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COLLABORATION AGREEMENT

Collaboration Agreement

COLLABORATION AGREEMENT You are currently viewing:
This Collaboration Agreement involves

ONYX PHARMACEUTICALS INC

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Title: COLLABORATION AGREEMENT
Governing Law: California     Date: 5/10/2006
Industry: BIOTRX     Law Firm: Jones Day;Cooley Godward     Sector: HEALTH

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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 10.1

COLLABORATION AGREEMENT

BETWEEN

MILES INC.

AND

ONYX PHARMACEUTICALS, INC.

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

 


 

TABLE OF CONTENTS

 

 

 

 

 

 

 

Page

 

CHAPTER 1

 

 

1

 

Article 1 — Defined Terms

 

 

1

 

1.1 “Advertising and Education”

 

 

1

 

1.2 “Advertising and Education Expense”

 

 

1

 

1.3 “Affiliate”

 

 

1

 

1.4 “Allocable Overhead Costs”

 

 

2

 

1.5 “Allowable Expenses”

 

 

2

 

1.6 “Analoging Program”

 

 

2

 

1.7 “Back-Up Compound”

 

 

2

 

1.8 “Clinical Development Period”

 

 

2

 

1.9 “Collaboration Compound”

 

 

2

 

1.10 “Collaboration Product”

 

 

3

 

1.11 “Collaboration Revenue”

 

 

3

 

1.12 “Control”

 

 

3

 

1.13 “Cost of Goods Sold”

 

 

3

 

1.14 “Co-Development”

 

 

3

 

1.15 “Co-Development Costs”

 

 

4

 

1.16 “Co-Development Plan”

 

 

4

 

1.17 “Co-Promote”

 

 

4

 

1.18 “Co-Promotion Program”

 

 

4

 

1.19 “Co-Promotion Product”

 

 

4

 

1.20 “Development Compound”

 

 

4

 

1.21 “Distribution Costs”

 

 

4

 

1.22 “Effective Date”

 

 

4

 

1.23 “Field”

 

 

4

 

1.24 “Field of Collaborative Research”

 

 

5

 

1.25 “Information”

 

 

5

 

1.26 “Joint Research and Development Committee” or “JRDC”

 

 

5

 

1.27 “Lead Structure”

 

 

5

 

1.28 “Marketing Plan”

 

 

5

 

1.29 “Marketing Profit or Loss”

 

 

5

 

1.30 “Miles Know-How”

 

 

5

 

1.31 “Miles Patents”

 

 

5

 

1.32 “Net Sales”

 

 

5

 

1.33 “Onyx Know-How”

 

 

6

 

1.34 “Onyx Patents”

 

 

6

 

1.35 “Patent”

 

 

6

 

1.36 “Preclinical Development Period”

 

 

6

 

1.37 “Pre-Marketing Activities”

 

 

6

 

1.39 “Post-Collaboration Compound”

 

 

6

 

1.40 “Ras Pathway”

 

 

7

 

1.41 “Ras Function”

 

 

7

 

1.42 “Regulatory Approval”

 

 

7

 

1.43 “Research”

 

 

7

 

[ * ] = 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.

1


 

 

 

 

 

 

 

 

Page

 

1.44 “Research Plan”

 

 

7

 

1.45 “Research Term”

 

 

7

 

1.46 “Royalty-Bearing Product”

 

 

7

 

1.47 “Selling and Promotion Expenses”

 

 

8

 

1.48 “Sublicense Revenues”

 

 

8

 

1.49 “Third Party”

 

 

8

 

1.50 “Third Party Royalties”

 

 

8

 

CHAPTER 2

 

 

9

 

Article 2 — Initial Payment And Board Representation

 

 

9

 

2.1 Purchase of Series D Preferred Stock

 

 

9

 

2.2 Board Representation

 

 

9

 

3.1 Joint Research and Development Committee

 

 

10

 

3.2 Meetings of the JRDC

 

 

10

 

3.3 Functions and Powers of the JRDC

 

 

10

 

3.4 Obligations of Parties

 

 

11

 

3.5 Project Leader

 

 

11

 

3.6 General

 

 

11

 

Article 4 — Licenses

 

 

12

 

4.1 Research Licenses

 

 

12

 

4.2 Collaboration Product Commercialization Licenses

 

 

12

 

4.3 Limitations on Exclusivity

 

 

12

 

4.4 Royalty-Bearing Product Commercialization Licenses

 

 

13

 

4.6 Onyx License After Research Termination

 

 

13

 

CHAPTER 3

 

 

14

 

Article 5 — Collaborative Research Program

 

 

14

 

5.1 Program Management

 

 

14

 

5.2 Decision Points During Research

 

 

14

 

5.3 Research Efforts and Expenses

 

 

14

 

5.4 Annual Plan and Budget

 

 

14

 

5.5 Extension of Research Term

 

 

14

 

5.6 Termination of Research with Substitution of New Research Target

 

 

15

 

5.7 Consequences of Research Substitution

 

 

15

 

5.8 Termination of Research by Miles

 

 

16

 

5.9 Key Employee Departure

 

 

16

 

Article 6 — Specification of Research Field and Assays

 

 

18

 

6.1 Refinement of Field of Collaborative Research

 

 

18

 

6.2 Restriction of the Field of Collaborative Research

 

 

18

 

6.3 Specification of Ras Function Assay Standards

 

 

19

 

Article 7 — Allocation of Research Tasks

 

 

19

 

7.1 Onyx Research Obligations

 

 

19

 

7.2 Miles Research Obligations

 

 

19

 

7.3 Independent Funded Research Of Onyx Subject to Buy-Back

 

 

20

 

7.4 Miles Buy-Back

 

 

20

 

7.6 Conduct of Studies

 

 

20

 

Article 8 — Research Material and Information

 

 

21

 

[ * ] = 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


 

 

 

 

 

 

 

 

Page

 

8.1 Rights In Materials

 

 

21

 

8.2 Acquisition of Third Party Technology

 

 

21

 

Article 9 — Research Funding

 

 

21

 

9.1 Miles Financial Support

 

 

22

 

9.2 Minimum Level of Financial Support

 

 

22

 

9.3 Restriction on Government Support

 

 

22

 

9.4 Manner of Payments

 

 

22

 

9.5 Application of Funds; Reporting

 

 

22

 

9.6 Research Activities After Research Term

 

 

22

 

Article 10 — Research Reports

 

 

24

 

10.1 Information and Reports During Research

 

 

24

 

10.2 Reports After Research Term

 

 

24

 

CHAPTER 4

 

 

25

 

Article 11 — Co-Development

 

 

25

 

11.1 Scope of Development

 

 

25

 

11.2 Preclinical Investigation and Development

 

 

25

 

11.3 Synthesis of Preclinical Materials

 

 

25

 

11.4 Selection of Collaboration Compounds for Co-Development

 

 

25

 

11.5 Budget for Development

 

 

26

 

11.6 Performance of Co-Development

 

 

26

 

11.7 Funding of Co-Development

 

 

27

 

11.8 Development Payments