|
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
| |
|
|
Page
|
|
|
|
|
|
1.
|
DEFINITIONS
|
1
|
|
|
|
|
|
|
2.
|
LICENSE GRANTS; TECHNOLOGY TRANSFER
|
8
|
|
|
|
|
|
|
|
2.1
|
License Grants
|
8
|
|
|
2.2
|
Right to Sublicense
|
8
|
|
|
2.3
|
Retained Rights of ImmunoGen
|
9
|
|
|
2.4
|
No Other Rights
|
9
|
|
|
2.5
|
Technology Transfer; ImmunoGen
Activities
|
9
|
|
|
2.6
|
Compliance
|
10
|
|
|
2.7
|
Manufacture of Licensed Products for
Development
|
10
|
|
|
|
|
|
|
3.
|
DEVELOPMENT AND COMMERCIALIZATION OF LICENSED
PRODUCTS
|
10
|
|
|
|
|
|
|
|
3.1
|
Responsibility for Development and
Commercialization
|
10
|
|
|
3.2
|
Diligence
|
10
|
|
|
3.3
|
Reportable Events
|
10
|
|
|
3.4
|
Manufacture of Licensed Products for Commercial
Sale
|
11
|
|
|
3.5
|
Product Recalls
|
11
|
|
|
4.
|
PAYMENTS
|
11
|
|
|
4.1
|
Upfront Fee
|
11
|
|
|
4.2
|
Research License Term Extension Fee
|
11
|
|
|
4.3
|
ImmunoGen Activity Payments
|
11
|
|
|
4.4
|
Milestone Payments
|
11
|
|
|
4.5
|
Payment of Royalties; Royalty Rates; Accounting
and Records
|
12
|
|
|
|
|
|
|
5.
|
TREATMENT OF CONFIDENTIAL INFORMATION;
|
16
|
|
|
|
|
|
|
PUBLICITY
|
16
|
|
|
5.1
|
Confidentiality
|
16
|
|
|
5.2
|
Publicity
|
17
|
|
|
5.3
|
Publications and Presentations
|
17
|
|
|
|
|
|
|
6.
|
FILING, PROSECUTION AND MAINTENANCE OF PATENT
RIGHTS
|
18
|
|
|
|
|
|
|
|
6.1
|
Patent Filing, Prosecution and
Maintenance
|
18
|
|
|
6.2
|
Abandonment
|
18
|
|
|
6.3
|
Legal Actions
|
18
|
|
|
|
|
|
|
7.
|
TERM AND TERMINATION
|
19
|
|
|
|
|
|
|
|
7.1
|
Term
|
19
|
|
|
7.2
|
Termination
|
20
|
|
|
7.3
|
Consequences of Termination of
Agreement
|
20
|
|
|
7.4
|
Surviving Provisions
|
21
|
i
|
8.
|
REPRESENTATIONS AND WARRANTIES
|
22
|
|
|
|
|
|
|
|
8.1
|
Mutual Representations and Warranties
|
22
|
|
|
8.2
|
Additional Representations of
ImmunoGen
|
22
|
|
|
|
|
|
|
9.
|
INDEMNIFICATION
|
23
|
|
|
|
|
|
|
|
9.1
|
Indemnification of sanofi-aventis by
ImmunoGen
|
23
|
|
|
9.2
|
Indemnification of ImmunoGen by
sanofi-aventis
|
23
|
|
|
9.3
|
Conditions to Indemnification
|
23
|
|
|
9.4
|
Warranty Disclaimer
|
24
|
|
|
9.5
|
Limited Liability
|
24
|
|
|
|
|
|
|
10.
|
MISCELLANEOUS
|
24
|
|
|
|
|
|
|
|
10.1
|
Notices
|
24
|
|
|
10.2
|
Governing Law
|
25
|
|
|
10.3
|
Binding Effect
|
25
|
|
|
10.4
|
Headings
|
25
|
|
|
10.5
|
Counterparts
|
25
|
|
|
10.6
|
Amendment; Waiver
|
25
|
|
|
10.7
|
No Third Party Beneficiaries
|
25
|
|
|
10.8
|
Purposes and Scope
|
25
|
|
|
10.9
|
Assignment and Successors
|
26
|
|
|
10.10
|
Force Majeure
|
26
|
|
|
10.11
|
Interpretation
|
26
|
|
|
10.12
|
Integration; Severability
|
26
|
|
|
10.13
|
Further Assurances
|
26
|
|
|
|
|
|
|
Schedules
|
|
|
|
|
|
|
|
|
Schedule 1
|
Licensed Patent Rights
|
|
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.
2
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.
3
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,
4
(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
5
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.
6
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:
|
Definition
|
|
Section
|
|
|
|
|
|
Agreement
|
|
Recitals
|
|
Claims
|
|
9.1
|
|
Collaboration Agreement
|
|
Recitals
|
|
Covered Results
|
|
5.3
|
|
ImmunoGen Indemnitees
|
|
9.2
|
|
Indemnified Party
|
|
9.3
|
|
Indemnifying Party
|
|
9.3
|
|
Infringement
|
|
6.3.1(a)
|
|
Infringement Notice
|
|
6.3.1(a)
|
|
Losses
|
|
9.1
|
|
Research License Term Extension
|
|
2.1.2
|
|
Research License Term Extension Fee
|
|
4.2
|
|
sanofi-aventis Indemnitees
|
|
9.1
|
|
Term
|
|
7.1
|
|
Third Party Payments
|
|
4.5.3
|
|
Withholding Taxes
|
|
4.5.7
|
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 . 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 P
|