CONFIDENTIAL
AMENDED AND RESTATED
RESEARCH, DEVELOPMENT AND MARKETING
COLLABORATION AGREEMENT
DATED AS OF MAY 2, 1995
BETWEEN
ONYX PHARMACEUTICALS, INC.
AND
XXXXXX-XXXXXXX COMPANY
TABLE OF CONTENTS
PAGE
ARTICLE 1. DEFINITIONS. . . . . . . . . . . . . . . . . . . . . . 1
ARTICLE 2. RESEARCH PROGRAM . . . . . . . . . . . . . . . . . . . 5
2.1 Undertaking and Scope. . . . . . . . . . . . . . . . . . . 5
2.2 Personnel and Resources. . . . . . . . . . . . . . . . . . 6
2.3 Term of the Research Collaboration . . . . . . . . . . . . 7
2.4 Rights to Know-How and Patents for Research. . . . . . . . 7
2.5 Collaboration Expenses . . . . . . . . . . . . . . . . . . 7
ARTICLE 3. COMMITTEES . . . . . . . . . . . . . . . . . . . . . . 7
3.1 Research Management Committee. . . . . . . . . . . . . . . 7
3.2 Marketing Committee. . . . . . . . . . . . . . . . . . . . 8
3.3 Meetings . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.4 SAB Attendance . . . . . . . . . . . . . . . . . . . . . . 8
ARTICLE 4. PATENTS, KNOW-HOW, RIGHTS AND INVENTIONS . . . . . . . 9
4.1 Rights to Inventions . . . . . . . . . . . . . . . . . . . 9
4.2 Joint Inventions . . . . . . . . . . . . . . . . . . . . . 9
4.3 Protection of Patent Rights. . . . . . . . . . . . . . . .10
4.4 Allegations of Infringement by Third Parties . . . . . . .10
ARTICLE 5. DESIGNATION OF LEAD COMPOUNDS AND MARKETING RIGHTS . .11
5.1 Designation of Lead Compound . . . . . . . . . . . . . . .11
5.2 Collaboration Product. . . . . . . . . . . . . . . . . . .11
5.3 Independent Development. . . . . . . . . . . . . . . . . .11
5.4 Warner's Re-engagement Option. . . . . . . . . . . . . . .12
ARTICLE 6. LICENSES AND ROYALTIES . . . . . . . . . . . . . . . .13
6.1 Grant by Onyx. . . . . . . . . . . . . . . . . . . . . . .13
6.2 Grant by Warner. . . . . . . . . . . . . . . . . . . . . .13
6.3 Royalties Payable by Warner. . . . . . . . . . . . . . . .13
6.4 Royalties Payable by Onyx. . . . . . . . . . . . . . . . .14
6.5 Currency of Payment. . . . . . . . . . . . . . . . . . . .15
6.6 Payment and Reporting. . . . . . . . . . . . . . . . . . .15
6.7 Records. . . . . . . . . . . . . . . . . . . . . . . . . .15
6.8 Taxes Withheld . . . . . . . . . . . . . . . . . . . . . .16
6.9 Computation of Royalties . . . . . . . . . . . . . . . . .16
i.
TABLE OF CONTENTS
(CONTINUED)
PAGE
6.10 Licenses to Affiliates . . . . . . . . . . . . . . . . . .16
6.11 Restrictions on Payment. . . . . . . . . . . . . . . . . .16
ARTICLE 7. CO-PROMOTION OF COLLABORATION PRODUCTS . . . . . . . .17
7.1 Co-Promotion Rights. . . . . . . . . . . . . . . . . . . .17
7.2 Election or Revocation of Co-Promotion Right . . . . . . .17
7.3 Onyx's Promotional Percentage. . . . . . . . . . . . . . .17
7.4 Marketing and Marketing Plans. . . . . . . . . . . . . . .17
7.5 Promotional Materials. . . . . . . . . . . . . . . . . . .18
7.6 No Delegation. . . . . . . . . . . . . . . . . . . . . . .18
7.7 Returns. . . . . . . . . . . . . . . . . . . . . . . . . .18
7.8 Orders . . . . . . . . . . . . . . . . . . . . . . . . . .18
7.9 Samples. . . . . . . . . . . . . . . . . . . . . . . . . .18
7.10 Completion of Sales. . . . . . . . . . . . . . . . . . . .18
7.11 Training . . . . . . . . . . . . . . . . . . . . . . . . .18
7.12 Exchange of Marketing Information. . . . . . . . . . . . .18
ARTICLE 8. FDA. . . . . . . . . . . . . . . . . . . . . . . . . .19
8.1 Side Effects . . . . . . . . . . . . . . . . . . . . . . .19
8.2 Regulatory and other Inquiries . . . . . . . . . . . . . .19
8.3 Product Recall . . . . . . . . . . . . . . . . . . . . . .19
8.4 Responsibility if not Co-Promoting . . . . . . . . . . . .19
ARTICLE 9. RESEARCH FUNDING AND MILESTONES. . . . . . . . . . . .20
9.1 Research Funding . . . . . . . . . . . . . . . . . . . . .20
9.2 Milestones . . . . . . . . . . . . . . . . . . . . . . . .20
ARTICLE 10. CONFIDENTIALITY. . . . . . . . . . . . . . . . . . . .21
10.1 Confidentiality. . . . . . . . . . . . . . . . . . . . . .21
10.2 Publicity. . . . . . . . . . . . . . . . . . . . . . . . .22
10.3 Publication. . . . . . . . . . . . . . . . . . . . . . . .22
ARTICLE 11. JAPAN. . . . . . . . . . . . . . . . . . . . . . . . .23
11.1 Japanese Company . . . . . . . . . . . . . . . . . . . . .23
11.2 Japanese Company Agreement . . . . . . . . . . . . . . . .23
11.3 Absence of Agreement . . . . . . . . . . . . . . . . . . .24
ii.
TABLE OF CONTENTS
(CONTINUED)
PAGE
ARTICLE 12. REPRESENTATIONS AND WARRANTIES . . . . . . . . . . . .24
12.1 Legal Authority. . . . . . . . . . . . . . . . . . . . . .24
12.2 No Conflicts . . . . . . . . . . . . . . . . . . . . . . .24
12.3 Others Bound . . . . . . . . . . . . . . . . . . . . . . .24
12.4 Third Party Rights . . . . . . . . . . . . . . . . . . . .24
12.5 Survival . . . . . . . . . . . . . . . . . . . . . . . . .25
12.6 Disclaimer . . . . . . . . . . . . . . . . . . . . . . . .25
12.7 Exclusivity. . . . . . . . . . . . . . . . . . . . . . . .25
ARTICLE 13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
13.1 Termination for Breach . . . . . . . . . . . . . . . . . .25
13.2 Effect of Bankruptcy . . . . . . . . . . . . . . . . . . .26
13.3 Key Personnel. . . . . . . . . . . . . . . . . . . . . . .26
13.4 Termination of Co-Promotion Rights . . . . . . . . . . . .26
13.5 Remedies . . . . . . . . . . . . . . . . . . . . . . . . .27
13.6 Voluntary Termination. . . . . . . . . . . . . . . . . . .27
ARTICLE 14. GENERAL PROVISIONS . . . . . . . . . . . . . . . . . .27
14.1 Indemnification. . . . . . . . . . . . . . . . . . . . . .27
14.2 Assignment . . . . . . . . . . . . . . . . . . . . . . . .28
14.3 Non-Waiver . . . . . . . . . . . . . . . . . . . . . . . .28
14.4 Research Dispute Resolution. . . . . . . . . . . . . . . .28
14.5 Governing Law. . . . . . . . . . . . . . . . . . . . . . .28
14.6 Partial Invalidity . . . . . . . . . . . . . . . . . . . .28
14.7 Notice . . . . . . . . . . . . . . . . . . . . . . . . . .29
14.8 Vaccines and Diagnostics . . . . . . . . . . . . . . . . .29
14.9 Headings . . . . . . . . . . . . . . . . . . . . . . . . .30
14.10 No Implied Licenses or Warranties. . . . . . . . . . . . .30
14.11 Force Majeure. . . . . . . . . . . . . . . . . . . . . . .30
14.12 Survival . . . . . . . . . . . . . . . . . . . . . . . . .30
14.13 Entire Agreement . . . . . . . . . . . . . . . . . . . . .30
14.14 Amendments . . . . . . . . . . . . . . . . . . . . . . . .31
14.15 Independent Contractors. . . . . . . . . . . . . . . . . .31
14.16 Counterparts . . . . . . . . . . . . . . . . . . . . . . .31
iii.
AMENDED AND RESTATED RESEARCH,
DEVELOPMENT AND MARKETING
COLLABORATION AGREEMENT
THIS AMENDED AND RESTATED RESEARCH, DEVELOPMENT AND MARKETING COLLABORATION
AGREEMENT (the "Agreement") is made and entered into by and between ONYX
PHARMACEUTICALS, INC., a California corporation located at 0000 Xxxxxxxx Xxxxx,
Xxxxxxxx, Xxxxxxxxxx 00000 ("Onyx"), and XXXXXX-XXXXXXX COMPANY, a Delaware
corporation located at 000 Xxxxx Xxxx, Xxxxxx Xxxxxx, Xxx Xxxxxx 00000
("Warner"). This Agreement is executed on July 31, 1997 but is deemed by the
parties to be effective as of May 2, 1995 and shall supersede and replace the
original Research, Development and Marketing Agreement between Onyx and Warner
dated as of May 2, 1995.
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"); and
WHEREAS, Warner and Onyx entered into that certain Research, Development
and Marketing Agreement dated as of May 2, 1995, and they now wish to amend and
restate the terms of such agreement by entering into this Agreement, thereby
superseding and replacing such earlier agreement;
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
promises, covenants and conditions contained herein, Onyx and Warner agree as
follows:
ARTICLE 1
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
1.
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" shall mean any compound identified by either party
during the Research Term or one year thereafter as showing sufficient activity
against targets in the Field 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.
"COLLABORATION LEAD COMPOUND" shall mean any Collaboration Compound
selected by Warner for further development as provided in Section 5.1.
"COLLABORATION PRODUCT" shall mean any Collaboration Lead Compound for
which an IND or foreign equivalent application has been filed, as provided in
Section 5.2.
"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 May 2, 1995.
"FDA" shall mean the United States Food and Drug Administration.
"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 [**]
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[**]. The Field will also include [**].
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) [**]
[**] shall mean therapeutics where the active agent is [**].[**]
specifically excludes [**].
"IND" shall mean an Investigational New Drug Application.
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3.
"INVENTION" shall mean any invention, idea, data, know-how or material that
is discovered or reduced to practice during the Term of this Agreement [**] and
that relates to the discovery, design, synthesis, delivery, development,
testing, use, manufacture or sale of agents acting in the Field.
"KNOW-HOW" shall mean Onyx Know-How and/or Warner Know-How, as the case may
be.
"MHW" shall mean the Ministry of Health and Welfare of Japan.
"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 to such customers, less the following deductions 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: (i) trade, quantity and cash discounts or rebates; (ii)
credits, rebates, charge-back rebates, reimbursements or similar payments
granted or given to wholesalers and other distributors, buying groups,
healthcare insurance carriers, governmental agencies and other institutions,
provided that such provisions will not grant a preference or otherwise favor
other products of Warner or Onyx, as the case may be, if based on the fact that
a royalty may be payable hereunder; (iii) credits or allowances for rejection or
return of such Product previously sold; (iv) any tax, tariff, duty or other
governmental charge (other than an income tax) levied on the sale,
transportation or delivery of a Product and borne by the seller thereof; (v)
payments or rebates paid in connection with state or federal Medicare, Medicaid
or similar programs; (vi) any charge for freight or insurance; and (vii)
allowance for bad debt expense. Any such deductions, if not for amounts
actually incurred or allowed with respect to the specific Products sold, shall
be no greater than the pro rata amount allocable to such Product, based on the
invoices for similar pharmaceutical products sold by the selling party, of the
total amount of such deductions allowed or incurred for all such similar
products. In the event that the selling party recognizes revenue due to excess
balance sheet reserves associated with the net sales deductions described above,
the pro rata amount of such revenue allocable to the Product shall be deemed Net
Sales hereunder, at the time such revenue is recognized.
"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 with activity 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
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4.
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.
"ONYX LEAD COMPOUND" shall mean a Collaboration Compound that Onyx obtains
the right to develop independently as provided in Section 5.3.
"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 with activity 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 patents and patent
applications that claim 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" shall have the meaning set forth in Section 5.3.
"ONYX PRODUCT EXCLUSIVE PERIOD" shall have the meaning set forth in Section
5.4.
"PATENTS" shall mean, Onyx Patents and/or Warner Patents, as the case may
be.
"PRODUCTS" shall mean Collaboration Products and/or Onyx Products, as
applicable.
"RESEARCH MANAGEMENT COMMITTEE" shall mean that entity organized and acting
pursuant to Section 3.1.
"RESEARCH PLAN" shall have the meaning set forth in Section 2.1.
"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 the period 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.
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"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 with activity 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 with activity in the Field, including,
without limitation, all reissues, extensions, substitutions, confirmations,
registrations, revalidations, additions, continuations, continuations-in-part,
and divisions thereof. Excluded from "Warner Patents" are patents and patent
applications that claim (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 2
RESEARCH PROGRAM
2.1 UNDERTAKING AND SCOPE. From time to time the Research Management
Committee will agree on the general direction of the research to be performed
hereunder. The 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 [**] to (i) develop and transfer to Warner [**] screening assays [**] 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
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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). During the Term of the Research Collaboration, or [**] thereafter,
the Research Management Committee and either party individually may from time to
time declare any compound that meets the definition therefor in Article 1 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.
2.2 PERSONNEL AND RESOURCES. Each party agrees to commit the personnel,
facilities, expertise and other resources needed 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 [**] 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).
2.3 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").
2.4 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
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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.
2.5 COLLABORATION EXPENSES. [**] the costs and expenses of work done
pursuant to the Collaboration at [**].
2.6 NEW ZEALAND RESEARCH WORK. Onyx acknowledges that Warner has amended
its existing agreement with the Auckland Division, Cancer Society of New
Zealand, Inc. ("CSNZ"), dated December 15, 1988 (as amended, the "Warner/CSNZ
Agreement"), to expand the field of research to be jointly conducted by Warner
and CSNZ to include the research in the cell cycle field which is the focus of
the collaborative research project being conducted pursuant to this Agreement.
Onyx is willing to permit Warner to conduct such research under the Warner/CSNZ
Agreement, subject to the following terms:
(a) As used in this Section 2.6, the term "ADDITIONAL RESEARCH" shall
have the meaning set forth in Section 1.04a of the Warner/CSNZ Agreement.
(b) The term "Collaboration Compounds" as used in this Agreement
shall also include any compounds identified as a result of the Additional
Research conducted by CSNZ or Warner in collaboration with CSNZ pursuant to
the Warner/CSNZ Agreement. Any work performed by CSNZ and Warner under
such Additional Research shall be considered to be work performed by the
parties pursuant to this Agreement.
(c) For the avoidance of doubt, and notwithstanding any other
interpretation of the Agreement, Warner and Onyx hereby agree that the
royalties payable by Warner under Section 6.3 shall not be reduced by any
royalty or other payments payable by Warner to CSNZ pursuant to the
Warner/CSNZ Agreement, whether by offset, credit or otherwise.
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ARTICLE 3
COMMITTEES
3.1 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 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.
3.2 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.
3.3 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.
3.4 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 directly 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
9.
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.
ARTICLE 4
PATENTS, KNOW-HOW, RIGHTS AND INVENTIONS
4.1 RIGHTS TO INVENTIONS.
(a) Ownership of all Inventions and any other technology,
information, data, know-how, compounds and material developed, discovered or
made hereunder shall be determined in accordance with United States laws of
inventorship. The owner (the "Inventor") of any 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.
4.2 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 4 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 [**]
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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) [**].
4.3 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
applications, 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 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.
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(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.
4.4 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 [**]. 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 5
DESIGNATION OF LEAD COMPOUNDS AND MARKETING RIGHTS
5.1 DESIGNATION OF LEAD COMPOUND. From time to time, Warner may formally
designate one or more Collaboration Compounds for further development, and such
designated compounds shall be deemed Collaboration Lead Compounds. 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 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.
5.2 COLLABORATION PRODUCT. Each Collaboration Lead Compound shall be
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
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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.
5.3 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"). After either (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 the date [**] after Warner's receipt of Onyx's
written request, then Onyx shall undertake continued research and development
(including the specific research and development requested by Onyx in its
request to Warner) of such Collaboration Compound independently (an "Onyx Lead
Compound"), at its sole cost and under its sole direction. Onyx may not utilize
the services of the personnel committed to the Collaboration pursuant to Section
2.2 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 Section 5.4 and the other terms of this
Agreement.
5.4 WARNER'S RE-ENGAGEMENT OPTION. Warner may elect in writing to Onyx 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 for
research and development of such Onyx Lead Compound. For purposes of this
Section,
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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 6
LICENSES AND ROYALTIES
6.1 GRANT BY ONYX. Onyx hereby grants and agrees to grant to Warner
exclusive, worldwide (except for Japan) licenses under the Onyx Patents solely
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.
6.2 GRANT BY WARNER. Warner hereby grants and agrees to grant to Onyx
exclusive, worldwide (except for Japan) licenses under the Warner Patents solely
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.
6.3 ROYALTIES PAYABLE BY WARNER. In part consideration for all rights
granted to Warner and efforts undertaken by Onyx hereunder, 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
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did not exist. Subject to the terms of the preceding sentence, if in a
particular country there is never an issued Patent that is necessary to sell
such Product in such country, then such [**] royalty will be payable, for sales
of such Product in such country, until the earliest of (x) the later to occur of
(i) the [**] anniversary of such first sale in such country 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 in such country 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 such 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 in such
country 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.
6.4 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 in a particular
country there is never an issued Patent that is necessary to sell such Product
in such country, then such [**] royalty will be payable, for sales of such
Product in such country, until the earliest of (x) the later to occur of (i) the
[**] anniversary of such first sale in such country and (ii) expiration of the
last Patent necessary to make or use such Product in such country, which Patent
was
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in existence on the date of such first commercial sale, (y) the first calendar
quarter in which the sale in such country 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 in such country by any entities
(taken in the aggregate), other than Onyx 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 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.
6.5 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.
6.6 PAYMENT AND REPORTING. The royalties due under Section 6.3 or Section
6.5 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
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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.
6.7 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 6. 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).
6.8 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.
6.9 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 6, 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 6, 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.
6.10 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
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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 6.3 or 6.5 hereof, as applicable.
6.11 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 7
CO-PROMOTION OF COLLABORATION PRODUCTS
7.1 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.
7.2 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.
7.3 ONYX'S PROMOTIONAL PERCENTAGE. If Onyx elects to exercise its
co-promotion rights pursuant to Section 7.2, the Marketing Committee will meet
and determine procedures 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) [**]
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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.
7.4 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.
7.5 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.
7.6 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.
7.7 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.
7.8 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.
7.9 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.
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7.10 COMPLETION OF SALES. All sales of Collaboration Products will be
completed, distributed, accounted for, billed and booked by Warner at prices
established by Warner.
7.11 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.
7.12 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 8
FDA
8.1 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.
8.2 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.
8.3 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
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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.
8.4 RESPONSIBILITY IF NOT CO-PROMOTING. Onyx will have the rights and
responsibilities referred to in this Article 8 only during the Term of
Co-Promotion and for [**] thereafter.
ARTICLE 9
RESEARCH FUNDING AND MILESTONES
9.1 RESEARCH FUNDING. Warner will pay Onyx the following amounts on the
following dates during the Term of the Research Collaboration in consideration
for work 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..... [ ** ]
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[ ** ]
9.2 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................... [ ** ]
Commencement of Phase II clinical trials by or on
behalf of Warner anywhere in the world................... [ ** ]
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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
(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 10
CONFIDENTIALITY
10.1 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:
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(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 10.1 shall survive the expiration
or termination of this Agreement.
10.2 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 reasonably in advance of such
disclosure and cooperates to minimize the scope and content of such disclosure.
10.3 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
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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 11
JAPAN
11.1 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.
11.2 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
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24.
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 [**] 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 an investment
bank familiar with valuations of privately-held biotechnology companies selected
by the parties in good faith agreement, with the cost of performing such
valuation borne equally by the parties.
11.3 ABSENCE OF AGREEMENT. If Onyx does not execute an agreement in the
Field with a Japanese company pursuant to Sections 11.1 or 11.2, 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 12
REPRESENTATIONS AND WARRANTIES
12.1 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.
12.2 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.
12.3 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.
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25.
12.4 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.
12.5 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.
12.6 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.
12.7 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 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 13
TERMINATION
13.1 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 2, the
non-breaching party may terminate the Term of the Research Collaboration.
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26.
(b) In the event of an uncured material breach of Section 6.3 by
Warner in respect of a Collaboration Product, Onyx may (i) terminate the
licenses granted by it pursuant to Section 6.1 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 6.5 by Onyx
in respect of an Onyx Product, Warner may (i) terminate the licenses granted by
it pursuant to Section 6.2 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 7, Warner may immediately terminate the Term of
Co-Promotion.
13.2 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.
13.3 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.
13.4 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.
13.5 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
27.
Effective Date pursuant to Section 9.1 (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 6.1 will terminate
and (iv) the licenses granted to Warner under Section 2.4 will terminate.
ARTICLE 14
GENERAL PROVISIONS
14.1 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, 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.
14.2 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
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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.
14.3 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.
14.4 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.
14.5 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.
14.6 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
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.
14.7 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 President & CEO
Research Division, Onyx Corporation
Xxxxxx-Xxxxxxx Company 0000 Xxxxxxxx Xxxxx
0000 Xxxxxxxx Xxxx Xxxxxxxx X
Xxx Xxxxx, XX 00000 Xxxxxxxx, XX 00000
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with a copy to: with a copy to:
President, Xxxxx-Xxxxx Xxxxxx X. Xxxxx, Esq.
United States and Mexico Cooley Godward LLP
Xxxxxx-Xxxxxxx Company 5 Palo Alto Square
201 Xxxxx Road 0xx Xxxxx
Xxxxxx Xxxxxx, XX 00000 Xxxx Xxxx, XX 00000
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.
14.8 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
[**].
14.9 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.
14.10 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
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expressly provided in the terms of this Agreement. Neither party warrants the
success of any clinical or other studies undertaken by it.
14.11 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.
14.12 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.
14.13 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.
14.14 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.
14.15 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.
14.16 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.
31.
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/ Xxxxxx X. Xxxxxxxxx
-------------------------------- --------------------------------
Name: Hollings C. Renton Name: Xxxxxx X. Xxxxxxxxx
------------------------------ ------------------------------
Title: President & CEO Title: Vice President and Chairman
----------------------------- Xxxxx-Xxxxx Pharmaceutical
Research
Xxxxxx-Xxxxxxx Company
-----------------------------
32.
SCHEDULE 1
PRE-EXISTING CONFIDENTIALITY OBLIGATIONS
