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
8
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
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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
