COLLABORATION AGREEMENT

Collaboration Agreement

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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

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

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