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Exhibit 10.3
EXECUTION COPY
LICENSE AGREEMENT
This License Agreement (the "Agreement") is made effective as of
July 22, 2005 (the "Effective Date") by and between GENENTECH,
INC., a Delaware corporation having its principal business office
at 1 DNA Way, South San Francisco, California 94080 ("GENENTECH"),
and IMMUNOGEN, INC., a Massachusetts corporation with its principal
place of business at 128 Sidney Street, Cambridge, Massachusetts
02139 ("IMMUNOGEN"). GENENTECH and IMMUNOGEN are each
hereafter referred to individually as a "Party" and together as the
"Parties".
WHEREAS, the Parties entered into the Heads of Agreement
(defined below) pursuant to which IMMUNOGEN granted GENENTECH the
right to obtain up to [***] exclusive options at any given time to
obtain an exclusive license to use IMMUNOGEN’s proprietary
maytansinoid conjugation technology with certain proprietary
antibodies of GENENTECH and other binding proteins relating thereto
that bind to any antigen target selected by GENENTECH and
determined by IMMUNOGEN to be available for licensing as described
more fully in the Heads of Agreement; and
WHEREAS, pursuant to the Heads of Agreement, GENENTECH was
granted an Exclusive Target Option (as defined in the Heads of
Agreement) with respect to [***] and has exercised such Exclusive
Target Option pursuant to the terms set forth in the Heads of
Agreement, resulting in the grant of an exclusive license from
IMMUNOGEN to GENENTECH on the terms set forth in the Heads of
Agreement; and
WHEREAS, pursuant to the Heads of Agreement, the Parties have
agreed to enter into an agreement setting forth the detailed terms
of the exclusive license from IMMUNOGEN to GENENTECH.
NOW, THEREFORE, in consideration of the mutual covenants
contained herein, and for other good and valuable consideration,
the receipt and adequacy of which are hereby acknowledged, the
Parties hereby agree as follows:
1. DEFINITIONS
Whenever used in the Agreement with an initial capital letter,
the terms defined in this Section 1 shall have the meanings
specified.
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.
1.1.
" Adverse Event " shall mean any
untoward medical occurrence in a patient or subject who is
administered a Licensed Product, whether or not considered related
to the Licensed Product, including, without limitation, any
undesirable sign (including abnormal laboratory findings of
clinical concern), symptom or disease temporally associated with
the use of such Licensed Product.
1.2.
" Affiliate " shall mean any
corporation, firm, limited liability company, partnership or other
entity which directly or indirectly controls or is controlled by or
is under common control with a Party to this Agreement. For
purposes of this Section 1.2, "control" means ownership, directly
or indirectly through one or more Affiliates, of fifty percent
(50%) or more of the shares of stock entitled to vote for the
election of directors, in the case of a corporation, or fifty
percent (50%) or more of the equity interests in the case of any
other type of legal entity, or status as a general partner in the
case of any partnership, or any other arrangement whereby a Party
controls or has the right to control the Board of Directors or
equivalent governing body or management of a corporation or other
entity.
1.3.
" Agreement " shall mean this
Agreement between the Parties, dated as of the Effective Date,
including any exhibits, schedules or other attachments hereto and
incorporated herein, as any of the foregoing may be validly amended
from time to time. In the event of any inconsistency between
the terms of this Agreement and the terms of any exhibits,
schedules or other attachments incorporated herein, the terms of
this Agreement shall govern unless the Parties expressly agree
otherwise in writing.
1.4.
" Allocable Overhead " shall mean
overhead costs incurred by IMMUNOGEN attributable to
IMMUNOGEN’s supervisory services, occupancy costs, and its
payroll, information systems, human relations, purchasing, accounts
receivable or accounts payable functions which are allocated to
company departments based on space occupied or headcount or another
activity-based method, and shall include the "General
Administrative Fee" as defined hereinbelow. For purposes of
any given calculation of "Allocable Overhead" hereunder, the
"General and Administrative Fee" shall equal [***] percent ([***]%)
of the total amount of Allocable Overhead (as calculated before the
inclusion of any such fee). However, "Allocable Overhead"
shall not include any costs attributable to general corporate
activities, executive management, investor relations, corporate
communications, business development, legal affairs or
finance.
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1.5.
" [***] " shall mean a protein that
corresponds to GenPept Accession Number [***], or any variant or
fragments thereof.
1.6.
" [***] Antibody " shall mean any
monoclonal antibodies Controlled by GENENTECH that bind to [***]
and any other proteins binding to [***], and shall include, without
limitation, any variants (including, without limitation, humanized
versions), fragments (including, without limitation, single-chain
versions) or derivatives of any of the foregoing.
1.7.
" [***] Product " shall mean any
product containing an anti-[***] monoclonal antibody conjugated to
a MAY Compound.
1.8.
" Clinical Materials " shall mean
(a) supplies of ansamitocin P-3, and/or any other MAY Compound as
manufactured in accordance with all applicable GMPs and other legal
requirements and all applicable Specifications for such MAY
Compound for use in human clinical testing, and (b) supplies of any
Licensed Product as manufactured in accordance with all applicable
GMPs and other legal requirements and all applicable Specifications
for such Licensed Product for use in human clinical testing of any
Licensed Product.
1.9.
" Collaboration Committee " shall
mean the committee with representatives of each Party established
as set forth in Section 3.4.
1.10.
" Combination Product " shall mean
any Licensed Product that contains, in addition to any conjugate of
a [***] Antibody with any MAY Compound, one or more other
ingredients that has biologic activity as a therapeutic agent when
present alone.
1.11.
" Confidential Information " shall
have the meaning set forth in Section 5.1.
1.12. " Control " or " Controlled " shall
mean, with respect to any Patent Rights or Technology (including,
without limitation, any MAY Compound, [***] Antibody or other
proprietary biologic material covered under this Agreement), the
possession by a Party of the ability to grant a license or
sublicense of such patent rights, know-how or other intellectual
property and the rights thereto or to supply such compounds or
materials as provided for in this Agreement without violating the
terms of any arrangement or agreement between such Party and any
Third Party.
1.13. " Development " and " Develop "
shall mean, with respect to any Licensed Product, all activities
with respect to such Licensed Product relating to research and
development in connection with seeking, obtaining and/or
maintaining any Regulatory Approval for such Licensed Product in
the Field in the Territory, including without limitation, all
pre-clinical
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research and development activities, all human
clinical studies, all activities relating to developing the ability
to manufacture any Licensed Product or any component thereof
(including, without limitation, process development work), and all
other activities relating to seeking, obtaining and/or maintaining
any Regulatory Approvals from the FDA and/or any Foreign Regulatory
Authority.
1.14. " Drug Approval Application " shall mean any
application for Regulatory Approval (including pricing and
reimbursement approvals) required prior to any commercial sale or
use of a Licensed Product in any country or jurisdiction in the
Territory, including, without limitation, (a) any NDA or MAA filed
with the FDA or any Foreign Regulatory Authority, and (b) any
equivalent application filed with any Foreign Regulatory Authority
for Regulatory Approval (including pricing and reimbursement
approvals) required prior to any commercial sale or use of a
Licensed Product in any country or jurisdiction in the
Territory.
1.15. " Effective Date " shall mean the date first
written above in the introductory paragraph to this
Agreement.
1.16. " FDA " shall mean the United States Food and
Drug Administration and any successor agency or authority
thereto.
1.17. " Field " shall mean any and all human
uses.
1.18. " First Commercial Sale " shall mean the date of
the first commercial sale (other than for purposes of obtaining
Regulatory Approval) of a Licensed Product by or on behalf of
GENENTECH or any Sublicensee.
1.19.
" [***] Indication " shall mean the
[***] use permitted by the FDA or any Foreign Regulatory Authority
in any Regulatory Approval of a given Licensed Product.
1.20. " Foreign Regulatory Authority " shall mean any
applicable supranational, national, federal, state or local
regulatory agency, department, bureau or other governmental entity
of any country or jurisdiction in the Territory (other than the FDA
in the United States), having responsibility in such country or
jurisdiction for any Regulatory Approvals of any kind in such
country or jurisdiction, and any successor agency or authority
thereto.
1.21. " Fully Burdened Manufacturing Cost " shall mean,
with respect to any Preclinical Materials or Clinical Materials
produced by IMMUNOGEN for GENENTECH under this Agreement, the sum
of the following components: (a) the costs of goods produced, as
determined by IMMUNOGEN in accordance with generally accepted
accounting principles in
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the United States, consistently applied,
including, without limitation, direct labor, material and product
testing costs of such Preclinical Materials or Clinical Materials;
(b) any Third Party royalty costs directly allocable to the
manufacture or use of such Preclinical Materials or Clinical
Materials; (c) all Allocable Overhead on the cost of goods under
clause (a) above; and (d) any other costs borne by IMMUNOGEN, for
the transport, customs clearance, duty, insurance and/or storage of
such Preclinical Materials or Clinical Materials.
1.22. " GENENTECH " shall mean Genentech, Inc., a
Delaware corporation, and its successors and permitted assigns
under this Agreement.
1.23. " GLPs " shall mean all good laboratory practices
under Title 21 of the United States Code of Federal Regulations, as
amended from time to time.
1.24. " GMPs " shall mean all good manufacturing
practices under Title 21 of the United States Code of Federal
Regulations, as amended from time to time.
1.25.
" Heads of Agreement " shall mean
the Heads of Agreement, dated May 2, 2000, as amended, whereunder
the Parties agreed upon the terms and conditions for a broader
arrangement relating to the conjugation of a larger array of
antibodies and binding proteins to maytansine derivatives such as
DM1.
1.26.
" HER2 License Agreement " shall
mean that certain License Agreement dated as of May 2, 2000, as
amended May 3, 2006, by and between the Parties with respect to the
use of IMMUNOGEN’s proprietary maytansinoid conjugation
technology with GENENTECH’s Anti-HER2 antibodies and other
HER-2 binding proteins.
1.27. " IMMUNOGEN " shall mean ImmunoGen, Inc., a
Massachusetts corporation, and its successors and permitted assigns
under this Agreement.
1.28. " IMMUNOGEN Field " shall mean any and all uses
other than any use that involves an antibody that
binds to an antigen that is subject to an exclusive license from
IMMUNOGEN under, or arising from, the Heads of Agreement or an
antigen that is subject to an Exclusive Target Option under the
Heads of Agreement, during the period that such exclusive license
or Exclusive Target Option remains in effect.
1.29. " Improvement " shall mean: (a) improvements to
any MAY Compound, (b) improvements to methods of making any
MAY Compound, and (c) improvements to the conjugation process
for making antibody-drug conjugates that include any MAY Compound
(including, for example, reaction conditions or changes in process
that create improvements in
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the yield of such conjugate). "Improvement"
excludes any and all of the following items ("GNE Exclusions"):
(w) any improvement that is specific to any antibody-drug
conjugates that bind to an antigen that is subject to an exclusive
license from IMMUNOGEN under, or arising from, the Heads of
Agreement or is subject to an Exclusive Target Option under the
Heads of Agreement during the period that such exclusive license or
Exclusive Target Option remains in effect; (x) improvements to
[***] [***] [***] or [***] [***], or the [***] of [***] or [***]
[***] of the foregoing; (y) improvements arising out of
GENENTECH [***] or [***] activities (whether or not the associated
[***] is the subject of a license or option to GENENTECH by
IMMUNOGEN); or (z) the [***] or [***] of [***] [***] [***] (
i.e. ,the [***] or [***] of such [***] [***] ( e.g.
,the [***] of [***] or the [***] of [***] to [***]) and [***] the
manner of [***] such [***] [***]) that binds to an antigen that is
subject to an exclusive license from IMMUNOGEN under, or arising
from, the Heads of Agreement or an antigen that is subject to an
Exclusive Target Option under the Heads of Agreement, during the
period that such exclusive license or Exclusive Target Option
remains in effect.
1.30. " IND " shall mean an investigational new drug
application (as defined in Title 21 of the United States Code of
Federal Regulations, as amended from time to time) filed or to be
filed with the FDA with regard to any Licensed Product.
1.31. " Indemnitees " and " Indemnifying
Party " shall have the meanings set forth in Section
9.
1.32. " Licensed Patent Rights " shall mean any and all
Patent Rights in the Field in the Territory which are Controlled by
IMMUNOGEN as of the Effective Date or become Controlled by
IMMUNOGEN during the Term, to the extent that any of the foregoing
is necessary or useful for the Development, manufacture, use,
import, export or sale of any Licensed Product (or any component
thereof) in the Field in the Territory. The Licensed Patent
Rights as of the Effective Date include, without limitation, the
patents and patent applications set forth in the Existing License
Agreement, as updated from time to time.
1.33. " Licensed Product " shall mean any product
containing any conjugate of a [***] Antibody with any MAY Compound,
and shall include, without limitation, any formulation thereof
(including, without limitation, any lyophilized, liquid, sustained
release or aerosolized formulation). "Licensed Product" shall
also include any and all Combination Products (if any).
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1.34. " Licensed Technology " shall mean any and all
Technology which relates to the use of any Licensed Product in the
Field in the Territory which is Controlled by IMMUNOGEN as of the
Effective Date or becomes Controlled by IMMUNOGEN during the Term,
to the extent that any of the foregoing relates to any Licensed
Patent Rights or is necessary or useful for the Development,
manufacture, use, import, export or sale of any Licensed Product in
the Field in the Territory.
1.35. " MAA " shall mean an application filed with the
relevant Foreign Regulatory Authority in Europe seeking Regulatory
Approval to market and sell any Licensed Product in Europe or any
country or territory therein for a particular indication within the
Field.
1.36. " MAY Compound " shall mean any and all
maytansinoid compounds (including, without limitation, maytansine,
ansamitocin P-3 and DM1), whether produced by a botanical source,
natural fermentation or chemical synthesis, and shall include,
without limitation, all variants, fragments or derivatives of any
of the foregoing, in each case owned or otherwise Controlled by
IMMUNOGEN. MAY shall include, without limitation, that
certain maytansine derivative known as "DM1" whose more specific
chemical name is N 2’
-deacetyl-N 2’
-(3-mercapto-1-oxopropyl)-maytansine.
1.37. " NDA " shall mean a new drug application (as
defined in Title 21 of the United States Code of Federal
Regulations, as amended from time to time) filed with the FDA
seeking Regulatory Approval to market and sell any Licensed Product
in the United States for a particular indication within the
Field.
1.38. " Net Sales " shall mean, as to each calendar
quarter during the Term, the gross invoiced sales prices charged
for all Licensed Products sold by GENENTECH or its Sublicensees to
Third Parties throughout the Territory during such calendar
quarter, less the following amounts incurred or paid by GENENTECH
or its Sublicensees during such calendar quarter with respect to
sales of Licensed Products regardless of the calendar quarter in
which such sales were made:
(a)
trade, cash and quantity discounts or rebates
actually allowed or taken, including discounts or rebates to
governmental or managed care organizations;
(b)
credits or allowances actually given or made for
rejection of or return of, and for uncollectible amounts on,
previously sold Licensed Products or for retroactive price
reductions (including Medicare and similar types of
rebates);
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(c)
any charges for insurance, freight, and other
transportation costs directly related to the delivery of Licensed
Product to the extent included in the gross invoiced sales
price;
(d)
any tax, tariff, duty or governmental charge levied
on the sales, transfer, transportation or delivery of a Licensed
Product (including any tax such as a value added or similar tax or
government charge) borne by the seller thereof, other than
franchise or income tax of any kind whatsoever; and
(e)
any import or export duties or their equivalent
borne by the seller. "Net Sales" shall not include sales or
transfers between GENENTECH and its Sublicensees, unless the
Licensed Product is consumed by the Sublicensee.
1.39. " Patent Rights " shall mean the rights and
interests in and to any and all issued patents and pending patent
applications (including inventor’s certificates and utility
models) in any country or jurisdiction in the Territory, including
any and all provisionals, non-provisionals, substitutions,
continuations, continuations-in-part, divisionals and other
continuing applications, supplementary protection certificates,
renewals, and all letters patent on any of the foregoing, and any
and all reissues, reexaminations, extensions, confirmations,
registrations and patents of addition on any of the
foregoing.
1.40. " Phase II Clinical Study " shall mean, as to a
particular Licensed Product for a particular indication, a
controlled and lawful study in humans of the safety, dose ranging
and efficacy of such Licensed Product for such indication, which is
prospectively designed to generate sufficient data (if successful)
to commence a Phase III Clinical Trial of such Licensed Product for
such indication.
1.41.
" Phase III Clinical Trial " shall
mean, 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 an NDA to obtain Regulatory Approval
to market and sell that Licensed Product in the United States for
the indication under investigation in such study.
1.42.
" Phase III Equivalent Decision "
shall mean the date (if any) on which GENENTECH (or its
Sublicensee) decides, based on notification and input from the FDA,
that the data and results generated from the Phase II Clinical
Studies of a Licensed Product for a
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particular indication are sufficient, without any
Phase III Clinical Trial of such Licensed Product for such
indication, to support the filing of an NDA to obtain Regulatory
Approval to market and sell that Licensed Product in the United
States for the indication under investigation.
1.43.
" Preclinical Materials " shall
mean (a) supplies of ansamitocin P-3, DM1 and/or any other MAY
Compound as manufactured in accordance with all applicable legal
requirements and all applicable Specifications for such MAY
Compound for use in preclinical testing, and (b) supplies of any
Licensed Product as manufactured in accordance with all applicable
legal requirements and all applicable Specifications for such
Licensed Product for use in preclinical testing of any Licensed
Product.
1.44. " Regulatory Approval " shall mean any and all
approvals (including pricing and reimbursement approvals), product
and establishment licenses, registrations or authorizations of any
kind of the FDA or any Foreign Regulatory Authority necessary for
the development, pre-clinical and/or human clinical testing,
manufacture, quality testing, supply, use, storage, importation,
export, transport, marketing and sale of a Licensed Product (or any
component thereof) for use in the Field in any country or other
jurisdiction in the Territory. "Regulatory Approval" shall
include, without limitation, any NDA, MAA or other Drug Approval
Application.
1.45.
" [***] Indication " shall mean the
[***] use permitted by the FDA or any Foreign Regulatory Authority
in any Regulatory Approval of a given Licensed Product and with
respect to which GENENTECH has made a [***] [***] [***] based on
[***] [***] that such indication will [***] at least a $[***] [***]
in [***] ([***]) [***] [***] [***] in the [***] [***].
1.46. " Specifications " shall mean any specifications
agreed upon in writing by the Parties relating to the manufacturing
and supply of any MAY Compound and/or Licensed Product
hereunder.
1.47. " Sublicensee " shall have the meaning set forth
in Section 2.2, and " Material Sublicensee " shall
have the meaning set forth in Section 3.3.
1.48. " Technology " shall mean and include any and all
unpatented proprietary ideas, inventions, discoveries, Confidential
Information, biologic materials, data, results, formulae, designs,
specifications, methods, processes, formulations, techniques,
ideas, know-how, technical information (including, without
limitation, structural and functional information), process
information, pre-clinical information, clinical information, and
any and all proprietary
9
biological, chemical, pharmacological,
toxicological, pre-clinical, clinical, assay, control and
manufacturing data and materials.
1.49. " Term " shall mean the period commencing on the
Effective Date and continuing until the expiration or termination
of this Agreement in accordance with the terms hereof (including
Section 7).
1.50. " Territory " shall mean all countries and
jurisdictions of the world.
1.51.
" [***] Indication " shall mean the
[***] use permitted by the FDA or any Foreign Regulatory Authority
in any Regulatory Approval of a given Licensed Product and with
respect to which GENENTECH has made a [***] [***] [***] based on
[***] [***] that such indication will [***] at least [***] [***] in
[***] ([***]) [***] [***] [***] in the [***] [***].
1.52. " Third Party " shall mean any entity other than
GENENTECH, IMMUNOGEN and their respective Affiliates.
1.53. " Third Party Payments " shall have the meaning
set forth in Section 4.2.2.
1.54. " Valid Claim " shall mean a claim in an issued,
unexpired patent within the Licensed Patent Rights that (i) has not
been finally cancelled, withdrawn, abandoned or rejected by any
administrative agency or other body of competent jurisdiction, and
(ii) has not been 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, and (iii) has not been rendered
unenforceable through disclaimer or otherwise, and (iv) is not lost
through an interference proceeding.
2. GRANT OF RIGHTS
2.1.
License Grants .
(a)
License to GENENTECH . IMMUNOGEN
hereby grants to GENENTECH an exclusive (even as to IMMUNOGEN)
royalty-bearing license within the Territory, including the right
to grant sublicenses as described in Section 2.2 below, under the
Licensed Patent Rights and Licensed Technology, to Develop, have
Developed, make, have made, use, have used, sell, have sold, offer
for sale, import, have imported, export and have exported Licensed
Products in the Field in the Territory, subject to the other terms
and conditions of this Agreement.
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(b)
License to IMMUNOGEN . GENENTECH
hereby grants to IMMUNOGEN a non-exclusive, royalty-free license
(i) under GENENTECH’s intellectual property interest in
Improvements, to develop, make, use, sell, offer for sale, import,
and export any product that is not a Licensed Product or a [***]
Product, only within the IMMUNOGEN Field and subject to Section
2.3(b) below and the remaining terms of this Section 2.1(b); and
(ii) also under GENENTECH’s intellectual property interest in
Improvements, to otherwise exploit Improvements for all uses within
the IMMUNOGEN Field, subject to Section 2.3(b) below and the
remaining terms of this Section 2.1(b). The foregoing license
includes the right to sublicense the rights granted under this
Section 2.1(b) only if all of the following three conditions (i),
(ii) and (iii) are met:
(i)
the sublicense is limited to the IMMUNOGEN
Field;
(ii)
the sublicense is granted only in connection with a
license to IMMUNOGEN MAY Technology (where " IMMUNOGEN MAY
Technology " means Technology Controlled by IMMUNOGEN and
used in the conjugation of MAY Compounds to binding proteins), and
the rights granted for IMMUNOGEN MAY Technology are of the same
scope ( e.g. , for the same product or technology and within
the same field and the same territory) as the rights granted for
GENENTECH’s Improvements; and
(iii)
GENENTECH obtains Substantially Similar Grant Back
Rights without incurring an obligation to pay any additional
consideration (either to IMMUNOGEN or to IMMUNOGEN’s
sublicensee). " Substantially Similar Grant Back
Rights " means non-exclusive rights in and to that
sublicensee’s "improvements" (improvements to MAY Compounds,
methods of making MAY Compounds, and methods of making
antibody-drug conjugates) that are of substantially the same scope
( e.g., within the same field and the same territory) as the
rights granted in and to Improvements under this Agreement.
(GENENTECH may obtain such rights directly from IMMUNOGEN’s
sublicensee or indirectly through IMMUNOGEN; if GENENTECH obtains
such rights from IMMUNOGEN, IMMUNOGEN may have obtained such rights
under license or by transfer of ownership).
Nothing in this Agreement or the course of dealings between the
Parties or usage or custom in the industry or trade shall be
construed to confer any other rights or licenses to any other
intellectual property Controlled by either Party or its Affiliates
by implication, estoppel or
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otherwise. GENENTECH has no obligation to
[***] in any [***] [***] or [***] of [***] [***] to [***] or a
[***] of [***] with respect to [***].
2.2
Sublicenses . GENENTECH
shall have the right freely to grant sublicenses to all or any
portion of its rights under the license rights granted pursuant to
Section 2.1(a) hereof to any Affiliate or Third Party (in any case,
a " Sublicensee "); provided , however
, that (a) each such sublicense shall be consistent with the
terms and conditions of this Agreement, and (b) GENENTECH
shall remain obligated to ensure payment of all of its milestone
and royalty obligations as set forth in Section 4 hereof.
2.3
IMMUNOGEN Retained Rights and Covenants;
GENENTECH Technology or Patent Rights .
(a)
Retained Rights . Subject to the
other terms of this Agreement, including, without limitation,
Section 2.3(b) hereof, IMMUNOGEN retains the right to use the
Licensed Technology and practice the Licensed Patent Rights (i) to
perform its work under Sections 3.3, 3.4, 3.5 and 3.6 hereof
relating to the Collaboration Committee and to manufacture and
supply Preclinical Materials and Clinical Materials for GENENTECH
(and its Sublicensees), and (ii) 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 or a [***] Product, subject to Section
2.3(b) below.
(b)
Covenants . It is hereby further
agreed that (i) during the Term of this Agreement, IMMUNOGEN shall
not Develop, have Developed, make, have made, use, have used, sell,
have sold, offer for sale, import, have imported, export and have
exported any [***] Product, which restriction shall be [***] for
[***] [***] [***] [***] [***] of this Agreement if, during a [***]
[***] [***] [***] prior to expiration or termination of this
Agreement, [***] is [***] or [***] with a [***] [***], if [***] is
subject to a [***] of [***], or if this Agreement is [***] pursuant
to [***] [***], and (ii) during the Term of this Agreement, and for
[***] [***] [***] [***] (which [***] [***] [***] [***] shall not
apply in connection with expiration of this Agreement under [***]
[***] below or in connection with [***] [***] of this Agreement by
[***] under [***] [***] below, but which shall apply in connection
with any other [***] [***] of this Agreement, including by [***]
under [***] [***] below), IMMUNOGEN shall not grant to
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any Third Party any license or other right under
any Patent Rights or Technology owned or Controlled by IMMUNOGEN 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.
(c)
No Rights to GENENTECH Technology or Patent
Rights . Except for the license granted to IMMUNOGEN
by GENENTECH in Section 2.1(b) above, nothing in this Section 2.3
or any other provision of this Agreement shall be construed as a
grant to IMMUNOGEN of any license or other rights with respect to
any Technology (including, without limitation, any Confidential
Information) or Patent Rights owned or Controlled (in whole or in
part) by GENENTECH.
3. DEVELOPMENT AND COMMERCIALIZATION
OF LICENSED PRODUCTS .
3.1
Development and Commercialization
.
(a)
Responsibility . On and after the
Effective Date, except as otherwise agreed in writing with respect
to certain process development and manufacturing activities,
GENENTECH shall have full control and authority over, and sole
responsibility for, all Development and commercialization of
Licensed Products in the Field in the Territory, including, without
limitation, (i) all pre-clinical Development activities (including
any pharmaceutical development work on formulations or process
development relating to any Licensed Product), (ii) all activities
related to human clinical trials (including any phase I clinical
studies, any Phase II Clinical Studies or any Phase III Clinical
Trials), (iii) all activities relating to manufacture and supply of
[***] Antibodies, all MAY Compounds (including ansamitocin P-3 and
DM1) and all Licensed Products, solely to the extent such
activities relate to the development and commercialization of
Licensed Products (including all required process development and
scale up work with respect thereto), (iv) all marketing, promotion,
sales, distribution, import and export activities relating to any
Licensed Product (including any post-marketing trials or databases
and post-marketing safety surveillance), and (v) all activities
relating to any regulatory filings, registrations, applications and
Regulatory Approvals relating to any of the foregoing (including
any INDs or foreign equivalents, any manufacturing facility
13
validation and/or licensure, any Drug Approval
Applications and any other Regulatory Approvals). Except as
described in the next sentence, GENENTECH shall own all data,
results and all other information arising from any such activities
under this Agreement, including, without limitation, all regulatory
filings, registrations, applications and Regulatory Approvals
relating to Licensed Products (including any INDs or foreign
equivalents, any Drug Approval Applications and any other
Regulatory Approvals), and all of the foregoing information,
documentation and materials shall be considered Confidential
Information and Technology solely owned by GENENTECH.
IMMUNOGEN shall own all data, results and all other information
arising from IMMUNOGEN’s activities relating to the
manufacture and supply of MAY Compounds (including ansamitocin P-3
and DM1) to GENENTECH, and all of the foregoing information,
documentation and materials shall be considered Confidential
Information and Technology solely owned by IMMUNOGEN. All
activities relating to Development and commercialization under this
Agreement shall be undertaken at GENENTECH’s sole cost and
expense, except as otherwise expressly provided in this
Agreement.
(b)
Due Diligence . GENENTECH will
exercise its commercially reasonable efforts and diligence in
Developing and commercializing Licensed Products in accordance with
its business, legal, medical and scientific judgment, and in
undertaking investigations and actions required to obtain
appropriate Regulatory Approvals necessary to market Licensed
Products in the Field in the Territory, such reasonable efforts and
diligence to be in accordance with the efforts and resources
GENENTECH would use for a compound owned by it or to which it has
rights, which is of similar market potential at a similar stage in
development as the applicable Licensed Product, taking into account
the competitiveness of the marketplace, the proprietary position of
the Licensed Product, the relative potential safety and efficacy of
the Licensed Product, the regulatory requirements involved in its
Development, commercialization and Regulatory Approval,the cost of
goods and availability of capacity to manufacture and supply the
Licensed Product at commercial scale, the profitability of the
applicable Licensed Product, and other relevant factors including,
without limitation, technical, legal, scientific or medical
factors. In the event that GENENTECH fails to use due
diligence as required hereunder, then on a Licensed
Product-by-Licensed Product and country-by-country basis as to the
Licensed Product in the country in which GENENTECH has failed to
use due diligence as required
14
hereunder, IMMUNOGEN’s exclusive remedy
shall be, in its sole discretion (i) to terminate the licenses
granted under Section 2.1 this Agreement for breach under Section
7.2(a) below (including the notice and cure provisions therein) or
(ii) to convert the licenses granted under Section 2.1 of this
Agreement from exclusive licenses to non-exclusive licenses, in
either case only as such licenses apply to such Licensed Product in
such country, which termination or conversion, as the case may be,
shall be effective upon expiration of the cure period specified in
7.2(a) below provided that such failure remains uncured upon such
expiration.
3.2
Updates and Reports; Exchanges of Adverse
Event Information .
(a)
Updates and Reports . GENENTECH
shall keep IMMUNOGEN informed of the progress of GENENTECH’s
efforts to Develop and commercialize Licensed Products in the Field
in the Territory as provided in this Section 3.2(a).
GENENTECH (or its Sublicensee) shall provide IMMUNOGEN with brief
written reports as provided herein no less frequently than on each
anniversary of the Effective Date during the Term (commencing with
the first anniversary of the Effective Date). Such reports
shall summarize GENENTECH’s material efforts to Develop and
commercialize all Licensed Products hereunder, identify the Drug
Approval Applications with respect to any Licensed Product that
GENENTECH and its Sublicensees have filed, sought or obtained in
the prior twelve (12)-month period, and any they reasonably expect
to make, seek or attempt to obtain in the following twelve
(12)-month period. In addition, GENENTECH (or its
Sublicensee) shall provide IMMUNOGEN with prompt written notice of
the occurrence of any event giving rise to an obligation to make a
milestone payment to IMMUNOGEN under Section 4.1, and shall provide
IMMUNOGEN with prompt written notice of the occurrence of the First
Commercial Sale of any particular Licensed Product. All such
reports and notices shall be sent to the attention of
IMMUNOGEN’s designated representative, who shall be its Chief
Executive Officer unless IMMUNOGEN otherwise notifies
GENENTECH.
(b)
Adverse Events . In addition to such
reports, GENENTECH agrees to provide IMMUNOGEN with Adverse Event
information and product complaint information relating to Licensed
Products (but not relating to any other products of GENENTECH,
including any antibody that may be included in a Licensed Product,
to the extent that antibody is used in its "naked" form or in
connection with a different effector molecule) as compiled and
prepared by GENENTECH in the normal course of business in
connection with the Development,
15
commercialization or sale of any Licensed
Product, within time frames consistent with reporting obligations
under applicable laws and regulations. To the extent it could
reasonably apply or could reasonably be relevant to a Licensed
Product, IMMUNOGEN agrees to provide GENENTECH with Adverse Event
and product complaint information relating to any product
containing any MAY Compound that is compiled and prepared by
IMMUNOGEN or any Third Party in the normal course of business in
connection with the development, commercialization or sale of any
such product, within time frames consistent with reporting
obligations under applicable laws and regulations; provided
, however , that the foregoing shall not require IMMUNOGEN
to violate any agreements with or confidentiality obligations owed
to any Third Party. GENENTECH shall provide its Adverse Event
and product complaint information hereunder to IMMUNOGEN’s
designated representative, who shall be its Chief Regulatory
Officer unless IMMUNOGEN otherwise notifies GENENTECH. IMMUNOGEN
shall provide its Adverse Event and product complaint information
hereunder to GENENTECH’s designated representative, who shall
be the head of its Drug Safety group in GENENTECH’S Medical
Affairs Department unless GENENTECH otherwise notifies
IMMUNOGEN.
(c)
Confidential Information . All
reports, updates, Adverse Event, product complaint and other
information provided by one Party to the other Party under this
Agreement (including under this Section 3), shall be considered
Confidential Information of the disclosing Party, subject to the
terms of Section 5.
3.3
Reasonable Assistance by IMMUNOGEN
. In connection with the exclusive grant of rights to
GENENTECH under Section 2.1 above, and subject to the other terms
of this Agreement, IMMUNOGEN shall provide GENENTECH (and any
Sublicensee of GENENTECH with respect to all of GENENTECH’s
license rights hereunder to make or have made all Licensed Products
or any particular Licensed Product(s) throughout the Territory or
in a particular geographic region of the Territory, and/or all of
GENENTECH’s license rights hereunder to Develop or
commercialize all Licensed Products or any particular Licensed
Product(s) throughout the Territory or in a particular geographic
region of the Territory (in any case, a " Material
Sublicensee ")) such information and materials comprising the
Licensed Technology and/or Licensed Patent Rights as GENENTECH (or
its Material Sublicensee) may reasonably request. Without
limiting the generality of the foregoing, IMMUNOGEN shall
16
provide all of such technical assistance within
IMMUNOGEN’s area of expertise (or its subcontractors)
concerning the Development and commercialization of Licensed
Products as may be reasonably requested by GENENTECH (or its
Material Sublicensee) from time to time during the Term, provided
that such technical assistance and expertise is within the scope of
the Licensed Technology and/or Licensed Patent Rights covered under
this Agreement. Such technical assistance and expertise shall
include, but not be limited to, visits by IMMUNOGEN personnel to
GENENTECH and visits by GENENTECH to IMMUNOGEN (or its
subcontractors), at GENENTECH’s expense, at such times and
for such periods of time as may be reasonably acceptable to the
Parties. Without limiting the generality of the
foregoing, within [***] ([***]) days after GENENTECH’s
reasonable written request, IMMUNOGEN shall deliver to GENENTECH a
list or description of the documents and information that embody
the Licensed Technology. GENENTECH will inform IMMUNOGEN
which of those identified documents and information GENENTECH
believes are reasonably related to its exercise of the license
rights under this Agreement and, within [***] ([***]) days after
that identification, IMMUNOGEN shall deliver to GENENTECH a copy of
those documents and other information.
3.4
Collaboration Committee .
(a)
Mandate of Committee . Promptly
after the Effective Date, the Parties shall form a "
Collaboration Committee " to serve as a forum for
coordination and communication between the Parties with respect to
activities related to Licensed Products for which the Parties agree
there is a need for coordination and communication (including,
without limitation, all process science and process development
work, formulation work, and quality control/ assurance work
hereunder), and to assist GENENTECH in its exercise of its rights
to make or have made Licensed Products under this Agreement.
Within [***] ([***]) days after the Effective Date, the Parties
shall each nominate an equal number of representatives (which shall
be no less than two (2) each) for membership on the Collaboration
Committee. Each Party may change its representative(s) as it
deems appropriate by notice to the other Party. The input of
the IMMUNOGEN representatives on the Collaboration Committee shall
be fully considered by the Collaboration Committee; provided
, however , that all decisions of the Collaboration
Committee shall be subject to final approval by GENENTECH.
(b)
Chair of Committee; Meetings . The
Parties hereby agree that (i) the chair of the Collaboration
Committee shall be one of the GENENTECH representatives on
the
17
Collaboration Committee, as designated by
GENENTECH; provided , however , that [***] the [***]
[***] [***] [***] after the Effective Date, the Collaboration
Committee shall be [***] by a [***] [***] on the Collaboration
Committee (as designated by [***]) and an [***] [***] on the
Collaboration Committee (as designated by [***]); (ii) all
decisions of the Collaboration Committee shall be subject to the
approval of the GENENTECH chair (including [***] the [***] [***]
there is a [***] [***] [***]); (iii) the Collaboration Committee
shall meet on a semi-annual basis or other schedule agreed upon by
the Parties, unless at least thirty (30) days in advance of any
meeting the chair (or co-chairs during the first twelve (12)
months) of the Collaboration Committee determine that there is no
need for a meeting (in which instance, the next Collaboration
Committee meeting shall also be scheduled as agreed upon by the
Parties); (iv) the location of meetings of the Collaboration
Committee shall alternate between IMMUNOGEN’s offices in
Massachusetts and GENENTECH’s offices in California, unless
otherwise agreed by the Parties and, as agreed upon by the Parties,
Collaboration Committee meetings may be face-to-face or may be
conducted through teleconferences and/or videoconferences. In
addition to its Collaboration Committee representatives, each Party
shall be entitled to have other employees attend such meetings to
present and participate, though not in a decision-making
capacity. Each Party shall bear all costs and expenses,
including travel and lodging expense, that may be incurred by its
Collaboration Committee representatives or other of its attendees
at Collaboration Committee meetings, as a result of such meetings
hereunder. Minutes of each Collaboration Committee meeting
will be transcribed and issued to members of the Collaboration
Committee by the chair (or the GENENTECH co-chair, as the case may
be) within thirty (30) days after each meeting, and such minutes
shall be reviewed and modified as mutually required to obtain
approval of such minutes promptly thereafter.
3.5
Supply of Preclinical Materials
. During the Term of this Agreement, IMMUNOGEN shall supply
to GENENTECH (or its Material Sublicensee) with such quantities of
Preclinical Materials as may be reasonably requested by GENENTECH
(or its Material Sublicensee) in order to conduct all pre-clinical
Development activities relating to Licensed Products.
GENENTECH (or its Material Sublicensee) shall order all amounts of
Preclinical Materials, and IMMUNOGEN shall deliver all such ordered
amounts, in accordance with advance ordering timeframes and
delivery timeframes to be agreed upon by the Parties through the
Collaboration Committee. IMMUNOGEN shall use its commercially
reasonable efforts to
18
deliver such amounts of Preclinical Materials
ordered in accordance with the foregoing (including such agreed
upon timeframes) in a timely manner. In connection with any
ordering of Preclinical Materials by GENENTECH (or its Material
Sublicensee), IMMUNOGEN shall provide GENENTECH (or its
Materi
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