Contract
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EXHIBIT 10.2
RESEARCH, DEVELOPMENT AND MARKETING
DATED AS OF MAY 2, 1995
BETWEEN
ONYX PHARMACEUTICALS, INC.
AND
XXXXXX-XXXXXXX COMPANY
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TABLE
OF CONTENTS
ARTICLE A DEFINITIONS |
1 | |||
Affiliate |
1 | |||
Collaboration Compound(s) |
1 | |||
Collaboration Lead Compound(s) |
1 | |||
Collaboration Product(s) |
1 | |||
Collaboration Product Exclusive Period |
1 | |||
Co-Promotion Country |
1 | |||
Effective Date |
1 | |||
FDA |
1 | |||
Field |
2 | |||
IND |
2 | |||
Invention(s) |
3 | |||
Know-How |
3 | |||
NDA |
3 | |||
Net Sales |
3 | |||
Onyx Know-How |
3 | |||
Onyx Lead Compound(s) |
3 | |||
Onyx Patents |
3 | |||
Onyx Product(s) |
4 | |||
Onyx Product Exclusive Period |
4 | |||
Patent(s) |
4 | |||
Product(s) |
4 | |||
Research Management Committee |
4 | |||
Research Plan |
4 | |||
Term of Co-Promotion |
4 | |||
Term of this Agreement |
4 | |||
Term of the Research Collaboration |
4 | |||
Warner Know-How |
4 | |||
Warner Patents |
4 | |||
ARTICLE I RESEARCH PROGRAM |
5 | |||
1.1 Undertaking and Scope |
5 | |||
1.2 Personnel and Resources |
5 | |||
1.3 Term of the Research Collaboration |
6 | |||
1.4 Rights to Know-How and Patents for Research |
6 | |||
1.5 Collaboration Expenses |
6 | |||
ARTICLE II COMMITTEES |
6 | |||
2.1 Research Management Committee |
6 | |||
2.2 Marketing Committee |
7 | |||
2.3 Meetings |
7 | |||
2.4 SAB Attendance |
7 | |||
ARTICLE III PATENTS, KNOW-HOW, RIGHTS AND INVENTIONS |
7 | |||
3.1 Rights to Inventions |
7 | |||
3.2 Joint Inventions |
8 | |||
3.3 Protection of Patent Rights |
8 | |||
3.4 Allegations of Infringement by Third Parties |
9 |
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ARTICLE IV
DESIGNATION OF LEAD COMPOUNDS AND MARKETING RIGHTS |
9 | |||
4.1 Designation of Lead Compound |
9 | |||
4.2 Collaboration Product |
10 | |||
4.3 Independent Development |
10 | |||
4.4 Warner’s Re-engagement Option |
10 | |||
ARTICLE V LICENSES AND ROYALTIES |
11 | |||
5.1 Grant by Onyx |
11 | |||
5.2 Grant by Warner |
11 | |||
5.3 Royalties Payable by Warner |
11 | |||
5.4 Royalties Payable by Onyx |
12 | |||
5.5 Currency of Payment |
13 | |||
5.6 Payment and Reporting |
13 | |||
5.7 Records |
13 | |||
5.8 Taxes Withheld |
13 | |||
5.9 Computation of Royalties |
13 | |||
5.10 Licenses to Affiliates |
14 | |||
5.11 Restrictions on Payment |
14 | |||
ARTICLE VI CO-PROMOTION OF COLLABORATION PRODUCTS |
14 | |||
6.1 Co-Promotion Rights |
14 | |||
6.2 Election or Revocation of Co-Promotion Right |
14 | |||
6.3 Onyx’s Promotional Percentage |
14 | |||
6.4 Marketing and Marketing Plans |
15 | |||
6.5 Promotional Materials |
15 | |||
6.6 No Delegation |
15 | |||
6.7 Returns |
15 | |||
6.8 Orders |
15 | |||
6.9 Samples |
15 | |||
6.10 Completion of Sales |
15 | |||
6.11 Training |
15 | |||
6.12 Exchange of Marketing Information |
16 | |||
ARTICLE VII FDA |
16 | |||
7.1 Side Effects |
16 | |||
7.2 Regulatory and other Inquiries |
16 | |||
7.3 Product Recall |
16 | |||
7.4 Responsibility if not Co-Promoting |
16 | |||
ARTICLE VIII RESEARCH FUNDING AND MILESTONES |
16 | |||
8.1 Research Funding |
16 | |||
8.2 Milestones |
17 | |||
ARTICLE IX CONFIDENTIALITY |
18 | |||
9.1 Confidentiality |
18 | |||
9.2 Publicity |
18 | |||
9.3 Publication |
19 | |||
ARTICLE X JAPAN |
19 | |||
10.1 Japanese Company |
19 | |||
10.2 Japanese Company Agreement |
19 | |||
10.3 Absence of Agreement |
20 |
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ARTICLE XI REPRESENTATIONS AND WARRANTIES |
20 | |||
11.1 Legal Authority |
20 | |||
11.2 No Conflicts |
20 | |||
11.3 Others Bound |
20 | |||
11.4 Third Party Rights |
21 | |||
11.5 Survival |
21 | |||
11.6 Disclaimer |
21 | |||
11.7 Exclusivity |
21 | |||
ARTICLE XII |
21 | |||
12.1 Termination for Breach |
21 | |||
12.2 Effect of Bankruptcy |
22 | |||
12.3 Key Personnel |
22 | |||
12.4 Termination of Co-Promotion Rights |
22 | |||
12.5 Remedies |
23 | |||
12.6 Voluntary Termination |
23 | |||
ARTICLE XIII GENERAL PROVISIONS |
23 | |||
13.1 Indemnification |
23 | |||
13.2 Assignment |
24 | |||
13.3 Non-Waiver |
24 | |||
13.4 Research Dispute Resolution |
24 | |||
13.5 Governing Law |
24 | |||
13.6 Partial Invalidity |
24 | |||
13.7 Notice |
24 | |||
13.8 Vaccines and Diagnostics |
25 | |||
13.9 Headings |
25 | |||
13.10 No Implied Licenses or Warranties |
25 | |||
13.11 Force Majeure |
25 | |||
13.12 Survival |
26 | |||
13.13 Entire Agreement |
26 | |||
13.14 Amendments |
26 | |||
13.15 Independent Contractors |
26 | |||
13.16 Counterparts |
26 |
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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 0000 Xxxxxxxx Xxxxx,
Xxxxxxxx, Xxxxxxxxxx 00000, and Xxxxxx-Xxxxxxx Company, a Delaware corporation (“Warner”), located
at 000 Xxxxx Xxxx, Xxxxxx Xxxxxx, Xxx Xxxxxx 00000.
W I T N E S S E T H:
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:
ARTICLE A
DEFINITIONS
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.
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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.
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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,
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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.
ARTICLE I
RESEARCH PROGRAM
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.
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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 [ * ].
ARTICLE II
COMMITTEES
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
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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.
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BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406
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7
ARTICLE III
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
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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.
ARTICLE IV
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
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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 information that Warner may request regarding the relevant Onyx Lead Compound,
at least [ * ] prior to submitting such filing to the FDA or its foreign equivalent. Onyx will be
entitled to commercialize any Onyx Product at its sole direction, alone or with another partner,
subject to the terms of this Agreement.
4.4 Warner’s Re-engagement Option. Warner may elect to resume the research and
development of an Onyx Lead Compound at its own cost and under its sole direction at any time prior
to [ * ] in respect of such compound. In such event, such Onyx Lead Compound shall immediately
become a Collaboration Lead Compound for all purposes under this Agreement. Promptly after Warner
makes such election, Warner will pay Onyx [ * ] Onyx’s costs incurred
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for research and development
of such Onyx Lead Compound. For purposes of this Section, Onyx’s cost for research and development
will mean (i) Onyx’s “Burdened Cost” (as defined below) for each professional research and
development FTE (not including the personnel committed to the Collaboration pursuant to Section
1.2) dedicated to the research and development of such Onyx Lead Compounds (with appropriate
adjustment for staff members not fully dedicated to such work or not working a full year) and (ii)
payments made to unaffiliated third parties, each to the extent incurred in connection with the
relevant compound on or after its declaration as an Onyx Lead Compound and to the extent reasonably
supported by invoices, time sheets or other appropriate records. The “Burdened Cost” for each Onyx
FTE shall mean [ * ] for work performed during 1995, and will be revised for work performed during
each succeeding calendar year by the change in the Consumer Price Index (as determined by the
United States of America Department of Labor) during the preceding calendar year (except that the
Burdened Cost for work performed during 1996 will be revised only by the change in the Consumer
Price Index from the Effective date to December 31, 1995).
ARTICLE V
LICENSES AND ROYALTIES
5.1 Grant by Onyx. Onyx hereby grants and agrees to grant to Warner exclusive,
worldwide (except for Japan) licenses under the Onyx Patents to the extent necessary to make, have
made, use and sell (with the right to sublicense) each compound designated as a Collaboration Lead
Compound or as a Collaboration Product. Such licenses with respect to a Collaboration Lead
Compound are co-exclusive between Onyx and Warner. Such licenses with respect to a Collaboration
Product are exclusive even as to Onyx.
5.2 Grant by Warner. Warner hereby grants and agrees to grant to Onyx exclusive,
worldwide (except for Japan) licenses under the Warner Patents to the extent necessary to make,
have made, use and sell (with the right to sublicense) each compound designated as an Onyx Lead
Compound or as an Onyx Product. Such licenses with respect to an Onyx Lead Compound are
co-exclusive between Onyx and Warner. Such licenses with respect to an Onyx Product are exclusive
even as to Warner.
5.3 Royalties Payable by Warner. Warner will pay Onyx [ * ] of Net Sales as a royalty
on worldwide sales (except for Japan) of Collaboration Products. If at the time of the first
commercial sale of such Product in such country a Patent exists that is necessary to sell such
Product in such country, or if at any time after such sale a composition of matter Patent
necessary to sell such Collaboration Product issues in such country, such [ * ] royalty shall be
payable in respect of sales in such country until the later of (a) the expiration of the last such
Patent to expire and (b) the date such [ * ] royalty would expire under the provisions of the
following sentence assuming that such Patent did not exist. Subject to the terms of the preceding
sentence, if at the time of the first commercial sale of such Product in such country no Patent
exists that is necessary to sell such Product in such country, such [ * ] royalty will be payable
until the earliest of (x) the later to occur of (i) the [ * ] anniversary of such first sale and
(ii) expiration of the last Patent necessary to make or use such Product in such country, which
Patent was in existence on the date of such first commercial sale, (y) the first calendar quarter
in which
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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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the sale by any one entity (together with its Affiliates), other than Warner or its
Affiliates or licensees, of one or more products containing the same active ingredient as the
Product, constitutes [ * ] or more of all units sold in such country containing such active
ingredient and (z) the first calendar quarter in which the sale by any entities (taken in the
aggregate), other than Warner or its Affiliates or licensees, of one or more products containing
the same active ingredient as the Product, constitutes [ * ] or more of all units sold in such
country containing such active ingredient (the period from first commercial sale in each country
until the earlier of (x), (y) and (z) above is referred to herein as the “Collaboration Product
Exclusive Period”). In the case of (y) and (z) above, the [ * ] royalty will terminate as to Net
Sales of Product sold on or after the day following the end of the triggering calendar quarter.
Warner will pay Onyx [ * ] and [ * ] of Net Sales as a royalty on sales of Collaboration Products
in each country (except for Japan) for the [ * ], respectively, following (a) such final Patent
expiration (in the event that the required Patent necessary to sell such Product in such country
existed on the date of first commercial sale or issued thereafter) or (b) the end of the
Collaboration Product Exclusive Period (if no such Patent existed or issued thereafter, and
provided that the Collaboration Product Exclusive Period lasted at least [ * ] years); provided,
however, that no such royalty will be payable in respect of Collaboration Products sold without the
use of one or more trademarks developed by Warner for such Product during the time that the [ * ]
royalty was applicable.
5.4 Royalties Payable by Onyx. Onyx will pay Warner [ * ] of Net Sales as a royalty
on worldwide sales (except for Japan) of Onyx Products. If at the time of the first commercial
sale of such Product in such country a Patent exists that is necessary to sell such Product in such
country, or if at any time after such sale a composition of matter Patent necessary to sell such
Collaboration Product issues in such country, such [ * ] royalty shall be payable in respect of
sales in such country until the later of (a) the expiration of the last such Patent to expire and
(b) the date such [ * ] royalty would expire under the provisions of the following sentence
assuming that such Patent did not exist. Subject to the terms of the preceding sentence, if at the
time of the first commercial sale of such Product in such country no Patent exists that is
necessary to sell such Product in such country, such [ * ] royalty will be payable until the
earliest of (x) the later to occur of (i) the [ * ] anniversary of such first sale and (ii)
expiration of the last Patent necessary to make or use such Product in such country, which Patent
was in existence on the date of such first commercial sale, (y) the first calendar quarter in which
the sale by any one entity (together with its Affiliates), other than Warner or its Affiliates or
licensees, of one or more products containing the same active ingredient as the Product,
constitutes [ * ] or more of all units sold in such country containing such active ingredient and
(z) the first calendar quarter in which the sale by any entities (taken in the aggregate), other
than Warner or its Affiliates or licensees, of one or more products containing the same active
ingredient as the Product, constitutes [ * ] or more of all units sold in such country
containing such active ingredient (the period from first commercial sale in each country until the
earliest of (x), (y) and (z) above is referred to herein as the “Onyx Product Exclusive Period”).
In the case of (y) and (z) above, the [ * ] royalty will terminate as to Net Sales of Product sold
on or after the day following the end of the triggering calendar quarter. Onyx will pay Warner [ *
] of Net Sales as a royalty on sales of Onyx Products in each country (except for Japan) for the [
* ], respectively, following (a) such final Patent expiration (in the event that the required
Patent necessary to sell such Product in such country existed on the date of first commercial sale
or issued thereafter) or (b) the end of the Onyx Product Exclusive Period (if no such Patent
existed or issued thereafter, and provided that the Onyx Product Exclusive Period lasted at least [
* ] years); provided, however, that no
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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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such royalty will be payable in respect of an Onyx product
sold without the use of one or more trademarks developed by Onyx for such Product during the time
that the [ * ] royalty was applicable.
5.5 Currency of Payment. All payments to be made under this Agreement shall be made
in United States dollars in the United States to a bank account designated by the party to be paid.
Royalties earned shall first be determined in the currency of the country in which they are earned
and then converted to its equivalent in United States currency. Such conversion shall be based on
the average buying rates of exchange for the currencies involved into the currency of the United
States quoted by Citibank (or its successor in interest) in New York, New York at the close of
business on each business day of the quarterly period in which the royalties were earned.
5.6 Payment and Reporting. The royalties due under Section 5.3 or Section 5.4 shall
be paid quarterly, within 45 days after the close of each calendar quarter immediately following
each quarterly period in which such royalties are earned, or earlier if practical. With each such
quarterly payment, the payor shall furnish the payee a royalty statement, setting forth on a
country-by-country basis the total number of units and Net Sales of each royalty-bearing Product
made, used and/or sold hereunder for the quarterly period for which the royalties are due. In
addition, the payor shall furnish such a royalty statement on a country-by-country basis for the
first quarter during which payor makes sales of Product for which no royalty payment in respect of
such country is due hereunder, and shall state the basis for such sales then being free of royalty
obligations hereunder. The payor shall thereafter have no further obligation to report the number
of units or Net Sales of such Product made, used and/or sold in such country.
5.7 Records. The royalty paying party shall keep accurate books and accounts of
record in connection with the manufacture, use and/or sale by or for it of the Products hereunder
in sufficient detail to permit accurate determination of all figures necessary for verification of
royalty obligations set forth in this Article V. Such records shall be maintained for a period of
3 years from the end of each year in which sales occurred. The payee, at its expense, through a
certified public accountant, shall have the right to access such books and records for the sole
purpose of verifying the royalty statements; such access shall be conducted after reasonable prior
notice by the payee to the payor during the payor’s ordinary business hours and shall not be more
frequent than once during each calendar year. Said accountant shall not disclose to the payee or
any other party any information except that which should properly be contained in a royalty report
required under this Agreement. If such accounting determines that a party’s error resulted in the
other party receiving at least 5% less than properly due in respect of any quarter, then the party
in error will reimburse such amount and reimburse the other party
for the costs of such accounting (including the fees and expenses of the certified public
accountant).
5.8 Taxes Withheld. Any income or other tax that one party hereunder, its Affiliates
or sublicensees is required to withhold (the “withholding Party”) and pay on behalf of the other
party hereunder (the “Withheld Party”) with respect to the royalties payable under this Agreement
shall be deducted from and offset against said royalties prior to remittance to the Withheld Party;
provided, however, that in regard to any tax so deducted, the Withholding Party shall give or cause
to be given to the Withheld Party such assistance as may reasonably be necessary to enable the
Withheld Party to claim exemption therefrom or credit therefor, and in each case shall furnish the
Withheld Party proper evidence of the taxes paid on its behalf.
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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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5.9 Computation of Royalties. All sales of Onyx Products between Onyx and any of its
Affiliates and sublicensees shall be disregarded for purposes of computing royalties under this
Article V, but in such instances royalties shall be payable only upon sales to unlicensed third
parties. Nothing herein contained shall obligate Onyx to pay Warner more than one royalty on any
unit of an Onyx Product. All sales of Collaboration Products between Warner and any of its
Affiliates and sublicensees shall be disregarded for purposes of computing royalties under this
Article V, but in such instances royalties shall be payable only upon sales to unlicensed third
parties. Nothing herein contained shall obligate Warner to pay Onyx more than one royalty on any
unit of a Collaboration Product or a Warner Product.
5.10 Licenses to Affiliates. Each party shall, at the other party’s request, sign
license and/or royalty agreements directly with the other party’s Affiliates and sublicensees in
those situations where such agreements would not decrease the amount of royalties which would be
owed hereunder. Such agreements shall contain the same language as contained herein with
appropriate changes in parties and territory. No such license and/or royalty agreement will
relieve Warner or Onyx, as the case may be, of its obligations hereunder, and such party will
guarantee the obligations of its Affiliate or sublicensee in any such agreement. Royalties
received directly from one party’s Affiliates and sublicensees shall be credited towards such
party’s royalty obligations under Section 5.3 or 5.4 hereof, as applicable.
5.11 Restrictions on Payment. The obligation to pay royalties under this Agreement
shall be waived and excused to the extent that statutes, laws, codes or government regulations in a
particular country prevent such royalty payments by the seller of Products; provided, however, that
if legally permissible, the seller of Products shall pay the royalties owed to the other party
hereto by depositing such amounts in a bank account in such country that has been designated by the
party owed such royalties.
ARTICLE VI
CO-PROMOTION OF COLLABORATION PRODUCTS
6.1 Co-Promotion Rights. Onyx will have the right to co-promote each Collaboration
Product in the Co-Promotion Country during the Term of Co-Promotion pursuant to the terms and
conditions hereof.
6.2 Election or Revocation of Co-Promotion Right. Warner will give Onyx at least [ *
] prior written notice of the anticipated first commercial sale of a Collaboration Product in the
Co-Promotion Country. Onyx will notify Warner in writing at least [ * ] prior to such anticipated
first commercial sale whether it elects to exercise its right to co-promote such Collaboration
Product in such Co-Promotion Country beginning with the date of first commercial sale. If Onyx
fails timely to give such notice to Warner, it shall be deemed to have waived its rights to
co-promote. Onyx may terminate the Term of Co-Promotion at any time following [ * ] month’s
written notice to Warner. The Term of Co-Promotion can not be reinstated after delivery of such
notice.
6.3 Onyx’s Promotional Percentage. If Onyx elects to exercise its co-promotion rights
pursuant to Section 6.2, the Marketing Committee will meet and determine procedures
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whereby Onyx will supply up to [ * ], but not less than [ * ], of the sales efforts (including details, if
determined to be an appropriate sales activity) for the relevant Collaboration Product in the
Co-Promotion Country. Warner will compensate Onyx for such effort at the lesser of (i) [ * ] and
(ii) [ * ]. Prior to initiation of the Term of Co-Promotion in the Co-Promotion Country, the
parties will negotiate in good faith and agree on appropriate accounting procedures and payment
terms to (i) confirm each party’s performance of its required sales effort, (ii) calculate the
costs for each party to provide its sales effort and (iii) compensate Onyx as required by this
Section.
6.4 Marketing and Marketing Plans. Each Collaboration Product will be marketed with
one label and will bear one or more trademarks owned by Warner. The Marketing Committee will be
responsible for developing and approving marketing plans and the advertising and other promotional
materials to be used in co-promoting each Collaboration Product. Warner will be responsible for
obtaining acceptance of each Collaboration Product on formularies, if applicable. Warner will keep
Onyx informed of and will solicit and consider in good faith Onyx’s opinions regarding strategies
for obtaining formulary acceptance.
6.5 Promotional Materials. Onyx shall not create any promotional or advertising
materials for Collaboration Products. Onyx shall disseminate only those promotional and
advertising materials which have been provided or approved for Onyx’s use by Warner. Warner shall
supply timely to Onyx, at Warner’s cost, quantities of promotional materials needed by Onyx to
exercise its rights under this Agreement. Onyx shall not, and shall cause its employees,
representatives and agents not, to make any claims or representations in respect of the
Collaboration Products that have not been approved by Warner.
6.6 No Delegation. Onyx may use only its own employees or the employees of one or
more of its subsidiaries in the course of exercising its co-promotion rights under this Agreement.
6.7 Returns. Warner shall be responsible for handling all returns relating to
Collaboration Products. Any Collaboration Product returned to Onyx shall be shipped by Onyx to the
address designated by Warner with shipping costs authorized by Warner to be paid by Warner.
6.8 Orders. All customer orders for Collaboration Products shall be received and
executed by Warner. Onyx shall transmit any such orders that it receives to Warner no later than
the following business day.
6.9 Samples. Each of the parties will keep accurate records as to the distribution of
samples of Collaboration Products and comply with all applicable laws, rules and regulations
dealing with the distribution of samples.
6.10 Completion of Sales. All sales of Collaboration Products will be completed,
distributed, accounted for, billed and booked by Warner at prices established by Warner.
6.11 Training. Consistent with the marketing plans established by the Marketing
Committee, but not less than [ * ] prior to the commencement of the Term of Co-Promotion for each
Collaboration Product, Warner shall provide, at Onyx’s expense, reasonable access to its sales
training staff and facilities for appropriate, initial training of the Onyx sales force.
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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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6.12 Exchange of Marketing Information. From time-to-time the Marketing Committee
will develop call lists, schedules, and other appropriate information for the purpose of
determining the physicians and other persons involved in the drug purchase decision-making process
to whom Onyx and Warner, respectively, may detail each Collaboration Product. The parties agree to
cooperate in finding an inexpensive and expeditious way to provide a call list and other
information indicating the identity of those physicians and other persons involved in the
decision-making process regarding the purchase of pharmaceuticals.
ARTICLE VII
FDA
7.1 Side Effects. Each party shall promptly advise the other by telefax or overnight
delivery service addressed to the attention of its Vice President, Medical Affairs (or, in Onyx’s
case, the party with similar responsibilities), of any unexpected side effect, adverse reaction or
injury which has been brought to that party’s attention at any place and which is alleged to have
been caused by a Collaboration Product. Warner shall have all rights and responsibility to report
such side effect, adverse reaction or injury to regulatory authorities and others as appropriate.
7.2 Regulatory and other Inquiries. Upon being contacted by the FDA or any drug
regulatory agency for any regulatory purpose pertaining to this Agreement or to a Collaboration
Product, Onyx and Warner shall immediately notify and consult with one another and Warner shall
provide a response as it deems appropriate. Warner shall have sole responsibility for responding
to all inquiries to Warner or Onyx regarding the benefits, side effects and other characteristics
of Collaboration Products.
7.3 Product Recall. In the event that Warner or Onyx determines that an event,
incident or circumstance has occurred which may result in the need for a recall or other removal of
any Collaboration Product or any lot or lots thereof from the market, it shall advise and
consult with the other party with respect thereto. Warner shall make the final determination
to recall or otherwise remove the Collaboration Product or any lot or lots thereof from the market
and shall be responsible for the cost and expense of notifying customers and the cost and expense
associated with return of the recalled Collaboration Product from a customer. Onyx shall have no
such rights or responsibilities in respect of territories outside of the Co-Promotion Country.
7.4 Responsibility if not Co-Promoting. Onyx will have the rights and
responsibilities referred to in this Article 7 only during the Term of Co-Promotion and for [ * ]
thereafter.
ARTICLE VIII
Research Funding and Milestones
8.1 Research Funding. Warner will pay Onyx the following amounts on the following
dates during the Term of the Research Collaboration in consideration for work
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performed by Onyx
prior to the Effective Date and to provide support for Onyx’s work under the Research Plan:
The Effective Date |
[ * ] | |||
Three month anniversary of the Effective Date |
[ * ] | |||
Six month anniversary of the Effective Date |
[ * ] | |||
Nine month anniversary of the Effective Date |
[ * ] | |||
Twelve month anniversary of the Effective Date |
[ * ] | |||
Fifteen month anniversary of the Effective Date |
[ * ] | |||
Eighteen month anniversary of the Effective Date |
[ * ] | |||
Twenty-one month anniversary of the Effective Date |
[ * ] | |||
Twenty-four month anniversary of the Effective Date |
[ * ] | |||
Twenty-seven month anniversary of the Effective Date |
[ * ] | |||
Thirty month anniversary of the Effective Date |
[ * ] | |||
Thirty-three month anniversary of the Effective Date |
[ * ] | |||
[ * ] |
8.2 Milestones. (a) Warner will pay Onyx the following amounts with respect to the
first Collaboration Product to achieve each stated milestone:
Commencement of Phase I clinical trials by or on
behalf of Warner anywhere in the world |
$500,000 | |
Commencement of Phase II clinical trials by or on
behalf of Warner anywhere in the world |
[ * ] | |
Commencement of Phase III clinical trials by or on
behalf of Warner anywhere in the world |
[ * ] | |
The FDA’s acceptance for filing of an NDA |
[ * ] | |
Acceptance for filing of an MAA applicable to any of
the following countries: (i) United Kingdom, (ii) Spain, (iii) Italy, (iv) France and (v) Germany (each
a “Major European Country”) |
[ * ]/country, up to [ * ] total | |
Approval by the FDA of an NDA |
[ * ] | |
Approval of an MAA applicable to a Major European
Country |
[ * ]/country, up to [ * ] total |
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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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(b) Warner will pay Onyx [ * ] upon the approval by the FDA of an NDA for the second and each
subsequent Collaboration Product so approved and [ * ] upon the approval of an MAA applicable to
each Major European Country, up to [ * ], for the second and each subsequent Collaboration Product
so approved.
(c) Onyx will pay Warner [ * ] upon the approval by the FDA of an NDA for each Onyx Product
and [ * ] upon the approval of an MAA applicable to each Major European Country, up to [ * ], for
each Onyx Product.
ARTICLE IX
CONFIDENTIALITY
9.1 Confidentiality. (a) Except as specifically permitted hereunder, each party
hereby agrees to hold in confidence and not use on behalf of itself or others all data, samples,
technical and economic information (including the economic terms hereof), commercialization,
clinical and research strategies and know-how provided by the other party (the “Disclosing Party”)
during the Term of this Agreement and all data, results and information developed pursuant to the
Collaboration and solely owned by the other party (collectively the “Confidential Information”),
except that the term “Confidential Information” shall not include:
(i) information that is or becomes part of the public domain through no fault of the
non-Disclosing Party or its Affiliates;
(ii) information that is obtained after the date hereof by the non-Disclosing Party or one of
its Affiliates from any third party which is lawfully in possession of such Confidential
Information and not in violation of any contractual or legal obligation to the Disclosing Party
with respect to such Confidential Information;
(iii) Information that is known to the non-Disclosing Party or one or more of its Affiliates
prior to disclosure by the Disclosing Party, as evidenced by the non-Disclosing Party’s written
records; and
(iv) information that is necessary to be disclosed to any governmental authorities or pursuant
to any regulatory filings, provided that in such case the non-Disclosing Party notifies the
Disclosing Party reasonably in advance of such disclosure and cooperates with the Disclosing Party
to minimize the scope or content of such disclosure.
(b) The obligations of this Section 9.1 shall survive the expiration or termination of this
Agreement.
9.2 Publicity. All publicity, press releases and other announcements relating to this
Agreement or the transactions contemplated hereby shall be reviewed in advance by, and subject to
the approval of, both parties; provided, however, that either party may (i) publicize the existence
and general subject matter of this Agreement without the other party’s approval and (ii) disclose
the terms of this Agreement insofar as required to comply with applicable securities laws, provided
that in the case of such securities disclosures the disclosing party notifies the other party
[ * ] = 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.
18
reasonably in advance of such disclosure and cooperates to minimize the scope and content of such
disclosure.
9.3 Publication. The parties shall cooperate in appropriate publication of the
results of research and development work performed pursuant to this Agreement, but subject to the
predominating interest to obtain patent protection for any patentable subject matter. To this end,
it is agreed that prior to any public disclosure, the party proposing disclosure shall send the
other party a copy of the information to be disclosed, and shall allow the other party [ * ] from
the date of receipt in which to determine whether the information to be disclosed contains subject
matter for which patent protection should be sought prior to disclosure. If notification is not
received during the [ * ] period, the party proposing disclosure shall be free to proceed with the
disclosure. If due to a valid business reason or a belief by the nondisclosing party that the
disclosure contains subject matter for which a patentable invention should be sought, then prior to
the expiration of the [ * ] period, the nondisclosing party shall so notify the disclosing party,
who shall then delay public disclosure of the information for an additional period of up to [ * ]
to permit the preparation and filing of a patent application on the subject matter to be disclosed
or other action to be taken. The party proposing disclosure shall thereafter be free to publish or
disclose the information. The determination of authorship for any paper shall be in accordance
with accepted scientific practice. In no event may any publication or other disclosure contain a
party’s Confidential Information without such party’s prior written consent.
ARTICLE X
JAPAN
10.1 Japanese Company. Neither party may license any of its Patents or Know-How to,
or otherwise collaborate in the Field with, any person or other entity for use in Japan, except
pursuant to an agreement mutually acceptable to Onyx and Warner (the “Japanese
Company Agreement”). Onyx and Warner will work together to select a Japanese company to
collaborate with (the “Japanese Company”) and to hold negotiations with the Japanese Company
regarding the terms of the Japanese Company Agreement.
10.2 Japanese Company Agreement. Warner agrees that it will accept any proposed
Japanese Company Agreement that includes the following provisions: (i) [ * ]; provided, however,
that [ * ], (ii) [ * ], (iii) [ * ], (iv) [ * ], (v) [ * ], (vi) [ * ]; provided, however, that
this provision shall not apply to (a) any compound identified by the Japanese Company as a
candidate for cGLP/cGMP studies before the effective date of the Japanese Company Agreement, or
analogs or derivatives thereof not identified pursuant to any collaboration between Onyx and the
Japanese Company or (b) any compound identified after the [ * ] anniversary of the term of the
research collaboration under such agreement; and further provided that this provision will apply to
compounds identified during the term of the research collaboration under such agreement or [ * ]
year thereafter, and any derivatives or analogs of such compounds whenever identified, and (vii) [
* ]. For purposes of clause (i) of this section, any dispute about the [ * ] that cannot be
resolved by good faith negotiations between senior executive officers of Onyx and Warner will be
resolved by the decision of [ * ] selected by the parties in good faith agreement, with the cost of
[ * ] borne [ * ].
[ * ] = 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.
19
10.3 Absence of Agreement. If Onyx does not execute an agreement in the Field with a
Japanese company pursuant to Sections 10.1 or 10.2, then neither party shall market or license
others to market any Collaboration Compounds in the Field in Japan without the consent of the other
party.
ARTICLE XI
REPRESENTATIONS AND WARRANTIES
11.1 Legal Authority. Each party represents and warrants to the other that it has the
legal power, authority and right to enter into this Agreement and to perform its respective
obligations set forth herein.
11.2 No Conflicts. Each party represents and warrants that as of the date of this
Agreement it is not a party to any agreement or arrangement with any third party or under any
obligation or restriction, including pursuant to its Certificate of Incorporation or By-Laws, which
in any way limits or conflicts with its ability to fulfill any of its obligations under this
Agreement.
11.3 Others Bound. Each party represents and warrants that anyone performing services
under this Agreement on its behalf shall be bound by all of the conditions of this Agreement, to
the extent necessary to give full effect to this Agreement.
11.4 Third Party Rights. Each party represents and warrants that to the best of its
knowledge its performance of the work under the Collaboration as contemplated by this Agreement
will not infringe the patent, trade secret or other proprietary rights of any third party
except insofar as any infringement may relate to technology, data or information provided by
the other party hereunder.
11.5 Survival. The foregoing representations and warranties shall survive the
execution, delivery and performance of this Agreement, notwithstanding any investigation by or on
behalf of either party.
11.6 Disclaimer. Except as otherwise expressly stated herein, Warner hereby disclaims
any warranty expressed or implied as to any Onyx Product sold or placed in commerce by or on behalf
of Onyx. Except as otherwise expressly stated herein, Onyx hereby disclaims any warranty expressed
or implied as to any Collaboration Product sold or placed in commerce by or on behalf of Warner.
11.7 Exclusivity. Except pursuant to the Japanese Company Agreement, during the Term
of the Research Collaboration and [ * ] thereafter (i) neither party will conduct any research or
development in the Field except pursuant to this Agreement, (ii) neither party will license (or
otherwise permit access to) any of its Patents or Know-How for research or development in the Field
to (or otherwise collaborate on research or development in the Field with) any other person or
entity and (iii) Onyx will not license (or otherwise permit access to) any assay developed by it
pursuant to the Collaboration to any other person or entity. In respect of (i), above, each party
shall have the right to conduct its own research and development in the
[ * ] = 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.
20
Field during [ * ] following the end of the Term of the Research Collaboration, provided that all results of such work
discovered during such period (including without limitation compounds and assays), and analogs and
derivatives of compounds identified during such period whenever identified, are promptly disclosed
to the other party and are covered by the licenses granted under Sections 1.4, 5.1 and 5.2, as
applicable.
ARTICLE XII
12.1 Termination for Breach. In the event of a material breach of the provisions of
this Agreement described below, the breaching party shall have 30 days after receipt of written
notice from the non-breaching party to cure such breach.
(a) In the event of an uncured material breach of Article I, the non-breaching party may
terminate the Term of the Research Collaboration.
(b) In the event of an uncured material breach of Section 5.3 by Warner in respect of a
Collaboration Product, Onyx may (i) terminate the licenses granted by it pursuant to Section 5.1 in
respect of such Product and (ii) require Warner to grant it an exclusive (even as to Warner),
worldwide license (with the right to sublicense) under the Patents relating to such Product and
owned or controlled by Warner, to the extent necessary to make, use or sell such Product.
(c) In the event of an uncured material breach of Section 5.4 by Onyx in respect of an Onyx
Product, Warner may (i) terminate the licenses granted by it pursuant to Section 5.2 in respect of
such Product and (ii) require Onyx to grant it an exclusive (even as to Onyx),
worldwide license (with the right to sublicense) under the Patents relating to such Product
and owned or controlled by Onyx, to the extent necessary to make, use or sell such Product.
(d) In the event of an uncured material breach by Onyx of any provision of Article VI, Warner
may immediately terminate the Term of Co-Promotion.
12.2 Effect of Bankruptcy. If either party files a voluntary petition in bankruptcy,
is adjudicated a bankrupt, makes a general assignment for the benefit of creditors, admits in
writing that it is insolvent or fails to discharge within 15 days an involuntary petition in
bankruptcy filed against it, then the other party will have 60 days to determine whether or not (a)
the Term of the Research Collaboration shall immediately terminate and/or (b) the Term of
Co-Promotion shall immediately terminate.
12.3 Key Personnel. In the event that on or before the second anniversary of the
Effective Date Xxxxx XxXxxxxxx (i) is physically and mentally capable of overseeing Onyx’s work
under the Research Plan but (ii) for any reason fails to oversee such work, then Onyx shall
immediately notify Warner thereof and Onyx will have up to six months after such failure to hire a
replacement for XxXxxxxxx (the “Search Period”). By notice delivered to Onyx during the one week
period after the end of the Search Period, Warner may voluntarily terminate the Term of the
Research Collaboration, effective [ * ] after the end of the Search Period, if in its sole opinion
it does not wish to continue the Research Plan with such replacement (or with XxXxxxxxx if he
becomes available again). Any stock purchases that Warner may be required
[ * ] = 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.
21
to make pursuant to the Preferred Stock Purchase Agreement dated the date hereof shall be delayed during the Search Period
and during the [ * ] thereafter. Warner’s obligation to purchase such stock and any other stock
under such Purchase Agreement will terminate if it elects to terminate the Term of the Research
Collaboration pursuant to this Section. Warner will, however, be required to make any research
funding payments under Section 8.1 that come due on or before the effective date of such
termination, and Onyx will continue to be obligated under the terms of Section 1.2 during such
period. Onyx and Warner will be released from the provisions of Section 11.7 immediately upon
termination of the Term of the Research Collaboration pursuant to this Section. Upon termination
of the Term of the Research Collaboration under this Section, Warner will promptly pay Onyx (i) [ *
] multiplied by the number of full months from the Effective Date until such termination, plus (ii)
[ * ], minus (iii) [ * ]. Onyx will pay such amount to Warner in the event such amount is
negative.
12.4 Termination of Co-Promotion Rights. Warner may terminate Onyx’s right to
co-promote Collaboration Products hereunder if (i) any entity or person in the pharmaceutical
industry directly or indirectly acquires ownership or control of more than 50% of Onyx’s voting
capital stock or substantially all of its assets or (ii) Onyx develops or acquires a financial
interest in any product that could compete with any Collaboration Product as to which product an
NDA has been filed with or approved by the FDA.
12.5 Remedies. In the event of any breach of any provision of this Agreement, in
addition to the termination rights set forth herein, each party shall have all other rights and
remedies at law or equity to enforce this Agreement.
12.6 Voluntary Termination. Warner may terminate this Agreement by providing written
notice thereof to Onyx on the eighteen month anniversary of the Effective Date. In such event, the
Term of this Agreement will automatically terminate, and Warner’s obligation to purchase stock on
the second anniversary of the Effective Date under the Preferred Stock Purchase Agreement dated the
date hereof will also terminate. Notwithstanding the termination of the Term of this Agreement,
(i) Warner will make all research payments to Onyx that are due before the second anniversary of
the Effective Date pursuant to Section 8.1 (payable on the dates that such payments are due) and
shall make a termination payment of [ * ] on the second anniversary of the Effective Date, (ii)
Warner will grant Onyx an exclusive (even as to Warner), world-wide, fully-paid, perpetual license
under Warner’s Patents and Warner’s Know-How discovered or reduced to practice prior to the [ * ]
anniversary of the termination of the Term of this Agreement that are necessary to make, use and
sell any Collaboration Compound for therapeutic or diagnostic use in the Field, (iii) the licenses
granted under Section 5.1 will terminate and (iv) the licenses granted to Warner under Section 1.4
will terminate.
ARTICLE XIII
GENERAL PROVISIONS
13.1 Indemnification. Each of Warner and Onyx agrees to indemnify and hold harmless
the other party and its Affiliates and their respective employees, agents, officers, directors and
permitted assigns (such party’s “Indemnified Group”) from and against any claims,
[ * ] = 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.
22
judgments, expenses (including reasonable attorney’s fees), damages and awards (collectively a “Claim”)
arising out of or resulting from (i) its negligence or misconduct in regard to any Product, (ii) a
breach of any of its representations or warranties hereunder or (iii) the manufacture, use or sale
of a Collaboration Product (in the case of Warner) or an Onyx Product (in the case of Onyx), except
to the extent that such Claim arises out of or results from the negligence or misconduct of a party
seeking to be indemnified and held harmless or the negligence or misconduct of a member of such
party’s Indemnified Group. A condition of this obligation is that, whenever an indemnified party
has information from which it may reasonably conclude an incident has occurred which could give
rise to a Claim, such indemnified party shall immediately give notice to the indemnifying party of
all pertinent data surrounding such incident and, in the event claim is made or suit is brought,
all indemnified parties shall assist the indemnifying party and cooperate in the gathering of
information with respect to the time, place and circumstances and in obtaining the names and
addresses of any injured parties and available witnesses. No indemnified party shall, except at
its own cost, voluntarily make any payment or incur any expense in connection with any such Claim
or suit without the prior written consent of the indemnifying party. The obligations set forth in
this Section shall survive the expiration or termination of this Agreement.
13.2 Assignment. This Agreement shall not be assignable by either party without the
prior written consent of the other party, such consent not to be unreasonably withheld. In no
event will any assignment relieve the assigning party of its obligations hereunder. This Agreement
shall be binding upon and, subject to the terms of the foregoing sentence, inure to the benefit of
the parties’ successors, legal representatives and assigns. Notwithstanding the foregoing, Warner
may assign this Agreement to any of its wholly-owned subsidiaries or any entity succeeding to a
majority of its Xxxxx-Xxxxx business, and either party may assign this Agreement to its successor
in connection with any merger, consolidation or sale of all or substantially all of its assets.
13.3 Non-Waiver. The waiver by either of the parties of any breach of any provision
hereof by the other party shall not be construed to be a waiver of any succeeding breach of such
provision or a waiver of the provision itself.
13.4 Research Dispute Resolution. The parties recognize that the collaborative
research program under the Research Plan may require the resolution of certain issues or the
negotiation of additional agreements in the future. In the event the Research Management Committee
is unable to resolve a dispute under the Research Plan, either party may have the dispute referred
to the President of Onyx and the senior officer of Warner’s pharmaceutical business for good faith
resolution.
13.5 Governing Law. This Agreement shall be construed and interpreted in accordance
with the laws of the State of New York, other than those provisions governing conflicts of law.
13.6 Partial Invalidity. If and to the extent that any court or tribunal of competent
jurisdiction holds any of the terms or provisions of this Agreement, or the application thereof to
any circumstances, to be invalid or unenforceable in a final nonappealable order, the parties shall
use their best efforts to reform the portions of this Agreement declared invalid to realize the
[ * ] = 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.
23
intent of the parties as fully as practical, and the remainder of this Agreement and the
application of such invalid term or provision to circumstances other than those as to which it is
held invalid or unenforceable shall not be affected thereby, and each of the remaining terms and
provisions of this Agreement shall remain valid and enforceable to the fullest extent of the law.
13.7 Notice. Any notice to be given to a party under or in connection with this
Agreement shall be in writing and shall be (i) personally delivered, (ii) delivered by a nationally
recognized overnight courier or (iii) delivered by certified mail, postage prepaid, return receipt
requested to the party at the address set forth below for such party:
To Warner: | To Onyx: | |||
Senior Vice President, Research | Hollings Renton | |||
Xxxxx-Xxxxx Pharmaceutical Research | President & CEO | |||
Division, | Onyx Corporation | |||
Xxxxxx-Xxxxxxx Company | 0000 Xxxxxxxx Xxxxx | |||
0000 Xxxxxxxx Xxxx | Xxxxxxxx X | |||
Xxx Xxxxx, XX 00000 | Xxxxxxxx, XX 00000 | |||
with a copy to: | with a copy to: | |||
President, Xxxxx-Xxxxx North America | Xxxxxx X. Xxxxx., Esq. | |||
Xxxxxx-Xxxxxxx Company | Cooley Godward Xxxxxx | |||
000 Xxxxx Xxxx | Xxxxxxxxx & Xxxxx | |||
Xxxxxx Xxxxxx, XX 00000 0 | Xxxx Xxxx Xxxxxx | |||
Xxxx Xxxx, XX 00000 | ||||
4th Floor | ||||
and a copy to: | ||||
Vice President and General Counsel | ||||
Xxxxxx-Xxxxxxx Company | ||||
000 Xxxxx Xxxx | ||||
Xxxxxx Xxxxxx, XX 00000 |
or to such other address as to which the party has given notice thereof. Such notices shall be
deemed given upon receipt.
13.8 Vaccines and Diagnostics. Pursuant to an Agreement, between Chiron Corporation
(“Chiron”) and Onyx, dated April 24, 1992, Chiron has certain rights to Vaccines and Diagnostics
developed by Onyx. Warner and Onyx agree that, notwithstanding any other term or provision of this
Agreement to the contrary, neither party shall license to the other any Patents or Know-How to
make, use or sell Vaccines or Diagnostics. Furthermore, each party hereto may make, use or sell
Vaccines and Diagnostics in the Field without obligation to the other party, including as relates
to payment of milestones and royalties. As used in this Section, (i) “Vaccines” shall mean [ * ]
and (ii) “Diagnostics” shall mean [ * ].
[ * ] = 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.
24
13.9 Headings. The headings appearing herein have been inserted solely for the
convenience of the parties hereto and shall not affect the construction, meaning or interpretation
of this Agreement or any of its terms and conditions.
13.10 No Implied Licenses or Warranties. No right or license under any patent
application, issued patent, know-how or other proprietary information is granted or shall be
granted by implication. All such rights or licenses are or shall be granted only as expressly
provided in the terms of this Agreement. Neither party warrants the success of any clinical or
other studies undertaken by it.
13.11 Force Majeure. No failure or omission by the parties hereto in the performance
of any obligation of this Agreement shall be deemed a breach of this Agreement nor shall it create
any liability if the same shall arise from any cause or causes beyond the reasonable control of the
affected party, including, but not limited to, the following, which for purposes of this Agreement
shall be regarded as beyond the control of the party in question: acts of nature; acts or
omissions of any government; any rules, regulations, or orders issued by any governmental authority
or by any officer, department, agency or instrumentality thereof; fire; storm; flood; earthquake;
accident; war; rebellion; insurrection; riot; invasion; strikes; and lockouts or the like; provided
that the party so affected shall use its best efforts to avoid or
remove such causes or nonperformance and shall continue performance hereunder with the utmost
dispatch whenever such causes are removed.
13.12 Survival. The representations and warranties contained in this Agreement as
well as those rights and/or obligations contained in the terms of this Agreement which by their
intent or meaning have validity beyond the term of this Agreement shall survive the termination or
expiration of this Agreement.
13.13 Entire Agreement. This Agreement constitutes the entire understanding between
the parties with respect to the subject matter contained herein and supersedes any and all prior
agreements, understandings and arrangements whether oral or written between the parties relating to
the subject matter hereof. This Agreement will control in the event of any conflict between this
Agreement and the Research Plan.
13.14 Amendments. No amendment, change, modification or alteration of the terms and
conditions of this Agreement shall be binding upon either party unless in writing and signed by the
party to be charged.
13.15 Independent Contractors. It is understood that both parties hereto are
independent contractors and engage in the operation of their own respective businesses, and neither
party hereto is to be considered the agent or partner of the other party for any purpose
whatsoever. Neither party has any authority to enter into any contracts or assume any obligations
for the other party or make any warranties or representations on behalf of the other party.
13.16 Counterparts. This Agreement may be executed in counterparts, each of which
shall be deemed an original and both of which together shall constitute one and the same
instrument.
[ * ] = 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.
25
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly
authorized officers as of the date first above written,
ONYX PHARMACEUTICALS, INC. | XXXXXX-XXXXXXX COMPANY | |||||||
By:
|
/s/ Hollings C. Renton
|
By: | /s/ X. X. Xxxxxx
|
|||||
Title: President & CEO | Title: Chairman and CEO |
[ * ] = 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.
26
SCHEDULE 1
Pre-existing Confidentiality Obligations
None.
[ * ] = 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.