Exhibit 10.2
DEVELOPMENT AND LICENSE
AGREEMENT
This Development
and License Agreement (this “Agreement”) is made
effective as of December 23, 2004 (the “Effective
Date”) by and between Centocor, Inc., a wholly owned
subsidiary of Johnson & Johnson, with its principal place of
business at 200 Great Valley Parkway, Malvern, Pennsylvania 19355
(“Centocor”), and ImmunoGen, Inc., a Massachusetts
corporation with its principal place of business at 128 Sidney
Street, Cambridge, Massachusetts 02139
(“ImmunoGen”). Centocor and ImmunoGen are
sometimes each hereinafter referred to individually as a
“Party” and collectively as the
“Parties”.
WHEREAS, Centocor
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, Centocor desires to
obtain from ImmunoGen, and ImmunoGen desires to grant to Centocor,
a license under certain of ImmunoGen’s Technology and/or
Patent 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
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
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 Ace of 1934.
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 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.
[***************************] shall mean any
[**************************] consisting of an [**************] in
[*********************************].
1.5.
[***************************] -MAY Conjugate ” shall
mean any conjugate of an [********************************]
Antibody with a MAY Compound.
1.6.
“ Ansamitocins ” shall mean
precursor(s) of MAY Compound produced by microbial fermentation,
such as Ansamitocin P0, P1, P2, P3, P3’, P4, and
P4’.
1.7.
[***************************] Antibody ” shall mean any
Antibody (including [********] that is Controlled by Centocor and
that targets [*************************].
1.8.
“ Antibody ” shall mean a
composition comprising a whole antibody or fragment
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 Ace of 1934.
2
thereof (whether
polyclonal or monoclonal, human, humanized, chimeric or murine, or
derived from another relevant species, 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.
1.9.
“ Centocor Background
Technology ” means any Technology used by
Centocor or provided by Centocor for use, in the Research Program
that is useful in the Field and that is (a) Controlled by Centocor
as of the Effective Date or (b) Controlled by Centocor and
developed or conceived by employees of, or consultants to, Centocor
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. Any Centocor Background Technology
Controlled by Centocor as of the Effective Date is, or that becomes
Controlled by Centocor on and after the Effective Date shall be,
described in Schedule C attached hereto and
incorporated herein by reference.
1.10.
“ Centocor Patent
Rights ” shall mean all Patent Rights with
respect to Centocor Background Technology.
1.11.
“ Centocor Program
Technology ” shall mean any Program Technology
made solely by employees of, or others obligated to assign
inventions to, Centocor or any Affiliate of Centocor.
1.12.
“ Clinical
Materials ” shall mean any MAY Compound or
Licensed Product supplied by ImmunoGen to Centocor pursuant to
Section 4.3 and/or the terms of a Supply Agreement for use in
human clinical testing.
1.13.
“ Collaboration
Co mmittee ” shall mean the
committee with representatives of each Party established as set
forth in Section 3.4.
1.14.
[***************************************] shall mean a [*****] of
[************] in [********************] to [***************] of
[********] of [****************] to
[***********************************] and [********] launch of a
product incorporating MAY Compound.
1.15.
“ Commercialization ” or
“ Commercialize ” shall mean
any and all activities
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 Ace of 1934.
3
directed to pre-launch
and launch of Licensed Products, including marketing, promoting,
distributing, offering for sale and selling such Licensed Product,
importing Licensed Products for sale, manufacturing for commercial
sale (except for scale-up activities, which shall be Development
activities) and securing reimbursement for sales. When used as a
verb, “Commercialize” shall mean to engage in
Commercialization.
1.16.
“ 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, licensees or sublicensees, except to the
extent that the receiving Party can demonstrate by written record
or other suitable physical evidence that such information,
(a) as of the date of 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, (a) any technical
or financial information of a disclosing Party disclosed at any
meeting of the Collaboration Committee, or disclosed through an
audit 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 Centocor 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 Centocor to
ImmunoGen in connection with the license set forth in
Section 2 of this Agreement shall constitute Confidential
Information of Centocor.
1.17.
“ 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
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 Ace of 1934.
4
Labor.
1.18.
“ Contract
Year ” shall mean the period beginning on the
Effective Date and ending on December 31, 2005 and each
succeeding twelve (12) month period thereafter during the Term.
1.19.
“ 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 of such Patent Rights or Technology and the rights
thereto or to supply such 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.
1.20.
“ Cost
” shall mean, with respect to any Preclinical Materials or
Clinical Materials manufactured 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 Centocor without modification,
the amount paid by ImmunoGen to such Third Party for the same; (b)
manufacturing overhead costs attributable to the cost of goods
under the foregoing clause (a) (1), 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 and customary
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 directly attributable or reasonably
allocable to company departments
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 Ace of 1934.
5
based on space occupied
or headcount or another activity-based method. In no event
shall Manufacturing Costs include costs associated with idle
capacity. Manufacturing overhead costs under the foregoing
clause (b) and general 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 [**********] for the [**********] (including [*****************]
and [*******]) if Preclinical Materials or Clinical Materials, as
the use may be, 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.
1.21.
“ Dedicated
Equipment ” shall mean any equipment,
instrument or machinery used by ImmunoGen exclusively in the
manufacturing of Preclinical Materials or Clinical Materials.
1.22.
“ 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.
1.23.
“ Drug Approval
Application ” shall mean any application for
Regulatory Approval (including pricing and reimbursement approvals)
required prior to any commercial sale or use of a Licensed Product
in any country or jurisdiction in the Territory, including, without
limitation, (a) any NDA or 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
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 Ace of 1934.
6
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.
1.24.
“ Effective
Date ” shall mean the date first written above
in the introductory paragraph to this Agreement.
1.25.
“ FDA
” shall mean the United States Food and Drug Administration
and any successor agency or authority thereto.
1.26.
“ Field
” shall mean all human therapeutic uses.
1.27.
“ First Commercial
Sale ” shall mean the date of the first
commercial transfer or disposition for value to a Third Party of a
Licensed Product by or on behalf of Centocor or any Affiliate or
Sublicensee of Centocor.
1.28.
“ 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), including, without limitation, the Europeon Medicines
Agency, 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.
1.29.
“ Full Time
Equivalent ” or “ FTE ” a full time person
dedicated to the Research Program, or in the case of less than a
full-time dedicated person, a full-time, equivalent person year,
based on a total of at least [************] or
[*******************] per year of work, on or directly related to
the Research Program, and which is carried out by employees,
contractors or agents of ImmunoGen having the appropriate
scientific expertise to conduct such activities.
1.30.
“ 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.
1.31.
“ 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
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 Ace of 1934.
7
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.
1.32.
“ GMPs
” shall mean all good manufacturing practices under Title 21
of the United States Code of Federal Regulations, as amended from
time to time.
1.33.
“ 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.
1.34.
“ 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 Affiliate of ImmunoGen.
1.35.
“ Improvement ” shall mean
any enhancement, improvement or modification to the Licensed
Technology or the Licensed Patent Rights which is conceived or
reduced to practice by either Party in the conduct of the Research
Program and/or in connection with the development of any Licensed
Product.
1.36.
“ 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.
1.37.
“ Indemnitees ” and “
Indemnifying
Party ” shall have the meanings set forth in
Section 9.
1.38.
“ Joint Program
Technology ” shall mean any Program Technology
made jointly by one or more employees of or agents to, or other
persons obligated to assign inventions to, ImmunoGen or an
ImmunoGen Affiliate, and by one or more employees of or agents to,
or other persons obligated to assign inventions to, Centocor or a
Centocor Affiliate.
1.39.
“ Licensed Patent
Rights ” shall mean any Patent Rights in the
Field which are Controlled by ImmunoGen as of the Effective Date or
become Controlled by ImmunoGen during the Term (including
ImmunoGen’s interest in any ImmunoGen Program Technology and
Joint
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 Ace of 1934.
8
Program Technology
covered by Patent Rights that are Controlled by ImmunoGen), to the
extent necessary to Develop, have Developed, make, have made, use,
sell, have sold, import or export any Licensed Product in the Field
in the Territory. Licensed Patent Rights as of the Effective
Date are set forth in Schedule A attached hereto and
incorporated herein by reference.
1.40.
“ Licensed
Product ” shall mean any product that
incorporates, is comprised of, or is otherwise derived from, an
[***************]- MAY Conjugate.
1.41.
“ Licensed
Technology ” shall mean any Technology in the
Field which is Controlled by ImmunoGen as of the Effective Date or
becomes Controlled by ImmunoGen during the Term (including
ImmunoGen’s interest in any ImmunoGen Program Technology and
Joint Program Technology), which is necessary or useful to Develop,
have Developed, make, have made, use, sell, have sold, import or
export any Licensed Product in the Field in the Territory.
1.42.
“ MAA
” shall mean an application filed with the relevant Foreign
Regulatory Authorities in Europe seeking Regulatory Approval to
market and sell any Licensed Product in Europe or any country or
territory therein for a particular indication within the Field.
1.43.
[*****************************] shall mean the [*********] of (a)
an [*****] (such [*****] to [*****] the [****] under (b) below) of
a [****************] by [******] that [*******************] to
[******************] that the [*******************] is [*******] of
using [***********************************] to
[******************** ****************] to [**********************]
in terms of [************************] and [***************] for
[*********] to be used in (i) [***************************]
involving [**************] and (ii)
[******************************] of a [****************], and (b)
the [*********] by [*********] or [******] and [************
*************] of a [***************] that
[*********************************] is [***********] with the
[*****] of [*******] as described under (a) above. For the
avoidance of doubt, if [*******] chooses [***] to [*******] the
[*****] under (a) above [*****] to the [********] of the
[****************] referenced under (b) above, the
[****************** *************] will be [**************] and
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 Ace of 1934.
9
[*********] upon the
[*********] of only (b) above.
1.44.
“ MAY
Compound ” shall mean any and all maytansinoid
compounds and any and all derivatives of any such maytansinoid
compounds, to the extent, in any case, Controlled by ImmunoGen,
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).
1.45.
“ MTA ” shall mean that certain Material
Transfer and Evaluation Agreement between Centocor and ImmunoGen
dated [***************], as amended on [********************] and
[********************].
1.46.
“ 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.
1.47.
“ Net
Sales ” shall mean, as to each calendar
quarter during the Term, the gross invoiced sales prices charged
for all Licensed Products sold by Centocor or its Sublicensees to
Third Parties throughout the Territory during such calendar
quarter, less the following amounts incurred or paid by Centocor 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)
(i) trade, cash and quantity discounts actually allowed or taken,
including discounts to governmental or managed care organizations;
(ii) rebates actually paid or credited, including government
rebates such as Medicaid chargebacks or rebates; (iii) retroactive
price reductions or allowances actually allowed or granted from the
billed amount; and (iv) commercially reasonably promotional
allowances actually granted to customers as reflected on the same
invoice as for the sale of Licensed Product
(b)
credits or allowances actually given or made for rejection of or
return of, previously sold Licensed Products;
(c)
any charges for insurance, freight, and other transportation costs
directly
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 Ace of 1934.
10
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 Centocor and its
Affiliates, unless the Licensed Product is consumed by the
Affiliates.
1.48.
“ 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.
1.49.
“ 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.
1.50.
“ 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 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.
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 Ace of 1934.
11
1.51.
“ Preclinical
Materials ” shall mean any MAY Compound and/or
[***************************]-MAY Conjugate supplied by ImmunoGen
to Centocor in accordance with Section 4.2 for the purpose of
conducting research activities and/or preclinical testing under the
Research Program with respect to a Licensed Product.
1.52.
“ Program
Technology ” shall mean any Technology,
whether or not patentable, conceived or reduced to practice in the
conduct of the Research Program, or, during the manufacture of
Preclinical Material or Clinical Material in accordance with
Section 4 of this Agreement.
1.53.
“ 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.
1.54.
“ 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
any other Drug Approval Application.
1.55.
“ Regulatory Authority ” shall mean the FDA
and/or a Foreign Regulatory Authority.
1.56.
“ Research Budget ” shall mean the budget
for the Research Plan as agreed to by the parties.
1.57.
“ Research
Plan ” shall mean the written plan
describing the research activities to be carried out by each Party
pursuant to this Agreement attached hereto as Appendix 3.1
.
1.58.
“ Research
Program ” shall mean the research activities
in the Field commencing on the Effective Date to be conducted
by the Parties pursuant to Section 3.1 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 investment under Rule 24b-2 under the Securities
Exchange Ace of 1934.
12
and reflected in the
Research Plan.
1.59.
“ Sublicensee ” shall mean
any Third Party to which Centocor grants a sublicense of the rights
granted to Centocor pursuant to this Agreement.
1.60.
“ Technology ” shall mean
and include any and all unpatented proprietary ideas, inventions,
trade secrets, 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 Materials, including all proprietary biological,
chemical, pharmacological, toxicological, pre-clinical, clinical,
assay, control and manufacturing data and materials.
1.61.
“ 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.
1.62.
“ Territory ” shall mean all
countries and jurisdictions of the world.
1.63.
“ Third
Party ” shall mean, as to a Party, any entity
other than that Party and its respective Affiliates.
1.64.
“ Third Party
Payments ” shall have the meaning set forth in
Section 5.3.2.
1.65.
“ Upfront
Fee ” shall have the meaning set forth in
Section 5.1.1.
1.66.
“ Valid
Claim ” shall mean any claim within an issued,
unexpired patent or pending patent application 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, and (b) 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 (c) has not been
rendered unenforceable through disclaimer or otherwise, and (d) is
not lost through an interference proceeding.
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 Ace of 1934.
13
2.
GRANT OF RIGHTS
2.1
License Grants .
(a)
Commercialization License .
(i)
License to Centocor Subject to the terms and
conditions of this Agreement, ImmunoGen hereby grants to Centocor
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 and
ImmunoGen’s interest in Improvements, 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.
(ii)
Right to Sublicense . Centocor 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) Centocor 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.
(b)
Research Licenses .
(i)
Research License to Centocor Subject to the terms and
conditions of this Agreement, during the Term of this Agreement,
ImmunoGen hereby grants to Centocor a fully paid-up, non-exclusive,
royalty-free, worldwide license, without the right to grant
sublicenses, under the Licensed Technology and Licensed Patent
Rights and ImmunoGen’s interest in any Improvements, for the
sole purpose of conducting the activities it is required to perform
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, Centocor hereby grants to ImmunoGen a fully paid-up,
non-exclusive, royalty-free, worldwide license, without the right
to grant sublicenses, under the Centocor Background Technology and
Centocor Patent Rights and Centocor’s interest in any
Improvements, Centocor Program Technology and Joint Program
Technology, for the sole purpose of conducting the activities it is
required to perform as part of the Research Program.
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 Ace of 1934.
14
2.2
Retained Rights and Covenants .
(a)
Retained Rights . Subject to the other terms of this
Agreement (including, without limitation, Section 2.2(b)),
ImmunoGen retains the right to use the Licensed Technology and its
interest in any Improvements and practice the Licensed Patent
Rights (a) 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) (b) to develop, have developed,
make, have made, use, have used, sell, have sold, offer for sale,
import, have imported, export and have exported any product that is
not a Licensed Product, and (c) for any and all uses outside of the
Field.
(b)
Covenants . Notwithstanding anything to the contrary
contained in Section 2.2(a) or 2.3 of this Agreement,
ImmunoGen hereby agrees during the Term of this Agreement, that it
shall not grant to any Third Party any license or other right under
any Patent Rights or Technology Controlled by ImmunoGen to develop,
have developed, commercialize, have commercialized, make or have
made any product containing a conjugate of a MAY Compound to an
Antibody which selectively and specifically binds with
[**************************].
2.3
Improvement License to ImmunoGen . Centocor hereby
grants to ImmunoGen a non-exclusive, fully paid, irrevocable,
royalty-free license, including the right to grant sublicenses,
under Centocor’s interest in Improvements Controlled by
Centocor (a) to manufacture Clinical Materials or Preclinical
Materials pursuant to the terms of this Agreement, and/or each
applicable Supply Agreement (b) to develop, make, have made, use,
sell, have sold, offer for sale, import, have imported, export and
have exported any product that is not a Licensed Product, and (c)
to otherwise exploit such Improvements for all uses outside of the
Field.
3.
RESEARCH PROGRAM; DEVELOPMENT
AND COMMERCIALIZATION OF LICENSED PRODUCTS .
3.1
Research Program .
(a)
Implementation of Research Program . Promptly
following the execution of this Agreement, the Parties shall
cooperate in conducting the Research Program as described
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 Ace of 1934.
15
in
the Research Plan in Appendix 3.1 attached hereto. The Research
Program shall be designed to facilitate the selection of the
appropriate [************************] Antibodies and MAY Compounds
to be used in preparing [*********************]-MAY Conjugates and
the conduct of initial research with respect to the
[*********************]-MAY Conjugates. The Research Program shall
be conducted pursuant to a Research Budget agreed to by the
Parties. The Parties may, by mutual agreement, make
adjustments in the Research Plan and Research Budget from time to
time during the Term of this Agreement. Each Party undertakes
that the activities assigned to it in a 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 Centocor 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 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
activities, as ImmunoGen, in its sole discretion, are necessary as
useful for the Development of Licensed Products. Without
limiting the generality of the foregoing, ImmunoGen may from time
to time, provide Centocor 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
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 Ace of 1934.
16
assistance and expertise shall include, but not
be limited to, visits by ImmunoGen personnel to Centocor and visits
by Centocor Personnel to ImmunoGen (or its subcontractors), at
Centocor’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 Term, 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 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; (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.
3.2
Development and Commercialization .
(a)
Responsibility . Subject to Section 3.3 of this
Agreement, on and after the Effective Date, Centocor shall have
sole control and authority over the Development and
Commercialization of Licensed Products in the Field in the
Territory, including, without limitation, (i) the conduct of all
research and pre-clinical Development activities (including the
assessment of alternative designs for the
[**********************]-MAY Conjugates, the selection of the final
[************************] Antibodies and MAY Compounds to be used
in the [*********************]-MAY Conjugates and the selection of
the [***********************]-MAY Conjugates to be Developed as
Licensed Products, all preclinical and IND-enabling studies,
including toxicology testing, any pharmaceutical development work
on formulations or process development relating to any such
Licensed Products), (ii) all activities related to human clinical
trials, (iii) subject to Section 4 of this
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 Ace of 1934.
17
Agreement, all activities relating to the
manufacture and supply of [***********************] Antibodies, MAY
Compounds and 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
other Regulatory Approvals). Except as described in the next
sentence, Centocor shall own all Technology 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 Technology and
filings, registrations and applications shall be considered
Confidential Information solely owned by Centocor.
Notwithstanding the foregoing, ImmunoGen shall own all Technology
arising from ImmunoGen’s activities relating to the
manufacture and supply of MAY Compounds to Centocor and all of the
foregoing Technology shall be considered Confidential Information
solely owned by ImmunoGen. Notwithstanding anything to the
contrary in this Agreement, (i) all activities relating to
Development and Commercialization of Licensed Products under this
Agreement shall be undertaken at Centocor’s sole cost and
expense, except as otherwise expressly provided in this Agreement,
(ii) a ll business decisions, including, but not limited to,
the design, sale, price and promotion of Licensed Products under
this Agreement and the decision whether to market any particular
Licensed Product shall be within the sole discretion of Centocor,
(iii) any marketing of a Licensed Product in one market or country
shall not obligate Centocor to market said Licensed Product in any
other market or country and (iv) Centocor makes no warranty or
representation that the marketing of any Licensed Product shall be
the exclusive means by which Centocor will participate in the Field
to which the Licensed Product relates.
(b)
Due Diligence . Centocor will use commercially
reasonable efforts to
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 Ace of 1934.
18
Develop and Commercialize 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, such commercially
reasonable efforts to be in accordance with the efforts and
resources Centocor 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 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. In determining whether Centocor is using the
efforts described in this Section 4.4 to Develop a Licensed
Product the Parties shall consider, among other things, whether
such Licensed Product is in Active Development. “Active
Development” shall mean that at any given time Centocor shall
be diligently engaging in one or more of the following Development
activities for a given Licensed Product:
[*************************************************************]
from the [************************] or
[****************************] for any
[********************************************************] being
[*******] or [***************] or
[*******************************************************
**************************************************************] and
[*******************] or [********************] and
[*****************] from a [**********************] and
[********************] within [******************] to [********]
any of the preceding activities. Notwithstanding the
foregoing, Centocor shall not be considered to have failed to meet
its obligation to use such efforts or have a Licensed Product in
Active Development if such failure is due to the failure on the
part of ImmunoGen to provide Preclinical or Clinical Materials
under Article 4 hereof. In the event that Centocor fails
to use commercially reasonable efforts as required hereunder, then,
ImmunoGen’s sole remedy shall be the right, in its sole
discretion to (i) terminate the licenses granted under
Section 2.1 this Agreement for breach under
Section 8.2(b) below (including the notice and cure
provisions
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 Ace of 1934.
19
therein) or (ii) 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 8.2(b) below provided that such
failure remains uncured upon such expiration.
3.3
Updates and Reports; Notification of Milestones; Exchange of
Adverse Event Information .
(a)
Updates and Reports . Centocor shall keep ImmunoGen
informed of the progress of Centocor’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 each anniversary of the Effective Date during the Term of
this Agreement (commencing with the first anniversary of the
Effective Date) which shall summarize Centocor’s efforts to
Develop and Commercialize such Licensed Products, identify the Drug
Approval Applications that Centocor 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. The Parties agree
that the minutes of the Collaboration Committee meetings may serve
as reports hereunder, to the extent such minutes adequately address
the above issues.
(b)
Notification of Milestone Achievement . Centocor 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 5.1.2, which shall in any event be
no later than [***********] 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 Licensed
Product. In the event that, notwithstanding the fact that
Centocor has not given any such notice, ImmunoGen believes any such
milestone event has occurred, it shall so notify Centocor in
writing, and shall provide to Centocor the data and information
demonstrating that the conditions for payment have been
achieved. Within [***] ([***]) 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.
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 Ace of 1934.
20
(c)
Adverse Events . As the owner of all regulatory
approvals, Centocor will be primarily responsible for Adverse
Event, safety and pharmacovigilence reporting on all Licensed
Products. To the extent that it may apply to a Licensed
Product, ImmunoGen agrees to provide Centocor 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, in accordance with procedures that shall be agreed to
by the Parties based, in general, on Schedule D
attached hereto (it being the understanding of the Parties that
such Schedule D is included as an example only and
shall not be binding upon the Parties); provided ,
however , that the foregoing shall not require ImmunoGen to
violate any agreements with or confidentiality obligations owed to
any Third Party. In addition, Centocor agrees to provide
ImmunoGen with agreed upon Adverse Event information and product
complaint information relating to Licensed Products as compiled and
prepared by Centocor in the normal course of business in connection
with the Development or Commercialization of any Licensed Product,
within time frames consistent with reporting obligations under
applicable laws and regulations in accordance with procedures that
shall be agreed to by the Parties based, in general, on
Schedule D attached hereto (it being the understanding
of the Parties that such Schedule D is included as an
example only and shall not be binding upon the Parties).
Centocor 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 Centocor. ImmunoGen shall
provide its Adverse Event and product complaint information
hereunder to Centocor’s designated representative identified
on Schedule D unless Centocor otherwise notifies
ImmunoGen.
(d)
Correspondence for Licensed Products. To the extent
reasonably practicable and subject to any Third Party
confidentiality obligations, Centocor shall provide ImmunoGen with
copies of any material documents or correspondence pertaining to
ImmunoGen’s manufacture of Preclinical Materials, Clinical
Materials or any Licensed Product and prepared for submission to
the FDA and any material documents or other correspondence
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 Ace of 1934.
21
received from the FDA pertaining to
ImmunoGen’s manufacture of Preclinical Materials, Clinical
Materials or any Licensed Product. ImmunoGen shall complete
its review within [********] days after receipt of the proposed
submission. When requested in writing, ImmunoGen shall provide
reasonable assistance to Centocor in obtaining Regulatory Approvals
for Licensed Product. Notwithstanding the foregoing, Centocor
shall have the sole responsibility for, and ImmunoGen agrees that
Centocor shall be the sole owner of, any Regulatory Approval for
the Licensed Product.
(e)
Confidential Information . All reports, updates,
Adverse Event, 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 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 Centocor in its exercise of its rights to
make or have made Licensed Products under this Agreement.
Within thirty (30) 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.
(b)
Chair of Committee; Meetings . The chair of the
Collaboration Committee shall be one of the Centocor
representatives on the Collaboration Committee, as designated by
Centocor. 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 of the Collaboration Committee determines that there is
no need for a meeting. In such instance,
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 Ace of 1934.
22
the
next Collaboration Committee meeting shall also be scheduled as
agreed upon by the Parties. The location of meetings of the
Collaboration Committee shall alternate between ImmunoGen’s
offices and Centocor’s offices in Cambridge, Massachusetts
and Malvern/Radnor/Horsham/ Chesterbrook/Springhouse, Pennsylvania,
respectively, unless otherwise agreed by the Parties. 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 its
own costs and expenses, including travel and lodging expense, that
may be incurred by Collaboration Committee representatives or other
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 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.
4.
SUPPLY AND MANUFACTURING
OBLIGATIONS
4.1
Supply of Preclinical Materials, Clinical Materials and Licensed
Product . Centocor shall be responsible, at its sole
cost, for manufacturing or having manufactured through Third Party
contract manufacturers, any materials (including without
limitation, all [**********************] Antibodies, MAY Compounds
and [******************]-MAY Conjugates) as may be required for all
preclinical and clinical studies necessary to obtain Regulatory
Approval of Licensed Products and any materials and/or quantities
of each Licensed Product as may required for all preclinical and
clinical studies applicable to such Licensed Product and for
Commercialization of such Licensed Product.
4.2
Supply of Preclinical Materials by ImmunoGen .
Notwithstanding anything to the contrary in Section 4.1,
during the Term of this Agreement, Centocor may request ImmunoGen
to supply Centocor with such quantities of Preclinical Materials as
may be reasonably required by Centocor in order to conduct all
pre-clinical Development activities
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 Ace of 1934.
23
(including, without limitation, toxicology
testing) relating to Licensed Products. Centocor shall order
all amounts of Preclinical Materials, and ImmunoGen shall deliver
all such ordered amounts, in accordance with advance ordering
timeframes and delivery timeframes and specifications to be agreed
upon by the Parties. To the extent Centocor requests
ImmunoGen to manufacture any [*********************]-MAY Conjugate,
Centocor shall supply ImmunoGen with quantities of
[***************************] Antibodies sufficient to enable
ImmunoGen to produce such [**************************]-MAY
Conjugate. ImmunoGen shall use commercially reasonable
efforts to deliver to Centocor such amounts of Preclinical
Materials as are ordered by Centocor in accordance with the
foregoing (including such agreed upon timeframes) in a timely
manner; provided , that , to the extent such
Preclinical Materials are [************************]-MAY
Conjugates, ImmunoGen’s obligations shall be contingent on
ImmunoGen’s receipt of the required quantities of
[************************] Antibodies from Centocor. In
connection with any ordering of Preclinical Materials by Centocor,
ImmunoGen shall provide Centocor promptly with ImmunoGen’s
good faith estimate of the Cost for manufacture and supply of such
Preclinical Materials. ImmunoGen’s price to supply
Preclinical Materials to Centocor shall equal
[*************************] for such Preclinical Materials.
In connection with such supply, Centocor hereby agrees that (a) it
shall not use the Preclinical Materials in any human subject, (b)
it shall use the Preclinical Materials in compliance with all
applicable federal, state and local laws and regulations, and (c)
it (as a matter of contract between itself and ImmunoGen) shall
assume all liability for damages that may arise from the use,
storage and disposal of any Preclinical Materials. Centocor
shall be entitled to transfer Preclinical Materials to any Third
Party under terms obligating such Third Party not to transfer or
use such Preclinical Materials except in compliance with the
foregoing clauses (a) and (b) of this Section 4.2.
4.3
Supply of Clinical Materials by ImmunoGen . If,
during the Term of this Agreement, Centocor requests in writing
that ImmunoGen supply Centocor with such quantities of Clinical
Materials as may be reasonably required by Centocor in order to
conduct human clinical trials of such Clinical Materials through
the completion of non-pivotal Phase II Clinical
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 Ace of 1934.
24
Trials for such Clinical Materials, ImmunoGen
will use commercially reasonable efforts to supply Centocor with
such Clinical Materials. If, during the Term of this
Agreement, Centocor requests in writing that ImmunoGen supply it
with Clinical Materials in connection with the conduct of Pivotal
Clinical Trials, ImmunoGen will supply Centocor with such Clinical
Materials only to the extent ImmunoGen has the capability to do so
at the time of Centocor’s request. In either event, the
Parties shall share information concerning specifications,
forecasting and capacity requirements in order to adequately plan
for the manufacture of such Clinical Materials. To the extent
Centocor requests ImmunoGen to manufacture Clinical Materials as
provided in the foregoing sentences, ImmunoGen and Centocor shall
enter into a separate supply and quality agreements detailing the
terms of supply for any Clinical Materials that ImmunoGen is so
requested to supply to Centocor for the purpose of conducting
clinical trials, which supply agreement shall include, without
limitation, the terms set forth on Schedule B attached
hereto and the remainder of this Section 4.3 (the
“Supply Agreement”). Subject to the foregoing,
Centocor shall order all amounts of Clinical Materials, and
ImmunoGen shall deliver all such ordered amounts, in accordance
with forecasting parameters, advance ordering timeframes and
delivery timeframes to be agreed upon by the Parties in the Supply
Agreement. The Supply Agreement further shall provide that
ImmunoGen shall use commercially reasonable efforts to deliver such
amounts of Clinical Materials ordered in accordance with the
foregoing (including such agreed upon timeframes) in a timely
manner; provided , that , ImmunoGen’s
obligations shall be contingent on ImmunoGen’s receipt of the
required quantities of [************************] Antibodies from
Centocor. In connection with any ordering of Clinical
Materials by Centocor, ImmunoGen shall provide Centocor promptly
with ImmunoGen’s good faith estimate of the Cost for
manufacture and supply of such Clinical Materials. The Supply
Agreement shall provide that ImmunoGen’s price to supply
Clinical Materials to Centocor shall equal
[************************************] for such Clinical
Materials. Centocor hereby agrees that (a) it shall use the
Clinical Materials in compliance with all applicable federal, state
and local laws, and (b) it (as a matter of contract between itself
and ImmunoGen) shall assume all liability for damages that may
arise from 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 investment under Rule 24b-2 under the Securities
Exchange Ace of 1934.
25
use, storage and disposal of such Clinical
Materials. Centocor shall be entitled to transfer Clinical
Materials to any Third Party under terms obligating such Third
Party not to transfer or use such Clinical Materials except in
compliance with the foregoing clause (a) of this
Section 4.3.
4.4
Purchase of Dedicated Equipment . If, during the Term of this
Agreement, ImmunoGen determines in good faith that it is necessary
or advisable to purchase Dedicated Equipment in order to perform
any of its obligations to manufacture Preclinical Materials and
Clinical Materials under Sections 4.2 or 4.3 of this Agreement,
then ImmunoGen shall provide Centocor with written notice of such
determination, along with the estimated price for such purchase and
quality parameters for the Dedicated Equipment, for
Centocor’s approval of such price and features.
Promptly after the consummation of such purchase, assuming that
Centocor has provided its approval hereunder, ImmunoGen shall
provide Centocor with a copy of the invoice or invoices reflecting
such purchase, and Centocor shall reimburse ImmunoGen for the
purchase of all such approved Dedicated Equipment hereunder within
[****************] of its receipt of such invoice from ImmunoGen;
provided , however , that no costs reimbursed by
Centocor hereunder (or depreciation of such purchased equipment or
instruments) shall be included within the calculation of any Costs
under this Agreement. Centocor shall have title and ownership
of all such Dedicated Equipment purchased pursuant to this
Section 4.4, and shall have the right to reclaim or retain
possession of such Dedicated Equipment at its expense upon
reasonable notice at such time as it is no longer required for use
by ImmunoGen to carry out this Agreement. Notwithstanding the
foregoing, the purchase of items including, but not limited to,
routine lab equipment, biological materials, products and reagents
reasonably required by ImmunoGen to conduct the Research Program
shall be included in the Research Budget and shall be
ImmunoGen’s obligation and responsibility.
4.5
Process Development Activities . To the extent
that Centocor requests that ImmunoGen manufacture Preclinical
Materials or Clinical Materials as described in this
Section 4, ImmunoGen shall conduct such process development
activities as the Parties agree are necessary to produce the
quantities of Preclinical Materials or Clinical Materials so
ordered,
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 Ace of 1934.
26
which process development activities shall be
included within the calculation of Cost to be paid by Centocor
pursuant to Sections 4.2 and/or 4.3 of this Agreement and/or the
Supply Agreement.
4.6
Audit Rights
4.6.1
Audit of Records . ImmunoGen will maintain complete
and accurate records which are relevant to its supply of
Preclinical Materials as described in this Section 4, for
subsequent use in GLP toxicology studies, including records
concerning the Costs, purchase of Dedicated Equipment and Process
Development Activities. ImmunoGen shall maintain all records
relating thereto in good order. At the request of Centocor,
upon at least [***********] business days’ prior written
notice, but no more often than once per year, and at its sole
expense (except as otherwise provided herein), ImmunoGen shall
permit an independent certified public accountant reasonably
selected by Centocor and reasonably acceptable to ImmunoGen to
inspect (during regular business hours) the relevant records
required to be maintained by ImmunoGen under this Section 4.5
(including records pertaining to ImmunoGen’s compliance with
the Policy described in Section 9.1). At
Centocor’s request, the accountant shall be entitled to audit
the then-preceding [***********] years of ImmunoGen’s records
for purposes of verifying ImmunoGen’s records concerning
Costs and its purchase of Dedicated Equipment. To the extent
requested by ImmunoGen the accountant shall enter into a
confidentiality agreement with both Parties substantially similar
to the provisions of Section 6 limiting the disclosure and use
of such information by such accountant to authorized
representatives of the Parties and the purposes germane to this
Section 4.5. The results of any such audit shall be made
available to both Parties and shall be binding on both
Parties. Centocor agrees to treat the results of any such
accountant’s review of ImmunoGen’s records under this
Section 4.5 as Confidential Information of ImmunoGen subject
to the terms of Section 6. If any such audit reveals an
overcharge to Centocor attributable to a deficiency in the
calculation of Costs, or the purchase of Dedicated Equipment,
ImmunoGen shall promptly pay Centocor the amount of the overpayment
(plus interest thereon at the rate provided in Section 5.7
above), and if such overpayment is by [****] percent [*******] or
more, ImmunoGen shall pay the costs and expenses of the audit.
4.6.2
Audit of Facility . ImmunoGen agrees that, to the
extent ImmunoGen
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 Ace of 1934.
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manufactures any Preclinical Materials under
this Section 4 for subsequent use in GLP toxicology studies,
Centocor shall have the right to audit, under appropriate
confidentiality provisions, during normal business hours and not
more often than once per year, the facilities employed and the
documentation utilized by ImmunoGen or its contractors or
subcontractors for manufacturing Preclinical Materials.
Centocor may appoint a Third Party reasonably acceptable to
ImmunoGen to perform such audit; provided Centocor hereby warrants
that such Third Party will abide by secrecy and non-use obligations
no less stringent than those contained in this Agreement and, to
the extent requested by ImmunoGen, Cenotocor to provide ImmunoGen
with a copy of the confidentiality agreement evidencing such
secrecy and non-use obligations. All such audits shall be at
Centocor’s sole cost and expense. Centocor will notify
ImmunoGen at least [************] business days in advance of such
an audit by Centocor and [***********] business days in advance of
such an audit by a Third Party. ImmunoGen shall use
commercially reasonable efforts to remedy any material deficiencies
identified in such audit as soon as possible. In the event
that, subject to the obligation of ImmunoGen to use commercially
reasonable efforts, such deficiencies cannot be remedied within
[**************] business days, ImmunoGen shall so notify Centocor
and Centocor shall, as its sole remedy, be entitled to
terminate
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