[ * ] =
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 406 OF THE
SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.
RESEARCH, DEVELOPMENT AND
MARKETING
ONYX PHARMACEUTICALS,
INC.
[ *
] = 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 406 OF THE SECURITIES EXCHANGE ACT OF
1933, AS AMENDED.
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1
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1
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Collaboration Compound(s)
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1
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Collaboration Lead Compound(s)
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1
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1
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Collaboration Product Exclusive
Period
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1
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1
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1
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1
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2
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2
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3
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3
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3
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3
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3
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3
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3
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4
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Onyx Product Exclusive Period
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4
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4
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4
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Research Management Committee
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4
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4
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4
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4
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Term of the Research Collaboration
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4
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4
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4
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ARTICLE I RESEARCH PROGRAM
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5
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1.1 Undertaking and Scope
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5
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1.2 Personnel and Resources
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5
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1.3 Term of the Research
Collaboration
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6
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1.4 Rights to Know-How and Patents for
Research
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6
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1.5 Collaboration Expenses
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6
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6
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2.1 Research Management Committee
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6
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7
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7
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7
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ARTICLE III PATENTS, KNOW-HOW, RIGHTS AND
INVENTIONS
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7
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7
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8
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3.3 Protection of Patent Rights
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8
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3.4 Allegations of Infringement by Third
Parties
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9
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[ *
] = 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 406 OF THE SECURITIES EXCHANGE ACT OF
1933, AS AMENDED.
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ARTICLE IV DESIGNATION OF LEAD COMPOUNDS AND
MARKETING RIGHTS
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9
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4.1 Designation of Lead Compound
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9
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4.2 Collaboration Product
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10
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4.3 Independent Development
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10
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4.4 Warner’s Re-engagement
Option
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10
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ARTICLE V LICENSES AND ROYALTIES
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11
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11
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11
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5.3 Royalties Payable by Warner
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11
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5.4 Royalties Payable by Onyx
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12
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13
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5.6 Payment and Reporting
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13
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13
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13
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5.9 Computation of Royalties
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13
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5.10 Licenses to Affiliates
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14
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5.11 Restrictions on Payment
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14
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ARTICLE VI CO-PROMOTION OF COLLABORATION
PRODUCTS
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14
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14
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6.2 Election or Revocation of Co-Promotion
Right
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14
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6.3 Onyx’s Promotional
Percentage
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14
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6.4 Marketing and Marketing Plans
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15
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6.5 Promotional Materials
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15
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15
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15
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15
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15
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15
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15
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6.12 Exchange of Marketing
Information
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16
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16
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16
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7.2 Regulatory and other Inquiries
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16
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16
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7.4 Responsibility if not
Co-Promoting
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16
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ARTICLE VIII RESEARCH FUNDING AND
MILESTONES
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16
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16
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17
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ARTICLE IX CONFIDENTIALITY
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18
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18
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18
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19
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19
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19
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10.2 Japanese Company Agreement
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19
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10.3 Absence of Agreement
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20
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[ *
] = 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 406 OF THE SECURITIES EXCHANGE ACT OF
1933, AS AMENDED.
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ARTICLE XI REPRESENTATIONS AND
WARRANTIES
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20
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20
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20
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21
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21
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21
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21
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12.1 Termination for Breach
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21
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12.2 Effect of Bankruptcy
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22
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22
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12.4 Termination of Co-Promotion
Rights
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22
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23
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12.6 Voluntary Termination
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23
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ARTICLE XIII GENERAL PROVISIONS
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23
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23
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24
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24
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13.4 Research Dispute Resolution
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24
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24
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24
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24
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13.8 Vaccines and Diagnostics
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25
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25
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13.10 No Implied Licenses or
Warranties
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25
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25
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26
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26
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26
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13.15 Independent Contractors
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26
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26
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[ *
] = 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 406 OF THE SECURITIES EXCHANGE ACT OF
1933, AS AMENDED.
RESEARCH, DEVELOPMENT AND
MARKETING COLLABORATION AGREEMENT
Research,
Development and Marketing Collaboration Agreement, dated as of
May 2, 1995, between Onyx Pharmaceuticals, Inc., a California
corporation (“Onyx”), located at 3031 Research Drive,
Richmond, California 94806, and Warner-Lambert Company, a Delaware
corporation (“Warner”), located at 201 Tabor Road,
Morris Plains, New Jersey 07950.
WHEREAS, Onyx and
Warner each has certain expertise in the discovery and development
of agents acting in the field of cell cycle control; and
WHEREAS, Warner
and Onyx each wish to enter into a collaborative effort to share
such expertise, to develop new expertise in the field of cell cycle
control, to research together potential applications thereof and,
if successful, to market certain of such applications (the
“Collaboration”);
NOW, THEREFORE, in
consideration of the foregoing premises and the mutual promises,
covenants and conditions contained herein, Onyx and Warner agree as
follows:
The following
capitalized terms shall have the meanings indicated for purposes of
this Agreement:
“
Affiliate ” shall mean any corporation, association or
other entity which directly or indirectly controls, is controlled
by or is under common control with the party in question. As used
herein the term “control” means possession of the power
to direct, or cause the direction of, the management and policies
of a corporation, association or other entity.
“
Collaboration Compound(s) ” shall have the meaning set
forth in Section 1.1.
“
Collaboration Lead Compound(s) ” shall have the
meaning set forth in Section 4.1.
“
Collaboration Product(s) ” shall have the meaning set
forth in Section 4.2.
“
Collaboration Product Exclusive Period ” shall have
the meaning set forth in Section 5.3.
“
Co-Promotion Country ” shall mean the United States of
America and its territories and possessions, including the
Commonwealth of Puerto Rico.
“
Effective Date ” shall mean the date of this Agreement
first written above.
“ FDA
” shall mean the United States Food and Drug
Administration.
[ *
] = 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 406 OF THE SECURITIES EXCHANGE ACT OF
1933, AS AMENDED.
2
“
Field ” shall mean research, drug discovery and
development collaboration aimed at therapeutic agents to restore
control of, or otherwise intervene in, misregulated cell cycle
transitions in tumor cells, vascular smooth muscle cells, or other
pathological conditions, in each case insofar as it relates to the
targets listed below. Such agents may restore growth control and/or
result in death of cells with aberrant control.
The
Collaboration will seek to identify agents that modulate biological
targets within the Field. The Collaboration will include all
therapeutic benefits of such agents.
The Field will
consist initially of [ * ] . The Field shall also include
the [ * ] . The Field will also include the [ * ]
.
The parties may
agree during the Term of the Research Collaboration to expand the
Field by designating additional targets, and it is their intention
to do so in the event logical extensions of the Field are
identified and may be accommodated within the resource commitment
of the parties. Such expansion will be in writing signed by all
members of the Research Development Committee. However, neither
party shall be obligated to agree to expand the Field.
Notwithstanding
the general description of the Field provided above, the Field will
exclude:
(a) All
molecular entitles that are part of or that regulate [ * ] .
This includes but is not restricted to [ * ] . This also
includes molecules that directly or indirectly regulate the
aforementioned molecules, [ * ] . This also includes [ *
] . This exception shall not include (by way of example and not
limitation) [ * ]
“ IND
” shall mean an Investigational New Drug
Application.
“
Invention(s) ” shall have the meaning set forth in
Section 3.1.
“
Know-How ” shall mean Onyx Know-How and/or Warner
Know-How, as the case may be.
“ NDA
” shall mean a New Drug Application.
“ Net
Sales ” shall mean the gross amount invoiced by a party
hereto or one of its Affiliates to customers who are not Affiliates
of the selling party for all Products sold after deduction of the
following items calculated in accordance with United States
generally accepted accounting principles and Warner’s (or
Onyx’s, as the case may be) normal internal accounting
standards consistently applied: [ * ]
“ Onyx
Know-How ” shall mean all technology, inventions,
information, data, know-how, compounds and materials that
(i) are not Onyx Patents, (ii) Onyx owns or otherwise has
the right to license to Warner and (iii) relate to the
discovery, design, synthesis, delivery, development, testing, use,
manufacture or sale of agents acting in the Field. Excluded from
“Onyx Know-How” are compounds and information relating
to compounds that have been identified by Onyx as candidates for
cGLP/cGMP studies on or before the Effective Date, or are hereafter
so identified without material application of information provided
by Warner or developed by either party pursuant to the
Collaboration.
[ *
] = 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 406 OF THE SECURITIES EXCHANGE ACT OF
1933, AS AMENDED.
3
“ Onyx
Lead Compound(s) ” shall have the meaning set forth in
Section 4.3.
“ Onyx
Patents ” shall mean all United States and foreign
patents that are owned by Onyx or that Onyx otherwise has the right
to license to Warner and that relate to the discovery, design,
synthesis, delivery, development, testing, use, manufacture or sale
of agents acting in the Field, including, without limitation, all
reissues, extensions, substitutions, confirmations, registrations,
revalidations, additions, continuations, continuations-in-part, and
divisions thereof. Excluded from “Onyx Patents” are
compounds and information relating to compounds that have been
identified by Onyx as candidates for cGLP/cGMP studies on or before
the Effective Date, or are hereafter so identified without material
application of information provided by Warner or developed pursuant
to the Collaboration.
“ Onyx
Product(s) ” shall have the meaning set forth in
Section 4.3.
“ Onyx
Product Exclusive Period ” shall have the meaning set
forth in Section 5.4.
“
Patent(s) ” shall mean, Onyx Patents and/or Warner
Patents, as the case may be.
“
Product(s) ” shall mean Collaboration Products and/or
Onyx Products, as applicable.
“
Research Management Committee ” shall mean that entity
organized and acting pursuant to Section 2.1.
“
Research Plan ” shall have the meaning set forth in
Section 1.1.
“ Term of
Co-Promotion ” for a Collaboration Product shall mean the
period beginning upon the first commercial sale of a Collaboration
Product in the Co-Promotion Country and [ * ] .
“ Term of
this Agreement ” shall mean from the Effective Date until
the expiration of all licenses granted pursuant to this Agreement
or until this Agreement is otherwise terminated pursuant to its
terms.
“ Term of
the Research Collaboration ” shall have the meaning set
forth in Section 1.3.
“ Warner
Know-How ” shall mean all technology, inventions,
information, data, know-how, compounds and materials that
(i) are not Warner Patents, (ii) Warner owns or otherwise
has the right to license to Onyx and (iii) relate to the
discovery, design, synthesis, delivery, development, testing, use,
manufacture or sale of agents acting in the Field. Excluded
from”Warner Know-How” are (i) Warner’s
high-volume screening technology and (ii) compounds and
information relating to compounds that have been identified by
Warner as candidates for cGLP/cGMP studies on or before the
Effective Date, or are hereafter so identified without material
application of information provided by Onyx or developed by either
party pursuant to the Collaboration.
“ Warner
Patents ” shall mean all United States and foreign
patents that are owned by Warner or that Warner otherwise has the
right to license to Onyx and that relate to the discovery, design,
synthesis, delivery, development, testing, use, manufacture or sale
of agents acting in the Field, including, without limitation, all
reissues, extensions, substitutions, confirmations,
[ *
] = 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 406 OF THE SECURITIES EXCHANGE ACT OF
1933, AS AMENDED.
4
registrations,
revalidations, additions, continuations, continuations-in-part, and
divisions thereof. Excluded from”Warner Patents” are
(i) Warner’s high volume screen technology and (ii)
compounds and information relating to compounds that have been
identified by Warner as candidates for cGLP/cGMP studies on or
before the Effective Date, or are hereafter so identified without
material application of information provided by Onyx or developed
pursuant to the Collaboration.
1.1 Undertaking
and Scope. From time to time the Research Management Committee
will agree on the general direction of the research to be performed
hereunder. Correspondence and other material documenting such
agreement are collectively referred to herein as the
“Research Plan.” Each party agrees to use its best
efforts to perform the activities detailed in the Research Plan, in
a professional and timely manner. Onyx agrees to use its best
efforts at its cost (including the cost of any royalties or other
amounts payable by Onyx to third parties) to (i) develop and
transfer to Warner [ * ] screening assays per each year of
the Term of the Research Collaboration for specific targets in the
Field selected by the Research Management Committee,
(ii) supply protein required to run such screens and
(iii) provide for the testing of substantially all of
Onyx’s compound library in such screens. Onyx shall not
knowingly provide or perform research on any compounds the use of
which would require a royalty or other payment to any third party,
unless the Research Management Committee agrees that such compound
should be provided and the parties agree in writing how such
royalty or other payment will be paid. Warner agrees to use its
best efforts at its cost (including the cost of any royalties or
other amounts payable by Warner to third parties) to
(i) screen substantially all of its compound library with such
screens provided by onyx and (ii) conduct medicinal chemistry
and animal pharmacology as the Research Management Committee deems
appropriate. Promptly after the Effective Date, Onyx and Warner
will disclose to each other all information possessed by it
relevant to the Field and necessary or helpful to perform the work
described in the Research Plan (except to the extent precluded by
the pre-existing confidentiality obligations described on
Schedule 1 hereto). Compounds identified by either
party during the Term of the Research Collaboration (or [ *
] thereafter) as showing sufficient activity against targets
identified by the Research Management Committee in assays
contributed to or developed under the Collaboration such that
further research on such compound for such target is pursued, and
any analogs or derivatives of such compounds whenever identified,
are referred to herein as “Collaboration Compounds.”
The Research Management Committee and either party individually may
from time to time declare each such compound to be a Collaboration
Compound. Notwithstanding the foregoing, neither party will be
required to offer the other party any compounds or information
relating to compounds that have been identified as candidates for
cGLP/cGMP studies on or before the Effective Date, or are hereafter
so identified without material application of information provided
by the other party or developed pursuant to the Collaboration.
Neither party shall be required to screen under this Collaboration
or to offer to the other party any information regarding any
compounds identified as having activity in pathways expressly
excluded from the Field, if so identified prior to being designated
a “Collaboration Compound” hereunder.
[ *
] = 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 406 OF THE SECURITIES EXCHANGE ACT OF
1933, AS AMENDED.
5
1.2 Personnel
and Resources. Each party agrees to commit the personnel,
facilities, expertise and other resources to perform this Agreement
in accordance with its terms; provided, however, that neither party
warrants that the Collaboration shall achieve any of the research
objectives contemplated by them. During the Term of the Research
Collaboration, Warner and Onyx will each maintain at its cost an
average of 15 full-time equivalents (“FTEs”) devoted to
cooperative work under the Research Plan. During the first-year of
the Term of the Research Collaboration Warner need maintain only 10
such FTEs; provided however, that Warner will staff at higher
levels in later periods to achieve an average of 15 FTEs during the
Term of the Research Collaboration, unless such term is terminated
early as permitted hereunder. The scientific priorities and
direction of such staff of both parties will be determined by the
Research Management Committee. Such staff will include, as
appropriate, scientists in the areas of mass screening, molecular
biology, biochemistry, biochemical pharmacology, cancer and
cardiovascular pharmacology, synthetic chemistry (including peptide
synthesis), computer-assisted drug design, and analytical chemistry
(e.g., NMR spectroscopy).
1.3 Term of the
Research Collaboration. Work under the Research Plan will
commence as of the date of this Agreement and, unless terminated
earlier by either party pursuant to the terms of this Agreement or
extended by mutual agreement of the parties, will terminate on the
third anniversary hereafter (as terminated, expired or extended,
the “Term of the Research Collaboration”).
1.4 Rights to
Know-How and Patents for Research. Each party hereby grants and
agrees to grant to the other a non-exclusive, royalty-free license
to use such party’s Know-How and Patents that are conceived
or reduced to practice prior to the [ * ] anniversary of the
end of the Term of the Research Collaboration for (a) research
and development purposes in the Field and (b), beginning [ *
] after termination of the Term of the Research Collaboration,
research and development outside of the Field; provided, however,
that the granting party may terminate such licenses granted by it
immediately upon its termination of this Agreement for cause.
Notwithstanding the foregoing, neither party is granted any
interest in the other’s compounds (or analogs or derivatives
thereof) except as specifically set forth in this Agreement. In the
event that one party does nonetheless conceive or reduce to
practice any invention that is comprised of the other party’s
compound (or analog or derivative thereof) and if such invention is
not in the Field, such party will promptly assign its entire
interest therein exclusively to the other party without charge and
will not be entitled to any milestones, royalties or other
consideration in connection therewith.
1.5
Collaboration Expenses. [ * ] the costs and expenses
of work done pursuant to the Collaboration at [ * ]
.
2.1 Research
Management Committee. Warner and Onyx will each appoint up to 4
representatives to a research management committee (the
“Research Management Committee”), which will oversee
the operational aspects of performing the Research Plan. The
Research
[ *
] = 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 406 OF THE SECURITIES EXCHANGE ACT OF
1933, AS AMENDED.
6
Management
Committee will assure that agendas and minutes are prepared for
each of its meetings. The personnel, facilities, expertise and
other resources of each party to be used in performance of the
Research Plan shall be established by the Research Management
Committee. The Research Management Committee will meet quarterly,
or more frequently if mutually agreed. Warner’s and
Onyx’s initial representatives to the Research Management
Committee will be appointed by each of them promptly after the date
of this Agreement. All actions taken and decisions made by the
Research Management Committee shall be by unanimous agreement. A
party may change any of its appointments to the Research Management
Committee at any time upon giving written notice to the other
party.
2.2 Marketing
Committee. At the time that Warner appoints a committee to plan
the marketing of a Collaboration Product (the “Marketing
Committee”), it shall promptly inform Onyx and for so long as
Onyx has the right to co-promote such Collaboration Product, Onyx
shall have the authority to appoint one of its employees as a
non-voting member of such committee. Onyx’s non-voting member
of the Marketing Committee will have the right to attend all
meetings of the Marketing Committee and will be kept current on the
plans and proceedings of the Marketing Committee. All actions taken
and decisions made by the Marketing Committee shall be under the
direction and control of Warner. A party may change any of its
appointments to the Marketing Committee at any time upon giving
written notice to the other party.
2.3
Meetings. The Research Management Committee and the
Marketing Committee may meet by telephone or in person at such
times as are agreeable to the members of each such committee.
Attendance at meetings shall be at the respective expense of the
participating parties. Warner and Onyx shall alternate the right to
determine the location of each meeting of the Research Management
Committee, with Onyx determining the location of the first meeting
of such committee. Warner shall determine the location of all
meetings of the Marketing Committee.
2.4 SAB
Attendance. During the Term of this Agreement, Warner will be
entitled to have up to three of its representatives attend all
meetings of Onyx’s Scientific Advisory Board that relate to
the Field and such other general symposia that do not contain
confidential information outside the Field of Onyx or of any third
party to which Onyx owes a duty of confidentiality that would be
breached by Warner’s attendance. Onyx will provide Warner
reasonable advance notice of all such meetings and will provide
Warner copies of all written material given to the members of the
Scientific Advisory Board in connection with such meetings.
Attendance at such meetings by Warner’s representatives will
be at Warner’s expense. As a condition of such attendance and
access to such written material, Warner will execute appropriate
Confidentiality Agreements with respect to information disclosed at
such meetings and in such written material.
[ *
] = 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 406 OF THE SECURITIES EXCHANGE ACT OF
1933, AS AMENDED.
7
PATENTS, KNOW-HOW, RIGHTS AND
INVENTIONS
3.1 Rights to
Inventions. (a) Ownership of technology, inventions,
information, data, know-how, compounds and material shall be
determined in accordance with United States laws of inventorship.
The owner (the “Inventor”) of any invention that is
discovered or reduced to practice during the Term of this Agreement
or [ * ] thereafter and that relates to the discovery,
design, synthesis, delivery, development, testing, use, manufacture
or sale of agents acting in the Field (an “Invention”)
shall have the right, at its option and expense, to prepare, file
and prosecute in its own name any patent applications with respect
to any Invention owned by it and to maintain any patents issued. In
connection therewith, the non-Inventor party agrees to cooperate
with the Inventor at the Inventor’s expense in the
preparation and prosecution of all such patent applications and in
the maintenance of any patents issued. This obligation shall
survive the expiration or termination of this Agreement.
(b) The
parties will co-own technology, inventions, information, data,
know-how, compounds and materials (whether or not patentable) that
relate to [ * ] and that are developed in connection with
performance of the Research Plan (“ [ * ]
Inventions”). The parties will cooperate in the joint filing
of patent applications claiming [ * ] Inventions. The
parties will negotiate in good faith regarding the collaborative
commercial exploitation of the [ * ] Inventions; provided,
however, that each party will retain an undivided ownership
interest in the [ * ] Inventions and will be free to exploit
the same without obligation to the other party.
3.2 Joint
Inventions. Inventions that are jointly invented by Onyx and
Warner will be jointly owned by them; however, [ * ] will
have the rights and responsibilities of the “Inventor”
as described in this Article III in respect of any such
patentable, jointly owned Inventions and [ * ] shall have
the rights and responsibilities of a non-Inventor therein. [ *
] shall pay all expenses in connection with its preparation,
filing and prosecution of patent applications that claim
patentable, jointly owned Inventions. [ * ] shall from time
to time notify [ * ] of the amount of such expenses and [
* ] shall promptly thereafter pay [ * ] of its
out-of-pocket expenses. As used in the preceding sentence
“out-of-pocket expenses” shall mean direct costs,
excluding internal labor costs. Onyx may elect in writing to
disclaim all interest in any jointly invented Invention, in which
case (i) such Invention will be solely owned by Warner and
Onyx will co-operate to assure Warner’s sole ownership,
(ii) Onyx will have no further interest in such Invention, by
ownership, license or otherwise and (iii) [ * ] the date
that Warner receives Onyx’s written disclaimer. Warner may
elect in writing to disclaim all interest in any jointly invented
Inventions, in which case (i) such Invention will be solely
owned by Onyx and Warner will co-operate to assure Onyx’s
sole ownership, (ii) Warner will have no further interest in
such Invention, by ownership, license or otherwise and (iii) [ *
] .
3.3 Protection
of Patent Rights. (a) The Inventor shall keep the other
party currently informed of all steps to be taken in the
preparation, prosecution and maintenance of all of its patents and
patent applications which claim an Invention and shall furnish the
other party with copies of patents and application, amendments
thereto and other related correspondence relating to such Invention
to and from patent offices and permit the other party to offer its
comments thereon before the Inventor makes a submission to a patent
office which could materially affect
[ *
] = 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 406 OF THE SECURITIES EXCHANGE ACT OF
1933, AS AMENDED.
8
the scope or
validity of the patent coverage that may result. The non-Inventor
party shall offer its comments promptly. Onyx and Warner shall each
promptly notify the other of any infringement and/or unauthorized
use of an Invention which comes to its attention.
(b) The
non-Inventor party may request in writing that the Inventor take
specific, reasonable actions to (i) prepare, file or prosecute
a patent application with respect to an Invention, (ii) maintain
any patents issued with respect to an Invention, (iii) protect
against abandonment of a patent or application which claims an
Invention or (iv) obtain a discontinuance of an infringement
or unauthorized use of such patent or application. If such actions
are not undertaken within thirty days of the Inventor’s
receipt of such written request and timely pursued thereafter, the
Inventor shall permit, and the non-Inventor party at its option and
expense may undertake, such actions. The party not undertaking such
actions shall fully cooperate with the other party and shall
provide to the other party whatever assignments and other documents
that may be needed in connection therewith. The party not
undertaking such actions may require a suitable indemnity against
all damages, costs and expenses and impose such other reasonable
conditions as such party’s advisors may require.
(c) If either
party commences any actions or proceedings (legal or otherwise)
pursuant to this Section, it shall prosecute the same vigorously at
its expense and shall not abandon or compromise them or fail to
exercise any rights of appeal without giving the other party the
right to take over their conduct at its own expense. The party
finally conducting legal actions or proceedings against an alleged
infringer or other party shall be entitled to any damages or costs
awarded against such infringer or other party.
3.4 Allegations
of Infringement by Third Parties. In the event that Warner or
Onyx receives notice that any action by either of them under this
Agreement is alleged to be a violation of the patent or other
intellectual property rights of a third party, it shall notify the
other party to this Agreement, and they shall jointly determine an
appropriate response and course of action. The costs of such
defense, and any damages, costs or expenses resulting from such
action, shall be paid (i) 100% by Warner in the case of a
Collaboration Product, (ii) 100% by Onyx in the case of an
Onyx Product and (iii) 50% by Warner and 50% by Onyx if such
violation does not relate to the manufacture, use or sale of a
Collaboration Product or an Onyx Product; provided, however, that
each party will pay 100% of all such costs relating to allegations
that it was aware of prior to the Effective Date. The Research
Management Committee will decide whether or not to continue any
activity following notice that such activity may be a violation of
the patent or other intellectual property rights of a third
party.
DESIGNATION OF LEAD COMPOUNDS AND
MARKETING RIGHTS
4.1 Designation
of Lead Compound. From time to time, Warner may formally
designate one or more Collaboration Compounds for further
development as a result of work performed under the Research Plan
(each, a “Collaboration Lead Compound”). Such
designation shall be made under Warner’s then current
standards for declaring one of its own compounds a “lead
compound.” Such designation generally indicates that Warner
has identified such
[ *
] = 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 406 OF THE SECURITIES EXCHANGE ACT OF
1933, AS AMENDED.
9
compound as a
candidate for cGLP/cGMP studies. Warner will pursue the research
and development of each Collaboration Lead Compound at its own
expense and under its sole direction. Warner will provide Onyx
quarterly, written updates regarding the status of each
Collaboration Lead Compound.
4.2
Collaboration Product. Each Collaboration Lead Compound is
referred to herein as a “Collaboration Product” from
and after filing of an IND in respect of such compound with the FDA
or the filing of its equivalent in any foreign country other than
Japan. The preparation, filing and prosecution of IND’s,
NDA’s and other regulatory filings required to be filed with
the FDA and its foreign equivalents (other than in Japan) in regard
to any Collaboration Product will be at the sole expense of, in the
name of and under the direction of Warner. Warner does not warrant
that any regulatory filings will actually be filed or, if filed,
will be approved.
4.3 Independent
Development. From time to time, Onyx may request Warner in
writing to undertake specific research and development regarding a
Collaboration Compound or to declare a Collaboration Compound to be
a Collaboration Lead Compound. Warner will notify Onyx within [
* ] of receiving Onyx’s written request if it determines
before such date that it will not undertake such specific research
and development (or declare such Collaboration Compound to be a
Collaboration Lead Compound) within [ * ] of such request
(“Warner’s Notice to Decline”). If Warner does
not so notify Onyx within such [ * ] period, it will
periodically review Onyx’s request and if it determines not
to undertake such specific research and development (or declare
such Collaboration Compound to be a Collaboration Lead Compound)
then it shall promptly so notify Onyx (also, “Warner’s
Notice to Decline”). Onyx shall undertake the continued
research and development (including the specific research and
development requested by it) of such Collaboration Compound
independently (an “Onyx Lead Compound”), at its sole
cost and under its sole direction, promptly upon (i) receipt
of Warner’s Notice to Decline or (ii), if Warner does not so
notify Onyx and if Warner does not itself undertake the requested
action within [ * ] of Onyx’s written request, then
[ * ] after Warner’s receipt of Onyx’s written
request. Onyx may not utilize the services of the personnel
committed to the Collaboration pursuant to Section 1.2 in
performance of research or development of an Onyx Lead Compound.
Onyx may declare no more than [ * ] Onyx Lead Compounds
during the Term of this Agreement. Onyx will keep Warner currently
informed of all material information in its research and
development of each Onyx Lead compound and will allow Warner to
comment on the direction of such research and development. Each
Onyx Lead Compound is referred to herein as an “Onyx
Product” from and after filing of an IND in respect of such
compound with the FDA or the filing of its equivalent in any
foreign country other than Japan. Onyx will provide Warner a
complete and accurate copy of the proposed filing, together with
any additional inf
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