Exhibit 10.80
RESEARCH AND COMMERCIALIZATION AGREEMENT
THIS RESEARCH AND COMMERCIALIZATION AGREEMENT (the "Agreement"),
effective as of February 9, 1998 (the "Effective Date"), is entered by and
between GenPharm International, Inc., a wholly owned subsidiary of Medarex,
Inc., and Medarex, Inc., a New Jersey corporation, with a principal place of
business at 0000 Xxxxx 00 Xxxx, Xxxxxxxxx, Xxx Xxxxxx 00000 (together
"Medarex"), and Schering AG, with a principal place of business at
Xxxxxxxxxxxxxx, 000 Xxxxxx, Xxxxxxx D-13342 ("Schering").
BACKGROUND
A. Medarex is the sole and exclusive owner of certain transgenic
Mice useful for the preparation of fully human monoclonal antibodies;
B. Schering desires to have Medarex conduct research with the Mice
to evaluate their utility for the development of fully human monoclonal
antibodies to a certain Antigen (as defined below) for use as a human
therapeutic product, and Medarex is willing to conduct such Research, on the
terms and conditions herein; and
C. Schering wishes to acquire from Medarex an option to acquire a
commercial license for the use of monoclonal antibodies with specificity for the
Antigen to commercialize Products (as defined below), on the terms and
conditions herein.
NOW, THEREFORE, Medarex and Schering agree as follows:
1. DEFINITIONS
1.1 "Affiliate" means any corporation or other entity which is
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directly or indirectly controlling, controlled by or under the common control
with Schering. For the purpose of this Agreement, "control" shall mean the
direct or indirect ownership of fifty percent (50%) or more of the outstanding
shares or other voting rights of the subject entity to elect directors, or if
not meeting the preceding, any entity owned or controlled by or owning or
controlling at the maximum control or ownership right permitted in the country
where such entity exists.
1.2 "Antibody" shall mean any human monoclonal antibody with
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binding affinity for an Antigen derived from cells obtained from one or more of
the Mice pursuant to this Agreement.
1.3 "Antigen" shall mean *****, as described in the Research Plan
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***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
1.4 "Biological License Application" or "BLA" shall mean Biological
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License Application as defined in the U.S. Food, Drug and Cosmetic Act and the
regulations promulgated thereunder, and any corresponding foreign application,
registration or certification.
1.5 "Confidential Information" shall mean (i) any proprietary or
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confidential information or material in tangible form disclosed hereunder that
is marked as "Confidential" at the time it is delivered to the receiving party,
or (ii) proprietary or confidential information disclosed orally hereunder which
is identified as confidential or proprietary when disclosed and such disclosure
of confidential information is confirmed in writing within thirty (30) days by
the disclosing party, except that to the extent that it can be established by
the receiving party by competent proof that such Confidential Information:
(i) was already known to the receiving party, other than
under an obligation of confidentiality, at the time of disclosure;
(ii) was generally available to the public or otherwise part
of the public domain at the time of its disclosure to the receiving party;
(iii) became generally available to the public or otherwise
part of the public domain after its disclosure and other than through any act or
omission of the receiving party in breach of this Agreement;
(iv) was independently developed by the receiving party as
demonstrated by documented evidence prepared contemporaneously with such
independent development; or
(v) was subsequently lawfully disclosed to the receiving
party by a person other than a party hereto.
1.6 "Control" or "Controlled" shall mean possession of the ability
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to grant the licenses or sublicenses as provided for herein without violating
the terms of any agreement or other arrangement with any third party.
1.7 "Evaluation Period" shall mean the period commencing on the
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Effective Date and ending three (3) months after the end of the Research Period,
unless Schering terminates the Research Program or Agreement pursuant to Section
13.4.1, in which case the Evaluation Period shall end as of the effective date
of such termination.
1.8 "IND" shall mean an Investigational New Drug application, as
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defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated
thereunder for initiating clinical trials in the United States, or any
corresponding foreign application, registration or certification.
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1.9 "Medarex Technology" shall mean the Patent Rights and Know How.
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1.9.1 "Know How" shall mean the Confidential Information and
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Mice and Mice Materials owned or Controlled by Medarex and transferred to
Schering by Medarex necessary or useful for the exercise of the Patent Rights,
including, without limitation, technical data, protocols and methods and
processes. For the avoidance of doubt, the Know How does not include any
subject matter within the scope of the Patent Rights.
1.9.2 "Patent Rights" shall mean all United States and foreign
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patents (including all reissues, extensions, substitutions, confirmations,
re-registrations, re-examinations, revalidations and patents of addition) and
patent applications (including, without limitation, all continuations,
continuations-in-part and divisions thereof) owned or Controlled by Medarex, in
each case, which claims an Antibody, or an invention which is necessary or
useful for the use of the Antibodies or a hybridoma cell line transferred to
Schering hereunder, or to make, use or sell Products.
1.10 "Mice" shall mean immunizable transgenic mice covered by the
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Patent Rights containing unrearranged human immunoglobulin genes.
1.11 "Mice Materials" shall mean any parts or derivatives of the Mice
prepared by Medarex in connection with the Research Program, including without
limitation, cells, hybridomas, Antibodies, genes, DNA sequences or other
biological materials derived directly or indirectly from the Mice.
1.12 "NDA" means an application for approval to market a
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pharmaceutical product in the United States filed with the United States Food
and Drug Administration ("FDA"), or a similar application with an equivalent
regulatory authority in another country.
1.13 "Net Sales" shall mean *****.
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***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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*****
1.14 "Phase I", "Phase II" and "Phase III" shall mean Phase I (or
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Phase I/II), Phase II, and Phase III clinical trials, respectively, in each
case as prescribed by the U.S. Food and Drug Administration or a corresponding
foreign entity.
1.15 "Pivotal Trial" means a clinical trial that is designed to
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provide data sufficient for the purpose of obtaining regulatory approval from
the U.S. Food and Drug Administration or a corresponding foreign entity, and
which when completed will have demonstrated that the Product (i) is safe and
efficacious, (ii) has an established dose, (iii) has an established route of
administration, and (iv) has a treatment schedule in the target population.
1.16 "Product" shall mean any product for the treatment of human
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disease containing an Antibody or a portion thereof. A Product used for several
indications is considered to be a single Product.
1.17 "Research" shall mean the activities conducted by Medarex in the
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Research Period in connection with the preparation of Antibodies.
1.18 "Research Period" shall mean the period from the Effective Date
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until the earlier of (i) *****, or if extended pursuant to Section 2.6, *****,
and (ii) the termination of the Research Program or the Agreement.
1.19 "Research Plan" shall mean the plan for the conduct of the
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Research attached hereto as Exhibit A, as may be amended by the written
agreement of the parties.
1.20 "Sublicensee" shall mean a third party (except an Affiliate) to
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whom Schering has granted a license or sublicense to make, have made, import,
use, sell, offer for sale or otherwise exploit Products in the Territory. As
used in this Agreement, "Sublicensee" shall also include any third party (except
an Affiliate) to whom Schering has granted the right to distribute a Product.
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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1.21 "Territory" shall mean all countries of the world.
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2. RESEARCH
2.1 Research.
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2.1.1 Immunization. Subject to the terms and conditions set
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forth herein, Medarex will immunize Mice with the Antigen during the Research
Period to produce Antibodies for evaluation by Schering for commercial
development pursuant to the Research Plan. Medarex shall immunize ***** Mice
with the Antigen provided by Schering and isolate Antibodies from such Mice.
2.1.2 Reasonable Efforts. Medarex shall use reasonable
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efforts to conduct the Research Program in a professional manner and agrees to
commit the personnel, facilities and other resources necessary to perform the
immunizations; provided, however, it does not warrant that the Research shall
result in the preparation of any Antibody suitable for development as a Product.
2.2 Research Support. Schering shall pay to Medarex a research support
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payment of ***** for the conduct of the Research. The first payment shall be
due on the Effective Date, and subsequent payments shall be due on the quarterly
anniversary thereof during the Research Period, including any extension thereof
pursuant to Section 2.6.
2.3 Delivery of Antigens. Schering shall deliver to Medarex a mutually
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agreed quantity of the Antigen in a substantially pure form for the immunization
of the Mice. Medarex shall only use the Antigen provided by Schering to conduct
immunizations of the Mice, and shall not conduct other activities with or any
analysis of the Antigen.
2.4 Delivery of Antibodies. Upon the preparation of an Antibody for
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the Antigen, Medarex shall deliver to Schering the amount of milligrams of such
Antibody for evaluation by Schering as specified in the Research Plan.
2.5 Research License. Medarex hereby grants to Schering and its
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Affiliates ***** license to use the Antibodies prepared by Medarex during the
Research Period solely for research and evaluation purposes.
2.6 Term. The Research shall commence on the Effective Date and
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terminate *****; provided, with notice to Medarex at least thirty (30) days
prior to *****, Schering may extend the term of the Research until *****.
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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2.7 Ownership
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2.7.1 Mice. Title to the Mice and, subject to Sections 3.1 and
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3.2, Mice Materials shall at all times remain with Medarex.
2.7.2. Intellectual Property. *****
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3. OPTION; COMMERCIAL LICENSE
3.1 Option.
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3.1.1 Option. During the Evaluation Period, Schering shall
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have an option to obtain an exclusive (even as to Medarex), worldwide commercial
license as set forth in Section 3.2 solely to develop Antibodies for use in the
development and commercialization of Products. Schering may exercise such option
by notice to Medarex during the foregoing period specifying ***** to be covered
by the commercial license, and concurrently paying to Medarex the applicable
license fee due pursuant to Section 4.1. Medarex shall not license, sell,
transfer or use in any manner any Antibodies arising out of the Research to any
third party except Schering. At Schering's request, Medarex shall destroy any
Antibodies, and related Mice Materials prepared by Medarex in the Research.
3.1.2 Extension. *****
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3.2 Commercial License. Effective upon Schering's election to
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acquire a commercial license, subject to the terms and conditions of this
Agreement (including without limitation, the timely payment of the license fee
due pursuant to Section 4.1) Medarex shall grant to Schering the following
licenses:
3.2.1 an exclusive (even as to Medarex), worldwide,
non-transferable (except as set forth in Section 14.3), royalty bearing license
under the Medarex Technology with the right to sublicense, to use hybridomas
delivered by Medarex to Schering to make or have made Antibodies, and
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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3.2.2 an exclusive (even as to Medarex), worldwide, non-
transferable (except as set forth in Section 14.3), royalty bearing license
under the Medarex Technology, with the right to sublicense, to use Antibodies to
make, have made, import, have imported, use, offer for sale and sell Products.
3.3 Delivery of Hybridomas. If Schering acquires a commercial license
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for a particular Antibody, Medarex shall deliver to Schering a hybridoma cell
line producing such Antibody.
3.4 Retained Rights; No Further Rights. Only the license granted
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pursuant to the express terms of this Agreement shall be of any legal force or
effect. No other license rights shall be granted or created by implication,
estoppel or otherwise. It is understood and agreed that Medarex shall retain
rights to make, have made, import, use, offer for sale, sell and otherwise
commercialize the Mice itself which have not been used for the Research or
immunized with any Antigens or with third parties for any uses.
4. CONSIDERATION
4.1 Commercial License Fee. If Schering wishes to acquire a commercial
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license from Medarex pursuant to Section 3.2 above, concurrently with
Schering's notice to Medarex of its exercise of its option, upon delivery
of Mice Materials to Schering pursuant to Section 3.3, Schering shall pay
to Medarex a commercial license fee of *****.
4.9 Milestone Payments. Within thirty (30) days following the
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occurrence of the relevant events specified below with respect to each Product
which contains an Antibody, Schering shall pay to Medarex the following amounts:
Milestones Amounts
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***** *****
Milestones shall be paid once per Product. *****.
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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*****
4.3 Royalties.
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4.3.1 Royalty on Net Sales. In partial consideration for the
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commercial license, Schering shall pay to Medarex a royalty on annual Net Sales
of Products, on a Product-by-Product basis, as follows:
*****
4.3.2 Royalty Term. The royalties due pursuant to this
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Section 4.3 shall be payable on a Product-by-Product and country-by-country
basis until: *****
4.3.3 Minimum Royalty Obligation. *****
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5. PAYMENTS
5.1 Payment Method. All amounts due Medarex hereunder shall be paid
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in U.S. dollars by wire transfer in immediately available funds to an account
designated by Medarex.
5.2 Currency; Foreign Payments. If any currency conversion shall be
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required in connection with the payment of any royalties hereunder, such
conversion shall be made by using the exchange rate for the purchase of U.S.
dollars reported by the Chase Manhattan Bank on the last business day of the
calendar quarter to which such royalty payments relate. If at any time legal
restrictions prevent the prompt remittance of any royalties owed on Net Sales in
any jurisdiction, Schering may notify Medarex and make such payments by
depositing the amount thereof in local currency in a bank account or other
depository in such country in the name of Medarex, and Schering shall have no
further obligations under this Agreement with respect thereto.
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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5.3 Taxes. Any tax paid or required to be withheld by Schering on
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account of royalties payable to Medarex under this Agreement shall be deducted
from the amount of royalties otherwise due. Schering shall secure and send to
Medarex proof of any such taxes withheld and paid by Schering for the benefit of
Medarex and shall, at Medarex's request, provide reasonable assistance in
recovering said taxes, if possible, and shall reasonably assist Medarex to
obtain the benefit of any applicable tax treaty.
6. REPORTS AND RECORDS
6.1 Payment of Royalties.
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6.1.1 Royalty Report. Schering shall provide a royalty report
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and, if applicable, a royalty payment to Medarex on a quarterly calendar basis.
The report relating to Net Sales within the U.S. shall be provided within *****
after the end of the calendar quarter to which such report and payment apply and
the report relating to Net Sales for countries other than the U.S. shall be
provided within ***** after the end of the calendar quarter to which such report
and payment apply.
6.1.2 Records Retention. Schering shall keep and requires its
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Affiliates and Sublicensees to keep, for a period of not less than seven (7)
years, complete and accurate records of all Net Sales of Products. Medarex shall
have the right, at its sole expense, through a certified public accountant
reasonably acceptable to Schering, and following reasonable notice, to examine
records of Net Sales during regular business hours during the royalty term,
provided, however, that such examination shall not (i) be of records for more
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than the *****, (ii) take place more often than once a year, and (iii) cover any
records which date prior to the date of the last examination, and provided
further that, such accountants shall report to Medarex only as to the accuracy
of the royalty statements and payments and the amount of any underpayment or the
accuracy of statements. Copies of such reports shall be supplied to Schering. In
the event the report demonstrates that Schering has underpaid royalties,
Schering shall promptly pay such amounts to Medarex. In addition, if the amount
of underpayment of royalty due pursuant to this Agreement in any quarter is
lower than the amount due by ***** or more, then Schering shall also pay the
costs of such audit *****.
6.1.3 Form of Payment. All payments to Medarex hereunder shall
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be made in United States Dollars, for such Medarex's account, by wire transfer
to a bank in the United States designated in writing by Medarex; provided that
where payments in respect of Net Sales are based on Net Sales in non-U.S.
currencies, the amount of Net Sales and any deductions used to calculate Net
Sales, if any, shall be converted monthly to United States Dollars at the
average of the average daily "bid" and "asked" exchange rates as provided by
Reuters (or a different independent wire service providing international spot
exchange rates agreed to by the Parties) for the applicable month.
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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6.2 Reports on Net Sales Exclusions. In the event that Schering or
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its Affiliates or Sublicensees distributes Products to any entity for research
or clinical testing purposes, or indigent or other public support programs, and
determines that such distributions shall be excluded from the computation of Net
Sales, then Schering shall provide an annual written report on February 15 of
each calendar year describing such distribution of all such Products, the
purpose for which such Products were distributed, and the quantities of Products
so distributed in the preceding calendar year.
7. ANTIBODY SUPPLY
If Schering wishes to have Medarex manufacture Antibodies for use in
Products for commercial sale it may notify Medarex, and in such case Schering
and Medarex shall negotiate in good faith the terms of a supply agreement.
8. CONFIDENTIALITY
8.1 Confidential Information. Except as expressly provided herein, the
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parties agree that, for the term of this Agreement and for five (5) years
thereafter, the receiving party shall keep completely confidential and shall not
publish or otherwise disclose and shall not use for any purpose except for the
purposes contemplated by this Agreement any Confidential Information furnished
to it by the disclosing party hereto pursuant to this Agreement, except that to
the extent that it can be established by the receiving party by competent proof
that such Confidential Information:
(i) was already known to the receiving
party, other than under an obligation of confidentiality, at the time of
disclosure,
(ii) was generally available to the public
or otherwise part of the public domain at the time of its disclosure to the
receiving party;
(iii) became generally available to the
public or otherwise part of the public domain after its disclosure and other
than through any act or omission of the receiving party in breach of this
Agreement;
(iv) was independently developed by the
receiving party as demonstrated by documented evidence prepared
contemporaneously with such independent development; or
(v) was subsequently lawfully disclosed to
the receiving party by a person other than a party hereto.
8.2 Permitted Use and Disclosures. Each party hereto may use or
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disclose information disclosed to it by the other party to the extent such use
or disclosure is reasonably necessary in complying with applicable governmental
regulations or otherwise submitting information to tax or other governmental
authorities, conducting clinical trials, or making a permitted sublicense or
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otherwise exercising its rights hereunder provided that if a party is required
to make any such disclosure of another party's confidential information, other
than pursuant to a confidentiality agreement, it will give reasonable advance
notice to the latter party of such disclosure and, save to the extent
inappropriate in the case of patent applications, will use its reasonable
efforts to secure confidential treatment of such information prior to its
disclosure (whether through protective orders or otherwise).
8.3 Public Disclosure. Except as otherwise required by law, neither party
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shall issue a press release or make any other public disclosure of the terms of
this Agreement without the prior approval of such press release or public
disclosure. Each party shall submit any such press release or public disclosure
to the other party, and the receiving party shall promptly review such press
release or public disclosure, but in no event within fifteen (15) days to
review and approve any such press release or public disclosure, which approval
shall not be unreasonably withheld. If the receiving party does not respond
within such fifteen (15) day period, the press release or public disclosure
shall be deemed approved. In addition, if a public disclosure is required by
law, including without limitation in a filing with the Securities and Exchange
Commission, the disclosing party shall provide copies of the disclosure
reasonably in advance of such filing or other disclosure for the nondisclosing
party's prior review and comment.
8.4 Confidential Terms. Except as expressly provided herein, each party
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agrees not to disclose any terms of this Agreement to any third party without
the consent of the other party, provided, disclosures may be made as required by
securities or other applicable laws, or to actual or prospective investors or
corporate partners, or to a party's accountants, attorneys and other
professional advisors.
9. DILIGENCE
Schering agrees to use reasonable efforts to diligently develop and
commercialize the Products and obtain such approvals as may be necessary for
the sale of such Products in the United States and other markets worldwide.
Schering's efforts shall be comparable to those efforts Schering makes with
respect to its other products of comparable value, stage of development and
patent protection. Schering shall notify Medarex within thirty (30) days after
the first commercial sale of each Product.
10. REPRESENTATIONS AND WARRANTIES
10.1 Medarex. Medarex, Inc. represents and warrants that: (i) it is a
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corporation duly organized validly existing and in good standing under the laws
of the State of New Jersey; (ii) the execution, delivery and performance of this
Agreement have been duly authorized by all necessary corporate action on the
part of Medarex, Inc.; (iii) it is the sole and exclusive owner of all right,
title and interest in the Mice; and (iv) it has the right to grant the rights
and licenses granted herein.
10.2 Schering. Schering represents and warrants that: (i) it is a
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corporation duly organized validly existing and in good standing under the laws
of Germany; and (ii) the execution, delivery and
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performance of this Agreement have been duly authorized by all necessary
corporate action on the part of Schering.
10.3 Disclaimer of Warranties. THE MICE MATERIALS ARE PROVIDED "AS
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IS", AND EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, MEDAREX AND
ITS RESPECTIVE AFFILIATES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OR
CONDITIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE MICE,
ANTIBODIES, PRODUCTS OR MEDAREX TECHNOLOGY, INCLUDING, BUT NOT LIMITED TO,
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF THE
PATENT RIGHTS LICENSED HEREUNDER, OR NONINFRINGEMENT OF THE INTELLECTUAL
PROPERTY RIGHTS OF THIRD PARTIES.
10.4 Disclaimer. Nothing in this Agreement is or shall be construed
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as:
(a) A warranty or representation by Medarex as to the
validity or scope of any claim or patent within the
Patent Rights;
(b) A warranty or representation that anything made, used,
sold or otherwise disposed of under any license granted
in this Agreement is or will be free from infringement
of any patent rights or other intellectual property
right of any third party;
(c) An obligation to bring or prosecute actions or suits
against third parties for infringement of any of the
Patent Rights or the use of any Know-How; or
(d) Granting by implication, estoppel, or otherwise any
licenses or rights under patents or other rights of
Medarex or third parties, regardless of whether such
patents or other rights are dominant or subordinate to
any intellectual property rights within the Medarex
Technology.
11. INTELLECTUAL PROPERTY
11.1 Patent Rights.
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*****
11.2 Failure to Prosecute.
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*****
*****REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
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*****
11.3 Cooperation. *****
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11.4 Infringement Claims. If the manufacture, importation, sale or
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use of the Product pursuant to this Agreement results in any claim, suit or
proceeding alleging patent infringement against Medarex or Schering, such party
shall promptly notify the other party hereto, and if the notified party has an
obligation to indemnify the other party pursuant to Section 13.1 or 13.2, such
party shall have the right to control the defense of such claim, suite or
proceeding. The defendant shall keep each other party hereto reasonably informed
of all material developments in connection with any such claim, suit or
proceeding.
12. DISPUTE RESOLUTION
12.1 Mediation. If a dispute arises out of or relates to this
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Agreement, or the breach thereof, and if said dispute cannot be settled through
negotiation, the parties agree first to try in good faith to settle the dispute
by mediation under the Commercial Mediation Rules of the American Arbitration
Association, before resorting to litigation, or some other dispute resolution
procedure.
12.2 Venue. The exclusive venue of any dispute arising out of or in
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connection with the performance of or any breach of this Agreement, shall be the
state courts or U.S. district court located in or for New Jersey, and the
parties hereby irrevocably consent to the personal jurisdiction of such courts.
13. INDEMNIFICATION
13.1 Medarex. Medarex shall indemnify, defend and hold harmless
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Schering and its directors, officers, employees and agents (each a "Schering
Indemnitee") from and against any and all liabilities, damages, losses, costs or
expenses (including attorneys' and professional fees and other expenses of
litigation and/or arbitration) (a "Liability") resulting from a claim, suit or
proceeding made or brought by a third party against an Schering Indemnitee
arising from or occurring as a result of any reach of the representations and
warranties set forth in Section 10.1, except to the extent caused by the
negligence or willful misconduct of Schering.
13.2 Schering. Schering shall indemnify, defend and hold harmless
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Medarex and its directors, officers, employees and agents (each a "Medarex
Indemnitee") from and against any and
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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all liabilities, damages, losses, costs or expenses (including attorneys
and professional fees and other expenses of litigation and/or arbitration) (a
"Liability") resulting from a claim, suit or proceeding made or brought by a
third party against a Medarex Indemnitee, arising from or occurring as a result
of (i) any breach of the representations and warranties set fort in Section
10.2, (ii) the use of the Antigen by Medarex, to conduct the Research, (iii) the
practice by Schering of any right granted herein, or (iv) any development
testing, manufacture, importation, use, offer for sale, sale or other
distribution of any Product by Schering or its Affiliates Sublicensees
(including, without limitation, product liability claims), except in each case
to the extent caused by the negligence or willful misconduct of Medarex.
13.3 Procedure. In the event that any Indemnitee intends to claim
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indemnification under this Article 13 it shall promptly notify the other party
(the "Indemnitor") in writing of such alleged Liability. The Indemnitor shall
have the sole right to control the defense and settlement thereof. The
Indemnitees shall cooperate with the Indemnitor and its legal representatives in
the investigation of any action, claim or liability covered by this Article 13.
The Indemnitee shall not, except at its own cost, voluntarily make any payment
or incur any expense with respect to any claim or suit without the prior written
consent of the Indemnitor, which the Indemnitor shall not be required to give.
14. TERM AND TERMINATION
14.1 Term. The term of this Agreement shall commence on the Effective
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Date. Unless earlier terminated as provided in this Article 14, this Agreement
shall continue in full force and effect on a country-by-country and Product-by-
Product basis until there are no remaining royalty payment obligations in a
country, at which time the Agreement shall expire in its entirety in such
country.
14.2 Termination for Cause. Either party may terminate this
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Agreement in the event the other party has materially breached or defaulted in
the performance of any of its obligations hereunder, and such default has
continued for ninety (90) days after written notice thereof was provided to the
breaching party by the nonbreaching party. Any termination shall become
effective at the end of such ninety (90) day period unless the breaching party
has cured any such breach or default prior to the expiration of the ninety (90)
day period. Notwithstanding the above, in the case of a failure to timely pay
any amounts due hereunder, the period for cure of any subsequent default
following notice thereof shall be ten (lO) days and, unless payment is made
within such period the termination shall become effective at the end of such
period.
14.3 Termination for Insolvency. If voluntary or involuntary
--------------------------
proceedings by or against a party are instituted in bankruptcy under any
insolvency law, or a receiver or custodian is appointed for such party, or
proceedings are instituted by or against such party for corporate reorganization
or the dissolution of such party, which proceedings, if involuntary, shall not
have been dismissed within sixty (60) days after the date of filing, or if such
party makes an assignment for the benefit of creditors, or substantially all of
the assets of such party are seized or attached and not released within sixty
(60) days thereafter, the other party may immediately terminate this Agreement
effective upon notice of such termination.
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14.4 Permissive Termination.
----------------------
14.4.1 Schering. Schering may terminate the Research Program
--------
and this Agreement with ***** written notice to Medarex.
14.4.2 Medarex. In that event that Schering fails to obtain a
-------
commercial license pursuant to Section 3.2 on or before the end of the
Evaluation Period, Medarex may terminate the Agreement with written notice to
Schering.
14.5 Effect of Termination and Expiration.
------------------------------------
(a) Accrued Rights and Obligations. Termination of
------------------------------
this Agreement for any reason shall not release any party hereto from any
liability which, at the time of such termination, has already accrued to the
other party or which is attributable to a period prior to such termination nor
preclude either party from pursuing any rights and remedies it may have
hereunder or at law or in equity with respect to any breach of this Agreement.
It is understood and agreed that monetary damages may not be a sufficient remedy
for any breach of this Agreement and that the non-breaching party may be
entitled to injunctive relief as a remedy for any such breach.
(b) Return of Confidential Information. Upon any
----------------------------------
termination or expiration of this Agreement, Schering and Medarex shall promptly
return to the other party all confidential Information of the other; provided
counsel of each party may retain one (1) copy of such Confidential Information
for archival purposes and for ensuring compliance with Article 8.
(c) Stock on Hand. In the event this Agreement is
-------------
terminated for any reason, Schering shall have the right to sell or otherwise
dispose of the stock of any Product subject to this Agreement then on hand,
subject to Articles 5 and 6 until the first anniversary of the effective date
of such termination.
(d) Return of Mice Materials. Upon any termination
------------------------
of this Agreement, Schering shall promptly return to Medarex, or destroy all
hybridomas provided by Medarex and all cells capable of producing Antibodies,
and in the event of such destruction an officer of Schering shall provide
Medarex with written certification thereof. Upon any termination or upon
completion of the Research Program, Medarex shall return to Schering any
quantities of Antigen not used in connection with the Research.
(e) Licenses. The option and license rights granted
--------
in Section 3.1 shall terminate upon any termination of this Agreement, and in
such event Schering and its Affiliates and Sublicensees shall cease all
development and commercialization of Products.
14.6 Survival. Section 2.7, the last two sentences of Section
--------
3.l.1, 3.4, 14.5 and 14.6, and Articles 5,6,8,10,11,12 and 15 of this Agreement
shall survive termination of this Agreement for any reason.
*****REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
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15. MISCELLANEOUS
15.1 Governing Law. This Agreement and any dispute, including
-------------
without limitation any arbitration, arising from the performance or breach
hereof shall be governed by and construed and enforced in accordance with the
laws of the state of California, without reference to conflicts of laws
principles.
15.2 Independent Contractors. The relationship of the parties hereto
-----------------------
is that of independent contractors. The parties hereto are not deemed to be
agents, partners or joint venturers of the others for any purpose as a result of
this Agreement or the transactions contemplated thereby.
15.3 Assignment. This Agreement shall not be assignable by Schering
----------
to any third party hereto without the written consent of Medarex which consent
shall not be unreasonably withheld; except Schering may assign this Agreement,
without such consent, to an entity that acquires all or substantially all of
its business or assets to which this Agreement pertains, whether by merger,
reorganization, acquisition, sale, or otherwise. Medarex may assign this
Agreement after the Research Period with prior notice to Schering. This
Agreement shall be binding upon and inure to the benefit of the parties and
their successors and assigns.
15.4 Notices. All notices, requests and other communications
-------
hereunder shall be in writing and shall be personally delivered or sent by
telecopy or other electronic facsimile transmission or by registered or
certified mail, return receipt requested, postage prepaid, in each case to the
respective address specified below, or such other address as may be specified in
writing to the other parties hereto:
If to Medarex: Medarex, Inc.
0000 Xxxxx 00 Xxxx
Xxxxxxxxx, Xxx Xxxxxx 00000
Attn: President
If to Schering: Schering AG
Xxxxxxxxxxxxxx
000 Xxxxxx
Xxxxxxx D-13342
Attn: Legal Department
with a copy to: Berlex Biosciences
00000 Xxx Xxxxx Xxxxxx
Xxxxxxxx, XX 00000-0000
Attn: Executive Director & General Counsel
15.5 Force Majeure. Neither party shall lose any rights hereunder or
-------------
be liable to the other party for damages or losses (except for payment
obligations) on account of failure of performance by
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the defaulting party if the failure is occasioned by war, strike, fire, Act of
God, earthquake, flood, lockout, embargo, governmental acts or orders or
restrictions, failure of suppliers, or any other reason where failure to perform
is beyond the reasonable control and not caused by the negligence, intentional
conduct or misconduct of the nonperforming party has exerted all reasonable
efforts to avoid or remedy such force majeure; provided, however, that in no
event shall a party be required to settle any labor dispute or disturbance.
15.6 Injunctive Relief. Schering acknowledges that limitations and
------------------
restrictions on its possession and use of Mice, Mice Materials, Antibodies,
Antigens and Confidential Information hereunder are necessary and reasonable,
and expressly agrees that monetary damages would be inadequate to compensate
Medarex for any violation. Schering agrees that any such violation would cause
irreparable injury to Medarex and agrees 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 shall be entitled to obtain
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 or the posting an any bond.
15.7 Advice of Counsel. Medarex and Schering have each consulted
-----------------
counsel of their choice regarding this Agreement, and each acknowledges and
agrees that this Agreement shall not be deemed to have been drafted by one party
or another and will be construed accordingly.
15.8 Compliance with Laws. Each party shall furnish to the other party
--------------------
any information requested or required by that party during the term of this
Agreement or any extensions hereof to enable that party to comply with the
requirements of any U.S. or foreign federal, state and/or government agency.
15.9 Further Assurances. At any time or from time to time on and after
-------------------
the date of this Agreement, either party shall at the request of the other
party hereto (i) deliver to the requesting party any records, data or other
documents consistent with the provisions of this Agreement, (ii) execute, and
deliver or cause to be delivered, all such consents, documents or further
instruments of transfer or license, and (iii) take or cause to be taken all such
actions, as the requesting party to obtain the full benefits of this Agreement
and the transactions contemplated hereby.
15.10 Export Controls. Schering agrees that it will take all actions
----------------
necessary to insure compliance with all U.S. laws, regulations, orders or other
restrictions on exports and further will not sell, license or reexport,
directly, or indirectly, the Product(s) to any person or entity for sale in any
country or territory, if, to the knowledge of Schering based upon reasonable
inquiry, such sale, would cause the parties to be in violation of any such laws
or regulations now or hereafter in effect. Schering agrees to secure form any
recipient of Product(s) adequate manually signed written assurances prior to
shipment from the United States as are required by the U.S. Export Regulations.
-17-
15.11 Severability. In the event that any provisions of this Agreement
------------
are determined to be invalid or unenforceable by a court of competent
jurisdiction, the remainder of the Agreement shall remain in full force and
effect without said provision, in such event, the parties shall in good faith
negotiate a substitute clause for any provision declared invalid or
unenforceable, which shall most nearly approximate the intent of the parties in
entering this Agreement.
15.12 Waiver. It is agreed that no waiver by either party hereto of any
------
breach or default of any of the covenants or agreements herein set forth shall
be deemed a waiver as to any subsequent and/or similar breach or default.
15.13 Complete Agreement. This Agreement with its Exhibits, constitutes
------------------
the entire agreement, both written and oral, between the parties with respect to
the subject matter hereof, and that all prior agreements respecting the subject
matter hereof, either written or oral, expressed or implied, are merged and
canceled, and are null and void and of no effect. No amendment or change hereof
or addition hereto shall be effective or binding on either of the parties
hereto unless reduced to writing and duly executed on behalf of both parties.
15.14 Use of Name. Neither party shall use the name or trademarks of
-----------
the other party without the prior written consent of such other party.
15.15 Headings. The captions to the several Sections and Articles
--------
hereof are not a part of this Agreement, but are included merely for
convenience of reference only and shall not affect its meaning or
interpretation.
15.16 Counterparts. This Agreement may be executed in two counterparts,
------------
each of which shall be deemed an original and which together shall constitute
one instrument.
IN WITNESS WHEREOF, Medarex and Schering have executed this Agreement by
their respective duly authorized representatives.
MEDAREX, INC. SCHERING AG
By: /s/ Xxxxxxx Xxxxxxxxx By: /s/ Prof. Dr. G. Stock Xx. X.X. Xxxx
-------------------------------- --------------------------- -----------------
Print Name: Xxxxxxx Xxxxxxxxx Print Name: Prof. Dr. G. Stock Xx. X.X. Xxxx
----------------------- ------------------ -----------------
Title: Executive Vice President Title: Feb. 10, 1998
---------------------------- ----------------------- -----------------
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Medarex Research Plan
*****
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
-19-
*****
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
-20-
