Exhibit 10.1
DEVELOPMENT AND LICENSE
AGREEMENT
This Development
and License Agreement (this “Agreement”) is made
effective as of October 1, 2004 (the “Effective Date”)
by and between Biogen Idec MA Inc., a Massachusetts corporation
with its principal place of business at 14 Cambridge Center,
Cambridge, Massachusetts 02142 (“Biogen Idec”), and
ImmunoGen, Inc., a Massachusetts corporation with its principal
place of business at 128 Sidney Street, Cambridge, Massachusetts
02139 (“ImmunoGen”). Biogen Idec and ImmunoGen
are sometimes each hereinafter referred to individually as a
“Party” and collectively as the
“Parties”.
WHEREAS, Biogen
Idec is the owner of or otherwise controls certain rights in
proprietary technology and know-how relating to certain
[***] Antibodies (as
defined below); and
WHEREAS, ImmunoGen
is the owner of or otherwise controls certain rights in proprietary
technology and know-how relating to or otherwise useful in the
conjugation of maytansine derivatives to binding proteins;
and
WHEREAS, pursuant
to the terms and conditions set forth herein, Biogen Idec desires
to obtain from ImmunoGen, and ImmunoGen desires to grant to Biogen
Idec, a license under certain of ImmunoGen’s technology
and/or intellectual property rights to develop and commercialize
one or more Licensed Products (as defined below).
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.
1.1.
“ Adverse Drug
Experience ” is defined in 21 CFR 310.305, 21
CFR 314.80, and 21 CFR 600.80, as amended, or any replacements
thereof.
CONFIDENTIAL
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 investment under Rule 24b-2
under the Securities Exchange Act of 1934.
1
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 Development and License 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, unless the Parties expressly agree otherwise
in writing, the terms of this Agreement shall govern.
1.4.
“ Antibody ” shall mean a
composition comprising a whole antibody or fragment thereof
(whether polyclonal or monoclonal, multiple or single chain,
recombinant, transgenic animal derived or naturally occurring, and
any constructs thereof) or having been derived from nucleotide
sequences encoding, or amino acid sequences of, such an antibody or
fragment.
1.5.
“[******************]” shall mean any Program
Technology that is a structural modification, formulation, method
of use, administration or delivery of an [***] [***] or other [***] not [***] to a [***] [***********] .
1.6.
“ [***]
Antibody
” shall mean any Antibody that is Controlled by Biogen Idec
and that binds with a protein encoded by any gene within the
[***] Gene
Family.
1.7.
“ Biogen Idec
Background Technology ” means any Technology
used by Biogen Idec, or provided by Biogen Idec for use, in the
Research Program that is useful in the Field and that is (a)
Controlled by Biogen Idec as of the Effective Date or (b)
Controlled by Biogen Idec and developed or conceived by employees
of, or consultants to, Biogen Idec on and after the Effective Date
in the conduct of activities outside the Research Program and
without the use of any Licensed Technology, Licensed Patent Rights
or Joint Program Technology.
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
2
1.8.
“ Biogen Idec Patent
Rights ” shall mean all Patent Rights with
respect to Biogen Idec Background Technology.
1.9.
“ Biogen Idec Program
Technology ” shall mean any Program Technology
made solely by employees of, or agents or others obligated to
assign inventions to, Biogen Idec or a Biogen Idec Affiliate.
1.10.
“ BLA ” shall mean a biologics license
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.
1.11.
“ Clinical
Materials ” shall mean any MAY Compound and/or
[*****] -MAY
Conjugates supplied by ImmunoGen to Biogen Idec pursuant to
Section 4.3 and/or the Supply Agreement for use in human
clinical testing.
1.12.
“ Collaboration
Co mmittee ” shall mean the
committee with representatives of each Party established as set
forth in Section 3.4.
1.13.
“ Combination
Product ” shall mean a product containing both
a Licensed Product and one or more other active ingredients in
addition to the Licensed Product that are not covered by the
Licensed Patent Rights or do not incorporate Licensed Technology
where the other active ingredients have independent, additive or
synergistic diagnostic, prophylactic or therapeutic effect in the
disease or indication for which the Combination Product is labeled,
whether the Licensed Product and the other active ingredients are
together in a physical mixture or packaged and priced together as a
single product.
1.14.
“ Commercialization ” or
“ Commercialize ” shall mean
any and all activities constituting importing, marketing,
distributing, offering for sale, selling, making, having made,
exporting, having exported and supporting the Licensed Product in
the Territory for use in the Field. Commercialization shall
include, but not be limited to, promotion as well as post-approval
clinical trial and regulatory activities, including Adverse Drug
Experience reporting. When used as a verb, Commercialize
shall mean to engage in Commercialization.
1.15.
“ Confidential
Information ” shall mean, with respect to a
Party (the “receiving Party”), all information which is
disclosed by the other Party (the “disclosing Party”)
to the receiving Party hereunder or to any of its employees,
consultants, Affiliates or Sublicensees,
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
3
except to the extent
that the receiving Party can demonstrate by written record or other
suitable physical evidence that such information, (a) prior to
the disclosure is demonstrably known to the receiving Party or its
Affiliates other than by virtue of a prior confidential disclosure
to such Party or its Affiliates; (b) as of the date of
disclosure is in, or subsequently enters, the public domain,
through no fault or omission of the receiving Party; (c) is
obtained from a Third Party having a lawful right to make such
disclosure free from any obligation of confidentiality to the
disclosing Party; or (d) is independently developed by or for
the receiving Party without reference to or reliance upon any
Confidential Information of the Disclosing Party. For
purposes of clarity, subject to the exceptions in the preceding
sentence or as otherwise set forth in this Agreement, (a) any
technical or financial information of a disclosing Party disclosed
at any meeting of the Collaboration Committee, or disclosed through
an audit or other report shall constitute Confidential Information
of such disclosing Party, (b) the terms of this Agreement, to the
extent not disclosed in a public filing or press release permitted
under Section 6 of this Agreement, shall constitute Confidential
Information of each Party unless otherwise specified, (c) all
know-how and trade secrets disclosed by ImmunoGen to Biogen Idec in
connection with the licenses set forth in Section 2.1 of this
Agreement shall constitute Confidential Information of ImmunoGen,
and (d) all know-how and trade secrets disclosed by Biogen Idec to
ImmunoGen in connection with the license set forth in
Section 2 of this Agreement shall constitute Confidential
Information of Biogen Idec.
1.16.
“ Consumer Price Index
or CPI” shall mean the CPI for All Urban
Consumers published from time to time by the Bureau of Labor
Statistics of the United States Department of Labor.
1.17.
“ Contract
Year ” shall mean the period beginning on the
Effective Date and ending on December 31, 2004 and each succeeding
calendar year thereafter during the Term.
1.18.
“ Control ” or “
Controlled
” shall mean, with respect to any Patent Rights Technology or
Proprietary Materials (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 (other than by rights granted in this
Agreement) of such Patent Rights or Technology and the rights
thereto or to supply such
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
4
Proprietary Materials
as provided for in this Agreement without violating the terms of
any arrangement or agreement between such Party or its Affiliates
and any Third Party.
1.19.
“ Cost
” shall mean, with respect to any Preclinical Materials or
Clinical Materials manufactured and QC tested by ImmunoGen,
ImmunoGen’s fully-burdened costs (including the costs
associated with product testing and release activities) of
producing and packaging such Preclinical or Clinical Materials,
including the sum of the following components: (a) direct
costs, including (1) materials directly used in producing and
packaging such Preclinical Materials or Clinical Materials and (2)
with respect to any Preclinical Materials or Clinical Materials
obtained by ImmunoGen from a Third Party and supplied to Biogen
Idec without modification, the amount paid by ImmunoGen to such
Third Party for the same; (b) an allocation of manufacturing
overhead costs, including manufacturing and quality labor and
manufacturing and quality supervisory services, operating and
administrative costs of the manufacturing and quality departments
and occupancy costs which are allocable to company departments
based on space occupied or headcount, or another activity-based
method; (c) any other reasonable out-of-pocket costs borne by
ImmunoGen for the testing, transport, customs clearance, duty,
insurance and/or storage of such Preclinical Materials or Clinical
Materials; and (d) ImmunoGen’s general and administrative
costs, including purchasing, human resources, payroll, information
system and accounting, which are allocable to its departments based
on space occupied or headcount or another activity-based method,
according to GAAP. Manufacturing overhead costs under the
foregoing clause (b) and administrative costs under the foregoing
clause (d) are allocable to each batch of Preclinical Material
and/or Clinical Material produced based upon the [***] of [***] , or any portion of a
[***] , that a
manufacturing [***]
is [***] to the
[***] (including
[******] and
[********] ) of
[***] -MAY Conjugate
at ImmunoGen’s facilities. Notwithstanding the
foregoing, Cost shall not include the cost of purchasing any
Dedicated Equipment pursuant to Section 4.4 of this
Agreement.
1.20.
“ [***] Gene
Family ” shall mean the family of human
[***] genes that
encode the proteins known as, [*****] or [**************************] (
[***] )
[***] , the
polypeptide sequences which are set forth on Schedule C
attached hereto, any polynucleotide encoding an amino acid sequence
at least [***] %
identical to the aforementioned polypeptide sequences.
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
5
1.21.
“ [***] -MAY
Conjugate ” shall mean any conjugate of an
[***] Antibody with a
MAY Compound.
1.22.
“ Dedicated
Equipment ” shall mean any equipment,
instrument or machinery used by ImmunoGen exclusively in the
manufacturing of Preclinical Materials or Clinical Materials.
1.23.
“ 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,
test method development and stability testing, toxicology,
formulation, process development, manufacturing scale-up,
development-stage manufacturing, quality assurance/quality control
development and performance, 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 and Adverse Drug Experience
reporting.
1.24.
“ 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 BLA, NDA or other regulatory application filed
with the FDA prior to any commercial sale or use of a Licensed
Product in the United States, and (b) any MAA or other equivalent
regulatory 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 other country or jurisdiction in the
Territory.
1.25.
“ Effective
Date ” shall mean the date first written above
in the introductory paragraph to this Agreement.
1.26.
“ EMEA
” shall mean the European Medicines Agency and any successor
agency or authority thereto.
1.27.
“ FDA
” shall mean the United States Food and Drug Administration
and any successor agency or authority thereto.
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
6
1.28.
“ Field
” shall mean all human therapeutic, diagnostic and
prophylactic uses.
1.29.
“ First Commercial
Sale ” shall mean the date of the first
commercial transfer or disposition to a Third Party of a Licensed
Product by or on behalf of Biogen Idec or any Affiliate or
Sublicensee of Biogen Idec.
1.30.
“ Foreign Regulatory
Authority ” shall mean the EMEA and any other
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.
1.31.
“ Full Time
Equivalent ” or “ FTE ” shall mean the
equivalent of one person-year of work on the Research Program,
consisting of [*****]
or [*************] ,
and which is carried out by employees, contractors or agents of
ImmunoGen having the appropriate scientific expertise to conduct
such activities. For the purposes of this Agreement,
[***] person
[***] be
[***] as
[***] than
[***] [***] in any given year.
1.32.
“ FTE
Cost ” shall mean, for any period during the
Term of this Agreement, the FTE Rate multiplied by the number of
FTEs expended over such period.
1.33.
“ FTE
Rate ” shall mean, for the [***] [***] [***] Contract Year commencing on
the Effective Date, [***] ; and, for each Contract Year
thereafter, the result obtained by multiplying [***] by the sum of (1+CPI) where
CPI is a fraction, the numerator of which is the difference between
the Consumer Price Index as of the last month of the immediately
preceding Contract Year and the Consumer Price Index as of the
month immediately preceding the Effective Date and the denominator
of which is the Consumer Price Index as of the month immediately
preceding the Effective Date.
1.34.
“ GMPs
” shall mean all good manufacturing practices under Title 21
of the United States Code of Federal Regulations, as amended from
time to time.
1.35.
“ Gross
Sales ” shall mean the gross amount invoiced
by Biogen Idec or its Affiliates or Sublicensees for sales of a
Licensed Product to Third Parties in the Territory, including sales
to distributors. Note for purposes of clarification, Gross
Sales will include Biogen Idec’s revenue from distributors,
and not revenue of the distributors themselves. A sale
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
7
or transfer of a
Licensed Product by Biogen Idec to one of its Affiliates or
Sublicensees shall not be considered a sale to a Third Party for
the purpose of this provision but the resale of such Licensed
Product by such Affiliate or Sublicensee to a Third Party shall be
a sale for such purposes. In the event the Licensed Product
is sold in the form of a Combination Product, Gross Sales will be
determined by multiplying actual Gross Sales of such Combination
Product by the fraction A/(A + B), where A is the invoice price of
the Licensed Product, if sold separately, and B is the invoice
price of any other active component or components in the
combination, if sold separately, in each case in the same country
and in the same class, purity and dosage as in the Combination
Product. If, on a country-by-country basis, the other active
component or components in the combination are not sold separately
in such country, Gross Sales shall be calculated by multiplying
actual Gross Sales of such Combination Product by the fraction A/C
where A is the invoice price of the Licensed Product if sold
separately, and C is the invoice price of the Combination Product,
in each case in the same country and in the same class, purity and
dosage as in the Combination Product. If, on a
country-by-country basis, the Licensed Product component of the
Combination Product is not sold separately in such country, but the
other active component or components are sold separately, Gross
Sales shall be calculated by multiplying actual Gross Sales of such
Combination Product by the fraction (C-B)/C where B is the invoice
price of the other active component or components, if sold
separately, and C is the invoice price of the Combination Product,
in each case in the same country and in the same class, purity and
dosage as in the Combination Product. If, on a
country-by-country basis, neither the Licensed Product nor the
other active component or components of the Combination Product is
sold separately in such country, Gross Sales, for such Combination
Product shall be determined by the Parties in good
faith.
1.36.
“ ImmunoGen
Materials ” shall mean any Proprietary
Materials Controlled by ImmunoGen and used by ImmunoGen, or
provided by ImmunoGen for use, in the Research Program.
ImmunoGen Materials shall include, without limitation, any MAY
Compound.
1.37.
“ ImmunoGen Program
Technology ” shall mean any Program Technology
made solely by employees of, or agents or others obligated to
assign inventions to, ImmunoGen or an ImmunoGen Affiliate.
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
8
1.38.
“ Improvements ” shall mean,
collectively, [********************] , Licensed
Technology Improvements, [*************] and MAY Compound
Improvements.
1.39.
“ 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.
1.40.
“ Indemnitees ” and “
Indemnifying
Party ” shall have the meanings set forth in
Section 9.
1.41.
“ Joint Program
Technology ” shall mean any Program Technology
made jointly by at least one employee or agent to, or other person
obligated to assign inventions to, ImmunoGen or an ImmunoGen
Affiliate, and by at least on employee or agent to, or other person
obligated to assign inventions to, Biogen Idec or a Biogen Idec
Affiliate.
1.42.
“ Licensed Patent
Rights ” shall mean any Patent Rights which
are Controlled by ImmunoGen or its Affiliates as of the Effective
Date or become Controlled by ImmunoGen or its Affiliates during the
Term (including without limitation ImmunoGen’s interest in
any Improvements Controlled by ImmunoGen or an ImmunoGen Affiliate,
and ImmunoGen Program Technology and Joint Program Technology
covered by Patent Rights), to the extent necessary or useful to
Develop, have Developed, Commercialize, have Commercialized, make,
have made, use, have used, sell, have sold, offer for sale, import,
have imported, export and have exported any [***] -MAY Conjugate in the Field in
the Territory. Certain Licensed Patent Rights existing as of
the Effective Date are set forth in Schedule A attached
hereto and incorporated herein by reference.
1.43.
“ Licensed
Product ” shall mean any product (a) that
incorporates, is comprised of, or is otherwise derived from
Licensed Technology, or (b) the Development, Commercialization,
manufacture, use, sale, offer for sale, importation or exportation
of which would, but for the license granted herein, infringe a
Valid Claim of the Licensed Patent Rights.
1.44.
“ Licensed
Technology ” shall mean any Technology which
is Controlled by ImmunoGen or its Affiliates as of the Effective
Date or becomes Controlled by ImmunoGen of its Affiliates during
the Term (including without limitation ImmunoGen’s interest
in any Improvements Controlled by ImmunoGen or its Affiliates,
ImmunoGen Program Technology and Joint Program Technology), which
is necessary or useful for the Development,
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
9
Commercialization,
manufacture, use, sale, offer for sale, import or export of any
[***] -MAY Conjugate
in the Field in the Territory.
1.45.
“ Licensed
Technology Improvements ” shall mean
any Technology (including without limitation any Program
Technology), other than [*******] [***] , MAY Compound Improvements or
[*****]
[*****] , conceived
or reduced to practice in the course of Development of Licensed
Products as a result of the use of Licensed Technology or Licensed
Patent Rights or ImmunoGen Materials, that is an enhancement,
improvement or modification to the Licensed Technology or to an
invention claimed in the Licensed Patent Rights. Licensed
Technology Improvements does not include modifications related to
humanization or other structural modifications, formulation, method
of use, administration or delivery of an Antibody.
1.46.
“ [*****************] ” shall mean any
Program Technology that is an [***] , [***] or [***] to [***] useful for [***] a [***] or [********] , such as a
[*******] , to
[***] or other
[***********] .
1.47.
“ MAA
” shall mean an application filed with the EMEA to market and
sell any Licensed Product in the European Union or any country or
territory therein for a particular indication within the Field.
1.48.
“ MAY
Compound ” shall mean any and all maytansinoid
compounds, including, without limitation (a) N 2’
-deacetyl-N 2’
-(3-mercapto-1-oxopropyl)-maytansine (CAS No. 139504-50-0)
(commonly referred to as DM1); (b) N 2’
-deacetyl-N 2 -(4-mercapto-1-oxopentyl)-maytansine
(commonly referred as DM3); and (c) N 2’
-deacetyl-N 2
-(4-mercapto-4-methyl-1-oxopentyl)-maytansine (commonly referred as
DM4), and all fragments, variants and derivatives of such
maytansinoid compounds.
1.49.
“ MAY Compound Improvements ” shall mean any
Technology (including without limitation any Program Technology)
conceived or reduced to practice in the course of Development of
Licensed Products, that is an enhancement, improvement or
modification of a MAY Compound, and any compositions or methods
useful for the manufacture of such MAY Compound.
1.50.
“ MTA ” shall mean that certain Material
Transfer and Evaluation Agreement between Biogen, Inc. and
ImmunoGen dated [***]
, [***] , as amended
by amendments dated [***] , [***] , [***] , [***] , [***] , [***] and [***] , [***] .
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
10
1.51.
“ 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.
1.52.
“ Net
Sales ” shall mean Gross Sales of a Licensed
Product less applicable Sales Returns and Allowances.
1.53.
“ Patent
Rights ” shall mean the rights and interests
in and to any and all issued patents and pending patent
applications (including inventor’s certificates, applications
for inventor’s certificates, statutory invention
registrations, applications for statutory invention registrations,
utility models, and any foreign equivalents thereof) 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.
1.54.
“ Phase II Clinical
Trial ” 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
Pivotal Clinical Trial of such Licensed Product for such
indication.
1.55.
“ Pivotal 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 or BLA to obtain Regulatory Approval to market and sell that
Licensed Product in the United States or in any other country in
the Territory for the indication under investigation in such
study.
1.56.
“ Preclinical
Materials ” shall mean any MAY Compound and/or
[***] -MAY Conjugates
supplied by ImmunoGen to Biogen Idec under Section 4.2 for the
purpose of conducting research activities and/or preclinical
testing with respect to a Licensed Product.
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
11
1.57.
“ Program
Technology ” shall mean any Technology,
whether or not patentable, conceived or reduced to practice in the
conduct of the Research Program, or during manufacture of
Preclinical Material or Clinical Material.
1.58.
“ Proprietary
Materials ” shall mean any tangible chemical,
biological or physical research materials that are furnished by or
on behalf of one Party to the other Party in connection with this
Agreement, regardless of whether such materials are specifically
designated as proprietary by the transferring Party.
1.59.
“ Regulatory
Approval ” shall mean any and all approvals
(including pricing and reimbursement approvals), product and
establishment licenses, registrations or authorizations of any kind
of any 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.
1.60.
“ Regulatory
Authority ” shall mean the FDA and/or a
Foreign Regulatory Authority.
1.61.
“ Research
Plan ” shall mean the written plan describing
the research activities to be carried out by each Party pursuant to
this Agreement.
1.62.
“ Research
Program ” shall mean the research activities
in the Field commencing after the Effective Date to be conducted by
the Parties pursuant to Section 3.1 of this Agreement and
reflected in the Research Plan.
1.63.
“ Sales Returns and
Allowances ” shall mean the sum of (a) and
(b), where: (a) is a provision, determined by Biogen Idec under
U.S. GAAP for sales of Licensed Product in the Territory for (i)
trade, cash and quantity discounts on Licensed Product (other than
price discounts granted at the time of invoicing and which are
already included in the determination of Gross Sales), (ii) credits
or allowances given or made for rejection or return of previously
sold Licensed Product or for rebates or retroactive price
reductions (including Medicare, Medicaid and similar types of
rebates and chargebacks), (iii) taxes, duties or other governmental
charges levied on or measured by the billing amount for Licensed
Product, as adjusted for rebates and refunds (excluding income and
franchise taxes), (iv) charges for freight and insurance directly
related to the distribution of Licensed Product, to the extent
included in Gross Sales, and (v)
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
12
credits for allowances
given or made for wastage replacement, indigent patient and any
other sales programs for Licensed Product to the extent the sale of
the Licensed Product was included in Gross Sales and the credit is
applied against such Gross Sales; and (b) is a periodic adjustment
of the provision determined in (a) to reflect amounts actually
incurred by Biogen Idec in the Territory for items (i), (ii),
(iii), (iv) and (v) in clause (a).
1.64.
“ Sublicensee ” shall mean
any Third Party expressly sublicensed by Biogen Idec in accordance
with Section 2.1(a)(ii) of this Agreement. A Sublicensee
shall not include (a) a distributor or other Third Party who
purchases Licensed Products for the sole purpose of selling such
Licensed Products but not to make, have made or formulate Licensed
Product (other than a license to perform final packaging of
Licensed Product) or (b) a Third Party who primarily performs sales
and/or marketing activities with respect to such Licensed
Products.
1.65.
“ Target
” shall mean any antigen with which a particular Antibody
interacts, and any fragment, peptide or epitope thereof.
1.66.
“ Technology ” shall mean
and include any and all unpatented proprietary ideas, trade
secrets, inventions, discoveries, data, results, formulae, designs,
specifications, methods, processes, formulations, techniques,
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.
1.67.
“ 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.
1.68.
“ Territory ” shall mean all
countries and jurisdictions of the world.
1.69.
“ Third
Party ”, as to a Party, shall mean any entity
other than the Party and its respective Affiliates.
1.70.
“ Third Party
Payments ” shall have the meaning set forth in
Section 5.3(b).
1.71.
“ Upfront
Fee ” shall have the meaning set forth in
Section 5.1(a).
1.72.
“ Valid
Claim ” shall mean a claim (i) of any issued,
unexpired patent within the Licensed Patent Rights that (a) has not
been finally cancelled, withdrawn, abandoned or rejected by any
administrative agency or other body of competent jurisdiction, or
(b) has not been revoked, held invalid, or declared unpatentable or
unenforceable in a decision of a court or other
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
13
body of competent
jurisdiction that is unappealable or unappealed within the time
allowed for appeal, or (c) has not been rendered unenforceable
through disclaimer or otherwise, or (d) is not lost through an
interference proceeding; or (ii) of any patent application within
the Licensed Patent Rights that shall not have been (a) cancelled,
withdrawn, abandoned, or (b) been pending for more than
[***] (
[***] )
years.
2.
GRANT OF RIGHTS
2.1
License Grants .
(a)
Commercialization License .
(i)
License to Biogen Idec . Subject to the terms and
conditions of this Agreement, ImmunoGen hereby grants to Biogen
Idec an exclusive, royalty-bearing license, including the right to
grant sublicenses as described in Section 2.1(a)(ii) below,
under the Licensed Patent Rights and Licensed Technology, to
Develop, have Developed, Commercialize, have Commercialized, 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. Biogen Idec shall have the full and
unrestricted right to extend the licenses granted under this
Section 2.1(a)(i) and elsewhere under this Agreement to its
Affiliates. Biogen Idec shall promptly advise ImmunoGen in
writing of any such extension to its Affiliates.
[***] shall be
responsible for paying any royalty obligations that ImmunoGen may
have to any of its Affiliates or to any Third Party under
agreements between ImmunoGen and such Affiliates or Third Parties
in effect as of the Effective Date arising from the license grant
herein.
(ii)
Right to Sublicense . Biogen Idec 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)(i)
hereof to any Third Party; provided , however , that
(1) ImmunoGen shall be notified in writing of each such sublicense,
(2) any and all sublicenses shall be consistent with the terms and
conditions of this Agreement, and (3) Biogen Idec shall remain
obligated for the payment to ImmunoGen of all of its payment
obligations hereunder, including, without limitation, the payment
of any milestones and royalties described in Section 5
hereof.
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
14
(b)
Research Licenses .
(i)
Research License to Biogen Idec . Subject to the terms
and conditions of this Agreement, during the Term of this
Agreement, ImmunoGen hereby grants to Biogen Idec a fully paid up,
non-exclusive, royalty free, worldwide license, without the right
to grant sublicenses, under the Licensed Technology and Licensed
Patent Rights for the sole purpose of conducting the activities
required in the performance of its obligations hereunder as part of
the Research Program.
(ii)
Research License to ImmunoGen . Subject to the terms
and conditions of this Agreement, during the Term of this
Agreement, Biogen Idec hereby grants to ImmunoGen a paid-up,
non-exclusive, royalty-free, worldwide license, without the right
to grant sublicenses, under the Biogen Idec Background Technology
and Biogen Idec Patent Rights and Biogen Idec’s interest in
any Improvements Controlled by Biogen Idec or its Affiliates,
Biogen Idec Program Technology and Joint Program Technology, for
the sole purpose of conducting the activities required in the
performance of its obligations hereunder as part of the Research
Program.
2.2
Retained Rights and Covenants .
(a)
Retained Rights . Subject to the other terms of this
Agreement (including, without limitation, Sections 2.2(b) and
2.3), ImmunoGen retains the right to use the Licensed Technology
and Improvements Controlled by ImmunoGen and practice the Licensed
Patent Rights (i) to perform its obligations under this Agreement
(including without limitation its obligation to manufacture
Preclinical Materials and Clinical Materials in accordance with
Section 4 of this Agreement) (ii) to develop, have developed,
commercialize, have commercialized, make, have made, use, have
used, sell, have sold, offer for sale, import, have imported,
export and have exported any product that does not contain a
conjugate of a MAY Compound to an Antibody which selectively and
specifically binds with a protein encoded by a gene within the
[***] Gene Family,
and (iii) for any and all uses outside of the Field.
(b)
Covenants . Notwithstanding anything to the contrary
contained in this Agreement, ImmunoGen hereby agrees during the
Term of this Agreement, that it shall not (i) grant to any Third
Party any license or other right under any Patent Rights,
Improvements or Technology Controlled by ImmunoGen or its
Affiliates to develop, have developed, commercialize, have
commercialized, make, have made, use, have used, sell, have sold,
offer for
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
15
sale, import, have imported, export and have
exported any product containing a conjugate of a MAY Compound to an
Antibody which selectively and specifically binds with a protein
encoded by a gene within the [***] Gene Family, or (ii) outside
the performance of its obligations under this Agreement, develop,
have developed, commercialize, have commercialized, make, have
made, use, have used, sell, have sold, offer for sale, import, have
imported, export and have exported any products containing a
conjugate of a MAY Compound to an Antibody which selectively and
specifically binds with a protein encoded by a gene within the
[***] Gene
Family.
2.3
Improvement Licenses .
(a)
License to ImmunoGen . Biogen Idec hereby grants to
ImmunoGen a non-exclusive, fully paid, irrevocable, royalty-free
license, including, except as set forth below, the right to grant
sublicenses, (i) under Biogen Idec’s interest in Improvements
Controlled by Biogen Idec or its Affiliates to manufacture Clinical
Materials or Preclinical Materials pursuant to the terms of this
Agreement, and/or each applicable Supply Agreement, (ii) under
Biogen Idec’s interest in [**********] , MAY Compound
Improvements, and Licensed Technology Improvements, Controlled by
Biogen Idec or its Affiliates, to develop, have developed,
commercialize, have commercialized, make, have made, use, sell,
have sold, offer for sale, import, have imported, export, and have
exported any product that is conjugated to a MAY Compound that is
not a conjugate of a MAY Compound to an Antibody which selectively
and specifically binds with a protein encoded by a gene within the
[***] Gene Family,
and (iii) under Biogen Idec’s interest in MAY Compound
Improvements and Licensed Technology Improvements Controlled by
Biogen Idec or its Affiliates to exploit such MAY Compound
Improvements and Licensed Technology Improvements for any and all
uses outside of the Field. The licenses granted under Biogen
Idec’s interest in Improvements Controlled by Biogen Idec or
its Affiliates are limited to such Improvements only.
Notwithstanding the foregoing, ImmunoGen shall only be permitted to
sublicense rights to Improvements granted by Biogen Idec under this
Section 2.3(a) to any Third Party which has entered into an
agreement with ImmunoGen involving the license to such Third Party
of ImmunoGen’s Technology used in the conjugation of
maytansine derivatives to binding proteins (“ImmunoGen MAY
Technology”)
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
16
and
which contains Substantially Similar Grant Back Rights (as defined
below) (each such Third Party, a “Qualified ImmunoGen MAY
Licensee”). For purposes of this Agreement,
“Substantially Similar Grant Back Rights” shall mean
the grant by a Qualified ImmunoGen MAY Licensee to ImmunoGen of a
non-exclusive license to MAY Improvement Patent Rights (as defined
below) with the right to sublicense to all other Qualified
ImmunoGen MAY Licensees, the grant by a Qualified ImmunoGen MAY
Licensee of a non-exclusive license to MAY Improvement Patent
Rights (as defined below) to all other Qualified ImmunoGen MAY
Licensees, or the ownership by ImmunoGen of MAY Improvement Patent
Rights, which ownership results in ImmunoGen Controlling such MAY
Improvement Patent Rights. For purposes of the foregoing,
“MAY Improvement Patent Rights” shall mean Patent
Rights which are (a) discovered by (or on behalf of) such Qualified
ImmunoGen MAY Licensee through the use of ImmunoGen MAY Technology
and (b) which represent an enhancement or improvement to ImmunoGen
MAY Technology. 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 Biogen Idec or its
Affiliates by implication, estoppel or otherwise.
(b)
Licenses to Biogen Idec . ImmunoGen hereby grants to
Biogen Idec (i) a perpetual, worldwide, non-exclusive, fully paid,
irrevocable, royalty-free license, including the right to
[*******], under
ImmunoGen’s interest in [************] Controlled by
ImmunoGen or its Affiliates to develop, have developed,
commercialize, have commercialized, make, have made, use, sell,
have sold, offer for sale, import, have imported, export and have
exported [*****************************] for
[***] and
[***] and (ii) a
[******************]
(even as to ImmunoGen) [*******************************] ,
under ImmunoGen’s interest in [*****] Controlled by ImmunoGen or
its Affiliates, to develop, have developed, commercialize, have
commercialized, make, have made, use, sell, have sold, offer for
sale, import, have imported, export and have exported
[********] for
[***] and
[***] . The
licenses granted under ImmunoGen’s interest in Improvements
Controlled by ImmunoGen or its Affiliates are limited to such
Improvements only. 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
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
17
confer any other rights or licenses to any
other intellectual property Controlled by ImmunoGen or its
Affiliates by implication, estoppel or otherwise.
2.4
Right to [************************] . In
accordance with and subject to this Section 2.4, Biogen Idec
shall have the right, at any time during the period commencing on
the Effective Date and continuing until [***] , [***] (the “ [**********************] ”) to
[***] that ImmunoGen
[***] into an
[****************] on
[***************]
to the [***]
set forth in this [***] (each, an “
[*********************] ”)
with respect to any Antibody (other than an [***] Antibody) and Target (each, a
“ [*******]
”) by providing a written notice to ImmunoGen, which notice
shall specify in reasonable detail the [*******] that it wishes to be the
subject of an [*************] (the “
[*************]
”). ImmunoGen shall provide a written notice to Biogen
Idec within [***] (
[***] ) days of its
receipt of any [*************] specifying whether
or not it wishes to [***] into an [*************] with respect to the
[******] (the “
[**********]
”). In the event that ImmunoGen indicates in its
[*************]
that it [***]
to the [***] of an
[*************] with
respect to the [******] described in the
[*************] , the
Parties shall negotiate in good faith an [*************] in the form of
[*****] with respect
to the [*****]
. If in the [*************] , ImmunoGen
indicates that it does not wish to [***] into an [*************] with respect to the
[*****] described in
the [*************] ,
ImmunoGen shall have no further obligations to Biogen Idec under
this Section 2.4 with respect to the [*****] described in the
[*************]
. Notwithstanding anything to the contrary set forth in this
Agreement, the Parties hereby agree that (a) on and after the
expiration of the [****************] , ImmunoGen shall
have no further obligations to Biogen Idec under this Section 2.4
and (b) Biogen Idec shall have the right to select and maintain no
more than [***] (
[***] )
[*****************************] (in
addition to [******]
).
3.
RESEARCH PROGRAM; DEVELOPMENT
AND COMMERCIALIZATION
OF LICENSED PRODUCTS
3.1
Research Program .
(a)
Implementation of Research Program . As soon as
practicable after the Effective Date, the Parties shall prepare a
Research Plan which shall set forth with reasonable specificity the
research objectives and tasks to be conducted by the Parties under
the Research
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
18
Program, which shall be designed to facilitate
the selection of the appropriate [***] Antibodies and MAY Compound to
be used in preparing the [***] -MAY Conjugate. Without
limiting the foregoing, to the extent that Biogen Idec requests
that ImmunoGen manufacture Preclinical Materials and Clinical
Materials, ImmunoGen shall, in consultation with Biogen Idec, as
part of the Research Program, conduct all process development
activities as ImmunoGen determines in its discretion are reasonably
necessary to produce the quantities of Preclinical Materials and
Clinical Materials so ordered, which process development activities
shall be [***] within
the [***] of
[***] to be
[***] by Biogen Idec
pursuant to Sections 4.2 and 4.3 of this Agreement, provided that
[******] shall have
[***] -
[***] the
[***] for such
[******]
activities. The Parties acknowledge and agree that Biogen
Idec shall have the final decision making authority with respect to
the establishment of, additions to and modifications of the
Research Plan, provided that allocation of activities specifically
to ImmunoGen under the Research Plan, including any amendments or
updates to such activities, shall be subject to ImmunoGen’s
prior written consent, which consent shall not be unreasonably
withheld. Each Party agrees that the activities assigned to
it in the Research Plan shall be conducted diligently and in good
scientific manner in accordance with accepted laboratory practices
and in compliance with any and all laws, regulations and bioethical
conventions applicable to the jurisdiction in which those
activities take place.
(b)
Collaborative Efforts and Reports . The Parties agree
that the successful execution of the Research Program will require
the collaborative use of both Parties’ areas of
expertise. The Parties shall keep the Collaboration Committee
and each other fully informed about the status of the Research
Program. Scientists at ImmunoGen and Biogen Idec shall
cooperate in the performance of the Research Program and, subject
to any confidentiality obligations to Third Parties, shall exchange
information and materials in a mutually acceptable secure manner as
necessary to carry out the Research Program, but subject to the
provisions of Section 6 hereof. The Parties expect that
such exchange of information and materials may involve short-term
on-site visits (up to a few weeks) by scientists of each Party to
the facilities of the other Party.
(c)
Additional Obligations of ImmunoGen . Subject to the
other terms of this Agreement, ImmunoGen may, [***] [***] [***] [***] , conduct such additional
research
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
19
activities that ImmunoGen determines, in its
sole discretion are necessary or useful for the Development of
Licensed Products. ImmunoGen shall provide Biogen Idec with
all information and materials Controlled by ImmunoGen resulting
from such research activities. Without limiting the
generality of the foregoing, at Biogen Idec’s request,
ImmunoGen shall from time to time, provide Biogen Idec with
technical assistance within ImmunoGen’s area of expertise (or
its subcontractors) concerning the Development of Licensed
Products, 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 Biogen Idec and visits by Biogen
Idec personnel to ImmunoGen (or its subcontractors), at Biogen
Idec’s expense, at such times and for such periods of time as
may be reasonably acceptable to the Parties.
(d)
Supply of Proprietary Materials . From time to time
during the Research Program, either Party (the “transferring
Party”) may supply the other Party (the “recipient
Party”) with its Proprietary Materials for use in the
Research Program. In connection therewith, the recipient
Party hereby agrees that (i) it shall not use Proprietary Materials
for any purpose other than exercising any rights specifically
granted to it or reserved by it hereunder; (ii) it shall use the
Proprietary Materials only in compliance with all applicable,
federal, state, and local laws and regulations; (iii) it shall not
transfer any Proprietary Materials to any Third Party without the
prior written consent of the transferring Party, except as
expressly permitted hereby or by Article 6; (iv) the transferring
Party shall retain full ownership of all such Proprietary
Materials; and (v) upon the expiration or termination of this
Agreement, the recipient Party shall at the instruction of the
transferring Party either destroy or return any Proprietary
Materials which are not the subject of the grant of a continuing
license hereunder.
(e)
Transition of Services Being Provided by ImmunoGen .
In the event that ImmunoGen fails to carry out its material
obligation(s) under Section 3.1(a), 3.2(b) 4.2 or 4.3 of this
Agreement, (i) Biogen Idec shall provide ImmunoGen with written
notice which shall identify such material obligation(s) and (ii)
solely to the extent ImmunoGen fails to remedy such failure on or
before [***] (
[***] ) days of
receipt of such notice, Biogen Idec may, in addition to other
remedies available to it under this Agreement at law and in equity,
assume such obligations which ImmunoGen has failed to carry out
under such Sections or assign them to a Third Party.
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
20
ImmunoGen agrees to reasonably cooperate with
Biogen Idec in the transition of its activities under this Section
3.1(e) to Biogen Idec or a Third Party as contemplated by the
preceding sentence, such cooperation to include without limitation
using commercially reasonable efforts to [**************************] of
[********] to permit
Biogen Idec or a Third Party to carry out the activities
transitioned under this Section 3.1(e). Upon completion of
the transition of activities set forth above, the Parties shall
negotiate in good faith an [****************] to any provisions
related to [***] and
[***] from Biogen
Idec to ImmunoGen under this Agreement to [***] for the [***] of such services.
3.2
Development and Commercialization .
(a)
Responsibility . Subject to Section 3.3 of this
Agreement, on and after the Effective Date, Biogen Idec shall have
sole control and authority over the Development and
Commercialization of Licensed Products in the Field in the
Territory, including, without limitation, (i) research and all
pre-clinical Development activities (including the assessment of
alternative designs for the [***] -MAY Conjugate, the selection
of the final [***]
Antibody and MAY Compound to be used in the [***] -MAY Conjugate and the
selection of the [***] -MAY Conjugate to be Developed
as a Licensed Product, all preclinical and IND-enabling studies,
including toxicology testing, any pharmaceutical development work
on formulations or process development relating to any such
Licensed Product), (ii) all activities related to human clinical
trials (including any Phase II Clinical Trials and/or Pivotal
Trials), (iii) subject to Section 4 of this Agreement, all
activities relating to manufacture and supply of all
[***] Antibodies, all
MAY Compounds, all [***] -MAY Conjugates and all
Licensed Products, 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 Commercialization, activities relating to any
Licensed Product, 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
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
21
other Regulatory Approvals). Biogen Idec
shall own all Technology arising from any such activities under
this Agreement as well as 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 Technology, filings, registrations, applications and
Regulatory Approvals relating to Licensed Products shall be
considered Confidential Information solely owned by Biogen
Idec. Notwithstanding the foregoing, ImmunoGen shall own all
Technology arising from ImmunoGen’s activities relating to
the manufacture and supply of MAY Compounds and Licensed Products
to Biogen Idec, and all such Technology shall be considered
Confidential Information solely owned by ImmunoGen. All
activities relating to Development and Commercialization of
Licensed Products under this Agreement shall be undertaken at
Biogen Idec’s sole cost and expense, except as otherwise
expressly provided in this Agreement.
(b)
Licensed Technology and Information – Regulatory
Authorities and Manufacturing . ImmunoGen shall disclose
and make available to Biogen Idec in a timely manner all Licensed
Technology requested by Biogen Idec for use by Biogen Idec, its
Affiliates and Sublicensees in connection with Development and
Commercialization activities and filings with Regulatory
Authorities including, without limitation, the Licensed Technology
relating to the manufacture and supply of MAY Compounds and
Licensed Products owned by ImmunoGen under Section 3.2(a) and other
Confidential Information and Proprietary Materials of
ImmunoGen. Upon request by Biogen Idec and at Biogen
Idec’s expense, ImmunoGen shall transfer to Biogen Idec
(and/or a Third Party designated by Biogen Idec) all
manufacturing-related Licensed Technology (including without
limitation Confidential Information, Proprietary Materials, batch
records, assays and SOPs) necessary or useful for Biogen Idec
and/or its designee to manufacture and supply Licensed Product and
related materials (including without limitation, the MAY Compound
and the [***] -MAY
Conjugate, Preclinical Materials and Clinical Materials) and
ImmunoGen shall use commercially reasonable efforts to ensure that
such transfer of Licensed Technology is completed promptly
following each such Biogen Idec request.
(c)
Due Diligence . Biogen Idec will use commercially
reasonable efforts to Develop Licensed Products, and to undertake
investigations and actions required to obtain appropriate
Regulatory Approvals necessary to market Licensed Products, in the
Field and in the Territory and, if approved, to Commercialize
Licensed Products, such commercially reasonable efforts to be in
accordance with the efforts and resources Biogen Idec would use for
a compound
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
22
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
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, and other relevant factors including,
without limitation, technical, legal, scientific or medical
factors.
3.3
Updates and Reports; Notification of Milestones; Exchange of
Adverse Drug Experience Information .
(a)
Updates and Reports . Biogen Idec shall keep ImmunoGen
reasonably informed of the progress of Biogen Idec’s efforts
to Develop and Commercialize Licensed Products in the Field in the
Territory by providing ImmunoGen with brief written reports no less
frequently than on or about December 31 of each year during the
Term of this Agreement (other than December 31, 2004) which shall
summarize Biogen Idec’s efforts to so Develop and
Commercialize Licensed Products hereunder, identify the Drug
Approval Applications with respect to any Licensed Product that
Biogen Idec and its Affiliates and 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.
(b)
Notification of Milestone Achievement . Biogen Idec
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 5.1(b), which
shall in any event be no later than ten (10) business days after
the occurrence of such event, and shall provide ImmunoGen with
prompt written notice of the occurrence of the First Commercial
Sale of any particular Licensed Product. In the event that,
notwithstanding the fact that Biogen Idec has not given any such
notice, ImmunoGen believes any such milestone event has occurred,
it shall so notify Biogen Idec in writing, and shall provide to
Biogen Idec the data and information demonstrating that the
conditions for payment have been achieved. Within ten (10)
business days of its receipt of such notice, the Parties shall meet
to review the data and information and shall agree in good faith
whether or not the conditions for payment have been achieved.
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
23
(c)
Adverse Drug Experiences . The Parties agree to
negotiate in good faith a safety data exchange agreement within a
commercially reasonable period of time before the commencement of a
first human clinical trial with Licensed Products, such agreement
to cover, among other things, information sharing between the
Parties regarding Adverse Drug Experiences relating to Licensed
Products; provided , that , the Parties hereby
acknowledge and agree that the failure of the Parties to negotiate
such agreement foregoing shall in no way limit or otherwise affect
the Parties’ respective obligations to provide the other
Party with any and all Adverse Drug Experiences in its Control
relating to Licensed Products or other MAY Compound-conjugated
products as is reasonably necessary to ensure the safe use of MAY
Compound-conjugated products by the Parties.
(d)
Review of Correspondence for Licensed Products .
Biogen Idec shall use reasonable commercial efforts to provide
ImmunoGen with at least [***] ( [***] ) days advance notice of any
material meeting with the FDA which is for the purpose of obtaining
Regulatory Approval for any Licensed Product and Biogen Idec shall
provide to ImmunoGen the minutes of any such meeting communicated
to or from the Regulatory Authority within [***] ( [***] ) days from the date on which
the meeting minutes were submitted to, or received from such
Regulatory Agency.
(e)
Confidential Information . All information, reports,
updates, Adverse Drug Experience, product complaint and other
information provided by the disclosing Party to the receiving Party
under this Agreement (including under this Section 3.3), shall
be considered Confidential Information of the disclosing Party,
subject to the terms, exceptions and permitted disclosures of
Section 6.
3.4
Collaboration Committee .
(a)
Mandate and Establishment 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 the Research Program and/or the
Development of manufacturing processes applicable to any MAY
Compound or Licensed Product covered by this Agreement (including,
without limitation, all process science and process development
work, formulation work, and quality control/assurance work
hereunder), and to assist Biogen Idec in the exercise of its rights
to make or have made Licensed Products
CONFIDENTIAL
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 investment under Rule 24b-2 under the
Securities Exchange Act of 1934.
24
under this Agreement. The Collaboration
Committee shall solely serve as a forum for coordination and
communication and shall not have any authority to make
decisions. Within a reasonable period of time after the
Effective Date, the Parties shall each nominate representatives
(which shall be no less than two (2) and no more than five (5)
each) for membership on the Collaboration Committee. Each
representative shall be an individual of suitable authority and
seniority who has sufficient experience in biopharmaceutical drug
research, development, manufacturing or commercialization.
Each Party may change its representative(s) as it deems appropriate
by notice to the other Party.
(b)
Chair of Committee; Meetings . The ch
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