AMENDMENT NUMBER 4 TO DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT

Requirements Supplier Agreement

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JAZZ PHARMACEUTICALS INC | Elan Corporation | Elan Pharma International Limited | Jazz Pharmaceuticals, Inc | Solvay Pharmaceuticals, Inc

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Title: AMENDMENT NUMBER 4 TO DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT
Governing Law: Georgia Date: 3/31/2008

Exhibit 10.66

AMENDMENT NUMBER 4

TO DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT

This Fourth Amendment (“ Amendment No. 4 ”) is made and entered into as of this 26 day of October 2007 (“ Amendment No. 4 Effective Date ”)

BETWEEN:

(1) Elan Pharma International Limited , a company incorporated under the laws of Ireland, and having its registered office at Monksland, Athlone, County Westmeath, Ireland (“ EPIL ”); and

(2) Jazz Pharmaceuticals, Inc. , 3180 Porter Drive, Palo Alto CA 94304, USA (“ Jazz Pharma ”).

RECITALS:

WHEREAS , Elan Corporation plc, an Irish company, and Solvay Pharmaceuticals, Inc., a Georgia corporation, entered into a development, license and supply agreement dated December 22, 1997, as amended by Amendment No. 1 dated March 1, 1999, Amendment No. 2 dated April 13, 2000 and Amendment No. 3 dated November 7, 2006 (collectively the “ Development, License and Supply Agreement ”).

WHEREAS , on December 31, 2006, Elan Corporation, plc, assigned all of its rights and obligations in and to the Development, License and Supply Agreement to EPIL and EPIL has assumed said rights and obligations;

WHEREAS , on January 31, 2007, Solvay Pharmaceuticals, Inc. assigned all of its rights and interest in and to the Development, License and Supply Agreement to Jazz Pharma and Jazz Pharma assumed said rights and obligations.

WHEREAS , Jazz Pharma and EPIL now wish to amend the terms of the quality agreement set out in Appendix E of the Development, License and Supply Agreement as set forth below;

NOW, THEREFORE , for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, EPIL and Jazz Pharma hereby agree as follows:

1. Appendix E of the Development, License and Supply Agreement is hereby deleted and replaced by the Appendix E which is set out in Schedule 1 hereto.

2. All other terms and conditions of the Development, License and Supply Agreement remain unchanged and continue to be in full force and effect.

3. Capitalized terms not defined in this Amendment No. 4 shall have the same meaning as set forth in the Development, License and Supply Agreement.

[ * ] = 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 24B-2 of the Securities Exchange Act of 1934, as amended.

4. This Amendment No. 4 may be signed in any number of counterparts with the same effect as if the signatures to each counterpart were upon a single instrument, and all such counterparts together shall be deemed an original of this Amendment No. 4.

5. This Amendment No. 4 shall be governed by and construed solely in accordance with the laws of the State of Georgia, without regard to its conflict of laws principles that would require the application of any other law. Any dispute arising in relation to this Amendment No. 4 shall be resolved in the same manner as a dispute under the Development, License and Supply Agreement.

IN WITNESS WHEREOF EPIL AND Jazz Pharma have caused this Amendment No 4 to be executed by their duly authorized representatives as of the Amendment No. 4 Effective Date.


ELAN PHARMA INTERNATIONAL LIMITED

By:		/s/ William Daniel

Title:		Director

JAZZ PHARMACEUTICALS, INC.

By:		/s/ Janne Wissel

Title:		Sr. VP

Technical Agreement: Jazz Pharmaceuticals, Inc. and Elan Pharma International Limited.

TECHNICAL AGREEMENT

This AGREEMENT is executed as of the 26 day of October , 2007

between

Jazz Pharmaceuticals, Inc.

3180 Porter Drive

Palo Alto, CA 94304

USA

a corporation existing under the laws of the state of Delaware, USA

(hereinafter referred to as “ Jazz Pharmaceuticals ”)

and

Elan Pharma International Limited

Monksland, Athlone

County Westmeath, Ireland

a corporation existing under the laws of Ireland

(hereinafter referred to as “ Elan ”)


Confidential		Page 1

Technical Agreement: Jazz Pharmaceuticals, Inc. and Elan Pharma International Limited.

Table of Contents



1.	Objective	3

2.	General	3

3.	Definitions	3

4.	Regulatory	4

5.	GMP	5

6.	Validation	6

7.	API and Raw Materials	6

8.	Manufacturing and Packaging	7

9.	Change Controls	8

10.	Deviations	8

11.	Product Complaints	8

12.	Product Release	9

13.	Stability	10

14.	Confidentiality	10

15.	Review of Technical Agreement	10

16.	Quality Contacts	10

17.	Approvals	11


Confidential		Page 2

Technical Agreement: Jazz Pharmaceuticals, Inc. and Elan Pharma International Limited.

1.	Objective

1.1

The purpose of this Technical Agreement is to ensure a mutual understanding and agreement of key responsibilities between Jazz Pharmaceuticals and Elan with respect to the Luvox ^® CR (fluvoxamine maleate) 100 and 150 mg Capsules (the “Product”), for use and sale in the United States.

2.	General

2.1

This Technical Agreement specifies the responsibilities of the parties hereto with respect to quality control matters related to the manufacture of the Product. If there is a conflict, between that certain license agreement dated December 22, 1997 as amended by Amendment No. 1 to the License Agreement dated March 1, 1999, Amendment No. 2 to the License Agreement dated April 13, 2000 and Amendment No. 3 to the License Agreement dated November 7, 2006 by and between Solvay Pharmaceuticals, Inc. (“Solvay”) and Elan and assigned to Jazz Pharmaceuticals by Solvay on January 31, 2007 (as may be amended from time to time, the “Agreement”), the Agreement shall govern.

2.2

In the event that a dispute arises between Elan and Jazz Pharmaceuticals regarding the nonconformity of the Product or regarding other matters, the senior management of the quality departments from both companies shall in good faith promptly attempt to resolve disputed issues.

2.3

Elan will manufacture, package, test and store the Product in accordance with the cGMPs, approved SOPs, Specifications and all applicable governing regulations including:

•

cGMPs

•

U.S. Federal Food Drug and Cosmetic Act (FD&C Act)

•

All applicable USP, NF and ICH requirements

•

Environmental and occupational health and safety laws

•

EU Regulations

3.	Definitions

3.1.

API: the Active Pharmaceutical Ingredient – (fluvoxamine maleate)

3.2.

Batch: A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits and is produced according to a manufacturing formula or a batch record by a continuous manufacturing process.

3.3.

cGMPs: Current Good Manufacturing Practices as defined in the United States (U.S. 21 CFR parts 210 and 211) regulations

3.4.

C of A: Certificate of Analysis

3.5.

C of C: Certificate of Compliance

3.6.

CDER: Center for Drug Evaluation and Research

3.7.

CMC: Chemistry, manufacturing and controls


Confidential		Page 3

Technical Agreement: Jazz Pharmaceuticals, Inc. and Elan Pharma International Limited.

3.8.

DMF: Drug Master File submitted by Elan and all updates thereto, including amendments and annual reports filed with the regulatory authorities by Elan for the purposes of supporting and maintaining regulatory approval of the Product through Jazz Pharmaceuticals NDA in USA

3.9.

FDA: United States Food and Drug Administration or any successor entity (CDER) charged with the approval and regulation of pharmaceutical products in the United States.

3.10.

ICH: International Conference on Harmonisation

3.11.

NDA: New Drug Application; Application in the United States to market a new drug for human use.

3.12.

Non-Conformance: Any deviation from an approved written procedure, method or a Specification.

3.13.

Product: Luvox ^® CR (fluvoxamine maleate) 100 mg and 150 mg capsules packaged in bulk containers.

3.14.

Raw Material: Any ingredient intended for use in the manufacture of the Product.

3.15.

Specifications: Parameters, test values as they relate to test methods, procedures, analytical specifications or equipment.

3.16.

USP, NF: The United States Pharmacopoeia, National Formulary is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, drug substance, excipient and other healthcare products manufactured and sold in the United States.

4.	Regulatory

4.1.

Elan agrees to allow regulatory authorities to inspect its facilities and records as required under the cGMPs in connection with the Product.

4.2.

Elan will promptly notify Jazz Pharmaceuticals of any product specific regulatory inspection (local, state, federal from US, or other foreign government agency) or regulatory request for product samples, batch documentation or other information related to the Product.

4.3.

Elan will notify Jazz Pharmaceuticals, within one (1) business day of receipt of any Form 483s or warning letters from any governing regulatory agencies relating to: (1) the Product and (2) the facilities specifically used in the manufacture, packaging, testing and storage of the Product.

4.4.

Elan will provide copies to Jazz Pharmaceuticals of all written communication from any Health Authority (e.g. FDA 483) that are specifically related to the Product or to the facilities used in manufacture, packaging, testing and storage of the Product. Elan will promptly provide copies of the above documentation after such communications are available for distribution. Jazz Pharmaceuticals may participate in the development of corrective action plans that are directly related to the Product.

4.5.

Elan is responsible for registering the facilities with the appropriate regulatory bodies and maintaining the registration forms such that it is readily available for any regulatory inspection. Elan is responsible for drug listing as the manufacturer of the Product for Jazz Pharmaceutica

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