EXHIBIT 10.57
***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and
240.24b-2(b)(1)
Development
Collaboration and Supply Agreement
DEVELOPMENT COLLABORATION AND
SUPPLY AGREEMENT
This Development Collaboration and Supply
Agreement (the “Agreement”) is made and entered
into as of May 24, 2002 (the “Effective
Date”), by and between Medarex, Inc., a New Jersey
corporation, with its principal place of business at 707 State Road
#206, Princeton, New Jersey 08540, (“Medarex”),
and IDM S.A., a French corporation with its principal place
of business at 172 rue de Charonne, 75011 Paris, France
(“IDM”).
Whereas, IDM is a company that
develops and commercializes cellular therapy products;
Whereas, Medarex owns
intellectual property rights relating to the anti-CTLA-4 antibody,
and operates an antibody manufacturing facility;
Whereas, IDM and Medarex signed a
Letter of Intent dated January 17, 2000 in which Medarex has
agreed to grant to IDM certain rights to the anti-CTLA-4 antibody
for use in cellular therapy applications;
Whereas, IDM and Medarex executed
an Amended and Restated Technology Access Agreement dated
July 21, 2000 (as amended, the “Technology Access
Agreement”) in which IDM has agreed to fund a research
and development program at Medarex in the amount of
[...***...];
Whereas, IDM and Medarex have
agreed that IDM may meet its commitment for funding the
above-mentioned research and development program by spending a
portion of the [...***...] on certain internal research programs
related to antibodies received from Medarex;
Whereas, IDM and Medarex have
agreed to restructure their relationship with respect to the
anti-CTLA-4 antibody and the research and development program to be
funded by IDM;
Whereas, under the restructured
relationship, IDM now wishes to purchase, and Medarex now wishes to
supply anti-CTLA-4 antibodies for use in the development of
cellular therapy products, and the parties agree that certain costs
related to the development of cellular therapy products using
anti-CTLA-4 antibodies, and the supply price paid by IDM for the
anti-CTLA-4 antibodies paid under this Agreement will be credited
against the above mentioned [...***...];
Now,
Therefore, in
consideration of the mutual promises and covenants set forth below,
IDM and Medarex mutually agree as follows:
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Confidential Treatment
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under 17 C.F.R.
§§ 200.80(b)(4) and
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240.24b-2(b)(1)
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Each of the
capitalized terms used in this Agreement (other than the section
headings), whether used in the singular or the plural form, shall
have the meaning as set forth below or, if not listed below, the
meaning as defined in places throughout this Agreement.
1.1
“Affiliate” shall mean any Person that, directly or
indirectly, through one or more intermediaries, controls, is
controlled by, or is under common control with another Person. For
purposes of this definition only, “control” and, with
correlative meanings, the terms “controlled by” and
“under common control with” shall mean (a) the
possession, directly or indirectly, of the power to direct the
management or policies of a Person, whether through the ownership
of voting securities or by contract relating to voting rights or
corporate governance, or (b) the ownership, directly or
indirectly, of at least fifty percent (50%) of the voting
securities or other ownership interest of a Person, or if lower,
the maximum ownership percentage permitted by local law where such
local law restricts foreign ownership. For purposes of this
definition only, “Person” shall mean a partnership,
limited partnership, limited liability partnership, corporation,
limited liability company, business trust, joint stock company,
trust, unincorporated association, joint venture or other similar
entity or organization, including a government or political
subdivision, department or agency of a government. Notwithstanding
the above, Medarex and IDM shall not be deemed Affiliates of each
other.
1.2 “
Antibody ” shall mean the antibody identified as
Anti-CTLA-4, as further described in the Specifications, and any
fragments or derivatives thereof, used for boosting immune response
in conjunction with the administration of the Cell-Based Vaccine.
By way of clarification, references in the Agreement to an
“Antibody” shall not include (a) cells expressing
or secreting such antibody or containing nucleotide sequences
(whether coding or non-coding) with respect lo the expression of
such Antibody, or (b) nucleotide sequences (whether coding or
non-coding) with respect to the expression of such Antibody or a
fragment of such entire Antibody containing that portion of such
Antibody conferring binding specificity for an antigen.
1.3
“Batch” shall mean a specific quantity of Antibody
that is intended to have uniform character and quality, within
specified limits, and is produced according to a single
manufacturing order during the same cycle of
manufacture.
1.4 “
BLA ” shall mean a Biologics License Application as
defined in the U.S. Food, Drug and Cosmetics Act and the
regulations promulgated thereunder, and any corresponding or
equivalent marketing authorization application registration or
certification in countries other than the USA
(“MAA”).
1.5
“Cell-based Vaccine” shall mean a product for the
prevention of human diseases comprising (a) IDM’s
proprietary whole dendritic cells that have been modified through
the selective isolation, engineering, expansion or activation of
specific cell populations performed in vitro, (b) an
antigen, (c) a vector for introducing the antigen into the
cell, and possibly (d) a maturation agent, (each a
“Subcomponent”).
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1.6
“cGMP” shall mean current good manufacturing
practices for medicinal products established by regulations in the
USA (including 21 CFR §§210 and 211, as amended, and any
successor regulations thereto).
1.7
“Confidential Information” shall mean any
Information, whether in oral, written, graphic, electronic or
tangible form, disclosed by one party to the other under this
Agreement and all pre-existing confidentiality and nondisclosure
agreements between the parties relating to the subject matter of
this Agreement or obtained in the course of this
Agreement.
1.8
“Contract Year” shall mean the twelve
(12) month period following the Effective Date and any
anniversary thereof.
1.9
“DMF” shall mean a drug master file to be
maintained with the FDA and the equivalent thereof, as applicable,
in jurisdictions outside the United States.
1.10
“FDA”, shall mean United States Food and Drug
Administration and any successor agency thereto.
1.11
“ Field ” shall mean the treatment and
prevention of the human diseases listed in Exhibit A (as may
be amended from time to time by written agreement of the parties)
using Cell- based Vaccines.
1.12
“IND” shall mean an Investigational New Drug
Application filed with the FDA in conformance with applicable laws
and regulations, and the equivalent thereof, as applicable, in
jurisdictions outside the United States.
1.13 *
“Information” shall mean any information, either
enabling or disabling, including the terms of this Agreement, any
information contained in any batch record, purchase order, or
databases, and any practices, methods, techniques, specifications,
formulations, formulae, knowledge, know-how, skill, experience,
test data, analytical and quality control data, stability data,
studies and manufacturing procedures and protocols, and any cost
information related to the manufacture of Antibody.
1.14
“Invention”, shall mean any invention or discovery,
including any improvement, alteration or enhancement of or
modification to an existing invention or discovery, that is or may
be patentable.
1.15
“Marketing Authorization Approval” shall mean, with
respect to a particular country, the approval by the Regulatory
Authority of the BLA or MAA filed in such country for the Product,
Product Component, or Antibody.
1.16
“Medarex Development Program” shall have the
meaning as set forth in Section 2.1.
1.17
“Net Revenues” shall mean the gross cash amount or
the fair market value of stock (“Consideration”)
received by Medarex from a third party in connection with the grant
of rights or sublicenses to such third party pursuant to
Section 7.4(b), less the following deductions:
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(a) if
the Consideration is received by Medarex in consideration of the
supply of Antibody, any amounts corresponding to Medarex’s
cost of goods sold of the Antibody, determined by Medarex in
accordance, with US GAAP consistently applied, and any prompt
payment or other customary trade or quantity discounts actually
allowed and taken, amounts repaid or credited by reason of timely
rejections or returns, taxes on the sale of a product (other than
franchise or income taxes on the income of the seller) actually
paid or withheld, and transportation and delivery charges,
including transport insurance premiums, actually
incurred;
(b) any
Consideration received as payment for the fair market value of any
equity issued by Medarex (as determined in good faith by the party
issuing such equity);
(c) any
Consideration received as research and development funding;
and
(d) any
Consideration received as a loan.
1.18
“Product” shall mean any product for use in the Field
that consists of two contemporaneously administered components,
with the first component being a Cell-based Vaccine and the second
component being the Antibody.
1.19
“Product Component” shall mean the Cell-based Vaccine
or the Antibody developed and intended for use as components of a
Product.
1.20 “QC
Sample” shall have the meaning as set forth in
Section 5.2.
1.21
“Regulatory Authorities” shall mean the FDA and any
corresponding non-US health regulatory authorities.
1.22
“Serious Adverse Event/Experience” or “SAE”
shall have the meaning promulgated by the FDA, including but not
limited to, any adverse experience occurring at any dose that
results in any of the following outcomes: death, a life-threatening
adverse experience, inpatient hospitalization or prolongation of
existing hospitalization, a persistent or significant
disability/incapacity, or a congenital anomaly/birth defect.
Important medical events that may not result in death, be
life-threatening, or require hospitalization may be considered a
serious adverse experience when, based upon appropriate medical
judgment, they may jeopardize the patient or subject and may
require medical or surgical intervention to prevent one of the
outcomes listed in this definition. Examples of such medical events
include allergic bronchospasm requiring intensive treatment in an
emergency room or at home, blood dyscrasias or convulsions that do
not result in inpatient hospitalization, or the development of drug
dependency or drug abuse.
1.23 “Sole
Patent” means any patent or patent application owned or
assigned solely to Medarex or IDM, as applicable, during the term
of this Agreement.
1.24
“Specifications” shall mean the specifications of the
Antibody contained in Exhibit B (as amended from time to time
by written agreement between the parties).
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1.25
“Sponsor” shall have the meaning defined by the
International Conference on Harmonisation: Good Clinical Practice:
Consolidated Guideline (Federal Register Vol. 62, No. 90: pp.
25691-25709).
1.26
“Technology Access Agreement” shall have the
meaning set forth in the recitals of this Agreement.
2.
Development
Collaboration
2.1 Scope of
the Development Collaboration.
(a) IDM
and Medarex shall collaborate on the development of the Product,
with Medarex having primary responsibility for developing the
commercial scale manufacturing process for the Antibody for Phase
III and commercial sale, and for any clinical trials prior to Phase
III studies, if so required by the FDA or any European or Japanese
equivalent, and IDM having the primary responsibility for
conducting alone or with or through third parties the preclinical
and the clinical trials with the Product Components except the
Antibody other than as part of the Product (the “Product
Development Program”) as further described in this
Section 2. Notwithstanding the above, if Japanese regulatory
authorities have specific requirements regarding the manufacturing
process for the Antibody that Medarex has not already fulfilled,
Medarex will not be required to perform such process development as
required by such Japanese regulatory authorities; provided that
Medarex will perform such process development if IDM agrees to fund
such process development program, and provided further, that if IDM
funds such process development program, IDM shall not be required
to make the milestone payment set forth in Exhibit C upon MAA
approval in Japan.
(b) independent
of the Product Development Program, Medarex shall have the right to
conduct development programs with the Antibody for any use and
purpose (each such development program a “Medarex
Development Program”). Medarex may obtain Marketing
Authorization Approval of the Antibody separate from the Marketing
Authorization Approval obtained for the Product. Medarex shall have
complete discretion as to the scope of such independent development
of the Antibody and the resources applied to such development, and
may decide to discontinue any Medarex Development Program at any
time.
2.2
Collaboration Governance.
(a) Establishment of the Steering Committee. The
parties shall establish a joint committee (the “Steering
Committee”), which shall oversee the Product Development
Program. IDM and Medarex shall each appoint two
(2) representatives with the requisite experience and
seniority to enable them to make decisions on behalf of the parties
with respect to the Product Development Program. The Steering
Committee meetings shall be held not less than twice a year. From
time to time, IDM and Medarex each may substitute any of its
representatives to the Steering Committee.
(b) Tasks of the Steering Committee. The Steering
Committee shall: (i) prepare a plan and budget for the Product
Development Program (the “Product
Development
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Plan”); (ii) approve all protocols for clinical
trials that are part of the Product Development Program, and any
changes to such protocols; (iii) review and monitor the
progress of the Product Development Program; (iv) discuss and
approve any updates and amendments to the Product Development Plan
proposed by either of the parties; (v) coordinate and monitor
dissemination or publication of research results obtained from and
the exchange of information and materials that relate to the
Product Development Program; and (vi) perform any other tasks
specifically assigned to it in this Agreement. The Steering
Committee shall not have any power to amend this Agreement and
shall have only such powers as are specifically delegated to it
hereunder.
(c) Procedures and Decisions of the Steering Committee.
Except as explicitly set forth in this subsection (c), the Steering
Committee shall establish its own procedural rules for its
operation.
(i) The Steering Committee shall take action by
unanimous consent of IDM and Medarex, with each such party having a
single vote, irrespective of the number of representatives actually
in attendance at a meeting, or by a written resolution signed by
the designated representatives of each of IDM and
Medarex.
(ii) If the Steering Committee is unable to arrive at
an unanimous consent regarding a matter within its powers pursuant
to subsection (b) above within twenty (20) days after one
of the parties requests a formal decision thereon, such matter
shall be referred to the Chief Executive Officers of each of the
parties (or their respective designees) who shall use their good
faith efforts to mutually agree upon the proper course of action to
resolve the matter.
(iii) If the matter is not resolved by the Chief
Executive Officers of the parties (or their designees) within ten
(10) business days after such matter is referred to them
pursuant to the preceding subsection (ii), then Medarex’s
Chief Executive Officer or his designee shall have the right to
make the final decision with respect to matters relating to the
Antibody (including, the Product Development Program relating to
the Antibody, the Specifications and the manufacturing process for
the Antibody), and IDM’s Chief Executive Officer shall have
the right to make the final decision with respect to matters
relating to the Cell-based Vaccine (including the Product
Development Program relating to the Cell-based Vaccine).
Notwithstanding the above, any decision of Medarex’s Chief
Executive Officer to discontinue the supply of Antibody to IDM for
use in the Product Development Program must be based on reasons
other than mere commercial reasons, such as safety, efficacy, or
other extraordinary regulatory issues, including any such issues
that may adversely affect the development and commercialization of
the Antibody developed by Medarex in a Medarex Development
Program.
2.3 Process
Development Program. Medarex shall use commercially reasonable
efforts to develop the manufacturing process for the Antibody for
clinical trials and commercial sale meeting the Specifications for
manufacture of the Antibody for use in clinical trials.
Notwithstanding anything in this Agreement, Medarex may discontinue
at any time and in its sole discretion all Medarex Development
Programs, and the development of a manufacturing process for the
Antibody. Medarex shall inform IDM promptly upon such
discontinuation. IDM may request that Medarex continue with the
process development for the Antibody at IDM’s expense. If
Medarex does not wish to undertake such process development,
Medarex shall at the request and expense of IDM, transfer the
manufacturing process for the Antibody as it exists at
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that time to
IDM or a third party manufacturer designated by IDM pursuant to a
technology transfer plan and budget agreed upon by the
parties.
2.4 Product
Development Program.
(a) IDM shall use
commercially reasonable efforts to conduct the Product Development
Program in accordance with the Product Development Plan. IDM shall
be the Sponsor of any clinical trial based upon the Cell-based
Vaccine or the Product.
(b) All expenses
incurred by IDM in connection with the Product Development Program
consisting of internal research and development costs or payments
to Medarex pursuant Section 4 of this Agreement (collectively,
the “Anti-CTLA-4 Costs”) shall be credited to
IDM’s research funding obligation pursuant to the Technology
Access Agreement and performance of this Agreement by Medarex shall
be deemed performance in full of Medarex’s obligations under
Section 3.3 of the Technology Access Agreement. The
Anti-CTLA-4 Costs shall be included as a separate line item in
IDM’s periodic financial reports to Medarex.
(c) If the Product
Development Program is terminated or abandoned prior to IDM’s
fulfillment of its research funding obligation pursuant to the
Technology Access Agreement, the parties shall negotiate and agree
on the manner in which the unspent balance shall be expended for
the mutual benefit of the parties. If the parties cannot reach
agreement on this matter, Medarex shall receive [...***...] of the
unspent balance in cash.
2.5 Exchange
of Information
(a) IDM
shall provide to Medarex all scientific and clinical data relating
to the Antibody generated in the course of the Product Development
Program at least every three (3) months in the form of updated
written reports, or in any other fashion presenting such data in an
organized and reproducible manner (e.g. electronic files). IDM
shall have the right to redact from any such reports or information
any information that relates to the Cell-Based Vaccine or any
Subcomponents thereof. Within thirty (30) days after the end
of each Contract Year, or as otherwise required by the Steering
Committee, IDM shall provide to Medarex a written progress report,
which shall (i) describe any research, development or
commercialization activities with respect to the Product and the
Product Components that it has performed, or caused to be
performed, since the last such report, (ii) evaluate the work
performed in relation to the goals of this Agreement and the
Product Development Plan, and (iii) provide such other
information as may be reasonably requested by Medarex. In addition
to the 3-month scientific reports and the annual progress reports
to be provided hereunder, it is contemplated that the parties shall
maintain informal communications through the Steering Committee and
their day-to-day activities under this Agreement. Any information
disclosed by IDM pursuant to this Section 2.5(a) shall be
Confidential Information and subject to the provisions of
Section 10.
(b) Within thirty
(30) days after the end of each Contract Year, or as otherwise
required by the Steering Committee, Medarex shall provide to IDM a
written progress report of new scientific and clinical data
generated in the course of the Medarex Development Programs as
Medarex in its reasonable discretion may deem to be necessary for
the Product Development Program or for preparing and filing BLAs
for the Product;
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Confidential Treatment
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under 17 C.F.R.
§§ 200.80(b)(4) and
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240.24b-2(b)(1)
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provided that
Medarex shall not be required to disclose any such data that is
subject to any confidentiality obligations that Medarex has
vis-a-vis third parties. Any information disclosed by Medarex
pursuant to this Section 2.5(b) shall be Confidential
Information and subject to the provisions of
Section 10.
2.6 Regulatory
Filings and Approvals.
(a) Manufacturing Approvals. Medarex shall be
responsible for any filings, permits and approvals necessary for
the manufacture of the Antibody pursuant to the Medarex Development
Programs. Medarex shall be responsible for the costs and expenses
incurred by it in connection with the filings, permits and
approvals made or obtained pursuant to this subsection 2.6(a). If
Medarex discontinues all Medarex Development Programs and if IDM
decides to fund the process development for the Antibody, then IDM
shall bear the costs and expenses incurred by Medarex following
such discontinuance in connection with such filings, permits and
approvals.
(b) Marketing Authorization Approvals for the
Antibody.
(i) Medarex shall be responsible for preparing and
filing at its own expense the BLAs and any other regulatory
filings, permits and approvals necessary for the distribution and
commercialization of the Antibody in the course of performing the
Medarex Development Program.
(ii) If Medarex has not filed a BLA for the Antibody
in a country where IDM has filed a BLA for the Cell-based Vaccine,
Medarex shall, at IDM’s written request and expense, file a
BLA for the Antibody in such country. Medarex shall use for such
filings any data and information it has previously used for the
filing of BLAs in other countries. If additional information is
needed for the filing of a BLA and obtaining Marketing
Authorization Approval in such country, Medarex shall provide such
additional information at IDM’s cost and expense; provided
that if Medarex has abandoned all Medarex Development Programs, and
if so requested by Medarex, IDM shall provide such additional
information at IDM’s cost and expense.
(iii) If Medarex starts selling the Antibody in a
country under a Marketing Authorization Approval for which IDM has
borne Medarex’s costs and expenses pursuant to the preceding
subsection 2.6(b)(ii), Medarex shall reimburse IDM all of such
costs and expenses previously paid for by IDM.
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(c) Marketing Authorization Approvals for the
Product.
(i) IDM shall, in its sole discretion be responsible
for preparing and filing the BLAs for the Cell-based Vaccine and
the simultaneous use of the Cell-based Vaccine and the Antibody as
the Product by cross-referencing the BLAs or Marketing
Authorization Approvals filed or obtained by Medarex for the
Antibody, and the clinical data for concomitant use of the
Cell-based Vaccine and the Antibody generated in the course of the
Product Development Program (the “Product
BLA”).
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(ii) IDM shall provide to Medarex full access to all
data and information compiled in support of the Product BLAs. IDM
shall provide to Medarex copies of all correspondence to and from
Regulatory Authorities relating to the Product BLAs, and shall duly
consider in its responses to Regulatory Authorities any comments
and information that Medarex may provide. Medarex shall have the
right to attend as a silent observer any meetings and conference
calls with Regulatory Authorities that may include a discussion of
issues relating to a Product or the Antibody.
(a) IDM covenants to use the Antibody solely for
purposes of conducting the Product Development Program, and not to
use the Antibody for any other purpose including any research,
development or commercialization outside the Field, or any sale or
transfer of Antibody to a third party for a purpose other than
performing tasks identified in the Product Development Plan. Any
breach of this subsection 2.7(a) by a third party that receives the
Antibody from IDM or pursuant to an agreement with IDM shall be
deemed to be a breach committed by IDM.
(b) Only
the right to use the Antibody for the Product Development Program
granted pursuant to the express terms of this Agreement shall be of
any legal force or effect. No other rights to the Antibody, or to
any other intellectual property of Medarex, either express or
implied, shall be granted or created by estoppel or otherwise. The
parties understand and agree that Medarex shall retain rights to
make, have made, import, use, offer for sale, sell and otherwise
commercialize the Antibody, itself or with third parties, for any
use.
(c) IDM
acknowledges that limitations and restrictions on its possession
and use of the Antibody hereunder are necessary and reasonable to
protect Medarex, and expressly agrees that monetary damages would
be inadequate to compensate Medarex for any violation by IDM of any
such limitations or restrictions. The parties agree that any such
violation would cause irreparable injury to Medarex and agree that
without resorting to prior mediation or arbitration, and, in
addition to any other remedies that may be available in law, in
equity or otherwise, Medarex may be entitled to seek temporary and
permanent injunctive relief against any threatened violation of
such limitations or restrictions or the continuation of any such
violation in any court of competent jurisdiction, without the
necessity of proving actual damages.
2.8 Supply of
Antibody for Commercial Use.
(a) If IDM requires Antibody for clinical trials
intended for use in Marketing Authorization. Approval applications
and if Medarex has not developed a commercial scale manufacturing
process for the Antibody at that time, the parties shall meet to
discuss and negotiate in good faith a process development plan and
the terms for an agreement between the parties regarding the
process development and the supply of Antibody to IDM for use in
such clinical trials.
(b) If
Medarex is selling the Antibody pursuant to an approved BLA in a
country at the time IDM, or an Affiliate or licensee of IDM,
obtains approval of the Product BLA in that country, IDM or its
customers shall purchase the Antibody from
Medarex’s
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distributors in
that country. Notwithstanding the foregoing, upon request of IDM,
the Parties will discuss in good faith alternative supply
arrangements for the Antibody with respect to those countries where
the Product is being sold.
(c) If Medarex is not selling the Antibody pursuant to an
approved BLA in a country at the time IDM obtains BLA approval for
the Cell-based Vaccine in that country, Medarex shall supply to IDM
or its Affiliates or licensees the Antibody pursuant to an
agreement for the supply of Antibodies for commercial use. The
parties shall commence good faith negotiations regarding such
agreement promptly after IDM or its Affiliate or licensee has filed
the Product BLA. The terms of such agreement shall include without
limitation the term of the supply arrangements, customary warranty,
indemnification and liability provisions, an obligation of IDM to
make milestone payments as provided in Exhibit C hereto,
provisions related to the number of months for which IDM or its
Affiliates or licensees shall make a rolling forecast, the time at
which such forecasts shall become binding, the percentage by which
IDM may vary or reschedule binding orders (subject to limitations
to be agreed upon), volume-based pricing, and other terms that are
customary in connection with the manufacture and supply of
biopharmaceutical products.
3.
Forecasts; Orders;
Deliveries
3.1
Forecasts. Within thirty (30) days after the Effective
Date and on or before each anniversary of the Effective Date, the
Steering Committee shall determine the quantities of Antibody
required by IDM during the Contract Year following such date. In
addition, the Steering Committee shall determine the schedule of
delivery dates for such quantities subject to Medarex’s
manufacturing capacity, and Medarex’s own requirements and
supply commitments to third parties, provided however that if the
available supply of Antibody is not sufficient to meet the demand
therefore after Medarex’s requirements have been met, orders
will be filled on a first come first serve basis.
(a) Not
more than once every six (6) months during the term of this
Agreement, IDM shall place orders in quantities corresponding to
complete Batches in accordance with the forecasts and the delivery
schedules prepared by the Steering Committee pursuant to
Section 3.1 above, provided that Medarex shall use good faith
efforts to supply quantities of Antibody in excess of the
forecasted quantities upon request of IDM, subject to available
manufacturing capacity and Medarex’s own requirements and
supply obligations to third parties. Medarex shall fulfill all
purchase orders that IDM places in accordance with this
Section 3 that are within the quantity limitations and that
adhere to the delivery schedule agreed upon by the Steering
Committee pursuant to Section 3.1.
(b) Any
purchase orders for Antibody submitted by IDM shall reference this
Agreement and shall be governed exclusively by the terms contained
herein. Any term or condition in any order, confirmation or other
document furnished by IDM or Medarex which is different from or in
addition to the terms of this Agreement is hereby expressly
rejected.
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3.3
Deliveries. Unless otherwise agreed by the parties in writing,
all QC Samples and Batches of Antibody shall be delivered FCA
(Incoterms 2000) Medarex’s facility. Medarex shall not
deliver any Batch of Antibody until IDM accepts or is deemed to
have accepted the QC Sample in accordance with the provisions of
Section 5.3(a), or a third party laboratory reasonably
acceptable to both Medarex and IDM determines that a sample of a
Batch meets Specifications in accordance with the provisions of
Section 5.3(b).
4.1 Price.
The price of Antibody ordered by IDM shall be Medarex’s cost
of goods of the Antibody calculated in accordance with US GAAP
consistently applied plus [...***...]. The “cost of
goods”, shall include any payments made by Medarex to its
direct and indirect licensors through multiple tiers of licenses
that become due as a result of the performance of this Agreement by
Medarex or IDM.
4.2 Method of
Payments. All payments due under this Agreement to Medarex
shall be paid in United States Dollars not later than forty-five
(45) days following the receipt of the applicable invoice. Any
invoiced amount not paid by its due date shall be assessed a late
payment fee at the rate of one percent (1%) per month, or the
maximum rate permitted by applicable law with respect to such
obligations, whichever is less.
5.
Product Warranty;
Acceptance and Rejection
5.1 Limited
Warranty. Medarex warrants that (a) each Batch of Antibody
delivered hereunder shall have been manufactured in accordance with
cGMP and in accordance with the manufacturing procedures described
in the master batch records, as may be modified in accordance with
the provisions of Section 6.1, and (b) each QC Sample and
Batch conforms to the Specifications at the time of delivery
pursuant to Section 3.3. This warranty is the only warranty
made by Medarex with respect to Antibodies. THE EXPRESS WARRANTY IN
THIS SECTION 5.1 IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, OR NON-INFRINGEMENT OF THIRD PARTY
RIGHTS.
5.2 Delivery
Documentation; Testing.
(a) Prior to the delivery of a Batch of Antibody, Medarex
shall provide IDM with (i) a certificate of analysis
confirming that the Batch has been tested and meets the
Specifications, (ii) a written confirmation that such batch
records have been reviewed and approved by Medarex’s quality
assurance unit, and (iii) a sample of sixty
(60) milligrams drawn from such Batch (the “ QC
Sample ”). In addition, IDM may inspect at
Medarex’s facility a copy of the batch records during
business hours upon reasonable advance notice.
(b) IDM may retest the QC Samples and Batches upon receipt
to confirm that they meet Specifications.
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*
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Confidential Treatment
Requested
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under 17 C.F.R.
§§ 200.80(b)(4) and
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240.24b-2(b)(1)
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5.3 Acceptance
and Rejection.
(a) IDM
may reject a QC Sample or Batch which does not meet the
Specifications by providing notice thereof to Medarex. Any such
notice of rejection shall be in writing and shall indicate the
reasons for such rejection, and must be received by Medarex within
(i) fifteen (15) days after delivery by Medarex of the QC
Sample and the associated documentation or (ii) thirty
(30) days after delivery by Medarex of a Batch and the
associated documentation (each, a “Testing Period”). If
no such notice of rejection is received by Medarex within the
applicable Testing Period, IDM shall be deemed to have accepted
such QC Sample or the Batch of Antibody upon the expiration of the
applicable Testing Period. Medarex shall be authorized to make
delivery of the full Batch of Antibody only after acceptance of the
QC Sample. Once IDM accepts or is deemed to have accepted a Batch
of Antibody, IDM shall have no recourse against Medarex if Antibody
of that Batch is subsequently deemed unsuitable for use for any
reason.
(b) If
IDM provides a notice of rejection, Medarex shall notify IDM as
promptly as reasonably possible whether it accepts IDM’s
basis for the rejection. IDM shall cooperate with Medarex in
determining whether the rejection is justified. If Medarex
disagrees with IDM’s determination that a QC Sample or a
Batch does not meet the Specifications, a sample drawn from the
corresponding Batch of Antibody shall be submitted to a mutually
acceptable third party laboratory. Such third party laboratory
shall determine whether such sample meets the Specifications and
the parties agree that such laboratory’s determination shall
be final and determinative. The party against whom the third party
tester rules shall bear all costs of the third party
testing.
(c) Medarex
shall investigate, and cooperate fully with IDM in investigating,
the cause for any QC Sample or Batch failing to meet
Specifications. Medarex shall keep IDM informed of the status of
any investigation
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