EXHIBIT 10.74
DEVELOPMENT AND LICENSE AGREEMENT
This DEVELOPMENT AND LICENSE AGREEMENT (the "Agreement"), effective as of
April 24, 1996 (the "Effective Date"), is made by and between Centeon L.L.C., a
Delaware limited liability company, with a principal place of business at 0000
Xxxxx Xxxxxx, Xxxx xx Xxxxxxx, Xxxxxxxxxxxx 00000-00 10 ("Centeon"), and
Medarex, Inc., a New Jersey corporation, with a principal place of business 0000
Xxxxx 00 Xxxx, X.X. Xxx 000, Xxxxxxxxx, Xxx Xxxxxx 00000 ("Medarex").
RECITALS
WHEREAS, Medarex is the owner of certain monoclonal antibodies within the
scope of the Patent Rights (as defined below), including but not limited to H-
22, and has conducted pre-clinical studies on the H-22 antibody, and intends to
conduct further clinical trials with the H-22 antibody, and may, subject to the
terms and conditions hereof, conduct pre-clinical and clinical studies on one or
more other monoclonal antibodies within the scope of the Patent Rights in
conjunction with the Development Program (as defined below);
Whereas, Centeon wishes to commercialize a Product (as defined below)
within the Field and support further developmental efforts by Medarex with
respect thereto, and has at its disposal broad capabilities for clinical
testing, obtaining necessary regulatory approvals and registration with
governmental agencies and marketing therapeutic products throughout the world;
WHEREAS, Medarex is willing to allow Centeon to commercialize a Product
and has facilities and experienced personnel that enable it to conduct further
development of the H-22 antibody or another antibody Medarex owns within the
scope of the Patent Rights that subsequently is developed as a Product in the
Development Program; and
WHEREAS, Centeon and Medarex have entered into a Stock Purchase Agreement
of even date herewith
NOW THEREFORE, it is agreed by and between the parties as follows:
1. DEFINITIONS
1.1 "Affiliate(s)" shall mean all corporations or business entities which,
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directly or indirectly, are controlled by, control, or are under common control
with a Party. For this purpose, the meaning of the word "control" ("Control")
shall mean the ownership of fifty percent (50%) or more of the voting shares of
interest of such corporation or business entity or any corporation or business
entity in which a Party can demonstrate, even though the extent of ownership of
a Party in such corporation or business entity is less than fifty percent (50%),
that the operation and management of such corporation or business entity is
carried out in conformity with a Party's standing policy, such corporation or
business entity to be deemed an Affiliate only so long as such ownership of
voting shares or interest or adherence to such standing policy continues.
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Confidential treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designated as "[*****]".
1.2 "Celltech/MRC Agreement" shall mean that certain agreement entered
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between Celltech and the Medical Research Council effective as of November 27,
1987, pursuant to which the Medical Research Council has granted Medarex the MRC
Sublicense.
1.3 "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.
1.4 "Core Countries " shall mean [*****]
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1.5 "Development Plan" shall have the meaning set forth in Section 2.1.2
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below.
1.6 "FDA" means the U.S. Food and Drug Administration or any corresponding
foreign registration or foreign regulatory authority.
1.7 "Field"" shall mean [*****]
1.8 "IND" shall mean an Investigational New Drug application, as 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.
1.9 [*****]
***** 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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1.10 "Know-How" shall mean any and all unpatented and/or non-patentable
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technical data, materials (including without limitation, biological materials
such as plasmids, vectors, DNA sequences, organisms, cell lines and antibodies),
samples and other information (A) which are owned or controlled by Medarex
during the term of the Agreement, (B) which Medarex has the right to license or
sublicense, including, without limitation, information and materials developed
by Medarex in connection with the performance of the Development Program, and
(C) which (i) relate to the Product, including, without limitation, its
chemical, biological, pharmacological, toxicological, nonclinical and clinical
data, formulations, specifications and/or usage, or (ii) relate to processes,
techniques and specifications for the manufacture of the Product including,
without limitation, preparation, synthesis, culture, recovery, purification,
formulation and quality control processes, techniques and specifications. Know-
How shall not include the Patent Rights.
1.11 "Manufacturing Cost " shall mean [*****]
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1. 12 "Medarex Technology" means the Know-How and Patent Rights.
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1.13 "MRC Sublicense" shall mean that certain Sublicense Agreement entered
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by and between Medarex, Inc. and the Medical Research Council, effective as of
May 16, 1995, as may be amended from time to time.
1-14 "MRC/Scotgen Agreement" shall mean that certain agreement entered
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between Scotgen and the Medical Research Council effective as of January 31,
1989, pursuant to which Scotgen has granted Medarex the Scotgen Sublicense.
1-15 "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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[*****]
1.16 "Patent Rights" shall mean (i) the U.S, and foreign patent
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applications and patents listed on Exhibit B hereto; (ii) any U.S. or foreign
patent application or patent which is not listed on Exhibit B and that claims
priority from one or more patent applications listed on Exhibit 13 or that
corresponds thereto and relates to the Product or the manufacture thereof or to
the use thereof in the Field; (iii) any U.S. or foreign patent or patent
application which claims an invention made or conceived and reduced to practice
by one or more employees, agents or consultants of Medarex or of a Medarex
Affiliate in connection with the performance of the Development Program and
related to the Product or the manufacture thereof or to the use thereof in the
Field and which is not jointly owned by Centeon and which is added to the Patent
Rights pursuant to Section 8.2 of this Agreement; (iv) any U. S. or foreign
patent application or patent which (A) claims an invention that is made or
conceived and reduced to practice by one or more employees, agents or
consultants of Medarex or of a Medarex Affiliate after the termination of the
Development Program, but during the term of this Agreement, and that is related
to the Product or to the manufacture thereof or to the use thereof in the Field
and that falls within the scope of one or more of the claims of any of the
patent applications or patents which are referenced in subsection (i) or (ii) of
this Section 1. 16; (B) is not jointly owned by Centeon; and (C) is added to the
Patent Rights pursuant to Section 8.2 of this Agreement; and (v) any U. S. or
foreign patent application or patent which claims an invention that is related
to the Product or to the manufacture thereof or to the use thereof in the Field,
that falls within the scope of one or more of the claims of any of the patent
applications or patents which are referred to in subsection (i) or (ii) of this
Section 1. 16, and that is acquired by Medarex or by a Medarex Affiliate from a
Third Party(ies) during the term of this Agreement; and any substitution,
continuation, continuation-in-part, or divisional application of any of the
preceding, and any patent issuing thereon, including any reissue, reexamination,
renewal or extension thereof.
1.17 "Phase I", "Phase II", and "Phase III " shall mean Phase I (or Phase
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I/II), Phase II (or Phase II/III), and Phase III clinical trials, respectively,
in each case as prescribed by applicable FDA regulations, or corresponding
regulations of any comparable foreign entity.
***** 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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1.18 "Product" shall mean a monoclonal antibody which is within the
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scope of U.S. Patent No. 4,954,617, and which has an antigen binding region
having a binding affinity for cd64. As used herein, cd64 shall mean the human
high affinity Fc receptor for IgG present on macrophages and monocytes. For the
avoidance of doubt, it is understood that any other monoclonal antibody,
including without limitation, a bifunctional antibody or a hetero antibody or a
single chain antibody, shall not be a Product. The humanized anti-cd64
monoclonal antibody known as H-22 shall be the Product for initial development
under the Development Program.
1.19 "Product License Application" or "PLA" means a Product License
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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.
1-20 "Scotgen Sublicense" shall mean that certain Sublicense Agreement
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entered by and between Medarex, Inc. and Scotgen, Ltd., effective as of May 16,
1995, as amended from time to time.
1.21 "Stock Purchase Agreement" shall mean that certain Stock Purchase
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Agreement entered by Centeon and Medarex of even date herewith.
1.22 "Sublicensee" shall mean a third party to whom Centeon has granted a
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license or sublicense under the Medarex Technology to make, use and/or sell the
Product. As used in this Agreement, it is understood that "Sublicensee" shall
also include a Third Party or Third Parties to whom Centeon has granted the
right to distribute the Product, provided that such Third Party or Third Par-
ties has (have) the responsibility for marketing and promotion of the Product
within the field or territory for which such distribution rights are granted.
1.23 "Territory" shall mean worldwide.
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1.24 "Third Party(ies)" shall mean any person or entity other than Centeon,
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Medarex, their respective Affiliates, or their respective employees.
2. DEVELOPMENT PROGRAM
2.1 DEVELOPMENT PROGRAM
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2.1.1 Development Program Activities. Subject to the terms and
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conditions set forth herein, Medarex shall (i) conduct clinical development of
the Product pursuant to the Development Plan, and (ii) for a three (3) year
period commencing on the Effective Date, perform research with regard to Product
manufacture improvements. Such activities shall comprise the "Development
Program." Medarex shall use reasonable efforts to conduct the Development
Program in accordance with the Development Plan and within the time schedules
contemplated therein, and shall use reasonable efforts to comply with all
submission procedures to the appropriate regulatory authorities,
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to respond timely to inquires of said regulatory authorities and to maintain
submissions and support new submissions. Medarex shall keep the Development
Committee reasonably informed of the progress of the Development Program and
shall provide the Development Committee a reasonable opportunity to review and
comment on trial protocols, study designs, endpoints, target patient population
and other relevant factors to such trials.
2.1.2 Development Plan. Medarex will conduct the Development Program
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in accordance with a plan approved by the Development Committee (the
"Development Plan"). The Development Plan shall establish: (i) the scope of the
development which will be performed; (ii) development objectives, work plan
activities and time schedules with respect to the development and (iii) the
annual research goals of Medarex with regard to Product manufacture
improvements. The initial Development Plan is attached hereto as Exhibit A. The
Development Committee shall review the Development Plan on an ongoing basis and
may make changes to the Development Plan then in effect. Each year during the
Development Program prior to the end of the tenth month of such year, the
parties shall agree on an annual Development Plan for the following calendar
year.
2.1.3 Product Changes. During the term of the Development Program, the
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Development Committee may agree to discontinue the activities of the Development
Program with respect to the H-22 monoclonal antibody, and redirect those
activities with respect to a different monoclonal antibody which is a Product.
In such event, subject to the provisions of Section 4.3.2, the parties shall
discuss and agree on (i) the substitute monoclonal antibody, (ii) the objectives
of the redirected Development Program, and (iii) the further payments, if any,
which will be made by Centeon in support of the Development Program, which shall
cover the fully burdened costs of all such activities.
2.2 Development Committee.
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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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[*****]
2.2.3 Responsibilities. It will be the responsibility of the
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Development Committee, among other things, to (i) oversee the conduct of the
Development Program, (ii) prepare and approve the Development Plan and the
detailed working program (including timetables) to be carried out, and (iii)
determine whether Medarex has materially achieved its annual research goals with
regard to Product manufacture improvements. The activities conducted in
connection with the Development Plan shall be monitored by the Development
Committee and periodically reviewed.
2.2.4 Meetings, During the term of this Agreement, the Development
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Committee shall meet quarterly, or more often as may be necessary, to discharge
its responsibilities. Such meeting shall alternate between Annandale, New
Jersey, and King of Prussia, Pennsylvania, or such other locations as the
parties agree, or by way of video or telephone conference, if possible and
appropriate. Each party will be responsible for paying its own expenses in
connection with the meetings of the Development Committee. Medarex shall prepare
minutes of the Development Committee meetings covering all essential points
discussed, which minutes shall be approved and signed by a Development Committee
representative of each party.
2.3 Records; Exchange of Information.
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2.3.1 Records. The Parties shall maintain (i) financial records in
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sufficient detail to establish how Development Program funds are expended, and
(ii) scientific records as will properly reflect all work done and results
achieved in the performance of the Development Plan (including all data in the
form required under any applicable governmental regulations). During the term of
this Agreement, the Parties shall provide each other access to such records,
upon request, during ordinary business hours. During the Development Program,
Medarex shall provide Centeon with a quarterly accounting report regarding
Development Program expenditures by Medarex.
2.3.2 Reports. The Development Committee shall periodically and not
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less often than semiannually during the term of the Development Program, request
and the Parties shall have the obligation to prepare and provide to the
Development Committee written reports summarizing the progress of the research
performed pursuant to the Development Plan during the preceding half-year.
2.4 Development Program Funding.
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2.4.1 Product Manufacture Research. In consideration for Medarex'
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research activities with regard to Product manufacture improvements in
connection with the Development Program, Centeon shall pay to Medarex [*****]
***** 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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2.4.2 Clinical Trial Expenses
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[*****]
2.5 Termination Of Support of Product Manufacture Research. In the event
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that the Development Committee determines that Medarex has materially failed to
achieve the research goals with regard to Product manufacture improvements
established by the Development Committee for a particular year, Centeon may,
with sixty (60) days notice to Medarex, terminate its support for research by
Medarex regarding Product manufacture in connection with the Development Program
as provided in Section 2.4.1; provided, however, Centeon shall continue to be
responsible for the payment of all clinical activities conducted by Medarex in
connection with the Development Program. In such an event, Medarex may continue
such research at its own expense, and such later activities shall not be
included in or be part of the Development Program but shall be subject to the
provisions of Section 3.6 below.
***** 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. LICENSE GRANT
3.1 License to Centeon. Subject to the terms and conditions of this
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Agreement, Medarex hereby grants to Centeon an exclusive (subject to Sections
3.4 and 3.6), worldwide, royalty-bearing license under the Medarex Technology to
make, have made, import, use, offer for sale and sell the Product for use in the
Field in the Territory. The preceding rights granted Centeon to make and have
made the Product shall only become effective upon receipt by Medarex of notice
from Centeon pursuant to Section 7.2 that Centeon wishes to manufacture the
Product.
3.2 Sublicenses. Centeon may sublicense the rights granted in Section 3.1
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to its Affiliates without the prior consent of Medarex, and to Third Parties
with the prior written consent of Medarex, which consent shall not be
unreasonably withheld. Each such sublicense shall be consistent with all the
terms and conditions of this Agreement. Centeon shall remain responsible to
Medarex for all of each such Sublicensee's applicable financial and other
obligations under the sublicense.
3.3 Affiliate Licenses. Medarex agrees, if Centeon so requests, to enter
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into a separate agreement with any Affiliate(s) of Centeon granting a license in
accordance with the provisions of this Agreement. Such agreement shall be
consistent with all of the provisions hereof and incorporate all of the terms of
this Agreement to the extent that they are applicable. Centeon shall guarantee
the performance of any and all responsibilities of the Affiliate(s) under such
separate agreement. Centeon shall reimburse Medarex for its reasonable
attorneys' fees and costs incurred in connection with the preparation, review
and execution of any such separate license agreement.
3.4 Acknowledgments.
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3.4.1 Scotgen Sublicense. Notwithstanding Section 3.1 above, Centeon
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acknowledges that it has been informed by Medarex that the patent applications
and patents subject to the Scotgen Sublicense were licensed to Medarex on a non-
exclusive basis, and that the sublicenses granted Centeon under such particular
Patent Rights are accordingly non-exclusive. Medarex agrees, however, that the
license granted Centeon with respect to such Patent Rights shall be exclusive
with respect to the Product and the Field as to Medarex' interest in such Patent
Rights. The parties further acknowledge that Centeon has been provided a copy of
the Scotgen Sublicense, and understand that pursuant to the Scotgen Sublicense
Centeon shall have the right to acquire sublicense from Scotgen if the Scotgen
Sublicense terminates, pursuant to Clause 8(xiv) of the Scotgen Sublicense which
states in its entirety:
The duration of any sublicense which the Sublicensee shall validly grant
pursuant to the provisions of this Agreement shall be independent of the
term of this Agreement but that only insofar as each Medarex sublicensee
(as hereinafter defined) may, upon termination of this Agreement, apply
direct to Scotgen for the adoption of such sublicense direct whereupon
Scotgen shall, if the Medarex sublicensee is not in default and there are
no other impediments to such adoption, adopt the same, always provided that
in no circumstances shall the provisions of this Clause operate so as to
impose
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upon Scotgen any Obligation which is more extensive or more onerous or
different in nature to the obligations undertaken by Scotgen to Medarex
under this Agreement, and further provided that each Medarex sublicensee
shall from the date of termination of this Agreement owe to Scotgen all of
its royalty and other obligations under its sublicense. For the purposes of
this Clause 8(xiv), a "Medarex sublicensee" means any person to which
Medarex shall have granted a sublicense in accordance with and pursuant to
the provisions of Clause 8(iv) of this Agreement.
3.4.2 MRC Sublicense. Centeon further acknowledges that Medarex does
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not have the right to grant Centeon a sublicense under the MRC Sublicense, and
that the sublicense under the Scotgen Sublicense to the Winter patents granted
Centeon pursuant to Section 3.1 may only be practiced with a concurrent
sublicense from the MRC under the Boss patents; provided, however, [*****]
3.4.3 Boss Interference.
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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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[*****]
3.5 Right of First Negotiation for Product Commercialization Outside the
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Field.
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3.5.1 Commercialization of the Product Outside the Field by Third
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Parties.
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If at any time during the Development Program or two (2) years thereafter,
Medarex wishes to develop or commercialize the Product for the treatment of an
autoimmune disorder outside the Field [*****]
with a Third Party, or Centeon wishes to acquire a license from Medarex with
respect to the development or commercialization of the Product for the treatment
of an autoimmune disorder outside the Field, such party shall notify the other
party hereto, identifying the indication of interest. In such event, the parties
shall negotiate in good faith for a period of ninety (90) days with respect to
an agreement regarding co-development and commercialization of such products by
Centeon and Medarex. If Centeon and Medarex fail to agree on the terms of such
an agreement within the ninety (90) day period, or such longer period as the
parties may agree, Medarex shall be free to develop and commercialize the
Product for such indication, itself or with third parties, and Centeon shall
have no further rights with respect thereto. In the event that Medarex and
Centeon enter a further agreement regarding the development and
commercialization of such products for the treatment of any autoimmune
disorder outside the Field, Centeon shall pay Medarex such additional
consideration as is mutually agreed.
3.5.2 Commercialization of the Product Outside the Field by Medarex.
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If Medarex intends to itself develop or commercialize the
Product for the treatment of an autoimmune disorder outside the Field, it shall
notify Centeon. In such event, Centeon may notify Medarex it wishes to negotiate
an agreement regarding co-development and commercialization of the Products for
such indication, and the parties shall negotiate the terms of such an agreement
in good faith. If Medarex and Centeon fail to enter into a written letter of
intent for such an agreement within ninety (90) days from Medarex' notice to
Centeon, or such longer period as the parties may agree, then Medarex shall be
free to conduct any such activities, itself or with a third party, and Centeon
shall have no rights with respect thereto.
3.6 Right of First Refusal for Other Products in the Field. During the
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term of the Agreement, if Medarex develops a monoclonal antibody or product
(other than a Product) which it intends to commercialize, itself or with a Third
Party, in the Field (an "Improvement"), Medarex
***** 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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hereby grants to Centeon a right of first refusal to negotiate for an exclusive,
worldwide license to Medarex' interest in any patent rights other than the
Patent Rights for the development and commercialization of such Product in
the Field, to the extent that Medarex may grant such rights. Medarex shall
promptly notify Centeon of any Improvement and provide Centeon with a detailed
written description of such Improvement. Centeon shall have thirty (30) days
from the date it receives such written description of any Improvement to
exercise its exclusive right of first refusal with respect to negotiating a
license with Medarex for such Improvement. If Centeon notifies Medarex it wishes
to negotiate for such a license, the parties shall negotiate in good faith for a
period of up to one hundred and twenty (120) days. If the parties fail to enter
into a written letter of intent for such an agreement or a written agreement
within such period, or mutually agreed extension thereof, Medarex shall have the
right to seek other licensees of said Improvement; provided however that Medarex
shall not offer a license to such Improvement to any Third Parties on financial
terms substantially more favorable in their entirety to such Third Parties than
those offered to Centeon for the Improvement without first offering such terms
to Centeon.
3.7 Retained Rights. It is understood and agreed that Medarex shall retain
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rights to (i) make, have made, import, use, offer for sale, sell and otherwise
commercialize the Product for all uses outside the Field; and (ii) to make, have
made, import, use, and offer for sale and sell Product to Centeon in connection
with the activities conducted by Medarex pursuant to this Agreement, unless and
until Centeon assumes manufacture of the Product pursuant to Section 7.2. It is
understood that such retained rights shall not permit Medarex to knowingly sell
the Product to a third party which intends to sell it for use in the Field or
use it in the Field.
3.8 Product License. It is understood and agreed that the license granted
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Centeon under the Medarex Technology herein relates only to specific monoclonal
antibodies which are within the scope of the Product definition in Section
1.18, and does not extend to any other monoclonal antibody, heteroantibody,
bifunctional antibody or any other product.
4. PAYMENTS
[*****]
4.2 Purchase of Medarex Common Stock. On the Effective Date, Centeon shall
--------------------------------
enter into the Stock Purchase Agreement with Medarex.
4.3 Milestone Payments.
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4.3.1 Within thirty (30) days following each occurrence of the events
specified below, Centeon shall pay to Medarex the following amounts:
***** 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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[*****]
The amounts paid upon achievement of such milestones shall be non-refundable and
not be creditable against any other amounts due Medarex.
4.3.2. Back-up Products. [*****]
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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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[*****]
4.3.3 Acknowledgment. For purposes of this Section 4.3, the parties
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acknowledge and agree that a clinical trial shall be deemed completed when all
patients enrolled in such trial have been treated with the Product, and all
patient case report forms have been submitted to the sponsor of the trial (or
its designee). As soon as practicable after the completion of a particular
clinical trial the Development Committee shall review the data from such trial
and within forty-five (45) days of such review, or such longer period as may be
agreed by the parties, shall issue or decline to issue a positive recommendation
to proceed to the next clinical trial or filing, as the case may be. As used in
this Section 4.3, the parties acknowledge and agree that "front line therapy"
means a therapeutic treatment for patients with [*****]
disorder that is administered to said patients before they become refractory to
other treatments or is administered in combination with other treatments.
4.3.4 Further Payment. [*****]
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4.4 Royalties. In consideration of the rights granted hereunder, Centeon
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shall pay the following royalties to Medarex:
[*****]
***** 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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[*****]
4.7 Single Royalty; Non-Royalty Sales. No royalty shall be payable under
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Section 4.4 above with respect to sales of the Product among Centeon, its
Affiliates and sublicensees for resale and in no event shall more than one
royalty be due Medarex hereunder with respect to any Product unit.
[*****]
***** 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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4.9 Royalty Term. The royalties due hereunder shall be payable on a
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country-by-country basis in each country until the date which is the later of
(i) the expiration of the last to expire of the patents within the Patent Rights
covering the Product or the manufacture, use or sale of the Product in such
country (such expiration to occur only after expiration of extensions of any
nature to such patents which may be obtained under applicable statutes or
regulations in the respective countries of Territory, such as the Drug Price
Competition and Patent Term Restoration Act of 1984 in the U.S.A. and similar
patent extension laws in other countries), or (ii) if there are no Patent Rights
covering the Product or the manufacture, use or sale of the Product in a
country, until [*****] years following the first commercial sale of a Product
in such country.
4.10 Payment Method. Amounts due Medarex hereunder shall be paid in U. S.
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dollars by wire transfer in immediately available funds to an account designated
by Medarex.
4.11 Currency Conversion. If any currency conversion shall be required in
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connection with the calculation of royalties due on a quarterly basis hereunder,
such conversion shall be made using the monthly exchange rates used by Centeon
to translate its net sales to U.S. dollars. Such monthly rate is a simple
average of the daily noon bid/ask exchange rates for the month. At such time
that Centeon provides any royalty report and payment to Medarex pursuant to
Section 5.1 which relates to payments based on Net Sales in any country outside
the U.S., Centeon shall provide Medarex with a detailed calculation setting
forth how each applicable monthly exchange rate was determined and applied by
Centeon.
4.12 Taxes.
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4.12.1 Withholding Taxes. All royalty amounts required to be paid to
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Medarex pursuant to this Agreement may be paid with deduction for withholding
for or on account of any taxes (other than taxes imposed on or measured by net
income) or similar governmental charge imposed by a jurisdiction other than
the United States ("Withholding Taxes"). At Medarex' request, Centeon shall
provide Medarex a certificate evidencing payment of any Withholding Taxes
hereunder and shall reasonably assist Medarex to obtain the benefit of any
applicable tax treaty.
4.12.2 Sales Taxes. Any sales taxes, use taxes, transfer taxes or
--------------
similar governmental charges required to be paid in connection with the transfer
of any Products manufactured by Medarex and sold by Centeon hereunder shall be
the sole responsibility of Centeon. In the event that Medarex is required to pay
any such amounts, and reasonably documents payment, Centeon shall promptly remit
payment to Medarex of such amounts.
5. BOOKS AND RECORDS
5.1 Royalty Reports and Payments. After the first commercial sale of a
----------------------------
Product on which royalties are required hereunder, Centeon shall make quarterly
written reports to Medarex within ninety (90) days after the end of each
calendar quarter, stating in each such report, by country, the
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
-16-
number, description, and aggregate Net Sales of the Product sold during the
calendar quarter upon which a royalty is payable under Article 4 above. Medarex
shall treat all such reports as Confidential Information of Centeon.
Concurrently with the making of such reports, Centeon shall pay Medarex the
royalties specified in Sections 4.4 and 4.8.
5.2 Records; Inspection. Centeon and its Affiliates and Sublicensees shall
-------------------
keep complete, true and accurate books of account and records for the purpose of
determining the royalty amounts payable under this Agreement. Such books and
records shall be kept at the principal place of business of Centeon or its
Affiliate or Sublicensee, as the case may be, for at least four (4) years
following the end of the calendar quarter to which they pertain. Such records
will be open for inspection during such four (4) year period by a representative
of Medarex for the purpose of verifying the royalty statements. Such inspections
may be made no more than once each calendar year, at reasonable times mutually
agreed. The representative will be obliged to execute a reasonable
confidentiality agreement prior to commencing any such inspection. Inspections
conducted under this Section 5.2 shall be at the expense of Medarex, unless a
variation or error producing an increase exceeding five percent (5%) of the
amount stated for any period covered by the inspection is established in the
course of any such inspection, whereupon all costs relating to the inspection
for such period and any unpaid amounts that are discovered will be paid by
Centeon, with interest from the date such amounts were due, at the prime rate
reported by the Chase Manhattan Bank.
6. COMMERCIALIZATION
6.1 Reasonable Efforts. Centeon shall use commercially reasonable efforts,
-------------------
comparable to those efforts Centeon makes with respect to other products of
comparable value, developmental stage and clinical indication, to obtain and
maintain all approvals, registrations and government authorizations necessary
for commercial sale of the Product worldwide. Centeon will use commercially
reasonable efforts to actively pursue commercial sales of the Product in each
country in which regulatory approval is obtained. Centeon shall notify Medarex
as provided in Section 6.4 below should it elect to abandon its rights to pursue
commercialization of the Product in a country.
6.2 Reports to Medarex. During the term of this Agreement, Centeon shall
--------------------
keep Medarex fully informed of its activities subject to this Agreement,
including without limitation, the achievement of the milestones set forth in
Section 4.3 and the commercialization of the Product, and following January 31
of each year shall provide Medarex with a written report detailing such events
and activities. When the registration package requesting approval for commercial
sale of the Product (including approval for reimbursement by the appropriate
health insurance authorities as well as price approvals where required) is first
filed in the U.S., the European Union and Japan, and in each case when approval
is received therefor, Centeon will notify Medarex in writing immediately by
facsimile.
6.3 Regulatory Filings. Centeon shall submit registration packages
------------------
requesting approval for commercial sale of the Product as soon as reasonably
practicable. Centeon (or its designee) shall file and hold title to all clinical
results, regulatory applications, approvals and supplements thereto.
-17-
Medarex and its Affiliates, shall have the irrevocable right, without charge, to
refer to, access, cross reference, and use all such documents, including
clinical studies and other supporting information, and any written
communications to and with the FDA and comparable foreign regulatory bodies in
connection with the Development Program and with regard to any product for use
outside the Field. Centeon shall have no obligation to provide and Medarex shall
not provide, without the written consent of Centeon, such access or rights to
any third party, including, without limitation, a Medarex Affiliate, which has
acquired the right to use a Product in monoclonal antibody form (as opposed to a
bi-specific antibody) for indications outside the Field.
6.4 Abandoned Products. Centeon may voluntarily abandon its right
------------------
hereunder to market the Product in any individual country, upon sixty (60) days
written notice to Medarex at any time. Such notice will effectuate Centeon's
voluntary abandonment of its right hereunder to market the Product in such
country; provided, the abandonment of the Product in any particular country
hereunder shall not be construed to be a termination of this Agreement for any
other country.
6.5 Consultation. If Medarex at any time should advise Centeon of its
--------------
concern, and the specific reasons for same, that Centeon is not pursuing
development, commercialization and sale of the Product in the manner
contemplated by this Agreement, then the parties shall discuss the situation in
good faith to reach a satisfactory resolution addressing Medarex' concerns as
appropriate. In the event that the parties are unable to agree upon a
resolution, Medarex may submit the matter to arbitration pursuant to Section
13.2, and in the event that Centeon is found not to have used reasonable efforts
to obtain regulatory approval for the Product in any country, or actively
commercialize the Product in any country where the Product has received
regulatory approval, then Centeon's rights hereunder shall terminate in such
country, but shall not be construed as termination for any other country.
6.6 Loss of Rights. If Centeon abandons its right to market the Product in
--------------
a country in accordance with Section 6.4, or loses such rights in a country
pursuant to Section 6.5, or as result of the termination of this Agreement by
Medarex pursuant to Section 12.2 or Centeon pursuant to Section 12.4 or Section
12.5, such rights shall revert to Medarex, and Medarex shall thereafter have the
exclusive rights to market the Product in such country. In such event, Medarex
or a Third Party licensee or sublicensee of Medarex may freely carry on future
development and commercialization of the Product in any such country. At
Medarex' request, Centeon shall cooperate with and assist Medarex in exercising
such rights, including without limitation, by providing Medarex, without charge,
access to and the right to use all regulatory approvals relating to the Product
in such country.
6.7 Adverse Reactions. If Medarex and Centeon market the Product at the
-------------------
same time, the parties shall have a continuing obligation to timely advise one
another of all adverse drug reactions and other similar matters relevant to
maintaining approvals and registrations of the Product in accordance with
applicable laws and regulations.
-18-
6.8 Delivery of Know-How. During the term of this Agreement, Medarex
---------------------
shall deliver to Centeon such Know-How relating to the Product as is necessary
for Centeon's performance under this Agreement.
7. PRODUCT MANUFACTURE
7.1 Product for Use in Clinical Trials. Medarex shall be responsible for
----------------------------------
the manufacture of all Product for use in Xxxxx 0, Xxxxx II and Phase III
clinical trials pursuant to the terms of the Development Plan. All such Products
manufactured by or on behalf of Medarex for all such clinical trials will
conform to all FDA requirements relating to Good Manufacturing Practices and all
applicable comparable foreign laws and regulations. [*****]
7.2 Election of Product Manufacture. Medarex shall be responsible for the
----------------------------------
manufacture of all Product for commercial uses unless Centeon elects to
manufacture the Product as provided in this Section 7.2. All Product
manufactured by or on behalf of Medarex will conform with all FDA regulations
relating to Good Manufacturing Practices and all applicable comparable foreign
laws and regulations. During the term of this Agreement, Centeon shall have the
right to elect whether it wishes to (i) manufacture Products for sale by Centeon
and its Affiliates and Sublicensees pursuant to this Agreement, or (ii) purchase
for resale from Medarex Product manufactured by or on behalf of Medarex. To
exercise such option, Centeon shall notify Medarex that it wishes to manufacture
the Product at least six (6) months prior to the date Centeon wishes to commence
Product manufacture. In such event, Centeon shall purchase all Product
manufactured by Medarex pursuant to invoices or requests for Product manufacture
received by Medarex prior to the date Centeon provides Medarex notice that it
wishes to assume responsibility for Product manufacture.
7.3 Transfer of Manufacturing Know-How. Within sixty (60) days of the
----------------------------------
election by Centeon to manufacture the Product, or at such other time as the
parties agree, subject to Section 7.5, Medarex will deliver to Centeon all Know-
How relating to the manufacture of the Product existing as of the Effective Date
and developed in connection with the Development Program. In such event, the
parties shall cooperate with each other in order that Centeon may initiate
manufacture of the Product as soon as practicable, and shall take such actions
as are appropriate to achieve such goal.
7.4 Manufacture by Centeon or a Third Party.
---------------------------------------
7.4.1 Centeon Responsibilities. If Centeon elects to manufacture the
------------------------
Product for commercialization itself or through a Third Party, Centeon shall be
responsible thereafter for the
***** 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-
development of scale-up and manufacturing procedures, and all costs associated
therewith. All Product manufactured by or on behalf of Centeon will conform with
all FDA regulations relating to Good Manufacturing Practices and all applicable
comparable foreign laws and regulations. Centeon shall keep Medarex fully
informed of the Product manufacturing procedure and developments relating
thereto and Medarex shall have the right for reasonable purposes and on
reasonable prior notice to visit the manufacturing facility during ordinary
business hours and review any relevant records relating to Product manufacture,
and to comment thereon.
7.4.2 Third Party Manufacture. If Medarex is unable to meet its
-------------------------
obligations to supply Product as established in any Supply Agreement entered by
the parties pursuant to Section 7.6 below, or with the prior written consent of
Medarex, Centeon may have the Product manufactured on its behalf by a Third
Party; provided, Centeon shall not enter into a supply agreement for the Product
with such Third Party on terms more favorable than those offered to Medarex for
Product manufacture. If a Third Party manufactures the Product for
commercialization, Centeon shall inform Medarex of the outcome of the
negotiations with such Third Party.
7.4.3 Site of Manufacturing. In the event that Centeon or its designee
---------------------
manufactures the Product, such manufacturing may only be conducted in a country
where an issued, unexpired patent within the Patent Rights covering the Product
is in effect, unless otherwise agreed by the parties.
7.5 Manufacturing Technology Fee. If Centeon elects to terminate its
----------------------------
funding of Product manufacture improvements in connection with the Development
Program pursuant to Section 2.6, and Medarex, at its own expense, conducts
further research which leads to improvements relating to the manufacture of the
Product, then even if Centeon elects to manufacture the Product, Medarex shall
have no obligation to provide Centeon with access to or rights to any such
technology developed after the date that Centeon provides notice that it will
not fund such activities in connection with the Development Program [*****]
7.6 Manufacture by Medarex - If Centeon elects to purchase the Product
----------------------
from Medarex for commercial sale, Centeon and Medarex shall promptly negotiate
in good faith and enter into a Supply Agreement containing reasonable and
customary terms; provided, such agreement shall provide that Centeon will
purchase the Product from Medarex at a transfer price equal [*****]
***** 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-
8. INTELLECTUAL PROPERTY
8.1 Ownership of Inventions. Title to all inventions and other
-----------------------
intellectual property made solely by employees of Medarex during the term of the
Agreement shall be owned by Medarex; provided, any inventions and other
intellectual property made by Medarex employees in connection with the
Development Program which relate solely to improvements in Product manufacture
processes shall be jointly owned by Medarex and Centeon. Title to all inventions
and other intellectual property made solely by Centeon employees in connection
with the Development Program shall be owned by Centeon. Title to all inventions
and other intellectual property made jointly by employees of Centeon and Medarex
in connection with the Development Program shall be jointly owned by Medarex and
Centeon (each a "Centeon/Medarex Invention"). Inventorship of inventions and
other intellectual property rights conceived and/or reduced to practice in
connection with the Development Program and ownership rights with respect
thereto shall be determined in accordance with the patent and other intellectual
property laws of the United States and the State of New York, as applicable.
[*****]
8.2 Patent Prosecution.
------------------
8.2.1 Patent Rights. Medarex shall be responsible, at its expense, for
--------------
the preparation, filing, prosecution and maintenance of the patent applications
and patents within Patent Rights in countries selected by Medarex, and for
conducting any interferences, reexaminations, reissues, oppositions, or request
for patent term extension relating thereto.
8.2.2 Failure to Prosecute. In the event that Medarex declines to file
---------------------
or, having filed, declines to further prosecute and maintain any patent
applications or patents subject to Section 8.2.1 above, Medarex shall provide
Centeon notice thereof prior to the expiration of any deadline relating to such
activities, but in any event at least thirty (30) days prior notice, and Centeon
shall have the right to file, prosecute and maintain such patent applications or
patents in the name of Medarex, at Centeon's expense, using counsel of its
choice.
8.2.3 Medarex/Centeon Inventions.
----------------------------
(a) The parties will cooperate to file, prosecute and maintain patent
applications covering the Centeon/Medarex Invention(s) in the Core Countries
[*****] and other countries agreed by the parties. The parties shall agree which
parties shall be responsible for conducting such activities with respect to a
particular Centeon/Medarex Invention. The party conducting such activities shall
keep the other party fully informed as to the status of such patent matters,
including, without limitation, by providing the other party the opportunity, at
the other party's expense, to review and comment on any documents relating to
the Centeon/Medarex Invention which will be filed in any patent office at least
thirty (30) days before such filing, and promptly providing the other party
copies of any documents relating to Centeon/Medarex Invention which the party
conducting such activities receives from such patent
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
-21-
offices, including notice of all interferences, reissues, reexaminations,
oppositions or requests for patent term extensions. The parties will share
equally all expenses and fees associated with the filing, prosecution, issuance
and maintenance of any patent application and resulting patent for a
Centeon/Medarex Invention in the Core Countries and other agreed countries.
(b) In the event that either party wishes to seek patent protection
with respect to any Centeon/Medarex Invention outside the Core Countries, it
shall notify the other party hereto. If both parties wish to seek patent
protection with respect to such Centeon/Medarex Invention in such country or
countries, activities shall be subject to Section 8.2.3(a) above. If only one
party wishes to seek patent protection with respect to such Centeon/Medarex
Invention in such country or countries, it may file, prosecute and maintain
patent applications and patents with respect thereto, at its own expense. In any
such case, the party declining to participate in such activities shall not grant
any third party a license under its interest in the applicable Centeon/Medarex
Invention without the prior written consent of the other party.
8.2.4 Notice. During the term of this Agreement, each party will
--------
advise the other of the filing of any patent applications subject to Section
8.1 promptly after such patent application is filed. With respect to inventions
solely owned by Medarex, at Centeon's option, any patent application or patent
covering such an invention may be added to the list of Patent Rights as
described in Exhibit B hereto, with a writing signed by the parties.
8.2.5 Cooperation. Centeon shall be given an opportunity to review
-----------
Medarex' activities pursuant to Section 8.2.1 and provide input thereto. Medarex
shall include in such patent applications such claims as Centeon may request.
Medarex shall keep Centeon fully informed as to the status of such patent
matters, including, without limitation, by providing Centeon the opportunity, at
Centeon's expense, to review and comment on any documents relating to Medarex
Technology which will be filed in any patent office at least thirty (30) days
before such filing, and promptly providing Centeon copies of any documents
relating to Medarex Technology which Medarex receives from such patent offices,
including notice of all interferences, reissues, reexaminations, oppositions or
requests for patent term extensions.
8.3 Enforcement. In the event that any Medarex Technology necessary for
-----------
manufacture, use and sale of a Product is infringed or misappropriated by a
third party in any country or is subject to a declaratory judgment action
arising from such infringement or misappropriation in such country, or is the
subject of an interference, re-examination, reissue or opposition proceeding,
the party becoming aware thereof shall promptly notify the other party hereto.
Medarex shall have the initial right (but not the obligation), at its expense,
to bring suit to xxxxx any infringement or misappropriation of Medarex
Technology, using counsel of its choice. In the event that Medarex fails to
initiate a suit to enforce such Medarex Technology against a commercially
significant infringement in the Field by a third party within one hundred eighty
(180) days, Centeon may initiate such suit to xxxxx such infringement or
misappropriation, and the parties shall equally share the expenses associated
therewith, provided, Centeon may not enter into any settlement without the prior
consent of Medarex, which shall not be unreasonably withheld, and may not make
any statement which admits
-22-
that any of the Patent Rights or other intellectual property licensed to Centeon
pursuant to this Agreement are invalid or unenforceable. The party involved in
any such claim, suit or proceeding, shall keep the other party hereto reasonably
informed of the progress of any such claim, suit or proceeding and each party
shall cooperate reasonably in connection with the pursuit of any such action, at
the request and expense of the party requesting such cooperation. Any recovery
by such party received as a result of any such claim, suit or proceeding shall
be used first to reimburse the parties hereto for all expenses (including court
costs, attorneys and professional fees and other expenses of all kinds) incurred
in connection with such claim, suit or proceeding. [*****]
8.4 Infringement Claims. If the manufacture, sale or use of the Product
-------------------
pursuant to this Agreement results in any claim, suit or proceeding alleging
patent infringement against Centeon or Medarex, such party shall promptly notify
the other party hereto. If Medarex is not named as a party in such a suit or
proceeding, Medarex may, at its own expense and through counsel of its own
choice, seek leave to intervene in such suit or proceeding. Centeon agrees not
to oppose such intervention. If Medarex, and not Centeon, is named as a party to
such suit or proceeding, Medarex shall have the right to control the defense and
settlement of such suit or proceeding, at its own expense, using counsel of its
own choice, however Centeon, at its own expense and through counsel of its
own choice, may seek to intervene if the suit or proceeding relates to the
commercialization of the Product in the Field. Medarex agrees not to oppose
such intervention. If both Medarex and Centeon are named as parties in such suit
or proceeding, or become parties through intervention, each shall have the
right, at its own expense and through counsel of its own choice, to present its
own defense and to determine its own terms for settlement. [*****] The parties
shall cooperate with each other in connection with any such claim, suit or
proceeding and shall keep each other reasonably informed of all material
developments in connection with any such claim, suit or proceeding.
9. REPRESENTATIONS AND WARRANTIES
9.1 Medarex. Medarex represents and warrants that:
-------
9.1.1 it is a corporation duly organized, validly existing and in good
standing under the laws of the State of New Jersey;
9.1.2 when executed and delivered, this Agreement will become valid
and binding on Medarex, and enforceable against Medarex in accordance with its
terms;
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
-23-
9.1.3 it is not a party to any agreement, indenture or other
instrument and has no by-law or charter provision and knows of no law or
regulation which would prohibit it from entering into this Agreement, performing
the agreement contemplated hereunder or granting the licenses granted hereunder;
9.1.4 it has not previously granted and will not grant any rights in
conflict with the rights and license granted to Centeon herein, and is the owner
or licensee of the Medarex Technology, with the right to license the Medarex
Technology to Centeon, except as expressly set forth in Section 3.4;
9.1.5 Medarex bas not been served with any lawsuit with respect to the
Medarex Technology or the right of Medarex to enter into and perform its
obligations under this Agreement and, to the best of Medarex' knowledge as of
the Effective Date, there are no existing or threatened actions, suits or claims
pending with respect to the Medarex Technology or the right of Medarex to enter
into and perform its obligations under this Agreement;
9.1.6 the Medarex Technology owned by Medarex is free and clear of any
lien, encumbrance, security interest and restriction on transfer and license,
and to the best of Medarex' knowledge as of the Effective Date, the Medarex
Technology licensed from third parties is free and clear of any lien,
encumbrance, security interest and restriction on transfer and license;
9.1.7 as of the Effective Date, the MRC Sublicense and the Scotgen
Sublicense, are in full force and effect and there are no existing defaults, or
events, which, with the passage of time, would become defaults under such
agreements, which, individually or taken as a whole, would materially and
adversely affect the ability of Medarex to enter into this Agreement or the
ability of the parties to perform the transactions contemplated hereunder;
9.1.8 to the best of Medarex' knowledge as of the Effective Date,
the Celltech/MRC Agreement and the MRC/Scotgen Agreement, are in full force and
effect and there are no existing defaults, or events, which, with the passage of
time, would become defaults under such agreements, which, individually or taken
as a whole, would materially and adversely affect the ability of Medarex to
enter into this Agreement or the ability of the parties to perform the
transactions contemplated hereunder;
9.1.9 as of the Effective Date, the execution, delivery of this
Agreement and performance hereunder by Medarex does not conflict with, or cause
a default under, the MRC Sublicense or the Scotgen Sublicense; and
9.1.10 to the best of Medarex' knowledge as of the Effective Date,
the execution, delivery of this Agreement and performance hereunder by Medarex
does not conflict with, and will not cause a default under, the Celltech/MRC
Agreement or the MRC/Scotgen Agreement;
-24-
[*****]
9.2 Centeon. Centeon represents and warrants that:
-------
9.2.1 it is a limited liability company duly organized, validly
existing and in good standing under the laws of the State of Delaware;
9.2.2 when executed and delivered, this Agreement will become valid
and binding on Centeon, and enforceable against Centeon in accordance with its
terms.
9.3 Effect of Representations and Warranties. It is understood that if the
-----------------------------------------
representations and warranties under this Article 9 are not true and accurate
and Medarex or Centeon incurs liabilities, costs or other expenses as a result
of such falsity, Medarex or Centeon, as the case may be, shall indemnify, defend
and hold the other party harmless from and against any such liabilities, costs
or expenses incurred, provided that the indemnifying party receives prompt
notice of any claim against Medarex or Centeon, as the case may be, resulting
from or related to such falsity, the cooperation of the indemnified party, as
requested in connection with any such claim, and the sole right to control the
defense or settlement thereof.
9.4 Notice. Upon learning of any default under or material adverse changes
---------
in or to the Celltech/MRC Agreement, MRC/Scotgen Agreement, Scotgen Sublicense
and MRC Sublicense, Medarex shall promptly send notice to Centeon of such
defaults or material adverse changes.
9.5 Disclaimer of Warranties, Medarex specifically disclaims that the
--------------------------
Development Program will be successful in whole or part. EXCEPT AS OTHERWISE
EXPRESSLY SET FORTH IN THIS AGREEMENT AND SUBJECT TO THE INDEMNITY PROVISIONS OF
ARTICLE 11, MEDAREX AND CENTEON AND THEIR RESPECTIVE AFFILIATES MAKE NO
REPRESENTATIONS AND EXTEND NO WARRANTIES OR CONDITIONS OF ANY KIND, EITHER
EXPRESS OR IMPLIED, WITH RESPECT TO THE PATENT RIGHTS AND KNOW-HOW, OR PRODUCTS
INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, VALIDITY OF THE PATENT RIGHTS OR KNOW-HOW LICENSED
HEREUNDER, OR NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES.
10. CONFIDENTIALITY
10.1 Confidential Information. Except as expressly provided herein, the
---------------------------
parties agree that, for the term of this Agreement and for five (5) years
thereafter, the receiving party shall keep
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
-25-
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:
(a) was already known to the receiving party, other than under an
obligation of confidentiality, at the time of disclosure;
(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving party;
(c) 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;
(d) was independently developed by the receiving party as demonstrated
by documented evidence prepared contemporaneously with such independent
development; or
(e) was subsequently lawfully disclosed to the receiving party by a
person other than a party.
10.2 Permitted Use and Disclosures. Each party hereto may use or disclose
--------------------------------
information disclosed to it by the other party, to the extent such use or
disclosure is reasonably necessary in filing or prosecuting patent applications,
prosecuting or defending litigation, complying with applicable governmental
regulations or otherwise submitting information to tax or other governmental
authorities, conducting clinical trials, or making a permitted sublicense or
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 best efforts to
secure confidential treatment of such information (including the significant
financial terms of this Agreement) prior to its disclosure (whether through
protective orders or otherwise) and disclose such information only to the
minimum extent necessary to comply with such requirements.
10.3 Public Disclosure. Except as otherwise required by law, neither party
-----------------
shall issue a press release or make any other public disclosure of the terms of
this Agreement or regarding the results of the Development Program 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 have 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 disclo-
-26-
sure reasonably in advance of such filing or other disclosure for the
nondisclosing party's prior review and comment.
10.4 Injunctive Relief Notwithstanding Section 13.2, Medarex and Centeon
------------------
hereby acknowledge that damages at law may be an inadequate remedy for the
breach of any of the covenants, promises and agreements contained in this
Section 10, and accordingly, Medarex or Centeon, as the case may be, may be
entitled to injunctive relief with respect to any such breach, including
specific performance of such covenants, promises or agreements or an order
enjoining Medarex or Centeon from any threatened, or from the continuation of
any actual, breach of covenants, promises or agreements. The rights set forth in
this Section 10.4 shall be in addition to any other rights which Medarex or
Centeon may have at law or in equity.
11. INDEMNIFICATION
[*****]
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
-27-
[*****]
12. TERM AND TERMINATION
12.1 Term. This Agreement shall be effective as of the Effective Date and
----
unless otherwise terminated earlier pursuant to this Article 12, shall continue
in full force and effect on a country-by-country basis until Centeon and it's
Affiliates and Sublicensees have no remaining royalty obligations in such
country. Following the expiration of royalty obligations in any country,
Centeon shall have a non-exclusive, fully paid license under the Know-How to
commercialize the Product in the Field in such country.
12.2 Termination for Cause. Either party may terminate this 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 sixty (60) 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 sixty (60) day period unless the breaching party has cured any such
breach or default prior to the expiration of the sixty (60) day period.
Notwithstanding the above, in the case of a failure to pay any amount due
hereunder the period for cure of any such default following notice thereof shall
be ten (10) days and, unless payment is made within such period, the termination
shall become effective at the end of such period. Notwithstanding the above, if
Centeon disputes the amount of a particular payment obligation, Centeon shall
timely pay to Medarex all amounts except the specific amount in dispute and may
establish an interest-bearing escrow account and tender the disputed amount
thereto, and the balance of the account shall be paid out to either party
pursuant to the outcome of arbitration conducted in accordance with the
provisions of Section 13.2 of this Agreement.
12.3 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
***** 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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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.
12.4 [*****]
12.5 [*****]
12.6 Effect of Breach or Termination.
-------------------------------
12.6.1 Accrued 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 all rights and remedies it may have hereunder or at law or in
equity with respect to any breach of this Agreement. For the avoidance of doubt,
it is agreed that following the termination of the Agreement Centeon shall have
no obligation to pay Medarex any amount for Product development after such date,
or the achievement of any milestone after such date.
12.6.2 Return of Materials. Upon any termination of this Agreement,
-------------------
Centeon and Medarex shall promptly return to the other party all Confidential
Information received from the other party (except one copy of which may be
retained for archival purposes).
12.6.3 Stock on Hand. In the event this Agreement is terminated for
-------------
any reason, Centeon and its Affiliates and Sublicensees shall have the right to
sell or otherwise dispose of the stock of any Product then on hand or purchased
pursuant to Section 12.6.5, subject to Articles 4 and 5 and the other applicable
terms of this Agreement.
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
-29-
12.6.4 Licenses. Subject to Section 12.6.3 regarding post-termination
---------
Product sales, upon any termination of this Agreement pursuant to Section 12.2
or 12.3, the licenses and rights granted Centeon shall terminate concurrently.
Upon any termination of this Agreement pursuant to Section 12.4, the licenses
granted to Centeon shall terminate concurrently.
12.6.5 Product in Manufacture. In the event of any termination by
----------------------
Centeon pursuant to Section 12.4, Centeon shall purchase from Medarex all
Product which Medarex. commenced the manufacture of at Centeon's request prior
to the date Medarex received notice from Centeon of such termination.
12.7 Survival. Sections 3.6, 5.1, 5.2, 6.3, 6.6, 6.7, 8.1, 8.4 and
----------
Articles 9, 10, 11 and 13 shall survive the expiration or termination of this
Agreement for any reason.
13. MISCELLANEOUS
13.1 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 New York, without reference to conflicts of laws principles.
13.2 Arbitration. Any dispute under this Agreement which is not settled by
-----------
mutual consent shall be finally settled by binding arbitration, conducted
in accordance with the Commercial Arbitration Rules of the American Arbitration
Association by three (3) arbitrators appointed in accordance with said rules.
The arbitration shall be held in New York, New York and at least one of the
arbitrators shall be an independent expert in pharmaceutical product development
(including clinical development and regulatory affairs). The arbitrators shall
determine what discovery will be permitted, consistent with the goal of limiting
the cost and time which the Parties must expend for discovery; provided the
arbitrators shall permit such discovery as they deem necessary to permit an
equitable resolution of the dispute. Any written evidence originally in a
language other than English shall be submitted in English translation
accompanied by the original or a true copy thereof. The costs of the
arbitration, including, administrative and arbitrators' fees, shall be shared
equally by the parties and each party shall bear its own costs and attorneys'
and witness' fees incurred in connection with the arbitration. A disputed
performance or suspended performances pending the resolution of the arbitration
must be completed within thirty (30) days following the final decision of the
arbitrators or such other reasonable period as the arbitrators determine in a
written opinion. Any arbitration subject to this Section 13.2 shall be completed
within one (1) year from the filing of notice of a request for such arbitration.
The arbitration proceedings and the decision shall not be made public without
the joint consent of the parties and each party shall maintain the
confidentiality of such proceedings and decision unless otherwise permitted by
the other party. Any decision which requires a monetary payment shall require
such payment to be payable in United States dollars, free of any tax or other
deduction. The parties agree that the decision shall be the sole, exclusive and
binding remedy between them regarding any and all disputes, controversies,
claims and counterclaims
-30-
presented to the arbitrators. Application may be made to any court having
jurisdiction over the party (or its assets) against whom the decision is
rendered for a judicial recognition of the decision and an order of enforcement.
13.3 Waiver. Neither party may waive or release any of its rights or
------
interests in this Agreement except in writing. The failure of either party to
assert a right hereunder or to insist upon compliance with any term or condition
of this Agreement shall not constitute a waiver of that right or excuse a
similar subsequent failure to perform any such term or condition.
13.4 Assignment. This Agreement shall not be assignable by either party to
------------
any third party hereto without the written consent of the other party hereto;
except either party may assign this Agreement, without such consent, to an
entity that acquires all or substantially all of the business or assets of such
party to which this Agreement pertains, whether by merger, reorganization,
acquisition, sale, or otherwise.
13.5 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:
CENTEON: Centeon L.L.C.
0000 Xxxxx Xxxxxx
Xxxx xx Xxxxxxx, Xxxxxxxxxxxx 00000-0000
Attn: General Counsel
MEDAREX Medarex, Inc.
0000 Xxxxx 00 Xxxx
X.X. Xxx 000
Xxxxxxxxx, Xxx Xxxxxx 00000
Attn: President
13.6 Performance by Affiliates. Centeon shall warrant the performance of
--------------------------
any and all rights and obligations of this Agreement by its Affiliate(s) and
Sublicensees.
13.7 Force Majeure. Neither party shall be liable to the other for failure
-------------
or delay in the performance of any of its obligations under this Agreement for
the time and to the extent such failure or delay is caused by riots, civil
commotions, wars, hostilities between nations, governmental laws, orders or
regulations, embargoes, actions by the government or any agency thereof, acts
of God, storms, fires, accidents, labor disputes or strikes, sabotage,
explosions or other similar or different contingencies, in each case, beyond the
reasonable control for the respective parties. The party affected by Force
Majeure shall provide the other party with full particulars thereof as soon as
it becomes aware of the same (including its best estimate of the likely extent
and duration of the
-31-
interference with its activities), and will use its best endeavors to overcome
the difficulties created thereby and to resume performance of its obligations as
soon as practicable. If the performance of any obligation under this Agreement
is delayed owing to a force majeure for any continuous period of more than six
(6) months, the parties hereto shall consult with respect to an equitable
solution, including the possible termination of this Agreement.
13.8 Independent Contractors. Both parties are independent contractors
----------------------
under this Agreement. Nothing contained ih this Agreement is intended nor is to
be construed so as to constitute Medarex or Centeon as partners or joint
venturers with respect to this Agreement. Neither party shall have any express
or implied right or authority to assume or create any obligations on behalf of
or in the name of the other party or to bind the other party to any other
contract, agreement, or undertaking with any Third Party.
13.9 Advice of Counsel. Medarex and Centeon 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.
13.10 Trademarks. Centeon and its Affiliates shall have the right to
------------
market the Product under their own labels and trademark(s). All Product packages
shall carry the notice "Manufactured under license from Medarex, Inc." or a
similar slogan, in a typeface and size agreed by the parties.
13.11 Other Obligations. Except as expressly provided in this Agreement or
-------------------
as separately agreed upon in writing between Medarex and Centeon, each party
shall bear its own costs incurred in connection with the implementation of the
obligations under this Agreement.
13.12 Severability. In the event that any provision of this Agreement
-----------
becomes or is declared by a court of competent jurisdiction to be illegal,
unenforceable or void, this Agreement shall continue in full force and effect
without said provision.
13.13 No Implied Licenses. No rights or licenses with respect to the
-------------------
Medarex Technology are granted or deemed granted hereunder or in connection
herewith, other than those rights expressly granted in this Agreement.
13.14 Patent Marking. Centeon agrees to xxxx and have its Affiliates and
-----------------
sublicensees xxxx all Products they sell or distribute pursuant to this
Agreement in accordance with the applicable statute or regulations in the
country or countries of manufacture and sale thereof.
13.15 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.
-32-
13.16 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,
13.17 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.
13.18 Counterparts. This Agreement may be executed in counterparts, each
--------------
of which shall be deemed to be an original, and both together shall be deemed to
be one and the same agreement.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
duly executed by their authorized representatives as of the Effective Date.
CENTEON L.L.C. MEDAREX, INC.
By: /s/ Xxxx X. Xxxxx By: /s/ Xxxxxxx Xxxxxxxxx
--------------------
Name: Xxxx X. Xxxxx Name: Xxxxxxx Xxxxxxxxx
-------------------- --------------------
Title: CEO Title: Sr. Vice President
-------------------- --------------------
By: /s/ P. Fuhge
--------------------
Name: P. Fuhge
--------------------
Title: Senior Executive V.P.
------------------------
and Chief Research &
Development Officer
-33-
EXHIBIT A
Development 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.
-34-
[*****]
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
-35-
EXHIBIT B
U.S. and Foreign Patent Applications and Patents
-36-
