
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Boston,
Massachusetts 02111
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Attention: [***]
[***], Esq.
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Tel: (617)
542-6000
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Fax: (617)
542-2241
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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 10.2.
10.2 Governing Law. This
Agreement shall be governed by and construed in accordance with the laws of the
state of Delaware (USA), without regard to the application of principles of
conflicts of law.
10.3 Binding Effect. This
Agreement shall be binding upon and inure to the benefit of the Parties and
their respective legal representatives, successors and permitted assigns.
10.4 Headings.
Section and subsection headings are inserted for convenience of
reference only and do not form a part of this Agreement.
10.5 Counterparts. This
Agreement may be executed simultaneously in two or more counterparts, each of
which shall be deemed an original and both of which, together, shall constitute
a single agreement.
10.6 Amendment; Waiver. This
Agreement may be amended, modified, superseded or canceled, and any of the
terms of this Agreement may be waived, only by a written instrument executed by
each Party or, in the case of waiver, by the Party or Parties waiving
compliance. The delay or failure of either Party at any time or times to
require performance of any provisions shall in no manner affect the rights at a
later time to enforce the same. No waiver by either Party of any condition or
of the breach of any term contained in this Agreement, whether by conduct, or
otherwise, in any one or more instances, shall be deemed to be, or considered
as, a further or continuing waiver of any such condition or of the breach of
such term or any other term of this Agreement.
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10.7 No Third Party Beneficiaries.
Except as set forth in Sections 9.1 and 9.2, no Third Party (including,
without limitation, employees of either Party) shall have or acquire any rights
by reason of this Agreement.
10.8 Purposes and Scope. The
Parties hereto understand and agree that this License Agreement is limited to
the activities, rights and obligations as set forth in this Agreement. Nothing
in this Agreement shall be construed (a) to create or imply a general
partnership between the Parties, (b) to make either Party the agent of the
other for any purpose, (c) to alter, amend, supersede or vitiate any other
arrangements between the Parties with respect to any subject matters not
covered hereunder, (d) to give either Party the right to bind the other, (e) to
create any duties or obligations between the Parties except as expressly set
forth herein, or (f) to grant any direct or implied licenses or any other right
other than as expressly set forth herein.
10.9 Assignment and Successors.
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.
10.10 Force Majeure.
Neither sanofi-aventis nor ImmunoGen 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 a
Force Majeure. In event of such Force
Majeure, the Party affected shall use reasonable efforts to cure or overcome
the same and resume performance of its obligations hereunder.
10.11 Interpretation. The
Parties hereto acknowledge and agree that: (a) each Party and its counsel
reviewed and negotiated the terms and provisions of this Agreement and have
contributed to its revision; (b) the rule of construction to the effect that
any ambiguities are resolved against the drafting Party shall not be employed
in the interpretation of this Agreement; and (c) unless a context
otherwise requires, wherever used, the singular shall include the plural, the
plural the singular, the use of any gender shall be applicable to all genders
and the word “or” is used in the inclusive sense (and/or).
10.12 Integration; Severability. This
Agreement and the Collaboration Agreement are the entire agreements with
respect to the subject matter hereof and supersede all other agreements and
understandings between the Parties with respect to such subject matter. If any provision of this Agreement is or
becomes invalid or is ruled invalid by any court of competent jurisdiction or
is deemed unenforceable, it is the intention of the Parties that the remainder
of this Agreement shall not be affected.
10.13 Further Assurances. Each
of ImmunoGen and sanofi-aventis agrees to duly execute and deliver, or cause to
be duly executed and delivered, such further instruments and do and cause to be
done such further acts and things, including, without limitation, the filing of
such additional assignments, agreements, documents and instruments, as the
other Party may at any time and from time to time reasonably request in
connection with this Agreement or to carry out
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more effectively the provisions and purposes of, or to better assure
and confirm unto such other Party its rights and remedies under, this Agreement.
[Remainder
of page intentionally left blank.]
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be
executed by their duly authorized representatives.
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IMMUNOGEN, INC.
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By:
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Name:
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Title:
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SANOFI-AVENTIS U.S. LLC
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By:
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Name:
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Title:
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SANOFI-AVENTIS U.S. LLC
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By:
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Name:
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Title:
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