UNITED STATES COLLABORATION AGREEMENT

Collaboration Agreement

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This Collaboration Agreement involves

SHIRE PHARMACEUTICALS GROUP PLC | NEW RIVER PHARMACEUTICALS INC.

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Title: UNITED STATES COLLABORATION AGREEMENT
Governing Law: New York Date: 4/1/2005

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Exhibit 10.13

Exhibit 10.13

Certain confidential information contained in this document, marked by brackets and asterisks, [*], has been omitted pursuant to a request for confidential treatment pursuant to Rule 24b–2 of the Securities Exchange Act of 1934, as amended, and has been filed separately with the Securities and Exchange Commission.

UNITED STATES

COLLABORATION AGREEMENT

BY AND AMONG

SHIRE LLC

SHIRE PHARMACEUTICALS GROUP PLC

AND

NEW RIVER PHARMACEUTICALS INC.

DATED AS OF MARCH 31, 2005

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	27

4.1	Principles of Commercialization	27

4.2	Sales and Distribution of Collaboration Products to Third Parties	27

4.3	Marketing Plans and Budgets for the US Territory	28

4.4	Regulatory Obligations During Commercialization	28

4.5	Diligence in Commercialization	29

4.6	Cost of Commercialization	29

4.7	Use of Third Parties	30

4.8	Promotional Materials	30

TABLE OF CONTENTS

(continued)


		Page
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	33

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	36

ARTICLE 6	MANUFACTURE OF COLLABORATION PRODUCTS	37

6.1	Manufacture and Supply	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	38

ARTICLE 7	FINANCIAL TERMS	39

7.1	Licensing Fee	39

7.2	Milestone Payments	39

7.3	Refunds by New River	39

7.4	Sharing of US Product Profit	39

ARTICLE 8	PAYMENT TERMS	41

8.1	Payment Method	41

8.2	Payment Schedules; Reports	41

8.3	Currency Conversion	41

8.4	Legal Restrictions	42

8.5	Taxes	42

8.6	Records Retention; Audit	42

TABLE OF CONTENTS

(continued)


		Page
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