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COLLABORATION AGREEMENT

Collaboration Agreement

COLLABORATION AGREEMENT You are currently viewing:
This Collaboration Agreement involves

SHIRE PLC | SHIRE PHARMACEUTICALS PLC | NEW RIVER PHARMACEUTICALS INC.

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Title: COLLABORATION AGREEMENT
Governing Law: New York     Date: 5/9/2005
Industry: BIOTRX     Law Firm: Cooley Godward LLP; Morgan, Lewis & Bockius LLP     Sector: HEALTH

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Exhibit 10

Exhibit 10.1

*Represents language for which confidential treatment has been requested.

COLLABORATION AGREEMENT

 

BY AND AMONG

SHIRE LLC

SHIRE PHARMACEUTICALS PLC

AND

NEW RIVER PHARMACEUTICALS INC.

 

DATED AS OF JANUARY 31, 2005

 


 

TABLE OF CONTENTS

 

 

 

 

 

 

 

PAGE

 

 

 

 

ARTICLE 1.

       DEFINITIONS

1

ARTICLE 2.

       MANAGEMENT OF COLLABORATION

13

 

2.1

General

13

 

2.2

Joint Development Committee (JDC)

13

 

2.3

Joint Marketing Committee (JMC)

14

 

2.4

Joint Supply Committee (JSC)

15

 

2.5

Joint Intellectual Property Committee (JIPC)

16

 

2.6

General Committee Membership and Procedures

17

 

2.7

Committee Decision-Making

18

ARTICLE 3.

       DEVELOPMENT AND REGULATORY RESPONSIBILITIES

19

 

3.1

Overview

19

 

3.2

Development Plans

20

 

3.3

Development in the US Territory for ADHD

21

 

3.4

Development in the ROW Territory for ADHD and Other Indications

23

 

3.5

Development in the US Territory for Indications other than ADHD

25

 

3.6

Shared Expenses

27

 

3.7

Use of Third Parties

28

 

3.8

Right to Audit

28

 

3.9

Assistance

28

 

3.10

Compliance with Laws

28

ARTICLE 4.

       COMMERCIALIZATION OF COLLABORATION PRODUCTS

29

 

4.1

Principles of Commercialization

29

 

4.2

Sales and Distribution of Collaboration Products to Third Parties

29

 

4.3

Marketing Plans and Budgets for the US Territory

29

 

4.4

Marketing Plans for ROW Territory

30

 

4.5

Regulatory Obligations During Commercialization

30

 

4.6

Diligence in Commercialization

31

 

4.7

Cost of Commercialization

31

 

4.8

Use of Third Parties

31

 

4.9

Promotional Materials

32

 

4.10

Provisions Applicable to Sales Representatives

32

 

4.11

Reporting

35

 

4.12

Compliance with Laws

35

 

i

 


 

TABLE OF CONTENTS

(CONTINUED)

 

 

 

PAGE

 

 

 

 

ARTICLE 5.

       CO-PROMOTION OF COLLABORATION PRODUCTS

34

 

5.1

Option

34

 

5.2

Exercise of Option

34

 

5.3

Co-Promotion Period

35

 

5.4

Amendment of Marketing Plan to Include Co-Promotion Activities

35

 

5.5

Scope

35

 

5.6

Advertising and Promotional Materials

35

 

5.7

Shipment, Storage and Allocation of Samples

36

 

5.8

Training

36

 

5.9

Provisions Applicable to All New River Sales Representatives

37

ARTICLE 6.

       MANUFACTURE OF COLLABORATION PRODUCTS

37

 

6.1

Manufacture and Supply – US Territory

37

 

6.2

Specifications and Terms of Supply; Multiple Sources

38

 

6.3

Manufacture by Shire; Commercial Supply by Shire

38

 

6.4

Supply Terms

39

 

6.5

Manufacture and Supply – ROW Territory

39

ARTICLE 7.

       FINANCIAL TERMS

40

 

7.1

Licensing Fee

40

 

7.2

Milestone Payments

40

 

7.3

Refunds by New River

41

 

7.4

Sharing of US Product Profit

41

 

7.5

Royalties on Net Sales in ROW Territory

42

ARTICLE 8.

       PAYMENT TERMS

43

 

8.1

Payment Method

43

 

8.2

Payment Schedules; Reports

44

 

8.3

Currency Conversion

44

 

8.4

Legal Restrictions

44

 

8.5

Taxes

44

 

8.6

Records Retention; Audit

45

ARTICLE 9.

       LICENSES

46

 

9.1

Licenses to Shire

46

 

9.2

Licenses to New River

46

 

9.3

Sublicensing

47

 

ii

 


 

TABLE OF CONTENTS

(CONTINUED)

 

 

 

PAGE

 

 

 

 

 

9.4

Scope of Licenses

47

 

9.5

No Implied Licenses

47

 

9.6

Exclusivity

47

 

9.7

Nonassertion

47

 

9.8

[*]

47

ARTICLE 10.

       CONFIDENTIALITY

48

 

10.1

Confidential Information

48

 

10.2

Publicity; Filing of this Agreement

49

 

10.3

Publication

50

 

10.4

Use of Names

50

 

10.5

Confidentiality of this Agreement

50

 

10.6

Disclosures Under Existing NDA

50

 

10.7

Survival

51

ARTICLE 11.

       OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT

 

 

 

       RIGHTS

51

 

11.1

Ownership

51

 

11.2

Disclosures; Disputes Regarding Inventions

51

 

11.3

Patent Filings

52

 

11.4

Third-Party Patent Rights

54

 

11.5

Enforcement and Defense of Patents

54

 

11.6

Notice of Certification

57

 

11.7

Patent Term Extensions

57

 

11.8

Listing of Patents

57

 

11.9

Trademarks and Copyrights

57

ARTICLE 12.

       REPRESENTATIONS AND WARRANTIES; EXCLUSIVITY

60

 

12.1

Representations, Warranties and Covenants

60

 

12.2

Limitation on Representations or Warranties

64

 

12.3

Performance by Affiliates

65

 

12.4

Disclaimer of Warranty

65

 

12.5

Limitation of Liability

65

 

12.6

Essential Basis

65

ARTICLE 13.

       TERM AND TERMINATION

65

 

13.1

Term

65

 

iii

 


 

TABLE OF CONTENTS

(CONTINUED)

 

 

 

 

 

 

 

PAGE

 

 

 

 

 

13.2

Breaches (General)

66

 

13.3

Allegations of Material Breach

66

 

13.4

Other Termination by Shire

68

 

13.5

Other Termination By New River

68

 

13.6

Termination for Government Action

68

ARTICLE 14.

       EFFECTS OF TERMINATION

69

 

14.1

Post-Termination Activities by Shire

69

 

14.2

Post-Termination Activities by New River

71

 

14.3

Accrued Rights

73

 

14.4

Confidential Information

73

 

14.5

Survival

73

 

14.6

Liability Following Termination

73

ARTICLE 15.

       INDEMNIFICATION; INSURANCE

73

 

15.1

Indemnification