AMENDED AND RESTATED RESEARCH, DEVELOPMENT AND MARKETING COLLABORATION AGREEMENT
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
Exhibit 10.2(i)
AMENDED AND RESTATED RESEARCH,
DEVELOPMENT AND MARKETING
COLLABORATION AGREEMENT
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.
WITNESSETH:
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
1.
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” 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 [*] The Field will also
include [*]
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
2.
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.
“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
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
3.
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 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.
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
4.
“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.
“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.
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
5.
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 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 one year 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
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
6.
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).
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 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
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
7.
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.
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
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
8.
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 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.
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
9.
(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 [*] 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)
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
10.
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.
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.
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
11.
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 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.
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
12.
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, 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
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
13.
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 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
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
14.
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 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
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
15.
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.
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
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
16.
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 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
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
17.
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.
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.
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
18.
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 final determination to recall or
otherwise remove the Collaboration Product or any lot or
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
19.
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 |
$ | 250,000 | ||
Three month anniversary of the Effective Date |
4250,000 | |||
Six month anniversary of the Effective Date |
$ | 750,000 | ||
Nine month anniversary of the Effective Date |
$ | 250,000 | ||
Twelve month anniversary of the Effective Date |
$ | 1,000,000 | ||
Fifteen month anniversary of the Effective Date |
$ | 250,000 | ||
Eighteen month anniversary of the Effective Date |
$ | 250,000 | ||
Twenty-one month anniversary of the Effective Date |
$ | 500,000 | ||
Twenty-four month anniversary of the Effective Date |
$ | 1,500,000 | ||
Twenty-seven month anniversary of the Effective Date |
$ | 250,000 | ||
Thirty month anniversary of the Effective Date |
$ | 250,000 | ||
Thirty-three month anniversary of the Effective Date |
$ | 666,667 | ||
$ | 6,166,667 |
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 |
$ | 500,000 | ||
Commencement of Phase II clinical trials by or on behalf
of Warner anywhere in the world |
$ | 1,000,000 |
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
20.
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:
(i) information that is or becomes part of the public domain through no fault of the non-Disclosing Party or its Affiliates;
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
21.
(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 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
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
22.
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 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
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
23.
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.
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 for one year 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 the one year
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
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
24.
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.
(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
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
25.
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 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 one
year 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,
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
26.
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 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.
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
27.
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 Xxxxx-Xxxxx Pharmaceutical Research Division, Xxxxxx-Xxxxxxx Company 0000 Xxxxxxxx Xxxx Xxx Xxxxx, XX 00000 |
Hollings Renton President & CEO Onyx Corporation 0000 Xxxxxxxx Xxxxx Xxxxxxxx X Xxxxxxxx, XX 00000 |
|
with a copy to:
|
with a copy to: | |
President, Xxxxx-Xxxxx United States and Mexico Xxxxxx-Xxxxxxx Company 000 Xxxxx Xxxx Xxxxxx Xxxxxx, XX 00000 |
Xxxxxx X. Xxxxx, Esq. Cooley Godward LLP 5 Xxxx Xxxx Xxxxxx 0xx Xxxxx 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 [*]
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
28.
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 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
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
29.
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.
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 |
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
30.
AMENDED AND RESTATED
RESEARCH, DEVELOPMENT AND MARKETING
COLLABORATION AGREEMENT
RESEARCH, DEVELOPMENT AND MARKETING
COLLABORATION AGREEMENT
DATED AS OF MAY 2, 1995
BETWEEN
ONYX PHARMACEUTICALS, INC.
AND
XXXXXX-XXXXXXX COMPANY
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
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 | ||||||
6.10
|
Licenses to Affiliates | 16 |
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
i.
Table Of Contents
(Continued)
(Continued)
Page | ||||||||
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 | ||||||
Article 12. | Representations and Warranties | 24 | ||||||
12.1
|
Legal Authority | 24 | ||||||
12.2
|
No Conflicts | 24 |
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
ii.
Table Of Contents
(Continued)
(Continued)
Page | ||||||||
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 |
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
iii.
Schedule 1
PRE-EXISTING CONFIDENTIALITY OBLIGATIONS
[*] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.