Document:

Xyrem Manufacturing Services 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 
 EXHIBIT 10.50 
 XYREM® 
 Manufacturing Services and Supply Agreement 
 Between 
 Patheon Pharmaceuticals Inc. 
 and 
 Jazz Pharmaceuticals, Inc. 

 Table of Contents 
  

					
	 ARTICLE 1
	  	1
	 INTERPRETATION
	  	1
	     1.1
	  	DEFINITIONS	  	1
	     1.2
	  	CURRENCY	  	5
	     1.3
	  	SECTIONS AND HEADINGS	  	6
	     1.4
	  	SINGULAR TERMS	  	6
	     1.5
	  	SCHEDULES	  	6
	 ARTICLE 2
	  	7
	 MANUFACTURING SERVICES
	  	7
	     2.1
	  	MANUFACTURING SERVICES	  	7
	     2.2
	  	STANDARD OF PERFORMANCE	  	9
	     2.3
	  	ACTIVE MATERIAL REPORTS AND QUOTA	  	9
	ARTICLE 3	  	10
	CLIENT'S OBLIGATIONS	  	10
	     3.1
	  	PAYMENT	  	10
	     3.2
	  	ACTIVE MATERIALS	  	11
	ARTICLE 4	  	11
	 CONVERSION FEES AND COMPONENT COSTS
	  	11
	    4.1	  	PRICING	  	11
	    4.2	  	ADJUSTMENTS DUE TO TECHNICAL CHANGES	  	11
	 ARTICLE 5
	  	12
	 ORDERS, SHIPMENT, INVOICING, PAYMENT
	  	12
	     5.1
	  	ORDERS AND FORECASTS	  	12
	     5.2
	  	RELIANCE BY PATHEON	  	12
	     5.3
	  	MINIMUM ORDERS	  	13
	     5.4
	  	SHIPMENTS	  	13
	     5.5
	  	INVOICES AND PAYMENT	  	14
	 ARTICLE 6
	  	14
	 PRODUCT CLAIMS AND RECALLS
	  	14

  

 - i - 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

					
	     6.1
	  	PRODUCT CLAIMS	  	14
	     6.2
	  	PRODUCT RECALLS AND RETURNS	  	15
	     6.3
	  	DISPOSITION OF DEFECTIVE OR RECALLED PRODUCT	  	16
	     6.4
	  	CUSTOMER QUESTIONS AND COMPLAINTS	  	17
	     6.5
	  	SOLE REMEDY	  	17
	 ARTICLE 7
	  	17
	 CO-OPERATION
	  	17
	     7.1
	  	QUARTERLY REVIEW	  	17
	     7.2
	  	GOVERNMENTAL AGENCIES	  	17
	     7.3
	  	RECORDS AND ACCOUNTING BY PATHEON	  	18
	     7.4
	  	INSPECTION; AUDIT	  	18
	     7.5
	  	ACCESS	  	18
	     7.6
	  	REPORTS	  	19
	     7.7
	  	REGULATORY FILINGS	  	19
	 ARTICLE 8
	  	20
	 TERM AND TERMINATION
	  	20
	     8.1
	  	INITIAL TERM	  	20
	     8.2
	  	TERMINATION FOR CAUSE	  	20
	     8.3
	  	TERMINATION BY THE CLIENT	  	21
	     8.4
	  	TERMINATION DUE TO PRODUCT DISCONTINUATION	  	21
	     8.5
	  	OBLIGATIONS ON TERMINATION	  	21
	     8.6
	  	SURVIVAL	  	22
	 ARTICLE 9
	  	22
	 REPRESENTATIONS, WARRANTIES AND COVENANTS
	  	22
	     9.1
	  	AUTHORITY	  	22
	     9.2
	  	CLIENT WARRANTIES	  	22
	     9.3
	  	PATHEON WARRANTIES	  	23
	     9.4
	  	DEBARRED PERSONS	  	23
	     9.5
	  	REGULATORY APPROVALS	  	23
	     9.6
	  	COMPLIANCE WITH LAWS	  	23
	     9.7
	  	NO WARRANTY	  	24
	 ARTICLE 10
	  	24
	 REMEDIES AND INDEMNITIES
	  	24
	     10.1
	  	CONSEQUENTIAL DAMAGES	  	24
	     10.2
	  	LIMITATION OF LIABILITY	  	24

  

 - ii - 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

					
	     10.3
	  	PATHEON	  	25
	     10.4
	  	CLIENT	  	25
	     10.5
	  	REASONABLE ALLOCATION OF RISK	  	26
	 ARTICLE 11
	  	26
	 CONFIDENTIALITY
	  	26
	     11.1
	  	CONFIDENTIALITY	  	26
	 ARTICLE 12
	  	26
	 DISPUTE RESOLUTION
	  	26
	     12.1
	  	COMMERCIAL DISPUTES	  	26
	     12.2
	  	TECHNICAL DISPUTE RESOLUTION	  	27
	 ARTICLE 13
	  	27
	 MISCELLANEOUS
	  	27
	     13.1
	  	INVENTIONS	  	27
	     13.2
	  	INTELLECTUAL PROPERTY	  	28
	     13.3
	  	INSURANCE	  	28
	     13.4
	  	INDEPENDENT CONTRACTORS	  	29
	     13.5
	  	NO WAIVER	  	29
	     13.6
	  	ASSIGNMENT	  	29
	     13.7
	  	FORCE MAJEURE	  	29
	     13.8
	  	NOTICES	  	30
	     13.9
	  	SEVERABILITY	  	31
	     13.10
	  	ENTIRE AGREEMENT	  	31
	     13.11
	  	OTHER TERMS	  	31
	     13.12
	  	THIRD PARTY BENEFICIARY	  	32
	     13.13
	  	EXCLUSIVITY	  	32
	     13.14
	  	PUBLICITY	  	32
	     13.15
	  	EXECUTION IN COUNTERPARTS	  	32
	     13.16
	  	GOVERNING LAW	  	32

  

 - iii - 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 MANUFACTURING SERVICES AND SUPPLY AGREEMENT 
 THIS MANUFACTURING SERVICES AND SUPPLY AGREEMENT (the "Agreement") made as of the 13th day of March, 2007, and with an Effective Date and a
Manufacturing Commencement Date as set forth below. 
 B E T W E E N: 
 PATHEON PHARMACEUTICALS INC., 
 a corporation existing under the laws of the 
 State of Delaware, 
 (hereinafter referred
to as "Patheon"), 
 - and - 
 JAZZ PHARMACEUTICALS, INC., 
 a corporation existing under the laws of the State of Delaware, 
 (hereinafter referred to as the "Client"). 
 THIS AGREEMENT WITNESSES THAT in consideration of the rights conferred and the obligations assumed herein, and for other good and valuable consideration (the receipt and sufficiency of which are acknowledged by each party), and intending to
be legally bound the parties agree as follows: 
 ARTICLE 1 
 INTERPRETATION 
 1.1 Definitions. 
 The following terms shall have the respective meanings set out below and grammatical variations of such terms shall have corresponding meanings:

 "Act" means the United States Food, Drug and Cosmetic Act, as amended from time to time, and the regulations promulgated thereunder.

 "Active Material" means the active pharmaceutical ingredient listed on Schedule D hereto; 
 "Active Material Reimbursement Value" means the actual cost to Client of the Active Materials for the purposes of Section 10.2(b) of this
Agreement as set forth in Schedule D hereto and as may be amended from time to time by the Client to reflect the actual cost of such Active Materials paid by the Client; 

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 

 "Affiliate" means: 
  

	 	(a)	a business entity which owns, directly or indirectly, a controlling interest in a party to this Agreement, by stock ownership or otherwise; or 

  

	 	(b)	a business entity which is controlled by a party to this Agreement either directly or indirectly, by stock ownership or otherwise. 

 For the purposes of this definition, "control" means the ownership of shares carrying at least a majority of the votes in respect of the election of the
directors of a corporation. Notwithstanding the foregoing, the owners of preferred stock (or common stock issued upon conversion thereof) of the Client such as financial institutions, venture capital funds and private equity investors will not be
its “Affiliates” for purposes of this Agreement; 
 "Annual Volume" means the volume of Product to be manufactured in any
Year of this Agreement as set forth in Schedule B hereto. 
 "Authority" means any governmental or regulatory authority, department,
body or agency or any court, tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or municipal; 
 "Batch" means a specific quantity of Active Material and Components that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of
manufacture. 
 "Bulk Product" means unlabeled bottled and capped Product packaged in accordance with the applicable packaging
configurations as set forth in the Specifications and Schedule M hereto which, prior to the Manufacturing Commencement Date, will be packaged in shippers by current supplier of Product and then delivered to Patheon for secondary packaging only;

 "Business Day" means a day other than a Saturday, Sunday or a day that is a statutory holiday in the State of Ohio which have been
provided in writing to the Client by Patheon; 
 "cGMPs" means current good manufacturing practices, as applicable, as described in:

  

	 	(a)	Parts 210 and 211 of Title 21 of the United States' Code of Federal Regulations; 

  

	 	(b)	Division 2 of Part C of the Food and Drug Regulations (Canada); 

  

	 	(c)	EC Directive 91/356/EEC; and 

  

 - 2 - 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

	 	(d)	the latest Health Canada, FDA and EMEA guidance documents pertaining to manufacturing and quality control practice, as updated, amended and revised from time to time and as
applicable under the particular circumstances; 

 "Components" means, collectively, all packaging components, raw
materials and ingredients, required to be used in order to produce the Product in accordance with the Specifications, other than the Active Material; 
 "Deficiency Notice" shall have the meaning ascribed thereto in Section 6.1(a); 
 "DEA"
means the United States Drug Enforcement Administration or its international counterparts. 
 “Effective Date” means
March 13, 2007 unless revised by mutual written agreement of the parties in accordance with this Agreement. 
 "EMEA" means the
European Medicines Agency or any successor European governmental agency performing similar functions with respect to pharmaceutical products; 
 "FDA" means the United States government department known as the Food and Drug Administration or any successor United States governmental agency performing similar functions with respect to pharmaceutical products; 
 "Firm Orders" has the meaning specified in Section 5.1(b); 
 "Fully Packaged Product" means the Product packaged in accordance with the applicable packaging configurations as set forth in the Specifications and Schedule L hereto. 
 "Health Canada" means a section of the Canadian Government known as Health Canada and includes, among other departments, the Therapeutic Products
Directorate and Health Products and Food Branch Inspectorate or any successor Canadian governmental agency performing similar functions with respect to pharmaceutical products; 
 "Intellectual Property" includes, without limitation, rights in patents, patent applications, formulae, trade-marks, trade-mark applications,
trade-names, Inventions, copyright and industrial designs; 
 "Invention" means information relating to any innovation, improvement,
development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which it is contained and whether or not
patentable or copyrightable; 
  

 - 3 - 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 "Inventory" means all inventories of Components and work-in-process produced or held by Patheon in
connection with the manufacture of the Product but, for greater certainty, does not include the Active Material; 
 "Laws" means all
laws, statutes, ordinances, regulations, rules, by-laws, judgments, decrees or orders of any Authority applicable to the activities hereunder; 
 "Manufacturing Commencement Date” means a date certain, specified in a written notice from Client to Patheon delivered at least sixty (60) days prior to such date, when Patheon will commence Manufacturing Services to
manufacture and package Product hereunder. 
 “Manufacturing Services" means (i) during the period commencing on the
Effective Date and ending on the day immediately preceding the Manufacturing Commencement Date, the Packaging Services only; and (ii) during the period commencing on the Manufacturing Commencement Date and throughout the term of this Agreement,
all of the manufacturing, quality control, quality assurance and stability testing, packaging and related services, as contemplated in this Agreement, required to produce Product from the Active Material and Components; 
 "Manufacturing Site" means the US facility owned and operated by Patheon that is located at [ * ]; 
 "Minimum Run Quantity" means the minimum number and size of Batches of Product to be produced during the same cycle of manufacturing as set forth
in Schedule B hereto; 
 "NDA" means a New Drug Application for the Product made in accordance with applicable regulations and
requirements of the FDA as from time to time in effect; 
 “Packaging Services” means the packaging and related services
performed or to be performed by Patheon hereunder to accept Bulk Product and package it into Fully Packaged Product after the Effective Date and prior to the Manufacturing Commencement Date. 
 "Patheon Manufacturing Responsibilities" means Patheon’s responsibilities and obligations with respect to the provision of Manufacturing
Services as set forth in Sections 2.1 and 2.2; 
 "Product" means the product listed on Schedule A hereto; 
 "Quality Agreement" means the agreement entered into between the parties hereto setting out the quality assurance standards to be applicable to the
Manufacturing Services provided by Patheon, which agreement shall be in the form attached hereto as Schedule E; 
 "Quota" means the
procurement quota quantity of Active Material allotted by the DEA to Patheon in order for Patheon to perform the Manufacturing Services. 
  

 - 4 - 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 “Regulatory Filings” means the NDA and any other filing under the United States Federal
Food, Drug and Cosmetic Act and rules and regulations thereunder, and any corresponding filing required in other countries and jurisdictions (including, without limitation, the EMEA), in connection with the registration, manufacturing, sale and use
of the Product, other than local or federal permits required to be obtained by Patheon in connection with performance of the Manufacturing Services. 
 "Specifications" means the file, for the Product, which is provided by the Client to Patheon in accordance with the procedures listed in Schedule A hereto and which contains documents relating to such Product, including, without
limitation: 
  

	 	(a)	specifications for the Active Material and Components; 

  

	 	(b)	manufacturing specifications, vendors, directions and processes; 

  

	 	(c)	storage requirements; 

  

	 	(d)	environmental, health and safety information relating to the Product including material safety data sheets; and, 

  

	 	(e)	the finished Product specifications, applicable packaging specifications and shipping requirements for each Product; 

  

	 	all	as updated, amended and revised from time to time by the Client in accordance with the terms of this Agreement; 

 "Technical Dispute" has the meaning specified in Section 12.2; 
 "Territory" means the entire world; 
 "United States" means the United States of America, its
territories and possessions, including Puerto Rico and the U.S Virgin Islands; and 
 "Year" means in the first year of this Agreement,
the period from the Commencement Date up to and including December 31 of the same calendar year, and thereafter shall mean a calendar year. 
 1.2
Currency. 
 Unless otherwise specifically provided herein, all monetary amounts are expressed in this Agreement in the lawful
currency of the United States of America. 
  

 - 5 - 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 1.3 Sections and Headings. 
 The division of this Agreement into Articles, sections, subsections and Schedules and the insertion of headings are for convenience of reference only and
shall not affect the interpretation of this Agreement. Unless otherwise specifically provided herein, any reference in this Agreement to a Section or Schedule refers to the specified Section or Schedule to this Agreement. In this Agreement, the
terms "this Agreement", "hereof", "herein", "hereunder" and similar expressions refer to this Agreement and not to any particular part, Section, Schedule or the provision hereof. 
 1.4 Singular Terms. 
 Except as
otherwise expressly provided herein or unless the context otherwise requires, all references to the singular shall include the plural and vice versa. 
 1.5 Schedules. 
 The following Schedules are attached to, incorporated in and form part of this Agreement:

  

					
	 Schedule A
	 		  	Product Specifications
	 Schedule B
	 	-	  	Minimum Run Quantity, Annual Volume, Fees & Price Adjustments
	 Schedule C
	 	-	  	Stability Testing
	 Schedule D
	 	-	  	Active Material & Active Material Reimbursement Value
	 Schedule E
	 	-	  	Batch Numbering & Expiration Dates
	 Schedule F
	 	-	  	Technical Dispute Resolution
	 Schedule G
	 	-	  	Quality Agreement
	 Schedule H
	 	-	  	Quarterly Active Materials Inventory Report
	 Schedule I
	 	-	  	Report of Annual Active Materials Inventory Reconciliation and Calculation of Actual Annual Yield
	 Schedule J
	 	-	  	Form of Exclusive Components Purchasing Summary
	 Schedule K
	 	-	  	Bill-Back Items
	 Schedule L
	 	-	  	Packaging Configurations for Full Packaged Product
	 Schedule M
	 		  	Packaging Configurations for Bulk Package Product

  

 - 6 - 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 ARTICLE 2 
 MANUFACTURING SERVICES 
 2.1 Manufacturing Services. 
 Patheon shall provide the Manufacturing Services for the fees specified in Schedules B and C. Patheon may change the Manufacturing Site for the Product
only with the prior written consent of Client. None of the Manufacturing Services may be subcontracted by Patheon without the Client’s prior written consent. 
 Client shall specify the Manufacturing Commencement Date by [ * ] days’ written notice to Patheon. For clarity, the parties acknowledge that the Manufacturing Commencement Date is conditioned upon
(i) the approval of Patheon as a manufacturer of the Product, including approval of Patheon’s facility by the FDA and any other applicable regulatory Authority, (ii) receipt of appropriate Quota and (iii) [ * ] of
Client’s [ * ], 
 During the period from the Effective Date through the day immediately preceding the Manufacturing Commencement
Date, Patheon shall perform Packaging Services for Bulk Product on a non-exclusive basis in accordance with the description of services below as applicable to Packaging Services. 
 From and after the Manufacturing Commencement Date, Patheon shall perform the Manufacturing Services set forth below. The Client shall purchase
(A) its entire requirements of [ * ] and [ * ] for distribution in [ * ]; provided, however, that the Client may establish other third party suppliers as additional manufacturers of the Product for [ * ], and may
purchase Product from such manufacturers, if [ * ] pursuant to the terms and conditions of this Agreement and (B) [ * ] for distribution in [ * ], in each case, from Patheon pursuant to the terms of this Agreement. In
providing the Manufacturing Services, Patheon shall perform the following services: 
  

	 	(a)	Conversion of Active Materials and Components. Patheon shall convert Active Material and Components into Product. 

  

	 	(b)	 Quality Control and Quality Assurance of Product manufactured by Patheon. Patheon shall perform the quality control and quality assurance testing specified
in the Quality Agreement. Each time Patheon ships Product to the Client, it shall provide the Client with a certificate of analysis that sets out the test results for each Batch of Product, and that certifies that such Batch has been evaluated by
Patheon's Quality Control/Quality Assurance department and that the Product complies with the Specifications and was manufactured in accordance with cGMPs. Patheon shall test or cause to be tested each Batch of Product to be supplied pursuant to
this Agreement, in accordance with the testing 

  

 - 7 - 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

	 	 
methods for the Product set forth in the Specifications, before delivery of such Batch to the Client. Notwithstanding the foregoing, the Client reserves the
right to test or have tested all Product supplied by Patheon and pursuant to Section 6.1 hereof to reject any Product that fails to comply with the Specifications or Product that is not made in accordance with cGMPs.

  

	 	(c)	Testing of Components and Active Material. 

  

	 	(i)	Components. Patheon shall purchase and test all Components at Patheon's expense and as specified by the Specifications. The Client will have the right to specify the suppliers for
the Components. Patheon shall not change any Specifications or supplier of such Components without the prior written consent of the Client. 

  

	 	(ii)	Active Material. Promptly following receipt of the Active Material to be supplied by Client, Patheon will test (pursuant to test methods and drug specifications to be
provided by the Client) and approve such Active Material as acceptable for performing Manufacturing Services under this Agreement. Patheon will notify the Client in writing within [ * ] days of receipt of any failure of Active Material unless
earlier notice is required by Law; absent any such notice Active Material will be deemed to be accepted and approved by Patheon. 

  

	 	(d)	Stability Testing. Patheon shall conduct stability testing on the Product in accordance with agreed upon protocols and Specifications in Schedule C. Patheon shall not
make any changes to these Specifications or testing protocols without prior written approval from the Client. Patheon will promptly provide any and all data and results relating to the stability testing upon request by the Client. In the event that
any Batch of the Product fails, or is suspected to fail, stability testing, Patheon will notify the Client within one Business Day and Patheon and the Client shall jointly determine the proceedings and methods to be undertaken to investigate the
causes of such failure. 

  

	 	(e)	 Packaging. During the period between the Effective Date and the Manufacturing Commencement Date, Patheon shall convert Bulk Product into Fully Packaged
Product for the Client in accordance with the applicable Specifications from time to time as requested by Client. From and after the Manufacturing Commencement Date, Patheon shall package Bulk Product and Fully Packaged Product, as specified by
Client in its purchase orders, each in accordance with the applicable Specifications. In addition, Patheon shall assign Batch numbers and expiration dates for all Product shipped, if applicable. Such Batch numbers and expiration dates shall be
affixed on the Product and on the shipping cartons, as applicable, of each Product as outlined in the Specifications and as required by cGMPs. The system used by Patheon for Batch numbering and expiration dates of Product manufactured by Patheon is
detailed in the Quality Agreement attached hereto as Schedule G. The Client may, in its sole discretion, make changes to labels, product inserts and other 

  

 - 8 - 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

	 	 
packaging for the Product. Patheon's name shall not appear on the label or anywhere else on the Product unless: (i) required by any Laws; or
(ii) [ * ] expressly consents to such use of its name in writing. 

  

	 	(f)	Active Materials and Client Supplied Components Importing. The Client will deliver all Active Materials and Components which Client is responsible for supplying (if any) to
Patheon [ * ] (INCOTERMS 2000). 

  

	 	(g)	Bill-Back Items. The expenses in respect of all third party supplier fees for the purchase of columns, standards, tooling, and other project specific items necessary for
Patheon to perform the Manufacturing Services, and which are not included as Components, shall be set forth on Schedule K hereto, as may be amended from time to time by the written consent of both parties, and charged to the Client at [ * ].

 2.2 Standard of Performance. 
 Patheon shall provide the Manufacturing Services in accordance with the Specifications, all applicable Laws and cGMPs. 
 2.3 Active Material Reports and Quota. 
 (a) Reporting. Patheon shall provide the Client with a quarterly
inventory report of the Active Materials held by Patheon in accordance with the inventory report form annexed hereto as Schedule H, which shall contain the following information for such quarter: 
 Quantity Received: The total quantity of Active Materials that complies with the Specifications and is received at the Manufacturing Site during
the applicable period. 
 Quantity Dispensed: The total quantity of Active Materials dispensed at the Manufacturing Site during the
applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Active Materials that complies with the Specifications and is held at the beginning of the applicable period, less the inventory of Active
Materials that complies with the Specifications and is held at the end of such period. The Quantity Dispensed shall only include Active Materials received and dispensed in connection with commercial manufacturing of Product and, for certainty, shall
not include any Active Materials received or dispensed in connection with technical transfer activities or development activities during the applicable period, including, without limitation, any regulatory, stability, validation or test batches
manufactured during the applicable period. 
 Quantity Converted: The total amount of Active Materials contained in the Product
produced with the [ * ] (including any [ * ] in accordance with [ * ]), delivered by Patheon, and not rejected, recalled or returned in accordance with Section 6.1 or 6.2 as a result of a failure by Patheon to provide
Manufacturing Services in accordance with Specifications, cGMPs and all applicable Laws. 
  

 - 9 - 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 (b) Quota. The parties acknowledge that the Active Material is scheduled under the Federal
Controlled Substances Act. Patheon is required to obtain a Quota from the DEA before producing Product. In that regard, throughout the term hereof, Patheon will submit to DEA in a timely manner all necessary documents to obtain a Quota sufficient to
meet Client’s forecasts made pursuant to Section 5.1(a). Additional request(s) will be submitted by Patheon to DEA in a timely manner as necessary to reflect changes in Client’s forecast requirements of Active Material and Product.
Patheon further agrees to [ * ] obtain a Quota from the DEA that allows Patheon to manufacture all of Client’s forecasted requirements for Product including cooperating with the Client in connection with any discussions with the DEA
regarding a Quota. PATHEON ACKNOWLEDGES THAT TIME IS OF THE ESSENCE IN PERFORMING ITS OBLIGATIONS UNDER THIS PROVISION. 
 (c) Unused
Active Material; Reports. Patheon will use [ * ] to avoid any loss of Active Material. If and to the extent that Active Material is spilled, lost, scrapped or otherwise unusable hereunder, Patheon will dispose of such Active Material in
accordance with applicable regulations and will prepare all necessary disposal reporting documents and furnish such to DEA in accordance with applicable regulations and take such steps as are necessary to reclaim such lost amounts of Active Material
for the Quota in the same Quota year any such loss occurs. In the event of any diversion of Active Material, Patheon will prepare all required diversion reports and will, contemporaneously with the filing thereof with DEA in accordance with
applicable regulations, provide a copy to Client. 
 (d) Registrations. Patheon will acquire and maintain current DEA registrations
required to manufacture, hold, import and export Product 
 (e) Volumes Constrained by Quota. Notwithstanding any other provision of
this Agreement, in the event of any inconsistency or conflict between this Agreement and any terms or provisions hereof relating to quantity of Product to be ordered, manufactured, purchased or sold under this Agreement, applicable law and
regulations relating to Quota shall control. 
 ARTICLE 3 
 CLIENT'S OBLIGATIONS 
 3.1 Payment. 
 Pursuant to the terms of this Agreement, the Client shall pay Patheon for the provision of the Manufacturing Services according to the fees specified in
Schedules B and C hereto (such fees being subject to adjustment in accordance with the terms hereof). 
  

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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 3.2 Active Materials. 
 The Client shall [ * ], deliver the Active Materials to Patheon (in accordance with Section 2.1(f)) in sufficient quantities and at such times to facilitate the provision of the Manufacturing Services by
Patheon. The Active Materials shall be [ * ] by Patheon [ * ] on the terms and subject to the conditions herein contained. [ * ] shall pay [ * ] $[ * ] per [ * ] (each [ * ] to hold [ * ]), per
[ * ] for [ * ] Active Materials in [ * ] plus a [ * ]. The parties acknowledge and agree that title to the Active Materials shall [ * ] the property of [ * ]. Any Active Materials received by it
shall only be used by Patheon to provide the Manufacturing Services. Patheon's liability with respect to any lost or damaged Active Materials shall be as set forth in Section 10.2(b). 
 ARTICLE 4 
 CONVERSION FEES AND COMPONENT COSTS 
 4.1 Pricing. 
 The fees for the
Manufacturing Services (which fees include [ * ]) shall be as set forth in Schedules B and C and are subject to the adjustments set forth therein and in Section 4.2 hereof. Subsequent Year’s pricing, and adjustments to pricing,
are set forth in Schedule B hereof. 
 4.2 Adjustments Due to Technical Changes. 
 For changes to the Specifications or manufacturing processes that are required by applicable Laws ("Required Manufacturing Changes"), Patheon and
the Client shall cooperate in making such changes and use commercially reasonable efforts to implement such changes promptly in a manner that minimizes any effect on the supply hereunder to the Client of Product meeting Specifications. All costs
associated with Required Manufacturing Changes directly related to the [ * ] shall be borne by [ * ]. All other costs associated with Required Manufacturing Changes under this Agreement, including, without limitation, obsolete
Components, Regulatory Filings, work in process, equipment and Product shall be borne by [ * ]. Amendments to the Specifications or the Quality Agreement requested by the Client that are not Required Manufacturing Changes ("Client
Requested Changes") will only be implemented following [ * ] necessitated by any such amendment. Amendments to the Specifications, the Quality Agreement or the Manufacturing Site requested by Patheon that are not Required Manufacturing
Changes ("Patheon Requested Changes") will only be implemented following the approval of Client, [ * ], and the costs of the Patheon Requested Changes will be borne by [ * ]. If the Client accepts a proposed fee change, the
proposed change in the Specifications shall be implemented, and the fee change shall become effective only with respect to those orders of the Product that are manufactured in accordance with the revised Specifications. In addition, with respect to
the [ * ] Requested Changes, the [ * ] agrees to purchase, at [ * ] (including all costs incurred by [ * ] in connection with the purchase and handling of such [ * ]), all [ * ] utilized under the [ *
] Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with Section 5.2, to the extent that such [ * ] can [ * ] under the revised Specifications. Open purchase orders for 

  

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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 
Components no longer required under any revised Specifications that were placed by Patheon in accordance with this Agreement with suppliers in order to fill
Firm Orders or in accordance with Section 5.2 shall be cancelled where possible, and where such orders are not subject to cancellation without penalty, shall be [ * ]. 
 ARTICLE 5 
 ORDERS, SHIPMENT, INVOICING, PAYMENT 
 5.1 Orders and Forecasts. 
 (a)
Rolling Forecasts. The Client shall provide Patheon with a written non-binding [ * ] forecast of the volume of each Product that the Client then anticipates will be required to be produced and delivered to the Client during each [ *
] of that [ * ] period. Such forecast will be updated by the Client [ * ] on or before the [ * ] day of each [ * ] on a rolling [ * ] basis. The most recent [ * ] forecast shall prevail. 
 (b) Firm Orders. On or before the [ * ] day of each [ * ] the Client shall issue firm written orders ("Firm Orders") for the
Product from time to time at Client’s discretion to be produced and delivered to the Client on a date not less than [ * ] from the [ * ] the date that the Firm Order is submitted. Such Firm Orders submitted to Patheon shall
specify the Client's purchase order number, quantities by Product, type of packaging, delivery schedule and any other elements necessary to ensure the timely production and shipment of the Product. The quantities of Product ordered in such written
orders shall be firm and binding on the Client. Notwithstanding the foregoing, and subject to the availability of required Components, Patheon will permit amendments and substitutions to Firm Orders issued by the Client upon prior written notice to
Patheon in respect of Product packaging; provided, however no amendments or substitutions will be accepted by Patheon once [ * ], as the case may be, has commenced. 
 (c) Acceptance. Firm Orders placed with Patheon by the Client pursuant to the provisions of Section 5.1(b) shall be acknowledged by Patheon
in writing within [ * ] days of receipt thereof. Patheon will [ * ] ensure that all Product ordered by the Client in accordance with this Agreement will be shipped in accordance with the delivery dates specified in the Client’s
purchase order but in no event shall the [ * ] delivery date be [ * ] from the [ * ], and Patheon will notify the Client promptly of any significant anticipated delay no later than [ * ] prior to such delivery date.

 5.2 Reliance by Patheon. 
 The Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to Sections 5.1(a) and (b) in ordering the Components required to meet such Firm Orders. In addition, the Client
understands that to ensure an orderly supply of such Components, it may be desirable for Patheon to purchase such Components in sufficient volumes to meet the production requirements for Product during [ * ] of the forecasted periods referred
to in Section 5.1(a) or to meet the production requirements of any longer period agreed in writing to by Patheon and the 

  

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AMENDED. 

 
Client. Accordingly, the Client authorizes Patheon to purchase Components in order to satisfy the production requirements for Product for the first [ * ]
contemplated in the most recent forecast provided by the Client pursuant to Section 5.1(a) and agrees that Patheon may make such other purchases of Components to meet production requirements during such longer periods as may be agreed to in
writing from time to time by the Client at the request of Patheon or the Client. If Components ordered by Patheon pursuant to Firm Orders under this Section 5.2 are not included in finished Product purchased by the Client within [ * ] after the
date of the Firm Order in respect of which such purchases have been made (or such longer period as the parties may agree) or if such Components have expired during such period, then [ * ]; provided, however, that in the event such Components are
incorporated into Product subsequently purchased by the Client or into third party products manufactured by Patheon and subsequently purchased by a third party, the [ * ] of such Components [ * ]. 
 Patheon shall provide Client, initially upon execution of this Agreement and thereafter on an annual basis, with a listing of all Components which
Patheon anticipates purchasing pursuant to the terms of this Agreement in the form set out in Schedule J (the "Components Purchasing Summary"). Patheon will advise the Client in writing which Components have a limited shelf-life and which are
subject to minimum order quantities specified by the supplier. [ * ] for the [ * ] Components [ * ] purchased by Patheon in accordance with the terms of this Agreement but not used to perform the Manufacturing Services prior to
the expiry of the Component’s shelf life, so long as such Components have expiration dating of at least [ * ] from the date of purchase by Patheon. If Patheon is able to use such Components in activities other than the Manufacturing
Services, Patheon will [ * ] the Client any [ * ] for such Components. 
 5.3 Minimum Orders. 
 The Client may only order Product in multiples of the Minimum Run Quantities set out in Schedule B. 
 5.4 Shipments. 
 Shipments of Product shall be
made [ * ] (as such term is defined in INCOTERMS 2000) Patheon’s shipping point unless otherwise mutually agreed to in writing by the parties. Risk of loss or of damage to Product shall remain with Patheon until [ * ] at which
time risk of loss or damage shall transfer to the Client. Patheon shall, in accordance with the Client’s instructions and as agent for the Client, (i) arrange for shipping to be paid by the Client and (ii) at the Client’s risk
and expense, obtain any export licence or other official authorization necessary to export the Product from the US. The Client shall arrange for insurance and shall select the freight carrier used by Patheon to ship Product and may monitor
Patheon’s shipping and freight practices as they pertain to this Agreement. Product shall be transported in accordance with the Specifications and other applicable Laws. 
  

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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 5.5 Invoices and Payment. 
 Invoices shall be sent by fax or e-mail to such fax number or e-mail address as may be provided by the Client in writing from time to time but no earlier than [ * ]; provided, however, that if Client requests
Patheon to hold or store Bulk Product or Fully Packaged Product for more than [ * ] after completion of the applicable Manufacturing Services, Patheon may invoice Client for any such Product [ * ]. Patheon shall also submit to the
Client, with each shipment of Product, a duplicate copy of the invoice covering such shipment. Patheon shall also provide the Client with an invoice covering [ * ] pursuant to the terms and conditions of this Agreement and, in accordance with
Section [ * ]. Each such invoice shall, to the extent applicable, identify the Client purchase order number, Product numbers, names and quantities, unit price, freight charges and the total amount to be remitted by the Client. The Client
shall pay all such invoices within thirty (30) days of the date thereof. Notwithstanding the foregoing, the Client may withhold any amounts invoiced by Patheon that it disputes. If the Client disputes any invoice, the Client shall within [ *
] after such invoice is furnished to it notify Patheon that it disputes the accuracy or appropriateness of such invoice and specify the particular respects in which such invoice is inaccurate or inappropriate. The Client and Patheon will make
good faith efforts to resolve any disputes within [ * ] thereafter. Any amounts that are disputed by the Client shall not be due until [ * ] following the resolution of such dispute. 
 ARTICLE 6 
 PRODUCT CLAIMS AND
RECALLS 
 6.1 Product Claims. 
 (a) Product Claims. The Client has the right to reject any portion of any shipment of Product that deviates from the Specifications or cGMPs, without invalidating any remainder of such shipment. The Client or its designee shall
inspect the Product manufactured by Patheon upon receipt thereof and shall use its commercially reasonable efforts to give Patheon written notice (a "Deficiency Notice") of all claims for Product that deviate from the Specifications or cGMPs
within [ * ] after the Client’s or its designee’s receipt thereof (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, within [ * ] after discovery thereof by the Client, but in
no event after the expiration date of the Product). Should the Client fail to provide Patheon with the Deficiency Notice within the applicable period described above, then the delivery shall be deemed to have been accepted by the Client on the day
after the end of the period described above. 
 (b) Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall
have [ * ] to advise the Client by notice in writing that it disagrees with the contents of such Deficiency Notice. If the Client and Patheon fail to agree within [ * ] after Patheon's notice to the Client as to whether any Product
identified in the Deficiency Notice deviates from the Specifications or cGMPs, then the parties shall mutually select a laboratory to evaluate if the Product deviates from the Specifications or cGMPs. Such evaluation shall be binding on the parties,
and if such evaluation certifies that any Product deviates 

  

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AMENDED. 

 
from the Specifications or cGMPs, the Client may reject such Product in the manner contemplated in this Section 6.1. If such evaluation does not so
certify in respect of any such Product, then the Client shall be deemed to have accepted delivery of such Product on the [ * ] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the
Product, on the [ * ] day after discovery thereof by the Client, but in no event after the expiration date of the Product). 
 (c)
Patheon Responsibility. In the event the Client rejects Product in accordance with this Section 6.1, and the deviation is determined to arise from Patheon’s failure to provide the Manufacturing Services in accordance with
Specifications or cGMPs, Patheon will credit the Client’s account for Patheon’s invoice price to the Client for such defective Product. If the Client shall have previously paid for such defective Product, Patheon shall promptly, at the
Client’s election, either: (i) refund the invoice price for such defective Product; (ii) offset such amount against other amounts due to Patheon hereunder; or (iii) replace such Product with conforming Product without the Client
being liable for payment therefor under Section 3.1, contingent upon the receipt from the Client of all Active Material required for the manufacture of such replacement Product. Subject to the conditions and limitations set out in
Section 10.2, Patheon shall be responsible for paying for any Active Material used for the rejected Product under this Section 6.1(c). 
 (d) Shortages. In the event of a shortage of Product in any shipment by Patheon, at the Client’s election, Patheon shall [ * ] to make up the shortage [ * ]; provided, however, that if the shortage is more than
[ * ]% of the quantity ordered [ * ], Patheon will [ * ] to make up the shortage [ * ] after the shortage is reported to Patheon, but no later than [ * ] thereafter, if so requested by the Client, on the following
terms: (i) Patheon will manufacture Product in increments of any Minimum Run Quantity listed on Schedule B as determined by the Client and (ii) the [ * ] such Product will equal the [ * ] set forth on [ * ] without
regard to [ * ]. 
 6.2 Product Recalls and Returns. 
 (a) Records and Notice. Patheon and the Client shall each maintain such records as may be necessary to permit a Recall of any Product delivered to the Client or customers of the Client. Each party shall
promptly notify the other by telephone (to be confirmed in writing) of any information which might affect the marketability, safety or effectiveness of the Product and/or which might result in the Recall or seizure of the Product. Upon receiving any
such notice or upon any such discovery, each party shall cease and desist from further shipments of such Product in its possession or control until a decision has been made whether a Recall or some other corrective action is necessary. The decision
to initiate a Recall or to take some other corrective action, if any, shall be made and implemented by the Client. For purposes of this Agreement, "Recall" shall mean any action (i) by the Client to recover title to or possession of
quantities of the Product sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Product from the market); or (ii) by any regulatory authorities to detain or destroy any of the Product. Recall shall also
include any action by either party to refrain from selling or shipping quantities of the Product to third parties which would have been subject to a Recall if sold or shipped. 
  

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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 (b) Recalls. In the event (i) any governmental or regulatory authority issues a directive,
order or, following the issuance of a safety warning or alert with respect to a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders such a Recall, or (iii) the Client determines that any
Product should be Recalled or that a “dear doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by the Client, having regard to all applicable Laws. 
 (c) Product Returns. The Client shall have the responsibility for coordinating customer returns of the Product. Patheon shall provide the Client
with such assistance as the Client may reasonably require to coordinate Product returns. 
 (d) Patheon's Responsibility. To the
extent that a Recall or return results from, or arises out of, a failure by Patheon to provide the Manufacturing Services in accordance with the Specifications and cGMPs, Patheon shall be responsible for the documented out-of-pocket expenses of such
Recall or return and shall [ * ] to replace the Recalled or returned Product with new Product, contingent upon the receipt of all Active Materials required for the manufacture of such replacement Product. In the event that Patheon is unable
to replace the Recalled or returned Product (except where such inability results from a failure to receive the required Active Materials due to the fault of Client), then at Client’s request, Patheon will reimburse the Client for the price that
the Client paid to Patheon for manufacturing the affected Product. In either case, subject to the conditions and limitations set out in Section 10.2, Patheon shall pay all costs related to the Active Materials required for the manufacture of
replacement Product. In all other circumstances, Recalls, returns or other corrective actions shall be made at the Client's cost and expense. 
 (e) Patheon will be responsible for investigating all Recalls and returns (other than as a result of the expiration of such Product) resulting from Patheon’s failure to manufacture the Product in accordance with the Specifications and
cGMPs, at its own expense, and Patheon will promptly report to the Client in writing the results of any such investigation. 
 6.3 Disposition of
Defective or Recalled Product. 
 The Client shall not dispose of any damaged, defective, returned or Recalled Product in
relation to which it intends to assert a claim against Patheon without Patheon’s prior written authorization to do so. Alternatively, Patheon may instruct the Client to return such Product to Patheon at Patheon’s expense, provided that
Client will reimburse Patheon for the cost of such shipping if it is determined that Patheon does not bear any liability for such damaged, defective, returned or Recalled Product. Patheon shall bear the cost of disposition with respect to any
damaged, defective, returned or Recalled Product in relation to which it bears responsibility under Section 6.1 or 6.2 hereof. In all other circumstances, the Client shall bear the cost of disposition with respect to any damaged, defective,
returned or Recalled Product. 
  

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AMENDED. 

 6.4 Customer Questions and Complaints. 
 The Client shall have the sole responsibility for responding to questions and complaints from the Client's customers. Questions or complaints received by
Patheon from the Client's customers shall be promptly referred to the Client. Patheon shall co-operate as reasonably required to allow the Client to determine the cause of and resolve any customer questions and complaints. Such assistance shall
include follow-up investigations, including testing. In addition, within ten (10) days from the date of request, Patheon shall provide the Client with all necessary information in Patheon’s possession or control that will enable the Client
to respond properly to questions or complaints relating to the Product. If it is determined that the cause of any customer complaint resulted from a failure by Patheon to provide the Manufacturing Services in accordance with the Specifications and
cGMPs and any additional procedures agreed upon in writing by Patheon and the Client, or a breach of this Agreement by Patheon, all costs incurred in respect of this Section 6.4 shall be borne by Patheon. In all other circumstances, the Client
shall bear the cost incurred with respect to this Section 6.4. 
 6.5 Sole Remedy. 
 Except for the indemnity provided in Section 10.3 and subject to the limitations set forth in Sections 10.1 and 10.2, the remedies described in this
Article 6 shall be the Client’s sole remedy for any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, Applicable Laws or any additional procedures agreed upon in writing by the Client and
Patheon. 
 ARTICLE 7 
 CO-OPERATION 
 7.1 Quarterly Review. 
 Each party shall forthwith upon execution of this Agreement appoint one of its employees to be a relationship manager responsible for liaison between the parties. The relationship managers shall meet not less than
quarterly to review the current status of the business relationship, including, but not limited to, equipment and facilities updates, current and anticipated manufacturing capacity, planned work or changes to the Manufacturing Site where the Product
is being produced and anticipated shut downs of such site, and manage any issues that have arisen. 
 7.2 Governmental Agencies. 
 Subject to Section 7.7 and the Confidentiality Agreement (as defined in Section 11.1), Patheon may communicate with any governmental agency,
including but not limited to governmental agencies responsible for granting regulatory approval for the Product, regarding the manufacture by Patheon of the Product if in the opinion of Patheon’s counsel, such communication is necessary to

  

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AMENDED. 

 
comply with the terms of this Agreement or the requirements of any law, governmental order or regulation; provided, however, that unless in the reasonable
opinion of Patheon’s counsel there is a legal prohibition against doing so, Patheon shall permit the Client to accompany and take part in Patheon’s communications with the agency, and to receive copies of all such communications from such
agency to Patheon. 
 7.3 Records and Accounting by Patheon. 
 Patheon shall keep records of the manufacture, testing and shipping of the Product, and retain samples of such Product as are necessary to comply with the Specifications and all manufacturing regulatory requirements
and Laws applicable to Patheon, as well as to assist with resolving Product complaints and other similar investigations. Copies of such records and samples shall be retained for a period of [ * ] following the date of Product expiry, or
longer if required by Law, after which Patheon may destroy such records or samples; provided, however, Patheon shall notify the Client in writing at least thirty (30) days prior to such destruction and shall retain or deliver such records or
samples to the Client, at the Client’s option and expense, if the Client so requests. 
 7.4 Inspection; Audit. 
 The Client may inspect Patheon reports and records relating to this Agreement during normal business hours and with reasonable advance notice, provided a
Patheon representative is present during any such inspection. Furthermore, the Client shall have the right, if Client reasonably deems it necessary, to request additional documentation from Patheon to verify Patheon’s calculation of [ *
] and Patheon will use its reasonable commercial efforts to provide such documentation. 
 7.5 Access. 
 Patheon shall provide the Client with reasonable access at mutually agreeable times to its Manufacturing Site in which the Product is manufactured,
stored, handled or shipped in order to permit the Client's verification of Patheon's compliance with the Patheon Manufacturing Responsibilities and with all applicable Laws. Patheon agrees to permit the Client to review Patheon’s standard
operating procedures for the manufacture of the Product and those associated with the general facilities, equipment, or procedures required for compliance with cGMPs or DEA requirements. For greater certainty, the right of access provided in this
Section 7.5 shall not include a right to access or inspect Patheon’s financial records. Patheon shall [ * ] obtain the right for the Client to have similar inspection rights with respect to all third party suppliers used by Patheon
to provide the Components. If deficiencies are found by the Client during the course of such inspections, the parties will promptly meet to discuss and resolve them, and the Client will be entitled to make reasonable follow up inspections to monitor
correction of the deficiencies. Patheon shall notify the Client of any inspections by, or communications with, any governmental agency involving the Product. Patheon shall furnish to the Client all material information supplied to, or supplied by,
such regulatory Authority or third party supplier to the extent that such report relates to Product, or the ability of Patheon to supply such Product, within three (3) Business Days of their receipt of such information or delivery of such
information, as the case may be. Patheon will promptly correct any deficiencies noted by governmental agencies in any such inspections. 
  

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AMENDED. 

 7.6 Reports. 
 Patheon will supply on [ * ] basis all Product data, including release test results, complaint test results, all investigations (in manufacturing, testing and storage), and the like, that the Client reasonably
requires in order to complete any filing under any applicable regulatory regime, including any annual product report that the Client is required to file with the FDA. Patheon will supply the Client, no later than five (5) days following the
last day of the preceding month, with a written summary report of the Active Material inventory for such prior month, in such detail requested and satisfactory to the Client, in order that the Client may properly account for the Active Material held
by Patheon pursuant to this Agreement. At the Client’s request and subject to an additional fee to be agreed by the parties, Patheon will prepare on behalf of the Client additional specialized [ * ] product reports in accordance with the
Client’s instructions. At the Client’s request and expense, Patheon will provide the data described in this Section 7.6 on a [ * ] basis. 
 7.7 Regulatory Filings. 
 (a) Regulatory Filings. The Client shall have the sole responsibility for
filing all documents with the FDA and other regulatory Authorities and taking any other actions that may be required of Client to obtain Regulatory Approval for the commercial manufacture of the Product (except as provided in the last sentence of
this clause 7.7(a)). Patheon shall use commercially reasonable efforts to assist the Client, to the extent consistent with Patheon’s obligations under this Agreement, to obtain FDA and other regulatory approval for the commercial manufacture of
the Product by Patheon as quickly as reasonably possible. Copies of all relevant Chemistry and Manufacturing Controls ("CMC") submissions and any related FDA correspondence are to be provided to Patheon by the Client. Patheon shall have the
sole responsibility to obtain and maintain any required local, federal or other permits or approvals (other than the NDA or foreign equivalents) to allow Patheon to perform Manufacturing Services hereunder. 
 (b) [ * ] Data. [ * ] filing any CMC-related documents with the FDA or other regulatory Authority that incorporate data generated by
Patheon, [ * ] incorporating such data so as to [ * ] of such documents [ * ] data. 
 (c) [ * ] CMC. At
least [ * ] filing with the FDA the CMC section of a NDA covering manufacture of the Product by Patheon, the Client [ * ] supporting documents which have been relied upon to prepare the CMC portion so as to [ * ] the CMC portion
accurately describes the work [ * ] pursuant to this Agreement. 
 (d) Pre-Approval Inspection. Subject to subsection
(e) below, if [ * ] under paragraph (c) above within the time stipulated in these paragraphs and if [ * ] reasonably believes that [ * ] with the FDA may be jeopardized, [ * ] may, in its reasonable, good faith
discretion, [ * ] provided that such [ * ] within [ * ] of [ * ]. 
  

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AMENDED. 

 (e) Deficiencies. If in [ * ] good faith discretion, acting reasonably, [ * ]
determines that any of the information [ * ] in accordance with [ * ] is [ * ] in any material manner (the "[ * ]"), [ * ] within [ * ] of receipt of such information from [ * ]. Failure to notify the
Client within the applicable period set forth above will constitute [ * ] acceptance of the [ * ] in accordance with [ * ]. Until such [ * ] or agreement has been reached with the [ * ], [ * ] reserves the
right [ * ]. In such event, [ * ] shall not be construed as a breach of any of its obligations under this Agreement. Any such [ * ] that is delayed shall be rescheduled as soon as reasonably practicable. 
 (f) Client Responsibility. For clarity, the parties agree that in [ * ] the documents referred to in [ * ] above, Patheon’s
role will be limited to [ * ] of the description of the [ * ]. As such, Patheon shall not assume any responsibility for the accuracy of a Regulatory Filing except as to [ * ]. Subject to Patheon’s obligation to cooperate
with the Client pursuant to the terms and conditions of this Agreement, the responsibility of the preparation and filing of a Regulatory Filing shall be borne by the Client. 
 ARTICLE 8 
 TERM AND TERMINATION 
 8.1 Initial Term. 
 This Agreement shall become
effective as of the date hereof and shall continue until five (5) years following the Manufacturing Commencement Date (the "Initial Term"), unless terminated earlier by one of the parties in accordance with Article 8 of this Agreement;
provided further that the Client shall have the option, in its sole discretion, to extend the Initial Term of this Agreement for successive terms of two years each by providing Patheon with written notice of such election not less than twelve
(12) months prior to the expiration of the then current term. 
 8.2 Termination for Cause. 
 (a) Either party at its sole option may terminate this Agreement upon written notice in circumstances where the other party has failed to remedy a
material breach of any of its representations, warranties or other obligations under this Agreement within sixty (60) days following receipt of a written notice (the "Remediation Period") of said breach that expressly states that it is a
notice under this Section 8.2(a) (a "Breach Notice"). The aggrieved party's right to terminate this Agreement pursuant to this Section 8.2(a) may only be exercised for a period of sixty (60) days following the expiry of the
Remediation Period (in circumstances where the breach has not been remedied) and if the termination right is not exercised during this period then the aggrieved party shall be deemed to have waived the breach of the representation, warranty or
obligation described in the Breach Notice. 
  

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AMENDED. 

 (b) Either party at its sole option may immediately terminate this Agreement upon written notice, but
without prior advance notice, to the other party in the event that: (i) the other party is declared insolvent or bankrupt by a court of competent jurisdiction; (ii) a voluntary petition of bankruptcy is filed in any court of competent
jurisdiction by such other party; or (iii) this Agreement is assigned by such other party for the benefit of creditors. 
 (c) The
Client may terminate this Agreement upon thirty (30) days' prior written notice in the event that any governmental agency takes any action, or raises any objection, that prevents the Client from importing, exporting, purchasing or selling the
Product. 
 (d) Patheon may terminate this Agreement at any time on or after [ * ] on [ * ] days’ prior written notice if
the Client has not delivered written notice specifying a Manufacturing Commencement Date as of the date of such notice. 
 (e) Patheon may
terminate this Agreement on [ * ] prior written notice if the Client assigns pursuant to Section 13.6 any of its rights under this Agreement to an assignee that, [ * ], is: (i) [ * ] under this Agreement; or
(ii) [ * ] provided, however, no [ * ] shall be permitted to have access to the Manufacturing Site. For purposes of this Agreement, a [ * ] is a legal entity, [ * ] pharmaceutical contract manufacturing services.

 8.3 Termination by the Client. 
 (a) The Client may terminate this Agreement at any time upon [ * ] prior written notice to Patheon. 
 (b) The Client may
terminate this Agreement at any time on or after [ * ] upon [ * ] days notice if Patheon has not (i) obtained approval as a manufacturer of the Product, including approval of Patheon’s facility by the FDA and any other
applicable regulatory Authority or (ii) obtained a Quota for the Product for calendar year [ * ]. 
 8.4 Termination due to Product
Discontinuation. 
 Except as provided in Section 8.2(c), the Client may terminate this Agreement upon [ * ] days’
prior notice if it intends to no longer order the Product due to the Product's discontinuance in the market. 
 8.5 Obligations on Termination.

 If this Agreement expires or is terminated in whole or in part for any reason, then (in addition to any other remedies either party may
have in the event of default by the other party): 
 (a) subject to Sections 6.1 and 6.2, the Client shall take delivery of and pay for all
undelivered Product (i) that is manufactured and/or packaged pursuant to a Firm Order and (ii) that meets the Specifications and (iii) was manufactured in accordance with cGMPs and any additional procedures agreed upon in writing by
the parties, at the price in effect at the time the Firm Order was placed; 
  

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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 (b) the Client shall purchase, [ * ], the Inventory applicable to the Product which was purchased,
produced or maintained by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2 prior to notice of termination being given; 
 (c) the Client shall [ * ] pursuant to Patheon's orders with suppliers of Components, provided such orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2; and 

(d) Patheon shall return to the Client all unused Active Materials (with shipping and related expenses, if any, to be borne by [ * ]).

 Any termination or expiration of this Agreement shall not affect any outstanding obligations or payments due hereunder prior to such
termination or expiration, nor shall it prejudice any other remedies that the parties may have under this Agreement. 
 8.6 Survival.

 The provisions of Articles 1, 6, 9, 10, 11 and 12 and Sections 2.2, 5.5, 7.3, 7.6, 8.5, 8.6, 13.1, 13.2, 13.3, 13.5, 13.6, 13.8, 13.9,
13.12, 13.13, 13.14, and 13.15, shall survive the termination of this Agreement for any reason. 
 ARTICLE 9 
 REPRESENTATIONS, WARRANTIES AND COVENANTS 
 9.1 Authority. 
 Each party covenants, represents and warrants that it has the full right and authority to enter into
this Agreement, and that it is not aware of any impediment that would inhibit its ability to perform its obligations hereunder. 
 9.2 Client
Warranties. 
 The Client represents and warrants that: 
  

	 	(a)	The Client has the right to disclose the Specifications to Patheon; and 

  

	 	(b)	Except with respect to the Patheon Intellectual Property as to which the Client makes no representations or warranties, the Client is not aware of any Intellectual Property of any
third party that is necessary for the Client to make, have made, use or sell the Product as contemplated hereby; 

  

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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

	 	(c)	The Client is not aware of any action or other legal proceedings alleging that third party Intellectual Property rights would be infringed by the manufacture of the Product as
contemplated hereby. 

 9.3 Patheon Warranties. 
 Patheon covenants, represents and warrants that (a) it shall perform the Manufacturing Services in accordance with the Specifications, cGMPs and all applicable Laws and that any Product supplied by it hereunder
at the time of shipment, shall comply with the Specifications, (b) Patheon is not aware of any Intellectual Property of any third party that is necessary for Patheon to manufacture the Product as contemplated hereby and (c) the Active
Material will not be used for any purpose beyond or different from the scope of the Manufacturing Services or otherwise in violation of the terms and conditions of this Agreement. Patheon acknowledges that the Product is controlled under Schedule
III of the Controlled Substances Act and, as such, is subject to regulations and restrictions concerning its sale and distribution. Patheon agrees to comply with all such regulations and restrictions, as well as any reasonable instructions from the
Client with respect to the use and storage of the Product. Without limiting the foregoing, (a) Patheon will obtain and/or maintain in force during the term of the Agreement all licenses and authorizations from the Drug Enforcement
Administration or any other regulatory or governmental agency which are necessary for it to manufacture and possess the Product; and (b) Patheon will keep the Product in a secure location with access limited to authorized employees. 

9.4 Debarred Persons. 
 Patheon covenants
that it will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b). Patheon represents that it does not currently have, and covenants that it will not
hire, as an officer or an employee any person who has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the Act. 
 9.5 Regulatory Approvals. 
 The Client shall be
solely responsible for obtaining or maintaining, on a timely basis, any regulatory approvals in respect of the marketing of the Product by the Client or the regulatory approval of the Specifications, including, without limitation, all marketing and
post-marketing approvals. Patheon shall be solely responsible for obtaining and maintaining all permits, approvals and quotas necessary in order for Patheon to manufacture the Product in its facilities as contemplated hereby, and for those
facilities themselves. 
 9.6 Compliance with Laws. 
 Each party, in connection with its performance under this Agreement, shall comply with all applicable Laws. 
  

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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 9.7 No Warranty. 
 NEITHER PATHEON NOR THE CLIENT MAKES ANY WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT. PATHEON MAKES NO WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE OR WARRANTY OF MERCHANTABILITY WITH RESPECT TO THE PRODUCT. 
 ARTICLE 10 
 REMEDIES AND INDEMNITIES 
 10.1
Consequential Damages. 
 Neither party shall be liable to the other in contract, tort, negligence, breach of statutory duty
or otherwise for any (direct or indirect) loss of profits, of production, of anticipated savings, of business or goodwill or for any liability, damage, costs or expense of any kind incurred by the other party of an indirect or consequential nature.

 10.2 Limitation of Liability. 
 (a) [ * ]. Except as to the extent caused by the negligence or willful misconduct of Patheon, its employees or agents, under no circumstances whatsoever shall Patheon be responsible for any loss or damage to the [ * ].
Patheon’s maximum liability for loss or damage to the [ * ] shall not exceed the [ * ]. 
 (b) Product. Except as
expressly provided by applicable law or regulation or to the extent that Patheon has failed to provide the Manufacturing Services in accordance with the Specifications, cGMPs or all applicable Laws, Patheon shall not be liable nor have any
responsibility for any deficiencies in, or other liabilities associated with, any Product manufactured by it, including, without limitation, the costs and expenses of any Recall (collectively, "Product Claims"). For greater certainty, Patheon
shall have no obligation for any Product Claims to the extent such Product Claim (i) is caused by [ * ] provided by the Client, the [ * ] or any distribution thereof, (ii) results from a defect in a Component supplied by the
Client or the Active Material that is not reasonably discoverable by Patheon using the test methods set forth in the Specifications, (iii) is caused by actions of third parties occurring after such Product is shipped by Patheon pursuant to
Section 5.5, (iv) is due to packaging or labelling defects or omissions for which Patheon has no responsibility, or (v) is due to any other breach by the Client of its obligations under this Agreement. 
 (c) [ * ]. Except as set forth in this subsection (c), [ * ] under this Agreement for any reason whatsoever, including, without
limitation, any [ * ] hereof or resulting from a breach of its representations, warranties or other obligations under this Agreement shall [ * ]. For purposes of determining [ * ] hereunder, the [ * ] will be based upon
the [ * ] Notwithstanding the foregoing, [ * ]  

  

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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 
under this Agreement, for any liability under Section 10.3 hereof for personal injury, sickness, disease or death that results from the failure by
Patheon to provide the Manufacturing Services in accordance with the Specifications and cGMPs shall not [ * ]. 
 10.3 Patheon.

 Subject to Sections 10.1 and 10.2, Patheon agrees to defend, indemnify and hold the Client, its officers, employees and agents harmless
against any and all losses, damages, costs, claims, demands, judgments and liability to, from and in favor of third parties other than Affiliates, (together, “Losses”) resulting from, or relating to any claim of personal injury or property
damage to the extent that such injury or damage is the result of (i) a failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs or all applicable Laws, or (ii) the gross negligence or willful misconduct
of Patheon or (iii) the breach of this Agreement by Patheon, including without limitation, any representation or warranty of Patheon contained herein, and in each case, except to the extent that any such losses, damages, costs, claims, demands,
judgments and liability are due to the gross negligence or wrongful act(s) of the Client, its officers, employees or agents or Affiliates. 
 In the event of a claim, the Client shall: (a) promptly notify Patheon of any such claim; (b) use commercially reasonable efforts to mitigate the effects of such claim; (c) reasonably cooperate with Patheon in the defence of such claim; (d)
permit Patheon to control the defence and settlement of such claim, all at Patheon's cost and expense. 
 10.4 Client. 
 Subject to Sections 10.1 and 10.2, the Client agrees to defend, indemnify and hold Patheon, its officers, employees and agents (together “Patheon
Indemnitees”) harmless against any and all Losses resulting from, or relating to (a) any claim of personal injury or property damage to the extent that such injury or damage is the result of a breach of this Agreement by the Client,
including, without limitation, any representation or warranty of Client contained herein, (b) any claim that the Specifications for the Product do not conform to all applicable cGMPs, laws and regulations and (c) any claim that the
Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may not be lawfully sold and distributed in every jurisdiction in which the Client markets such Product, or (ii) is not safe for
human consumption, except to the extent that any such Losses are due to the gross negligence or wrongful act(s) of Patheon, its officers, employees or agents or Affiliates. 
 Subject to Sections 10.1 and 10.2, Client agrees to defend, indemnify and hold the Patheon Indemnitees harmless against any and all Losses resulting from
or relating to any claim that the manufacture, use or sale of the Product infringes any Third Party Rights, except to the extent such infringement or alleged infringement results from Patheon’s manufacturing processes. In the event of any claim
described in this Section 10.4, Patheon shall: (a) promptly notify the Client of any such claims; (b) use commercially reasonable efforts to mitigate the effects of such claim; (c) reasonably cooperate with the Client in the defence
of such claim; (d) permit the Client to control the defence and settlement of such claim, all at the Client's cost and expense. 
  

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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 10.5 Reasonable Allocation of Risk. 
 The parties acknowledge and agree that the provisions of this Agreement (including, without limitation, this Article 10) are reasonable and create a
reasonable allocation of risk having regard to the relative profits the parties respectively expect to derive from the Product, and that Patheon, in its fees for the provision of the Manufacturing Services, has not accepted a greater degree of the
risks arising from the manufacture, distribution and use of the Product, based on the fact that the Client has developed and holds the marketing approval for the Product and requires Patheon to manufacture and label the Product strictly in
accordance with the Specifications, and that the Client and not Patheon is in a position to inform and advise potential users of the Product as to the circumstances and manner of use of the Product. 
 ARTICLE 11 
 CONFIDENTIALITY

 11.1 Confidentiality. 
 The Confidentiality Agreement effective March 13, 2007 between the parties (the “Confidentiality Agreement”) will govern the confidentiality obligations of the parties hereunder; provided, however, that: 
 (a) Confidential Information disclosed orally need not be summarized in writing as provided in Paragraph 4 of the Confidentiality Agreement and;

 (b) The Confidentiality Agreement will continue in effect until termination of this Agreement; and 
 (c) The obligations of confidentiality and non-use under the Confidentiality Agreement will continue until [ * ] years after termination of
this Agreement for any reason, including the end of its term. 
 ARTICLE 12 
 DISPUTE RESOLUTION 
 12.1 Commercial Disputes. 
 In the event of any dispute arising out of or in connection with this Agreement (other than a dispute determined in accordance with Section 6.1(b) or
a Technical Dispute), the parties shall first try to solve it amicably. In this regard, any party may send a notice of dispute to the other, and each party 

  

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AMENDED. 

 
shall appoint, within [ * ] Business Days from receipt of such notice of dispute, a single representative having full power and authority to solve the
dispute. The representatives so designated shall meet as necessary in order to solve such dispute. If these representatives fail to solve the matter within [ * ] from their appointment, or if a party fails to appoint a representative within
the [ * ] Business Day period set forth above, such dispute shall immediately be referred to the Chief Operating Officer, Executive Vice President, Operations or Chief Business Officer (or such other officer as they may designate) of each
party who will meet and discuss as necessary in order to try to solve the dispute amicably. Should the parties fail to reach a resolution under this Section 12.1, their dispute will be referred to a court of competent jurisdiction in accordance
with Section 13.16. 
 12.2 Technical Dispute Resolution. 
 In the event of a dispute (other than disputes in relation to the matters set out in Sections 6.1(b) and 12.1) between the parties that is exclusively
related to technical aspects of the manufacturing, packaging, quality control testing, handling, storage or other activities under this Agreement (a "Technical Dispute"), the parties shall make all reasonable efforts to resolve the dispute by
amicable negotiations. In this regard, senior representatives of each party shall, as soon as practicable and in any event no later than [ * ] Business Days after a written request from either party to the other, meet in good faith to
resolve any Technical Dispute. In the event that the parties cannot agree whether a dispute is a Technical Dispute or are unable to resolve a Technical Dispute, Section 12.1 shall prevail. For greater certainty, the parties agree that the
release of the Product for sale or distribution pursuant to the applicable marketing approval for such Product shall not by itself indicate compliance by Patheon with its obligations in respect of the Manufacturing Services and further that nothing
in this Agreement (including Schedule F) shall remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Product is to be released for sale or distribution. 
 ARTICLE 13 
 MISCELLANEOUS

 13.1 Inventions. 
 (a) For the term of this Agreement, Client hereby grants to Patheon a non-exclusive, paid-up, royalty-free, non-transferable license of Client’s Intellectual Property which Patheon must use in order to perform the Manufacturing
Services solely for the manufacture of the Product for the Client. 
 (b) All Intellectual Property generated or derived by Patheon in the
course of performing the Manufacturing Services, to the extent it is specific to the development, manufacture, use and sale of the Product that is the subject of the Manufacturing Services, shall be the exclusive property of Client. 
 (c) All Intellectual Property generated or derived by Patheon in the course of performing the Manufacturing Services which are not related to or derived
from the Client’s Intellectual Property or specific to, or dependent upon, the Product and which have general application to manufacturing 

  

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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 
processes or formulation development of drug product or drug delivery systems shall be the exclusive property of Patheon (the “Patheon Intellectual
Property Rights”). Patheon hereby grants to Client, a non-exclusive, paid-up, royalty-free, transferable license of the Patheon Intellectual Property Rights which Client may use for the manufacture of the Product. 
 (d) Patheon shall give the Client written notice, as promptly as practicable, of all Inventions which can reasonably be deemed to constitute improvements
or other modifications of the Product or processes or technology owned or otherwise controlled by Client. 
 (e) Each party shall be solely
responsible for the costs of filing, prosecution and maintenance of patents and patent applications on its own Inventions. 
 (f) Each party
agrees and acknowledges that it will not acquire by virtue of this Agreement any interest in or to any trademarks or trade names of the other party; provided, however, that the Client shall have the right to identify Patheon as the manufacturer of
the Product. 
 13.2 Intellectual Property. 
 Subject to Section 13.1, all Intellectual Property of the Client shall be owned by the Client and all Intellectual Property of Patheon shall be owned by Patheon. The Client and Patheon hereby acknowledge that
neither party has, nor shall it acquire, any interest in any of the other party’s Intellectual Property unless otherwise expressly agreed to in writing. Each party agrees not to use any Intellectual Property of the other party, except as
specifically authorized by the other party or as required for the performance of its obligations under this Agreement. Each party agrees to execute all applications, assignments or other instruments reasonably requested by the other party, in order
for such party to establish its ownership of such Intellectual Property and to obtain whatever protection for such Intellectual Property, including patent and copyright rights, in any and all countries on such Intellectual Property as the requesting
party will determine. Each party further agrees to cooperate fully with the other party in the process of securing and enforcing the other party’s rights to such Intellectual Property, applicable. 
 13.3 Insurance. 
 Each party shall
maintain commercial general liability insurance, through the term of this Agreement, which insurance shall afford limits of not less than $[ * ] for each occurrence for personal injury or property damage liability. Furthermore, each party
shall maintain products liability insurance, through the term of this Agreement and for a period of [ * ] years thereafter, which insurance shall afford limits of not less than $[ * ] in the aggregate per annum with respect to product
and completed operations liability. This insurance shall be written to cover claims incurred, discovered, manifested, or made during or after the expiration of this Agreement. If requested each party will provide the other with a certificate of
insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date and the limits of liability. The insurance certificate shall further provide for a minimum of thirty
(30) days' written notice to the insured of a cancellation of, or material 

  

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AMENDED. 

 
change in, the insurance. If a party is unable to maintain the insurance policies required under this Agreement through no fault on the part of such party,
then such party shall forthwith notify the other party in writing and the parties shall in good faith negotiate appropriate amendments to the insurance provision of this Agreement in order to provide adequate assurances. 
 13.4 Independent Contractors. 
 The
parties are independent contractors and this Agreement shall not be construed to create between Patheon and the Client any other relationship such as, by way of example only, that of employer-employee, principal agent, joint-venturer, co-partners or
any similar relationship, the existence of which is expressly denied by the parties hereto. 
 13.5 No Waiver. 
 Either party's failure to require the other party to comply with any provision of this Agreement shall not be deemed a waiver of such provision or any
other provision of this Agreement. 
 13.6 Assignment. 
  

	 	(a)	Patheon may not assign this Agreement or any of its rights or obligations hereunder except with the written consent of the Client, such consent not to be unreasonably withheld,
provided that any assignee shall covenant in writing to be bound by the terms of this Agreement. 

  

	 	(b)	Subject to Section 8.2(d), the Client may assign this Agreement or any of its rights or obligations hereunder without approval from Patheon; provided, however, that
(i) the Client shall give prompt written notice of any assignment to Patheon after the assignment, and (ii) any assignee shall covenant in writing to be bound by the terms of this Agreement. 

  

	 	(c)	Notwithstanding the foregoing provisions of this Section 13.6, either party may assign this Agreement to any of its Affiliates or to a successor to or purchaser of all or
substantially all of its business, provided that such assignee executes an agreement with the non-assigning party hereto whereby it agrees to be bound hereunder. 

 13.7 Force Majeure. 
 Neither party shall be liable for the failure to perform its
obligations under this Agreement if such failure is occasioned by a cause or contingency beyond such party's reasonable control, including, but not limited to, strikes or other labour disturbances, lockouts, riots, quarantines, communicable disease
outbreaks, wars, acts of terrorism, fires, floods, storms, interruption of or delay in transportation, lack of or inability to obtain fuel, power or components (a “Force Majeure Event”). A party claiming a right to excused
performance under this Section 13.7 shall immediately notify the other party in writing of the extent of its inability to perform, which notice shall specify the occurrence beyond its reasonable control 

  

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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 
that prevents such performance and shall use its commercially reasonable efforts to eliminate, cure and overcome any of such causes and resume the
performance of its obligations. Neither party shall be entitled to rely on a Force Majeure Event [ * ] which would otherwise [ * ] under this Agreement. 
 13.8 Notices. 
 Any notice, approval, instruction or other written communication required or
permitted hereunder shall be sufficient if made or given to the other party by personal delivery, by facsimile communication or by sending the same by first class mail, postage prepaid to the mailing address, or facsimile number set forth below:

 If to the Client: 
 Jazz
Pharmaceuticals, Inc. 
 3180 Porter Drive 
 Palo Alto, CA 94304 
 U.S.A. 
 Attention: Vice President, Product Development 
 Facsimile No.: (650) 496-3781 
 with a copy to: 
 Jazz Pharmaceuticals Inc

 3180 Porter Drive 
 Palo Alto,
CA 04304 
 Attention: General Counsel 
 Facsimile No.: (650) 496-3781 
 If to Patheon: 
 Patheon Pharmaceuticals Inc. 
 c/o Patheon Inc., 
 7070 Mississauga Road, Suite 350 
 Mississauga, Ontario L5N 7J8 
 Canada 
 Attention: President 
 Facsimile No.: (905) 812-6705 
  

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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 with a copy to: 
 Patheon Pharmaceuticals Inc 
 2110 East Galbraith Road 
 Cincinnati, Ohio 45237-1625 
 Attention:
Director of Legal Services 
 Facsimile No.: (513)948-6927 
 or to such other addresses or facsimile number provided to the other party in accordance with the terms of this Section 13.9. Notices or written communications made or given by personal delivery or by facsimile
shall be deemed to have been sufficiently made or given when sent (receipt acknowledged), or if mailed, five (5) days after being deposited in the United States or Canadian mail, postage prepaid or upon receipt, whichever is sooner. 

13.9 Severability. 
 If any provision
of this Agreement is determined by a court of competent jurisdiction to be invalid, illegal or unenforceable in any respect, such determination shall not impair or affect the validity, legality or enforceability of the remaining provisions hereof,
and each provision is hereby declared to be separate, severable and distinct. 
 13.10 Entire Agreement. 
 This Agreement, together with the Quality Agreement, Confidentiality Agreement, that certain Capital Expenditure and Equipment Agreement dated as of the
date hereof, and that certain Pharmaceutical Development Services Agreement dated as of January 2, 2007, in each case by and between Patheon and the Client, to the extent expressly incorporated herein, constitutes the full, complete, final and
integrated agreement between the parties hereto relating to the subject matter hereof and supersedes all previous written or oral negotiations, commitments, agreements, transactions or understandings with respect to the subject matter hereof. Any
modification, amendment or supplement to this Agreement must be in writing and signed by authorized representatives of both parties. In case of conflict, this Agreement will prevail. 
 13.11 Other Terms. 
 The parties agree that no terms, provisions or conditions of any
purchase order or other business form or written authorization used by the Client or Patheon will have any effect on the rights, duties or obligations of the parties under or otherwise modify this Agreement, regardless of any failure of the Client
or Patheon to object to such terms, provisions, or conditions unless such document specifically refers to this Agreement and is signed by both parties. 
  

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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 13.12 Third Party Beneficiary. 
 Nothing in this Agreement shall confer or be construed as conferring on any other third party any benefit or the right to enforce any express or implied
term of this Agreement. 
 13.13 Exclusivity. 
 During the term of this Agreement and for [ * ] thereafter, Patheon will not develop, make, have made, use, sell, have sold, offer for sale, import or commercialize, or assist any other third party, in any of
the foregoing with respect to the Product, other than the Client pursuant to this Agreement. 
 13.14 Publicity. 
 Each party agrees not to issue any press release or other public statement disclosing the existence of, or relating to this Agreement, without the prior
written consent of the other party; provided, however, that neither party shall be prevented from complying with any duty of disclosure it may have pursuant to applicable Laws or governmental orders. 
 13.15 Execution in Counterparts. 
 This
Agreement may be executed in two counterparts, by original or facsimile signature, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. 
 13.16 Governing Law. 
 This Agreement shall be
construed and enforced in accordance with the laws of the State of New York. 
 IN WITNESS WHEREOF, the duly authorized representatives of
the parties have executed this Agreement as of the date first written above. 
  

			
	PATHEON PHARMACEUTICALS INC.
		
	By	 	 /s/ Riccardo Trecroce

	Name:	 	Riccardo Trecroce
	Title:	 	Secretary
	
	JAZZ PHARMACEUTICALS, INC.
		
	By	 	 /s/ Janne Wissel

	Name:	 	Janne Wissel
	Title:	 	Sr VP, Development

  

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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 SCHEDULE A 
 PRODUCT SPECIFICATIONS 
 If the Specifications provided are subsequently amended, then the Client shall
provide Patheon with copies of such revised Specifications. Upon receipt of the revised Specifications, Patheon shall provide the Client with a signed and dated receipt evidencing such acceptance of the revised Specifications by Patheon. 

[ * ] 

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 

 SCHEDULE B 
 MINIMUM RUN QUANTITY, ANNUAL VOLUME, FEES & PRICE ADJUSTMENTS 
 1. Xyrem Oral Solution – [
* ] mL Bottle 
  

									
	 Batch Size (L)
	 	[ * ]
	 Market
	 	US	 	EU/Canada
	 Minimum Annual Qty (bottle)
	 	[ * ]	 	[ * ]
	 Run Quantity (bottles)
	 	[ * ]	 	[ * ]	 	[ * ]	 	[ * ]
	 Pkg Run Quantity (batch)
	 	[ * ]	 	[ * ]	 	[ * ]	 	[ * ]
	 Materials
	 	[ * ]	 	[ * ]	 	[ * ]	 	[ * ]
	 Conversion Cost
	 	[ * ]	 	[ * ]	 	[ * ]	 	[ * ]
	 Price per Bottle*
	 	[ * ]	 	[ * ]	 	[ * ]	 	[ * ]
	 Split Lot Charge - [ * ]
 This charge is for splitting off a portion of a US lot for “EU” type bottles for the Canadian
market.

  

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 

 Price for Double Batch Size 
 Xyrem oral solution: [ * ] ml/bottle 
  

					
	 Batch size
	 	[ * ]	 	[ * ]
	 Market
	 	US	 	EU
	 Annual Qty (bottles)
	 	[ * ]	 	[ * ]
	 Run Quantity (bottles)
	 	[ * ]	 	[ * ]
	 Materials
	 	[ * ]	 	[ * ]
	 Conversion
	 	[ * ]	 	[ * ]
	 Price per bottle*
	 	[ * ]	 	[ * ]
	 Split lot charge [ * ]
 This charge is for splitting off a portion of a US lot for “EU” type bottles for the Canadian
market.

	*	Pricing is based on the fact that Patheon will do the following: 

 Procurement of raw materials and packaging components as defined in schedule J. Jazz Pharmaceuticals will furnish the API, Sodium Oxybate. Price does include the performance of all QC testing requirements for raw materials, packaging
components and finished product. 
 Manufacturing Assumptions [ * ] 
 Packaging Assumptions[ * ] 
 Product Release Testing for Non-Patheon Product [ * ] 
  

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 

 2. Subsequent Years’ Pricing. 
 The fees for the Manufacturing Services provided pursuant to the terms of this Agreement during any Year following December 31, 2008 shall be determined in accordance with the following: 
  

	 	(a)	Manufacturing and Component Costs. On the first day of the applicable Year during the term of this Agreement, Patheon shall [ * ] (i) for [ * ] in respect
of the Product [ * ] to reflect [ * ], unless the parties otherwise agree in writing; and (ii) for [ * ] in such costs. [ * ]. 

  

	 	(b)	Pricing Basis. The Client acknowledges that the fee for Manufacturing Services in respect of a Product in any Year is [ * ] and is subject to change if [ * ]
unless Client agrees [ * ] provided that such Product [ * ]. In addition, if Patheon and the Client agree that the [ * ] in respect of a Product shall be reduced whether as a result of a [ * ] or otherwise and, as a
result of such reduction, [ * ], then Patheon shall be entitled to [ * ]. 

 In connection with a [ * ] pursuant to clause
2 of this Schedule B, Patheon shall [ * ] a revised Schedule B in draft form and a statement outlining (i) [ * ] upon which such [ * ] is based and (ii) the [ * ] to Patheon [ * ] upon which any [ *
] is based, if applicable. In connection with all [ * ] pursuant to clauses 2(b) of this Schedule B, Patheon shall deliver to the Client by not later than [ * ] a revised Schedule B in draft form and such [ * ]. Upon
delivery of such a request, each of the Client and Patheon shall forthwith [ * ] in respect of the Product and [ * ]. Such [ * ] shall be effective with respect to any [ * ] after the end of the [ * ]. 

3. Adjustments to Pricing. 
 During
any Year of this Agreement, the fees set out in Schedule B shall be subject to adjustment in accordance with the following: 
  

	 	(a)	[ * ] Pricing. The Manufacturing Fees describe the fees that are payable by Client for Product based on the [ * ]. The parties shall estimate the Manufacturing
Fees payable by Client in any Year based on the [ * ]. Within [ * ] of the end of the each Year, the parties shall reconcile the difference which may be payable by either party based on the [ * ]. 

  

	 	(b)	[ * ]. 

  

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 

 In connection with a [ * ] pursuant to this clause 3 of Schedule B, Patheon shall deliver to the Client a revised
Schedule B and such [ * ]. Upon delivery of such a request, each of the Client and Patheon shall forthwith [ * ]. 

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 

 SCHEDULE C 
 STABILITY TESTING 
 [ * ] 

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 

 SCHEDULE D 
 ACTIVE MATERIALS 
  

			
	 Active Materials
	  	Supplier
	 Sodium Oxybate, Powder
	  	Lonza, Inc.

 [ * ] 

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 

 SCHEDULE E 
 BATCH NUMBERING & EXPIRATION DATES 
 Each batch of the Product manufactured by Patheon will bear a
unique batch number using the Patheon batch numbering system. This number will appear on all documents relating to the particular batch of Product. 
 Patheon will calculate the expiration date for the Product for each batch by adding the expiration period of the Product supplied by the Client to the date of Manufacture of each batch. 

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 

 SCHEDULE F 
 TECHNICAL DISPUTE RESOLUTION 
 Technical Disputes which cannot be resolved by negotiation as
provided in Section 12.2 shall be 
 resolved in the following manner: [ * ] 

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 

 SCHEDULE G 
 QUALITY AGREEMENT 
 {This Schedule G has been filed separately as an exhibit to the Jazz
Pharmaceuticals, Inc. Registration Statement on Form S-1 in executed form.} 

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 

 SCHEDULE H 
 QUARTERLY ACTIVE MATERIALS INVENTORY REPORT 
  

			
	 TO:
	  	JAZZ PHARMACEUTICALS, INC.
	 FROM:
	  	PATHEON PHARMACEUTICALS INC.
	 RE:
	  	Active Materials quarterly inventory report pursuant to Section 2.3(a) of the Manufacturing Services Agreement dated • (the "Agreement")

 [ * ] 
 Capitalized terms used in this report have the meanings given to such terms in the Agreement. 
 DATE:                          
  

			
	PATHEON PHARMACEUTICALS INC.
		
	Per:	 	  

	Name:	 	
	Title:	 	

 [ * ] 

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 

 SCHEDULE I 
 REPORT OF ANNUAL ACTIVE MATERIALS INVENTORY RECONCILIATION AND 
 CALCULATION OF ACTUAL ANNUAL YIELD.

 Intentionally Left Blank 

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 

 SCHEDULE J 
 COMPONENTS PURCHASING SUMMARY 
  

	
	 Dated: October 19, 2006

	 [ * ]

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 

 SCHEDULE K 
 POTENTIAL BILL-BACK ITEMS 
 [ * ] 

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 

 SCHEDULE L 
 PACKAGING CONFIGURATIONS 
 Referenced in the definition section 
 [ * ] 

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED.Quallity Agreement, dated as of March 13, 2007

 [ * ] = 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 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED. 
 EXHIBIT 10.51 
 QUALITY AGREEMENT 
 This AGREEMENT is executed as of the 13th day of March, 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 
 Patheon Pharmaceuticals Inc. 
 2110 East Galbraith Road 
 Cincinnati, OH 45237-1625 
 USA 
 a corporation existing under the laws of the state of Delaware, USA 
 (hereinafter referred to as
“Patheon”) 
  

 1 

 TABLE OF CONTENTS 
  

																	
	1.	  	Objective	  	 	  	 	  	 	  	3	  	 	  	 	  	 
	2.	  	Scope	  		  		  		  	3	  		  		  	
	3.	  	Definitions	  		  		  		  	3	  		  		  	
	4.	  	General	  		  		  		  	4	  		  		  	
	5.	  	Regulatory	  		  		  		  	5	  		  		  	
	6.	  	GMP	  		  		  		  	6	  		  		  	
	7.	  	Validation	  		  		  		  	7	  		  		  	
	8.	  	Specifications and Test Methods	  		  		  		  	7	  		  		  	
	9.	  	API and Raw Materials	  		  		  		  	8	  		  		  	
	10.	  	Manufacturing and Packaging	  		  		  		  	8	  		  		  	
	11.	  	Change Controls	  		  		  		  	9	  		  		  	
	12.	  	Deviations	  		  		  		  	9	  		  		  	
	13.	  	Product Complaints	  		  		  		  	10	  		  		  	
	14.	  	Product Release	  		  		  		  	10	  		  		  	
	15.	  	Stability	  		  		  		  	11	  		  		  	
	16.	  	Review of Quality Agreement	  		  		  		  	11	  		  		  	
	17.	  	Quality Contacts	  		  		  		  	12	  		  		  	
	18.	  	Approvals	  		  		  		  	13	  		  		  	

  

 2 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 1. Objective 
  

	 	 1.1.
	 The purpose of this Quality Agreement is to ensure a mutual understanding and agreement of key responsibilities between
Jazz Pharmaceuticals and Patheon with respect to the Xyrem® (sodium oxybate) oral solution
(the “Product”), for use and sale in the United States, Europe and Canada. 

  

	 	1.2.	To assure the Product is produced in accordance with cGMPs approved standard operating procedures (SOPs), specifications and all applicable governing regulations.

 2. Scope 
  

	 	2.1.	To document the responsibilities of Jazz Pharmaceuticals and Patheon regarding: 

  

	 	2.1.1.	    Manufacture of the Product 

  

	 	2.1.2.	    Packaging, testing, release, storage and shipment of the Product 

  

	 	2.1.3.	    Complaint reporting and investigations related to the Product 

  

	 	2.1.4.	    Testing, release and storage of API and Raw Materials 

 3. Definitions 
  

	 	3.1.	API: the Active Pharmaceutical Ingredient – (Sodium Oxybate) 

  

	 	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.	EU: European Union 

  

	 	3.8.	DEA: Drug Enforcement Agency 

  

	 	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.	IQ: Installation Qualification; documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s
recommendation and/or user requirements. 

  

 3 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

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

  

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

  

	 	3.14.	OQ: Operational Qualification; documented verification that the equipment or systems, as installed or modified, perform as intended and that it meets the previously defined
functional and performance specifications. 

  

	 	3.15.	PQ: Process Qualification; documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved
process methods and specifications. 

  

	 	 3.16.
	 Product: Xyrem® (sodium oxybate) oral solution packaged in bulk unlabeled bottles or in its final configuration. 

  

	 	3.17.	Raw Material: Any ingredient intended for use in the manufacture of the drug Product, including those that do not appear in such drug Product. 

  

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

  

	 	3.19.	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. General

  

	 	4.1.	This Quality 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 this Agreement and the Manufacturing Services and Supply Agreement (the “Supply Agreement) between Jazz Pharmaceuticals and Patheon dated March 13, 2007 (as may be amended from time to time, the “Supply Agreement”), the
Supply Agreement shall govern. In the event of a quality conflict between any of the provisions in the Supply Agreement and this Quality Agreement, this Quality Agreement shall govern. Any capitalized terms utilized herein and not otherwise defined
herein shall have the meanings set forth in the Supply Agreement. 

  

	 	4.2.	In the event that a dispute arises between Patheon and Jazz Pharmaceuticals regarding the nonconformity of a batch 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. If the parties cannot reach agreement, the matter shall be resolved in accordance with dispute resolution provisions of the Supply
Agreement. 

  

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

  

	 	•	 	 Current Good Manufacturing Practices (cGMPs), U.S. 21 CFR parts 210 and 211 

  

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

  

	 	•	 	 EU and Canadian Regulations 

  

	 	•	 	 All applicable USP, NF, Ph Eur. and ICH requirements 

  

 4 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

	 	•	 	 DEA Regulations (if applicable) 

  

	 	•	 	 Environmental and occupational health and safety laws 

  

	 	4.4.	Patheon will not subcontract any work related to the manufacture and testing of the Product to a third party vendor without the prior written consent, approval of Jazz
Pharmaceuticals. 

 5. Regulatory 
  

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

  

	 	5.2.	Patheon will notify Jazz Pharmaceuticals within one (1) business day of any 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. Jazz Pharmaceuticals may request to be present onsite during a regulatory inspection by a government body related to the Product. Patheon will
not make any representations to any government authority regarding any actions taken by Jazz Pharmaceuticals without Jazz Pharmaceuticals expressed prior approval. 

  

	 	5.3.	Patheon 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 used in the manufacture, packaging, testing and storage of the Product. 

  

	 	5.4.	Patheon will provide redacted 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. Patheon will provide copies of the above documentation promptly, no more than three (3) business days after such communications are available for distribution.
Jazz Pharmaceuticals may participate in the development and approval of corrective action plans that are directly related to the Product. 

  

	 	5.5.	Patheon is responsible for registering the facilities with the FDA and to maintain the registration form such that it is readily available for any regulatory inspection. Patheon is
responsible for drug listing as the manufacturer of the Product for Jazz Pharmaceuticals, while Jazz Pharmaceuticals is responsible for drug listing as the distributor of the Product. 

  

	 	5.6.	Jazz Pharmaceuticals will provide Patheon with all required information to register the Product with the regulatory agency. Jazz Pharmaceuticals will notify Patheon of changes in
the countries of market and scheduled Product launch, where applicable. 

  

	 	5.7.	Jazz Pharmaceuticals is responsible for ensuring all appropriate regulatory filings and import/export documentation are filed with regulatory agencies prior to shipment/human
administration. Jazz Pharmaceuticals will provide a copy of the applicable product registration as applicable to support regulatory inspection activities. 

  

	 	5.8.	 Jazz Pharmaceuticals will initiate and control all NDA Field Alert Reports and Product Recalls for Product not meeting the regulatory requirements. Patheon will
provide documentation, data and assistance if the field alert or recall is related to the Product manufactured at Patheon. Jazz Pharmaceuticals will provide Patheon copies of any regulatory correspondence related to the field alert or
Product recall. In the event that Patheon has reason to believe that any Product should be recalled or withdrawn from distribution, Patheon shall promptly inform Jazz Pharmaceuticals in writing. Patheon and Jazz Pharmaceuticals agree to cooperate
fully 

  

 5 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

	 	 
regarding any proposed recall, product withdrawal, or field correction; and the Parties agree to keep each other advised, and to exchange copies of such
documentation as may be required, to assure regulatory compliance. 

  

	 	5.9.	Upon request from Jazz Pharmaceuticals, Patheon will provide any documentation and data related to the Product or the facilities and the process used in the manufacture of the
Product that may be required by Jazz Pharmaceuticals for regulatory filings and submissions. 

  

	 	5.10.	Patheon will allow Jazz Pharmaceuticals to audit all relevant facilities used in the manufacture, packaging, testing and storage of the Product, including the applicable procedures
and documentation, at least once in each calendar year (and additional times, if the deficiencies are noted, to monitor correction thereof) at a mutually agreed upon date. Jazz Pharmaceuticals will provide a thirty (30) calendar days
notification for all planned audits conducted by Jazz Pharmaceuticals. 

  

	 	5.11.	Jazz Pharmaceuticals will provide a written report of all observations within thirty (30) business days to Patheon. Within thirty (30) business days of
receipt of the audit report, Patheon will provide a written response to all findings that require corrective action and the expected time-frame of implementation. Patheon will follow-up to ensure that all corrective actions are addressed and
implemented. 

  

	 	5.12.	Jazz Pharmaceuticals will provide Patheon at least five (5) business days notice prior to scheduling any visits (non-audits) to witness manufacturing operations or laboratory
testing related to the Product. Access to the manufacturing facility or laboratories for non-audit purposes must be agreed upon by Patheon in advance and such access, if justifiable, should not be unreasonably withheld or delayed.

 6. GMP 
  

	 	6.1.	Patheon or Jazz Pharmaceuticals will notify and obtain approval from the other party in writing prior to implementing any proposed changes to the process, materials, testing,
equipment or premises that may affect the quality, purity, safety or integrity of the Product. 

  

	 	6.2.	Patheon will not change or deviate from the defined manufacturing process, testing procedures and/or Specification directly relating to the Product or alter materials, or change
suppliers without obtaining prior written approval from Jazz Pharmaceuticals. 

  

	 	6.3.	Patheon will provide Jazz Pharmaceuticals an annual product review (APR) report for the Product. The information provided in the APR report will consist at the minimum the following
information: the batches processed, open and closed deviations, open and closed complaints, retain inspection, statistical trending of analytical data, active stability studies and change controls (documentation, equipment and processes). The report
shall be completed in writing and sent to Jazz Pharmaceuticals no later than sixty (60) business days after the scheduled APR start date. 

  

	 	6.4.	Jazz Pharmaceuticals will be responsible for submitting the Annual Report for the Product to the agencies as required by applicable regulations, including 21 CFR 314.70 and 314.81.
Jazz Pharmaceuticals will notify Patheon as to the approval date of the regulatory license. At least ninety (90) calendar days before the Annual Report due date, Jazz shall request in writing from Patheon the chemistry, manufacturing, and
controls data required for submission of the Annual Report. Patheon will provide the requested information to Jazz Pharmaceuticals within sixty (60) calendar days. 

  

 6 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

	 	6.5.	Patheon will retain reserve samples of the Product (bulk unlabeled or finished drug product) for at least one year after product expiration or longer as required by law.

  

	 	6.6.	Patheon will maintain records and evidence on the testing of API and all raw materials until five years after the materials were last used in the manufacture or packaging/labelling
of the Product. 

  

	 	6.7.	Patheon will retain all batch production and control records, laboratory testing and distribution records for at least [ * ] after the expiry date of the Product or longer as
required by the law. 

 7. Validation 
  

	 	7.1.	Patheon will establish and maintain a validation plan for the facility and the process used in the manufacture, packaging testing and storage of the Product.

  

	 	7.2.	Patheon will qualify (IQ/OQ/PQ) all facilities, utilities, processes and test equipment used in the manufacture, packaging and testing of the Product. 

  

	 	7.3.	Patheon will validate all manufacturing, packaging and testing activities for the Product in accordance with cGMPs and all other applicable governing regulations, including:

  

	 	7.3.1.	Process validation: All processes used in the manufacture and packaging of the Product 

  

	 	7.3.2.	Methods validation: All test methods for the API and the Product 

  

	 	7.3.3.	Facilities/Utilities: Facilities used in the manufacture, packaging, testing and storage of the Product, and all utility systems (e.g., HVAC, water, computer systems, etc.)

  

	 	7.3.4.	Cleaning validation: All cleaning procedures of production equipment 

  

	 	7.4.	Patheon will provide Jazz Pharmaceuticals copies of all protocols and the reports related to the Product for review and approval prior to execution and closure.

 8. Specifications and Test Methods 
  

	 	8.1.	Jazz Pharmaceuticals will provide Patheon all Specifications for the API, raw materials, packaging materials and the Product. 

  

	 	8.2.	Jazz Pharmaceuticals will provide Patheon all test methods for testing the API and the Product. 

  

	 	8.3.	Patheon will send Jazz Pharmaceuticals all specifications for the API and the Product for review and approval. 

  

	 	8.4.	Patheon will send Jazz Pharmaceuticals all test methods for testing the API and the Product for review and approval. 

  

	 	8.5.	Any changes to the approved Product Specifications and test methods must be sent to Jazz Pharmaceuticals for review and approval. 

  

 7 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 9. API and Raw Materials 
  

	 	9.1.	Patheon will qualify and approve all raw material suppliers in accordance with Patheon SOPs. Jazz Pharmaceuticals will qualify and approve the API supplier.

  

	 	9.2.	Patheon will procure Raw materials only from Qualified Suppliers for use in the manufacture and packaging of the Product. 

  

	 	9.3.	Patheon will procure Raw materials with the appropriate certificate of analysis (C of A), certificate of compliance (C of C) and will retain these documents along with the receiving
or testing records. 

  

	 	9.4.	Patheon will test, release and approve the API and all raw materials prior to use in production. Patheon will only use approved API and raw materials for use in the manufacture and
packaging of the Product. 

  

	 	9.5.	Patheon will store the API and all Raw materials in accordance with cGMPs, approved SOPs, DEA regulations (if applicable) and the Specifications. 

  

	 	9.6.	Patheon will pull and retain a reserve sample for each batch of API, at least twice the quantity necessary to perform all test required as per Specification.

  

	 	9.7.	Patheon will hold the API reserve samples for at least [ * ] or longer as required by the law. Patheon will notify and obtain approval from Jazz Pharmaceuticals in writing
prior to destruction of any API reserve samples. 

  

	 	9.8.	Patheon will retain reserve samples of inactive ingredients for a minimum of [ * ] as required by law. 

  

	 	9.9.	Patheon will provide Jazz Pharmaceuticals with a BSE/TSE certificate of compliance for each raw material confirming that any bovine, caprine, or ovine derived raw materials
purchased/used in the manufacture of the Product are appropriate for use in human pharmaceuticals. Jazz Pharmaceuticals will be responsible for procuring the BSE/TSE certification from the API supplier. 

  

	 	9.10.	Upon request, Patheon will provide copies of all Raw material C of A’s to Jazz Pharmaceuticals. Jazz Pharmaceuticals will provide C of A for the API to Patheon.

 10. Manufacturing and Packaging 
  

	 	10.1.	Patheon will create, control, issue and execute the master batch record. The Master Batch Record (original) used in the manufacture/ packaging of the Product will be submitted to
Jazz Pharmaceuticals QA for approval prior to issuance for production. 

  

	 	10.2.	Patheon will assign a unique identifier (batch number) for each unit operation of the Product manufactured per Patheon SOPs. 

  

	 	10.3.	Patheon will calculate the expiration date for each batch of Product by adding the expiration period supplied by Jazz Pharmaceuticals to the date of Manufacture of each batch.

  

	 	10.4.	Patheon will only use approved API and Raw materials for the manufacture and packaging of the Product. 

  

 8 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

	 	10.5.	Patheon will pull and retain a reserve sample (twice the quantity required to perform all test per Specifications) that is representative of each batch of drug Product
manufactured/packaged and stored with accordance to cGMPs. 

  

	 	10.6.	Patheon will be responsible for the accuracy, completeness and maintenance of batch records used in the manufacturing and packaging processes. 

  

	 	10.7.	Upon request, Patheon will provide Jazz Pharmaceuticals with copies of fully executed batch production and control records, laboratory testing records and any other associated
documentation related to the manufacturing, packaging, testing and release of the Product. 

  

	 	10.8.	Patheon will not rework or reprocess a batch or intermediate that does not conform to standards or specifications without prior written consent and approval from Jazz
Pharmaceuticals. 

 11. Change Controls 
  

	 	11.1.	Changes to the following (but not limited to) must be covered under a change control: 

  

	 	11.1.1.	  Revision to Master Batch Records, Test Methods, Specifications for the API, Raw materials and the Product 

  

	 	11.1.2.	  Packaging Specifications 

  

	 	11.1.3.	  Major facility and Equipment changes 

  

	 	11.2.	Patheon will notify Jazz Pharmaceuticals of any general procedural changes at Patheon that pertain to the manufacture, packaging or testing of the Product for Jazz Pharmaceuticals
review and assessment with respect to validation, quality, and regulatory impact. 

 12. Deviations 
  

	 	12.1.	Patheon will not deviate from approved procedures, methods or the Specifications used in the manufacture, packaging, testing and storage of the API, Raw materials or the Product.
Deviations (if any) to approved procedures must be investigated and documented under the established change control or non-conformance. 

  

	 	12.2.	Patheon will obtain Jazz Pharmaceuticals written approval on all deviations having an impact on safety, identity, quality, purity and/or potency of the Product. In addition, all
confirmed OOS deviations pertaining to testing of the Product must be approved by Jazz Pharmaceuticals. 

  

	 	12.3.	Patheon will inform Jazz Pharmaceuticals of any major or critical deviations impacting the safety, identity, quality, purity and/or potency of the Product within three
(3) business days of occurrence. 

  

	 	12.4.	Jazz Pharmaceuticals will provide written comments and approval to Patheon within three (3) business days of notification of any deviation. 

  

	 	12.5.	Patheon will notify Jazz Pharmaceuticals of any suspected or actual out-of-Specification (OOS) results within one business day after such results are confirmed.

  

	 	12.6.	Patheon will investigate and close all deviations (procedural, equipment, OOS etc) within thirty (30) calendar days from the time of initiation of the deviation notice. A
written justification must be provided by Patheon wherever deviations cannot be closed within the thirty (30) calendar days. 

  

	 	12.7.	Patheon will promptly provide copies of all completed deviations to Jazz Pharmaceuticals. 

  

 9 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 13. Product Complaints 
  

	 	13.1.	Jazz Pharmaceuticals will coordinate all customer-related contact and activities related to the Product complaints. Jazz Pharmaceuticals will maintain the Product complaint files.

  

	 	13.2.	Jazz Pharmaceuticals is responsible for the Product complaints and will be responsible for agency notification for any adverse event complaints. 

  

	 	13.3.	Any complaints received directly by Patheon related to the Product will be forwarded to Jazz Pharmaceuticals within one (1) business day of receipt. 

 

	 	13.4.	Jazz Pharmaceuticals will notify Patheon of all Product complaints (medical and technical) that will require an investigation from Patheon. 

  

	 	13.5.	Patheon will complete its investigation per Patheon policies (no later than forty five (45) calendar days for technical complaints and fifteen (15) calendar days for
medical complaints). Upon request, Patheon will provide Jazz Pharmaceuticals copies of the investigation for review prior to closure. 

  

	 	13.6.	Patheon will maintain complete documentation of all complaint investigation conducted at Patheon related to the Product and will provide Jazz Pharmaceuticals copy of all completed
investigations. 

 14. Product Release 
  

	 	14.1.	The Quality Assurance unit of Patheon is responsible for batch record review and release of the Product to Jazz Pharmaceuticals in accordance with approved procedures,
Specifications and all applicable regulations (cGMPs, US 21 CFR parts 210 and 211, regulations and all applicable USP, NF. requirements). 

  

	 	14.2.	Patheon will provide a certificate of compliance for each batch manufactured, packaged and released. The Certificate of Compliance at the minimum shall include the following:

  

	 	14.2.1.	    A product description with a unique identifier (item, batch number, product name and strength). 

  

	 	14.2.2.	    The quantity packaged for shipment and the manufacturing site. 

  

	 	14.2.3.	    The manufacture date for the Product with the expiration date. 

  

	 	14.2.4.	    A statement that the Product was manufactured and packaged in accordance with cGMPs and Specifications. 

  

	 	14.2.5.	    The certificate will be reviewed, signed and dated by Patheon’s Quality department. 

  

	 	14.3.	Jazz Pharmaceuticals has the sole responsibility for the final release of the finished Product to the market. 

  

	 	14.4.	Upon Jazz Pharmaceuticals QA release, Patheon may ship the Product to a site specified by the Jazz Pharmaceuticals for further processing, storage or distribution.

  

 10 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

	 	14.5.	Patheon in certain limited cases, may ship the Product in “quarantine” status to a site specified by Jazz Pharmaceuticals. In such exceptional cases, Jazz Pharmaceuticals
QA will provide a written authorization to release the Product in “quarantine” status for further processing. The terms of the quarantine shipment to be agreed by Patheon and Jazz Pharmaceuticals QA. 

 15. Stability 
  

	 	15.1.	Patheon will store the stability samples in accordance with cGMPs and all applicable regulations and Specifications. 

  

	 	15.2.	Patheon will perform stability testing for the Product as described in the approved stability protocol. 

  

	 	15.3.	Patheon will notify Jazz Pharmaceuticals of any suspect or actual stability failure for the Product within one business day of verification of the aberrant test data.

  

	 	15.4.	Patheon will provide stability data to Jazz Pharmaceuticals as agreed to in writing by both parties. 

  

	 	15.5.	In the event of the termination of this Quality Agreement, Patheon will continue to provide Jazz Pharmaceuticals with stability data until all Product distributed by Jazz
Pharmaceuticals has reached the end of its shelf life. 

 16. Review of Quality Agreement 
  

	 	16.1.	This Quality Agreement will be reviewed annually. 

  

	 	16.2.	Modifications can be made as required to ensure continued compliance with all applicable laws, regulations and procedures. Any such modifications must be in writing and approved by
both Patheon and Jazz Pharmaceuticals. 

  

 11 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 17. Quality Contacts 
  

			
	 Jazz Pharmaceuticals, Inc.
	  	Patheon Pharmaceuticals Inc.
		
	3180 Porter Drive	  	2110 East Galbraith Road
		
	Palo Alto, CA 94304	  	Cincinnati, OH 45237-1625
		
	USA	  	USA
		
	650.496.3777 (main)	  	513 948-9111 (main)
		
	[ * ]	  	[ * ]
	Director, Quality Sciences	  	Manager, GMP Services
	Jazz Pharmaceuticals, Inc.	  	Patheon Pharmaceuticals Inc.
		
	3180 Porter Drive	  	2110 East Galbraith Road
		
	Palo Alto, CA 94304	  	Cincinnati, OH 45237-1625
		
	USA	  	USA
		
	[ * ]	  	[ * ]
	650.496.2641 (fax)	  	[ * ]
	[ * ]	  	[ * ]
		
	[ * ]	  	[ * ]
	Director, Regulatory Affairs/Compliance	  	Manager, Quality Assurance
	Jazz Pharmaceuticals, Inc.	  	Patheon Pharmaceuticals Inc.
		
	3180 Porter Drive	  	2110 East Galbraith Road
		
	Palo Alto, CA 94304	  	Cincinnati, OH 45237-1625
		
	USA	  	USA
		
	[ * ]	  	[ * ]
	650.496.2641 (fax)	  	[ * ]
	[ * ]	  	[ * ]

  

 12 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED. 

 18. Approvals 
  

									
	Jazz Pharmaceuticals, Inc.	 	 	 	Patheon Pharmaceuticals Inc.
					
	Name:	 	Janne Wissel	 		 	Name:	 	Jack Domet
					
	Title:	 	Senior Vice President, Development	 		 	Title:	 	Director, Quality Operations
					
	Signature:	 	 /s/ Janne Wissel
	 		 	Signature:	 	 /s/ Jack Domet

					
	Date:	 	March 13, 2007	 		 	Date:	 	March 13, 2007

  

			
	Jazz Pharmaceuticals, Inc.
		
	Name:	 	Gopi Kurse
		
	Title:	 	Senior Director, Quality Sciences
		
	Signature:	 	 /s/ Gopi Kurse

		
	Date:	 	March 13, 2007

  

 13 
 [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.

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