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Exhibit 10.1
EXECUTION COPY
LICENSE AGREEMENT
This License Agreement (the "Agreement") is made effective as of
April 27, 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.
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.
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1.5.
" 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.
1.6.
" Collaboration Committee " shall
mean the committee with representatives of each Party established
as set forth in Section 3.4.
1.7.
" 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.
1.8.
" Confidential Information " shall
have the meaning set forth in Section 5.1.
1.9.
" 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.
1.10.
" 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 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.
1.11.
" 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
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.
3
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.
1.12.
" Effective Date " shall mean the date
first written above in the introductory paragraph to this
Agreement.
1.13.
" FDA " shall mean the United States
Food and Drug Administration and any successor agency or authority
thereto.
1.14.
" Field " shall mean any and all human
uses.
1.15.
" 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.
1.16.
" [***] Indication " shall mean the
[***] use permitted by the FDA or any Foreign Regulatory Authority
in any Regulatory Approval of a given Licensed Product.
1.17.
" 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.
1.18.
" 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 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.
1.19.
" GENENTECH " shall mean Genentech,
Inc., a Delaware corporation, and its successors and permitted
assigns under this Agreement.
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.
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1.20.
" GLPs " shall mean all good
laboratory practices under Title 21 of the United States Code of
Federal Regulations, as amended from time to time.
1.21.
" GMPs " shall mean all good
manufacturing practices under Title 21 of the United States Code of
Federal Regulations, as amended from time to time.
1.22.
" 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.
1.23.
" 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.
1.24.
" IMMUNOGEN " shall mean ImmunoGen,
Inc., a Massachusetts corporation, and its successors and permitted
assigns under this Agreement.
1.25.
" 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.
1.26.
" 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 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
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.
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(z) the [***] or [***] of any [***] (
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.
1.27.
" 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.
1.28.
" Indemnitees " and "
Indemnifying Party " shall have the meanings set
forth in Section 9.
1.29.
" 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.
1.30.
" 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).
1.31.
" 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.
1.32.
" 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.
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.
6
1.33.
" 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.
1.34.
" 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.
1.35.
" 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);
(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
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.
7
Licensed Product is consumed by the
Sublicensee.
1.36.
" 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.
1.37.
" 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.
1.38.
" 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.
1.39.
" 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 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.
1.40.
" 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.
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.
8
1.41.
" 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.
1.42.
" [***] 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
[***].
1.43.
" 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.
1.44.
" Sublicensee " shall have the meaning
set forth in Section 2.2, and " Material Sublicensee
" shall have the meaning set forth in Section 3.3.
1.45.
" 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 biological,
chemical, pharmacological, toxicological, pre-clinical, clinical,
assay, control and manufacturing data and materials.
1.46.
" [***] " shall mean a protein that
corresponds to Swiss-Prot Primary accession number [***], or any
variant or fragments thereof.
1.47.
" [***] 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.
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.
9
1.48.
" [***] Product " shall mean any
product containing an anti-[***] monoclonal antibody conjugated to
a MAY Compound.
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.
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.
10
(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
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.
11
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 Section
7.2(a) below, but which shall apply in connection with any other
[***] of this Agreement, including by [***] under [***] below),
IMMUNOGEN shall not grant to any Third Party any license or other
right under any Patent Rights or Technology owned or Controlled
by
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.
12
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
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
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
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.
13
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 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
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.
14
(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, 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
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.
15
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 provide all of such technical assistance within
IMMUNOGEN’s area of expertise (or its subcontractors)
concerning the Development and commercialization of Licensed
Products as
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.
16
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
Collaboration Committee, as designated by GENENTECH; provided ,
however , that [***] the [***] after the Effective Date, the
Collaboration Committee shall be [***] by a [***] on the
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.
17
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 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
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.
18
Preclinical Materials by GENENTECH (or its
Material Sublicensee), IMMUNOGEN shall provide GENENTECH (or its
Material Sublicensee) promptly
|