UNITED STATES COLLABORATION AGREEMENT

TABLE OF CONTENTS

Page

ARTICLE 1

DEFINITIONS

2

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)

17

                   2.6

General Committee Membership and Procedures

17

                   2.7

Committee Decision-Making

18

ARTICLE 3

DEVELOPMENT AND REGULATORY RESPONSIBILITIES

20

                   3.1

Overview

20

                   3.2

Development Plans

20

                   3.3

Development in the US Territory for ADHD

21

                   3.4

Right of Reference to the ROW Territory

23

                   3.5

Reporting

23

                   3.6

Development in the US Territory for Indications other than ADHD

23

                   3.7

Shared Expenses

25

                   3.8

Use of Third Parties

26

                   3.9

Right to Audit

27

                   3.10

Assistance

27

                   3.11

Compliance with Laws

27

ARTICLE 4

COMMERCIALIZATION OF COLLABORATION PRODUCTS

28

                   4.1

Principles of Commercialization

28

                   4.2

Sales and Distribution of Collaboration Products to Third Parties

28

                   4.3

Marketing Plans and Budgets for the US Territory

28

                   4.4

Regulatory Obligations During Commercialization

29

                   4.5

Diligence in Commercialization

29

                   4.6

Cost of Commercialization

30

                   4.7

Use of Third Parties

30

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                   4.8

Promotional Materials

30

                   4.9

Provisions Applicable to Sales Representatives

30

                   4.10

Reporting

33

                   4.11

Compliance with Laws

33

ARTICLE 5

CO-PROMOTION OF COLLABORATION PRODUCTS

33

                   5.1

Option

34

                   5.2

Exercise of Option

34

                   5.3

Co-Promotion Period

34

                   5.4

Amendment of Marketing Plan to Include Co-Promotion Activities

34

                   5.5

Scope

34

                   5.6

Advertising and Promotional Materials

35

                   5.7

Shipment, Storage and Allocation of Samples

35

                   5.8

Training

35

                   5.9

Provisions Applicable to All New River Sales Representatives

37

ARTICLE 6

MANUFACTURE OF COLLABORATION PRODUCTS

36

                   6.1

Manufacture and Supply

36

                   6.2

Specifications and Terms of Supply; Multiple Sources

37

                   6.3

Manufacture by Shire; Commercial Supply by Shire

38

                   6.4

Supply Terms

39

ARTICLE 7

FINANCIAL TERMS

39

                   7.1

Licensing Fee

39

                   7.2

Milestone Payments

39

                   7.3

Refunds by New River

40

                   7.4

Sharing of US Product Profit

40

ARTICLE 8

PAYMENT TERMS

41

                   8.1

Payment Method

41

                   8.2

Payment Schedules; Reports

41

                   8.3

Currency Conversion

42

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                   8.4

Legal Restrictions

42

                   8.5

Taxes

42

                   8.6

Records Retention; Audit

43

ARTICLE 9

LICENSES

44

                   9.1

Licenses to Shire

44

                   9.2

Licenses to New River

44

                   9.3

Sublicensing

44

                   9.4

Scope of Licenses

44

                   9.5

No Implied Licenses

44

                   9.6

Exclusivity

45

                   9.7

Nonassertion

45

                   9.8

[*]

45

ARTICLE 10

CONFIDENTIALITY

45

                   10.1

Confidential Information

46

                   10.2

Publicity; Filing of this Agreement

47

                   10.3

Publication

48

                   10.4

Use of Names

48

                   10.5

Confidentiality of this Agreement

48

                   10.6

Disclosures Under Existing NDA

48

                   10.7

Survival

49

ARTICLE 11

OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS

49

                   11.1

Ownership

49

                   11.2

Disclosures; Disputes Regarding Inventions

49

                   11.3

Patent Filings

50

                   11.4

Third-Party Patent Rights

51

                   11.5

Enforcement and Defense of Patents

51

                   11.6

Notice of Certification

54

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Page

11.7

Patent Term Extensions

54

11.8

Listing of Patents

54

11.9

Trademarks and Copyrights

55

ARTICLE 12

REPRESENTATIONS AND WARRANTIES; EXCLUSIVITY

57

12.1

Representations, Warranties and Covenants

57

12.2

Limitation on Representations or Warranties

62

12.3

Performance by Affiliates

62

12.4

Disclaimer of Warranty

62

12.5

Limitation of Liability

62

12.6