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COLLABORATION AND LICENSE AGREEMENT
between
KIRIN BREWERY CO., LTD.,
(on the one hand)
and
MEDAREX, INC. and GENPHARM INTERNATIONAL, INC.
(on the other hand)
Effective as of September 4, 2002
TABLE OF CONTENTS
Page
ARTICLE I DEFINITIONS ............................................................... 2
ARTICLE II ANTIGEN AND ANTIBODY LISTS AND RELATED LISTING
PROCEDURES AND DISCLOSURE REQUIREMENTS .................................... 33
2.1 Antibody Sequence List and Antigen Lists Maintained by Each Party ...... 33
2.2 In-House Target Lists and Medarex Internal Project List ................ 33
2.3 Listing Procedures ..................................................... 33
2.4 Disclosure of Certain Antigen Lists .................................... 41
2.5 Confidentiality of Antigen and Antibody Disclosures .................... 41
2.6 Records Retention; [*] ................................................. 41
ARTICLE III ANTIBODY AND ANTIGEN AVAILABILITY ......................................... 42
3.1 Principles of Antibody and Antigen Availability ........................ 42
3.2 Medarex Antigen Inquiries .............................................. 43
3.3 Kirin Antigen Inquiries ................................................ 44
3.4 Medarex Antibody Inquiries ............................................. 48
3.5 Kirin Antibody Inquiries ............................................... 49
3.6 Notices, Inquiries and Other Requests Relating to Antibodies and
Antigens ............................................................... 51
3.7 Covenants Relating to Lists and Disclosures ............................ 52
3.8 Purchase of Rights ..................................................... 52
ARTICLE IV ANTIGEN AND ANTIBODY SELECTION FOR EXERCISE OF
LICENSE RIGHTS ............................................................ 52
4.1 Projects Involving Use of Medarex Mice and/or Medarex Technology ....... 52
4.2 Reservation Licenses ................................................... 53
4.3 Commercial Licenses .................................................... 54
4.4 [*] .................................................................... 62
ARTICLE V IN-HOUSE PROJECTS ......................................................... 64
5.1 In-House Target List ................................................... 64
5.2 [*] Target Selection ................................................... 67
5.3 [*] Target Selection ................................................... 68
5.4 Abandoned Target Selection ............................................. 69
5.5 Removing Targets from the [*] and the Target List ...................... 69
ARTICLE VI PARTNER PROJECTS .......................................................... 69
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
-i-
TABLE OF CONTENTS
(continued)
Page
6.1 Partner Projects ...................................................... 69
6.2 Partner Projects Involving Special Relationships ...................... 70
6.3 [*] Advertisements or Other Promotions ................................ 70
6.4 Partner Opportunities ................................................. 71
6.5 Covenants ............................................................. 71
6.6 Offers of Collaboration Mice to Partners .............................. 73
ARTICLE VII CHANGE IN STATUS OF IN-HOUSE PROJECT OR PARTNER PROJECT .................. 74
7.1 Change in Rights Related to Target Designated for In-House Project .... 74
7.2 Change in Rights Related to Target Selected for Partner Project ....... 74
ARTICLE VIII GRANTS OF LICENSES ....................................................... 75
8.1 Present Grants of Licenses ............................................ 75
8.2 Medarex Licenses to Kirin ............................................. 75
8.3 Kirin Licenses to Medarex ............................................. 81
8.4 Negotiations Regarding Licenses Outside the Field ..................... 85
8.5 Sublicenses ........................................................... 85
8.6 Covenants Relating to Licenses and Sublicenses ........................ 91
8.7 Termination of Commercial License ..................................... 97
8.8 License Grants and Exercise Prior to the Effective Date ............... 97
8.9 Condition Precedent to Grant of a Commercial License .................. 99
8.10 Registration of Patent Licenses ....................................... 99
8.11 [*] and Rights Preserving Excuse ...................................... 99
8.12 No Other Rights ....................................................... 103
ARTICLE IX TRANSFER OF MATERIALS .................................................... 103
9.1 Transfer of Mice and Mice Materials ................................... 103
9.2 Information Disclosure ................................................ 105
9.3 Production Process Technology ......................................... 105
ARTICLE X LICENSE FEES, MILESTONES, ROYALTIES AND OTHER PAYMENTS ................... 105
10.1 Initial License Fees and Other Consideration .......................... 105
10.2 Reservation License Fees .............................................. 106
10.3 Commercial License Fees ............................................... 108
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
-ii-
TABLE OF CONTENTS
(continued)
Page
10.4 Antigen Exclusivity Fees ......................................................... 109
10.5 [*] Target Milestone Payments .................................................... 111
10.6 In-House Project Royalties ....................................................... 117
10.7 Partner Royalties and Partner Payments ........................................... 118
10.8 Equity Investments by a Party in Connection with Partner Projects ................ 123
10.9 In-House Project Royalty, Partner Royalty and Partner Payment Terms .............. 125
10.10 Partner Payments and Royalty Payments Periods .................................... 126
10.11 Statements ....................................................................... 127
10.12 Records Retention; Audit ......................................................... 127
10.13 Mode of Payment and Withholding and Similar Taxes ................................ 128
10.14 Payments in Other Currencies ..................................................... 128
ARTICLE XI RESEARCH AND COLLABORATION RELATING TO JOINT TECHNOLOGY ............................... 129
11.1 Research and Research Reports .................................................... 129
11.2 Collaboration Meetings for Development of Medarex, Kirin and Joint Technologies .. 129
ARTICLE XII INTELLECTUAL PROPERTY RIGHTS .......................................................... 129
12.1 Intellectual Property Ownership .................................................. 129
12.2 Prosecution of Patents and Trademarks ............................................ 131
12.3 Enforcement of Patents ........................................................... 135
12.4 Infringement of Third Party Rights ............................................... 137
ARTICLE XIII CONFIDENTIALITY ....................................................................... 140
13.1 Disclosure and Use Restrictions .................................................. 140
13.2 Authorized Disclosure ............................................................ 140
13.3 Use of Name ...................................................................... 141
13.4 Press Releases and Filings with the SEC .......................................... 141
13.5 Equitable Relief ................................................................. 142
13.6 Third Party Agreements ........................................................... 142
ARTICLE XIV TERM AND TERMINATION .................................................................. 142
14.1 Term ............................................................................. 142
14.2 Termination of this Agreement for Material Breach ................................ 142
14.3 Consequences of Expiration or Termination ........................................ 143
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchan
ge Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
-iii-
TABLE OF CONTENTS
(continued)
Page
14.4 Cure in Certain Instances ........................................................ 143
14.5 Rights in Bankruptcy ............................................................. 144
14.6 Accrued Rights; Surviving Obligations ............................................ 145
14.7 Notices Relating to Project Agreements for Kirin Partner Projects and
Kirin In-House Projects .......................................................... 146
ARTICLE XV INDEMNITY ............................................................................. 146
15.1 Indemnification of Medarex ....................................................... 146
15.2 Indemnification of Kirin ......................................................... 146
15.3 Indemnification Procedure ........................................................ 147
15.4 Insurance ........................................................................ 149
ARTICLE XVI REPRESENTATIONS AND WARRANTIES ........................................................ 149
16.1 Representations, Warranties and Covenants ........................................ 149
16.2 Additional Representations, Warranties and Covenants of Medarex .................. 150
16.3 Additional Representations, Warranties and Covenants of Kirin .................... 151
16.4 Knowledge; Officers .............................................................. 152
16.5 Limitation of Warranty ........................................................... 152
ARTICLE XVII DISPUTE RESOLUTION .................................................................... 152
17.1 General .......................................................................... 152
17.2 Interim Relief ................................................................... 153
17.3 Language ......................................................................... 153
17.4 Covenant Relating to "WHEREAS" Clauses ........................................... 153
ARTICLE XVIII MISCELLANEOUS ......................................................................... 153
18.1 Force Majeure .................................................................... 153
18.2 Governing Law .................................................................... 154
18.3 Notices .......................................................................... 154
18.4 Assignment ....................................................................... 156
18.5 Entire Agreement; Modifications .................................................. 157
18.6 Severability ..................................................................... 157
18.7 Waiver ........................................................................... 157
18.8 Independent Contractors .......................................................... 157
18.9 Language ......................................................................... 157
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchan
ge Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
-iv-
TABLE OF CONTENTS
(continued)
Page
18.10 Descriptive Headings ............................................ 158
18.11 Counterparts .................................................... 158
18.12 No Third Party Rights ........................................... 158
18.13 Further Assurances .............................................. 158
18.14 Cumulative Remedies ............................................. 158
18.15 Attorneys' Fees ................................................. 158
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
-v-
COLLABORATION AND LICENSE AGREEMENT
THIS COLLABORATION AND LICENSE AGREEMENT ("Agreement"), is made and entered
into as of September 4, 2002, by and between KIRIN BREWERY CO., LTD., having
principal offices at 10-1 Shinkawa 2-chome, Chuo-ku, Tokyo 104-8288, Japan
("Kirin") and MEDAREX, INC., having principal offices at 707 State Road, Suite
206, Princeton, New Jersey 08540-1437, United States of America, and a wholly
owned subsidiary, GENPHARM INTERNATIONAL, INC., with principal offices at 521
Cottonwood Drive, Milpitas, California 95035, United States of America
(collectively, "Medarex"). Kirin and Medarex each may be referred to herein
individually as a "Party," or collectively as the "Parties."
WHEREAS, Kirin, Medarex, and their respective Affiliates have developed,
and continue to refine and further develop, technologies in the area of
monoclonal antibody production utilizing mice carrying human immunoglobulin
loci;
WHEREAS, Medarex owns or otherwise has the right to license patent and
other intellectual property rights in and to a proprietary system for obtaining
high affinity monoclonal antibodies derived from mice carrying a portion of the
human immunoglobulin loci, a key component of which system is a transgenic mouse
referred to as the HuMAb Mouse(R) (as defined below);
WHEREAS, Kirin owns or otherwise has the right to license patent and other
intellectual property rights in and to a proprietary system for obtaining high
affinity monoclonal antibodies derived from mice carrying human immunoglobulin
loci, key components of which system are transchromosomic mice referred to as
the TC Mouse(TM) (as defined below) and the HAC Mouse(TM) (as defined below);
WHEREAS, Medarex and Kirin have collaborated to develop, and continue to
refine and further develop, a new proprietary system for obtaining high affinity
monoclonal antibodies derived from mice carrying a portion of the human
immunoglobulin loci, a key component of which system is a mouse referred to as
the KM-Mouse(TM) (as defined below);
WHEREAS, in the absence of the license grants contained in this Agreement,
Medarex believes that use or exploitation by Kirin of the TC Mouse(TM), HAC
Mouse(TM), HuMAb Mouse(R), or KM-Mouse(TM) and related information and
technology would infringe certain patent or other intellectual property rights
of Medarex, and Kirin believes that use or exploitation by Medarex of the TC
Mouse(TM), HAC Mouse(TM), or KM-Mouse(TM) and related information and technology
would infringe certain patent or other intellectual property rights of Kirin;
WHEREAS, while neither Kirin nor Medarex concedes that its use of such
technology would infringe any intellectual property rights of the other Party,
or concedes that there is any basis for any infringement claims by the other
Party, each Party nonetheless desires to avoid protracted and burdensome
litigation, and to secure licenses to any potential blocking patents of the
other Party that might prevent or hinder such Party from practicing and further
developing such technology, by entering this Agreement and granting each other
license rights to use and exploit the TC Mouse(TM), HAC Mouse(TM), HuMAb
Mouse(R), and KM-Mouse(TM) and related information and technology;
WHEREAS, subject to the terms and conditions of this Agreement, Medarex and
Kirin each desires the ability to grant to affiliates and/or third parties
licenses (and sublicenses) to exploit transgenic and/or transchromosomic mice
carrying at least a portion of the human immunoglobulin loci, specifically the
TC Mouse(TM), HAC Mouse(TM), HuMAb Mouse(R), KM-Mouse(TM) and related
information and technology, including rights to resulting products, so as to
allow affiliates and/or third parties to engage in research, development,
manufacture, and commercialization of such resulting products;
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
WHEREAS, affording each Party and its licensees access to and rights in
technology relating to the TC Mouse(TM), HAC Mouse(TM), HuMAb Mouse(R), and
KM-Mouse(TM) is likely to result in research and development synergies leading
to more rapid development and commercialization of marketable products;
WHEREAS, subject to the terms and conditions of this Agreement, Medarex and
Kirin each desires to grant to the other Party licenses to practice transgenic
and/or transchromosomic mouse technology, as the case may be, including that
technology related to the HuMAb Mouse(R), TC Mouse(TM), HAC Mouse(TM), and
KM-Mouse(TM) to generate antibodies derived from human immunoglobulin loci
carried by such mice in order to develop and commercialize antibody products
raised against and with affinity for antigens selected by Medarex, Kirin, or
their respective sublicensees;
WHEREAS, the Parties acknowledge and agree, in the spirit of equal
partnership, that they intend to provide each Party with access to the other
Party's Technology (as defined below) in a manner which encourages commercial
use by both Parties, consistent with the terms and conditions of this Agreement;
and
WHEREAS, Medarex and Kirin entered into that certain agreement entitled
"Agreement on Essential Terms for Collaboration," effective as of December 27,
1999, concerning the terms that form the basis of this Agreement, and the
Parties now desire to supersede such agreement with this Agreement.
NOW, THEREFORE, in accordance with the foregoing and for other valuable
consideration, the receipt and adequacy of which are hereby acknowledged, Kirin
and Medarex hereby agree as follows:
ARTICLE I
DEFINITIONS
The following capitalized terms used herein shall have the respective
meanings set forth below:
1.1 "1st Approval" shall mean, with respect to any Collaboration Product,
the first Marketing Approval obtained in any of the United States, a Major
European Country, or Japan.
1.2 "2nd Approval" shall mean, with respect to any Collaboration Product
as to which the 1st Approval has been obtained in any of the United States, a
Major European Country, or Japan, the immediately succeeding Marketing Approval
obtained with respect to such product in any of such territories in which the
1st Approval was not obtained. For the avoidance of doubt, in the event the 1st
Approval with respect to the Collaboration Product has been obtained in a Major
European Country for purposes of Section 1.1 hereof, in order for any succeeding
Marketing Approval with respect to such product to constitute the 2nd Approval
for purposes of this Section 1.2, such succeeding Marketing Approval must be
obtained in either the United States or Japan.
1.3 "3rd Approval" shall mean, with respect to any Collaboration Product
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