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RESEARCH, DEVELOPMENT AND MARKETING COLLABORATION AGREEMENT

Marketing Agreement

RESEARCH, DEVELOPMENT AND MARKETING COLLABORATION AGREEMENT | Document Parties: ONYX PHARMACEUTICALS INC You are currently viewing:
This Marketing Agreement involves

ONYX PHARMACEUTICALS INC

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Title: RESEARCH, DEVELOPMENT AND MARKETING COLLABORATION AGREEMENT
Governing Law: New York     Date: 5/10/2006
Industry: Biotechnology and Drugs     Law Firm: Cooley Godward     Sector: Healthcare

RESEARCH, DEVELOPMENT AND MARKETING COLLABORATION AGREEMENT, Parties: onyx pharmaceuticals inc
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.

EXHIBIT 10.2

RESEARCH, DEVELOPMENT AND MARKETING

COLLABORATION AGREEMENT

DATED AS OF MAY 2, 1995

BETWEEN

ONYX PHARMACEUTICALS, INC.

AND

WARNER-LAMBERT 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 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.

 


 

 

 

TABLE OF CONTENTS

 

 

 

 

 

ARTICLE A DEFINITIONS

 

 

1

 

 

 

 

 

 

Affiliate

 

 

1

 

Collaboration Compound(s)

 

 

1

 

Collaboration Lead Compound(s)

 

 

1

 

Collaboration Product(s)

 

 

1

 

Collaboration Product Exclusive Period

 

 

1

 

Co-Promotion Country

 

 

1

 

Effective Date

 

 

1

 

FDA

 

 

1

 

Field

 

 

2

 

IND

 

 

2

 

Invention(s)

 

 

3

 

Know-How

 

 

3

 

NDA

 

 

3

 

Net Sales

 

 

3

 

Onyx Know-How

 

 

3

 

Onyx Lead Compound(s)

 

 

3

 

Onyx Patents

 

 

3

 

Onyx Product(s)

 

 

4

 

Onyx Product Exclusive Period

 

 

4

 

Patent(s)

 

 

4

 

Product(s)

 

 

4

 

Research Management Committee

 

 

4

 

Research Plan

 

 

4

 

Term of Co-Promotion

 

 

4

 

Term of this Agreement

 

 

4

 

Term of the Research Collaboration

 

 

4

 

Warner Know-How

 

 

4

 

Warner Patents

 

 

4

 

 

 

 

 

 

ARTICLE I RESEARCH PROGRAM

 

 

5

 

 

 

 

 

 

1.1 Undertaking and Scope

 

 

5

 

1.2 Personnel and Resources

 

 

5

 

1.3 Term of the Research Collaboration

 

 

6

 

1.4 Rights to Know-How and Patents for Research

 

 

6

 

1.5 Collaboration Expenses

 

 

6

 

 

 

 

 

 

ARTICLE II COMMITTEES

 

 

6

 

 

 

 

 

 

2.1 Research Management Committee

 

 

6

 

2.2 Marketing Committee

 

 

7

 

2.3 Meetings

 

 

7

 

2.4 SAB Attendance

 

 

7

 

 

 

 

 

 

ARTICLE III PATENTS, KNOW-HOW, RIGHTS AND INVENTIONS

 

 

7

 

 

 

 

 

 

3.1 Rights to Inventions

 

 

7

 

3.2 Joint Inventions

 

 

8

 

3.3 Protection of Patent Rights

 

 

8

 

3.4 Allegations of Infringement by Third Parties

 

 

9

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.


 

 

 

 

 

 

 

ARTICLE IV DESIGNATION OF LEAD COMPOUNDS AND MARKETING RIGHTS

 

 

9

 

 

 

 

 

 

4.1 Designation of Lead Compound

 

 

9

 

4.2 Collaboration Product

 

 

10

 

4.3 Independent Development

 

 

10

 

4.4 Warner’s Re-engagement Option

 

 

10

 

 

 

 

 

 

ARTICLE V LICENSES AND ROYALTIES

 

 

11

 

 

 

 

 

 

5.1 Grant by Onyx

 

 

11

 

5.2 Grant by Warner

 

 

11

 

5.3 Royalties Payable by Warner

 

 

11

 

5.4 Royalties Payable by Onyx

 

 

12

 

5.5 Currency of Payment

 

 

13

 

5.6 Payment and Reporting

 

 

13

 

5.7 Records

 

 

13

 

5.8 Taxes Withheld

 

 

13

 

5.9 Computation of Royalties

 

 

13

 

5.10 Licenses to Affiliates

 

 

14

 

5.11 Restrictions on Payment

 

 

14

 

 

 

 

 

 

ARTICLE VI CO-PROMOTION OF COLLABORATION PRODUCTS

 

 

14

 

 

 

 

 

 

6.1 Co-Promotion Rights

 

 

14

 

6.2 Election or Revocation of Co-Promotion Right

 

 

14

 

6.3 Onyx’s Promotional Percentage

 

 

14

 

6.4 Marketing and Marketing Plans

 

 

15

 

6.5 Promotional Materials

 

 

15

 

6.6 No Delegation

 

 

15

 

6.7 Returns

 

 

15

 

6.8 Orders

 

 

15

 

6.9 Samples

 

 

15

 

6.10 Completion of Sales

 

 

15

 

6.11 Training

 

 

15

 

6.12 Exchange of Marketing Information

 

 

16

 

 

 

 

 

 

ARTICLE VII FDA

 

 

16

 

 

 

 

 

 

7.1 Side Effects

 

 

16

 

7.2 Regulatory and other Inquiries

 

 

16

 

7.3 Product Recall

 

 

16

 

7.4 Responsibility if not Co-Promoting

 

 

16

 

 

 

 

 

 

ARTICLE VIII RESEARCH FUNDING AND MILESTONES

 

 

16

 

 

 

 

 

 

8.1 Research Funding

 

 

16

 

8.2 Milestones

 

 

17

 

 

 

 

 

 

ARTICLE IX CONFIDENTIALITY

 

 

18

 

 

 

 

 

 

9.1 Confidentiality

 

 

18

 

9.2 Publicity

 

 

18

 

9.3 Publication

 

 

19

 

 

 

 

 

 

ARTICLE X JAPAN

 

 

19

 

 

 

 

 

 

10.1 Japanese Company

 

 

19

 

10.2 Japanese Company Agreement

 

 

19

 

10.3 Absence of Agreement

 

 

20

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.


 

 

 

 

 

 

 

ARTICLE XI REPRESENTATIONS AND WARRANTIES

 

 

20

 

 

 

 

 

 

11.1 Legal Authority

 

 

20

 

11.2 No Conflicts

 

 

20

 

11.3 Others Bound

 

 

20

 

11.4 Third Party Rights

 

 

21

 

11.5 Survival

 

 

21

 

11.6 Disclaimer

 

 

21

 

11.7 Exclusivity

 

 

21

 

 

 

 

 

 

ARTICLE XII

 

 

21

 

 

 

 

 

 

12.1 Termination for Breach

 

 

21

 

12.2 Effect of Bankruptcy

 

 

22

 

12.3 Key Personnel

 

 

22

 

12.4 Termination of Co-Promotion Rights

 

 

22

 

12.5 Remedies

 

 

23

 

12.6 Voluntary Termination

 

 

23

 

 

 

 

 

 

ARTICLE XIII GENERAL PROVISIONS

 

 

23

 

 

 

 

 

 

13.1 Indemnification

 

 

23

 

13.2 Assignment

 

 

24

 

13.3 Non-Waiver

 

 

24

 

13.4 Research Dispute Resolution

 

 

24

 

13.5 Governing Law

 

 

24

 

13.6 Partial Invalidity

 

 

24

 

13.7 Notice

 

 

24

 

13.8 Vaccines and Diagnostics

 

 

25

 

13.9 Headings

 

 

25

 

13.10 No Implied Licenses or Warranties

 

 

25

 

13.11 Force Majeure

 

 

25

 

13.12 Survival

 

 

26

 

13.13 Entire Agreement

 

 

26

 

13.14 Amendments

 

 

26

 

13.15 Independent Contractors

 

 

26

 

13.16 Counterparts

 

 

26

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.

 


 

 

RESEARCH, DEVELOPMENT AND MARKETING COLLABORATION AGREEMENT

     Research, Development and Marketing Collaboration Agreement, dated as of May 2, 1995, between Onyx Pharmaceuticals, Inc., a California corporation (“Onyx”), located at 3031 Research Drive, Richmond, California 94806, and Warner-Lambert Company, a Delaware corporation (“Warner”), located at 201 Tabor Road, Morris Plains, New Jersey 07950.

W I T N E S S E T H:

     WHEREAS, Onyx and Warner each has certain expertise in the discovery and development of agents acting in the field of cell cycle control; and

     WHEREAS, Warner and Onyx each wish to enter into a collaborative effort to share such expertise, to develop new expertise in the field of cell cycle control, to research together potential applications thereof and, if successful, to market certain of such applications (the “Collaboration”);

     NOW, THEREFORE, in consideration of the foregoing premises and the mutual promises, covenants and conditions contained herein, Onyx and Warner agree as follows:

ARTICLE A

DEFINITIONS

     The following capitalized terms shall have the meanings indicated for purposes of this Agreement:

     “ Affiliate ” shall mean any corporation, association or other entity which directly or indirectly controls, is controlled by or is under common control with the party in question. As used herein the term “control” means possession of the power to direct, or cause the direction of, the management and policies of a corporation, association or other entity.

     “ Collaboration Compound(s) ” shall have the meaning set forth in Section 1.1.

     “ Collaboration Lead Compound(s) ” shall have the meaning set forth in Section 4.1.

     “ Collaboration Product(s) ” shall have the meaning set forth in Section 4.2.

     “ Collaboration Product Exclusive Period ” shall have the meaning set forth in Section 5.3.

     “ Co-Promotion Country ” shall mean the United States of America and its territories and possessions, including the Commonwealth of Puerto Rico.

     “ Effective Date ” shall mean the date of this Agreement first written above.

     “ FDA ” shall mean the United States Food and Drug Administration.

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.


 

2

     “ Field ” shall mean research, drug discovery and development collaboration aimed at therapeutic agents to restore control of, or otherwise intervene in, misregulated cell cycle transitions in tumor cells, vascular smooth muscle cells, or other pathological conditions, in each case insofar as it relates to the targets listed below. Such agents may restore growth control and/or result in death of cells with aberrant control.

The Collaboration will seek to identify agents that modulate biological targets within the Field. The Collaboration will include all therapeutic benefits of such agents.

The Field will consist initially of [ * ] . The Field shall also include the [ * ] . The Field will also include the [ * ] .

The parties may agree during the Term of the Research Collaboration to expand the Field by designating additional targets, and it is their intention to do so in the event logical extensions of the Field are identified and may be accommodated within the resource commitment of the parties. Such expansion will be in writing signed by all members of the Research Development Committee. However, neither party shall be obligated to agree to expand the Field.

Notwithstanding the general description of the Field provided above, the Field will exclude:

(a) All molecular entitles that are part of or that regulate [ * ] . This includes but is not restricted to [ * ] . This also includes molecules that directly or indirectly regulate the aforementioned molecules, [ * ] . This also includes [ * ] . This exception shall not include (by way of example and not limitation) [ * ]

     “ IND ” shall mean an Investigational New Drug Application.

     “ Invention(s) ” shall have the meaning set forth in Section 3.1.

     “ Know-How ” shall mean Onyx Know-How and/or Warner Know-How, as the case may be.

     “ NDA ” shall mean a New Drug Application.

     “ Net Sales ” shall mean the gross amount invoiced by a party hereto or one of its Affiliates to customers who are not Affiliates of the selling party for all Products sold after deduction of the following items calculated in accordance with United States generally accepted accounting principles and Warner’s (or Onyx’s, as the case may be) normal internal accounting standards consistently applied: [ * ]

     “ Onyx Know-How ” shall mean all technology, inventions, information, data, know-how, compounds and materials that (i) are not Onyx Patents, (ii) Onyx owns or otherwise has the right to license to Warner and (iii) relate to the discovery, design, synthesis, delivery, development, testing, use, manufacture or sale of agents acting in the Field. Excluded from “Onyx Know-How” are compounds and information relating to compounds that have been identified by Onyx as candidates for cGLP/cGMP studies on or before the Effective Date, or are hereafter so identified without material application of information provided by Warner or developed by either party pursuant to the Collaboration.

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.


 

3

     “ Onyx Lead Compound(s) ” shall have the meaning set forth in Section 4.3.

     “ Onyx Patents ” shall mean all United States and foreign patents that are owned by Onyx or that Onyx otherwise has the right to license to Warner and that relate to the discovery, design, synthesis, delivery, development, testing, use, manufacture or sale of agents acting in the Field, including, without limitation, all reissues, extensions, substitutions, confirmations, registrations, revalidations, additions, continuations, continuations-in-part, and divisions thereof. Excluded from “Onyx Patents” are compounds and information relating to compounds that have been identified by Onyx as candidates for cGLP/cGMP studies on or before the Effective Date, or are hereafter so identified without material application of information provided by Warner or developed pursuant to the Collaboration.

     “ Onyx Product(s) ” shall have the meaning set forth in Section 4.3.

     “ Onyx Product Exclusive Period ” shall have the meaning set forth in Section 5.4.

     “ Patent(s) ” shall mean, Onyx Patents and/or Warner Patents, as the case may be.

     “ Product(s) ” shall mean Collaboration Products and/or Onyx Products, as applicable.

     “ Research Management Committee ” shall mean that entity organized and acting pursuant to Section 2.1.

     “ Research Plan ” shall have the meaning set forth in Section 1.1.

     “ Term of Co-Promotion ” for a Collaboration Product shall mean the period beginning upon the first commercial sale of a Collaboration Product in the Co-Promotion Country and [ * ] .

     “ Term of this Agreement ” shall mean from the Effective Date until the expiration of all licenses granted pursuant to this Agreement or until this Agreement is otherwise terminated pursuant to its terms.

     “ Term of the Research Collaboration ” shall have the meaning set forth in Section 1.3.

     “ Warner Know-How ” shall mean all technology, inventions, information, data, know-how, compounds and materials that (i) are not Warner Patents, (ii) Warner owns or otherwise has the right to license to Onyx and (iii) relate to the discovery, design, synthesis, delivery, development, testing, use, manufacture or sale of agents acting in the Field. Excluded from”Warner Know-How” are (i) Warner’s high-volume screening technology and (ii) compounds and information relating to compounds that have been identified by Warner as candidates for cGLP/cGMP studies on or before the Effective Date, or are hereafter so identified without material application of information provided by Onyx or developed by either party pursuant to the Collaboration.

     “ Warner Patents ” shall mean all United States and foreign patents that are owned by Warner or that Warner otherwise has the right to license to Onyx and that relate to the discovery, design, synthesis, delivery, development, testing, use, manufacture or sale of agents acting in the Field, including, without limitation, all reissues, extensions, substitutions, confirmations,

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.


 

4

registrations, revalidations, additions, continuations, continuations-in-part, and divisions thereof. Excluded from”Warner Patents” are (i) Warner’s high volume screen technology and (ii) compounds and information relating to compounds that have been identified by Warner as candidates for cGLP/cGMP studies on or before the Effective Date, or are hereafter so identified without material application of information provided by Onyx or developed pursuant to the Collaboration.

ARTICLE I

RESEARCH PROGRAM

     1.1 Undertaking and Scope. From time to time the Research Management Committee will agree on the general direction of the research to be performed hereunder. Correspondence and other material documenting such agreement are collectively referred to herein as the “Research Plan.” Each party agrees to use its best efforts to perform the activities detailed in the Research Plan, in a professional and timely manner. Onyx agrees to use its best efforts at its cost (including the cost of any royalties or other amounts payable by Onyx to third parties) to (i) develop and transfer to Warner [ * ] screening assays per each year of the Term of the Research Collaboration for specific targets in the Field selected by the Research Management Committee, (ii) supply protein required to run such screens and (iii) provide for the testing of substantially all of Onyx’s compound library in such screens. Onyx shall not knowingly provide or perform research on any compounds the use of which would require a royalty or other payment to any third party, unless the Research Management Committee agrees that such compound should be provided and the parties agree in writing how such royalty or other payment will be paid. Warner agrees to use its best efforts at its cost (including the cost of any royalties or other amounts payable by Warner to third parties) to (i) screen substantially all of its compound library with such screens provided by onyx and (ii) conduct medicinal chemistry and animal pharmacology as the Research Management Committee deems appropriate. Promptly after the Effective Date, Onyx and Warner will disclose to each other all information possessed by it relevant to the Field and necessary or helpful to perform the work described in the Research Plan (except to the extent precluded by the pre-existing confidentiality obligations described on Schedule 1 hereto). Compounds identified by either party during the Term of the Research Collaboration (or [ * ] thereafter) as showing sufficient activity against targets identified by the Research Management Committee in assays contributed to or developed under the Collaboration such that further research on such compound for such target is pursued, and any analogs or derivatives of such compounds whenever identified, are referred to herein as “Collaboration Compounds.” The Research Management Committee and either party individually may from time to time declare each such compound to be a Collaboration Compound. Notwithstanding the foregoing, neither party will be required to offer the other party any compounds or information relating to compounds that have been identified as candidates for cGLP/cGMP studies on or before the Effective Date, or are hereafter so identified without material application of information provided by the other party or developed pursuant to the Collaboration. Neither party shall be required to screen under this Collaboration or to offer to the other party any information regarding any compounds identified as having activity in pathways expressly excluded from the Field, if so identified prior to being designated a “Collaboration Compound” hereunder.

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.


 

5

     1.2 Personnel and Resources. Each party agrees to commit the personnel, facilities, expertise and other resources to perform this Agreement in accordance with its terms; provided, however, that neither party warrants that the Collaboration shall achieve any of the research objectives contemplated by them. During the Term of the Research Collaboration, Warner and Onyx will each maintain at its cost an average of 15 full-time equivalents (“FTEs”) devoted to cooperative work under the Research Plan. During the first-year of the Term of the Research Collaboration Warner need maintain only 10 such FTEs; provided however, that Warner will staff at higher levels in later periods to achieve an average of 15 FTEs during the Term of the Research Collaboration, unless such term is terminated early as permitted hereunder. The scientific priorities and direction of such staff of both parties will be determined by the Research Management Committee. Such staff will include, as appropriate, scientists in the areas of mass screening, molecular biology, biochemistry, biochemical pharmacology, cancer and cardiovascular pharmacology, synthetic chemistry (including peptide synthesis), computer-assisted drug design, and analytical chemistry (e.g., NMR spectroscopy).

     1.3 Term of the Research Collaboration. Work under the Research Plan will commence as of the date of this Agreement and, unless terminated earlier by either party pursuant to the terms of this Agreement or extended by mutual agreement of the parties, will terminate on the third anniversary hereafter (as terminated, expired or extended, the “Term of the Research Collaboration”).

     1.4 Rights to Know-How and Patents for Research. Each party hereby grants and agrees to grant to the other a non-exclusive, royalty-free license to use such party’s Know-How and Patents that are conceived or reduced to practice prior to the [ * ] anniversary of the end of the Term of the Research Collaboration for (a) research and development purposes in the Field and (b), beginning [ * ] after termination of the Term of the Research Collaboration, research and development outside of the Field; provided, however, that the granting party may terminate such licenses granted by it immediately upon its termination of this Agreement for cause. Notwithstanding the foregoing, neither party is granted any interest in the other’s compounds (or analogs or derivatives thereof) except as specifically set forth in this Agreement. In the event that one party does nonetheless conceive or reduce to practice any invention that is comprised of the other party’s compound (or analog or derivative thereof) and if such invention is not in the Field, such party will promptly assign its entire interest therein exclusively to the other party without charge and will not be entitled to any milestones, royalties or other consideration in connection therewith.

     1.5 Collaboration Expenses. [ * ] the costs and expenses of work done pursuant to the Collaboration at [ * ] .

ARTICLE II

COMMITTEES

     2.1 Research Management Committee. Warner and Onyx will each appoint up to 4 representatives to a research management committee (the “Research Management Committee”), which will oversee the operational aspects of performing the Research Plan. The Research

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.


 

6

Management Committee will assure that agendas and minutes are prepared for each of its meetings. The personnel, facilities, expertise and other resources of each party to be used in performance of the Research Plan shall be established by the Research Management Committee. The Research Management Committee will meet quarterly, or more frequently if mutually agreed. Warner’s and Onyx’s initial representatives to the Research Management Committee will be appointed by each of them promptly after the date of this Agreement. All actions taken and decisions made by the Research Management Committee shall be by unanimous agreement. A party may change any of its appointments to the Research Management Committee at any time upon giving written notice to the other party.

     2.2 Marketing Committee. At the time that Warner appoints a committee to plan the marketing of a Collaboration Product (the “Marketing Committee”), it shall promptly inform Onyx and for so long as Onyx has the right to co-promote such Collaboration Product, Onyx shall have the authority to appoint one of its employees as a non-voting member of such committee. Onyx’s non-voting member of the Marketing Committee will have the right to attend all meetings of the Marketing Committee and will be kept current on the plans and proceedings of the Marketing Committee. All actions taken and decisions made by the Marketing Committee shall be under the direction and control of Warner. A party may change any of its appointments to the Marketing Committee at any time upon giving written notice to the other party.

     2.3 Meetings. The Research Management Committee and the Marketing Committee may meet by telephone or in person at such times as are agreeable to the members of each such committee. Attendance at meetings shall be at the respective expense of the participating parties. Warner and Onyx shall alternate the right to determine the location of each meeting of the Research Management Committee, with Onyx determining the location of the first meeting of such committee. Warner shall determine the location of all meetings of the Marketing Committee.

     2.4 SAB Attendance. During the Term of this Agreement, Warner will be entitled to have up to three of its representatives attend all meetings of Onyx’s Scientific Advisory Board that relate to the Field and such other general symposia that do not contain confidential information outside the Field of Onyx or of any third party to which Onyx owes a duty of confidentiality that would be breached by Warner’s attendance. Onyx will provide Warner reasonable advance notice of all such meetings and will provide Warner copies of all written material given to the members of the Scientific Advisory Board in connection with such meetings. Attendance at such meetings by Warner’s representatives will be at Warner’s expense. As a condition of such attendance and access to such written material, Warner will execute appropriate Confidentiality Agreements with respect to information disclosed at such meetings and in such written material.

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.


 

7

ARTICLE III

PATENTS, KNOW-HOW, RIGHTS AND INVENTIONS

     3.1 Rights to Inventions. (a) Ownership of technology, inventions, information, data, know-how, compounds and material shall be determined in accordance with United States laws of inventorship. The owner (the “Inventor”) of any invention that is discovered or reduced to practice during the Term of this Agreement or [ * ] thereafter and that relates to the discovery, design, synthesis, delivery, development, testing, use, manufacture or sale of agents acting in the Field (an “Invention”) shall have the right, at its option and expense, to prepare, file and prosecute in its own name any patent applications with respect to any Invention owned by it and to maintain any patents issued. In connection therewith, the non-Inventor party agrees to cooperate with the Inventor at the Inventor’s expense in the preparation and prosecution of all such patent applications and in the maintenance of any patents issued. This obligation shall survive the expiration or termination of this Agreement.

     (b) The parties will co-own technology, inventions, information, data, know-how, compounds and materials (whether or not patentable) that relate to [ * ] and that are developed in connection with performance of the Research Plan (“ [ * ] Inventions”). The parties will cooperate in the joint filing of patent applications claiming [ * ] Inventions. The parties will negotiate in good faith regarding the collaborative commercial exploitation of the [ * ] Inventions; provided, however, that each party will retain an undivided ownership interest in the [ * ] Inventions and will be free to exploit the same without obligation to the other party.

     3.2 Joint Inventions. Inventions that are jointly invented by Onyx and Warner will be jointly owned by them; however, [ * ] will have the rights and responsibilities of the “Inventor” as described in this Article III in respect of any such patentable, jointly owned Inventions and [ * ] shall have the rights and responsibilities of a non-Inventor therein. [ * ] shall pay all expenses in connection with its preparation, filing and prosecution of patent applications that claim patentable, jointly owned Inventions. [ * ] shall from time to time notify [ * ] of the amount of such expenses and [ * ] shall promptly thereafter pay [ * ] of its out-of-pocket expenses. As used in the preceding sentence “out-of-pocket expenses” shall mean direct costs, excluding internal labor costs. Onyx may elect in writing to disclaim all interest in any jointly invented Invention, in which case (i) such Invention will be solely owned by Warner and Onyx will co-operate to assure Warner’s sole ownership, (ii) Onyx will have no further interest in such Invention, by ownership, license or otherwise and (iii) [ * ] the date that Warner receives Onyx’s written disclaimer. Warner may elect in writing to disclaim all interest in any jointly invented Inventions, in which case (i) such Invention will be solely owned by Onyx and Warner will co-operate to assure Onyx’s sole ownership, (ii) Warner will have no further interest in such Invention, by ownership, license or otherwise and (iii) [ * ] .

     3.3 Protection of Patent Rights. (a) The Inventor shall keep the other party currently informed of all steps to be taken in the preparation, prosecution and maintenance of all of its patents and patent applications which claim an Invention and shall furnish the other party with copies of patents and application, amendments thereto and other related correspondence relating to such Invention to and from patent offices and permit the other party to offer its comments thereon before the Inventor makes a submission to a patent office which could materially affect

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.


 

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the scope or validity of the patent coverage that may result. The non-Inventor party shall offer its comments promptly. Onyx and Warner shall each promptly notify the other of any infringement and/or unauthorized use of an Invention which comes to its attention.

     (b) The non-Inventor party may request in writing that the Inventor take specific, reasonable actions to (i) prepare, file or prosecute a patent application with respect to an Invention, (ii) maintain any patents issued with respect to an Invention, (iii) protect against abandonment of a patent or application which claims an Invention or (iv) obtain a discontinuance of an infringement or unauthorized use of such patent or application. If such actions are not undertaken within thirty days of the Inventor’s receipt of such written request and timely pursued thereafter, the Inventor shall permit, and the non-Inventor party at its option and expense may undertake, such actions. The party not undertaking such actions shall fully cooperate with the other party and shall provide to the other party whatever assignments and other documents that may be needed in connection therewith. The party not undertaking such actions may require a suitable indemnity against all damages, costs and expenses and impose such other reasonable conditions as such party’s advisors may require.

     (c) If either party commences any actions or proceedings (legal or otherwise) pursuant to this Section, it shall prosecute the same vigorously at its expense and shall not abandon or compromise them or fail to exercise any rights of appeal without giving the other party the right to take over their conduct at its own expense. The party finally conducting legal actions or proceedings against an alleged infringer or other party shall be entitled to any damages or costs awarded against such infringer or other party.

     3.4 Allegations of Infringement by Third Parties. In the event that Warner or Onyx receives notice that any action by either of them under this Agreement is alleged to be a violation of the patent or other intellectual property rights of a third party, it shall notify the other party to this Agreement, and they shall jointly determine an appropriate response and course of action. The costs of such defense, and any damages, costs or expenses resulting from such action, shall be paid (i) 100% by Warner in the case of a Collaboration Product, (ii) 100% by Onyx in the case of an Onyx Product and (iii) 50% by Warner and 50% by Onyx if such violation does not relate to the manufacture, use or sale of a Collaboration Product or an Onyx Product; provided, however, that each party will pay 100% of all such costs relating to allegations that it was aware of prior to the Effective Date. The Research Management Committee will decide whether or not to continue any activity following notice that such activity may be a violation of the patent or other intellectual property rights of a third party.

ARTICLE IV

DESIGNATION OF LEAD COMPOUNDS AND MARKETING RIGHTS

     4.1 Designation of Lead Compound. From time to time, Warner may formally designate one or more Collaboration Compounds for further development as a result of work performed under the Research Plan (each, a “Collaboration Lead Compound”). Such designation shall be made under Warner’s then current standards for declaring one of its own compounds a “lead compound.” Such designation generally indicates that Warner has identified such

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.


 

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compound as a candidate for cGLP/cGMP studies. Warner will pursue the research and development of each Collaboration Lead Compound at its own expense and under its sole direction. Warner will provide Onyx quarterly, written updates regarding the status of each Collaboration Lead Compound.

     4.2 Collaboration Product. Each Collaboration Lead Compound is referred to herein as a “Collaboration Product” from and after filing of an IND in respect of such compound with the FDA or the filing of its equivalent in any foreign country other than Japan. The preparation, filing and prosecution of IND’s, NDA’s and other regulatory filings required to be filed with the FDA and its foreign equivalents (other than in Japan) in regard to any Collaboration Product will be at the sole expense of, in the name of and under the direction of Warner. Warner does not warrant that any regulatory filings will actually be filed or, if filed, will be approved.

     4.3 Independent Development. From time to time, Onyx may request Warner in writing to undertake specific research and development regarding a Collaboration Compound or to declare a Collaboration Compound to be a Collaboration Lead Compound. Warner will notify Onyx within [ * ] of receiving Onyx’s written request if it determines before such date that it will not undertake such specific research and development (or declare such Collaboration Compound to be a Collaboration Lead Compound) within [ * ] of such request (“Warner’s Notice to Decline”). If Warner does not so notify Onyx within such [ * ] period, it will periodically review Onyx’s request and if it determines not to undertake such specific research and development (or declare such Collaboration Compound to be a Collaboration Lead Compound) then it shall promptly so notify Onyx (also, “Warner’s Notice to Decline”). Onyx shall undertake the continued research and development (including the specific research and development requested by it) of such Collaboration Compound independently (an “Onyx Lead Compound”), at its sole cost and under its sole direction, promptly upon (i) receipt of Warner’s Notice to Decline or (ii), if Warner does not so notify Onyx and if Warner does not itself undertake the requested action within [ * ] of Onyx’s written request, then [ * ] after Warner’s receipt of Onyx’s written request. Onyx may not utilize the services of the personnel committed to the Collaboration pursuant to Section 1.2 in performance of research or development of an Onyx Lead Compound. Onyx may declare no more than [ * ] Onyx Lead Compounds during the Term of this Agreement. Onyx will keep Warner currently informed of all material information in its research and development of each Onyx Lead compound and will allow Warner to comment on the direction of such research and development. Each Onyx Lead Compound is referred to herein as an “Onyx Product” from and after filing of an IND in respect of such compound with the FDA or the filing of its equivalent in any foreign country other than Japan. Onyx will provide Warner a complete and accurate copy of the proposed filing, together with any additional inf


 
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