Document:

Document

Master Manufacturing Services Agreement
			
	

[*] = Certain portions of this agreement have been the omitted because the omitted portions are both (i) not material and (ii) is the type that the registrant treats as private or confidential.
Exhibit 10.8

Master Manufacturing Services Agreement
October 1, 2015

Master Manufacturing Services Agreement
			
	

Table of Contents
												
	ARTICLE 1		STRUCTURE OF AGREEMENT AND INTERPRETATION	1
	1.1		Master Agreement.	1
	1.2		Product Agreements.	1
	1.3		Definitions.	2
	1.4		Currency.	8
	1.5		Sections and Headings.	8
	1.6		Singular Terms.	8
	1.7		Appendix 1, Schedules and Exhibits.	8
	ARTICLE 2		PATHEON'S MANUFACTURING SERVICES	9
	2.1		Manufacturing Services.	9
	2.2		Active Material Yield.	12
	ARTICLE 3		CLIENT'S OBLIGATIONS	13
	3.1		Payment.	13
	3.2		Active Materials and Qualification of Additional Sources of Supply.	13
	ARTICLE 4		CONVERSION FEES AND COMPONENT COSTS	14
	4.1		First Year Pricing.	14
	4.2		Price Adjustments - Subsequent Years' Pricing.	14
	4.3		Price Adjustments - Current Year Pricing.	16
	4.4		Adjustments Due to Technical Changes or Regulatory Authority Requirements.	16
	4.5		Multi-Country Packaging Requirements.	17
	ARTICLE 5		ORDERS, SHIPMENT, INVOICING, PAYMENT	17
	5.1		Orders and Forecasts.	17
	5.2		Reliance by Patheon.	19
	5.3		Minimum Orders.	20
	5.4		Delivery and Shipping.	20
	5.5		Invoices and Payment.	20
	ARTICLE 6		PRODUCT CLAIMS AND RECALLS	20
	6.1		Product Claims.	20
	6.2		Product Recalls and Returns.	21
	6.3		Patheon's Responsibility for Defective and Recalled Products.	22
	6.4		Disposition of Defective or Recalled Products.	23
	6.5		Healthcare Provider or Patient Questions and Complaints.	23
	6.6		Sole Remedy.	23
	ARTICLE 7		CO-OPERATION	24
	7.1		Quarterly Review.	24
	7.2		Governmental Agencies.	24
	7.3		Records and Accounting by Patheon.	24
	7.4		Inspection.	24
	7.5		Access.	25
	7.6		Notification of Regulatory Inspections.	25
	7.7		Reports.	25
	7.8		Regulatory Filings.	25
	7.9		Inspection by Regulatory Authorities.	26
	ARTICLE 8		TERM AND TERMINATION	27
	8.1		Initial Term.	27
	8.2		Termination for Cause.	27
	8.3		Termination by Client.	28
	8.4		Product Discontinuation.	28

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	8.5		Obligations on Termination.	28
	ARTICLE 9		REPRESENTATIONS, WARRANTIES AND COVENANTS	29
	9.1		Authority.	29
	9.2		Client Warranties.	29
	9.3		Patheon Warranties.	30
	9.4		Debarred Persons.	31
	9.5		Permits.	31
	9.6		Compliance and Laws.	31
	9.7		No Warranty.	31
	ARTICLE 10		REMEDIES AND INDEMNITIES	31
	10.1		Consequential Damages.	31
	10.2		Limitation of Liability.	32
	10.3		Patheon Indemnity.	32
	10.4		Client Indemnity.	33
	10.5		Reasonable Allocation of Risk.	33
	ARTICLE 11		CONFIDENTIALITY	33
	11.1		Confidential Information.	33
	11.2		Use Of Confidential Information.	34
	11.3		Exclusions.	34
	11.4		Photographs And Recordings.	35
	11.5		Permitted Disclosure.	35
	11.6		Return of Confidential Information.	35
	11.7		Remedies.	35
	ARTICLE 12		DISPUTE RESOLUTION	36
	12.1		Commercial Disputes.	36
	12.2		Technical Dispute Resolution.	36
	ARTICLE 13		MISCELLANEOUS	36
	13.1		Inventions.	36
	13.2		Intellectual Property.	37
	13.3		Insurance.	37
	13.4		Independent Contractors.	38
	13.5		No Waiver.	38
	13.6		Assignment.	38
	13.7		Force Majeure.	38
	13.8		Additional Product.	39
	13.9		Notices.	39
	13.10		Severability.	40
	13.11		Entire Agreement.	40
	13.12		Other Terms.	40
	13.13		No Third Party Benefit or Right.	40
	13.14		Execution In Counterparts.	40
	13.15		Use of Client Name.	41
	13.16		Taxes.	41
	13.17		Governing Law.	42

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Master Manufacturing Services Agreement
			
	

MASTER MANUFACTURING SERVICES AGREEMENT
THIS MASTER MANUFACTURING SERVICES AGREEMENT (the "Agreement") is made as of October 1, 2015 (the “Effective Date”)
B E T W E E N:
						
		PATHEON PHARMACEUTICALS INC.,
		a corporation existing under the laws of the State of Delaware
		
		("Patheon"),

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		JAZZ PHARMACEUTICALS IRELAND LIMITED,
		a corporation existing under the laws of Ireland
		
		("Client").

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
STRUCTURE OF AGREEMENT AND INTERPRETATION
1.1Master Agreement. 
    This Agreement establishes the general terms and conditions under which Patheon or any Affiliate of Patheon may perform Manufacturing Services for Client or any Affiliate of Client, at the manufacturing site where the Affiliate of Patheon resides. This “master” form of agreement is intended to allow the parties, or any of their Affiliates, to contract for the manufacture of multiple Products through Patheon’s global network of manufacturing sites through the issuance of site specific Product Agreements without having to re-negotiate the basic terms and conditions contained herein.
1.2Product Agreements.
    This Agreement is structured so that a Product Agreement may be entered into by the parties or their respective Affiliates for Manufacturing Services for a particular Product or multiple Products at a Patheon Manufacturing Site. Each Product Agreement will be governed by the terms and conditions of this Agreement unless the parties to the Product Agreement expressly reference the applicable section of this Agreement and modify its terms in the Product Agreement. Unless otherwise agreed by the parties, each Product Agreement will be in the general form and contain the information set forth in Appendix 1 
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hereto.   The parties intend that, after the parties enter into a Product Agreement with respect to the Client’s Xyrem® Product(s), this Agreement and such  Product Agreement issued hereunder related to Client’s Xyrem® Product(s) will supersede the Manufacturing Services and Supply Agreement between Patheon and Client (as successor in interest to Jazz Pharmaceuticals, Inc.) dated March 13, 2007 as amended.  
1.3Definitions.
The following terms will, unless the context otherwise requires, have the respective meanings set out below and grammatical variations of these terms will 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 Materials", “Active Pharmaceutical Ingredients” or “API” means the materials listed in a Product Agreement on Schedule D;
"Active Materials Credit Value" means the value of the Active Materials for certain purposes of this Agreement, as set forth in a Product Agreement on Schedule D;
“Actual Annual Yield” or “AAY” has the meaning specified in Section 2.2(a);
“Actual Yearly Volume” or “AYV” for each Product has the meaning specified in the applicable Product Agreement; 
"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; or
(c)    a business entity, the controlling interest of which is, directly or indirectly, under common control with a party to this Agreement;
For this definition, "control" means the ownership of shares carrying at least a majority of the votes for the election of the directors of a corporation;
“Annual Product Review Report” means the annual product review report, which will be prepared by Patheon, as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e); 
"Annual Report" means the annual report to the FDA, which is required to be prepared and filed by Client, regarding the Product as described in Title 21 of the United States Code of Federal Regulations, Section 314.81(b)(2);
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"Annual Volume" means the minimum volume of Product to be manufactured in any Year of this Agreement as set forth in Schedule B;
"Applicable Laws" means all applicable federal, state and local laws, rules, regulations and requirements;
"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;
“Bill Back Items” means the expenses for all third party supplier fees for the purchase or use of columns, standards, non-standard tooling, non-standard pallets, non-standard PAPR or PPE suits (where applicable) and other project-specific items necessary for Patheon to perform the Manufacturing Services, and which are not included as Components, as may be specified in the Product Agreement for a Product;
“Breach Notice” has the meaning specified in Section 8.2(a);
"Business Day" means a day other than a Saturday, Sunday or a day that is a statutory holiday in the country where the Manufacturing Site is located, unless another country is specified in the Product Agreement;
“Capital Equipment Agreement” means a separate agreement that the parties may enter into that will address responsibility for the purchase of capital equipment and facility modifications that may be required to perform the Manufacturing Services under a particular Product Agreement;
"cGMPs" means, as applicable, current good manufacturing practices as described in the laws of the applicable jurisdiction, including without limitation:
(a)    Parts 210 and 211 of Title 21 of the United States' Code of Federal Regulations; 
(b)    EC Directive 2003/94/EC; and
(c)    Division 2 of Part C of the Food and Drug Regulations (Canada);
together with the latest Health Canada, FDA and EMA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;
“Client Intellectual Property” means (a) Intellectual Property possessed, generated or derived by Client before entering into this Agreement and (b) Intellectual Property generated or derived  by Patheon while performing any Manufacturing Services or otherwise generated or derived by 
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Patheon in its business, to the extent this Intellectual Property is specific to, or dependent upon, Client’s Active Material or Product or its development, manufacture, use and sale;
“Client Property” has the meaning specified in Section 8.5(d); 
"Client Requested Changes" has the meaning specified in Section 4.4;
“Client-Supplied Components” means those Components to be supplied by Client or that have been supplied by Client, as specified in each Product Agreement;
"Components" means, collectively, all packaging components, raw materials, ingredients, and other materials (including labels, product inserts and other labelling for the Products) required to manufacture the Products in accordance with the Specifications, other than the Active Materials;
“Confidential Information” has the meaning specified in Section 11.1;
“CTD” has the meaning specified in Section 7.8(c);
“C-TPAT” has the meaning specified in Section 2.1(f); 
“DEA” means the United States Drug Enforcement Administration or its counterparts in other countries; 
“Deficiencies” have the meaning specified in Section 7.8(d);
"Deficiency Notice" has the meaning specified in Section 6.1(a);
“Delivery Date” means the date scheduled for shipment of Product under a Firm Order;
“Disclosing Party” has the meaning specified in Section 11.1;
"EMA" means the European Medicines Agency or any successor agency thereto; 
"FDA" means the United States Food and Drug Administration or any successor agency thereto; 
"Firm Orders" have the meaning specified in Section 5.1(c);
“Force Majeure Event” has the meaning specified in Section 13.7;
"GST" has the meaning specified in Section 13.16(a)(ii);
"Health Canada" means the section of the Canadian Government known as Health Canada and includes, among other departments, the Therapeutic Products Directorate and the Health Products and Food Branch Inspectorate or any successor agency thereto;
“Importer of Record” has the meaning specified in Section 3.2(a);
“Initial Product Term” has the meaning specified in Section 8.1;
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“Initial Set Exchange Rate” means as of the Effective Date of a Product Agreement, the initial exchange rate set forth in the Product Agreement to convert one unit of the billing currency into the Patheon Manufacturing Site local currency, calculated as the daily average interbank exchange rate for conversion of one unit of the billing currency into the Patheon Manufacturing Site local currency during the 90 day period immediately preceding the Effective Date as published by OANDA.com “The Currency Site” under the heading “FxHistory: historical currency exchange rates”  at www.OANDA.com/convert/fxhistory;
“Initial Term” has the meaning specified in Section 8.1;
"Intellectual Property" includes, without limitation, rights in patents, patent applications, formulae, trademarks, trademark applications, trade-names, Inventions, copyrights, industrial designs, and know how; 
"Invention" means information about 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; 
"Inventory" means all inventories of Components and work-in-process produced or held by Patheon for the manufacture of the Products but, for greater certainty, does not include the Active Materials;
"Laws" means all laws, statutes, ordinances, regulations, rules, by-laws, judgments, decrees or orders of any Authority applicable to the activities hereunder and include, without limitation, cGMPs;
“Long Term Forecast” has the meaning specified in Section 5.1(a); 
"Manufacturing Services" means all of the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Bill Back Items;
"Manufacturing Site" means the facility owned and operated by Patheon where the Manufacturing Services will be performed as identified in a Product Agreement; 
“Materials” means all Components and Bill Back Items required to manufacture the Products in accordance with the Specifications, other than the Active Materials;
"Maximum Credit Value" means the maximum value of Active Materials that may be credited by Patheon under this Agreement, as set forth in a Product Agreement on Schedule D;
"Minimum Order Quantity" means the minimum number of Batches of a Product to be produced during the same cycle of manufacturing as set forth in a Product Agreement on Schedule B;
“Obsolete Stock” has the meaning specified in Section 5.2(b); 
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“Patheon Competitor” means a business that derives greater than [*] of its revenues from performing contract pharmaceutical development or commercial manufacturing services;  
“Patheon Intellectual Property” means 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, a Product and which have general application to manufacturing processes or formulation development of drug product or drug delivery. But this definition will not include any Intellectual Property allocated to or assigned to Jazz Pharmaceuticals or any of its Affiliates under any prior agreement entered into with Patheon or any of its Affiliates which will remain the exclusive property of Jazz Pharmaceuticals or its Affiliate;
“PPI” has the meaning specified in Section 4.2(a);
"Patheon Requested Changes" has the meaning specified in Section 4.4;
“Price” means, with respect to each Product, the price to be charged by Patheon for performing the Manufacturing Services for such Product, and includes the cost of Components (other than Client-Supplied Components), certain cost items as set forth in a Product Agreement on Schedule B, and annual stability testing costs as set forth in a Product Agreement on Schedule C;
"Product(s)" means the product(s) listed in a Product Agreement on Schedule A hereto;
“Product Agreement” means the document, signed by Patheon and Client or their respective Affiliates and issued under this Agreement generally in the form set forth in Appendix 1 (including Schedules A to D) under which Patheon will perform Manufacturing Services at a particular Manufacturing Site under the terms and conditions hereof;
“Product Agreement Non-Renewal Notice Period” will have the meaning specified in Section 8.1;
“Product Claims” have the meaning specified in Section 6.3(d);  
"Quality Agreement" means the agreement between the parties entering a Product Agreement that sets out the quality assurance standards for the Manufacturing Services to be performed by Patheon for Client;
“Recall” has the meaning specified in Section 6.2(a);
“Recipient” has the meaning specified in Section 11.1;
“Regulatory Approval” has the meaning specified in Section 7.8(a); 
"Regulatory Authority" means the FDA, EMA, and Health Canada and any other foreign regulatory agencies competent to grant marketing approvals for pharmaceutical products including the Products in the Territory;
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“Remediation Period” has the meaning specified in Section 8.2(a);
“Representatives” means a party’s directors, officers, employees, agents, consultants, or subcontractors;
"Required Manufacturing Changes" has the meaning specified in Section 4.4;
“Resident Jurisdiction" has the meaning specified in Section 13.16(a)(i); 
“Set Exchange Rate” means the exchange rate to convert one unit of the billing currency into the Patheon Manufacturing Site local currency for each Year, calculated as the average daily interbank exchange rate for conversion of one unit of the billing currency into the Patheon Manufacturing Site local currency during the full year period (October 1st [preceding year] to September 30th) as published by OANDA.com “The Currency Site” under the heading “FxHistory: historical currency exchange rates” at www.OANDA.com/convert/fxhistory;
“Shortfall Credit” has the meaning specified in Section 2.2(b);
"Specifications" means the file, for each Product, which is given by Client to Patheon in accordance with the procedures listed in a Product Agreement on Schedule A and which contains documents relating to each Product, including, without limitation:
(a)    specifications for Active Materials and Components including approved vendor;
(b)    manufacturing specifications, directions, and processes;
(c)    storage requirements; 
(d)    environmental, health and safety information for each Product including material safety data sheets; and
(e)    the finished Product specifications, packaging specifications and shipping requirements for each Product; 
all as updated, amended and revised from time to time by Client in accordance with the terms of this Agreement;
“Target Yield” has the meaning specified in Section 2.2(a); 
“Target Yield Determination Batches” has the meaning specified in Section 2.2(a);
"Tax" or "Taxes" have the meaning specified in Section 13.6(a);
"Technical Dispute" has the meaning specified in Section 12.2;
"Territory" means the geographic area described in a Product Agreement where Products manufactured by Patheon will be distributed by Client; 
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"Third Party Rights" means the Intellectual Property of any third party; 
"VAT" has the meaning specified in Section 13.16(d); 
"Year" means in the first year of this Agreement or in the first year of a Product Agreement, the period from the Effective Date up to and including December 31 of the same calendar year, and thereafter will mean a calendar year; and
“Yearly Forecast Volume” or “YFV” has the meaning specified in Section 4.2.1; 
1.4Currency.  
Unless otherwise agreed in a Product Agreement, all monetary amounts expressed in this Agreement are in United States Dollars (USD). 
1.5Sections and Headings.  
The division of this Agreement into Articles, Sections, Subsections, an Appendix, Schedules and Exhibits and the insertion of headings are for convenience of reference only and will not affect the interpretation of this Agreement.  Unless otherwise indicated, any reference in this Agreement to a Section, Appendix, Schedule or Exhibit refers to the specified Section, Appendix, Schedule or Exhibit 
to this Agreement.  In this Agreement, the terms "this Agreement", "hereof", "herein", "hereunder" and similar expressions refer to this Agreement as a whole and not to any particular part, Section, Appendix, Schedule or Exhibit of this Agreement.
1.6Singular Terms.
Except as otherwise expressly stated or unless the context otherwise requires, all references to the singular will include the plural and vice versa.
1.7Appendix 1, Schedules and Exhibits.
Appendix 1 (including the Schedules thereto) and the following Exhibits are attached to, incorporated in, and form part of this Agreement:
Appendix 1    Form of Product Agreement (Including Schedules A to D)      
Exhibit A    Technical Dispute Resolution
Exhibit B    [Reserved]
Exhibit C    Quarterly Active Materials Inventory Report    
Exhibit D    Report of Annual Active Materials Inventory Reconciliation and Calculation of Actual Annual Yield
Exhibit E    Example of Price Adjustment Due to Currency Fluctuation
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ARTICLE 2
PATHEON'S MANUFACTURING SERVICES
2.1Manufacturing Services.
Patheon will perform the Manufacturing Services for the Territory for the Price set forth in the applicable Product Agreement in Schedules B and C to manufacture Products for Client.  Schedule B to a Product Agreement sets forth a list of cost items that are included or not included in the Price for Products; all cost items that are not included in the Price are subject to additional fees to be paid by Client.  The Price may be adjusted as set forth in Article 4.  Patheon may change the Manufacturing Site for the Products only with the prior written consent of Client.  If the parties agree that a minimum percentage of any Product will be manufactured by Patheon, (a) this agreement will be set forth in the applicable Product Agreement; and (b) Client may establish other suppliers as additional manufacturers of each Product and may purchase each Product from these manufacturers, if Patheon does not, or cannot, meet all of Client’s Firm Orders for the Product.  Patheon will be entitled to any applicable manufacturing tax credits that arise from performing the Manufacturing Services under this Agreement.  In performing the Manufacturing Services, Patheon and Client agree that:
(a)    Conversion of Active Materials and Components.  Patheon will convert each Active Material and the applicable Components into Product, as set forth in the applicable Product Agreement.
(b)    Quality Control and Quality Assurance.  Patheon will perform the quality control and quality assurance testing specified in the Quality Agreement.  Batch review and release to Client will be the responsibility of Patheon’s quality assurance group.  Unless otherwise set forth in the Quality Agreement, Patheon will perform its batch review and release responsibilities in accordance with Patheon’s standard operating procedures.  Unless otherwise set forth in the applicable Product Agreement or Quality Agreement, each time Patheon ships Products to Client, it will give Client a certificate of analysis and certificate of compliance including a certification that the 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 will test each Batch of Product to be supplied pursuant to this Agreement in accordance with the methods for the Product set forth in the Specifications before delivery of the Batch to Client.  Client reserves the right to test or have tested all Products supplied by Patheon and to reject Product that fails to comply with the applicable Specifications or Product that was not manufactured in accordance with cGMPs or Applicable Laws. Client will have sole responsibility for the release of Products to the market.  The form and style of batch documents, including, but not limited to, Batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of Patheon.  Specific Product related information contained in those Batch documents is Client Property. 
(c)    Components.  Patheon will purchase and test all Components (with the exception of Client-Supplied Components) at Patheon's expense and as required by the Specifications.  
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But Patheon may agree to test certain Client-Supplied Components as specified in the applicable Product Agreement.  Client will have the right to specify the suppliers for the Components but if the supplier is not an approved supplier currently used by Patheon, it will be Client’s responsibility to audit and approve the supplier.  At Client’s request and for an additional fee, Patheon may agree to audit and approve the supplier.  Patheon will not change any Specifications or supplier of any Components without the prior written consent of Client.
(d)    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 Client) and approve the Active Material as acceptable for performing Manufacturing Services under this Agreement and the applicable Product Agreement.  Unless otherwise agreed in a Product Agreement, Patheon will notify Client in writing within [*] days of receipt of any failure of Active Material unless earlier notice is required by Applicable Law; absent this notice, the Active Material will be deemed to be accepted and approved by Patheon.
(e)    Stability Testing.  Patheon will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the fees and at the time periods set out in Schedule C to a Product Agreement.  Patheon will not make any changes to these testing protocols or Specifications without prior written consent of Client.  Patheon will promptly provide any and all data and results relating to the stability testing upon request by Client. If any Batch of a Product fails or is suspected to fail stability testing, Patheon will notify Client within [*], after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation.  Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications and cGMPs.  Patheon will give Client all stability test data and results at Client’s request.  
(f)     Packaging and Artwork.  Patheon will package the Products in accordance with the Specifications.  Client will be responsible for the cost of artwork development.  Patheon will determine and imprint the Batch numbers and expiration dates for each Product shipped.  The Batch numbers expiration dates, and when agreed upon by the Parties, serial numbers will be affixed on the Products and on the shipping carton of each Product as outlined in the Specifications and as required by cGMPs.  Client may, in its sole discretion, make changes to labels, product inserts, and other packaging for the Products.  Those changes will be submitted by Client to all applicable Regulatory Authorities and other third parties responsible for the approval of the Products.  Client will be responsible for the cost of labelling obsolescence when changes occur, as contemplated in Section 4.4.  Patheon's name will not appear on the label or anywhere else on the Products unless: (i) required by any Laws; or (ii) Patheon consents in writing to the use of its name. At least [*] days prior to the Delivery Date of Product for which new or modified artwork is required, Client will provide at no cost to Patheon, final camera ready artwork for all packaging Components to be used in the manufacture of the Product that meet the Specifications.  But if this new or modified artwork is required in connection with a Product 
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launch or is due to changes in safety information or Regulatory Authority requirements, then Patheon will use commercially reasonable efforts to implement the changes to the artwork on an expedited basis.  For the avoidance of doubt, the parties acknowledge and agree that Client will be responsible for complying with any and all regulatory requirements for the labeling of the Product.
(g)     Active Materials and Client-Supplied Components.  If Patheon has advised Client of the scheduled production date, then, at least [*] days before the scheduled production date, Client will deliver the Active Materials and any Client-Supplied Components to the Manufacturing Site [*] (Incoterms 2010), at no cost to Patheon, in sufficient quantity to enable Patheon to manufacture the desired quantities of Product and to ship Product on the Delivery Date.  If the Active Materials and/or Client-Supplied Components are not received [*] days before the scheduled production date, Patheon may delay the shipment of Product by the same number of days as the delay in receipt of the Active Materials and/or Client-Supplied Components.  But if Patheon is unable to manufacture Product to meet this new shipment date due to prior third party production commitments, Patheon may delay the shipment until a later date as agreed to by the parties.  All shipments of Active Material will be accompanied by certificate(s) of analysis from the Active Material manufacturer and Client, confirming the identity and purity of the Active Materials and its compliance with the Active Material specifications.  For Active Materials or Client-Supplied Components which may be subject to import or export, Client agrees that it will use reasonable efforts to ensure that its vendors and carriers will comply with applicable requirements of the U.S. Customs and Border Protection Service and the Customs Trade Partnership Against Terrorism (“C-TPAT”).
(h)    Bill Back Items.  Bill Back Items will be charged to Client at Patheon’s cost plus a [*] handling fee.
(i)    Validation Activities (if applicable).  Patheon may assist in the development and approval of the validation protocols for analytical methods and manufacturing procedures (including packaging procedures) for the Products.  The fees for this service are not included in the Price and will be set out separately in Schedule C to a Product Agreement.
(j)    Additional Services.  If Client requests services other than those expressly set forth herein or in any Product Agreement (such as qualification of a new packaging configuration or shipping studies, or validation of alternative Batch sizes), Patheon will provide a good faith and reasonable written quote of the fee for the additional services and Client will advise Patheon whether it wishes to have the additional services performed by Patheon.  The scope of work and fees will be set forth in a separate statement of work signed by the parties, which will subject to the terms and conditions hereof. The title of this statement of work will reference the applicable Product Agreement and will be numbered sequentially.
2.2Active Material Yield.  
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(a)    Reporting.  Patheon will give Client a monthly inventory report of the Active Materials held by Patheon using the inventory report form set out in Exhibit C, which will contain the following information for the month:
Quantity Received:  The total quantity of each Active Material that complies with the applicable Specifications and is received at the applicable Manufacturing Site during the applicable period. 
Quantity Dispensed:  The total quantity of each Active Material dispensed at the applicable Manufacturing Site during the applicable period.  The Quantity Dispensed is calculated by [*].  The Quantity Dispensed will only include Active Materials received and dispensed in commercial manufacturing of Products and, for certainty, will not include any (i) Active Materials that must be retained by Patheon as samples, (ii) Active Materials contained in Product that must be retained as samples, (iii) Active Materials used in testing (if applicable), and (iv) Active Materials received or dispensed in 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 Products manufactured with the Quantity Dispensed (including any additional Products produced in accordance with Section 6.3(a) or 6.3(b)), delivered by Patheon, and not rejected, recalled or returned in accordance with Section 6.1or 6.2.  Within [*] days after the end of each Year, Patheon will prepare an annual reconciliation of Active Materials on the reconciliation report form set forth in Exhibit D including the calculation of the "Actual Annual Yield" or "AAY" for the Product at the Manufacturing Site during the Year.  AAY is the percentage of the Quantity Dispensed that was converted to Products and is calculated as follows:
Quantity Converted during the Year    x    100%    
Quantity Dispensed during the Year
After Patheon has produced a minimum of [*] successful commercial production Batches of Product and has produced commercial production Batches for at least [*] at the Manufacturing Site (collectively, the "Target Yield Determination Batches"), the parties will work in good faith to agree on the target yield for the Product at the Manufacturing Site (each, a "Target Yield").  The Target Yield will be revised annually as agreed by the parties to reflect the actual manufacturing experience.
(b)    Shortfall Credit Calculation.  The parties will agree in each Product Agreement to a specific Loss Tolerance Percentage, which will be used to calculate whether a shortfall in Active Material yield has occurred. If the Actual Annual Yield falls more than the agreed Loss Tolerance Percentage below the respective Target Yield in a Year, then the shortfall for the Year (the "Shortfall") for such Product will be calculated as follows:
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[*]
(c)    Credit for Shortfall.  If there is a Shortfall for a Product in a Year, then Patheon will credit Client’s account for the amount of the Shortfall not later than [*] days after the end of the Year.  Each credit under this Section 2.2(c) will be summarized on the reconciliation report form set forth in Exhibit D.  Upon expiration or termination of a Product Agreement, any remaining credit owing under this Section will be paid to Client.  The Annual Shortfall, if any, will be disclosed by Patheon on the reconciliation report form.
(d)    Maximum Credit.  Patheon's liability for Active Materials calculated in accordance with this Section 2.2 [for any Product] in a Year will not exceed, in the aggregate, the Maximum Credit Value set forth in Schedule D to a Product Agreement. 
(e)    No Material Breach.  If Patheon has used commercially reasonable efforts to achieve the Target Yield and if the Actual Yield is not less than 80% of the Target Yield, it will not be a material breach of this Agreement by Patheon under Section 8.2(a) if the Actual Annual Yield is less than the Target Yield.
ARTICLE 3
CLIENT'S OBLIGATIONS
3.1Payment.
Client will pay Patheon for performing the Manufacturing Services according to the Prices specified in Schedules B and C in a Product Agreement. These Prices may be subject to adjustment under other parts of this Agreement.  Client will also pay Patheon for any Bill Back Items.
3.2Active Materials and Qualification of Additional Sources of Supply.
(a)    Client will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(g). If applicable, Patheon and Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. [*]  The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement.  Title to the Active Materials will at all times remain the property of Client.  Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services. Client will be responsible for paying for all rejected Product that arises from defects in the Active Materials which could not be reasonably discoverable by Patheon using the test methods set forth in the Specifications. 
(b)    If Client asks Patheon to qualify an additional source for an Active Material or any Component, Patheon may agree to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The 
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parties will agree on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, this work at a minimum will include: (i) laboratory testing to confirm the Active Material meets existing specifications; (ii) manufacture of an experimental Batch of Product that will be placed on three months accelerated stability; and (iii) manufacture of a mutually agreed upon number of full-scale validation Batches that will be placed on concurrent stability (one Batch may be the registration Batch if manufactured at full scale). Section 6.1(d) will apply to all Product manufactured using the newly approved Active Material or Component because of the limited material characterization that is performed on additional sources of supply.
(c)    If  will promptly advise Client if it encounters supply problems, including delays and/or delivery of non-conforming Active Material or Components from a Client designated additional source.  Patheon and Client will cooperate to reduce or eliminate any supply problems from these additional sources of supply. Client will be obligated to re-qualify all Client designated sources of supply on an annual basis at its expense and will provide Patheon with copies of these annual re-qualifications.  If Patheon agrees to qualify or re-qualify Client designated additional sources of supply on behalf of Client, it will do so at Client’s expense.
ARTICLE 4
CONVERSION FEES AND COMPONENT COSTS
4.1First Year Pricing.
The Price for the first Year will be listed in Schedules B and C in a Product Agreement and will be subject to the adjustments set forth in Sections 4.2 and 4.3. The Price may also be increased or decreased by Patheon at any time upon written notice to Client if there are changes to the underlying manufacturing, packaging or testing assumptions set forth in Schedule B of the Product Agreement that result in an increase or decrease in the cost of performing the Manufacturing Services. 
4.2Price Adjustments – Subsequent Years’ Pricing.
After the first Year of the Product Agreement, Patheon may adjust the Price effective January 1st of each Year as follows:
(a)    Manufacturing and Stability Testing Costs. For Products manufactured in the United States or Puerto Rico, the conversion component of the Price and the annual stability testing costs may be adjusted to the extent of the preliminary number for any change in the Producer Price Index pcu325412325412 for Pharmaceutical Preparation Manufacturing (“PPI”) published by the United States Department of Labor, Bureau of Labor Statistics in August of the preceding Year compared to the final number for the same month of the Year prior to that, unless the parties otherwise agree in writing.  On or before November 30 of each Year, Patheon will give Client a statement setting forth the calculation for the adjustment to be applied in calculating the Price for the next Year.  For Products manufactured outside the United States or Puerto Rico, the conversion component of the 
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Price and the annual stability testing costs may be adjusted to the extent of the corresponding changes using an inflation index to be agreed by the parties in the applicable Product Agreement.     
(b)    Component Costs.  If Patheon incurs an increase in Component costs during the Year, it may increase the Price for the next Year to pass through the additional Component costs at Patheon’s actual cost.  [*]  On or before November 30 of each Year, Patheon will give Client information about the increase or decrease in Component costs which will be applied to the calculation of the Price for the next Year together with reasonable documentation to demonstrate that the Price increase or decrease is justified.  But Patheon will not be required to give information to Client that is subject to obligations of confidentiality between Patheon and its suppliers.  Patheon will use commercially reasonable efforts to minimize Component costs.  
(c)    Pricing Basis.  Client acknowledges that the Price in any Year is quoted based upon the Annual Volume specified in Schedule B to each Product Agreement.  The Price is subject to change if [*].  
[*].On or before November 30 of each Year, Patheon will give Client a statement setting forth the information to be applied in calculating those cost increases for the next Year.  But Patheon will not be required to give information to Client that is subject to obligations of confidentiality between Patheon and its suppliers.

(d)    Adjustments Due to Currency Fluctuations.  If the parties agree in a Product Agreement to invoice in a currency other than the local currency for the Manufacturing Site, Patheon will adjust the Price to reflect currency fluctuations.  The adjustment will be calculated after all other annual Price adjustments under this Section 4.2 have been made.  The adjustment will proportionately reflect the increase or decrease, if any, in the Set Exchange Rate compared to the Set Exchange Rate established for the prior Year or the Initial Set Exchange Rate, as the case may be.  An example of the calculation of the price adjustment (for a Canadian Manufacturing Site invoiced in USD) is set forth in Exhibit E.
(e)    Tier Pricing (if specified in a Product Agreement).  If the pricing in Schedule B of a Product Agreement is set forth in Annual Volume tiers based upon Client’s volume forecasts under Section 5.1(a), the parties will estimate the Price in any Year based on Client’s [*] forecast provided pursuant to Section 5.1(a).  Within [*] days of the end of each Year, the parties will reconcile the difference which may be payable by either party based on the Actual Ordered Product for the Year.  If the Actual Ordered Product for the Year is in a tier with a higher cost than that used to calculate the Price for the Year, Client will pay Patheon the difference owed in accordance with Section 5.5.  If the Actual Ordered Product for the year is in a tier with a lower cost than that used by the parties to estimate the Price for the year, Patheon will credit or refund, at Client’s option, Client for the overpayment.  
(f)    For all Price adjustments under this Section 4.2, Patheon will deliver to Client on or before November 30 of each Year a revised Schedule B to the Product Agreement to be effective for Product delivered on or after the first day of the next Year. If in any Year Patheon would 
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have been entitled to increase the Price based on any of the provisions of this Section 4.2 but Patheon did not exercise its right to do so, then at the expiry of any subsequent Year, Patheon will be entitled to make cumulative adjustments only for Product sold after the expiry of such Year, as set out in Section 4.2 to the extent of any permitted changes for all of the preceding Years since Patheon last adjusted the Price.
4.3Price Adjustments – Current Year Pricing.
During any Year, the Prices set out in Schedule B of a Product Agreement will be adjusted as follows:
Extraordinary Increases in Component Costs.  If, at any time, market conditions result in Patheon's cost of Components being materially greater or less than normal forecasted changes, then the Price may be adjusted for any affected Product to solely to reflect the changes to the Component costs.  Unless otherwise agreed in a Product Agreement, changes materially greater or less than normal forecasted increases will have occurred if: (i) the cost of a Component increases or decreases by [*] of the cost for that Component, as set forth in Schedule B to the applicable Product Agreement and subject to any prior adjustments made under Section 4.2(b); or (ii) the aggregate cost for all Components required to manufacture a Product increases or decreases by [*] of the total Component costs for the Product as set forth in Schedule B to applicable Product Agreement and subject to any prior adjustments made under Section 4.2(b).  If Component costs have been previously adjusted to reflect an increase or decrease in the cost of one or more Components, the adjustments set out in (i) and (ii) above will operate based on the last cost adjustment for the Components. 
For a Price adjustment under this Section 4.3, Patheon will deliver to Client a revised Schedule B to the Product Agreement and budgetary pricing information, adjusted Component costs or other documents reasonably sufficient to demonstrate that a Price adjustment is justified.  Patheon will have no obligation to deliver any supporting documents that are subject to obligations of confidentiality between Patheon and its suppliers.  The revised Price will be effective for any Product delivered on or after the first day of the month following Client’s receipt of the revised Schedule B to the Product Agreement.
4.4Adjustments Due to Technical Changes or Regulatory Authority Requirements.
For changes to the Specifications or manufacturing processes that are required by Applicable Laws ("Required Manufacturing Changes"), Patheon and Client will cooperate in making these changes and use commercially reasonable efforts to implement the changes promptly in a manner that minimizes any effect on the supply hereunder to Client of Product meeting Specifications.  All costs associated with Required Manufacturing Changes directly related to the Manufacturing Site will be borne by Patheon.  All other costs associated with Required Manufacturing Changes under this Agreement, including, without limitation, obsolete Components, Regulatory Filings, work in process, equipment and Product will be borne by Client.  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 a technical and cost review by Patheon and are subject to Client and Patheon reaching agreement as to revisions, if any, to the fees specified in Schedules B or C of the Product 
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Agreement necessitated by the 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, this approval not to be unreasonably withheld, and the costs of the Patheon Requested Changes will be borne by Patheon.  If Client accepts a proposed fee change, the proposed change in the Specifications will be implemented, and the fee change will become effective only for those orders of the Product that are manufactured in accordance with the revised Specifications.  In addition, for Client Requested Changes, Client agrees to purchase, at Patheon's cost (including all costs incurred by Patheon in connection with the purchase and handling of the Inventory), all Inventory held under the "old" Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with Section 5.2, to the extent that the Inventory can no longer be utilized under the revised Specifications.  Open purchase orders for 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 will be cancelled where possible, and where the orders are not subject to cancellation without penalty, will be assigned to and satisfied by Client. 
4.5Multi-Country Packaging Requirements.  
If Client decides to have Patheon perform Manufacturing Services for the Product for countries outside the Territory, then Client will inform Patheon of the packaging requirements for each new country and Patheon will prepare a quotation for consideration by Client of any additional costs for Components (other than Client-Supplied Components) and the change over fees for the Product destined for each new country.  The agreed additional packaging requirements and related packaging costs and change over fees will be set out in a written amendment to this Agreement.
ARTICLE 5
ORDERS, SHIPMENT, INVOICING, PAYMENT
5.1Orders and Forecasts.  
(a)    Long Term Forecast.  When each Product Agreement is executed, Client will give Patheon a non-binding [*] year forecast of Client’s volume requirements for the Product for each Year during the term of the Product Agreement (the “Long Term Forecast”).  The Long Term Forecast will thereafter be updated every six months (as of June 1 and December 1) during the Initial Product Term.  If Patheon is unable to accommodate any portion of the Long Term Forecast, it will notify Client and the parties will agree on any revisions to the forecast.
(b)    Rolling [*] Month Forecast.  When each Product Agreement is executed, Client will give Patheon a non-binding [*] month forecast of the volume of Product that Client expects to order in the first [*] months of commercial manufacture of the Product.  This forecast will then be updated by Client on or before the [*] day of each month on a rolling forward basis.  Client will update the forecast forthwith if it determines that the volumes estimated in the most recent forecast are anticipated to change by more than [*]. The most recent [*] month forecast will prevail over prior forecasts.
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(c)    Firm Orders.  On or before the [*] day of each month Client will issue firm written orders (“Firm Orders”) for each Product from time to time at Client’s discretion to be produced and delivered to Client on a date not less than [*] months from the [*] date of the month immediately following the date that the Firm Order is submitted unless otherwise agreed in a Product Agreement.  Firm Orders submitted to Patheon will specify 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 each Product.  The quantities of Product ordered in Firm Orders will be firm and binding on Client.  Notwithstanding the foregoing, and subject to the availability of required Components, for each Product, Patheon will permit amendments and substitutions to Firm Orders issued by Client upon prior written notice to Patheon for Product packaging no more than [*] per Year.  But Patheon will not accept these amendments or substitutions once manufacturing or packaging has commenced. 
(d)    Acceptance of Firm Order.  Firm Orders placed with Patheon by Client pursuant to the provisions of Section 5.1(b) will be acknowledged by Patheon in writing within [*] days of receipt thereof.  Patheon will use commercially reasonable efforts to ensure that all Product ordered by Client in accordance with this Agreement will be shipped in accordance with the delivery dates specified in Client’s purchase order but in no event will the actual delivery date be more or less than five days from the date of delivery specified in Client’s purchase order.  Patheon will notify Client promptly of any significant anticipated delay no later than [*] days prior to the delivery date.
(e)    Cancellation of a Firm Order.  Client may cancel a Firm Order upon written notice to Patheon within the first [*] days of the firm period if Patheon has not started the manufacturing process under the Firm Order before receipt of the cancellation notice. If Client cancels a Firm Order in any other circumstances, Client will pay Patheon [*] of the Price for the Firm Order. 
(f)    Controlled Substance Quota Requirements (if applicable).  Client will give Patheon the information set forth below for obtaining any required DEA or equivalent agency quotas needed to perform the Manufacturing Services. Patheon will be responsible for management of DEA quota information in accordance with DEA regulations. Patheon and Client will cooperate to communicate the information and to assist each other in DEA information requirements related to the Product as follows: (i) as of [*] for the applicable Product, Client will provide to Patheon the next Year’s annual quota requirements for the Product; (ii) as of [*], Client will provide to Patheon any changes to the next Year’s quota requirements; (iii) Client will pro-actively communicate any changes to the quota requirements for the then-current Year reasonably in advance of the time for Patheon to file and finalize DEA filings supporting the changes; (iv) upon Patheon receiving the necessary forecast information from Client in order to request additional quota, Patheon will submit to the DEA, on a timely basis, all filings necessary to obtain DEA or equivalent agency quotas for Active Materials and will use commercially reasonable efforts to secure sufficient quota from the DEA so as to achieve Delivery Dates for Product as set forth in applicable purchase orders and forecasts submitted to Patheon by Client or its designee; 
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and (v) Patheon will not be responsible for DEA’s refusal or failure to grant sufficient quota for reasons beyond the reasonable control of Patheon, provided that Patheon has met its obligations above. PATHEON ACKNOWLEDGES THAT TIME IS OF THE ESSENCE IN PERFORMING ITS OBLIGATIONS UNDER THIS PROVISION. 
5.2Reliance by Patheon.
(a)    Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted under Sections 5.1(a), and (b) in ordering the Components (other than Client-Supplied Components) required to meet the Firm Orders.  In addition, Client understands that to ensure an orderly supply of the Components, Patheon may want to purchase the Components in sufficient volumes to meet the production requirements for Products during part or all of the forecasted periods referred to in Section 5.1(a) or to meet the production requirements of any longer period agreed to by Patheon and Client.  Accordingly, Client authorizes Patheon to purchase Components to satisfy the Manufacturing Services requirements for Products for the first [*] months contemplated in the most recent forecast given by Client under Section 5.1(a).  Patheon may make other purchases of Components to meet Manufacturing Services requirements for longer periods if agreed to in writing by the parties.  Client will give Patheon written authorization to order Components for any launch quantities of Product requested by Client which will be considered a Firm Order when accepted by Patheon.  
(b)    Client will reimburse Patheon for the cost of Components ordered by Patheon under Firm Orders or under Section 5.2(a) that are not included in finished Products manufactured for Client within [*] months after the forecasted month for which the purchases have been made (or for a longer period as the parties may agree) or if the Components have expired or are rendered obsolete due to changes in artwork or applicable regulations during the period (collectively, “Obsolete Stock”).  This reimbursement will include Patheon’s cost to purchase and destroy the Obsolete Stock.  If any non-expired Components are used in Products subsequently manufactured for Client or in third party products manufactured by Patheon, Client will receive credit for any costs of those Components previously paid to Patheon by Client.
(c)    If Client fails to take possession or arrange for the destruction of non-expired Components within [*] months of purchase or, in the case of the delivery of conforming finished Product not accepted by Client within [*] of manufacture, Client will pay Patheon [*] per pallet, per month thereafter for storing the Components or finished Product.  Storage fees for Components or Product which contain controlled substances or require refrigeration will be charged at [*] per pallet per month.  Storage fees are subject to a one pallet minimum charge per month.  Patheon may ship finished Product held by it longer than [*] to the Client at Client’s expense on [*] days written notice to the Client.
5.3Minimum Orders.
Client may only order Manufacturing Services for Batches of Products only in multiples of the Minimum Order Quantities as set out in Schedule B to each Product Agreement.
5.4Delivery and Shipping.
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Delivery of Products will be made [*] (Incoterms 2010) Patheon’s shipping point unless otherwise agreed in a Product Agreement.  Risk of loss or of damage to Products will remain with Patheon until Patheon loads the Products onto the carrier’s vehicle for shipment at the shipping point at which time risk of loss or damage will transfer to Client. Patheon will, in accordance with Client’s instructions and as agent for Client, arrange for shipping to be paid by Client.  Client will arrange for insurance and will select the freight carrier used by Patheon to ship Products and may monitor Patheon’s shipping and freight practices as they pertain to this Agreement.  Products will be transported in accordance with the Specifications and Applicable Law. 
5.5Invoices and Payment.
Invoices will be sent by fax or email to the fax number or email address given by Client to Patheon in writing.  Unless otherwise agreed in a Product Agreement, invoices will be issued when the Product is manufactured and released by Patheon to Client, and in the case of invoices for stability studies, within [*] days of completion of the applicable study.  Patheon will also submit to Client, with each shipment of Products, a duplicate copy of the invoice covering the shipment.  Patheon will also provide Client with an invoice covering any Inventory or Components which are to be purchased by Client under Section 5.2 of this Agreement.  Each invoice will, to the extent applicable, identify Client’s purchase order number, Product numbers, names and quantities, unit price, freight charges, and the total amount to be paid by Client.  Unless otherwise agreed in a Product Agreement, Client will pay all invoices within [*] days of the date thereof.  If any portion of an invoice is disputed, Client will pay Patheon for the undisputed amount and the parties will use good faith efforts to reconcile the disputed amount as soon as practicable.  Any amounts that are disputed by Client will not be due until ten days following the resolution of the dispute.  Interest on undisputed past due accounts will accrue at [*] per month which is equal to an annual rate of [*]. 
ARTICLE 6
PRODUCT CLAIMS AND RECALLS
6.1Product Claims.
(a)    Product Claims.  Client has the right to reject any portion of any shipment of Product that deviates from the Specifications or was not manufactured in accordance with cGMPs or Applicable Laws without invalidating any remainder of the shipment.  Client or its designee will inspect the Products manufactured by Patheon upon receipt and will use commercially reasonable efforts to give Patheon written notice (a "Deficiency Notice") of all claims for Products that deviate from the Specifications, cGMPs, or Applicable Laws within [*] days after 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 [*] days after discovery by Client, but not after the expiration date of the Product).  Should Client fail to give Patheon the Deficiency Notice within the applicable period, then the delivery will be deemed to have been accepted by Client on the [*] day after delivery or discovery, as applicable.  Patheon will have no liability for any deviations for which it has not received notice within the applicable period.
(b)    Determination of Deficiency.  Upon receipt of a Deficiency Notice, Patheon will have [*] days to advise Client by notice in writing that it disagrees with the contents of the Deficiency Notice.  If 
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Client and Patheon fail to agree within [*] days after Patheon's notice to Client as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, or Applicable Laws, then the parties will mutually select an independent laboratory to evaluate if the Products deviate from the Specifications, cGMPs, or Applicable Laws.  This evaluation will be binding on the parties. If the evaluation certifies that any Products deviate from the Specifications, cGMPs, or Applicable Laws, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation.  If the evaluation does not so certify for any of the Products, then Client will be deemed to have accepted delivery of the Products 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 Client, but not after the expiration date of the Product) and Client will be responsible for the cost of the evaluation.
(c)    Shortages.  If there is a shortage of Product in any shipment by Patheon, at Client’s election, Patheon will use its commercially reasonable efforts to make up the shortage at the next scheduled delivery date.  But if the shortage is more than [*] of the quantity ordered for any individual package configuration, Patheon will use its commercially reasonable efforts to make up the shortage as soon as practical after the shortage is reported to Patheon, but no later than [*] days thereafter.
(d)    Product Rejection for Finished Product Specification Failure. Internal process specifications will be defined and agreed upon.  If Patheon manufactures Product in accordance with the agreed upon process specifications, the batch production record, and Patheon’s standard operating procedures for manufacturing, and a batch or portion of batch of Product does not meet a finished Product specification, Client will pay Patheon the applicable fee per unit for the non-conforming Product. The API in the non-conforming Product will be included in the “Quantity Converted” for purposes of calculating the “Actual Annual Yield” under Section 2.2(a). For avoidance of doubt, any dispute arising with respect to this Section shall be resolved in accordance with Section 12.2.
6.2Product Recalls and Returns.
(a)    Records and Notice.  Patheon and Client will each maintain records necessary to permit a Recall of any Products delivered to Client or customers of Client.  Each party will notify the other by telephone (to be confirmed in writing) within [*] of any information which might affect the marketability, safety or effectiveness of the Products or which might result in the Recall or seizure of the Products.  Upon receiving this notice or upon this discovery, each party will stop making any further shipments of any Products 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, will be made and implemented by Client.  "Recall" will mean any action (i) by Client to recover title to or possession of quantities of the Products sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Products from the market); or (ii) by any regulatory authorities to detain or destroy any of the Products.  Recall will also include any action by either party to refrain from selling or shipping quantities of the Products to third parties which would be subject to a Recall if sold or shipped.
(b)    Recalls.  If (i) any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or 
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that a "Dear Doctor" letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.
(c)    Product Returns.  Client will have the responsibility for handling customer returns of the Products.  Patheon will give Client any assistance that Client may reasonably require to handle the returns.
6.3Patheon’s Responsibility for Defective and Recalled Products.
(a)    Defective Product.  If Client rejects Products under Section 6.1 and the deviation is determined to have arisen from Patheon’s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will credit Client’s account for Patheon’s invoice price for the defective Products.  If Client previously paid for the defective Products, Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the defective Products; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Products with conforming Products, without Client being liable for payment therefor under Section 3.1, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Products.  If the defective Products were manufactured using Client-Supplied Components, then Patheon will, as determined by Client, (i) refund the value of these Client-Supplied Components to Client or (ii) offset the amount paid against other amounts due to Patheon hereunder.   For greater certainty, Patheon’s responsibility for any loss of Active Materials in defective Product will be captured and calculated in the Active Materials Yield under Section 2.2 and Client will receive a Shortfall Credit in connection therewith. 
(b)    Recalled Product.  To the extent  a Recall or return results from, or arises out of, a failure by Patheon to perform the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will be responsible for the documented out-of-pocket expenses of the Recall or return and will use its commercially reasonable efforts to replace the Recalled or returned Products with new Products, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Products.  For greater certainty, Patheon’s responsibility for any loss of Active Materials in Recalled Product will be captured and calculated in the Active Materials Yield under Section 2.2.  If Patheon is unable to replace the Recalled or returned Products (except where this inability results from a failure to receive the required Active Materials and Client-Supplied Components due to the fault of Client), then at Client’s request, Patheon will reimburse Client for the price that Client paid to Patheon for Manufacturing Services for the affected Products.  Patheon will also be responsible for investigating all Recalls and returns (other than as a result of the expiration of the Product) resulting from Patheon’s failure to manufacture the Product in accordance with the Specifications, cGMPs, or Applicable Laws, at its own expense and Patheon will promptly report to Client in writing the results of this investigation.  In all other circumstances, Recalls, returns, or other corrective actions will be made at Client's cost and expense.
(c)    Except as set forth in Sections 6.3(a) and (b) above, Patheon will not be liable to Client nor have any responsibility to Client for any deficiencies in, or other liabilities associated with, any Product manufactured by it in accordance with this Agreement, (collectively, "Product Claims").  For greater certainty but not limitation, except as set forth in Sections 6.3(a) and (b) above, Patheon will have no obligation for any Product Claims to the extent the Product Claim (i) is caused by deficiencies in the 
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Specifications, the safety, efficacy, or marketability of the Products or any distribution thereof after delivery in accordance with Section 5.4, (ii) results from a defect in a Component that is not reasonably discoverable by Patheon using the test methods set forth in the Specifications prior to use of the applicable Component in the performance of the Manufacturing Services, (iii) results from a defect in the Active Materials, Client-Supplied  Components or Components supplied by a Client designated additional source that is not reasonably discoverable by Patheon using the test methods set forth in the Specifications, (iv) is caused by actions of third parties occurring after the Product is shipped by Patheon under Section 5.4, (v) is due to packaging design or labelling defects or omissions for which Patheon has no responsibility, (vi) is due to any unascertainable reason despite Patheon having performed the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws, or (vii) is due to any breach by Client of its obligations under this Agreement.
6.4Disposition of Defective or Recalled Products.
Client will not dispose of any damaged, defective, returned, or Recalled Products for which it intends to assert a claim against Patheon without Patheon’s prior written authorization to do so.  Alternatively, Patheon may instruct Client to return the Products to Patheon.  Patheon will bear the cost of disposition for any damaged, defective, returned or Recalled Products for which it bears responsibility under Section 6.3.  In all other circumstances, Client will bear the cost of disposition, including all applicable fees for Manufacturing Services, for any damaged, defective, returned, or Recalled Products.
6.5Healthcare Provider or Patient Questions and Complaints.
Client will have the sole responsibility for responding to questions and complaints from its customers.  Questions or complaints received by Patheon from Client's customers, healthcare providers or patients will be promptly referred to Client.  Patheon will co-operate as reasonably required to allow Client to determine the cause of and resolve any questions and complaints.  This assistance will include follow-up investigations, including testing.  In addition, Patheon will give Client all necessary information in Patheon’s possession or control that will enable Client to respond properly to questions or complaints about the Products as set forth in the Quality Agreement.  If it is determined that the cause of the complaint resulted from a failure by Patheon to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws and any additional procedures agreed upon in writing by Patheon and Client or a breach of this Agreement by Patheon, all costs incurred under this Section 6.5 will be borne by Patheon.  In all other circumstances, Client will bear the cost incurred under this Section 6.5.
6.6Sole Remedy.
Except for the indemnity set forth 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 will be Client’s sole remedy for any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws or any additional procedures agreed upon in writing by Client and Patheon.
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ARTICLE 7
CO-OPERATION
7.1Quarterly Review.
Each party will 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 will 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 each Manufacturing Site and anticipated shut downs of each Manufacturing Site, and manage any issues that have arisen.
7.2Governmental Agencies.
Subject to Section 7.8 and Article 11, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting Regulatory Approval for the applicable Product, regarding such Product if, in the opinion of that party's counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation.  Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, each party will permit the other party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency.
7.3Records and Accounting by Patheon.
    Patheon will keep records of the manufacture, testing, and shipping of the Products, and retain samples of the Products as are necessary to comply with manufacturing regulatory requirements applicable to Patheon, as well as to assist with resolving Product complaints and other similar investigations.  Unless otherwise agreed to in the Quality Agreement, copies of the records and samples will be retained for [*] following the date of Product expiry, or longer if required by Applicable Law, following which time Patheon may destroy such records or samples; provided, however, Patheon will notify Client in writing at least [*] days prior to such destruction and will retain or deliver such records or samples to Client, at Client’s option and expense, if Client so requests. 
7.4Inspection.
Client may inspect Patheon reports and records relating to this Agreement during normal business hours and with reasonable advance notice, but a Patheon representative must be present during the inspection. 
7.5Access.
Patheon will give Client reasonable access at agreed times to the areas of each Manufacturing Site in which a Product is manufactured, stored, handled, or shipped to permit Client to verify that the Manufacturing Services are being performed in accordance with the Specifications, cGMPs, and Applicable Laws. But, with the exception of “for-cause” audits, for each Product, Client will be limited each Year to [*], lasting no more than [*] days, and involving no more than [*] auditors.  Client may request 
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additional cGMP-type audits, additional audit days, or the participation of additional auditors subject to payment to Patheon of a fee of [*] for each additional audit day and [*] per audit day for each additional auditor. Patheon agrees to permit 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.  The right of access provided in this Section 7.5 will not include a right to access or inspect Patheon’s financial records.  Patheon will use commercially reasonable efforts to obtain the right for Client to have similar inspection rights for Patheon’s third party Component suppliers.  If deficiencies are found by Client during these inspections, the parties will promptly meet to discuss and resolve them and Client will be entitled to make reasonable follow up inspections to monitor correction of the deficiencies.  
7.6Notification of Regulatory Inspections.
Patheon will notify Client within [*] of any inspections by or communications with, any governmental agency involving the Products.  Patheon will furnish to Client within [*] all material information supplied to, or supplied by the governmental agency or third party supplier to the extent that the report relates to a Product or the ability of Patheon to supply a Product.  Patheon will promptly correct any deficiencies noted by any governmental agency in these inspections.  Patheon will also notify Client of receipt of any form 483’s or warning letters or any other significant regulatory action which Patheon’s quality assurance group determines could impact the regulatory status of the Products. 
7.7Reports.
    Upon request, Patheon will supply on an annual basis all Product data, including release test results, complaint test results, and all investigations (in manufacturing, testing, and storage), that Client reasonably requires in order to complete any filing under any applicable regulatory regime, including any Annual Report that Client is required to file with the FDA.  Any additional report requested by Client beyond the scope of cGMPs and customary FDA requirements and beyond the scope of the reports provided by Section 2.2 will be subject to an additional fee to be agreed upon between Patheon and the Client.
7.8Regulatory Filings.
(a)    Regulatory Authority.  Client will have the sole responsibility at Client’s expense for filing all documents with all Regulatory Authorities and taking any other actions that may be required for the receipt and/or maintenance of Regulatory Authority approval for the commercial manufacture, distribution and sale of the Products (“Regulatory Approval”).  Patheon will assist Client, to the extent consistent with Patheon’s obligations under this Agreement, to obtain Regulatory Authority approval for the commercial manufacture, distribution and sale of all Products as quickly as reasonably possible.
(b)    Verification of Data.  Prior to filing any documents with any Regulatory Authority that incorporate data generated by Patheon, Client will give Patheon a copy of the documents incorporating this data to give Patheon the opportunity to verify the accuracy and regulatory validity of those documents as they relate to Patheon generated data. Patheon requires [*] days to perform this review but the parties may agree to a shorter time for the review as needed.
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(c)    Verification of CMC.  Prior to filing with any Regulatory Authority any documentation which is or is equivalent to the Quality Module (Drug Product Section) of the Common Technical Document (all such documentation herein referred to as “CTD”) related to any Marketing Authorization, such as a US New Drug Application, US Abbreviated New Drug Application, US Biologics Licence Application, or EU Marketing Authorisation Application, Client will give Patheon a copy of the CTD as well as all supporting documents which have been relied upon to prepare the CTD.  This disclosure will permit Patheon to verify that the CTD accurately describes the validation or scale-up work that Patheon has performed and the manufacturing processes that Patheon will perform under this Agreement.  Patheon requires [*] days to perform this review but the parties may agree to a shorter time for the review as needed.  Client will give Patheon copies of all relevant filings at the time of submission which contain CDT information regarding the Product.
(d)    Deficiencies.  If, in Patheon’s good faith discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever (the "Deficiencies"), Patheon will notify Client in writing of the Deficiencies.  The parties will work together to have the Deficiencies resolved prior to any pre-approval inspection.
(e)    Client Responsibility.  For clarity, in reviewing the documents referred to in clause (b) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon.  Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority, except as to information provided by or verified by Patheon.  Subject to Patheon’s obligation to cooperate with Client pursuant to the terms and conditions of this Agreement, Client is solely responsible for the preparation and filing of the application for approval by the Regulatory Authority.
7.9Inspection by Regulatory Authorities.  
If Client does not give Patheon the documents requested under clauses (b) and (c) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents, but this review must be completed within [*] days of Patheon’s receipt of the documentation from Client.
ARTICLE 8
TERM AND TERMINATION
8.1Initial Term.
This Agreement will become effective as of the Effective Date and will continue until December 31, 2020 (the "Initial Term"), unless terminated earlier by one of the parties in accordance herewith.  This Agreement will automatically renew after the Initial Term for successive terms of two Years each if there is a Product Agreement in effect, unless either party gives written notice to the other party of its intention to terminate this Agreement at least 18 months prior to the end of the then current term.  In 
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any event, the legal terms and conditions of this Agreement will continue to govern any Product Agreement in effect as provided in Section 1.2. Each Product Agreement will have an initial term of five years from the start of commercial manufacture at the Manufacturing Site for the Product unless the parties agree to a different number of years in the applicable Product Agreement (each, an “Initial Product Term”).  Unless otherwise agreed in a particular Product Agreement, Product Agreements will automatically renew after the Initial Product Term for successive terms of two years each unless either party gives written notice to the other party of its intention to terminate the Product Agreement at least 18 months (the “Product Agreement Non-Renewal Notice Period”) prior to the end of the then current term.  [*].
[*].
8.2Termination for Cause.
(a)    Either party at its sole option may terminate this Agreement or a Product Agreement upon written notice where the other party has failed to remedy a material breach of any of its representations, warranties, or other obligations under this Agreement or the applicable Product Agreement within 60 days following receipt of a written notice (the "Remediation Period") of the breach from the aggrieved party 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 or the applicable Product Agreement under this Section 8.2(a) may only be exercised for a period of 60 days following the expiry of the Remediation Period (where the breach has not been remedied) and if the termination right is not exercised during this period then the aggrieved party will be deemed to have waived the breach of the representation, warranty, or obligation described in the Breach Notice. The termination of a Product Agreement under this Section 8.2(a) will not affect this Agreement or any other Product Agreements where there has been no material breach of the other Product Agreements.
(b)    Either party at its sole option may immediately terminate this Agreement or a Product Agreement upon written notice, but without prior advance notice, to the other party if: (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 the other party; or (iii) this Agreement or a Product Agreement is assigned by the other party for the benefit of creditors.
(c)    Client may terminate a Product Agreement upon 30 days' prior written notice if any Authority takes any action, or raises any objection, that prevents Client from importing, exporting, purchasing, or selling the Product.  But if this occurs, Client must still fulfill all of its obligations under Section 8.4 below and under any Capital Equipment Agreement regarding the applicable Product.
(d)    Patheon may terminate this Agreement or a Product Agreement upon 12 months' prior written notice if Client assigns under Section 13.6 any of its rights under this Agreement or a Product Agreement to an assignee that (i), in the opinion of Patheon acting reasonably and in good faith, is unable to pay for Product it orders under this Agreement; or (ii) is a Patheon Competitor.
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8.3Termination by Client.
(a)    The Client may terminate this Agreement or any Product Agreement at any time upon 12 months’ prior written notice to Patheon.
(b)    For any Product that has not obtained Regulatory Authority approval at the time the applicable Product Agreement is executed, the Client may terminate the applicable Product Agreement at any time on 60 days prior written notice.
8.4Product Discontinuation.
Except as provided in Section 8.2(c), Client may terminate a Product Agreement upon 90 days’ prior written notice if it intends to no longer order Manufacturing Services for a Product due to this Product's discontinuance in the market.
8.5Obligations on Termination.
If a Product Agreement expires, or is terminated in whole or in part for any reason:
(a)    Client will take delivery of and pay for all undelivered Product that was manufactured and/or packaged in compliance with the Product Agreement and this Agreement under a Firm Order at the price in effect at the time the Firm Order was placed;
(b)    Client will purchase, at Patheon's cost (plus a [*] handling fee for Components), the Inventory applicable to the Products which was purchased, produced or maintained by Patheon in reliance on Firm Orders or in accordance with Section 5.2 prior to notice of termination being given;
(c)    Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2; 
(d)    Patheon will return to Client all unused Active Materials (with shipping and related expenses, if any, to be borne by Client).
(e)    Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(f)    Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [*] days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”).  If Client fails to remove the Client Property within [*] days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon [*] per pallet, per month, [*] minimum (except that 
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Client will pay [*] per pallet, per month, [*] minimum, for any of the Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property.  Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement.
(g)     In connection with the expiration or termination of this Agreement or any Product Agreement hereunder, at Client’s request, Patheon will provide assistance reasonably required to transfer the Manufacturing Services.  Such assistance may include, without limitation, providing documents required for the Manufacturing Services, attending meetings (in person or via teleconference), and subject to the confidentiality provisions hereof, hosting a Manufacturing Site visit.   Except in cases of termination by Client pursuant to Section 8.2, Client will reimburse Patheon for its costs incurred in providing such assistance in accordance with a tech transfer plan and budget negotiated in good faith and agreed upon by the parties.
Any, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement.  For greater certainty, the termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 9, 10 and 11 and Sections 5.4, 5.5, 8.5, 13.1, 13.2 and 13.3, all of which survive any termination or expiration.
ARTICLE 9
REPRESENTATIONS, WARRANTIES AND COVENANTS
9.1Authority.
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.
9.2Client Warranties.
Client represents, and warrants that:
(a)    Non-Infringement.
(i)    Client has the right to disclose the Specifications to Patheon;
(ii)    any Client Intellectual Property, used by Patheon in performing the Manufacturing Services according to the Specifications (A) is Client’s or its Affiliate's property or is the subject of a license to Client, (B and to Client’s knowledge, does not infringe and will not infringe any Third Party Rights;  
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(iii)    there are no actions or other legal proceedings against Client pending or threatened in writing alleging that the any of the Specifications, any of the Active Materials or Components, or the sale, use, or other disposition of any Product made in accordance with the Specifications as contemplated by this Agreement and the applicable Product Agreement infringes the Intellectual Property rights of any Third Party;
(b)    Quality and Compliance.
(i)    the Specifications for each Product conforms to the applicable regulatory approval;  
(ii)    the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws may be lawfully sold and distributed in every jurisdiction in which Client markets the Products;
(iii)    on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and the API will be contained, packaged, and labelled in accordance with Applicable Law and the Specifications, and will conform to the affirmations of fact on the container.
9.3Patheon Warranties.
Patheon covenants, represents, and warrants that:
(a)    it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws and that any Product supplied by it hereunder at the time of shipment, will comply with the Specifications; 
(b)    Patheon is not aware of any Intellectual Property of any third party that is necessary for Patheon to manufacture any Product as contemplated hereby;
(c)    The Active Material will not be used for any purposes 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 certain of the Products are controlled under the Controlled Substances Act and, as such, are subject to regulations and restrictions concerning sale and distribution.  Patheon agrees to comply with these regulations and restrictions, as well as any reasonable instructions from Client with respect to the use and storage of the Products.  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 these Products; and (b) Patheon will keep these Products in a secure location with access limited to authorized employees; and
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(d)    any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights.
9.4Debarred 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 Federal Food, Drug, and Cosmetic Act (United States). 
9.5Permits.
Client will be solely responsible for obtaining or maintaining, on a timely basis, any Regulatory Approvals for marketing the Products by Client or the Regulatory Approvals of the applicable Specifications, including, without limitation, all marketing and post-marketing approvals.
Patheon will be solely responsible for obtaining and maintain 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 including all FDA Establishment Registrations or equivalent Registrations as applicable.
9.6    Compliance with Laws.  
Each party, in connection with its performance under this Agreement, will comply with all Applicable Laws.
9.7No 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 FOR THE PRODUCTS.
ARTICLE 10
REMEDIES AND INDEMNITIES
10.1Consequential Damages.
Under no circumstances whatsoever will either party be liable to the other in contract, tort, negligence, breach of statutory duty, or otherwise for (i) any (direct or indirect) loss of profits, of production, of anticipated savings, of business, or goodwill or (ii) for any other liability, damage, costs, or expense of any kind incurred by the other party of an indirect or consequential nature, regardless of any notice of the possibility of these damages.
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10.2Limitation of Liability.
Except as set forth in the applicable Product Agreement, certain liabilities of Patheon are limited as set forth in subsections (a) through (c), below.
(a)    Defective or Recalled Product. Patheon’s maximum aggregate liability to Client for any obligation to (i) refund, offset or replace any defective Product under Section 6.3(a) or (ii) replace any recalled Products under Section 6.3(b), will not exceed [*] of the Price for the defective or recalled Product as applicable.  This Section 10.2(a) shall not be subject to Section 10.2(c).
(b)    Active Materials.  Except as expressly set forth in Section 2.2, under no circumstances will Patheon be responsible for any loss or damage to the Active Materials.  Patheon’s maximum responsibility for loss or damage to the Active Materials will not exceed the Maximum Credit Value set forth in Schedule D of a Product Agreement.
(c)    Maximum Liability.  Except for Patheon’s indemnity obligations under Section 10.3 and any liability arising from Patheon’s breach of its confidentiality obligations under Article 11, or from its obligations related to Intellectual Property or from its willful misconduct, Patheon’s maximum liability to Client under this Agreement or any Product Agreement for any reason whatsoever, including, without limitation, any liability arising under Section 6.3(b) relating to the expenses of a Recall or Product return, or Section 2.2 hereof or resulting from any and all breaches of its representations, warranties, or any other obligations under this Agreement or any Product Agreement will not exceed on a per Product basis [*] of revenues per Year to Patheon under the applicable Product Agreement.
10.3Patheon Indemnity.
(a)    Patheon agrees to defend and indemnify Client, its Affiliates and their respective officers, employees, and agents against all losses, damages, costs, claims, demands, judgments and liability to, from and in favor of third parties (other than Affiliates) resulting from, or relating to any claim of (i) a failure by Patheon to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws, (ii) Patheon’s breach of its obligations under this Agreement or any Product Agreement, or (iii) Patheon’s negligence, gross negligence  or willful misconduct, each except to the extent that the losses, damages, costs, claims, demands, judgments, and liability are due to the negligence, gross negligence or wrongful act(s) of Client, its officers, employees, agents, or Affiliates.  
(b)    If a claim occurs, Client will: (a) promptly notify Patheon of the claim; (b) use commercially reasonable efforts to mitigate the effects of the claim; (c) reasonably cooperate with Patheon in the defense of the claim; and (d) permit Patheon to control the defense and settlement of the claim, all at Patheon's cost and expense.
10.4Client Indemnity.
(a)    Client agrees to defend and indemnify Patheon, its officers, employees, and agents against all losses, damages, costs, claims, demands, judgments and liability to, from and in favor of third parties (other than Affiliates) resulting from, or relating to any claim of (i) infringement or alleged infringement of any Third Party Rights in the Products, or any portion thereof, (ii) personal injury or 
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property damage to the extent that the injury or damage is the result of a breach of this Agreement or any Product Agreement by Client, including, without limitation, any representation or warranty contained herein, (ii) product liability resulting in personal injury or property damage arising out of the Products that are labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws or (iii) Client’s negligence, gross negligence or willful misconduct, each except to the extent that the losses, damages, costs, claims, demands, judgments, and liability are due to the negligence, gross negligence or wrongful act(s) of Patheon, its officers, employees, or agents. 
(b)     If a claim occurs, Patheon will: (a) promptly notify Client of the claim; (b) use commercially reasonable efforts to mitigate the effects of the claim; (c) reasonably cooperate with Client in the defense of the claim; and (d) permit Client to control the defense and settlement of the claim, all at Client’s cost and expense.
10.5Reasonable Allocation of Risk.
This Agreement (including, without limitation, this Article 10) is reasonable and creates a reasonable allocation of risk having regard to the relative profits the parties each expect to derive from the Products.  Patheon assumes only a limited degree of risk arising from the manufacture, distribution, and use of the Products because Client has developed and holds the marketing approval for the Products, Client requires Patheon to manufacture and label the Products strictly in accordance with the Specifications, and Client, not Patheon, is best positioned to inform and advise potential users about the circumstances and manner of use of the Products.  
ARTICLE 11
CONFIDENTIALITY
11.1Confidential Information.
    “Confidential Information” means any information disclosed by the Disclosing Party to the Recipient (whether disclosed in oral, written, electronic or visual form), whether before the Effective Date or during the term hereof, that is non-public, confidential or proprietary including, without limitation, information relating to the Disclosing Party’s patent and trademark applications, process designs, process models, drawings, plans, designs, data, databases and extracts therefrom, formulae, methods, know-how and other Intellectual Property, its clients or client confidential information, finances, marketing, products and processes and all price quotations, manufacturing or professional services proposals, information relating to composition, proprietary technology, and all other information relating to manufacturing capabilities and operations.  In addition, all analyses, compilations, studies, reports or other documents prepared by any party's Representatives containing the Confidential Information will be considered Confidential Information. Samples or materials provided hereunder as well as any and all information derived from the approved analysis of the samples or materials will also constitute Confidential Information.  For the purposes of this ARTICLE 11, a party or its Representative receiving Confidential 
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Information under this Agreement is a “Recipient,” and a party or its Representative disclosing Confidential Information under this Agreement is the “Disclosing Party.”
11.2Use of Confidential Information. 
    The Recipient will use the Disclosing Party’s Confidential Information solely for the purpose of meeting its obligations under this Agreement.  The Recipient will keep the Disclosing Party’s Confidential Information strictly confidential.  As Recipient, Client will use the Confidential Information of Patheon solely for the purpose of performing its obligations hereunder and for obtaining the benefits hereof.  As Recipient, Patheon will use the Confidential Information of Client solely for the purpose of performing its obligations hereunder.   Each Party will not disclose the Disclosing Party’s Confidential Information in any manner whatsoever, in whole or in part, other than to those of its Representatives who (i) have a need to know the Confidential Information for the purpose of this Agreement; (ii) have been advised of the confidential nature of the Confidential Information and (iii) have obligations of confidentiality and non-use to the Recipient no less restrictive than those of this Agreement.  Recipient will protect the Disclosing Party’s Confidential Information disclosed to it by using all reasonable precautions to prevent the unauthorized disclosure, dissemination or use of the Confidential Information, which precautions will in no event be less than those exercised by Recipient with respect to its own confidential or proprietary Confidential Information of a similar nature.
11.3Exclusions.
    The obligations of confidentiality will not apply to the extent that the information:  
(a)    is or becomes publicly known through no breach of this Agreement by the Recipient or its Representatives;
(b)    is in the Recipient's possession at the time of disclosure by the Disclosing Party other than as a result of the Recipient's breach of any legal obligation;
(c)    is or becomes known to the Recipient on a non-confidential basis through disclosure by sources, other than the Disclosing Party, having the legal right to disclose the Confidential Information, 
provided that the other source is not known by the Recipient to be bound by any obligations (contractual, legal, fiduciary, or otherwise) of confidentiality to the Disclosing Party with respect to the Confidential Information;
(d)    is independently developed by the Recipient without use of or reference to the Disclosing Party's Confidential Information as evidenced by Recipient’s written records; or
(e)    is expressly authorized for release by the written authorization of the Disclosing Party.
    Any combination of information which comprises part of the Confidential Information are  not exempt from the obligations of confidentiality merely because individual parts of that Confidential Information were publicly known, in the Recipient’s possession, or received by the Recipient, unless the combination itself was publicly known, in the Recipient’s possession, or received by the Recipient.
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11.4Photographs and Recordings.
    Neither party will take any photographs or videos of the other party’s facilities, materials, Product, equipment or processes, nor use any other audio or visual recording equipment (such as camera phones) while at the other party’s facilities, without that party’s express written consent.
11.5Permitted Disclosure.
    Notwithstanding any other provision of this Agreement, the Recipient may disclose Confidential Information of the Disclosing Party to the extent required, in the reasonable opinion of counsel, in response to a valid order of a court or other governmental body or as required by law, regulation or stock exchange rule. But the Recipient will advise the Disclosing Party in advance of the disclosure to the extent practicable and permissible by the order, law, regulation or stock exchange rule and any other applicable law, will reasonably cooperate with the Disclosing Party, if requested, in seeking an appropriate protective order or other remedy, and will otherwise continue to perform its obligations of confidentiality set out herein.  If any public disclosure is required by law, the parties will consult concerning the form of announcement prior to the public disclosure being made.
11.6Return of Confidential Information.
    Upon the written request of the Disclosing Party, the Recipient will promptly return the Disclosing Party’s Confidential Information to the Disclosing Party or, if the Disclosing Party directs, destroy all of the Disclosing Party’s Confidential Information disclosed in or reduced to tangible form including any copies thereof and any summaries, compilations, analyses or other notes derived from the Disclosing Party’s Confidential Information except for one copy which may be maintained by the Recipient for its records.  The retained copy will remain subject to all confidentiality provisions contained in this Agreement.
11.7Remedies.
    The parties acknowledge that monetary damages may not be sufficient to remedy a breach by either party of this Article 11 and agree that the non-breaching party will be entitled to seek specific performance, injunctive and/or other equitable relief to prevent breaches of this Article 2  and to specifically enforce the provisions hereof in addition to any other remedies available at law or in equity. These remedies will not be the exclusive remedies for breach of this Article 11 but will be in addition to any and all other remedies available at law or in equity.
ARTICLE 12
DISPUTE RESOLUTION
12.1Commercial Disputes.
If any dispute arises out of or in connection with this Agreement or any Product Agreement (other than a dispute under Section 6.1(b) or a Technical Dispute, as defined herein), the parties will first try to resolve it amicably.  In that regard, any party may send a notice of dispute to the 
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other, and each party will appoint, within [*] Business Days from receipt of the notice of dispute, a single representative having full power and authority to resolve the dispute.  The representatives will meet as necessary in order to resolve the dispute.  If the representatives fail to resolve the matter within [*] from their appointment, or if a party fails to appoint a representative within the [*] Business Day period set forth above, the dispute will immediately be referred to the Chief Operating Officer or Executive Vice President (or another officer as he/she may designate) of each party who will meet and discuss as necessary to try to resolve the dispute amicably.  Should the parties fail to reach a resolution under this Section 12.1, the dispute will be referred to a court of competent jurisdiction in accordance with Section 13.16.
12.2Technical Dispute Resolution.
If a dispute arises (other than disputes under Sections (b) or 12.1) between the parties that is exclusively related to technical aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage, or other activities under this Agreement (a "Technical Dispute"), the parties will make all reasonable efforts to resolve the dispute by amicable negotiations.  In that regard, senior representatives of each party will, as soon as possible 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.  If the parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail.  For greater certainty, the parties agree that the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including Exhibit A) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are 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 Products for Client.
(b)    All Intellectual Property generated or derived by Patheon while performing the Manufacturing Services, to the extent it is specific to the development, manufacture, use, and sale of any of Client’s Products that are the subject of the Manufacturing Services, will be the exclusive property of Client.
(c)    All Patheon Intellectual Property will be the exclusive property of Patheon. Patheon hereby grants to Client a perpetual, irrevocable, non-exclusive, paid-up, royalty-free, transferable license to use the Patheon Intellectual Property used by Patheon to perform the Manufacturing Services to enable Client to manufacture the Product(s). 
(d)    Each party will be solely responsible for the costs of filing, prosecution, and maintenance of patents and patent applications on its own Inventions. 
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(e)    Either party will give the other party written notice, as promptly as practicable, of all Inventions which can reasonably be deemed to constitute improvements or other modifications of the Products or processes or technology owned or otherwise controlled by the party.  
(f)    Each party agrees and acknowledges that it will not acquire by virtue of this Agreement any interest in or any trademarks or trade names of the other party but Client will have the right to identify Patheon as the manufacturer of the Products.
13.2Intellectual Property.
Neither party has, nor will it acquire, any interest in any of the other party’s Intellectual Property unless otherwise expressly agreed to in writing.  Neither party will 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 that party to establish its ownership of the Intellectual Property and to obtain whatever protection for the Intellectual Property, including patent and copyright rights, in any and all countries on the 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 the Intellectual Property, as applicable.
13.3Insurance.
Each party will maintain commercial general liability insurance, including blanket contractual liability insurance covering the obligations of that party under this Agreement through the term of this Agreement and for a period of three years thereafter.  This insurance will have policy limits of not less than (i) [*] for each occurrence for personal injury or property damage liability; and (ii) [*] in the aggregate per annum for product and completed operations liability.  If requested each party will give the other 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 will further provide for a minimum of [*] days' written notice to the insured of a cancellation of, or material change in, the insurance.  If a party is unable to maintain the insurance policies required under this Agreement through no fault of its own, then the party will forthwith notify the other party in writing and the parties will in good faith negotiate appropriate amendments to the insurance provision of this Agreement in order to provide adequate assurances.
13.4Independent Contractors.
The parties are independent contractors and this Agreement and any Product Agreement will not be construed to create between Patheon and 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.
13.5No Waiver.
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Neither party’s failure to require the other party to comply with any provision of this Agreement or any Product Agreement will be deemed a waiver of the provision or any other provision of this Agreement or any Product Agreement, with the exception of Sections 6.1 and 8.2 of this Agreement.
13.6Assignment.
(a)    Patheon may not assign this Agreement or any Product Agreement or any of its associated rights or obligations without the written consent of Client, this consent not to be unreasonably withheld.  Patheon may subcontract any part of the Manufacturing Services under a Product Agreement to any of its Affiliates but Patheon will remain fully liable to Client for the Affiliate’s performance.
(b)    Subject to Section 8.2(d), Client may assign this Agreement or any Product Agreement or any of its associated rights or obligations without approval from Patheon.  But Client will give Patheon prompt written notice of any assignment, any assignee will covenant in writing with Patheon to be bound by the terms of this Agreement or the Product Agreement.
(c)    Despite the foregoing provisions of this Section 13.6, either party may assign this Agreement or any Product Agreement to any of its Affiliates or to a successor to or purchaser of all or substantially all of its business, but the assignee must execute an agreement with the non-assigning party whereby it agrees to be bound hereunder.
13.7Force Majeure.
Neither party will be liable for the failure to perform its obligations under this Agreement or any Product Agreement if the failure is caused by an event beyond that party's reasonable control, including, but not limited to, strikes or other labor 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, or compliance with any order or regulation of any government entity acting within colour of right (a "Force Majeure Event").  A party claiming a right to excused performance under this Section 13.7 will immediately notify the other party in writing of the extent of its inability to perform, which notice will specify the event beyond its reasonable control that prevents the performance.  Neither party will be entitled to rely on a Force Majeure Event to relieve it from an obligation to pay money (including any interest for delayed payment) which would otherwise be due and payable under this Agreement or any Product Agreement.
13.8Additional Product.
Additional Products may be added to, or existing Products deleted from, any Product Agreement by amendments to the Product Agreement including Schedules A, B, C, and D as applicable.
13.9Notices.
Unless otherwise agreed in a Product Agreement, any notice, approval, instruction or other written communication required or permitted hereunder will be sufficient if made or given to the 
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other party by personal delivery, by telecopy, facsimile communication, or internationally-recognized overnight courier or by sending the same by first class mail, postage prepaid to the respective addresses, telecopy or facsimile numbers set forth below:
If to Client:
Jazz Pharmaceuticals Ireland Limited 
Fourth Floor, Connaught House 
One Burlington Road 
Dublin 4, Ireland
Attention:  Head of Supply Chain
Facsimile No.: [*]
With a copy to:
Jazz Pharmaceuticals
3180 Porter Drive
Palo Alto, CA 94304
Attention:  Legal
Facsimile No.: [*]
If to Patheon:
Patheon Pharmaceuticals Inc.
2110 East Galbraith Road
Cincinnati, OH 45237-1625
Attention:  [*]
Facsimile No.: [*]
With a copy to:
Patheon Inc.
4721 Emperor Boulevard
Research Triangle Park,
NC 27703
Attention: [*]
Telecopier No.: [*]
or to any other addresses, telecopy or facsimile numbers given to the other party in accordance with the terms of this Section 13.9.  Notices or written communications made or given by personal delivery, telecopy, or facsimile, will be deemed to have been sufficiently made or given when sent (receipt acknowledged), or if mailed, five days after being deposited in the United States, Canada, or European Union mail, postage prepaid or upon receipt, whichever is sooner.

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13.10Severability.
If any provision of this Agreement or any Product Agreement is determined by a court of competent jurisdiction to be invalid, illegal, or unenforceable in any respect, that determination will not impair or affect the validity, legality, or enforceability of the remaining provisions, because each provision is separate, severable, and distinct.
13.11Entire Agreement.
This Agreement, together with the applicable Product Agreements and Quality Agreements constitute the full, complete, final and integrated agreement between the parties relating to the subject matter hereof and supersedes all previous written or oral negotiations, commitments, agreements, transactions, or understandings concerning the subject matter hereof.  Any modification, amendment, or supplement to this Agreement or any Product Agreement must be in writing and signed by authorized representatives of both parties.  In case of conflict, the prevailing order of documents will be this Agreement, the Product Agreement, and the Quality Agreement but the Product Agreement will prevail where it specifically states the intent to prevail over this Agreement.  If a topic or subject is addressed in two or more of the foregoing agreements, and it is possible to meet the obligations under both or all of these agreements without violating the terms of either or any agreement, then the terms of both or all of the agreements will apply and be met.
13.12Other Terms.
No terms, provisions or conditions of any purchase order or other business form or written authorization used by Client or Patheon will have any effect on the rights, duties, or obligations of the parties under or otherwise modify this Agreement or any Product Agreement, regardless of any failure of Client or Patheon to object to the terms, provisions, or conditions unless the document specifically refers to this Agreement or the applicable Product Agreement and is signed by both parties.
13.13No Third Party Benefit or Right.
For greater certainty, nothing in this Agreement or any Product Agreement will confer or be construed as conferring on any third party any benefit or the right to enforce any express or implied term of this Agreement or any Product Agreement.
13.14Execution in Counterparts.
This Agreement and any Product Agreement may be executed in two or more counterparts, by original or facsimile or “pdf” signature, each of which will be deemed an original, but all of which together will constitute one and the same instrument.
13.15Use of Client Name.
Patheon will not make any use of Client’s name, trademarks or logo or any variations thereof, alone or with any other word or words, without the prior written consent of Client.
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13.16Taxes. 
(a)    Client will bear all taxes, duties, levies and similar charges (and any related interest and penalties) ("Tax" or "Taxes"), however designated, imposed as a result of the provision by the Patheon of Services under this Agreement, except:
(i)    any Tax based on net income or gross income that is imposed on Patheon by its jurisdiction of formation or incorporation ("Resident Jurisdiction");
(ii)    any Tax based on net income or gross income that is imposed on Patheon by jurisdictions other than its Resident Jurisdiction if this tax is based on a permanent establishment of Patheon; and
(iii)    any Tax that is recoverable by Patheon in the ordinary course of business for purchases made by Patheon in the course of providing its Services, such as Value Added Tax (as more fully defined in subparagraph (d) below), Goods & Services Tax ("GST") and similar taxes. 
(b)    If Client is required to bear a tax, duty, levy or similar charge under this Agreement by any state, federal, provincial or foreign government, including, but not limited to, Value Added Tax, Client will pay the tax, duty, levy or similar charge and any additional amounts to the appropriate taxing authority as are necessary to ensure that the net amounts received by Patheon hereunder after all such payments or withholdings equal the amounts to which Patheon is otherwise entitled under this Agreement as if the tax, duty, levy or similar charge did not exist.
(c)    Patheon will not collect an otherwise applicable tax if Client's purchase is exempt from Patheon's collection of the tax and a valid tax exemption certificate is furnished by Client to Patheon. 
(d)    If subparagraph 13.16(a)(iii) does not apply, any payment due under this Agreement for the provision of Services to Client by Patheon is exclusive of value added taxes, turnover taxes, sales taxes or similar taxes, including any related interest and penalties (hereinafter all referred to as "VAT").  If any VAT is payable on a Service supplied by Patheon to Client under this Agreement, this VAT will be added to the invoice amount and will be for the account of (and reimbursable to Patheon by) Client.  If VAT on the supplies of Patheon is payable by Client under a reverse charge procedure (i.e., shifting of liability, accounting or payment requirement to recipient of supplies), Client will ensure that Patheon will not effectively be held liable for this VAT by the relevant taxing authorities or other parties. Where applicable, Patheon will use its reasonable commercial efforts to ensure that its invoices to Client are issued in such a way that these invoices meet the requirements for deduction of input VAT by Client, if Client is permitted by law to do so.
(e)    Any Tax that Client pays, or is required to pay, but which Client believes should properly be paid by Patheon pursuant hereto may not be offset against sums due by Client to Patheon whether due pursuant to this Agreement or otherwise.

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13.17Governing Law.
This Agreement and any Product Agreement, unless otherwise agreed by the parties in the Product Agreement, will be construed and enforced in accordance with the laws of the State of New York and the laws of the United States of America applicable therein.   The UN Convention on Contracts for the International Sale of Goods will not apply to this Agreement. 
[Signature page to follow]

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IN WITNESS WHEREOF, the duly authorized representatives of the parties have executed this Agreement as of the Effective Date.

									
		PATHEON PHARMACEUTICALS INC.
			
		By:	/s/ Francis P. McCune
		Name:	Francis P. McCune
		Title:	Secretary
			

									
		JAZZ PHARMACEUTICALS IRELAND LIMITED
			
		By:	/s/ Shawn Mindus
		Name:	Shawn Mindus
		Title:	VP, Head of Ireland Finance
			

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APPENDIX 1
FORM OF PRODUCT AGREEMENT
(Includes Schedules A to D)

PRODUCT AGREEMENT
This Product Agreement (this “Product Agreement”) is issued under the Master Manufacturing Services Agreement dated October 1, 2015 between Patheon Pharmaceuticals Inc., and Jazz Pharmaceuticals Ireland Limited (the “Master Agreement”), and is entered into [insert effective date] (the “Effective Date”), between Patheon Pharmaceuticals Inc., [or applicable Patheon Affiliate], a corporation existing under the laws of the State of Delaware [or applicable founding jurisdiction for Patheon Affiliate], having a principal place of business at 2110 East Galbraith Road, Cincinnati, OH 45237-1625 [or Patheon Affiliate address] (“Patheon”) and [insert Client name, legal entity, founding jurisdiction and address] (“Client”).
The terms and conditions of the Master Agreement are incorporated herein except to the extent this Product Agreement expressly references the specific provision in the Master Agreement to be modified by this Product Agreement.  All capitalized terms that are used but not defined in this Product Agreement will have the respective meanings given to them in the Master Agreement.
The Schedules to this Product Agreement are incorporated into and will be construed in accordance with the terms of this Product Agreement.

1.Product List and Specifications (See Schedule A attached hereto)
2.Minimum Order Quantity, Annual Volume, and Price (See Schedule B attached hereto)
3.    Annual Stability Testing and Validation Activities (if applicable) (See Schedule C attached hereto) 
4.    Active Materials, Active Materials Credit Value, and Maximum Credit Value (See Schedule D attached hereto)
5.    Business Day (if different from a Business Day at the Manufacturing Site under the definition in Section 1.3 of the Master Agreement)
6.    Manufacturing Site: (insert address of Patheon Manufacturing Site where the Manufacturing Services will be performed)
7.    Territory: (insert the description of the Territory here)
8.    Loss Tolerance Percentage (per Section 2.2(b) of the Master Agreement)
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9.    Extraordinary Increase in Component Cost materiality percentage (if different from the [*] that is stated in Section 4.3 of the Master Agreement)    
10.    Yearly Forecasted Volume: (insert for sterile products if applicable under Section 4.2.1)
11.    Delivery Date Under Firm Order (if different from the three month period set forth in Section 5.1(c) of the Master Agreement)     
12.    Payment Terms: (if different from Section 5.5 of the Master Agreement)  
13.    Governing Law: (if applicable under Section 13.17 of the Master Agreement) 
14.    Inflation Index: (if applicable under Section 4.2(a) of the Master Agreement for Products manufactured outside of the Unites States or Puerto Rico)
15.    Currency: (if applicable under Section 1.4 of the Master Agreement) 
16.    Initial Set Exchange Rate: (if applicable under Section 4.2(d) of the Master Agreement)
17.    Initial Product Term: (if applicable under Section 8.1 of the Master Agreement)
18.    Notices: (if applicable under Section 13.9 of the Master Agreement)
19.    Other Modifications to the Master Agreement: (if applicable under Section 1.2 of the Master Agreement)
________________________________________

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IN WITNESS WHEREOF, the duly authorized representatives of the parties have executed this Product Agreement as of the Effective Date set forth above.
						
	PATHEON PHARMACEUTICALS INC. [or applicable Patheon Affiliate]

		
	By:	
	Name:	
	Title:	
		

						
	JAZZ PHARMACEUTICALS IRELAND LIMITED [or applicable Jazz Affiliate]
		
	By:	
	Name:	
	Title:	
		

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SCHEDULE A
PRODUCT LIST AND SPECIFICATIONS
Product List
[insert product list]

Specifications
Prior to the start of commercial manufacturing of Product under this Agreement Client will give Patheon the originally executed copies of the Specifications as approved by the applicable Regulatory Authority.  If the Specifications received are subsequently amended, then the parties will follow the process set forth in the Quality Agreement.  

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SCHEDULE B
MINIMUM ORDER QUANTITY, ANNUAL VOLUME, AND PRICE
[*]

Master Manufacturing Services Agreement
			
	

[*]

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SCHEDULE C
ANNUAL STABILITY TESTING [and VALIDATION ACTIVITIES (if applicable)] 
Patheon and Client will agree in writing on any stability testing to be performed by Patheon on the Products.  This agreement will specify the commercial and Product stability protocols applicable to the stability testing and the fees payable by Client for this testing.
[NTD: Schedule C should clearly indicate when and/or under what conditions Patheon’s responsibility to perform stability testing will end]

Master Manufacturing Services Agreement
			
	

SCHEDULE D
ACTIVE MATERIALS

						
	Active Materials	Supplier
		
		

ACTIVE MATERIALS CREDIT VALUE
The Active Materials Credit Value will be as follows:
									
	PRODUCT	ACTIVE MATERIALS	ACTIVE MATERIALS
CREDIT  VALUE

			[*]

MAXIMUM CREDIT VALUE
Patheon's liability for Active Materials calculated in accordance with Section 2.2 of the Master Agreement [for any Product] in a Year will not exceed, in the aggregate, the maximum credit value set forth below:
						
	PRODUCT	MAXIMUM CREDIT VALUE
		

[End of Product Agreement] 

Master Manufacturing Services Agreement
			
	

EXHIBIT A
TECHNICAL DISPUTE RESOLUTION
Technical Disputes which cannot be resolved by negotiation as provided in Section 12.2 will be resolved in the following manner:
1.Appointment of Expert. Within [*] Business Days after a party requests under Section 12.2 that an expert be appointed to resolve a Technical Dispute, the parties will jointly appoint a mutually acceptable expert with experience and expertise in the subject matter of the dispute.  If the parties are unable to so agree within the [*] Manufacturing Site Business Day period, or in the event of disclosure of a conflict by an expert under Paragraph 2 hereof which results in the parties not confirming the appointment of the expert, then an expert (willing to act in that capacity hereunder) will be appointed by an experienced arbitrator on the roster of the American Arbitration Association.
2.Conflicts of Interest.  Any person appointed as an expert will be entitled to act and continue to act as an expert even if at the time of his appointment or at any time before he gives his determination, he has or may have some interest or duty which conflicts or may conflict with his appointment if before accepting the appointment (or as soon as practicable after he becomes aware of the conflict or potential conflict) he fully discloses the interest or duty and the parties will, after the disclosure, have confirmed his appointment.
3.Not Arbitrator.  No expert will be deemed to be an arbitrator and the provisions of the American Arbitration Act or of any other applicable statute (foreign or domestic) and the law relating to arbitration will not apply to the expert or the expert's determination or the procedure by which the expert reaches his determination under this Exhibit A.
4.Procedure.  Where an expert is appointed:
(a)    Timing.  The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within [*] Business Days (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
(b)    Disclosure of Evidence.  The parties undertake one to the other to give to any expert all the evidence and information within their respective possession or control as the expert may reasonably consider necessary for determining the matter before him which they will disclose promptly and in any event within [*] Business Days of a written request from the relevant expert to do so.
(c)    Advisors.  Each party may appoint any counsel, consultants and advisors as it feels appropriate to assist the expert in his determination and so as to present their respective cases so that at all times the parties will co-operate and seek to narrow and limit the issues to be determined.
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(d)    Appointment of New Expert.  If within the time specified in Paragraph 4(a) above the expert will not have rendered a decision in accordance with his appointment, a new expert may (at the request of either party) be appointed and the appointment of the existing expert will thereupon cease for the purposes of determining the matter at issue between the parties save this if the existing expert renders his decision with full reasons prior to the appointment of the new expert, then this decision will have effect and the proposed appointment of the new expert will be withdrawn.
(e)    Final and Binding.  The determination of the expert will, except for fraud or manifest error, be final and binding upon the parties.
(f)    Costs.  Each party will bear its own costs for any matter referred to an expert hereunder and, in the absence of express provision in the Agreement to the contrary, the costs and expenses of the expert will be shared equally by the parties.
For greater certainty, the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including this Exhibit A) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.

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EXHIBIT B
[Reserved]

Master Manufacturing Services Agreement
			
	

EXHIBIT C
QUARTERLY ACTIVE MATERIALS INVENTORY REPORT
TO:    JAZZ PHARMACEUTICALS IRELAND LIMITED

FROM:    PATHEON PHARMACEUTICALS INC. [or applicable Patheon entity] 

RE:    Active Materials quarterly inventory report under Section 2.2(a) of the Master Manufacturing Services Agreement dated October 1, 2015 (the "Agreement")

																					
					
	Reporting quarter:				
					
	Active Materials on hand
at beginning of quarter:
			kg	(A)
					
	Active Materials on hand
at end of quarter:
			kg	(B)
					
	Quantity Received during quarter:			kg	(C)
					
	[*]				
					
	Quantity Converted during quarter:			kg	
	(total Active Materials in Products produced and not rejected, recalled or returned)				
	
	Capitalized terms used in this report have the meanings given to the terms in the Agreement.
					
	PATHEON PHARMACEUTICALS INC.		DATE:	
	[or applicable Patheon Affiliate]				
					
	Per:					
	Name:					
	Title:					
							
					

Master Manufacturing Services Agreement
			
	

EXHIBIT D
REPORT OF ANNUAL ACTIVE MATERIALS INVENTORY RECONCILIATION 
AND CALCULATION OF ACTUAL ANNUAL YIELD 
TO:    JAZZ PHARMACEUTICALS IRELAND LIMITED

FROM:    PATHEON PHARMACEUTICALS INC. [or applicable Patheon entity] 

RE:    Active Materials annual inventory reconciliation report and calculation of Actual Annual Yield under Section 2.2(a) of the Master Manufacturing Services Agreement dated October 1, 2015 (the "Agreement")

																		
					
	Reporting Year ending:				
					
	Active Materials on hand
at beginning of Year:
			kg	(A)
					
	Active Materials on hand
at end of Year:
			kg	(B)
					
	Quantity Received during Year:			kg	(C)
					
	[*]				
					
	Quantity Converted during Year:			kg	(E)
	(total Active Materials in Products produced and not rejected, recalled or returned)				
					
	Active Materials Credit Value:		$		/kg	(F)
					
	Target Yield:			%	(G)
					
	Actual Annual Yield:			%	(H)
	((E ∕ D) * 100)				
						

Master Manufacturing Services Agreement
			
	

[*]

Based on the foregoing reimbursement calculation Patheon will reimburse Client the amount of $            .

Capitalized terms used in this report have the meanings given to the terms in the Agreement.

															
	DATE:		
		
	PATHEON PHARMACEUTICALS INC.		
	[or applicable Patheon Affiliate]		
			
	Per:			
	Name:			
	Title:			

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EXHIBIT E
EXAMPLE OF PRICE ADJUSTMENT DUE TO CURRENCY FLUCTUATION
Section 4.2(d)

-2-Document

[***] = CERTAIN PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED BECAUSE THE OMITTED PORTIONS ARE BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
                                                    Exhibit 10.12

AMENDED AND RESTATED LICENSE AGREEMENT
This Amended and Restated License Agreement (“Agreement”) is entered into as of October 14, 2020 (the “Restatement Effective Date”), by and between Pharma Mar, S.A., a corporation organized under the laws of Spain, with its principal place of business at 1 Avda. De los Reyes, 28770 - Colmenar Viejo, Madrid, Spain (“PharmaMar”), and Jazz Pharmaceuticals Ireland Limited, a corporation organized under the laws of Ireland, with its principal place of business at Fifth Floor, Waterloo Exchange, Waterloo Road, Dublin 4, Ireland (“Jazz”).  PharmaMar and Jazz are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

Recitals
Whereas, PharmaMar is a specialty biopharmaceutical company that is developing lurbinectedin (ZepzelcaTM) and owns or controls patent rights and know-how relating thereto; 
Whereas, Jazz is a biopharmaceutical company with expertise in the development, marketing, and commercialization of pharmaceutical products; 
Whereas, the Parties executed that certain License Agreement dated December 19, 2019 (the “Original License Agreement,” and such date the “Effective Date”) pursuant to which Jazz obtained from PharmaMar, and PharmaMar granted to Jazz an exclusive license to commercialize lurbinectedin in the United States; and
Whereas, Jazz now desires to obtain from PharmaMar, and PharmaMar is willing to grant to Jazz, among others, an exclusive license to commercialize lurbinectedin in Canada, and the Parties wish to amend and restate the Original License Agreement to grant such rights on the terms and subject to the conditions set forth herein.
Agreement
Now, Therefore, in consideration of the foregoing premises and the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Jazz and PharmaMar hereby agree as follows:
1

1.Definitions
1.1“Accounting Standards” means (a) with regard to Jazz, U.S. Generally Accepted Accounting Principles (GAAP) or (b) with regard to PharmaMar, International Financial Reporting Standards (IFRS); in either case, consistently applied throughout the organization of a particular entity and its Affiliates. 
1.2“Act” means the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C.  §§301 et seq., as amended from time to time.  
1.3“Additional Indication” means an Indication other than SCLC.
1.4“Additional Indication Pivotal Trial” has the meaning provided in Section 4.2(b).
1.5“Additional Indication Pivotal Trial Budget” has the meaning provided in Section 4.2(b).
1.6“Additional Indication Pivotal Trial Development Plan” has the meaning provided in Section 4.2(b).
1.7“Additional Indication Regulatory Milestone” has the meaning provided in Section 8.5.
1.8“Additional Indication Regulatory Milestone Payments” has the meaning provided in Section 8.5.
1.9“Adverse Safety Impact” has the meaning provided in Section 3.4(b).
1.10“Affiliate” means, with respect to any Entity (including a Party to this Agreement), any other Entity controlled by, controlling, or under common control with such Entity.  For the purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) means the possession, directly or indirectly, of more than 50% of the outstanding voting securities of a corporation or comparable equity interest in any other type of Entity, or otherwise having the power to direct the management and policies of such Entity.
1.11“Annual Commercialization Plan” means the plan for Commercialization of the Licensed Product in the Jazz Territory for each Calendar Year during the Term as required by Section 7.5, that contains the details for the Commercialization activities to be conducted with respect to the Licensed Product that are required by Section 7.5. 
1.12“Annual Sales Forecast Plan” or “ASFP” has the meaning provided in Section7.8(a)(i). 
1.13“Anti-Corruption Laws” means the U.S. Foreign Corrupt Practices Act, as amended, the Organization for Economic Co-operation and Development (OECD) Convention 
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on combating bribery of foreign public officials in international business transactions, and any other applicable anti-corruption laws.  
1.14“Applicable Laws” means the applicable provisions of any and all national, supranational, regional, state and local laws, treaties, statutes, rules, regulations, administrative codes, guidances, ordinances, judgments, decrees, directives, injunctions, orders, permits of or from any court, arbitrator, regulatory authority or governmental agency or authority having jurisdiction over or related to the subject item, including the Act, Anti-Corruption Laws and Export Control Laws. Applicable Laws shall also include all applicable legal requirements to pharmaceutical industry. 
1.15“ASFP Term” means [***] starting after [***].
1.16“Atlantis Development Plan” has the meaning provided in Section 4.1(a)(i).
1.17“Atlantis Trial” means the phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with SCLC who failed one prior platinum-containing line to determine whether there is a difference in Overall Survival (OS) between lurbinectedin (PM01183)/doxorubicin (DOX) and a control arm consisting of best investigator’s choice between CAV or topotecan and to analyze progression-free survival (PFS) by an Independent Review Committee (IRC); such clinical trial has the ClinicalTrials.gov Identifier: NCT02566993.
1.18“Best Knowledge” means, in respect of a Party, that such Party ́s [***]. 
1.19“Bulk Vials” means units of Licensed Product in the final dosage form containing the Licensed API as an active ingredient, in primary packaging but without secondary packaging, all meeting the specifications therefore as described in the Quality Agreement.
1.20“Business Day” means a day other than a Saturday, Sunday or bank or other public holiday in Dublin, Ireland or Madrid, Spain.  
1.21“Calendar Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term.
1.22“Calendar Year” means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.
1.23“Canada” means the country Canada, including its possessions and territories.
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1.24“Canada Annual Sales Forecast Plan” or “Canada ASFP” has the meaning provided in Section7.8(a)(i).
1.25“Change of Control” means, with respect to an Entity, (a) the sale to a Third Party of all or substantially all of the assets of such Entity relating to this Agreement, in one or a series of related transactions to which such Entity is a party; or (b) the acquisition of control of such Entity by a Third Party by means of any transaction or series of related transactions to which such Entity is a party (i) wherein such Third Party acquires more than fifty percent (50%) of the voting equity securities of such Entity or (ii) that is a merger, acquisition or consolidation of such Entity by or with such Third Party in which the voting securities of such entity outstanding immediately prior thereto cease to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization or consolidation.
1.26“Clinical Trial” means any clinical study involving the administration of a Licensed API or Licensed Product to a human subject for the purpose of evaluating the safety, efficacy, performance or other characteristic of such Licensed API or Licensed Product, including all Medical Affairs Clinical Trials.
1.27“Combination Product” means a Licensed Product that is sold in a finished dosage form containing Licensed API in combination with one or more Other Actives.  
1.28“Commercialization Activities” has the meaning provided in Section 7.1.
1.29“Commercialize” means to undertake those activities traditionally undertaken in the pharmaceutical industry to commercially exploit the Licensed Products, including, without limitation, pre-launch and launch activities, pricing and reimbursement activities, marketing, promoting, detailing, distributing, offering for sale and selling the Licensed Products, reporting of adverse events in patients, and interacting with regulatory or other authorities regarding any of the foregoing.  “Commercialization” shall have a correlative meaning.  
1.30“Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party to develop, register and commercialize any Licensed Product, [***], taking into account [***].  Without limiting the foregoing, to the extent it is commercially reasonable to do so, commercially reasonable efforts will [***]. 
1.31“Committee” means the JDC, JCC or any Working Group, as applicable.  
1.32“Committee Dispute” has the meaning provided in Section 3.4(a).
1.33“Competing Program” has the meaning provided in Section 2.4(c).
1.34“Confidential Information” has the meaning provided in Section 11.1.  
1.35“Confidentiality Agreement” means the Confidential Disclosure Agreement between Jazz and PharmaMar dated [***], as amended.  
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1.36“Control” or “Controlled by” means, with respect to any Patent Rights, Information or other intellectual property rights, the possession by a Party of the ability (whether by ownership, license or other right, other than pursuant to a license granted to such Party under this Agreement) to grant access to, or a license or sublicense of, such Patent Rights, Information or other intellectual property rights without violating the terms of any agreement or other arrangement with any Third Party.  
1.37“Co-Promotion Agreement” has the meaning provided in Section 7.9(b).
1.38“Co-Promotion Option” has the meaning provided in Section 7.9(a).
1.39“CPI” means (a) with respect to Jazz, the [***] and (b) with respect to PharmaMar, [***]. 
1.40“CPI Adjustment” means the percentage increase or decrease, if any, in the CPI applicable to FTE personnel for the most recent [***] available at the time of budgeting for the [***] for which the adjustment is being made.
1.41“Defensive Action” has the meaning provided in Section 10.5(a).
1.42“Detail” means a face-to-face, interactive (including through video-conference, internet, virtual or other similar means that allow for real-time communication and the exchange of visual information) selling presentation for a Licensed Product by a representative of a Party’s sales force to an eligible HCP in the Jazz Territory in accordance with Applicable Law during which time the Promotion Message involving the Licensed Product is presented [***] and, in each case, the Promotional Message is [***], provided that the following shall not constitute Details: [***].  For the avoidance of doubt, NAMs, reimbursement specialists and MSLs do not Detail the Licensed Product.
1.43“Develop” means to undertake those activities reasonably related to planning and undertaking research and preclinical development activities and clinical trials to obtain a regulatory approval from an applicable Regulatory Authority of the Jazz Territory in a Licensed Indication, including filing for regulatory approval in the Jazz Territory and interacting with each such Regulatory Authority.  “Development” shall have a correlative meaning.  For clarity, Develop shall not include those research and preclinical development activities and those clinical trials intended to obtain a regulatory approval from the EMA and other Regulatory Authorities in the PharmaMar Territory.  In addition, “Develop” does not include Medical Affairs Studies.
1.44“Development Costs” means, with respect to the SCLC Post-Approval Commitment Studies, the sum of [***] and as accounted for by Jazz (or its Affiliates) in accordance with Jazz’s Accounting Standards.
1.45“Dollar” means a U.S. dollar, and “$” shall be interpreted accordingly.
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1.46“Drug Conjugate” means any composition of matter wherein a product is linked or attached to a targeting moiety, including, without limitation, an antibody, protein, RNA, DNA or similar construct.
1.47“Enforcement Action” has the meaning provided in Section 10.4(b)(i).
1.48“Enforcing Party” has the meaning provided in Section 10.4(b)(iii).
1.49“Entity” means any corporation, general partnership, limited partnership, limited liability partnership, joint venture, estate, trust, company (including any limited liability company or joint stock company), firm or other enterprise, association, organization or entity.  
1.50“European Union” means all countries that are officially recognized as member states of the European Union at any particular time.  For clarity, European Union for the purposes of this Agreement shall at all times include the United Kingdom even if the United Kingdom exits the European Union prior to or during the Term.
1.51“Executive Officers” means with respect to PharmaMar, its [***], and with respect to Jazz, [***].
1.52“Expanded Access Programs” or “EAP” means those programs that allows the use of an authorized medicine before Regulatory Approval is obtained for patients in the Territory who have a disease with no satisfactory authorized therapies and who cannot enter a Clinical Trial and that are intended to facilitate the availability to patients of new treatment options under development.
1.53“Expired Territory” has the meaning provided in Section 13.5(b).
1.54“Export Control Laws” means: (a) all applicable U.S. laws and regulations relating to sanctions and embargoes imposed by OFAC; (b) all applicable U.S. export control laws, including the Arms Export Controls Act (22 U.S.C.  Ch.  39), the International Emergency Economic Powers Act (50 U.S.C. §§ 1701 et seq.), the Trading With the Enemy Act (50 U.S.C. app. §§ 1 et seq.), the Export Administration Act of 1979 (50 U.S.C. app. §§ 2401 et seq.), International Boycott Provisions of Section 999 of the U.S.  Internal Revenue Code of 1986, and all rules, regulations and executive orders relating to any of the foregoing, including but not limited to the International Traffic in Arms Regulations (22 C.F.R. §§ 120 et seq.), the Export Administration Regulations (15 C.F.R. §§ 730 et. seq.), and the regulations administered by the Office of Foreign Assets Controls of the United States Department of the Treasury; and (c) all export controls imposed on any Licensed Product by any country or organization or nations within the jurisdiction of which a Party operates or does business.  
1.55“FDA” means the U.S. Food and Drug Administration, or any successor Regulatory Authority thereto in the U.S. having substantially the same function. 
1.56“Finished Product” means single finished dosage form of Licensed Product consisting in a ready-to-sell pack including immediate packaging cartons, labels and package 
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leaflet of the Licensed Product and any unique identifiers that are required to be inserted in the packaging components of the Product under Applicable Laws, which are approved by Regulatory Authorities of the Jazz Territory.  
1.57“First Commercial Sale” means the first sale of a Licensed Product for which revenue has been recognized by Jazz or its Affiliates or Sublicensees for use or consumption by the general public of such Licensed Product after Regulatory Approval (and pricing or reimbursement approval, if legally required for such sale) for such Licensed Product has been obtained; provided, however, that the following shall not constitute a First Commercial Sale: 
(a)any [***]; 
(b)any use of such Licensed Product in [***]; and 
(c)[***].
The Parties agree and acknowledge that the First Commercial Sale of Licensed Product occurred on [***]. 
1.58“FTE” means the equivalent of a full-time employee’s work time over a 12-month period (including normal vacations, sick days and holidays).
1.59“FTE Costs” means, for a given period, the FTE Rate multiplied by the number of FTEs in such period utilized in connection with a particular activity. 
1.60“FTE Rate” means a rate of [***] per FTE; provided that, starting January 1, 2021, such rate shall be subject to an annual CPI Adjustment (as of January 1 of a given Calendar Year).  
1.61“Full Approval” shall mean that the Licensed Product (a) has received Regulatory Approval from the FDA in a subsequent filing, after submission and approval under the Subpart H regulations or their equivalents, without the FDA requiring any further confirmatory clinical trials to be conducted or (b) has received Regulatory Approval from the FDA without the FDA requiring any further confirmatory clinical trials to be conducted.
1.62“GCP” means current good clinical practices, as set forth in 21 C.F.R.  Parts 50, 54, 56, 312 and 314 and as interpreted by relevant ICH guidelines; in each case, as amended from time to time.  
1.63“Generic Product” means, with respect to a particular Licensed Product sold by Jazz or any of its Affiliates or Sublicensees in the Jazz Territory, a pharmaceutical product sold by a Third Party (other than a Sublicensee or any other Third Party in a chain of distribution originating from Jazz or any of its Affiliates or Sublicensees) in the Jazz Territory: (a) that contains Licensed API (and, if applicable, the same Other Active(s) as such Licensed Product); and (b) has received Regulatory Approval from the relevant Regulatory Authority in such country in reliance on the Regulatory Approval for such Licensed Product in the Jazz Territory.  
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1.64“GLP” means current good laboratory practices, as set forth in 21 C.F.R. Part 58 and as interpreted by relevant ICH guidelines; in each case, as amended from time to time.
1.65“GMP” means the current good manufacturing practices and standards for the production of drugs and finished pharmaceuticals, as set forth in 21 C.F.R. Parts 210 and 211 and as interpreted by relevant ICH guidelines; in each case, as amended from time to time.  
1.66“Governmental Authority” means any court, agency, department, authority or other instrumentality of any national, supra-national, state, county, city or other political subdivision.
1.67“HCPs” means healthcare professionals or healthcare providers.
1.68“Health Canada” means Health Canada, or any successor Regulatory Authority thereto in Canada having substantially the same function. 
1.69“HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder, or foreign equivalent thereof under Applicable Law.
1.70“HSR Clearance” means, as pertaining to this Agreement, the expiration or termination of all applicable waiting periods and requests for information (and any extensions thereof) under the HSR Act.
1.71“ICC Rules” has the meaning provided in Section 15.2(a).
1.72“ICH” means the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
1.73“IMRC” has the meaning provided in Section 7.8(a)(ii).
1.74“IND” means an investigational new drug application, clinical study application, clinical trial exemption, or similar application or submission filed with or submitted to a Regulatory Authority in a jurisdiction that is necessary to commence human clinical trials in such jurisdiction, including any such application filed with the FDA pursuant to 21 C.F.R.  Part 312 and any foreign equivalent.  
1.75“Indication” means a specific disease, disorder or condition which is recognized by Regulatory Authorities of Jazz Territory as a disease, disorder or condition.  
1.76“Information” means any and all tangible and intangible (a) techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, know-how, skill, experience, test data and results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms, and (b) compositions of matter, cells, cell lines, assays, animal models and physical, biological or chemical material; that, in each case, are not in the public domain.
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1.77“Invention” means any invention, whether or not patentable, made, conceived, created, generated or first reduced to practice (together with all intellectual property rights therein) in the course and as a result of the conduct of activities conducted pursuant to this Agreement
1.78“Investigator Sponsored Studies” or “ISS” means those Medical Affairs Studies involving the Licensed API or the Licensed Product which are not sponsored by a Party, its Affiliates, Sublicensees or its Third Party Partners, but by an investigator, an institution or any other Third Party sponsor even if such Studies are supported by such Party by providing the Licensed Products as study drug and/or by providing financial support and/or otherwise. 
1.79“Jazz Canada SCLC Post-Approval Commitment Studies” has the meaning provided in Section 4.1(b)(iii). 
1.80“Jazz Canada SCLC Post-Approval Commitment Studies Development Plan” has the meaning provided in Section 4.1(b)(iii). 
1.81“Jazz Canada SCLC Post-Approval Commitment Studies Development Budget” has the meaning provided in Section 4.1(b)(iii). 
1.82“Jazz Canada Territory” has the meaning provided in Section 1.95.
1.83“Jazz Generic Inventions” has the meaning provided in Section 10.1(e).
1.84“Jazz Generic Patents” means any Patent Right claiming a Jazz Generic Invention.
1.85“Jazz Know-How” means solely any Information Controlled as of the Effective Date or during the Term (including during the Term of the Original License Agreement) by Jazz or any of its Affiliates that [***].  For clarity, Jazz Know-How does not include [***].
1.86“Jazz License” has the meaning provided in Section 2.1.
1.87“Jazz Patents” means any Patent Right that is Controlled by Jazz or its Affiliates and Sublicensees as of the Effective Date or during the Term (including during the Term of the Original License Agreement) that claims [***].  For clarity, Jazz Patents shall include [***]. 
1.88“Jazz Proprietary Component” has the meaning provided in Section 10.1(d).
1.89“Jazz Prosecuted Patents” has the meaning provided in Section 10.2(c).
1.90“Jazz Solely Invented Specific Combination Inventions” means any Specific Combination Invention conceived, created or first reduced to practice solely by or on behalf of Jazz, its Affiliates or Sublicensees.
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1.91“Jazz Solely Invented Specific Inventions” means any Specific Invention conceived, created or first reduced to practice solely by or on behalf of Jazz, its Affiliates or Sublicensees
1.92“Jazz Specific Combination Inventions” has the meaning provided in Section 10.1(d).
1.93“Jazz Standard Trade Dress and Style” has the meaning provided in Section 10.9(e)
1.94“Jazz Technology” means Jazz Patents and Jazz Know-How.
1.95“Jazz Territory” means the U.S. (the “Jazz U.S. Territory”) and Canada (the “Jazz Canada Territory”), excluding any Terminated Territory.  
1.96“Jazz U.S. Territory” has the meaning provided in Section 1.95.
1.97“Joint Generic Inventions” has the meaning provided in Section 10.1(e).
1.98“Joint Generic Patent” means any Patent Right claiming a Joint Generic Invention.
1.99“Joint Patents” means Joint Specific Combination Patents and Joint Generic Patents.
1.100“Joint Specific Combination Invention” has the meaning provided in Section 10.1(d).
1.101“Joint Specific Combination Patent” means any Patent Right claiming a Joint Specific Combination Invention.
1.102“JCC” has the meaning provided in Section 3.1.  
1.103“JDC” has the meaning provided in Section 3.1.  
1.104“Licensed API” means (a) that composition of matter with the chemical structure identified more specifically in Exhibit A, otherwise known as lurbinectedin (PM1183); (b) any [***]; (c) any pro-drug, metabolite or degradant of any of the foregoing; or (d) any salt, free acid or base, crystal, co-crystal, hydrate, anhydrous form, solvate, ester, polymorph, isomer, regioisomer or stereoisomer (including enantiomer and diastereoisomer) of any of the foregoing.  
1.105“Licensed Indication” means the prevention, treatment, mitigation or cure of any disease, indication or medical condition, including cancer, whether as monotherapy or in combination with other drugs or biologics. 
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1.106“Licensed Product” means any pharmaceutical product containing or comprising a Licensed API as an active ingredient (whether or not as the sole active ingredient) in a form suitable for administration to a human. 
1.107“Licensed Product Data” means any and all results of research, preclinical studies, including in vitro and in vivo studies, clinical trials and other testing of Licensed API or Licensed Product conducted by or on behalf of a Party or any of its Affiliates (or in the case of PharmaMar, its Third Party Partners) to the extent Controlled by such Party either before the Effective Date or during the Term (including during the Term of the Original License Agreement), and any and all other data generated by or on behalf of a Party related to the development, manufacture or commercialization of Licensed API or Licensed Product, including safety data, biological, chemical, pharmacological, toxicological, pharmacokinetic, clinical, CMC, analytical, quality control, and other data, results and descriptions and, if requested, raw data associated with the conduct of any Clinical Trial for the Licensed API or Licensed Product (including the SCLC Post-Approval Commitment Studies); provided however that, except for that data that is necessary for Jazz to carry out its regulatory and quality obligations as the holder of an NDA for the Licensed Product, Licensed Product Data shall not include any data or Information which is included in any section of the DMF other than Section S of Module 3 of the NDA in the Jazz U.S. Territory (or its foreign equivalent in the Jazz Canada Territory) and is not otherwise publicly available. 
1.108“Major Tumour” means the following indications: (a) [***] and (b) any other , in each case of (a) and (b),[***] with a population of over [***], as determined in accordance with Section 5.4(c)(iii).  Notwithstanding the foregoing, the Parties agree that none of the following are Major Tumours: [***].  For the avoidance of doubt, [***] shall not be deemed a Major Tumour. 
1.109“Medical Affairs” means any and all processes and activities directed to interacting with physicians, healthcare professionals and other medical stakeholders with respect to the utilization, research and other medical (but not Commercialization) activities for a pharmaceutical product (including the Licensed Product), including: Medical Affairs Studies, Investigator Sponsored Studies; medical and scientific information; responding to external inquiries or complaints; medical education; health economics and outcomes research (HECOR, HEMAR); speaker programs; advisory boards; grants, fellowships and sponsorships; drug safety; local country government affairs; deployment of field-based medical science liaisons (MSLs); medical doctors in the field (separate from medical science liaisons); publications; medical communications; field medical education; registries; advocacy support; and slide libraries/kits, reprints and publication planning.  For clarity, Medical Affairs excludes any Clinical Trial that is (a) intended for use as a basis for obtaining Regulatory Approval (including for an additional indication or other label expansion or otherwise) or (b) a SCLC Post-Approval Commitment Study or other confirmatory trial requested by Regulatory Authorities.
1.110“Medical Affairs Studies” means any studies conducted within a country of the Territory after the granting of the Regulatory Approval of the Product in such country including ISS sponsored by an investigator or institution (and not in the name of either Party) under whose 
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supervision such study is being conducted and Clinical Trials sponsored by a Party; provided that Medical Affairs Studies shall exclude any such Clinical Trial which is (a) sponsored by a Party and conducted pursuant to a Regulatory Filing held in the name of a Party and whose primary purpose is to support a Regulatory Filing for the expansion or other modification of the label claims for such Product and (b) a SCLC Post-Approval Commitment Study or other confirmatory trial requested by Regulatory Authorities.
1.111“MSL” means, with respect to a Party, a medical science liaison employed by a Party or any of its Affiliates to perform activities with respect to a Licensed Product.
1.112“Mutual Canada SCLC Post-Approval Commitment Studies Development Plan” has the meaning provided in Section 4.1(b)(ii). 
1.113“Mutual Canada SCLC Post-Approval Commitment Studies” has the meaning provided in Section 4.1(b)(ii). 
1.114“NAM” means an account manager responsible for seeking coverage, coding and reimbursement of a Product by payers and managed market plans, including national account managers and regional account managers.
1.115“NDA” means: (a) in the United States, as applicable, a New Drug Application (as more fully described in 21 CFR Part 314.50, et seq., or its successor regulation) or a Biologics License Application (as more fully described in 21 CFR Part 601, et seq., or its successor regulation), filed with the FDA, or any successor application to either of the foregoing; or (b) in any other country or group of countries, the equivalent application or submission for approval to market a pharmaceutical product filed with the governing Regulatory Authority in such country or group of countries.  
1.116“NDA Approval” shall mean a Regulatory Approval by the FDA (whether under the Subpart H regulations or their equivalents or not) or by Health Canada, in each case, to market and/or promote a Licensed Product.
1.117“Net Sales” means, with respect to any Licensed Product, the [***] by Jazz and its Affiliates and Sublicensees for sales of such Licensed Product in the Licensed Indication in the Jazz Territory to unaffiliated Third Parties, less the following deductions [***]:
(a)[***];
(b)[***]; 
(c)[***]; 
(d)[***]; 
(e)[***];
(f)[***]; 
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(g)tariffs, taxes, custom duties and other governmental charges [***] levied on or measured by [***]; 
(h)[***]; and
(i)[***].
Notwithstanding the foregoing, amounts received or invoiced by Jazz or its Affiliates or Sublicensees for the sale of Licensed Products among Jazz and its Affiliates and Sublicensees shall not be included in the computation of Net Sales hereunder.  Net Sales shall be determined from the books and records of the Selling Party and its Affiliates maintained in accordance with Accounting Standards consistently applied.  
Notwithstanding the foregoing, “Net Sales” shall not include [***].  Further, [***], shall be disregarded in determining Net Sales.
Net Sales for a Combination Product in a country shall be calculated as follows:
(i)If the Licensed Product and Other Active(s) each are sold separately in such country, Net Sales will be calculated by multiplying the total Net Sales (as described above) of the Combination Product by the fraction A/(A+B), where A is the public or list price in such country of the Licensed Product sold separately in the same formulation and dosage, and B is the (sum of the) public or list price(s) in such country of the Other Active(s) sold separately in the same formulation and dosage, during the applicable Calendar Year.
(ii)If the Licensed Product is sold independently of the Other Active(s) in such country, but the public or list price of the Other Active(s) cannot be determined, Net Sales will be calculated by multiplying the total Net Sales (as described above) of such Combination Product by the fraction A/C, where A is the public or list price in such country of such Licensed Product sold independently and C is the public or list price in such country of the Combination Product.
(iii)If the Other Active(s) are sold independently of the Licensed Product therein in such country, but the public or list price of such Licensed Product cannot be determined, Net Sales will be calculated by multiplying the total Net Sales (as described above) of such Combination Product by the fraction [1-B/C], where B is the (sum of the) public or list price(s) in such country of the Other Active(s) and C is the public or list price in such country of the Combination Product.
(iv)If the public or list price of such Licensed Products and the Other Active(s) cannot be determined, Net Sales will be calculated by multiplying the total Net Sales (as described above) of such Combination Product by a fraction [***].  If [***].
1.118“Notice of Compliance” means a notification, issued pursuant to paragraph C.08.004(1)(a), indicating that a manufacturer has complied with sections C.08.002 or C.08.003 and C.08.005.1 of the Food and Drug Regulations issued by the Government of Canada.  
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1.119“OFAC” means the U.S. Department of Treasury’s Office of Foreign Assets Control (or its successor office or other body having substantially the same function).  
1.120“Other Active” means any active pharmaceutical ingredient other than Licensed API.  
1.121“Patent Rights” means (a) all national, regional and international patents and patent applications filed in any country of the world, including without limitation provisional patent applications, (b) all patent applications filed either from such patents and patent applications or from a patent application claiming priority from either of these, including any continuation, continuation-in-part, division, provisional, converted provisional and continued prosecution applications, or any substitute applications, (c) any patent issued with respect to or in the future issued from any such patent applications including utility models, petty patents and design patents and certificates of invention, and (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, reexaminations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications.  
1.122“Patent Term Extensions” has the meaning provided in Section 10.3.
1.123“Person” means any individual, Entity or Governmental Authority.  
1.124“PharmaMar Generic Inventions” has the meaning provided in Section 10.1(e).
1.125“PharmaMar Know-How” means (a) all Information Controlled by PharmaMar or its Affiliates as of the Effective Date or during the Term (including during the Term of the Original License Agreement) that [***].  PharmaMar Know-How does not include [***]. 
1.126“PharmaMar Patents” means (a) all Patent Rights Controlled by PharmaMar or its Affiliates as of the Effective Date or during the Term (including during the Term of the Original License Agreement) that claim [***].  PharmaMar Patents shall include [***].  Exhibit B shall be updated no less frequently than [***] by PharmaMar during the Term to include all PharmaMar Patents (except for Joint Specific Combination Inventions for which Jazz shall provide with updates of such Exhibit B no less frequently than [***] during the Term).   
1.127“PharmaMar Prosecuted Patents” has the meaning provided in Section 10.2(b).
1.128“PharmaMar Technology” means the PharmaMar Patents and the PharmaMar KnowHow.  
1.129“PharmaMar Territory” means all countries and jurisdictions in the world other than the Jazz Territory.  
1.130“Pivotal Trial” means: (a) a human Clinical Trial that would satisfy the requirements for a Phase 3 study as defined in 21 CFR § 312.21(c) or any foreign equivalent (or any amended or successor regulations); or (b) any other human Clinical Trial that the applicable Regulatory Authority has agreed [***], is sufficient to form the primary basis of an efficacy 
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claim in an NDA submission, regardless of whether the sponsor of such trial characterizes or refers to such trial as a “Phase 3,” “Phase 2b” or “Phase 2b/3” trial (or otherwise) in the applicable protocol, on clinicaltrials.gov, or in any other context.  
1.131“Pivotal Trial Costs” means, with respect to a given Joint Additional Indication Pivotal Trial, the sum of [***], in each case, in accordance with the applicable Joint Additional Indication Pivotal Trial Budget and as accounted for by each Party (or its Affiliates, Sublicensees or Third Party Partners) in accordance with such Party’s Accounting Standards.
1.132“Positive Results” means, for an Additional Indication Pivotal Trial, (a) that [***] and (b) for an Additional Indication Pivotal Trial not being a Phase 3 study, that [***].
1.133“Pricing Approval” means, in any country where a Governmental Authority or Regulatory Authority authorizes reimbursement for, or approves or determines pricing for, biopharmaceutical drugs, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).
1.134“Product Trademarks” has the meaning provided in Section 10.9(a).
1.135“Promotion Message” means the set of messages and communications prepared by Jazz intended to promote the use and/or prescribing of the Licensed Product.
1.136“Proposed Additional Indication Pivotal Trial” has the meaning provided in Section 4.2(a).
1.137“Prosecution and Maintenance” has the meaning provided in Section 10.2(b).
1.138“PV Agreement” has the meaning provided in Section 5.10.
1.139“Quality Agreement” has the meaning provided in Section 6.2.
1.140“Regulatory Approval” means all approvals from the relevant Regulatory Authority in a given country necessary to market and sell a pharmaceutical product in such country, including Pricing Approvals if required for marketing or sale of such product in such country.  
1.141“Regulatory Authority” means any country, federal, supranational, state or local regulatory agency, department, bureau or other governmental or regulatory authority having the administrative authority to regulate the development or marketing of pharmaceutical products in any country or other jurisdiction.  
1.142“Regulatory Exclusivity” means marketing or manufacturing exclusivity conferred by the applicable Regulatory Authority in a country or jurisdiction on the holder of a Regulatory Approval for a pharmaceutical product in such country or jurisdiction, including, by way of example and not of limitation, regulatory data exclusivity, orphan drug exclusivity, new chemical entity exclusivity and pediatric exclusivity.  
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1.143“Regulatory Filing” means any and all INDs, NDAs, drug dossiers or drug master files filed, requests for orphan designation, and Regulatory Approvals and orphan designations obtained, with respect to Licensed API or Licensed Product, including all amendments, supplements, annual reports and the like filed with or otherwise provided to the applicable Regulatory Authority.  
1.144“Regulatory Milestone” has the meaning provided in Section 8.4.
1.145“Regulatory Milestone Payment” has the meaning provided in Section 8.4.
1.146“Remedial Action” has the meaning provided in Section 5.8.  
1.147“Royalty Term” has the meaning provided in Section 8.7(b).
1.148“Sales Force” means, with respect to a Party, its sales organization, including field based sales representatives that [***].  
1.149“Sales Milestone” has the meaning provided in Section 8.6.
1.150“Sales Milestone Payment” has the meaning provided in Section 8.6.
1.151“SCLC” means small cell lung cancer. 
1.152“SCLC Initial Indication” shall mean the treatment of SCLC as second or subsequent treatment line in monotherapy or in combination with doxorubicin.  
1.153“SCLC Post-Approval Commitment Studies” means U.S. SCLC Post-Approval Commitment Studies, Mutual Canada SCLC Post-Approval Commitment Studies, or Jazz Canada SCLC Post-Approval Commitment Studies, as applicable. 
1.154“Specific Combination Invention” has the meaning provided in Section 10.1(c).
1.155“Specific Inventions” has the meaning provided in Section 10.1(b).
1.156“Sublicensee” means a Third Party sublicensee under the Jazz License, whether such Third Party’s sublicense was granted to it directly by Jazz or its Affiliate or indirectly through one or more tiers of sublicense.  
1.157“Supply Agreement” has the meaning provided in Section 6.1.  
1.158“Supply Failure” has the meaning to be set forth in the Supply Agreement.
1.159“Term” has the meaning provided in Section 13.1.  
1.160“Terminated Territory” means any country or jurisdiction in the Jazz Territory for which this Agreement is terminated by Jazz pursuant to Section 13.2 or by PharmaMar or Jazz pursuant to Section 13.3 or all of the countries or jurisdictions in the Jazz Territory at the time of termination if this Agreement is terminated in its entirety. 
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1.161“Territory” means (a) the Jazz Territory in the case of Jazz and (b) the PharmaMar Territory in the case of PharmaMar.  
1.162“Third Party” means an Entity other than Jazz or PharmaMar or an Affiliate of Jazz or PharmaMar.  
1.163“Third Party Partner” means a Third Party to whom PharmaMar, pursuant to a written or other legally binding agreement, grants any right to Develop and/or Commercialize the Licensed API or the Licensed Product in any jurisdiction in the PharmaMar Territory in each case, for so long as such agreement is in effect.  For clarity, Third Party Partner shall exclude any Third Party subcontracted by PharmaMar (or its Affiliates or Third Party Partners) solely to perform any Development, manufacturing or Commercialization activities on PharmaMar’s (or its Affiliate’s or Third Party Partner’s) behalf such as CROs, CMOs, CSOs and logistic subcontractors.  As of the Restatement Effective Date, existing Third Party Partners are set forth on Exhibit C. 
1.164“Title 11” has the meaning provided in Section 16.3(a).
1.165“Trademark” means any trademark, trade name, service mark, service name, brand, domain name, trade dress, logo, slogan or other indicia of origin or ownership in, including registrations and applications therefor as well as any unregistered rights therein and the goodwill and activities associated with each of the foregoing.
1.166[***] has the meaning provided in Section 10.8.
1.167“U.S.” means the United States of America, including its possessions and territories.
1.168“U.S. Annual Sales Forecast Plan” or “U.S. ASFP” has the meaning provided in Section7.8(a)(i).
1.169“U.S. SCLC Post-Approval Commitment Studies Development Plan” has the meaning provided in Section 4.1(b)(i).
1.170“U.S. SCLC Post-Approval Commitment Studies” has the meaning provided in Section 4.1(b)(i).
1.171“Valid Claim” means a claim contained in (a) an issued and unexpired patent which has not been held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through abandonment, reissue, disclaimer or otherwise or (b) a patent application that has not been irretrievably cancelled, withdrawn or abandoned and that has been pending for less than [***].  If a claim of a [***], then it shall [***].  
1.172“Working Group” has the meaning provided in Section 3.5.
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2.License Grants
2.1Jazz License.  
(a)Exclusive License Grant to Jazz. Subject to the terms and conditions of this Agreement, PharmaMar hereby grants to Jazz an exclusive (even as to PharmaMar, except as expressly set forth in subsection (vii) below and in Section 2.3), royaltybearing license, with the right to sublicense through multiple tiers in accordance with Section 2.1(c), under the PharmaMar Technology (i) to Commercialize Licensed Products under the Product Trademarks in the Licensed Indications in the Jazz Territory; (ii) to conduct Medical Affairs activities in the Jazz Territory; (iii) to Develop Licensed Products in Jazz Territory; (iv) to conduct research and preclinical development activities in the Jazz Territory; (v) to conduct SCLC Post-Approval Commitment Studies and Joint Additional Indications Pivotal Trials in the PharmaMar Territory; (vi) to use and import the Licensed API or Bulk Vials of Licensed Products supplied by PharmaMar to manufacture, have manufactured, use and import Licensed Products for use in accordance with this Section 2.1 in the Jazz Territory and the PharmaMar Territory; and (vii) solely in the event of a Supply Failure, a co-exclusive (solely with PharmaMar and its Affiliates and authorized Third Party manufacturers) license to, within and without the Jazz Territory, to manufacture and have manufactured Licensed API, Bulk Vials and Licensed Products and to import Licensed API, Bulk Vials and Licensed Products into the Jazz Territory, but only for use otherwise in accordance with this Section 2.1.  PharmaMar’s retained co-exclusive right shall include the right to, within and without the Jazz Territory, manufacture, have manufactured, import and export Licensed API, Bulk Vials and Licensed Products for any use in the PharmaMar Territory otherwise authorized by this Agreement. 
(b)Non-Exclusive License Grant to Jazz. In addition to Section 2.1(a), and subject to the terms and conditions of this Agreement, PharmaMar hereby grants to Jazz a non-exclusive, royaltybearing license, with the right to sublicense through multiple tiers in accordance with Section 2.1(c), under the PharmaMar Technology (i) to conduct research and preclinical development activities in the PharmaMar Territory; (ii) to conduct Jazz Additional Indication Clinical Trials [***]; and (iii) to conduct Joint Additional Indication Pivotal Trials in the PharmaMar Territory (the licenses in Section 2.1(a) and Section 2.1(b) collectively, the “Jazz License”). 
(c)Sublicensing.  Jazz shall have the right to grant sublicenses through multiple tiers, under any or all of the rights granted in the Jazz License (i) to its Affiliates and to Third Party contractors or service providers (including contract manufacturing organizations) [***] and (ii) to Third Parties that are not contractors or service providers [***].  Any sublicense granted by Jazz under the Jazz License shall be in writing and shall be consistent with the relevant terms and conditions of this Agreement.  [***].    
2.2PharmaMar License. 
(a)Exclusive License Grant to PharmaMar.  Subject to the terms and conditions of this Agreement, Jazz hereby grants to PharmaMar an exclusive (even as to Jazz), 
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royalty-free license, with the right to sublicense through multiple tiers in accordance with Section 2.2(c), under the Jazz Technology (i) to commercialize Licensed Products in the PharmaMar Territory; (ii) to conduct Medical Affairs activities in PharmaMar Territory; (iii) to develop Licensed Products in the PharmaMar Territory; and (iv) to conduct research and preclinical development activities in the PharmaMar Territory.
(b)Non-exclusive License Grant to PharmaMar.  Jazz hereby grants to PharmaMar a non-exclusive, royalty-free license, with the right to sublicense through multiple tiers in accordance with Section 2.2(c), under Jazz Technology, (i) to conduct Atlantis Trial and SCLC Post-Approval Commitment Studies in the Jazz Territory; (ii) to conduct PharmaMar Additional Indication Clinical Trials in the Jazz Territory; (iii) to conduct research and preclinical development activities in the Jazz Territory; and (iv) to manufacture, have manufactured, use and import Licensed API (solely in the event of a Supply Failure) and Licensed Products for use in accordance with the rights granted in Section 2.2(a) and Section 2.2(b)(i) – (iii) in the Jazz Territory and in the PharmaMar Territory (the licenses in Section 2.2(a) and Section 2.2(b) collectively, the “PharmaMar License”).
(c)Sublicensing.  Subject to Section 2.8, PharmaMar shall have the right to grant sublicenses through multiple tiers, under any or all of the rights granted in the PharmaMar License [***] to Affiliates, Third Party Partners and Third Party contractors or services providers (including contract manufacturing organizations), provided that sublicenses under Jazz Technology other than [***].  Any sublicense granted by PharmaMar under the PharmaMar License shall be in writing and shall be consistent with the relevant terms and conditions of this Agreement.  [***]  PharmaMar shall keep Jazz reasonably informed regarding any Third Party Partner’s use of any sublicensed Jazz Technology that it otherwise becomes aware of in the ordinary course, it being understood that PharmaMar shall have no independent duty of inquiry with respect to such uses. 
2.3    Reservation of Rights.  
(a)Notwithstanding the exclusivity of the Jazz License, PharmaMar retains for itself (and/or, solely with respect to subsection (i) and (ii), its Affiliates and Third Party Partner(s)), (i) the exclusive right under the PharmaMar Technology to manufacture and have manufactured the Licensed API in Jazz Territory and in PharmaMar Territory (subject to Jazz’s right to manufacture and have manufactured the Licensed API in the Jazz Territory and in the PharmaMar Territory in the event of a Supply Failure); (ii) the non-exclusive right under PharmaMar Technology to manufacture and have manufacture the Licensed Product in the Jazz Territory and in PharmaMar Territory for the sole purposes of (x) conducting development activities (including Clinical Trials, research and preclinical development) for Licensed Products in the PharmaMar Territory and those Development activities PharmaMar is entitled to conduct in the Jazz Territory in accordance with Section 4.1, 4.2 or 4.3, (subject to Section 3.4(b) if applicable), (y) conducting its Commercialization activities for Licensed Products in the PharmaMar Territory and (z) selling Licensed API or Licensed Products, as applicable, to Jazz in accordance with the terms of the Supply Agreement; and (iii) the right under the PharmaMar Technology to (A) complete the Atlantis Trial in accordance with Section 4.1(a) and (B) conduct 
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the development activities (including clinical trials, research and preclinical development) for Licensed Products that PharmaMar is entitled to conduct in the Jazz Territory in accordance with Section 4.1, 4.2 or 4.3 (subject to Section 3.4(b) if applicable).
(b)Notwithstanding the exclusivity of the PharmaMar License, Jazz retains for itself (and/or its Affiliates and Sublicensees), (i) the right under the Jazz Technology to manufacture and have manufacture Licensed API (in this case solely in the event of a Supply Failure) and Licensed Product in the Jazz Territory and in PharmaMar Territory for the sole purposes of (x) conducting development activities (including Clinical Trials, research and preclinical development) for Licensed Products in the Jazz Territory and those Development activities Jazz is entitled to conduct in the PharmaMar Territory in accordance with Section 4.2 or 4.3, (subject to Section 3.4(b) if applicable) and (y) conducting its Commercialization activities for Licensed Products in the Jazz Territory, (ii) the right under the PharmaMar Technology to conduct the development activities (including clinical trials, research and preclinical development) for Licensed Products that Jazz is entitled to conduct in the PharmaMar Territory in accordance with Section 4.2 or 4.3, (subject to Section 3.4(b) if applicable), and (iii) the right under the Jazz Technology to conduct research and preclinical development activities in the PharmaMar Territory. 
(c)PharmaMar reserves to itself (and/or its Third Party Partner(s)), all other rights not expressly granted to Jazz pursuant to this Agreement, including: (i) the right to conduct development activities of the Licensed API and Licensed Product in the PharmaMar Territory, (subject to Section 3.4(b) if applicable), (ii) the right to Commercialize Licensed Products in the PharmaMar Territory and (iii) the right to conduct Medical Affairs activities in the PharmaMar Territory.  Jazz reserves to itself (and/or its Affiliates, Sublicensees and licensees), all other rights in the Jazz Technology not expressly granted to PharmaMar pursuant to this Agreement.
2.4Negative Covenants.  
(a)By PharmaMar.  PharmaMar hereby covenants that until the [***], neither it nor its Affiliates will, directly or indirectly (including with or through any Third Party licenses): [***], provided, that the foregoing covenants [***] shall (x) not prohibit PharmaMar from fulfilling its obligations to Jazz under the Agreement or from filing an NDA application for the Licensed Product for the SCLC Initial Indication and (y) not apply to [***].  For clarity, [***]. 
(b)By Jazz.  Jazz hereby covenants that until the [***], neither it nor its Affiliates will, directly or indirectly (including with or through Third Party licensees): [***], provided, that the foregoing covenants [***] shall (A) not prohibit Jazz from Developing, manufacturing or Commercializing Licensed Products pursuant to the Jazz License or fulfilling its obligations to PharmaMar under this Agreement and (B) not apply to [***].  For clarity, [***].
(c)Exceptions for Mergers and Acquisitions.  Without limiting Section 7.10, in the event that a Third Party becomes an Affiliate of a Party after the Effective Date through merger, acquisition, consolidation or other similar transaction, and, as of the closing date 
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of such transaction, such Third Party is engaged in the research, development or commercialization of a product that, if further developed, manufactured or commercialized by such Party, would cause such Party to be in breach of its exclusivity obligations set forth in Section 2.4(a) or Section 2.4(b), as applicable (a “Competing Program”), then:
(1)if such transaction results in a Change of Control of a Party, then such new Affiliate [***]; provided, that such new Affiliate [***]; and  
(2)if such transaction does not result in a Change of Control of a Party, then such Party and its new Affiliate will [***] from the closing date of such transaction to wind down or complete the Divestiture of such Competing Program, and [***]; provided, that  [***].  “Divestiture” means the [***].
2.5No Implied Licenses.  Except as explicitly set forth in this Agreement, neither Party shall be deemed by estoppel or implication to have granted the other Party any license or other right to any Patent Rights or other intellectual property of such Party.  ALL RIGHTS WITH RESPECT TO TECHNOLOGY OR INTELLECTUAL PROPERTY RIGHTS THAT ARE NOT SPECIFICALLY GRANTED HEREIN ARE RESERVED TO THE OWNER OF SUCH TECHNOLOGY OR INTELLECTUAL PROPERTY RIGHTS.
2.6Technology Transfer.  Promptly after Jazz ́s request, but in any event within [***], PharmaMar shall disclose to Jazz all existing PharmaMar Know-How which is [***].  Thereafter, on an ongoing basis, PharmaMar shall also disclose to Jazz all additional PharmaMar Know-How generated after the Effective Date [***].  For clarity, [***], PharmaMar shall [***].  Without limiting the generality of the foregoing, PharmaMar shall provide to Jazz true and complete copies of all written, graphic or electronic embodiments of Licensed Product Data within the PharmaMar Know-How.  The PharmaMar Know-How shall be transferred to Jazz in a format to be agreed upon by the Parties, such agreement not to be unreasonably withheld and facilitated, where useful, by face to face technical exchange meetings or meetings at PharmaMar’s contract manufacturing sites.  With respect to any of the foregoing that is in a language other than English, PharmaMar shall also provide Jazz with English translations thereof. 
2.7 [***].  Jazz acknowledges and agrees that [***] – even if supported in any manner by PharmaMar, its Affiliates or its Third Party Partners - shall [***].  In addition, Jazz acknowledges and agrees that PharmaMar shall [***].  For clarity, nothing in this Agreement shall prevent PharmaMar (and its Affiliates and Third Party Partners) to [***] and Jazz agrees that if such occurs it shall not, by itself, be deemed a [***].  For further clarity, PharmaMar shall not have the right to [***]. In addition, Jazz shall not have the right [***].
2.8Third Party Partner Licenses in [***].  
(a)The Parties agree that notwithstanding any other provisions of this Agreement, within [***], Jazz shall, as set forth below, [***]. Therefore PharmaMar agrees that with respect to [***], PharmaMar shall not [***]. For clarity, PharmaMar shall be entitled to disclose [***] any Licensed Product Data obtained from Clinical Trials conducted by Jazz, and 
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[***] shall be entitled to use such Licensed Product Data in its Territory as may be reasonable necessary or useful for the development, manufacturing or commercialization of the Licensed API and Licensed Product in [***], including to support the filings and prosecuting of Regulatory Filings and obtaining and maintaining Regulatory Approvals in [***]. Furthermore, PharmaMar shall be entitled to provide [***] with (a) sufficient rights of reference and use regarding any Licensed Product Data, and Regulatory Filings, Regulatory Approvals and material communications in Jazz Territory to the extent such rights are necessary for [***] to exercise its rights and obligations under its existing agreement with PharmaMar and (b) true and complete copies of any Regulatory Filings, Regulatory Approvals and material communications with Regulatory Authorities in Jazz Territory with respect to the Licensed Product. 
(b)In addition, and with regard to [***], PharmaMar shall not [***], in each case, to [***].  Without limiting the provisions of Section 2.8(a), the foregoing obligations under this Section 2.8(b) shall also apply to [***], except to the extent PharmaMar has [***]. 
(c)If PharmaMar discloses or grants any rights to [***] with respect to any Jazz Technology, then at Jazz’s request and PharmaMar’s expense, PharmaMar shall take reasonable action to prevent or limit the possibility of such disclosure or grant from or of having an adverse effect on Jazz’s rights under this Agreement or with respect to such Jazz Technology. 
(d)For clarity, Jazz acknowledges and agrees that [***]. 
2.9Right of Negotiation.  In the event that development, manufacturing or Commercialization of Licensed Products by [***] (or its Affiliates or [***]), misappropriates any Know-how and/or infringe any Patents Rights that are Controlled by [***] but are not included in the [***], then at [***] request, the Parties will negotiate in good faith regarding the terms for [***] to grant a non-exclusive, royalty-bearing, sublicensable license to [***] under such Know-How or Patent Right for the development, manufacture and commercialization of Licensed API and Licensed Products [***] is entitled to conduct under this Agreement; upon reaching agreement regarding such terms, the Parties shall either enter into a separate license agreement or amend this Agreement to reflect such terms.  
3.Governance
3.1Joint Development Committee
(a)Formation and Role.  The Parties have established a Joint Development Committee (the “JDC”) to coordinate, oversee, review and discuss the Parties’ activities with respect to the Development and registration of Licensed Products in the Licensed Indication in the Jazz Territory and the PharmaMar Territory.  For that purpose and to the extent reasonably necessary, the JDC will:
(i)discuss and approve any amendments to the Atlantis Development Plan;
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(ii)prepare, discuss and approve the U.S. SCLC Post-Approval Commitment Studies Development Plan (and the U.S. SCLC Post-Approval Commitment Studies Budget if applicable); 
(iii)prepare, discuss and approve the Mutual Canada SCLC Post-Approval Commitment Studies Development Plan (and the Mutual Canada SCLC Post-Approval Commitment Studies Budget if applicable);
(iv)prepare, discuss and approve the Jazz Canada SCLC Post-Approval Commitment Studies Development Plan and the Jazz Canada SCLC Post-Approval Commitment Studies Budget; 
(v)prepare, discuss and approve the Proposed Additional Indication Pivotal Trial Development Plan and Proposed Additional Indication Pivotal Trial Budget; 
(vi)review and approve the protocols for any Proposed Additional Indication Pivotal Trial of Licensed Product to be performed by Jazz and/or PharmaMar in the Jazz Territory or the PharmaMar Territory;
(vii)prepare, discuss and approve changes to any Joint Additional Indication Pivotal Trial Development Plan or Joint Additional Indication Pivotal Trial Development Budget;
(viii)prepare, discuss and approve changes to Additional Indication Pivotal Trial Development Plan for an Additional Indication Pivotal Trial that is not a Joint Additional Indication Pivotal Trial;
(ix)[***], share information about and discuss such PharmaMar Additional Indication Clinical Trial;
(x)[***], share information about and discuss such Jazz Additional Indication Clinical Trial that Jazz intends to conduct;
(xi)review, discuss and approve Jazz’s conduct of a Jazz Additional Indication Clinical Trial in [***];
(xii)at each JDC meeting, review and discuss material research and preclinical development activities by either Party or their respective Affiliates with respect to the Licensed API and Licensed Product in the Jazz Territory and the PharmaMar Territory; 
(xiii)discuss about the regulatory strategy for the Licensed Product in Jazz Territory and in the EMA; 
(xiv)serve as the principal means by which: (i) Jazz keeps PharmaMar reasonably informed regarding Jazz’s Development and registration plans, efforts and results with respect to Licensed Products, and (ii) PharmaMar keeps Jazz reasonably informed regarding (A) PharmaMar’s performance of its obligations under Section 4.1 of this Agreement and 
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(B) PharmaMar’s development and registration plans, efforts and results with respect to Licensed Products;
(xv)share information regarding the global development and regulatory strategy with respect to Licensed Product in the Licensed Indications;
(xvi)establish such Working Groups as it deems necessary to achieve the objectives and intent of this Agreement; 
(xvii)perform such other duties as are specifically assigned to the JDC in this Agreement or the Supply Agreement; and
(xviii)determine appropriate wind-down procedures for any Expanded Access after the first NDA Approval for the Licensed Product;
 Each Party shall be responsible for ensuring that, at all times, its representatives on the JDC act reasonably and in good faith in carrying out their respective responsibilities hereunder.
(b)Members.  Each Party has appointed [***] to the JDC, each of whom is an officer or employee of the applicable Party having sufficient seniority within such Party to make decisions arising within the scope of the JDC’s responsibilities.  The JDC may change its size from time to time by mutual consent of its members, and each Party may replace its representatives at any time upon written notice to the other Party.  Each Party has appointed one of its representatives to the JDC to cochair the meetings of the JDC (each, a “CoChair”).  The role of the Co-Chairs shall be to coordinate and prepare the agenda (which agenda shall include all matters requested by a JDC representative from either Party), convene and preside at the meetings of the JDC ensuring the orderly conduct of the JDC meetings and to ensure the preparation of meeting minutes, but the Co-Chairs shall have no additional powers or rights beyond those held by other JDC representatives.
(c)Meetings.  The JDC shall meet as deemed necessary by the JDC members, but at least [***] for so long as either Party or their Affiliates (or any Third Party Partner) is conducting clinical development of any Licensed Product.  JDC meetings may be conducted in person, by teleconference or videoconference at times and places to be determined by the JDC members.  Unless otherwise agreed by the Parties, all in-person meetings of the JDC shall be held on an alternating basis between PharmaMar and Jazz facilities.  A reasonable number of additional representatives of a Party may attend meetings of the JDC in a non-voting capacity.  Each Party shall bear its own expenses of participating in meetings of the JDC.  
(d)Minutes.  Each Party, on an alternative basis, shall be responsible for preparing definitive minutes of each JDC meeting.  The Party in charge of the minutes shall circulate a draft of the minutes of each meeting to all members of the JDC for comments within [***] after such meeting.  Such minutes shall document all actions and decisions approved by the JDC at such meeting, including the approval of the Development Plan or any amendment thereto, which shall be attached to the minutes as an exhibit.  The Parties shall promptly discuss any 
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comments on such minutes and finalize the minutes no later than the date of the next JDC meeting.   
3.2Joint Commercialization Committee.  
(a)Formation and Role.  Within [***] after PharmaMar’s exercise of its Co-Promotion Option, if any, the Parties shall establish a Joint Commercialization Committee (the “JCC”) to coordinate, oversee, review and discuss the Parties’ activities with respect to the co-promotion of Licensed Products in the Licensed Indication in the Jazz U.S. Territory.  For that purpose and to the extent reasonably necessary, the JCC will:
(i)prepare, discuss and approve a plan for the Commercialization of Licensed Products in the Licensed Indication in the Jazz U.S. Territory (the “Co-Promotion Plan”); 
(ii)coordinate the Party’s performance of the Co-Promotion Plan;
(iii)serve as the principal means by which each Party keeps the other Party reasonably informed regarding such Party’s efforts and results with respect to marketing and promotion of Licensed Products in the Jazz U.S. Territory pursuant to the Co-Promotion Plan; and
(iv)perform such other duties as are specifically assigned to the JCC in this Agreement or the Co-Promotion Agreement.  
Each Party shall be responsible for ensuring that, at all times, its representatives on the JCC act reasonably and in good faith in carrying out their respective responsibilities hereunder.
(b)Members.  Upon formation of the JCC, each Party shall initially appoint up to [***] to the JCC, each of whom will be an officer or employee of the applicable Party having sufficient seniority within such Party to make decisions arising within the scope of the JCC’s responsibilities.  The JCC may change its size from time to time by mutual consent of its members, and each Party may replace its representatives at any time upon written notice to the other Party.  Each Party shall appoint one of its representatives to the JCC to cochair the meetings of the JCC (each, a “CoChair”).  The role of the Co-Chairs shall be to coordinate and prepare the agenda (which agenda shall include all matters requested by a JCC representative from either Party), convene and preside at the meetings of the JCC ensuring the orderly conduct of the JCC meetings and to ensure the preparation of meeting minutes, but the Co-Chairs shall have no additional powers or rights beyond those held by other JCC representatives.
(c)Meetings.  The JCC shall meet as deemed necessary by the JCC members, but at least [***] for so long as either Party is co-promoting Licensed Product in the Jazz U.S. Territory.  JCC meetings may be conducted in person by teleconference or videoconference at times and places to be determined by the JCC members.  Unless otherwise agreed by the Parties, all in-person meetings of the JCC shall be held on an alternating basis between PharmaMar and Jazz facilities.  A reasonable number of additional representatives of a Party may attend meetings 
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of the JCC in a non-voting capacity.  Each Party shall bear its own expenses of participating in meetings of the JCC.  
(d)Minutes.  Each Party, on an alternative basis, shall be responsible for preparing definitive minutes of each JCC meeting.  The Party in charge of the minutes shall circulate a draft of the minutes of each meeting to all members of the JCC for comments within [***] after such meeting.  Such minutes shall document all actions and decisions approved by the JCC at such meeting, including the approval of the Co-Promotion Plan or any amendment thereto, which shall be attached to the minutes as an exhibit.  The Parties shall promptly discuss any comments on such minutes and finalize the minutes no later than the date of the next JCC meeting.  
3.3Limitation of Committee Authority.  Each Committee shall only have the powers expressly assigned to it in this Agreement, and such powers shall be subject to the terms and conditions of this Agreement.  Without limiting the foregoing, no Committee will have the power to (a) modify or amend the terms and conditions of this Agreement; (b) waive either Party’s compliance with the terms and conditions of under this Agreement; or (c) determine any such issue in a manner that would conflict with the express terms and conditions of this Agreement.
3.4Decision-Making and Dispute Resolution.  
(a)Decision-Making.  Each Committee will attempt to reach decisions by consensus, with the Jazz representatives having collectively one vote and the PharmaMar representatives having collectively one vote.  Each Committee’s decision-making authority shall be limited to those matters expressly delegated to it in this Agreement.  If, after reasonable discussion and good faith consideration of each Party’s view on a particular matter before a Committee, the representatives of the Parties cannot reach an agreement as to such matter within [***] after such matter was brought to such Committee for resolution (each, a “Committee Dispute”), such disagreement shall be escalated to the Executive Officers for resolution within [***], who shall confer in good faith on the resolution of the issue.  Any final decision mutually agreed to by such Executive Officers shall be conclusive and binding on the Parties.
(b)Final Decisions.  If the Executive Officers are not able to agree on the resolution of any such Committee Dispute within [***] after such issue was first referred to them, then the following shall apply:
(i)Jazz shall have final decision-making authority for all matters relating to the Commercialization of Licensed Products in the Licensed Indication in the Jazz Territory;
(ii)Jazz shall have final decision-making authority for all matters relating to its, its Affiliates’ and Sublicensees’ conduct of preclinical and research development activities in the Jazz Territory and/or the PharmaMar Territory;
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(iii)Jazz shall have final decision-making authority for all matters relating to the Development of Licensed API or Licensed Product conducted in the Jazz Territory, including the conduct of the Jazz Canada SCLC Post-Approval Commitment Studies and the applicable Jazz Canada SCLC Post-Approval Commitment Studies Development Plan and Jazz Canada SCLC Post-Approval Commitment Studies Budget and any amendments thereto (as long as such activities and such plan are consistent with and do not exceed Health Canada requirements) (except for the conduct of the Atlantis Trial, PharmaMar Additional Indication Clinical Trials, Additional Indication Pivotal Trials, Joint Additional Indication Pivotal Trials and preclinical and research development activities conducted by PharmaMar, its Affiliates and Third Party Partners), and for all matters relating to the conduct of Jazz Additional Indication Clinical Trials in the PharmaMar Territory provided that PharmaMar shall have final decision making authority with respect to whether to permit or not the conduct of a Jazz Additional Indication Clinical Trial outside [***] in PharmaMar Territory;
(iv)To the extent Jazz performs any SCLC Post-Approval Commitment Studies pursuant to Section 4.1(b), Jazz shall have final decision-making authority for all matters relating to the conduct of such SCLC Post-Approval Commitment Studies in the Jazz Territory and the PharmaMar Territory, including with respect to the applicable SCLC Post-Approval Commitment Studies Plan and SCLC Post-Approval Commitment Studies Budget and any amendments thereto (as long as such activities and such plan are consistent with and do not exceed FDA or Health Canada requirements, as applicable); 
(v)PharmaMar shall have final decision-making authority for all matters relating to the development of Licensed API or Licensed Product conducted in the PharmaMar Territory (except for the conduct of Joint Additional Indication Approval Studies, Jazz Additional Indication Clinical Trials in [***] and preclinical and research development activities conducted by Jazz, its Affiliates and Sublicensees) and for all matters relating to the conduct of PharmaMar Additional Indication Clinical Trials in the Jazz Territory;
(vi)PharmaMar shall have final decision-making authority for all matters relating to the conduct of the Atlantis Trial, including any amendment to the Atlantis Development Plan;
(vii)PharmaMar shall have final decision-making authority for all matters relating to the conduct of Additional Indication Pivotal Trials (and for clarity, excluding the conduct of Joint Additional Indication Pivotal Trials);
(viii)Except to the extent Jazz performs SCLC Post-Approval Commitment Studies in accordance with Section 4.1(b), PharmaMar shall have final decision-making authority for all matters relating to the conduct of the U.S. SCLC Post-Approval Commitment Studies and Mutual Canada SCLC Post-Approval Commitment Studies in the Jazz Territory and the PharmaMar Territory; 
(ix)PharmaMar shall have final decision-making authority for all matters relating to its, its Affiliates’ and Third Party Partners’ conduct of preclinical and research development activities in the Jazz Territory and/or the PharmaMar Territory;
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provided, that, if a Party reasonably believes, based on regulatory and scientific evidence typically relied upon by the pharmaceutical industry, that any Development activity proposed by the other Party (whether or not such proposed activity is subject to the JDC’s final decision making authority) would [***] (an “Adverse Safety Impact”), such Party shall have the right to either (A) prevent the other Party from exercising its final decision-making authority set forth in Section 3.4(b)(ii), Section 3.4(b)(iv), Section 3.4(b)(vi) or Section 3.4(b)(vii), as applicable, to approve the conduct of any such Development activity or (B) impose additional conditions on the conduct of such Development activity that are [***], which right shall not be subject to further review or approval by the JDC.  In the event any Party disputes the other Party ́s determination of any Development activity having potentially an Adverse Safety Impact, the Parties shall submit the proposed Development activity to an independent Third Party or committee (such as an investigator review board in the case of an Adverse Safety Impact relating to [***]) to be appointed by both Parties jointly for determination of the existence or not of a potential Adverse Safety Impact.  Determination by such independent Third Party shall be binding to the Parties.
Nothing in this Section 3.4(b) shall relieve a Party who has or exercises any ‘final decision-making authority’ set forth herein of any contractual obligation to the other Party, including, without limitation any obligation to exercise Commercially Reasonable Efforts.
(c)Neither Party Final Decisions.  Neither Party shall have final decision-making authority for any matter relating to the conduct of a Joint Additional Indication Pivotal Trial, including any Additional Indication Pivotal Trial Development Plan or Additional Indication Pivotal Trial Budget for such Clinical Trial and any such decisions shall require the mutual consent of the Parties.  In the absence of mutual agreement of the Parties with respect to any such matter, the status quo in the then-current Additional Indication Pivotal Trial Development Plan or Additional Indication Pivotal Trial Budget shall prevail.
(d)Development and Commercialization Meetings.  During the Term, unless the Parties mutually agree otherwise, the Parties will have meetings at least once each Calendar Year, to discuss any other issue the Parties may consider regarding Development and Commercialization of the Licensed Products in each Party’s Territory, including sharing information regarding Jazz ́s Annual Commercialization Plan and information regarding commercialization and marketing strategies of each Party in its Territory.  Such meetings may be conducted in person at times and places to be determined by the Parties.  Alternatively, the Parties may meet by means of teleconference, videoconference or other similar communications equipment.  Each Party shall bear its own expenses of participating in meetings.  
3.5Working Groups.  From time to time, the JDC or the JCC may establish and delegate duties to other committees, sub-committees or directed teams (each, a “Working Group”) on an “as-needed” basis to discuss best practices, oversee particular projects or activities, such as regulatory or clinical activities, which delegation shall be reflected in the minutes of the meetings of the JDC.  Each such Working Group shall be constituted and shall operate as the JDC or JCC, as applicable, determines and shall report to the JDC or JCC, as applicable.  Each Working Group and its activities shall be subject to the oversight, review and 
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approval of the JDC or JCC, as applicable.  In no event shall the authority of the Working Group exceed that specified for the JDC in Section 3.1(a) or the JCC in Section 3.2(a), as applicable.  Any disagreement between the designees of PharmaMar and of Jazz on a Working Group shall be referred to the JDC or JCC, as applicable, for resolution.
3.6Alliance Manager.  Each Party has designated one or more employees (each an “Alliance Manager”) to facilitate communications between the Parties or the JDC (including coordinating the exchange of Information of each Party as required under this Agreement) and to act as the primary liaison between the Parties or the JDC with respect to such other matters as the Parties may mutually agree in order to maximize the efficiency of the exchange of Information, it being understood that the exchange of Information will require the cooperation and efforts of personnel from each Party in addition to the Alliance Manager.  Either Party may replace its respective Alliance Managers at any time with prior written notice to the other Party.
4.Development
4.1PharmaMar Responsibility.  Without limiting the generality of Section 4.4, PharmaMar shall have the obligations set forth in this Section 4.1.
(a)Atlantis Trial.  
(i)Responsibility.  PharmaMar shall have the sole responsibility for, and shall conduct and complete, the Atlantis Trial at its sole expense in accordance with the current referenced protocols and development plans attached hereto as Exhibit D (the “Atlantis Development Plan”).  
(ii)Material Changes; Suspension or Termination.  PharmaMar shall promptly propose to the JDC any material changes it wishes to make to the Atlantis Development Plan, and after discussion and approval by the JDC, such plan shall be amended to address them unless Jazz believes in good faith that such amendment is likely to have an Adverse Safety Impact, in which case the terms of the proviso in Section 3.4(b) shall apply.  PharmaMar may suspend or terminate the Atlantis Trial after discussion at the JDC, but without obtaining approval from the JDC, if there is [***] (a “Safety Reason”) or such suspension or termination is required by a Regulatory Authority or investigational review board.  If Jazz disputes the existence of a Safety Reason, the Parties shall submit the dispute to an independent Third Party or committee (such as an investigator review board) to be appointed by both Parties jointly for determination of the existence or not of such Safety Reason.  Determination by such independent Third Party shall be binding to the Parties.
(b)SCLC Post-Approval Commitment Studies.  
(i)U.S. SCLC Post-Approval Commitment Studies. PharmaMar shall be solely responsible for conducting, on Jazz’s behalf and at PharmaMar’s sole expense, any post-approval commitment studies that are required by the FDA with respect to any Regulatory Approval by the FDA of a Licensed Product for the SCLC Initial Indication in the Jazz U.S. Territory, including any drug-drug interaction studies or hepatic impairment studies 
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required by the FDA (collectively, “U.S. SCLC Post-Approval Commitment Studies”) in accordance with a development plan which shall include a clinical trial design, protocol and timing that satisfies the FDA’s requirements to be reviewed, discussed and approved by the JDC.  Upon approval by the JDC, such plan shall be deemed the “U.S. SCLC Post-Approval Commitment Studies Development Plan”.  JDC approval shall not be required with regard to design, protocol and timeline of those U.S. SCLC Post-Approval Commitment Studies whose protocol has been submitted to FDA prior to the Effective Date.  The JDC shall incorporate into such protocols any comments of Jazz to the extent such comments are consistent with FDA requirements.  Jazz shall conduct and be responsible, at its expense, for regulatory communications with the FDA regarding the U.S. SCLC Post-Approval Commitment Studies once Regulatory Approval by the FDA for Licensed Product in the SCLC Initial Indication has been transferred to Jazz pursuant to Section 5. 
(ii)Mutual Canada SCLC Post-Approval Commitment Studies. PharmaMar shall be solely responsible for conducting, at its sole expense, any post-approval commitment studies that are required by Health Canada with respect to any Regulatory Approval by Health Canada of a Licensed Product for the SCLC Initial Indication in the Jazz Canada Territory, including any drug-drug interaction studies or hepatic impairment studies required by Health Canada, in each case, to the extent each such study is the same as those U.S. SCLC Post-Approval Commitment Studies required by the FDA or any other such post-approval commitment studies which have already been required by applicable Regulatory Authorities of the [***], if the Licensed Product is already approved in such territory(ies) at the time Health Canada requires such post-approval commitment studies (collectively, “Mutual Canada SCLC Post-Approval Commitment Studies”) in accordance with a development plan which shall include a clinical trial design, protocol and timing that satisfies the Health Canada’s requirements to be reviewed, discussed and approved by the JDC. Upon approval by the JDC, such plan shall be deemed the “Mutual Canada SCLC Post-Approval Commitment Studies Development Plan”. PharmaMar shall promptly notify Jazz if any post-approval commitment study required by Health Canada with respect to any Regulatory Approval by Health Canada of a Licensed Product for the SCLC Initial Indication in the Jazz Canada Territory is not the same as those SCLC Post-Approval Commitment Studies required by the FDA or any other such post-approval commitment studies required by applicable Regulatory Authorities of the [***], if the Licensed Product is approved in such territory(ies)  at the time Health Canada requires such post-approval commitment studies. Jazz shall conduct and be responsible, at its expense, for regulatory communications with Health Canada regarding the Mutual Canada SCLC Post-Approval Commitment Studies.
(iii)Jazz Canada SCLC Post-Approval Commitment Studies. Jazz shall be solely responsible for conducting, at its sole expense, any post-approval commitment studies that are required by Health Canada with respect to any Regulatory Approval by Health Canada of a Licensed Product for the SCLC Initial Indication in the Jazz Canada Territory that is not a Mutual Canada SCLC Post-Approval Commitment Study (collectively, “Jazz Canada SCLC Post-Approval Commitment Studies”).  Jazz shall conduct and be responsible, at its expense, for regulatory communications with Health Canada regarding the Jazz Canada SCLC Post-Approval Commitment Studies. In such event, Jazz shall prepare a proposed development 
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plan and a proposed budget for such Jazz Canada SCLC Post-Approval Commitment Studies, including the number of FTEs to conduct such activities (each such development plan, a “Jazz Canada SCLC Post-Approval Commitment Studies Development Plan” and each such budget, a “Jazz Canada SCLC Post-Approval Commitment Studies Budget”), which shall each be reviewed, discussed and approved by the JDC. Development Costs incurred by Jazz from the performance of the Jazz Canada SCLC Post-Approval Commitment Studies shall be creditable up to [***] of the Jazz Canada SCLC Post-Approval Commitment Studies Budget for any such Study solely against those Regulatory Milestone Payment, Sale Milestone Payments and royalty payments referred to Jazz Canada Territory thereafter due and payable pursuant to Section 8.4, Section 8.6 and Section 8.7, as applicable, as set forth in Section 8.3(b).  Any amendment to Jazz Canada SCLC Post-Approval Commitment Studies Development Plan or to Jazz Canada SCLC Post-Approval Commitment Studies Budget shall be reviewed, discussed and approved by the JDC, with such approval by PharmaMar’s members of the JDC not to be unreasonably withheld (it being understood that an example of unreasonably withholding approval would be to not approve an amendment to the Jazz Canada SCLC Post-Approval Commitment Studies Budget if Jazz Canada SCLC Post-Approval Commitment Studies Development Plan is amended by JDC in a manner that implies a change, from the assumptions or the protocol which were taken into account at the time the initial Jazz Canada SCLC Post-Approval Commitment Studies Budget was approved, for the purposes of fulfilling any Health Canada requirement with regard to such Jazz Canada SCLC Post-Approval Commitment Studies). 
(iv)Jazz Performance of U.S. SCLC Post-Approval Commitment Studies or Mutual Canada SCLC Post-Approval Commitment Studies. If PharmaMar is not [***], then Jazz shall have the right, exercisable upon written notice to PharmaMar, to conduct such SCLC Post-Approval Commitment Studies itself at PharmaMar’s expense.  In such event, Jazz shall prepare a proposed SCLC Post-Approval Commitment Studies Development Plan and a proposed budget for such U.S. SCLC Post-Approval Commitment Studies or Mutual Canada SCLC Post-Approval Commitment Studies, as applicable, including the number of FTEs to conduct such activities (each, an “SCLC Post-Approval Commitment Studies Budget”), which shall be reviewed, discussed and approved by the JDC.  In such event, PharmaMar shall reimburse Jazz for one hundred percent (100%) of the Development Costs incurred in accordance with and up to [***] of the SCLC Post-Approval Commitment Studies Budget for any such study, as set forth in Section 8.3.  Any amendment to SCLC Post-Approval Commitment Studies Budget shall be reviewed, discussed and approved by the JDC, with such approval by PharmaMar’s members of the JDC not to be unreasonably withheld (it being understood that an example of unreasonably withholding approval would be to not approve an amendment to the SCLC Post-Approval Commitment Studies Budget if the SCLC Post-Approval Commitment Studies Development Plan is amended by JDC in a manner that implies a change, from the assumptions or the protocol which were taken into account at the time the initial SCLC Post-Approval Commitment Studies Budget was approved, for the purposes of fulfilling any FDA requirement with regard to such SCLC Post-Approval Commitment Studies). 
(v)For clarity, notwithstanding Section 4.1(b)(ii) or Section 4.1(b)(iii), Mutual Canada SCLC Post-Approval Commitment Studies and Jazz Canada SCLC 
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Post-Approval Commitment Studies each exclude (A) any studies solely required to obtain Pricing Approval by Health Canada and (B) any Medical Affairs Studies, each of which may be performed by Jazz at its sole discretion and expense.  
(c)No Additional Obligations.  Except as set forth in this Section 4.1 with respect to the Atlantis Trial, the U.S. SCLC Post-Approval Commitment Studies and the Mutual Canada SCLC Post-Approval Commitment Studies, PharmaMar shall have no further obligation to conduct any pre-clinical or clinical Development activities with respect to any Licensed Products.  
4.2Additional Indication Pivotal Trial.  
(a)Proposed Additional Indication Pivotal Trial.  If PharmaMar wishes to conduct a Pivotal Trial for an Additional Indication that (i) is initiated [***] and (ii) such Pivotal Trial is sufficient to support the filing of an NDA with the FDA, as evidenced by an agreement with or statement from the FDA on a Special Protocol Assessment procedure or equivalent, or other guidance or minutes issued by the FDA (each, a “Proposed Additional Indication Pivotal Trial”), then PharmaMar shall present to Jazz’s representatives at the JDC the proposed design of such Proposed Additional Indication Pivotal Trial, including the proposed protocol and budget for such study.  The JDC shall discuss such Proposed Additional Indication Pivotal Trial at its next meeting, and PharmaMar shall provide, within [***] after such JDC meeting (or such longer period of time as agreed upon in writing by the Parties), any additional information reasonably requested by Jazz’s JDC representatives prior to or during such JDC meeting.  
(b)Additional Indication Pivotal Trial.  If by the [***] day after the JDC meeting at which a particular Proposed Additional Indication Pivotal Trial is discussed (or such longer period of time as agreed upon in writing by the Parties) under to Section 4.5(a), Jazz has not notified PharmaMar that it believes that such Proposed Additional Indication Pivotal Trial is likely to have an Adverse Safety Impact, then such Proposed Additional Indication Pivotal Trial will be deemed an “Additional Indication Pivotal Trial” and the JDC shall review and approve a protocol for such Additional Indication Pivotal Trial and such approved protocol and the proposed budget for such Additional Indication Pivotal Trial shall be deemed an “Additional Indication Pivotal Trial Development Plan” and an “Additional Indication Pivotal Trial Budget”, respectively.  
(c)Pivotal Trial Costs.  On an Additional Indication Pivotal Trial-by-Additional Indication Pivotal Trial basis, within [***] days of the JDC’s approval of the applicable Additional Indication Pivotal Trial Development Plan and Additional Indication Pivotal Trial Budget, Jazz shall have the right to elect to either:
(i)have Jazz and PharmaMar share [***] all costs incurred to conduct such Additional Indication Pivotal Trial in accordance with Section 8.2 (any such Additional Indication Pivotal Trial, a “Joint Additional Indication Pivotal Trial” and the Additional Indication Pivotal Trial Development Plan and Additional Indication Pivotal Trial Budget therefor, a “Joint Additional Indication Pivotal Trial Development Plan” and “Joint Additional Indication Pivotal Trial Budget”, respectively); or
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(ii)have PharmaMar pay [***] of all costs incurred to conduct such Additional Indication Pivotal Trial, in which case Sections 5.3(c)(ii) and 8.5 shall apply.  
(d)Material Changes; Suspension or Termination.  
(i)Each Party shall promptly inform the JDC of any material changes it wishes to make to a Joint Additional Indication Pivotal Trial and Joint Additional Indication Pivotal Trial Budget.  All changes to any Joint Additional Indication Pivotal Trial Development Plan or Joint Additional Indication Pivotal Trial Budget and all suspensions or terminations of any Joint Additional Indication Pivotal Trial shall be by mutual agreement of the Parties’ representatives to the JDC. 
(ii)PharmaMar shall promptly inform the JDC of any material changes it wishes to make to an Additional Indication Pivotal Trial that is not a Joint Additional Indication Pivotal Trial and the JDC shall review, discuss and approve any amendment to the Additional Indication Pivotal Trial Development Plan in accordance with Section 3.4.  PharmaMar may suspend or terminate an Additional Indication Pivotal Trial that is not a Joint Additional Indication Pivotal Trial after discussion at the JDC, but without obtaining approval from the JDC, if there is a Safety Reason or such suspension or termination is required by a Regulatory Authority or investigational review board.  
(iii)Notwithstanding anything to the contrary in Section 4.2(d)(i), after transfer of Regulatory Approval and the associated Regulatory Filings to Jazz pursuant to Section 5.1, as the holder of the IND in the Jazz Territory, Jazz may require PharmaMar to suspend or terminate an Additional Indication Pivotal Trial in the Jazz Territory after discussion at the JDC, but without obtaining approval from the JDC, if there is a Safety Reason or such suspension or termination is required by a Regulatory Authority or investigational review board.
(iv)If any Party disputes the other Party ́s alleged Safety Reason, the Parties shall submit the dispute to an independent Third Party or committee (such as an investigator review board) to be appointed by both Parties jointly for determination of the existence or not of such Safety Reason.  Determination by such independent Third Party shall be binding to the Parties.
(e)PharmaMar Additional Indication Clinical Trial becomes a Pivotal Trial After Initiation.  In the event any PharmaMar Additional Indication Clinical Trial becomes a Pivotal Trial after Initiation of such Clinical Trial, then such PharmaMar Additional Indication Clinical Trial shall thereafter be deemed an Additional Indication Pivotal Trial and PharmaMar shall provide prompt written notice thereof to Jazz.  Such written notice shall include a copy of the protocol for such Clinical Trial.  Within [***] days of such notification, PharmaMar shall provide to Jazz a complete accounting of all Pivotal Trial Costs (as such term is modified mutatis mutandis to apply to such Clinical Trial) incurred to date and a proposed plan and budget for all additional activities and anticipated costs for conducting the remainder, if any, of such Clinical Trial for review and approval by the JDC (such plan after such approval be deemed an Additional Indication Pivotal Trial Development Plan and such accounting, together with the proposed budget, shall after such approval be deemed an Additional Indication Pivotal 
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Trial Development Budget).  Notwithstanding the timing set forth in Section 4.2(c), within [***] days of the JDC’s approval of the Additional Indication Pivotal Trial Development Budget for any such Additional Indication Pivotal Trial pursuant to this Section 4.2(e), Jazz shall have the right to elect to either:
(i)[***] all Pivotal Trial Costs incurred to conduct such Additional Indication Pivotal Trial in accordance with Section 8.2 as set forth in Section 4.2(c)(i), in which case (1) PharmaMar shall include in the next Reconciliation Report pursuant to Section 8.2 [***] of all Pivotal Trial Costs incurred in connection with such Additional Indication Pivotal Trial as of such election, (2) such Additional Indication Pivotal Trial shall be deemed to be a Joint Additional Indication Pivotal Trial, (3) such Additional Indication Pivotal Trial Plan shall be deemed to be a Joint Additional Indication Pivotal Trial Plan and (4) such Additional Indication Pivotal Budget shall be deemed to be a Joint Additional Indication Pivotal Budget; or
(ii)have PharmaMar pay [***] of all costs incurred to conduct such Additional Indication Pivotal Trial as set forth in Section 4.2(c)(ii).  
4.3Other Development Rights.
(a)Except with respect to the Atlantis Trial, the SCLC Post-Approval Commitment Studies and the Additional Indication Pivotal Trials addressed under Sections 4.1 and 4.2, each Party shall be entitled to conduct in its Territory any research and pre-clinical, clinical or other Development activities, including, without limitation, the conduct of Clinical Trials and Pivotal Trials with respect to Licensed API or Licensed Product for the purposes of obtaining or expanding Regulatory Approval of Licensed Product in its Territory at its sole responsibility and cost and without any prior approval by the JDC, but (i) with prior discussion by the JDC with respect to any Jazz Additional Indication Clinical Trial and PharmaMar Additional Indication Clinical Trial and (ii) with the JDC being informed of any other Clinical Trials. 
(b)In addition, each Party shall be entitled to conduct any research and preclinical development activities in the other Party ́s Territory at its sole discretion and expense and shall keep the other Party, through the JDC, regularly informed about such development activities provided however that no prior approval of those activities by the JDC would be required for its conduct.
(c)Jazz shall be entitled to conduct Clinical Trials (other than Medical Affairs Clinical Trials) in Additional Indications other than Additional Indication Pivotal Trials [***] (“Jazz Additional Indication Clinical Trials”), provided that prior to initiation of any Jazz Additional Indication Clinical Trials, Jazz will inform the JDC about such intended Jazz Additional Indication Clinical Trials for review and discussion by the JDC provided that, except as set forth in Section 3.4(b), Jazz shall have final decision making about Jazz Additional Indications Clinical Trials in [***].  Except as provided herein for research and preclinical Development activities in the PharmaMar Territory and for Jazz Additional Indication Clinical Trials [***], Jazz shall have no other right to conduct Development activities in the PharmaMar Territory.  PharmaMar shall ensure that any Third Party Partner agreement entered into after the 
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Effective Date includes the right for Jazz and its Affiliates and Sublicensees to conduct Jazz Additional Indication Clinical Trials in such Third Party Partner’s territory in a manner consistent with the terms of this Agreement, provided however that such rights may be subject to such Third Party Partner ́s prior written consent on a Clinical Trial by Clinical Trial basis provided that such Third Party Partner’s Clinical Trials in the Jazz Territory are subject to Jazz’s prior written consent.  
(d)PharmaMar shall be entitled to conduct Clinical Trials (other than Medical Affairs Clinical Trials) in Additional Indications other than Additional Indication Pivotal Trials in the Jazz Territory (“PharmaMar Additional Indication Clinical Trials”) provided that prior to initiation of any PharmaMar Additional Indication Clinical Trials, PharmaMar will inform the JDC about such intended PharmaMar Additional Indication Clinical Trials for review and discussion by the JDC provided that, except as set forth in Section 3.4(b), PharmaMar shall have final decision making about PharmaMar Additional Indications Clinical Trials in the PharmaMar Territory.  For clarity, PharmaMar Additional Indication Clinical Trials shall include any Pivotal Trial in an Additional Indication which is [***]. Except as provided herein for research and preclinical Development activities and for PharmaMar Additional Indication Clinical Trials in the Jazz Territory, PharmaMar shall have no other right to conduct Development activities in the Jazz Territory.
4.4Performance Standards.  Each Party shall conduct, or have conducted, all Licensed API and Licensed Product Development, manufacture and registration activities performed by it or on its behalf in good scientific manner and in compliance with all Applicable Laws and, as applicable, GLP, GCP and/or GMP.  
4.5Exchange of Data.  On an ongoing basis during the Term, each Party shall disclose to the other Party all Licensed Product Data generated by such Party or its Affiliates (or in the case of PharmaMar, its Third Party Partners or in the case of Jazz, its Sublicensees).  Each Party and its Affiliates shall have the right to use the Licensed Product Data disclosed by the other Party, for the purpose of obtaining and maintaining Regulatory Approval within its respective Territory of Licensed Products in the Licensed Indications.  Subject to Section 2.8, PharmaMar shall have the right to sublicense [***] such right to use such Licensed Product Data to its Third Party Partners in the PharmaMar Territory if and only if such Third Party Partners are obligated to share all Licensed Product Data generated by them or on their behalf with Jazz for Jazz’s and its Affiliates’ use in the Jazz Territory at no cost to Jazz.  
5.Regulatory
5.1Transfer of Regulatory Filings.  The Parties acknowledge that PharmaMar submitted to the FDA an NDA for a Licensed Product in the SCLC Initial Indication under the Subpart H regulations or their equivalent (the “Initial SCLC NDA Filing”) and the FDA granted NDA Approval for the Licensed Product in the SCLC Initial Indication. PharmaMar transferred and assigned such Regulatory Approval for the Licensed Product in the SCLC Initial Indication to Jazz prior to the Restatement Effective Date. To the extent not already transferred and assigned to Jazz, promptly after the Restatement Effective Date or as otherwise agreed by the Parties in writing, PharmaMar shall, transfer and assign to Jazz all Regulatory Filings for a 
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Licensed Product in the Jazz Territory and shall transfer to Jazz all Licensed Product Data and PharmaMar Know-How not previously transferred to Jazz, except for the DMF, which shall be maintained by and in the name of PharmaMar.  Cost of any such transfer shall be borne by both Parties equally.  After transfer of the Regulatory Approval to Jazz pursuant to this Agreement on an NDA Approval that is not a Full Approval, Jazz shall use Commercially Reasonable Efforts to achieve the next Regulatory Milestone that is based on Full Approval.  
5.2Additional Transfer of Regulatory Data. Promptly after the Restatement Effective Date, PharmaMar will, to the extent not already provided to Jazz, provide completed clinical study reports (CSRs) and submission-ready analysis datasets to Jazz for any of the studies supporting the Regulatory Approval by the FDA or Health Canada for a Licensed Product in the SCLC Initial Indication (including the Atlantis Trial, the U.S. SCLC Post-Approval Commitment Studies and the Mutual Canada SCLC Post-Approval Commitment Studies) promptly after such reports and datasets are available.  In addition, PharmaMar will also provide to Jazz, prior to database lock for cross-trial comparison of the Atlantis Trial, the pre-specified statistical analysis plan for cross-trial comparison of the treatment arm of the Atlantis Trial with the monotherapy data from PharmaMar’s Clinical Trial known as PM1183-B-005-14 (i.e. the “basket trial”), which comparison will be submitted to the FDA to support the granting of Full Approval.  
5.3Expanded Access Program.  Jazz acknowledges that PharmaMar has entered into a master service agreement and a related work order with [***] effective on [***], a copy of which has been provided to Jazz prior to the Effective Date, under which [***] was providing PharmaMar with services related to the set up and delivery of an EAP for the Licensed Product in the Jazz Territory in the SCLC Indication (“EAP Agreement”).  Upon Jazz ́s election under the Original License Agreement, the Parties acknowledge that the EAP Agreement was effectively assigned by PharmaMar to Jazz on [***]. 
5.4Jazz Territory.  
(a)Regulatory Responsibility in the Jazz Territory.  Except as for the DMF and any development activity PharmaMar is entitled to conduct in the Jazz Territory under its own IND, Jazz:
(i)shall have the sole right to prepare and file for all Regulatory Approvals for Licensed Products in the Licensed Indication in the Jazz Territory;
(ii)shall have the sole right to communicate with the FDA and Health Canada with respect to Licensed Products in the Licensed Indication;
(iii)shall use Commercially Reasonable Efforts to file for NDA Approval in the Jazz Canada Territory for a Licensed Product in the SCLC Initial Indication as soon as commercially reasonable after the Restatement Effective Date and within the timeline, if any, established by Health Canada for such filing; 
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(iv)shall use Commercially Reasonable Efforts to file for NDA Approval in the Jazz Canada Territory for a Licensed Product in each Additional Indication for which Jazz files for NDA Approval in the Jazz U.S. Territory in accordance with Section 5.4(b)(iii);
(v)shall use Commercially Reasonable Efforts to (A) file for and obtain Pricing Approval for each Licensed Product in the Licensed Indication, to the extent required by Applicable Law, as soon as possible from the applicable Regulatory Authorities of the provinces in the Jazz Canada Territory and (B) conduct, without unreasonable delay, any Development activities required to obtain Pricing Approval in the Jazz Canada Territory;
(vi)shall use Commercially Reasonable Efforts to start, within a reasonable time period after the Restatement Effective Date, but in any event no later than [***] after the first NDA Approval by the FDA for the Licensed Product in the SCLC Initial Indication, a paid (either by patients or their health insurance) named patient access program for the Jazz Canada Territory in which patients in need will be supplied with the Licensed Product on a named patient basis; 
(vii)shall be solely responsible for conducting pricing and reimbursement negotiations in the Jazz Territory for each Licensed Product in the Licensed Indication; and
(viii)shall own all Regulatory Filings (including Regulatory Approvals) for each Licensed Product in the Licensed Indication in the Jazz Territory.
(b)Cooperation.  
(i)Each Party shall, at the other Party ́s request, provide reasonable assistance with respect to regulatory matters concerning the Licensed Products in the other Party’s Territory, including assistance with respect to Regulatory Filings required to obtain or maintain Regulatory Approval for a Licensed Product in the other Party’s Territory.  Without limiting the generality of the foregoing, PharmaMar shall consult with Jazz and provide Jazz with all CMC documents and information related to Licensed Products and all Licensed Product Data included within the Initial SCLC NDA Filing, except those CMC Information of Licensed API which is included in any section of the DMF other than Section S of Module 3 of the NDA in the Jazz U.S. Territory (or its foreign equivalent in the Jazz Canada Territory) and not otherwise publicly available.  In the event that PharmaMar anticipates changes in the manufacture of the Licensed API which may impact the regulatory status of the Licensed Product in the Jazz Territory, the Parties shall review such changes and potential outcomes so Jazz may take the appropriate steps to support the Regulatory Filings.  Except with respect to the DMF or manufacture and development activities in the Jazz Territory that PharmaMar is entitled to conduct under this Agreement, or as otherwise expressly requested by Jazz in writing, PharmaMar (i) shall not submit any Regulatory Filings for Licensed Products in the Jazz Territory without the prior written consent of Jazz and (ii) shall not communicate with respect to the Licensed Products with Regulatory Authorities in the Jazz Territory, unless so required to comply with Applicable Law in the Jazz Territory, in which case PharmaMar shall promptly 
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notify Jazz of such requirement under Applicable Law and, to the extent practicable and permitted under Applicable Law, shall submit any proposed communication to Jazz for prior approval or, if not practicable or permitted, shall provide Jazz with a copy or summary thereof as soon as reasonably practicable thereafter.  
(ii)Jazz shall provide PharmaMar with drafts of proposed Regulatory Filings reasonably in advance of submission to the FDA, Health Canada or any other Regulatory Authority and PharmaMar shall have the right to review and comment on such Regulatory Filings prior to submission to Regulatory Authorities.  Jazz shall [***].  Jazz shall promptly provide PharmaMar with copies of all material correspondence, Regulatory Filings and Regulatory Approvals received from the Regulatory Authorities with respect to the Licensed Product.  To the extent allowed by the Regulatory Authorities, PharmaMar shall have the right to attend and participate with up to [***] representatives in all substantive meetings with the Regulatory Authorities with regard to Licensed Product. 
(iii)At Jazz’s reasonable request, PharmaMar shall reasonably cooperate and assist Jazz in facilitating launch activities with respect to the Licensed Product in the SCLC Initial Indication in the Jazz Territory, including cooperation and assistance with respect to preparing and submitting any Regulatory Filings relating to labeling, packaging materials and submission of the secondary packaging contractor designated by Jazz and with respect to discussions with the FDA or Health Canada related thereto.
(c)Additional Indications in the Jazz Territory.
(i)In the event that PharmaMar intends to conduct one or more Proposed Additional Indication Pivotal Trial, upon the written request of PharmaMar, in a manner consistent with the guidance and decisions of the JDC, Jazz shall promptly seek FDA and/or Health Canada guidance to ascertain if such Proposed Additional Indication Pivotal Trial would be a registration trial sufficient to support the filing of a NDA, as evidenced by an agreement with or statement from the FDA on a special protocol assessment procedure or the applicable procedure with respect to such guidance from Health Canada.  Additionally, upon the written request of PharmaMar, in a manner consistent with the guidance and decisions of the JDC, Jazz shall seek to hold a pre-NDA meeting with the FDA or Health Canada to discuss the NDA related to the data obtained from an Additional Indication Pivotal Trial.  To the extent allowed by the FDA and Health Canada, PharmaMar shall have the right to attend and participate in such meetings with the FDA and Health Canada.  PharmaMar shall be responsible, at its own cost, for preparing all documents and materials reasonably necessary for any activities under this Section 5.4(c)(i).  PharmaMar shall reimburse Jazz’s costs and expenses (including FTE Costs) incurred in connection with such activities under this Section 5.4(c)(i) (A) performed with relation to the FDA to the extent that, on an interaction-by-interaction basis, such costs do not exceed [***] and (B) performed with relation to Health Canada to the extent that, on an interaction-by-interaction basis, such costs do not exceed [***]. 
(ii)If any Joint Additional Indication Pivotal Trial obtains Positive Results, Jazz shall use Commercially Reasonable Efforts to obtain Regulatory Approval from the FDA for such Additional Indication.
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(iii)If any Additional Indication Pivotal Trial (other than a Joint Additional Indication Pivotal Trial) obtains Positive Results and Jazz determines in good faith that it will be profitable for Jazz to Commercialize the Licensed Product in such Additional Indication (which profitability determination shall take into account, without limitation, the probability of obtaining Regulatory Approval and the cost of obtaining Regulatory Approval and making the applicable Additional Indication Regulatory Milestone payment, provided, that, the profitability determination shall not take into account any potential loss of sales from a product (other than a Licensed Product) that was being developed or commercialized by Jazz or its Affiliates at the time such Additional Indication Pivotal Trial was Initiated), Jazz shall use Commercially Reasonable Efforts to obtain Regulatory Approval from the FDA for such Additional Indication.  Prior to filing an NDA for such Additional Indication, if such Additional Indication is [***], Jazz shall provide written notice to PharmaMar of Jazz’s good faith determination whether such Additional Indication is a Major Tumour, which determination shall be based on [***].  
(iv)If Jazz determines in good faith that it would not be profitable for Jazz to Commercialize the Licensed Product in such Additional Indication, Jazz shall provide PharmaMar with a detailed information and breakdown of Jazz’s calculations for such determination.  If PharmaMar disputes whether such non-profitability determination was made by Jazz in good faith, the Parties agree to submit the dispute to [***] for final determination of whether such determination was made by Jazz in good faith or not.  Once the IMRC makes such determination, it shall be fully applicable and binding on the Parties. 
(v)If Jazz determined that such Additional Indication is not a Major Tumour but PharmaMar believes in good faith, based on the same factors, that such Additional Indication [***] and as a result should be classified as a Major Tumour, then such dispute shall be resolved by an independent Third Party expert experienced in determining treatable patient populations in the U.S. (the “Expert”) as mutually agreed upon by the Parties.  If the Parties cannot agree upon any such Expert within [***], then each Party shall propose one expert having such experience and such two proposed experts shall jointly select the Expert.  Within [***] of the selection of the Expert, each party shall submit to the Expert and the other Party such information concerning [***]. The Expert shall determine whether or not such Additional Indication [***] and as a result should or should not be classified as a Major Tumour. The determination of the Expert shall be final and binding on the Parties, absent manifest error. 
(vi)If any Additional Indication Pivotal Trial obtains Positive Results and Jazz determines in good faith that it would not be profitable for Jazz to Commercialize the Licensed Product in such Additional Indication, Jazz shall use Commercially Reasonable Efforts, upon PharmaMar’s reasonable request, to include such Additional Indication in the NCCN Guidelines or any equivalent guidelines.  In addition, Jazz shall also use Commercially Reasonable Efforts to include an Additional Indication in the NCCN Guidelines or any equivalent guidelines, upon PharmaMar’s reasonable request, if PharmaMar conducts a Pivotal Trial in such Additional Indication that does not fulfill the conditions for being a Proposed Additional Indication Pivotal Trial but that obtains Positive Results. 
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(d)Drug Master File. PharmaMar shall file a Type II drug master file as described in and in accordance with the 21 CFR 314.420 and the foreign equivalent in the Jazz Canada Territory (each, a “DMF”) with the FDA and Health Canada, as applicable, for the Licensed API and shall provide the appropriate authorizations to the FDA in order to grant Jazz (or its Affiliates or Sublicensees) the right to reference such DMF.  PharmaMar shall be responsible for maintaining such DMF in accordance with Applicable Laws and ensuring that all Licensed Product Data incorporated therein is accurate and current as necessary to support filing and prosecuting the applicable Regulatory Filing and obtaining and maintaining the applicable Regulatory Approval for any Licensed Product hereunder.  PharmaMar shall permit Jazz to access, and shall provide Jazz with true and complete copies of, [***].  Except to the extent that the following would require disclosure of the contents of any section of the DMF other than [***], PharmaMar shall (i) provide Jazz with drafts of proposed Regulatory Filings related to such DMF reasonably in advance of submission to the applicable Regulatory Authority in the Jazz Territory for Jazz’s review and comment, (ii) consider Jazz’s comments in good faith, and (iii) provide Jazz with copies of all material correspondence received from the applicable Regulatory Authority in the Jazz Territory with respect to such DMF.  
(e)Other PharmaMar Regulatory Filings.  With respect to all Regulatory Filings (other than the Initial SCLC NDA Filing) made by PharmaMar with a Regulatory Authority in the Jazz Territory regarding development activities with regard to Licensed Product in the Jazz Territory that PharmaMar is entitled to conduct under this Agreement, PharmaMar shall provide Jazz with drafts of such Regulatory Filings reasonably in advance of submission to such Regulatory Authority.  Jazz shall have the right to review and comment on such Regulatory Filings prior to submission to any Regulatory Authority in the Jazz Territory, and PharmaMar shall [***].  PharmaMar shall promptly provide Jazz with copies of all material correspondence received from any Regulatory Authority in the Jazz Territory with respect thereto.  
5.5PharmaMar Territory. 
(a)Regulatory Responsibility in the PharmaMar Territory.  PharmaMar shall be responsible for preparing and filing for all Regulatory Approvals for Licensed Products in the Licensed Indication in the PharmaMar Territory and for communicating with all Regulatory Authorities with respect to Licensed Products in the Licensed Indication in the PharmaMar Territory.  PharmaMar shall own all Regulatory Filings (including all Regulatory Approvals) for each Licensed Product in the Licensed Indication in the PharmaMar Territory.  PharmaMar shall provide Jazz with copies of material Regulatory Filings for Licensed Products in the PharmaMar Territory and material correspondence received from any Regulatory Authority in the PharmaMar Territory related to Licensed Products.  To the extent allowed by the applicable Regulatory Authority, Jazz shall have the right to have [***] representatives attend any material meetings with any Regulatory Authority in the PharmaMar Territory relating to Licensed Products.  For the avoidance of doubt, notwithstanding Section 5.5 PharmaMar’s material Regulatory Filings, Regulatory Approvals and material correspondence received from Regulatory Authorities shall be deemed solely material Regulatory Filings and Regulatory Approvals filed and/or granted, as applicable, before/by [***]with regard to Licensed Products and material communications with such Regulatory Authorities associated thereto.  Such 
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documentation shall be provided in the languages that PharmaMar receives such documentation in, provided, that, if PharmaMar or its Affiliates translates any such documentation, PharmaMar shall also provide such translated versions to Jazz.
(b)Clinical Trials Conducted by Jazz. Upon the written request of Jazz, in a manner consistent with the guidance and decisions of the JDC, PharmaMar shall seek to hold meetings with the [***] to discuss the conduct of any Jazz Additional Indication Clinical Trial and Additional Indication Pivotal Trial of a Licensed Product conducted by Jazz [***].  To the extent allowed by the [***], Jazz shall have the right to attend and participate in all meetings with the [***] related to any Jazz Additional Indication Clinical Trial and Additional Indication Pivotal Trial of a Licensed Product conducted by Jazz [***].  Jazz shall reimburse all of PharmaMar’s out-of-pocket costs associated with such activities.
(c)Other Jazz Regulatory Filings.  With respect to Regulatory Filings made by Jazz with any Regulatory Authority in the PharmaMar Territory regarding development activities that Jazz is entitled to conduct under this Agreement in PharmaMar Territory, Jazz shall provide PharmaMar with drafts of such Regulatory Filings reasonably in advance of submission to any Regulatory Authority in the PharmaMar Territory.  PharmaMar shall have the right to review and comment on such Regulatory Filings prior to submission to Regulatory Authorities in PharmaMar Territory, and Jazz shall [***].  Jazz shall promptly provide PharmaMar with copies of all material correspondence received from Regulatory Authorities of PharmaMar Territory with respect thereto.  
5.6.Reporting.  Each Party shall keep the other Party informed on an on-going and regular basis regarding its (or its Affiliate’s or Third Party Partner’s) regulatory strategy, planned regulatory submission and material communications regarding Licensed Products with Regulatory Authorities in [***], as applicable.  
5.7.Notification of Threatened Action.  Each Party shall immediately notify the other Party of any information it receives regarding any material threatened or pending action, inspection or communication by or from any Third Party, including without limitation a Regulatory Authority, which may materially affect the Development, Commercialization or regulatory status of a Licensed Product in the Licensed Indication, including any issuance of notices of inspections, inspection reports and receipt of compliance violation letters in any country of their respective Territories.  Upon receipt of such information, the Parties shall consult with each other and assist each other in gathering and evaluating relevant information related thereto.
5.8.Remedial Actions.  Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that the Licensed Product may be subject to any recall, market withdrawal, corrective action or other regulatory action with respect to a Licensed Product taken by virtue of Applicable Laws (a “Remedial Action”).  The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action.  Each Party shall, and shall ensure that its Affiliates and Third Party Partners will, maintain adequate records to permit the Parties to trace the manufacture, distribution and use of the Licensed Product.  In the event 
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Jazz determines that any Remedial Action with respect to a Licensed Product in the Licensed Indication in the Jazz Territory should be commenced or is required by the applicable Regulatory Authority, Jazz shall have the right, at its expense, to control and coordinate all efforts necessary to conduct such Remedial Action.  
5.9.Rights of Access and Reference to Regulatory Documents.  
(a)Jazz hereby grants to PharmaMar (and its Affiliates and Third Party Partners in the PharmaMar Territory) the right to access and reference all Regulatory Filings submitted to, and Regulatory Approvals obtained from, the FDA or Health Canada by Jazz or its Affiliates for Licensed Products and to use the Licensed Product Data therein; in each case, solely for the purposes of (i) obtaining and maintaining Regulatory Approvals for Licensed Products in the Licensed Indication in the PharmaMar Territory, (ii) complying with applicable pharmacovigilance and other regulatory requirements with respect to Licensed Products in the PharmaMar Territory and (iii) exercising its rights and performing its obligations under this Agreement.  Jazz shall, promptly upon PharmaMar’s request, file with the applicable Regulatory Authority(ies) such letters of access or reference as may be necessary to accomplish the intent of this Section 5.9(a).  
(b)PharmaMar hereby grants to Jazz (and its Affiliates) the right to access and reference all Regulatory Filings submitted to, and Regulatory Approvals obtained from, any Regulatory Authority in the PharmaMar Territory by PharmaMar (and its Affiliates and Third Party Partners in the PharmaMar Territory) for Licensed Products and to use the Licensed Product Data therein; in each case, solely for the purposes of (i) obtaining and maintaining Regulatory Approvals for Licensed Products in the Licensed Indication in the Jazz Territory, (ii) complying with applicable pharmacovigilance and other regulatory requirements with respect to Licensed Products in the Jazz Territory and (iii) exercising its rights and performing its obligations under this Agreement.  PharmaMar shall, promptly upon Jazz’s request, file with the applicable Regulatory Authority(ies) such letters of access or reference as may be necessary to accomplish the intent of this Section 5.9(b).  
5.10Safety Data Exchange.  Each Party shall be solely responsible, at its own expense, for complying with all applicable regulatory requirements with respect to Licensed Products in such Party’s Territory, including all safety reporting to Regulatory Authorities in such Party’s Territory.  The Parties have entered into a pharmacovigilance/safety data exchange agreement for Licensed Products (the “PV Agreement”), which sets forth standard operating procedures governing the collection, investigation, reporting, and exchange of information concerning adverse drug reactions/experiences. The Parties shall, promptly after the Restatement Effective Date (but in any event within [***] days after the Restatement Effective Date), negotiate in good faith an amendment to the PV Agreement to address the addition of Canada as part of the Jazz Territory.  The terms of the PV Agreement shall be sufficient to permit each Party to comply with its regulatory and legal requirements for the management and reporting of safety data regarding such Licensed Products by providing for the exchange of relevant information in appropriate format within applicable timeframes.  
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6.Manufacturing. 
6.1Supply Agreement.  The Parties have executed that certain Supply Agreement dated [***] (the “Supply Agreement”), pursuant to which PharmaMar manufactures and supplies to Jazz certain quantities of Bulk Vials for launch in Jazz U.S. Territory and ongoing supply of Licensed API for the Jazz U.S. Territory, in each case, in accordance with the terms and conditions therein.  [***] after the Restatement Effective Date, the Parties shall negotiate in good faith and enter into an amendment to the Supply Agreement pursuant to which PharmaMar shall manufacture and supply to Jazz Licensed API also for the Jazz Canada Territory.  
6.2Quality Agreement.  The Parties have executed that certain Quality Agreement effective on [***] (the “Quality Agreement”), which allocates roles and responsibilities to each Party with respect to quality control and regulatory compliance with respect to the manufacture and supply of Finished Product, Bulk Vials and Licensed API under the Supply Agreement.  Timely after the Restatement Effective Date, unless the Parties mutually agree otherwise, the Parties shall discuss in good faith and enter into an amendment to the Quality Agreement in connection with the amendment to the Supply Agreement referenced in Section 6.1.  
6.3Technology Transfer.  Upon the written request of Jazz, and to the [***], PharmaMar shall, [***], commence a technology transfer to a Third Party contract manufacturer [***] of all Information, including PharmaMar Know-How, which is reasonably necessary or is otherwise used in the manufacture and supply of Licensed Product for the Jazz Territory from the Licensed API to be supplied by PharmaMar (or its designee) pursuant to the Supply Agreement.
6.4Jazz Territory Launch Responsibilities. Jazz shall be responsible for secondary manufacturing of the Finished Product, including the product required for the initial launch of the Licensed Product in the Jazz U.S. Territory in a timely manner from Bulk Vials supplied by PharmaMar pursuant to the Supply Agreement. Jazz shall be responsible to prepare, file and obtain, at its sole expense, any Regulatory Approval necessary to perform secondary packaging manufacturing activities of Bulk Vials supplied by PharmaMar at the secondary packager designated by Jazz as well as to obtain Regulatory Approvals required for packaging materials for the Licensed Product with Jazz trade dress. 
In order for Jazz to comply with its obligations under the first sentence of Section 7.3 and hereunder, PharmaMar shall reasonably cooperate with and assist Jazz in establishing a viable program for a rapid launch in the U.S., which shall include PharmaMar importing into the Jazz Territory Bulk Vials of Licensed Product to be purchased by Jazz and delivery of such Bulk Vials to the secondary packager designated by Jazz prior to first Regulatory Approval for the Licensed Product.    
For clarity, for launch of the Licensed Product in Jazz Canada Territory, PharmaMar will manufacture and supply to Jazz, in accordance with the Supply Agreement, Licensed API and, solely to the extent agreed by the Parties in the Supply Agreement, Bulk Vials. For clarity, except if the Parties agree in the amended Supply Agreement the supply of Bulk Vials for launch in Jazz Canada Territory, Pharma Mar shall not be obliged to supply Jazz with any quantities of Bulk Vials for the Jazz Canada Territory.  Except with respect to any Bulk Vials supplied by 
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PharmaMar in accordance with the Supply Agreement, Jazz shall be responsible to manufacture Bulk Vials and for performing secondary packaging at the manufacturer designated by Jazz as well as to obtain any Regulatory Approvals required for doing so from Regulatory Authorities of Canada. 
7.Commercialization 
7.1Commercialization in the Jazz Territory.  Subject to Section 7.9, Jazz shall have the exclusive right to conduct, and be solely responsible for all aspects of, the Commercialization of Licensed Products in the Licensed Indication in the Jazz Territory, including: (a) developing and executing a commercial launch and pre-launch plan, (b) negotiating with applicable Governmental Authorities regarding the price and reimbursement status of Licensed Products, (c) marketing and promotion, (d) booking sales and distribution and performance of related services, (e) handling all aspects of order processing, invoicing and collection, inventory and receivables, (f) providing customer support, including handling medical queries, and performing other related functions, and (g) conforming its practices and procedures to Applicable Laws relating to the marketing, detailing and promotion of Licensed Products in the Jazz Territory (collectively, the “Commercialization Activities”). Subject to Section 7.9, as between the Parties, Jazz shall bear all of its costs and expenses incurred in connection with such commercialization activities in the Jazz Territory.
7.2Commercialization in the PharmaMar Territory.  As between the Parties, PharmaMar will have the exclusive right to conduct, and be solely responsible for all aspects of, the Commercialization of Licensed Products in the Licensed Indication in the PharmaMar Territory, including the Commercialization Activities, and PharmaMar shall bear all of its costs and expenses incurred in connection with such commercialization activities in the PharmaMar Territory.
7.3Commercial Diligence.  Jazz shall commence Commercialization of the Licensed Product in each country in the Jazz Territory as soon as practical after receipt of the Regulatory Approval for a Licensed Product for the SCLC Initial Indication in such country within the Jazz Territory.  After such receipt of Regulatory Approval, Jazz shall use Commercially Reasonable Efforts to Commercialize such Licensed Product in such country within the Jazz Territory.
7.4Sales Force.  Jazz shall provide incentives consistent with Jazz’s standards to its Sales Force involved in the Commercialization of the Licensed Product in the applicable country in the Jazz Territory.  Jazz is responsible for the recruitment and training of its Sales Force for the Jazz Territory.  Jazz shall periodically provide training to its Sales Force including training in relation to Applicable Law and codes of practice applicable to Sales Force activities.  Jazz shall be responsible of preparing any training materials for its Sales Force training.
7.5Annual Commercialization Plan. 
(a)Jazz shall have the sole and final authority to determine the Annual Commercialization Plan.  The initial Annual Commercial Plan will be prepared and presented to PharmaMar no later than [***] months prior to the expected First Commercial Sale of the 
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Licensed Product in the Jazz Territory and shall include, to the extent consistent with Jazz’s standard practice for the preparation of commercialization plans for its other products, a comprehensive and, prior to launch, [***].  The Annual Commercialization Plan shall include [***]. Thereafter, Annual Commercialization Plan will be updated on a Calendar Year basis before the start of the applicable Calendar Year.  Each Annual Commercialization Plan will be shared with PharmaMar for good faith review and discussion and Jazz will respond to one set of reasonable inquiries from PharmaMar, provided that final content of the Annual Commercialization Plan shall be determined solely by Jazz consistent with its diligence obligations pursuant to Section 7.3.  For clarity, the content of Annual Commercialization Plan shall be deemed legally non-binding on Jazz and Jazz may change the Annual Commercialization Plan any time and anyhow as it may consider appropriate provided any such change is consistent with its diligence obligations pursuant to Section 7.3.
(b)The Annual Commercialization Plan will contain, in addition to the content referred subsection (a) above for the first Annual Commercialization Plan, at minimum, the following elements:  (i) the [***], (ii) the minimum [***], (iii) high level description of the Licensed Product positioning, [***], (iv) high level description of any training programs to be conducted in each country within Jazz Territory, (v) high level description of the specifications for the development of marketing materials in each country within Jazz Territory, (vi) anticipated dates for the commercial launch in the Jazz Territory (split by country), (vii) high level description of the general [***], (viii) publication plan, (ix) such other information relating to the Commercialization of the Product in the Jazz Territory, as deemed advisable by Jazz, and (x) an annualized sales forecast for each country within the Jazz Territory, measured by units of the Licensed Products forecasted to be sold during the applicable Calendar Year in each country, each of the foregoing (i) through (x) to the extent consistent with Jazz’s standard practice for the preparation of commercialization plans for its other products.
7.6Commercialization Materials.  
(a)Each Party shall promptly supply to the other Party at cost with one (1) copy in a format agreeable to both Parties (e.g., paper, electronic or digital), in accordance with such other Party’s reasonable requests, of each core form of marketing, advertising and promotional materials, and training manuals for its or its Affiliates’ medical and sales representatives, that are necessary or useful with respect to the Commercialization of the Licensed Product (collectively “Commercialization Materials”) and such other Party (including PharmaMar ́s Third Party Partners) shall have the right to reproduce, translate, use, directly or indirectly, any such Commercialization Materials in connection with the Commercialization of the Licensed Product.  PharmaMar shall use Commercially Reasonable Efforts to obtain from its Third Party Partners and provide Jazz with one (1) copy of all such Commercialization Materials used by such Third Party Partners in PharmaMar Territory, including the right for Jazz to reproduce, translate and use the same in connection with the Commercialization of the Licensed Product in the Jazz Territory.
(b)Jazz shall be responsible for preparing, at its own cost, all Commercialization Materials for the launch of the Licensed Product in the Jazz Territory 
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(“Launch Materials”), such Launch Materials to be submitted to Regulatory Authorities as may be required by Applicable Law. 
7.7Commercialization Compliance.  Each Party undertakes hereby to comply, with regard to all Commercialization Materials (including websites, e-commerce and other Internet uses) and Commercialization activities conducted, with all Applicable Laws in its respective Territory and the Pharmaceutical Research and Manufacturers of America (“PhRMA”) Code of Pharmaceutical Marketing Practices (the “PhRMA Code”).  Each Party shall promptly notify the other Party of and provide a copy of any material correspondence or other reports with respect to promotion of the Licensed Product submitted to or received from a Regulatory Authority or other Governmental Authority relating to compliance with Applicable Law in conducting the activities contemplated by this Agreement.   
7.8Annual Sales Performance. 
(a)Annual Sales Forecast Plan. 
(i)Before the end of each Calendar Year during the ASFP Term, Jazz will submit to PharmaMar (A) a proposed annualized sales forecast for the Jazz U.S. Territory, measured by units of the Licensed Products forecasted to be sold during the following Calendar Year for review and approval by PharmaMar, such approval not to be unreasonably withheld (the “U.S. Annual Sales Forecast Plan” or “U.S. ASFP”) and (B) commencing after the first full Calendar Year after the Calendar Year in which Jazz or its Affiliate makes the First Commercial Sale of a Licensed Product in the Jazz Canada Territory, a proposed annualized sales forecast for the Jazz Canada Territory, measured by units of the Licensed Products forecasted to be sold during the following Calendar Year for review and approval by PharmaMar, such approval not to be unreasonably withheld (the “Canada Annual Sales Forecast Plan” or “Canada ASFP” and together with the U.S. Annual Sales Forecast Plan or the U.S. ASFP, the “Annual Sales Forecast Plans” or “ASFPs”). 
(ii)If PharmaMar provides written notice of non-approval of a proposed ASFP within [***] days of receipt of such proposed ASFP from Jazz, then both Parties hereby agree that an independent market research company (“IMRC”) will serve as an independent market research company and will determine the ASFP that shall be reasonably achievable by Jazz in the Jazz U.S. Territory or Jazz Canada Territory, as applicable, for such Calendar Year, which shall take into consideration all available market research data and prescription trends as well as other commercially reasonable factors, including the actual volume of Annual Net Sales achieved in previous periods in the Jazz U.S. Territory or Jazz Canada Territory, as applicable, as well as market trends.  If PharmaMar does not provide notice of non-approval of a proposed ASFP within [***] days of receipt of such proposed ASFP from Jazz, then such proposed ASFP shall be deemed approved by PharmaMar. 
(iii)The Parties hereby agree that they shall jointly appoint [***] as the IMRC in the event PharmaMar provides written notice of non-approval of any proposed ASFP in accordance with the terms of this Section 7.8(a).  In the event [***] does not accept any such appointment within [***] days from the communication of its appointment, the Parties hereby 
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agree that each Party shall appoint one independent Third Party market research company and the IMRC shall be appointed by the two selected independent Third Party market research companies.
(iv)Within [***] days of the appointment of the IMRC for a particular Calendar Year, each of the Parties will provide the IMRC with accurate and detailed information and documentation about sales of the Licensed Product for at least the past [***] years and [***] year forecasted sales of the Licensed Product for the Jazz U.S. Territory or Jazz Canada Territory, as applicable (if such data is available at a given time), and any other information requested by the IMRC, acting in good faith at all times.  The IMRC will, within [***] after its appointment, issue a report determining the ASFP for the Jazz U.S. Territory or the Jazz Canada Territory, as applicable, that shall be reasonably achievable by Jazz in relation to the Calendar Year in the ASFP Term for which PharmaMar provides written notice of non-approval of any proposed ASFP within [***] days of receipt.  Once the IMRC determines the ASFP for the Jazz U.S. Territory or Jazz Canada Territory, as applicable, for a given Calendar Year, such ASFP shall be fully applicable and binding on the Parties with respect to such Calendar Year.  Fees and expenses of the IMRC in determining the ASFP shall be borne by PharmaMar. 
(b)Annual Sales Performance.  Jazz shall meet (i) [***] of the U.S. ASFP for the Jazz U.S. Territory of each Calendar Year during the applicable ASFP Term and (ii) [***] of the Canada ASFP for the Jazz Canada Territory of each Calendar Year during the applicable ASFP Term.  Nothing in this Section 7.8(b) shall be construed or understood as releasing Jazz’s diligence obligations pursuant to Section 7.3.
(c)Failure to Achieve Annual Sales Performance Standard.  In the event Jazz fails to achieve [***] of the U.S. ASFP in any Calendar Year during the applicable ASFP Term or fails to achieve [***] of the Canada ASFP in any Calendar Year during the applicable ASFP Term, then as PharmaMar’s sole and exclusive remedy for such failure, the terms of this Section 7.8(c) shall apply with respect to the Jazz U.S. Territory or Jazz Canada Territory, as applicable, provided Jazz has satisfied its diligence obligations pursuant to Section 7.3 with respect to such country.  For clarity, any failure to achieve [***] of the U.S. ASFP or Canada ASFP in any Calendar Year during the applicable ASFP Term shall not be deemed a material breach of this Agreement, provided Jazz has satisfied its diligence obligations pursuant to Section 7.3 with respect to such country. 
(i)In the event that Jazz fails to achieve [***] of the U.S. ASFP in any Calendar Year during the applicable ASFP Term and the cause for such failure is not attributable in part to acts or omissions of PharmaMar (including a failure to supply Licensed API or Licensed Product pursuant to the terms of the Supply Agreement) or a Force Majeure, then within [***] days after the end of such Calendar Year, Jazz shall submit to PharmaMar an action plan detailing [***].  Jazz will use Commercially Reasonable Efforts to implement such action plan during the following Calendar Year. 
(ii)In the event that Jazz fails to achieve [***] of the U.S. ASFP in [***] Calendar Years during the applicable ASFP Term and the cause for each such failure is not attributable in part to acts or omissions of PharmaMar (including a failure to supply Licensed 
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API or Licensed Product pursuant to the terms of the Supply Agreement) or a Force Majeure, then as of the start of the next Calendar Year after such failures and thereafter [***], the base royalty rate for the first tier under Section 8.7(a) shall be increased from [***] to [***] with respect to Net Sales in the Jazz U.S. Territory. Attached hereto as Exhibit E is an example demonstrating the implementation of such increase to the base royalty rate solely with respect to Net Sales in the Jazz U.S. Territory and not with respect to Net Sales in the Jazz Canada Territory. 
(iii)In the event that Jazz fails to achieve [***] of the U.S. ASFP in any Calendar Year during the applicable ASFP Term and the cause for such failure is not attributable in part to acts or omissions of PharmaMar (including a failure to supply Licensed API or Licensed Product pursuant to the terms of the Supply Agreement) or a Force Majeure, then PharmaMar shall have [***] months after the end of such Calendar Year for which such failure occurred to elect either (A) to exercise its Co-Promotion Option pursuant to Section 7.9(a) or (B) for the base royalty rate for the first tier under Section 8.7(a) to be increased from [***] to [***] with respect to Net Sales in the Jazz U.S. Territory as of the start of the next Calendar Year after such failure and continuing during the [***] (if Pharma Mar elects for the base royalty rate increase as set forth hereunder, Exhibit E attached includes an example demonstrating the implementation of such increase to the base royalty rate solely with respect to Net Sales in the Jazz U.S. Territory and not with respect to Net Sales in the Jazz Canada Territory). 
(iv)In the event that Jazz fails to achieve (A) [***] of the Canada ASFP in [***] Calendar Years during the applicable ASFP Term or (B) [***] of the Canada ASFP in any Calendar Year during the applicable ASFP Term, and in each case of (A) and (B), the cause for each such failure is not attributable in part to acts or omissions of PharmaMar (including a failure to supply Licensed API or Licensed Product pursuant to the terms of the Supply Agreement) or a Force Majeure, then solely upon the first such occurrence, (x) the ASFP Term as it relates to the Jazz Canada Territory shall be extended until the end of the [***] Calendar Year period starting after the end of the first full Calendar Year after the Calendar Year in which Jazz or its Affiliate makes the First Commercial Sale of a Licensed Product in the Jazz Canada Territory and (y) in addition to the royalties payable on Net Sales in the Jazz Canada Territory pursuant to Section 8.7, Jazz will pay PharmaMar an additional [***] royalty on Net Sales in the Jazz Canada Territory starting as of the start of the next Calendar Year and for [***] (as extended pursuant to subsection (x) above). For clarity, the remedy provided for pursuant to this Section 7.8(c)(iv) is applicable [***]. Exhibit E attached includes an example demonstrating the implementation of such increase to the royalty rates solely with respect to Net Sales in the Jazz Canada Territory and not with respect to Net Sales in the Jazz U.S. Territory.
7.9Co-Promotion Option
(a)Option.  In the event that either (i) (A) there is a Change of Control of Jazz Pharmaceuticals PLC within [***] years of the Effective Date by a [***] and (B) at any time during the [***], the [***], and such [***] or (ii) Jazz fails to achieve [***] of the U.S. ASFP in any Calendar Year during the ASFP Term and the cause for such failure is not attributable in part to acts or omissions of PharmaMar (including a failure to supply Licensed 
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API or Licensed Product to the Jazz U.S. Territory pursuant to the terms of the Supply Agreement) or a Force Majeure, then in each case of (i) or (ii), PharmaMar shall have the option to co-promote the Licensed Product in the Jazz U.S. Territory in accordance with this Section 7.9 (the “Co-Promotion Option”).  PharmaMar shall have the right, in its sole discretion, to exercise such Co-Promotion Option by delivering to Jazz written notice (x) at any time within [***] months after the end of [***] or (y) [***] months after the end of such Calendar Year for which such failure to achieve [***] of the U.S. ASFP in any Calendar Year during the ASFP Term occurred, as applicable based on the triggering event for such Co-Promotion Option, provided that, in each case, PharmaMar is then currently [***].
(b)Effect of Option Exercise.  Within [***] days after PharmaMar’s exercise of its Co-Promotion Option, pursuant to Section 7.9(a), the Parties will execute a joint commercial agreement that sets forth the terms and conditions pursuant to which the Parties will collaborate in promoting the Licensed Products in the Licensed Indications in the Jazz U.S. Territory, including the terms set forth on Exhibit F (the “Co-Promotion Agreement”).  
7.10Change of Control. In the event that there is a Change of Control of Jazz Pharmaceuticals PLC within [***] years of the Restatement Effective Date by a company who is engaged in a Competing Program (as defined in Section 2.4(c)) in the Jazz Canada Territory, then Jazz shall have the right to elect for its new Affiliate to either (a) wind down or complete the Divestiture of such Competing Program in the Jazz Canada Territory within [***] months from the closing date of such Change of Control, and Jazz’s new Affiliate’s conduct of such Competing Program during such [***] month period will not be deemed a breach of Jazz’s exclusivity obligations in Section 2.4(b); provided, that during such [***] month period such new Affiliate complies with the provisions of Section 2.4(c)(1) or (b) continue such Competing Program independently of the activities under this Agreem ent and Jazz’s new Affiliate’s conduct of such Competing Program will not be deemed a breach of Jazz’s exclusivity obligations in Section 2.4(b); provided, that such new Affiliate complies with the provisions of Section 2.4(c)(1). If Jazz elects for its new Affiliate to continue such Competing Program independently in accordance with subsection (b) above, then at any time during the [***] month period following the closing of such Change of Control, if the gross sales of Licensed Products in the Jazz Canada Territory obtained in the first [***] month period or the second [***] month period following the closing of such Change of Control are reduced by at least [***] in the Jazz Canada Territory in the [***] month period immediately preceding the closing of such Change of Control, and such reduction is not due in part to a Force Majeure or a significant market event such as the launch of a Generic Product or a competitive product for an approved Indication, then Jazz will pay PharmaMar an additional [***] royalty on Net Sales in the Jazz Canada Territory starting as of the start of the next Calendar Quarter after such reduction and for the remainder of the Royalty Term in the Jazz Canada Territory.  Exhibit E attached includes an example demonstrating the implementation of such increase to the royalty rates solely with respect to Net Sales in the Jazz Canada Territory and not with respect to Net Sales in the Jazz U.S. Territory.
7.11Medical Affairs
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(a)General.  Jazz shall have the sole and final authority to plan, determine and implement Medical Affairs activities in the Jazz Territory at its own cost.  Jazz shall share with PharmaMar any annual plan for Medical Affairs activities prepared by Jazz to be conducted in the Jazz Territory in each Calendar Year. Jazz will respond to any reasonable inquiries from PharmaMar provided however those Medical Affairs activities to be conducted in the Jazz Territory shall be determined solely by Jazz in a manner consistent with its standard practice.  It is understood by the Parties that Medical Affairs activities will be conducted for that purpose to produce good, objectively valid and reliable scientific evidence relating to the Licensed Product and/or the relevant disease, and not for commercial or promotional purposes.  For clarity, content of annual plan Medical Affairs shall be deemed legally non-binding on Jazz and Jazz may change such plan any time and anyhow as it may consider appropriate provided any such change is consistent with its standard practice.
(b)Exchange of Medical Affairs Studies Information.  Jazz and PharmaMar, respectively, shall provide the other Party with copies of the Information obtained from any and all Medical Affairs Studies conducted in each Party ́s Territory at no expense to the other Party provided such Information is available.  Each Party shall be entitled to use such Information for the development, manufacturing, use or commercialization of the Licensed Product in its Territory and shall be entitled to disclose such Information to any Sublicensees and Third Party Partners for the same purposes in its Territory.
(c)Medical Information.  Jazz shall be responsible at its own cost for medical information activities with respect to the Licensed Products in the Jazz Territory, including ensuring that adequate medical information is in place where relevant in the Jazz Territory and that all medical information requests are responded by Jazz in connection with the Licensed Product originating in the Jazz Territory.  Any medical enquiries which are related to adverse events of Licensed Products shall be managed according to Safety Data Exchange Agreement.  On a quarterly basis Jazz shall provide PharmaMar with a report of all medical information requests received and all responses provided to such requests in such quarter.  In addition, Jazz shall provide PharmaMar every [***] months during the Term with all standard letters generated by Jazz in the Jazz Territory with regard to the Licensed Product. 
8.Financial Terms
8.1Upfront Payments.  
(a)The Parties acknowledge that, Jazz timely made a one-time, non-refundable upfront payment to PharmaMar of two hundred million Dollars ($200,000,000) pursuant to the Original License Agreement. 
(b)Within [***] days after the Restatement Effective Date, Jazz shall pay to PharmaMar a one-time, non-refundable upfront payment of [***]. 
8.2Pivotal Trial Costs.  
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(a)Pivotal Trial Cost Sharing.  In the event Jazz elects pursuant to Section 4.2(c)(i) to share costs for a particular Additional Indication Pivotal Trial, then the Parties shall share all Pivotal Trial Costs for such Joint Additional Indication Pivotal Trial with [***] of such Pivotal Trial Costs.  Each Party may propose amendments to Joint Additional Indication Pivotal Trial Budget which shall not be implemented until approved by the JDC, such approval not to be unreasonably withheld (it would be unreasonable not to approve any amendment to the Joint Additional Indication Pivotal Trial Budget if the Joint Additional Indication Pivotal Trial is amended by the JDC in a manner that implies a change to the assumptions or a change in the protocol which were taken into account at the time the initial Joint Additional Indication Pivotal Trial Budget was approved).  Each Party shall be responsible for [***] of the Pivotal Trial Costs that it incurs in connection with any Joint Additional Indication Pivotal Trial that [***], except for those [***]. 
(b)Pivotal Trial Cost Reports; Reconciliation Report.  Within [***] days after the end of each Calendar Quarter during which either Party has incurred any Pivotal Trial Costs, such Party shall submit to the other Party a reasonably detailed written report setting forth the total of such Pivotal Trial Costs incurred by such Party in such Calendar Quarter.  Within [***] days before the end of each Calendar Quarter during which either Party has incurred any Pivotal Trial Costs, such Party shall submit to the other Party a good-faith, non-binding estimate of the total of such Pivotal Trial Costs incurred by such Party in such Calendar Quarter.  Within [***] days after the end of each such Calendar Quarter, PharmaMar shall provide Jazz with a written report setting forth the net payment due from one Party to the other Party to effectuate the sharing of Pivotal Trial Costs as set forth in this Section 8.2 (the “Reconciliation Report”).  The Party that is owed money pursuant to the Reconciliation Report shall issue an invoice to the paying Party for the applicable Pivotal Trial Costs promptly after receipt (or delivery, as applicable) of such Reconciliation Report.  Any payment owed by one Party to the other Party shall be paid within [***] days following receipt of such invoice.  
(c)Creditable Against Sales Milestone Payments.  All Pivotal Trial Costs paid by Jazz shall be fully creditable against all Sales Milestone Payments for the Jazz U.S. Territory due and payable thereafter pursuant to Section 8.6.
8.3Development Costs for SCLC Post-Approval Commitment Studies.  
(a)In the event Jazz exercises its right to conduct any U.S. SCLC Post-Approval Commitment Studies or Mutual Canada SCLC Post-Approval Commitment Studies itself in accordance with Section 4.1(b), then PharmaMar shall be responsible for one hundred percent (100%) of the Development Costs up to [***] of the U.S. SCLC Post-Approval Commitment Studies Budget or Mutual Canada SCLC Post-Approval Commitment Studies Budget, as applicable.  Within [***] days after the end of each Calendar Quarter during which Jazz has incurred any Development Costs with respect to the U.S. SCLC Post-Approval Commitment Studies or Mutual Canada SCLC Post-Approval Commitment Studies, Jazz shall submit to PharmaMar a reasonably detailed written report setting forth the total of such Development Costs incurred by Jazz in such Calendar Quarter and invoicing PharmaMar for [***] of such Development Costs provided however that Jazz shall be responsible for 100% of 
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the Development Costs that it incurs in connection with any U.S. SCLC Post-Approval Commitment Studies or Mutual Canada SCLC Post-Approval Commitment Studies that exceed [***], except for those [***].  PharmaMar shall pay any amount due and invoiced hereunder within [***] days after the receipt of the invoice.   
(b) Development Costs incurred for the performance of the Jazz Canada SCLC Post-Approval Commitment Studies shall be creditable up to [***] of the Jazz Canada SCLC Post-Approval Commitment Studies Budget solely against those Regulatory Milestone Payments, Sales Milestone Payments and royalty payments related to the Jazz Canada Territory thereafter due and payable pursuant to Section 8.4, Section 8.6 and Section 8.7, as applicable as set forth in Section 4.1(b)(iii) and this Section 8.3(b). For clarity, such Development Costs shall solely be creditable against Regulatory Milestone Payment no. 4 of Section 8.4, against Sales Milestone Payments no. 6, 7 and 8 of Section 8.6 and against those royalty payments under Section 8.7 which correspond to Net Sales in the Jazz Canada Territory.
8.4Regulatory Milestone Payments.  The Parties acknowledge that, Jazz timely made a one-time, non-refundable milestone payment to PharmaMar of one hundred million Dollars ($100,000,000) pursuant to the Original License Agreement upon NDA Approval for the Licensed Product in the Jazz U.S. Territory, with the requirement of confirmatory clinical trial(s), [***].  Within [***] days of the first achievement of each of the milestone events set forth in the table below by Jazz, its Affiliates or Sublicensees (each, a “Regulatory Milestone”), Jazz shall provide PharmaMar with written notice of such achievement and shall, subject to any credits available pursuant to Section 8.3(b), pay to PharmaMar the corresponding onetime, non-refundable milestone payment set forth below:  
						
	Milestone Event	Milestone Payment
	1.  [***]
	[***]
	2. [***]
	[***]
	3.  [***]
	[***]
	4.  [***]
	[***]

Each of the foregoing milestone payments (each, a “Regulatory Milestone Payment”) shall be payable only one time, for the first achievement of the applicable milestone event.  
Regulatory Milestone #1 and Regulatory Milestone #2 are mutually exclusive and cannot both be achieved.  
The maximum total of all remaining unpaid Regulatory Milestone Payments pursuant to this Section 8.4 as of the Restatement Effective Date is [***] Dollars [***], which can 
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be achieved through (a) the achievement of [***] (b) the achievement of [***] which together total [***]. 
8.5Additional Indication Regulatory Milestones.  In the event (a) Jazz elects to have PharmaMar fund [***] of the costs for an Additional Indication Pivotal Trial in accordance with Section 4.2(c)(ii), (b) such Additional Indication Pivotal Trial obtains Positive Results; and (c) Jazz determines in good faith that it will be profitable for Jazz to Commercialize such Licensed Product in the Additional Indication in the Jazz U.S. Territory (which profitability determination shall include, without limitation, the cost of obtaining Regulatory Approval and making the applicable Additional Indication Regulatory Milestone payment), then within [***] days of the first achievement for such Additional Indication of the applicable milestone event set forth in the table below by Jazz, its Affiliates or Sublicensees (each, an “Additional Indication Regulatory Milestone”), Jazz shall provide PharmaMar with written notice of such achievement and shall, subject to any credits available pursuant to Section 8.3(b), pay to PharmaMar the corresponding onetime milestone payment set forth below: 
						
	Milestone Event	Milestone Payment
	1.  [***]
	[***]
	2.  [***]
	[***]

For clarity, only one of the foregoing milestone payments (each, an “Additional Indication Regulatory Milestone Payments”) shall be payable for each Additional Indication.  
All Additional Indication Regulatory Milestone Payments shall be fully creditable against all Sales Milestone Payments for the Jazz U.S. Territory thereafter due and payable pursuant to Section 8.6.  
8.6Net Sales Milestone Payments.  Within [***] days of the end of the first Calendar Year in which each of the milestone events set forth in the table below is achieved by Jazz, its Affiliates or Sublicensees (each, a “Sales Milestone”), Jazz shall provide PharmaMar with written notice of such achievement and shall, subject to any credits available pursuant to Section 8.3(b), Section 8.2 or Section 8.5, pay to PharmaMar the corresponding onetime, non-refundable milestone payment set forth below:  
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	Milestone Event	Milestone Payment
	1. [***]
	[***]
	2. [***]
	[***]
	3. [***]
	[***]
	4. [***]
	[***]
	5. [***]
	[***]
	6. [***]
	[***]
	7.  [***]
	[***]
	8.  [***]
	[***]

Each of the foregoing milestone payments (each, a “Sales Milestone Payment”) shall be payable only one time, for the first achievement of the applicable milestone event.  The maximum total of all Sales Milestone Payments pursuant to this Section 8.5 is [***] Dollars [***].  For clarity, if more than one Sale Milestone Event is achieved in the same Calendar Year, all Sale Milestone Payments corresponding to such Events achieved in such Calendar Year shall be paid by Jazz in aggregate.
8.7Royalties.   
(a)Royalty Rates.  Jazz shall, subject to any credits available pursuant to Section 8.3(b), pay to PharmaMar royalties on incremental aggregate annual Net Sales in the Jazz Territory in each Calendar Year (the “Licensed Product Royalty”) at the applicable rate(s) set forth below: 
						
	Annual Net Sales in the Jazz Territory	Royalty Rate
	[***]	[***]
	[***]	[***]
	[***]	[***]
	[***]	30%

(b)Royalty Term.  Royalties under Section 8.7 shall be payable on a Licensed Product-by-Licensed Product and country-by-country basis in the Jazz Territory from First Commercial Sale of such Licensed Product in such country in the Jazz Territory until the 
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latest of (a) expiration of the last Valid Claim of the PharmaMar Patents (excluding Jazz Solely Invented Specific Inventions and Jazz Solely Invented Specific Combination Inventions) in the Jazz Territory covering the composition of matter of the Licensed API contained in such Licensed Product in such country, (b) expiration of Regulatory Exclusivity for such Licensed Product in such country in the Jazz Territory and (c) twelve (12) years after such First Commercial Sale in such country (the “Royalty Term”). 
(c)Loss of Exclusivity Reduction.  On a Licensed Product-by-Licensed Product and country-by-country basis, if, during the Royalty Term for such Licensed Product, one or more Generic Products of such Licensed Product is sold by a Third Party in such country, then as of the month in which such Generic Product was first sold in such country, for the remainder of the Royalty Term for such Licensed Product in such country, Jazz’s royalty payment obligations with respect to Net Sales of such Licensed Product in such country in the Jazz Territory shall be reduced by [***].  
(d)Third Party Licenses. 
(i)Notice. In the event either Party identifies any item of intellectual property controlled by a Third Party that it considers to be [***] for the manufacture, Development or Commercialization of a Licensed Product (alone or in combination with another composition of matter), it shall notify the other Party in writing and shall provide a reasonably detailed specification of the nature and scope of such item of intellectual property.   
(ii)Negotiation of Third Party Licenses.  Jazz shall have the right to negotiate the terms and conditions for a license from such Third Party under any intellectual property rights identified under a notice in Section 8.7(d)(i) to the extent applicable to the Jazz Territory and to the extent applicable to the exercise of Jazz’s rights under this Agreement in the PharmaMar Territory.  Upon agreement of the material terms of any such license agreement with such Third Party, Jazz shall disclose such material terms to PharmaMar and PharmaMar shall have a period of [***] days to elect whether it would like to negotiate for a worldwide license to such intellectual property rights. In the event PharmaMar provides notice in such [***] day period that it would like to negotiate a worldwide license for such intellectual property right, then PharmaMar shall have [***] days to negotiate a worldwide license agreement for such intellectual property rights with such Third Party. In the event (A) PharmaMar is [***] and (B) the Parties are able to agree upon the allocation of any non-royalty consideration that is not directly related to activities conducted solely by one of the Parties or their respective Affiliates or Sublicensees or Third Party Partners, as applicable, then upon agreement of the Parties that (A) and (B) have both been satisfied, PharmaMar shall have the right to enter into a worldwide license agreement on such agreed upon terms and conditions.  If either (x) PharmaMar does not elect to negotiate a worldwide license within such [***] day period, (y) either (A) or (B) above are not satisfied or (z) PharmaMar does not execute a worldwide license agreement with such Third Party within [***] days of agreement by the Parties that (A) and (B) above have been satisfied, then Jazz shall have the right to execute a license from such Third Party under such intellectual property rights to the extent applicable to the Jazz Territory and to the extent applicable to the exercise of Jazz’s rights under this Agreement in the PharmaMar Territory.   If 
55

PharmaMar enters into a license for such item of intellectual property, for the avoidance of doubt, such intellectual property shall be included in the Jazz License provided for by this Agreement and Jazz shall be responsible (subject to the reduction in (iv) below) for all payments owed under such agreement that are directly related to activities conducted solely by Jazz or its Affiliates or Sublicensees and for the agreed upon allocation of all other payments as agreed upon by the Parties under (B) above. 
(iii)PharmaMar Challenge. With respect to any intellectual property rights identified under a notice in Section 8.7(d)(i), if PharmaMar provides written notice to Jazz within [***] days of receipt of such notice that it elects to challenge such item of intellectual property, then PharmaMar shall be deemed to have [***] and PharmaMar shall keep Jazz reasonably informed of such challenge.  In the event Jazz [***] and PharmaMar [***], then Jazz shall [***]. 
(iv)Third Party License Reduction. For any license to Third Party intellectual property rights that are [***] for the manufacture, Development or Commercialization of Licensed Product entered into by Jazz or PharmaMar or their respective Affiliates pursuant to Section 8.7(d)(ii), Jazz shall have the right to deduct from any royalty that would otherwise have been due pursuant to this Section 8.7 in a particular Calendar Quarter an amount equal to [***] paid by Jazz or its Affiliates for such rights; provided, that if such license was entered in to by Jazz pursuant to Section 8.7(d)(ii), with respect to any [***], if the applicable Third Party license relates to [***], then such [***] for such rights shall be [***]; and, provided, further, that under no circumstances shall the royalty payments otherwise payable to PharmaMar pursuant to this Section 8.7 for any Calendar Quarter in the absence of this reduction be reduced by more than [***] as a result of this Section 8.7(d).  Jazz may carry forward to subsequent Calendar Quarters any deductions that it was not able to deduct as a result of the foregoing provision.  In the event that Jazz intends to deduct any amounts pursuant to this Section 8.7(d), it shall provide PharmaMar a copy of the agreement with the applicable Third Party. 
(v)Neither Party shall, in any event, enter in a written agreement that admits any infringement of any Third Party intellectual property rights by Jazz or Pharma Mar or its respective Affiliates, Sublicensees or Third Party Partners or invalidity or unenforceability of the PharmaMar Technology, without the prior written consent of the other Party.  
9.    Payments; Records; Audits
9.1Royalty Reports and Payments.  Royalties under Section 8.7 (and Section 7.8(c)(iv), if applicable) shall be calculated and reported for each Calendar Quarter during the Royalty Term and shall be paid within [***] days after the end of the Calendar Quarter.  Each such payment shall be accompanied or preceded by a report (the “Royalty Report”), on a Licensed Product-by-Licensed Product and country-by-country basis, of (a) the amount of gross sales and Net Sales of Licensed Products during the applicable Calendar Quarter, (b) units of Licensed Products sold during the applicable Calendar Quarter, (c) a calculation of the amount of royalty payment due on such sales for such Calendar Quarter, (d) any applicable royalty adjustments under Sections 8.7(c) and 8.7(d), and (e) a revised calculation of the payment due 
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after the application of such adjustments. Upon PharmaMar reasonable request, Jazz shall provide PharmaMar with any further information regarding calculations made in the Royalty Report.
9.2Manner of Payment.  All payments owed by Jazz under this Agreement shall be made by wire transfer in immediately available funds to a bank account designated in writing by PharmaMar.  All payment amounts in this Agreement are expressed in Dollars, and all payments hereunder shall be payable in Dollars, except for payment of transfer prices for the supply of the Licensed Products (whether as Bulk Vials or Finished Products as applicable) and Licensed API which shall be expressed and made in Euros according to Supply Agreement.
9.3Taxes.  
(a)Taxes on Income.  Each Party shall be solely responsible for the payment of all taxes imposed on its share of income arising directly or indirectly from the efforts of the Parties under this Agreement.
(b)Tax Cooperation.  The Parties agree to cooperate with one another and use reasonable efforts to reduce or eliminate tax withholding or similar obligations in respect of royalties, milestone payments, and other payments made by Jazz to PharmaMar under this Agreement.  To the extent Jazz is required to deduct and withhold taxes on any payment to PharmaMar, Jazz shall pay the amounts of such taxes to the proper Governmental Authority in a timely manner and promptly transmit to PharmaMar an official tax certificate or other evidence of such withholding sufficient to enable PharmaMar to claim such payment of taxes.  PharmaMar shall provide Jazz any tax forms that may be reasonably necessary in order for Jazz not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty.  Each Party shall provide the other with reasonable assistance to enable the recovery, as permitted by Applicable Laws, of withholding taxes, value added taxes, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding tax or value added tax.
9.4Audits.  Jazz and its Affiliates and Sublicensees will maintain complete and accurate records in reasonably sufficient detail to permit PharmaMar to confirm the accuracy of the calculation of Development Costs, royalty payments and Sales Milestone Payments.  Each Party and its Affiliates will maintain complete and accurate records in reasonably sufficient detail to permit the other Party to confirm the accuracy of the calculation of Pivotal Trial Costs incurred under this Agreement.  Upon reasonable prior notice, such records shall be available during regular business hours for a period of [***] years from the end of the Calendar Year to which they pertain for examination, not more often than once each Calendar Year, by an independent certified public accountant selected by the auditing Party and reasonably acceptable to the audited Party, for the sole purpose of verifying the accuracy of the financial reports furnished by the other Party pursuant to this Agreement.  Any such auditor shall enter into a confidentiality agreement with the audited Party and shall not disclose the audited Party’s Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by the audited Party or the amount of payments due by one Party to the other Party under this Agreement.  Any amounts shown to be owed but unpaid shall 
57

be paid together with the interest rate set forth in Section 9.5, and any amounts showed to be overpaid will be refunded, within [***] days from the accountant’s report.  The auditing Party shall bear the full cost of such audit unless such audit discloses an underpayment or overcharge by the audited Party of more than [***] of the amount due, in which case the audited Party shall bear the full cost of such audit. 
9.5Late Payments.  In the event that any payment due under this Agreement is not made when due, the payment shall accrue simple interest from the due date until the date of payment at a per-annum rate of prime (as reported in The Wall Street Journal (U.S., Eastern Edition)) plus [***] or the maximum rate allowable by Applicable Law, whichever is less.
10.Intellectual Property
10.1Ownership of Inventions.  
(a)PharmaMar Technology.  Nothing in this Agreement shall be deemed to constitute a transfer or assignment of the PharmaMar Technology in existence as of the Effective Date or generated by PharmaMar or its Affiliates or Third Party Partners during the Term (including during the Term of the Original License Agreement).  Subject only to the other provisions of this Agreement, PharmaMar Controls and shall continue to Control all aspects of such PharmaMar Technology, including, without limitation, the Prosecution and Maintenance of such PharmaMar Technology without any obligation to Jazz except as provided in Section 10.2.
(b)Specific Inventions.  As between the Parties and subject to the terms and conditions of this Agreement, all right, title and interest to Inventions directed solely and specifically to Licensed API or Licensed Product or which are not severable from Licensed API or Licensed Product, but excluding Specific Combination Inventions and Joint Specific Combination Inventions, regardless of which Party’s, its Affiliates’ or sublicensees’ or Third Party Partners’ personnel conceived or created or first reduced to practice such Invention (collectively, “Specific Inventions”), shall be solely owned by PharmaMar.  For clarity, all Specific Inventions and intellectual property rights therein shall be included in the PharmaMar Technology and licensed to Jazz pursuant to the Jazz License.
(c)Specific Combination Inventions.  Notwithstanding the provisions of Section 10.1(b), any Inventions directed solely and specifically to any Licensed API or Licensed Product in combination with any Other Active, other than a Joint Specific Combination Invention, shall be deemed a “Specific Combination Invention”.  Specific Combination Inventions shall be owned by PharmaMar. For clarity, Specific Combination Inventions and intellectual property rights therein shall be included in the PharmaMar Technology and licensed to Jazz pursuant to the Jazz License.  
(d)Joint Specific Combination Inventions.  Notwithstanding the provisions of Section 10.1(b), any Inventions directed solely and specifically to any Licensed API or Licensed Product in combination with any Other Active that is covered by Patent Rights owned by or licensed to Jazz or its Affiliates (a “Jazz Proprietary Component”) shall be deemed a “Joint Specific Combination Invention”.  Joint Specific Combination Inventions shall be 
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jointly owned by PharmaMar and Jazz in both Parties’ Territories except [***], where Patent Rights covering such Joint Specific Combination Invention shall be solely owned by Jazz (“Jazz Specific Combination Invention”).  For clarity, PharmaMar’s interest in the Joint Specific Combination Inventions and intellectual property rights therein shall be included in the PharmaMar Technology and licensed to Jazz pursuant to the Jazz License.  For further clarity, (i) as between the Parties, Jazz (itself or through its Affiliates or Third Parties) shall have the exclusive right to develop, manufacture and commercialize the Jazz Proprietary Component for all uses, including for use with a Licensed API or Licensed Product in the Jazz Territory and the PharmaMar Territory; (ii) nothing herein shall be deemed as a grant of any right to PharmaMar, its Affiliates or Third Party Partners to any Patent Rights or other intellectual property rights owned by or licensed to Jazz or its Affiliates that claim, cover or relate to the Jazz Proprietary Component and are not Joint Specific Combination Inventions; and (iii) nothing herein shall be deemed a grant of any right to Jazz, its Affiliates or Third Parties acting under its authority to Commercialize any Licensed API or Licensed Product in the PharmaMar Territory. 
(e)Generic Inventions.  Any Invention that is not a Specific Invention, a Specific Combination Invention or a Joint Specific Combination Invention shall be deemed a “Generic Invention”.  Inventorship of Generic Inventions shall be determined in accordance with the rules of inventorship under U.S. patent laws.  Any Generic Invention made, conceived, created, generated or first reduced to practice (i) by the personnel of Jazz or its Affiliates or under any agreement between Jazz or its Affiliates or a Third Party with respect to the Licensed Product, independently from the personnel of PharmaMar, its Affiliates and Third Party Partners, shall be solely owned by Jazz (collectively, “Jazz Generic Inventions”); (ii) by the personnel of PharmaMar, its Affiliates or Third Party Partners, independently from the personnel of Jazz and its Affiliates and Third Parties acting on Jazz’s or its Affiliate’s behalf, shall be solely owned by PharmaMar (collectively, “PharmaMar Generic Inventions”); and (iii) by personnel of Jazz, its Affiliates or Third Parties under any agreement between Jazz and an Affiliate or a Third Party with respect to the Licensed Product (on one hand) and PharmaMar, its Affiliates or Third Party Partners (on the other), shall be jointly owned by Jazz and PharmaMar (collectively, “Joint Generic Inventions”).  For clarity, (x) PharmaMar Generic Inventions and intellectual property rights therein and PharmaMar’s interest in the Joint Generic Inventions and intellectual property rights therein shall be included in the PharmaMar Technology and licensed to Jazz pursuant to the Jazz License and (y) Jazz Generic Inventions and intellectual property rights therein and Jazz’s interest in the Joint Generic Inventions and intellectual property rights therein shall be licensed to PharmaMar pursuant to the PharmaMar License.  
(f)Disclosure of Inventions.  Each Party shall promptly disclose to the other Party all Inventions made by such Party to which the other Party has rights hereunder, including any invention disclosures, or other similar documents, submitted to it by its employees, agents or independent contractors describing Specific Inventions, Specific Combination Inventions, Joint Specific Combination Inventions, Jazz Generic Inventions, PharmaMar Generic Inventions or Joint Generic Inventions, and shall promptly respond to reasonable request from the other Party for additional information relating to such Inventions.  
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(g)Assignment; Further Assurances.  Jazz hereby assigns to PharmaMar all right, title and interest in and to any Specific Inventions and Specific Combination Inventions.  In addition, each Party hereby assigns to the other Party fifty percent (50%) ownership interest of its right, title and interest in any Joint Specific Combination Invention and Joint Generic Invention, as applicable.  In accordance with the foregoing, each Party shall execute and shall have its employees execute (and cause its Affiliates and Third Parties, as applicable, to execute) all documents necessary to transfer such rights, title and interest in accordance with this Section 10.1(g).  Any remuneration for each Party ́s and its Affiliates’ employees’ inventions shall be solely borne by such Party. 
(h)No Accounting. Except as expressly provided otherwise in this Agreement, neither Party shall have any obligation to obtain any approval of the other Party for, nor pay the other Party any share of the proceeds from or otherwise account to the other Party for, the practice, licensing, assignment or other exploitation of Joint Specific Combination Inventions or Joint Generic Inventions and each Party hereby waives any right it may have under the Applicable Laws of any country to require such approval, sharing or accounting. 
10.2Patent Prosecution and Maintenance.
(a)General.  Except to the extent expressly specified to the contrary in this Agreement, as between the Parties, each Party shall retain the right to control the prosecution and maintenance of all intellectual property rights Controlled by such Party at such Party’s expense, including the Prosecution and Maintenance of Patent Rights.  Prosecution and maintenance costs and expenses shall include any prosecution fees, issue fees, maintenance fees and any fees of patent counsels, lawyers, experts and agents involved in the filing, prosecution and maintenance of such intellectual property rights.
(b)PharmaMar Prosecuted Patents.  Except as otherwise provided in this Section 10.2(b), PharmaMar shall have the first right, but not the obligation, to control the preparation, filing, prosecution (including any oppositions, interferences, reissue proceedings, reexaminations and post-grant proceedings) and maintenance (such activities collectively, the “Prosecution and Maintenance”) of PharmaMar Patents (including Joint Generic Patents but excluding Joint Specific Combination Patents) (collectively, the “PharmaMar Prosecuted Patents”) on a worldwide basis at its own expense, except for Joint Generic Patents, for which expenses shall be shared equally by the Parties.  PharmaMar shall provide Jazz reasonable opportunity to review and comment on material issues regarding such PharmaMar Prosecuted Patents in the Jazz Territory (and solely with respect to the Joint Generic Patents, in the PharmaMar Territory), including providing Jazz with copies of all relevant communications to or from any patent authority in the Jazz Territory regarding such PharmaMar Prosecuted Patents (and solely with respect to the Joint Generic Patents, from any patent authority in the PharmaMar Territory), and providing drafts of any material filings or responses to be made to such patent authorities reasonably in advance of the submission of such filings or responses for Jazz’s review and comment.  PharmaMar shall [***] in connection with the Prosecution and Maintenance of such PharmaMar Prosecuted Patents in the Jazz Territory (and solely with respect to the Joint Generic Patents on a worldwide basis); provided however that PharmaMar shall have the sole 
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and final decision making authority regarding Prosecution and Maintenance of PharmaMar Prosecuted Patents, with no obligation to Jazz whether to file, continue to prosecute, abandon and/or disclaim such Patent Right; provided further that if PharmaMar determines in its sole discretion to abandon or not file or maintain a PharmaMar Prosecuted Patents in the Jazz Territory (and solely with respect to the Joint Generic Patents on a worldwide basis), then PharmaMar shall provide Jazz with written notice of such determination sufficiently in advance (but no later than [***] days prior to the date any abandonment of such PharmaMar Prosecuted Patent would become effective or any date that would bar patentability) so that Jazz may, at its discretion, assume and control the Prosecution and Maintenance of such PharmaMar Prosecuted Patents at its own expense and in its own name.  In the event that Jazz elects to assume the Prosecution and Maintenance of a PharmaMar Prosecuted Patent as provided for in this Section 10.2(b), PharmaMar shall assign and hereby assigns to Jazz its interest in such PharmaMar Prosecuted Patent without further consideration and such Patent shall thereafter cease to be considered a PharmaMar Patent for all purposes of this Agreement.  If Jazz determines in its sole discretion to not contribute any further to the Prosecution and Maintenance of a Joint Generic Patent, then Jazz shall provide PharmaMar with written notice of such determination sufficiently in advance so that PharmaMar may, at its discretion, continue to control the Prosecution and Maintenance of such Joint Generic Patent, but at its sole expense or abandon such Joint Generic Patent.  In the event that PharmaMar elects to continue at its sole expense the Prosecution and Maintenance of a Joint Generic Patent, Jazz shall assign and hereby assigns to PharmaMar its interest into such Joint Generic Patent without further consideration and such Joint Generic Patent shall be then deemed to be a PharmaMar Patent for the purposes of this Agreement. 
(c)Jazz Prosecuted Patents.  Except as otherwise provided in this Section 10.2.(c), Jazz shall have the first right, but not the obligation, to control Prosecution and Maintenance of the Jazz Generic Patents and Joint Specific Combination Patents (collectively, “Jazz Prosecuted Patents”) on a worldwide basis at its own expense.  Jazz shall provide PharmaMar reasonable opportunity to review and comment on material issues regarding such Jazz Prosecuted Patents in the PharmaMar Territory, including providing PharmaMar with copies of all relevant communications to or from any patent authority in the PharmaMar Territory regarding such Jazz Prosecuted Patents, and providing drafts of any material filings or responses to be made to such patent authorities reasonably in advance of the submission of such filings or responses for PharmaMar ́s review and comments.  Jazz shall [***] in connection with the Prosecution and Maintenance of such Jazz Patents in the PharmaMar Territory, provided however that Jazz shall have the sole and final decision making authority regarding Prosecution and Maintenance of Jazz Prosecuted Patents, with no obligation to PharmaMar whether to file, continue to prosecute, abandon and/or disclaim such Patent Right.  Notwithstanding the foregoing, and with regard to any Jazz Generic Patent that is being exploited at any time by PharmaMar, its Affiliates or Third Party Partners in relation to the Licensed API or the Licensed Product, if Jazz determines in its sole discretion to abandon or not file or maintain such Jazz Generic Patent in the PharmaMar Territory, then Jazz shall provide PharmaMar with written notice of such determination sufficiently in advance (but no later than [***] days prior to the date any abandonment of such Jazz Prosecuted Patent would become effective or any date that would bar patentability) so that PharmaMar may, at its discretion, assume and control the Prosecution and Maintenance of such Jazz Generic Patent, at its own expense and in its own name and such 
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Jazz Generic Patent shall be then deemed to be a PharmaMar Patent for the purposes of this Agreement.  If Jazz determines in its sole discretion to abandon or not maintain a Joint Specific Combination Invention in the Jazz Territory or the PharmaMar Territory, then Jazz shall provide PharmaMar with written notice of such determination sufficiently in advance so that PharmaMar may, at its discretion, assume and control the Prosecution and Maintenance of such Joint Specific Combination Patent at its sole expense or abandon such Joint Specific Combination Patent.  In the event that PharmaMar elects to assume at its sole expense the Prosecution and Maintenance of a Joint Specific Combination Patent, Jazz shall assign and hereby assigns to PharmaMar its interest into such Joint Specific Combination Patent without further consideration and such Joint Specific Combination Patent shall be then deemed to be a PharmaMar Patent for the purposes of this Agreement.  For clarity, any such assignment shall not include an assignment, transfer or license to PharmaMar, its Affiliates or Third Party Partners to any Patent Rights or other intellectual property rights owned by or licensed to Jazz or its Affiliates that claim, cover or relate to any Jazz Proprietary Component.
(d)Cooperation in Prosecution.  Each Party shall provide the other Party all reasonable assistance and cooperation in the Patent Prosecution and Maintenance efforts provided above in this Section 10, including providing any necessary powers of attorney and executing any other required documents or instruments for such Prosecution and Maintenance consistent with the provisions of this Section 10 above, as well as further actions as set forth below:
(i)The Parties shall respectively Prosecute and Maintain the PharmaMar Prosecuted Patents and Jazz Prosecuted Patents as set forth in this Section 10.2.  
(ii)All communications between the Parties relating to the Prosecution or Maintenance of the PharmaMar Prosecuted Patents and Jazz Prosecuted Patents, including copies of any draft or final documents or any communications received from or sent to patent offices or patenting authorities with respect to such Patents, shall be considered Confidential Information of the owner of such Patent (and in case of Joint Patents, Confidential Information of both PharmaMar and Jazz) and subject to the confidentiality provisions of Article 11.
10.3Patent Term Extensions in the Jazz Territory.  The Parties shall coordinate and discuss which of the Patent Rights within the PharmaMar Patents or the Jazz Patents should be selected for patent term extensions (including any pediatric exclusivity extensions as may be available) or supplemental protection certificates or their equivalents in the Jazz Territory (collectively, “Patent Term Extensions”) with respect to any Licensed Product.  Notwithstanding anything to the contrary set forth in Section 10.2, Jazz shall have the right to apply for Patent Term Extensions with respect to any Licensed Product in the Jazz Territory and PharmaMar shall have final decision-making authority with respect to determining which Patent Right is selected for any such Patent Term Extensions in the Jazz Territory.  Each Party will cooperate fully with the other in making such filings or actions, for example and without limitation, making available all required regulatory data and other Information and executing any required authorizations to apply for such Patent Term Extension, including PharmaMar appointing Jazz as its agent with respect to any Patent Term Extension of a PharmaMar Patent or 
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Joint Patent in the Jazz Territory.  For clarity, the Parties agree that (i) the costs of obtaining a Patent Term Extension in the Jazz Territory (a) within a PharmaMar Patent (other than a Joint Patent) shall be borne by PharmaMar, (b) within a Jazz Patent (other than a Joint Patent) shall be borne by Jazz and (c) within the Joint Patents shall be shared equally by both Parties, and (ii) the costs of obtaining a Patent Term Extension in the PharmaMar Territory shall be borne by PharmaMar.  
10.4Infringement of Patents by Third Parties.  
(a)Notification.  Each Party shall promptly notify the other Party in writing within [***] days (except as expressly set forth below) of becoming aware of any alleged existing or threatened infringement by a Third Party of any of the PharmaMar Patents (including Joint Patents) (“Infringement”), including (x) any such alleged existing or threatened Infringement on account of a Third Party’s manufacture, use or sale of Licensed API or Licensed Product, (y) any certification filed in the United States under 21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) or similar provisions in other jurisdictions in connection with an ANDA (an Abbreviated New Drug Application in the United States or a comparable application for Regulatory Approval under Applicable Law in any country other than the United States) or other NDA for a Licensed Product (a “Patent Certification”), and (z) any declaratory judgment action filed by a Third Party alleging the invalidity, unenforceability or non-infringement of any of the PharmaMar Patents (a “Declaratory Judgment”) ((x)-(z), collectively, “Competitive Infringement”); provided, however, that each Party shall notify the other Party of any Patent Certification regarding any PharmaMar Patent that it receives, and provide the other Party with a copy thereof, within [***] days of receipt.  Each such notification shall include all evidence in such Party’s possession demonstrating such Competitive Infringement.  No later than [***] days following receipt by one Party from the other of a notice of existing or threatened Competitive Infringement, the Parties shall consult with each other regarding any actions to be taken with respect to such Competitive Infringement.
(b)PharmaMar Patents.  
(i)Jazz Territory.  Jazz shall have the first right, but not the obligation, to bring (or defend) and control an appropriate suit or other legal action against any Third Party engaged in any Competitive Infringement of any PharmaMar Patents (including Joint Patents) in the Jazz Territory at Jazz’s own expense and by counsel of its own choice.  If Jazz does not bring a suit or take other reasonable action (“Enforcement Action”) to abate any Competitive Infringement of any PharmaMar Patent in the Jazz Territory, within [***] days of either Party providing a notice of existing or threatened Competitive Infringement under Section 10.4(a), then after consultation with Jazz regarding its rationale for electing not to bring an Enforcement Action and after reasonably considering such rationale, PharmaMar shall have the right, at its own expense, to commence or defend any such Enforcement Action.  
(ii)PharmaMar Territory.  PharmaMar shall have the first right, but not the obligation, to bring (or defend) and control any action or proceeding with respect to Competitive Infringement of a PharmaMar Patent (including Joint Patents) in the PharmaMar Territory, at PharmaMar’s own expense and by counsel of its own choice.  If PharmaMar does 
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not bring an Enforcement Action to abate any Competitive Infringement of any Joint Patent in the PharmaMar Territory or to abate any Declaratory Judgment of a PharmaMar Patent (including Joint Patents) in the PharmaMar Territory, and solely if (A) any Third Party that is a Third Party Partner as of the Effective Date does not exercise any enforcement rights they may have in any country of PharmaMar Territory with respect to any PharmaMar Patent under the terms of the corresponding agreement between PharmaMar and such Third Party Partner (as such terms are in effect as of the Effective Date) within the timelines set forth in such agreement or (B) any Third Party that becomes a Third Party Partner after the Effective Date does not exercise any enforcement rights they may have in its specific licensed country(ies) within the PharmaMar Territory with respect to any PharmaMar Patent under the terms of the corresponding agreement between PharmaMar and such Third Party Partner within the timelines set forth in such agreement, in each case, within [***] days of either Party providing a notice of existing or threatened Competitive Infringement under Section 10.4(a) or within [***] days from PharmaMar notice that any Third Party Partner in any country of PharmaMar Territory has decided not to bring such an Enforcement Action, then after consultation with PharmaMar regarding its rationale for electing not to bring an Enforcement Action and after reasonably considering such rationale, Jazz shall have the right, at its own expense, to commence or defend any such Enforcement Action.  To the extent not inconsistent with the terms of any Third Party Partner agreement existing as of the Effective Date, PharmaMar shall not allow any Third Party Partner to enforce any Joint Patent in the PharmaMar Territory or the Jazz Territory.
(iii)Cooperation.  The Party commencing or defending any Enforcement Action pursuant to this Section 10.4 (the “Enforcing Party”) shall keep the other Party reasonably informed of the progress of any such Enforcement Action, and such other Party shall have the right to join, but not to control, such action with counsel of its own choice, at its own expense.  In any event, the other Party shall reasonably cooperate with the Enforcing Party, including providing information and materials, at the Enforcing Party’s request and expense.  In the event that the Enforcing Party is unable to initiate or prosecute such action solely in its own name or it is otherwise advisable in order to obtain an effective remedy, the other Party will join, but not control, at the Enforcing Party’s request and expense, such action and will execute all documents necessary for the Enforcing Party to initiate litigation and prosecute and maintain such action.  In any case, neither Party shall enter into any settlement or compromise of any action under this Section 10.4 which would in any manner alter, diminish, or be in derogation of the other Party’s rights under this Agreement without the prior written consent of such other Party, which shall not be unreasonably withheld.
(c)Recovery.  Except as otherwise agreed by the Parties in connection with a cost-sharing arrangement, any recovery realized by a Party as a result of any action or proceeding pursuant to this Section 10.4, whether by way of settlement or otherwise, shall be shared in order as follows:
(i)The Enforcing Party shall recoup all of its costs and expenses incurred in connection with such action;
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(ii)If the other Party joined such action at its own expense, then, to the extent possible, the other Party shall recover its costs and expenses incurred in connection with such action; and
(iii)The remainder, if any, shall be [***].
10.5Infringement of Third Party Rights in the Jazz Territory.  
(a)Notice.  If any Licensed Product manufactured, used or sold by either Party, its Affiliates, or their respective licensees becomes the subject of a Third Party’s claim or assertion of infringement of a Patent Right granted by a jurisdiction in either Party’s Territory, the Party first having notice of the claim or assertion shall promptly notify the other Party.  In the event that either Party notifies the other that it, or its Affiliates, or their respective licensees have become the subject of a Third Party’s claim or assertion of infringement of a Patent Right granted in its Territory (any, a “Defensive Action”), the Parties shall agree on and enter into a “common interest agreement” wherein such Parties agree to their shared, mutual interest in the outcome of such potential dispute, and thereafter, the Parties shall promptly meet to consider the claim or assertion and the appropriate course of action; provided that in the event such Third Party also alleges the invalidity, unenforceability or non-infringement of any of the PharmaMar Patents (including Joint Patents), such allegation or claim shall be handled as a Competitive Infringement.
(b)Defense.  The Party subject to such Defensive Action shall have the exclusive right to defend and control the defense of any such Defensive Action using counsel of its own choice, at its expense, provided that the provisions of Section 10.4 shall govern the right of such Party to assert a counterclaim of infringement of any PharmaMar Patent (including any Joint Patent).  In the event that Jazz is the Party against whom such Defensive Action is brought, if the Third Party Patent Rights are used for the manufacture, use or Commercialization of a Licensed Product in the Jazz Territory, then Jazz will be entitled to withhold up to [***] of royalties otherwise payable with respect to Net Sales of such Licensed Product under Section 8.7(d) and use such withheld royalties to reimburse any and all the legal defense costs, attorneys’ fees and liability incurred in such Defensive Action for the period beginning from the date Jazz receives notice of such Defensive Action from the Third Party plaintiff until the date of final non appealable judgment by a court or other body of competent jurisdiction or binding settlement by Jazz of such Defensive Action has been made.  Notwithstanding the foregoing, Jazz agrees to withhold only that portion of such royalties as may reasonably be necessary to reimburse amounts in accordance with this Section 10.5.  If Jazz is required to pay a royalty or other amount for Third Party Patent Rights that are used for the manufacture, use or Commercialization of a Licensed Product in the Jazz Territory, such amounts may be offset as set forth in Section 8.7(d).  The Party in any Defensive Action agrees (i) to keep the other Party reasonably informed of all material developments in connection with any such Defensive Action, (ii) to consult with the other Party regarding the strategy for such Defensive Action and (iii) to [***] input provided by the other Party with respect to the strategy for such Defensive Action.
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(c)Each Party shall not settle any Defensive Action that includes any statement that may be used as an admission of invalidity or unenforceability of the PharmaMar Technology or of the Jazz Technology without prior consent of the other Party.
10.6Patent Oppositions and Other Proceedings.
(a)Third-Party Patent Rights.  If either Party desires to initiate an opposition, action for declaratory judgment, nullity action, interference, declaration for non-infringement, reexamination or other attack upon the validity, title or enforceability of a Patent Right owned or controlled by a Third Party and having one or more claims that covers the Licensed API or the Licensed Product, or the manufacture, use, sale, offer for sale or importation of the Licensed API or the Licensed Product (except insofar as such action is a counterclaim to or defense of, or accompanies a defense of, a Third Party’s claim or assertion of a Competitive Infringement, in which case the provisions of Section 10.4 shall govern), such Party shall so notify the other Party and the Parties shall promptly confer to determine whether to bring such action or the manner in which to settle such action.  If the Parties do not agree otherwise, as between the Parties, (i) PharmaMar shall have the sole right to control such actions at its expense with regard to PharmaMar Prosecuted Patents and (ii) Jazz shall have the sole right to control such actions at its expense with regard to Jazz Prosecuted Patents, and the Party so controlling such action shall keep the other Party reasonably informed with respect thereto.
(b)Parties’ Patent Rights.  If a PharmaMar Prosecuted Patent in the Jazz Territory, or a Joint Generic Patent anywhere in the world, becomes the subject of any proceeding commenced by a Third Party in connection with an opposition, reexamination request, nullity action, interference or other attack upon the validity, title or enforceability thereof (except insofar as such action is brought by the Third Party in an action for Competitive Infringement, in which case the provisions of Section 10.4 shall govern), then PharmaMar shall control such defense at its own cost.  If a Jazz Generic Patent in the Jazz Territory, or a Joint Specific Combination Patent anywhere in the world becomes the subject of any proceeding commenced by a Third Party in connection with an opposition, reexamination request, nullity action, interference or other attack upon the validity, title or enforceability thereof (except insofar as such action is brought by the Third Party in an action for Competitive Infringement, in which case the provisions of Section 10.4 shall govern), then Jazz shall control such defense, at its own cost.  The controlling Party shall permit the non-controlling Party to participate in the proceeding to the extent permissible under Applicable Law, and to be represented by its own counsel in such proceeding, at the non-controlling Party’s expense.  If either Party decides that it does not wish to defend against such action, then the other Party shall have the backup right to assume defense of such Third Party action at its own expense.
10.7Jazz Third Party Agreements.  Jazz shall require (and shall cause its Affiliates to require) that any Third Party working in collaboration hereunder is bound by a written agreement containing provisions relating to ownership of Inventions consistent with the terms of Section 10.1 and obligating such Third Party to assign to Jazz (or such Affiliate) all right, title and interest in and to such Inventions developed by such Third Party as a result of any activities relating to Licensed API or Licensed Product to the extent required for Jazz to comply with the 
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terms of Section 10.1.  Upon PharmaMar ́s written request, Jazz shall provide to PharmaMar with a copy of any written agreements entered into by Jazz (or its Affiliates) within [***] days from PharmaMar ́s request; provided, that Jazz shall have the right to redact confidential information contained in such agreement to the extent disclosure of such terms are not required to verify compliance with the terms of this Agreement.
10.8[***]. If Jazz (or its Affiliates) [***], PharmaMar shall [***].  Jazz hereby [***].  The [***] arising out of such [***] shall not be [***].  [***] shall be entitled to seek any additional remedies available under Applicable Law or under this Agreement.
10.9Trademarks.  
(a)Selection and Display.  
(i)The Parties will consult with each other in good faith regarding the selection or replacement of any product-specific Trademarks for any Licensed Product in the Licensed Indication in the Jazz Territory, and PharmaMar shall have the final approval of all such product-specific Trademarks (collectively, the “Product Trademarks”).  As of the Restatement Effective Date, PharmaMar has decided to use the Trademark ZepzelcaTM set forth on Exhibit G for Licensed Products containing lurbinectedin. For clarity, subject to Section 10.9(e), in addition to the word mark ZepzelcaTM (or any alternative word Product Trademark), PharmaMar shall also decide at its sole discretion to use with respect to the Commercialization of any Licensed Product certain distinctive colors, figurative marks, combined word/figurative marks, symbols, images, logotypes or other marks and the manner of use thereof which shall also be deemed Product Trademarks, provided that the manner of use of such additional marks is consistent with Jazz Standard Trade Dress and Style and are not already in use or otherwise owned by Jazz. Such Trademark shall be the Product Trademark for such Licensed Products unless any Regulatory Authority in the Jazz Territory rejects such name.  PharmaMar shall be responsible for the costs and expenses of all legal and market research for selection and testing of the proposed Product Trademarks in the Jazz Territory.
(b)In the event Regulatory Authorities in the Jazz Territory do not approve the registration or use of the elected Trademark as Product Trademark for any Licensed Product, PharmaMar shall decide at its sole discretion any alternative Product Trademark for the Licensed Product in the Jazz Territory.  PharmaMar shall have final decision-making rights for any such alternative trademark for the Licensed Product (upon prior consultation with Jazz) at the time any alternative Product Trademark is needed in the Jazz Territory. 
(c)PharmaMar will keep Jazz informed of all product-specific Trademarks used by PharmaMar and its Third Party Partners for Licensed Products in the PharmaMar Territory.
(d)Jazz shall use Commercially Reasonable Efforts to display the applicable Product Trademark(s) on all packaging materials, labels and marketing materials for the applicable Licensed Product, provided that the Parties acknowledge and agree that final 
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packaging and label of each Licensed Product is subject to approval by and in compliance with the applicable Regulatory Authority.   
(e)Licensed Product(s) shall be sold in the Jazz Territory under the trade name of Jazz; provided, that Jazz shall use Commercially Reasonable Efforts to include PharmaMar’s name on the packaging materials, labels and marketing materials for Licensed Products.  The Trademarks of Jazz, trade dress, style of packaging, prominence of PharmaMar’s name and the like with respect to a Licensed Product in the Jazz Territory may be determined by Jazz in a manner that is consistent with Jazz’s standard trade dress and style (“Jazz Standard Trade Dress and Style”).  The ownership and all goodwill from use of Jazz Standard Trade Dress and Style shall vest in and inure to the exclusive benefit of Jazz.
(f)Grant of License.  Subject to the terms and conditions of this Agreement, PharmaMar hereby grants to Jazz an exclusive license under Product Trademarks (with the right to sublicense according to Section 2.1(c)), for its use, consistent with the usage guidelines provided by PharmaMar of such Product Trademarks in writing, in the Jazz Territory for the Commercialization of Licensed Product(s) in accordance with this Agreement.  The ownership and all goodwill from the use of the Product Trademarks shall vest in and inure to the exclusive benefit of PharmaMar.
(g)Registration of Trade Marks.  PharmaMar (or its designee) shall file, register and maintain at PharmaMar’s expense and in PharmaMar’s own name (to the extent permitted by Applicable Laws), appropriate registrations for the Product Trademarks in the Jazz Territory.  PharmaMar will keep Jazz regularly informed of the progress and status of such filings and provide Jazz with an opportunity to review and comment on any material draft filings related thereto.  PharmaMar shall [***] provided by Jazz with respect to such draft filings.  
(h)Enforcement.  
(i)If either Party becomes aware of any actual or threatened infringement of any Product Trademark or any registration of a proposed Trademark by a Third Party that is similar to a Product Trademark in the Jazz Territory or the PharmaMar Territory, such Party shall promptly notify the other Party in writing.  PharmaMar shall maintain an application and publication watch on the U.S. federal trademark registry for Product Trademark used on the Licensed Product in the Jazz Territory and shall promptly appraise Jazz of any Third Party filings for similar marks.
(ii)Jazz shall have the first right, at its own expense, to initiate infringement proceedings or take other appropriate actions against an infringement of any Product Trademark in the Jazz Territory or take appropriate actions with respect to the registration of a proposed Trademark by a Third Party that is similar to a Product Trademark in the Jazz Territory and/or to defend any actions or proceedings involving the Product Trademarks in the Jazz Territory, as the case may be.  
(iii)If Jazz does not initiate proceedings or take other appropriate action within [***] days of [***], then PharmaMar shall be entitled, at its own expense, to 
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initiate infringement proceedings or take other appropriate action against an infringement of a Product Trademark in the Jazz Territory, or to take appropriate actions with respect to the application or registration of a proposed Trademark by a Third Party that is similar to a Product Trademark in the Jazz Territory, or to defend any actions or proceedings involving or affecting a Product Trademark in the Jazz Territory, as the case may be.  
(iv)The Party conducting such action shall have full control over the conduct of such action, including settlement thereof; provided, however, that the Party conducting such action may not settle any such action, or make any admissions or assert any position in such action, in a manner that would materially adversely affect the Product Trademarks in the Jazz Territory or the rights or interests of the other Party, without the prior written consent of the other Party, which shall not be unreasonably withheld or delayed.  
(v)In any event, the Parties shall keep one another informed of the status of their respective activities regarding any litigation in the Jazz Territory involving a Product Trademark or settlement thereof and shall assist one another and cooperate in any such litigation at the other’s reasonable request and expense (including joining as a party plaintiff to the extent necessary and requested by the other Party).  
(vi)Jazz and PharmaMar shall recover their respective actual out-of-pocket expenses, or proportionate percentages thereof, associated with any litigation against infringers undertaken pursuant to this Section 10.9(h) or settlement thereof from any resulting recovery made by either Party.  Any excess amount of such recovery shall be split [***].
11.Confidentiality 
11.1Confidential Information.  Except to the extent expressly authorized by this Agreement, each Party agrees that, during the Term, and for [***] years thereafter, such Party (the “Receiving Party”) shall keep confidential, and shall not publish or otherwise disclose and shall not use for any purpose other than as expressly provided for in this Agreement, any Information furnished to it by the other Party (the “Disclosing Party”) pursuant to this Agreement or the Confidentiality Agreement (collectively, “Confidential Information”).  The Receiving Party may use Confidential Information only to the extent required to accomplish the purposes of this Agreement.  The Receiving Party shall use at least the same standard of care as it uses to protect proprietary or confidential information of its own (but in no event less than reasonable care) to ensure that its, and its Affiliates’, employees, agents, consultants and other representatives (“Representatives”) do not disclose or make any unauthorized use of the Confidential Information.  The Receiving Party shall promptly notify the Disclosing Party upon discovery of any unauthorized use or unauthorized disclosure of the Disclosing Party’s Confidential Information. 
11.2Exceptions.  Confidential Information shall not include any information which the Receiving Party can prove by competent evidence: (a) is now, or hereafter becomes, through no act or failure to act on the part of the Receiving Party in violation of this Article 11, generally known or available; (b) is known by the Receiving Party or any of its Affiliates at the time of receiving such information, as evidenced by its records; (c) is hereafter furnished to the 
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Receiving Party or any of its Affiliates by a Third Party, as a matter of right and without restriction on disclosure; or (d) is independently discovered or developed by the Receiving Party or any of its Affiliates, independently of the activities undertaken by the Receiving Party pursuant to this Agreement and without the use or knowledge of Confidential Information of the Disclosing Party.
11.3Authorized Disclosure.  Notwithstanding the provisions of Section 11.1, the Receiving Party may disclose Confidential Information of the Disclosing Party, including the terms of this Agreement, as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
(a)filing or prosecuting Patent Rights as permitted by this Agreement; 
(b)enforcing such Party’s rights under this Agreement and in performing its obligations under this Agreement;
(c)prosecuting or defending litigation as permitted by this Agreement, subject to the final paragraph of this Section 11.3;
(d)complying with applicable court orders, Applicable Laws, rules or regulations, subject to the final paragraph of this Section 11.3;
(e)as determined in the Receiving Party’s reasonable discretion, the listing rules of any exchange on which the Receiving Party’s securities are traded;
(f)disclosure in Regulatory Filings that the Receiving Party has the right to make under this Agreement; 
(g)disclosure to the Receiving Party’s Affiliates, to actual or potential Sublicensees and Third Party Partners, and to the Receiving Party’s and its Affiliates’ and Third Party Partners Representatives who, in each case, have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, that any such Affiliate, actual or potential Sublicensee, Third Party Partner or Representative agrees [***]; and 
(h)disclosure to Third Parties, including potential Third Party Partners, in connection with due diligence or similar investigations by such Third Parties, and disclosures to potential Third Party investors in confidential financing documents, provided, in each case, that [***].  
Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 11.3(c) or 11.3(d), it will, except where impracticable, (i) give reasonable advance notice to the Disclosing Party of such disclosure, (ii) use efforts to secure confidential treatment of such information at least as diligent as the Receiving Party would use to protect its own confidential information, but in no event less than reasonable efforts, and (iii) cooperate with any efforts by the Disclosing 
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Party, at the Disclosing Party’s request and expense, to secure confidential treatment of such Confidential Information.  Disclosure by the Receiving Party of Confidential Information in accordance with any of the foregoing provisions of this Section 11.3 shall not, in and of itself, cause the information so disclosed to cease to be treated as Confidential Information under this Agreement, except to the extent that, by virtue of disclosure by the Receiving Party in full compliance with this Section 11.3, such information becomes generally known or available.
11.4Publications.  Each Party and its Affiliates shall be free to publish, and to authorize Sublicensees and Third Party Partners to publish, the protocol or results of any preclinical study or clinical trial of a Licensed Product conducted by or on behalf of such Party or its Affiliate or Sublicensee, provided that solely with regard to (i) manuscripts, abstracts or other publications of PharmaMar (or its Third Party Partners) regarding Atlantis Trial, SCLC Post-Approval Commitment Studies conducted by PharmaMar and any other Clinical Trial conducted by PharmaMar or on its behalf in the Jazz Territory, or regarding Clinical Trials sponsored by PharmaMar or its Third Party Partners involving the Licensed Product conducted within [***] and (ii) any manuscripts, abstracts or other publications of Jazz (or its Sublicensees) regarding any Development activities conducted by Jazz or on its behalf in Jazz Territory, SCLC Post-Approval Commitment Studies conducted by Jazz and any other Development activity conducted by Jazz in the PharmaMar Territory, the other Party has a reasonable opportunity not less [***] days for abstracts, posters or other presentation materials and [***] days for all other publications prior to the date of publication to review the proposed publication and provide comments; provided, that, with respect to publications by Third Parties that are Third Party Partners as of the Effective Date, PharmaMar shall only have an obligation to provide drafts for review and comment in accordance with this Section 11.4 to the extent such Third Party Partner is obligated to provide PharmaMar with such drafts and Jazz’s timeline to review and comment shall be consistent with the timelines set forth in the applicable Third Party Partner agreement.  If such comments involve a redaction of Confidential Information of such reviewing Party, the publishing Party shall [***].  If such comments involve the identification of patentable material in such proposed publication, the publishing Party shall delay publication for up to [***] days until the appropriate Party seeks patent protection for such information.  Any such publication shall acknowledge, as appropriate, the contribution of the other Party, its employees, agents and representatives, or if appropriate. 
11.5Public Announcements.  
(a)Press Releases.  The Parties shall make a joint public announcement of the execution of this Agreement in the form attached as Exhibit H, which shall be issued at a mutually agreed time after the Restatement Effective Date. After release of such press release, neither Party may issue any further press releases without the prior review and approval of the other Party.  Notwithstanding the foregoing, each Party shall be free to issue such press releases without the prior review or approval of the other Party, that such Party determines are reasonably necessary to comply with Applicable Laws, including disclosure requirements of the U.S. Securities and Exchange Commission or to Spanish Securities Commission (CNMV-Comisión Nacional del Mercado de Valores), or with the requirements of any stock exchange on which securities issued by such Party is traded.  In addition, each Party may make public statements 
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regarding this Agreement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst calls, so long as the contents of any such public statement or press release do not reveal nonpublic information about the other Party or the terms of the Agreement.   
(b)Filing of this Agreement.  The Parties shall coordinate in advance with each other in connection with the filing of this Agreement (including redaction of certain provisions of this Agreement) with any securities authority or with any stock exchange on which securities issued by a Party or its Affiliate are traded, and each Party will use reasonable efforts to seek and obtain confidential treatment for the terms proposed to be redacted; provided that each Party will ultimately retain control over what terms are disclosed to any securities authority or stock exchange, as the case may be, to the extent such Party determines, on the advice of legal counsel, that disclosure is reasonably necessary to comply with Applicable Laws, including disclosure requirements of the U.S.  Securities and Exchange Commission or foreign counterpart, or with the requirements of any stock exchange on which securities issued by a Party or its Affiliates are traded, and provided further that the Parties will use their reasonable efforts to file redacted versions with any governing bodies which are consistent with redacted versions previously filed with any other governing bodies.
11.6Inside Information.  
(a)The Parties agree that certain Confidential Information disclosed by one Party to the other Party under this Agreement may qualify as inside information of such disclosing Party under Article 226 of the Restated Text of the Spanish Securities Market Law, Article 7 of Regulation (EU) 596/2014 of the European Parliament and of the Council dated April 16th 2014 on market abuse (“Regulation UE 596/2014”), or other applicable insider dealing, market abuse or similar law and/or equivalent securities market regulations in the Jazz Territory (such laws, “Inside Information Regulations” and such information, “Inside Information”).  To the extent required to comply with Inside Information Regulations, each Party agrees that it shall, unless it receives the prior written consent of the other Party: 
(i)not make any use whatsoever at any time of any Inside Information of the other Party except as for the purposes set forth in this Agreement;
(ii)disclose the Inside Information of the other Party only to those persons within its organization which need to access to the Information for the purposes set forth in this Agreement;
(iii)preserve the confidentiality of the Inside Information of the other Party, and take all necessary and reasonable precautions to prevent such information from being accessible to any Third Party;
(iv)comply with any and all obligations and prohibitions set forth in the aforementioned Regulation UE 596/2014 and the supplementary Regulations which develop it and in any other equivalent regulations in the Jazz Territory;
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(v)not engage or attempt to engage in insider dealing as provided under Regulation UE 596/2014 or under any other equivalent regulations in the Jazz Territory; 
(vi)not recommend that another person or entity engage in insider dealing or induce another person or entity to engage in insider dealing as provided under Regulation UE 596/2014 or under any other equivalent regulations in the Jazz Territory; and
(vii)promptly notify the other Party upon becoming aware of evidence or suspicion of any unauthorized use or disclosure of the Inside Information of the other Party.
(b)In case that any Inside Information of a Party is disclosed to the other Party under this Agreement, such disclosing Party shall specify with particularity which information disclosed is classified as Inside Information and such receiving Party shall appoint a person within its organization responsible for such Insider Information and shall provide all required information about such person to the other Party (“Contact Person”).  Each Party acknowledges that its company and its Contact Person will be included in an insider list under Article 18.1 of Regulation (UE) 596/2014 (or under equivalent regulations in the Jazz Territory) as soon as Inside Information is disclosed to such Party.  Each Party acknowledges the legal and regulatory duties entailed and declare they are aware of the sanctions applicable to insider dealing and unlawful disclosure of Inside Information. 
(c)Each Party shall keep a list of all the persons to whom Inside Information of the other Party is disclosed with the content and form that requires Regulation (EU) 596/2014 (or equivalent Applicable Laws in the Jazz Territory) and to make such list available to the other Party upon request.  Each Party shall take all reasonable steps to ensure that any person included in an insider list acknowledges in writing the legal and regulatory duties entailed as reflected in this Section 11.6 and is aware of the sanctions applicable to insider dealing and unlawful disclosure of inside information.
(d)The obligations, duties and prohibitions listed in this Section 11.6 with regard to each piece of Inside Information shall remain in force as long as the Inside Information continues to be qualified as inside information under Article 7 of Regulation (EU) 596/2014 (or under equivalent regulations in the Jazz Territory). 
(e)Notwithstanding anything to the contrary in this Section 11.6, each Party shall be permitted to make any disclosure required by Applicable Law (including pursuant to regulations of any securities authority or stock exchange) and such disclosure shall not constitute a breach of this Section 11.6.
12.Representations and Warranties 
12.1Mutual Representations and Warranties.  Each Party represents and warrants to the other that, as of the Restatement Effective Date: (a) it is duly organized and validly existing under the laws of its jurisdiction of incorporation or formation, and has full corporate or other power and authority to enter into this Agreement and to carry out the provisions hereof; (b) it is duly authorized to execute and deliver this Agreement and to perform its obligations 
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hereunder, and the person or persons executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate or partnership action; and (c) this Agreement is legally binding upon it, enforceable in accordance with its terms, and does not conflict with any agreement, instrument or understanding, oral or written, to which it is a Party or by which it may be bound, nor violate any material law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.  
12.2PharmaMar Representations and Warranties.  Except as disclosed to Jazz in writing as of the Restatement Effective Date, PharmaMar represents and warrants to Jazz that as of the Restatement Effective Date: 
(a)Exhibit B attached hereto contains a true and complete list of the PharmaMar Patents existing as of the Restatement Effective Date in the Jazz Territory;
(b)The PharmaMar Patents include all of the Patent Rights owned by or licensed to PharmaMar or its Affiliates that claim or disclose Licensed API or Licensed Product, or the manufacture, use, sale, offer for sale or import of Licensed API or Licensed Product; 
(c)PharmaMar (i) has the right to grant the Jazz License; and (ii) except as provided for the EAP Agreement, has not granted to any Third Party any license or other right with respect to Licensed API, Licensed Product or PharmaMar Technology that conflicts with the Jazz License and other rights granted to Jazz herein; 
(d)There are no agreements in effect as of the Restatement Effective Date between PharmaMar and a Third Party under which rights with respect to the PharmaMar Technology are licensed to PharmaMar; 
(e)No Information [***] is necessary for the manufacture, use, sale, offer for sale or importation of any Licensed API or Licensed Product or is otherwise used by PharmaMar, its Affiliates or Third Party Partners in the manufacture, use, sale, offer for sale or import of any Licensed API or Licensed Product as of the Restatement Effective Date; 
(f)PharmaMar is the sole and exclusive owner of all right, title and interest in and to the PharmaMar Patents;
(g)to PharmaMar ́s Best Knowledge, the issued and unexpired claims included in the PharmaMar Patents existing as of the Restatement Effective Date are valid and enforceable;
(h)to PharmaMar ́s Best Knowledge, no reexamination, interference, invalidity, opposition, nullity or similar claim or proceeding is pending or threatened with respect to any PharmaMar Patent;  
(i)to PharmaMar ́s Best Knowledge the manufacture, use, sale, offer for sale or import of Licensed API or Licensed Product does not infringe and would not infringe the patent or other intellectual property rights of any Third Party;
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(j)PharmaMar has not received any written notice from any Third Party alleging that the manufacture, use, sale, offer for sale or import of Licensed API or Licensed Product does infringe or would infringe the patent or other intellectual property rights of any Third Party; 
(k)there are no judgments or settlements against or owed by PharmaMar (or any of its Affiliates) with respect to the PharmaMar Technology, and PharmaMar is not a Party to any legal action, suit or proceeding relating to the PharmaMar Technology, nor has PharmaMar received any written communication from any Third Party, including, without limitation, any Regulatory Authority or other government agency, threatening such action, suit or proceeding;
(l)PharmaMar has made available to Jazz a list with all material data and Information regarding the Licensed Product currently available to PharmaMar and has provided Jazz with copies of any data or Information requested by Jazz during its due diligence process.  Such list was and is complete and accurate and all tangible or recorded information and data provided by or on behalf of PharmaMar to Jazz related to Licensed API or Licensed Product on or before the Restatement Effective Date in contemplation of this Agreement was and is true, accurate and complete in all material respects, and PharmaMar has not failed (i) to include in such due diligence list any such information or data related to Licensed API or Licensed Product in its possession and Control that would cause the information and data that has been disclosed to be misleading in any material respect or (ii) to disclose, or failed to cause to be disclosed, any information or data requested by Jazz; 
(m)Except with regard to Licensed Product Data obtained from ISS, with respect to patient records and with respect to publication rights under Clinical Trial agreements sponsored by PharmaMar, and with regard to Licensed Product Data obtained from those agreements for the conduct of preclinical and research activities under which no Patent Rights have been obtained as of the Restatement Effective Date, PharmaMar has the right to license pursuant to this Agreement all Licensed Product Data currently in existence and will solely own all Licensed Product Data arising from the Atlantis Trial, provided, that for the purposes of this Section 12.2(m) the definition of “Licensed Product Data” shall be deemed to not be limited to results and data that are Controlled by PharmaMar or its Affiliates;
(n)To PharmaMar ́s Best Knowledge, [***] in its manufacture of Bulk Vials pursuant to the [***], and PharmaMar has the right to transfer and license, to Jazz or its designee in accordance with the terms of this Agreement, the manufacturing process currently being used by [***] to manufacture Bulk Vials; 
(o)Except for Licensed API and Licensed Products, PharmaMar and its Affiliates are not developing any compound or product for second line treatment SCLC;  
(p)All research, manufacture and development of Licensed API and Licensed Products on or before the Restatement Effective Date was conducted in compliance with Applicable Laws;
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(q)Exhibit I sets forth a complete and accurate list of all Regulatory Filings for Licensed API or Licensed Product in the Jazz Territory filed by PharmaMar or any of its Affiliates or Third Party Partners; 
(r)neither PharmaMar nor any of its Affiliates is debarred under the Act or comparable Applicable Laws outside of the United States; 
(s)neither PharmaMar nor any of its Affiliates has employed or otherwise used in any capacity, in connection with the development or manufacture of Licensed API or Licensed Product, the services of any person debarred or disqualified under United States law, including 21 U.S.C. §335a, or any foreign equivalent thereof; 
(t)Except as for the EAP Agreement, Pharma Mar has not entered into any contract or agreement with any Third Party (including any funding agreement) pursuant to which a Third Party obtained any present or contingent right to commercialize Licensed API or Licensed Product in the Jazz Territory or pursuant to which there are contractual limitations or restrictions on Jazz’s right or ability to develop or commercialize Licensed API or Licensed Product in the Jazz Territory; and
(u)Except as for ISS and for those agreements for the conduction of preclinical and research activities under which no Patent Rights have been obtained as of the Restatement Effective Date, Pharma Mar has not entered into any contract or agreement with any Third Party (including any funding agreement) pursuant to which a Third Party generated any Information or Patent Rights pertaining to Licensed API or Licensed Products that PharmaMar does not have the right to exclusively license to Jazz pursuant the Jazz License or to otherwise develop or commercialize Licensed API or Licensed Product in the Jazz Territory.  
12.3Jazz Representations and Warranties.  Jazz represents and warrants to PharmaMar that as of the Restatement Effective Date:
(a)neither Jazz nor any of its Affiliates is debarred under the Act or comparable Applicable Laws outside of the United States; and
(b)to Jazz’s Best Knowledge, neither Jazz nor any of its Affiliates Controls any Patent Right that claims the Licensed API or the Licensed Product in the form existing on the Restatement Effective Date or the method of manufacturing the Licensed API or Licensed Product used as of the Restatement Effective Date.
12.4PharmaMar Covenants.  In addition to any covenants made by PharmaMar elsewhere in this Agreement, PharmaMar hereby covenants to Jazz during the Term, PharmaMar will not grant any Third Party any license or other right with respect to Licensed API, Licensed Product or PharmaMar Technology in derogation of the Jazz License or the rights granted to Jazz hereunder, except in connection with (i) any ISS supported by PharmaMar, its Affiliates or Third Party Partners pursuant to agreements in effect prior to the Effective Date or (ii) any ISS supported by PharmaMar, its Affiliates or Third Party Partners after the Effective Date in PharmaMar Territory, provided that in each case of (i) and (ii), such derogation is limited to the 
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grant by PharmaMar of a license to conduct the Clinical Trial of the Licensed Product that is the subject of such ISS.
12.5Mutual Covenants.  In addition to any covenants made by it elsewhere in this Agreement, each Party hereby covenants to the other Party that:
(a)neither such Party nor any of its Affiliates will employ or use the services of any Person who is debarred or disqualified under United States law, including 21 U.S.C.  §335a, or any foreign equivalent thereof, in connection with activities relating to Licensed API or Licensed Product; and in the event that such Party becomes aware of the debarment or disqualification or threatened debarment or threatened disqualification of any Person providing services to such Party or any of its Affiliates with respect to any activities relating to Licensed API or Licensed Product, such Party will immediately notify the other Party in writing and such Party will cease, or cause its Affiliate to cease (as applicable), employing, contracting with, or retaining any such Person to perform any services relating to Licensed API or Licensed Product; 
(b)neither such Party nor any of its Affiliates will, in connection with the exercise of such Party’s rights or performance of its obligations under this Agreement, directly or indirectly through Third Parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to a public official or entity or other Person for purpose of obtaining or retaining business for or with, or directing business to, any Person, including such Party and its Affiliates, nor will such Party or any of its Affiliates directly or indirectly promise, offer or provide any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a public official or entity or any other Person in connection with the exercise of such Party’s rights or performance of such Party’s obligations under this Agreement; 
(c)neither such Party nor any of its Affiliates (or any of their respective employees and contractors), in connection with the exercise of such Party’s rights or performance of such Party’s obligations under this Agreement, shall cause the other Party to be in violation of Anti-Corruption Laws or Export Control Laws; and
(d)such Party shall immediately notify the other Party if such Party has any information or suspicion that there may be a violation of Anti-Corruption Laws or Export Control Laws in connection with the exercise of such Party’s rights or performance of such Party’s obligations under this Agreement.
12.6Performance by Affiliates and Contractors.  The Parties recognize that each Party may perform some or all of its obligations or exercise some or all of its rights under this Agreement through one or more Affiliates, or Third Party contractors; provided, in each case, that (a) none of the other Party’s rights hereunder are diminished or otherwise adversely affected as a result of such delegation or contracting, and (b) each such Affiliate and Third Party contractor undertakes in writing obligations of confidentiality and non-use regarding Confidential Information and ownership of Inventions which are substantially the same as those undertaken by the Parties pursuant to Article 11 and Section 10.1; and provided, further, that 
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such Party shall at all times be fully responsible for the performance and payment of such Affiliate or Third Party Contractor.
12.7Disclaimer.  Except as expressly set forth in this Agreement, EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF PATENTS, NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES.  
13Term; Termination
13.1Term.  This Agreement shall commence on the Restatement Effective Date and, unless earlier terminated pursuant to this Article 13, shall remain in effect on a Licensed Product-by-Licensed Product and country-by-country basis, until the expiration of the Royalty Term of such Licensed Product in such country (the “Term”).  This Agreement has been executed by the Parties as of the Restatement Effective Date, with the Parties’ mutual intent that on the Restatement Effective Date, the Original License Agreement shall be amended and restated in its entirety as set forth in, and thereupon superseded by this Agreement. For clarity, the terms and conditions of the Original License Agreement apply to the period between the Effective Date and the Restatement Effective Date.  Upon the expiration of the Royalty Term for a Licensed Product in a given country, the Jazz License with respect to such Licensed Product in such country shall become royalty-free, fully-paid, irrevocable and perpetual; provided, that Jazz shall only have the right to practice the license to the Product Trademarks pursuant to the Trademark License Agreement post expiration of this Agreement in accordance with the terms of Section 13.5(b).  
13.2Unilateral Termination by Jazz.  Jazz may terminate this Agreement on a country-by-country basis, in each case for any or no reason (a) in Jazz Canada Territory prior to the achievement of Regulatory Milestone no. 4 pursuant to Section 8.4, upon [***] months written notice to PharmaMar and (b) (i) in the Jazz Canada Territory after achievement of Regulatory Milestone no. 4 pursuant to Section 8.4 and (ii) in the Jazz U.S. Territory any time after the Restatement Effective Date, in each case of (i) and (ii), upon the earlier of (A) completion of any agreed upon transfer of Jazz Technology or Regulatory Filings to PharmaMar pursuant to Section 13.5(c)(i) or (B) [***] after Jazz’s written notice to PharmaMar; provided, however (x) that Jazz shall not be entitled to exercise unilateral termination right hereunder that would result in a termination effective date (1) during [***] from Effective Date of the Original License Agreement with regard to Jazz U.S. Territory or (2) during the [***] from the Restated Effective Date with regard to Jazz Canada Territory and (y) that Jazz shall not be entitled to exercise unilateral termination right hereunder solely for Jazz U.S. Territory; if Jazz decides to 
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terminate the Agreement pursuant to this Section 13.2 with respect to the Jazz U.S. Territory, the Agreement shall be terminated for the Jazz Territory in its entirety. 
13.3Termination for Material Breach.  
(a)Breach.  Subject to Section 13.3(b), each Party shall have the right to terminate this Agreement solely with respect to the country to which such uncured material breach relates upon written notice to the other Party, if such other Party materially breaches its obligations under this Agreement and, after receiving written notice from the non-breaching Party identifying such material breach in reasonable detail, fails to cure such material breach within [***] days from the date of such notice; provided, that if such breach is not reasonably capable of cure within such [***]-day period, the breaching Party may submit a reasonable cure plan prior to the end of such [***]-day period, in which case the other Party shall not have the right to terminate this Agreement for so long as the breaching Party is using diligent efforts to implement such cure plan.  For clarity, if an uncured material breach pertains to an obligation under this Agreement that was not included in the Original License Agreement, then the non-breaching Party’s termination rights pursuant to this Section 13.3(a) for such breach shall be limited to termination of this Agreement with respect to the Jazz Canada Territory. 
(b)Disputed Breach.  If the alleged breaching Party disputes in good faith the existence or materiality of a breach specified in a notice provided by the other Party in accordance with Section 13.3(a), and such alleged breaching Party provides the other Party notice of such dispute within such [***] day period, then the non-breaching Party shall not have the right to terminate this Agreement under Section 13.3(a) unless and until the arbitrators, in accordance with Article 15.2, has determined that the alleged breaching Party has materially breached the Agreement and that such Party fails to cure such breach within [***] days following such arbitrators’ decision.  It is understood and agreed that during the pendency of such dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder.
13.4Termination for Bankruptcy.  Either Party may terminate this Agreement in its entirety upon written notice to the other Party in the event that (a) a case is commenced by or against such other Party under applicable bankruptcy, insolvency or similar laws, which case, if commenced against (not by) such other Party, is not dismissed within [***] days of the commencement thereof, (b) such other Party files for bankruptcy, reorganization, liquidation, receivership or similar proceedings, (c) such other Party assigns all or a substantial portion of its assets for the benefit of creditors, (d) a receiver or custodian is appointed for such other Party’s business, (e) a substantial portion of such other Party’s business is subject to attachment or similar process or (f) anything analogous to any of the events described in the foregoing clauses (a) through (f) occurs under the laws of any applicable jurisdiction.
13.5Effect of Expiration or Termination.  
(a)General.  Upon any termination (but not expiration) of this Agreement in its entirety, all licenses granted to Jazz and PharmaMar under this Agreement shall terminate. Upon any termination (but not expiration) of this Agreement with respect to one country within 
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the Jazz Territory but not in its entirety, then such Terminated Territory shall, as of the effective date of such termination, be excluded from the Jazz Territory. 
(b)Continued Use of Product Trademarks on Expiration.  Upon expiration (but not earlier termination) of this Agreement with respect to either the Jazz U.S. Territory, the Jazz Canada Territory or the Jazz Territory in its entirety (“Expired Territory”), Jazz shall have the continued right to Commercialize Licensed Product in such Expired Territory under the Product Trademarks in accordance with the license granted under this Agreement as long as either (i) the Parties execute an agreement pursuant to which Jazz is obligated to pay PharmaMar a running royalty of [***] of all Net Sales of Licensed Product sold by Jazz and its Affiliates and Sublicensees in the Expired Territory after expiration of the Agreement for the continued right to use the Product Trademarks or (ii) the Parties are parties to a commercial supply agreement pursuant to which PharmaMar is the [***] supplier of Licensed Product for Jazz in the Expired Territory.  Upon the written request of Jazz, PharmaMar shall negotiate in good faith and execute any such agreement on commercially reasonable terms and conditions.  
(c)Termination by PharmaMar Pursuant to Section 13.3 or Section 13.4 or by Jazz Pursuant to Section 13.2.  In the event of termination of this Agreement by PharmaMar pursuant to Section 13.3 or Section 13.4, or by Jazz pursuant to Section 13.2, the following provisions shall apply: 
(i)Regulatory Materials.  Subject to Section 13.5(c)(iii), to the extent permitted by Applicable Laws, Jazz shall promptly but no later than [***] days from termination date, transfer and assign to PharmaMar all Regulatory Filings and Regulatory Approvals for the Licensed Product in the Terminated Territory and, if this Agreement is terminated in its entirety, PharmaMar Territory at Jazz ́s sole cost; in addition, Jazz shall promptly provide to PharmaMar a copy of all Regulatory Filings, Regulatory Approvals and other regulatory materials related to the Licensed Product in the Terminated Territory to the extent not previously provided to PharmaMar;
(ii)Jazz License.  Jazz hereby grants to PharmaMar, effective only in event of such termination, a perpetual non-exclusive, fully paid-up and royalty-free license (except as set forth in Section 13.5(c)(iii)), with the right to grant and authorize sublicenses (subject to Section 2.8), under Jazz Technology which as of the effective date of termination is necessary for, or is being used by Jazz or its Affiliates or Sublicensees or by PharmaMar, its Affiliates and Third Party Partners in, the development, manufacture or commercialization of any Licensed Product (as defined below), to develop, make, have made, use, sell, offer for sale, have sold, import and otherwise exploit the Licensed API and the Licensed Products in the Terminated Territory and, if this Agreement is terminated in its entirety, the PharmaMar Territory;
(iii)Royalty Obligation.  Solely in the event of termination of this Agreement by Jazz pursuant to Section 13.2 and solely with regard to Jazz U.S. Territory (unless in [***]), the rights granted to PharmaMar pursuant to this Section 13.5(c) shall be subject to the Parties agreeing in good faith within [***] days of the effective date of termination on common and customary non-financial conditions for the grant of such rights, provided, that the financial 
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compensation shall be set at a royalty of [***] of Net Sales (applied mutatis mutandis to sales by PharmaMar, its Affiliates and (sub)licensees) of Licensed Product sold by PharmaMar, its Affiliates and (sub)licensees in the Terminated Territory. For clarity, this Section 13.6.(c)(iii) shall not apply to Jazz Canada Territory in case of termination of this Agreement by Jazz pursuant to Section 13.2 and no financial compensation shall be paid by PharmaMar hereunder with regard to Jazz Canada Territory; 
(iv)Transition Assistance.  Jazz shall provide at no cost to PharmaMar (subject to Section 13.5(c)(iii)) such assistance as may be reasonably necessary to transfer or transition over a reasonable period of time to PharmaMar, all then-existing commercial contractual arrangements, that is, or are, necessary or reasonably useful for PharmaMar to commence or continue developing, manufacturing or commercializing the Licensed Products in the Terminated Territory, to the extent Jazz is then performing or having performed such activities, including without limitation transferring, upon request of PharmaMar, any agreements or arrangements with Third Party suppliers or vendors to Develop, manufacture, supply, distribute or sell or otherwise commercialize the Licensed Product in the Terminated Territory.  To the extent that any contract between Jazz and a Third Party is not assignable to PharmaMar, then Jazz shall reasonably cooperate with PharmaMar to arrange the provision of such services for a reasonable time and service fee after termination;  
(v)Remaining Inventories.  In the event this Agreement is terminated in its entirety, PharmaMar shall have the right to purchase from Jazz any and all of the inventory of Licensed API or Licensed Products held by Jazz as of the effective date of such termination at a price equal to Jazz’s actual cost to acquire or manufacture such inventory.  Promptly after the effective date of such termination, Jazz shall submit to PharmaMar a list of its remaining inventory of Licensed API and Licensed Products and its acquisition cost.  PharmaMar shall notify Jazz whether PharmaMar elects to exercise such right within [***] days after receiving notice from Jazz reporting such inventory as of the effective date of such termination.  If PharmaMar does not exercise such right, Jazz shall not have the right to sell any remaining inventory in the Jazz Territory and Jazz shall destroy immediately such remaining inventory at its sole expense, providing PharmaMar with a certificate of destruction of such inventory; and 
(vi)In the event of termination of this Agreement by PharmaMar pursuant to Section 13.3 or Section 13.4, PharmaMar shall have all rights at law or in equity to pursue damages against Jazz for any uncured material breach.
(d)Termination by Jazz Pursuant to Section 13.3 or Section 13.4. In the event of termination of this Agreement by Jazz pursuant to Section 13.3 or Section 13.4 the following provisions shall apply: 
(i)Jazz shall have all rights at law or in equity to pursue damages against PharmaMar for any uncured material breach.  
(ii)effective as of such termination, Jazz shall, and it hereby does, grant to PharmaMar, a right of first negotiation, exercisable within [***] days after expiration, 
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upon commercially reasonable terms and conditions (including payments to Jazz) to be negotiated in good faith by the Parties for up to [***] days from the date of exercise:  
(1)to obtain an exclusive, royalty-bearing license, with the right to sublicense through multiple tiers of sublicense, under Jazz Technology which as of the effective date of termination is necessary for, or used by Jazz in, the development, manufacture or commercialization of any Termination Licensed Product (as defined below), solely to Develop, manufacture, have manufactured and Commercialize in the Terminated Territory Licensed Products that are being Developed, manufactured or Commercialized as of the effective date of termination (the “Termination Licensed Products”), and to have all such Jazz Technology transferred to PharmaMar; and  
(2)to have transferred or assigned to PharmaMar or its designee all Regulatory Filings for Licensed Products in the Licensed Indication in the Terminated Territory held in the name of Jazz or any of its Affiliates.  
(iii)In the event this Agreement is terminated in its entirety, PharmaMar shall have the right, but not the obligation, to purchase from Jazz any or all usable inventory of Licensed API and Licensed Product in Jazz’s or its Affiliates’ possession as of the date of expiration.  Such inventory shall be provided at a transfer price equal to Jazz’s cost of such inventory (as reflected on Jazz’s books and records used to prepare its financial statements), plus freight, insurance, transportation, postage and handling.  If PharmaMar elects not to purchase such inventory, Jazz shall have the right to sell in the Jazz Territory such remaining inventory over a period of no greater than [***] months after the effective date of such termination, provided that Jazz shall continue to make royalty payments on such sales in accordance with Section 8.7.
13.6Remedies in Lieu of Termination.  If Jazz would otherwise have the right to terminate this Agreement pursuant to Section 13.3, then Jazz may elect, by written notice to PharmaMar, not to terminate this Agreement on the basis of such material breach and to have no further financial obligations under this Agreement (including under Section 8.2, Section 8.4, Section 8.5, Section 8.6 and Section 8.7) solely with regard to the Terminated Territory.
13.7Accrued Obligations; Survival.  Upon any termination or expiration of this Agreement in its entirety, all rights and obligations of the Parties under this Agreement shall terminate, except as expressly provided in this Section 13.7 or elsewhere in this Article 13.  Upon any termination or expiration of this Agreement in a Terminated Territory or Expired Territory, as applicable, all rights and obligations of the Parties under this Agreement with regard to such Termination Territory or Expired Territory, as applicable, shall terminate, except as expressly provided in this Section 13.7 or elsewhere in this Article 13. Neither expiration nor any termination of this Agreement shall relieve either Party of any obligation or liability accruing prior to such expiration or termination, nor shall expiration or any termination of this Agreement preclude either Party from pursuing all rights and remedies it may have under this Agreement, at law or in equity, with respect to breach of this Agreement.  In addition, upon any termination of this Agreement or expiration of this Agreement, the Parties’ rights and obligations under Sections 9.4, 9.5, 10.1, 12.7, 13.1, 13.5, 13.7, 13.8, 13.9, 14.1, 14.2, 14.3,14.4  and Articles 1 (to 
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the extent used in any surviving provisions), 11 (other than Section 11.4 and Section 11.5), 15 and 16 of this Agreement shall survive expiration or any termination of this Agreement. 
13.8Return of Confidential Information.  Within [***] days following the expiration or termination of this Agreement in its entirety, except to the extent that a Party retains a license from the other Party as provided in this Article 13, each Party shall promptly return to the other Party, or delete or destroy, all relevant records and materials in such Party’s possession or control containing Confidential Information of the other Party; provided that such Party may keep one copy of such materials for archival purposes only subject to Article 11.
13.9Damages; Relief.  Termination of this Agreement shall not preclude either Party from claiming any other damages, compensation or relief that it may be entitled to hereunder as a result of the other Party’s breach of this Agreement.  
14.Indemnification
14.1Indemnification by Jazz.  Jazz hereby agrees to defend, indemnify and hold harmless PharmaMar, its Affiliates, its and their respective officers, directors, agents, employees, successors and assigns (the “PharmaMar Indemnitees”), from and against any and all losses, damages, liabilities, expenses and costs, including reasonable legal expense and attorneys’ fees (collectively, “Losses”), to which any PharmaMar Indemnitee may become subject as a result of any claim, demand, action or other proceeding by any Third Party (each, a “Claim”) to the extent such Losses arise out of or relate to: (a) the Development, manufacture, use, handling, storage, import or Commercialization of Licensed API or Licensed Products by or on behalf of Jazz, its Affiliates or Sublicensees (including during the Term of the Original License Agreement); (b) the negligence or willful misconduct of any Jazz Indemnitee; or (c) the breach by Jazz of any warranty, representation, covenant or agreement made by Jazz in this Agreement; except, in each case, to the extent such Losses result from the negligence or willful misconduct of any PharmaMar Indemnitee or the breach by PharmaMar of any warranty, representation, covenant or agreement made by PharmaMar in this Agreement.   
14.2Indemnification by PharmaMar.  PharmaMar hereby agrees to defend, indemnify and hold harmless Jazz, its Affiliates and their respective officers, directors, employees, consultants and agents (the “Jazz Indemnitees”) from and against any and all Losses to which any Jazz Indemnitee may become subject as a result of any Claim to the extent such Losses arise out of or relate to: (a) the development, manufacture, use, handling, storage, import or Commercialization of Licensed API or Licensed Products by or on behalf of PharmaMar, its Affiliates or licensees in the Jazz Territory or PharmaMar Territory prior to the Effective Date or during the Term (including during the Term of the Original License Agreement); (b) the negligence or willful misconduct of any PharmaMar Indemnitee; or (c) the breach by PharmaMar of any warranty, representation, covenant or agreement made by PharmaMar in this Agreement; in each case except to the extent such Losses result from the negligence or willful misconduct of any Jazz Indemnitee or the breach by Jazz of any warranty, representation, covenant or agreement made by Jazz in this Agreement.
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14.3Indemnification Procedures.  In the event a Party (the “Indemnified Party”) seeks indemnification under Section 14.1 or 14.2, it shall inform the other Party (the “Indemnifying Party”) of a claim as soon as reasonably practicable after it receives notice of the claim (it being understood and agreed, however, that the failure by an Indemnified Party to give notice of a claim as provided in this Section 14.3 shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only to the extent that such Indemnifying Party is actually damaged as a result of such failure to give notice), shall permit the Indemnifying Party to assume direction and control of the defense of the claim (including the right to settle the claim solely for monetary consideration) using counsel reasonably satisfactory to the Indemnified Party, and shall cooperate as requested (at the expense of the Indemnifying Party) in the defense of the claim.  If the Indemnifying Party does not assume control of such defense within [***] days after receiving notice of the claim from the Indemnified Party, the Indemnified Party shall control such defense and, without limiting the Indemnifying Party’s indemnification obligations, the Indemnifying Party shall reimburse the Indemnified Party for all costs, including reasonable attorney fees, incurred by the Indemnified Party in defending itself within [***] days after receipt of any invoice therefor from the Indemnified Party.  The Party not controlling such defense may participate therein at its own expense.  The Party controlling such defense shall keep the other Party advised of the status of such action, suit, proceeding or claim and the defense thereof and shall consider recommendations made by the other Party with respect thereto.  The Indemnified Party shall not agree to any settlement of such action, suit, proceeding or claim without the prior written consent of the Indemnifying Party, which shall not be unreasonably withheld, delayed or conditioned.  The Indemnifying Party shall not agree to any settlement of such action, suit, proceeding or claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto, that imposes any liability or obligation on the Indemnified Party or that acknowledges fault by the Indemnified Party without the prior written consent of the Indemnified Party.  If the Parties cannot agree as to the application of Section 14.1 or 14.2 to any claim, pending resolution of the dispute pursuant to Article 15, the Parties may conduct separate defenses of such claims, with each Party retaining the right to claim indemnification from the other Party in accordance with Section 14.1 or 14.2, as applicable, upon resolution of the underlying claim.  
14.4Limitation of Liability.  NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.  NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 14.4 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 14.1 OR 14.2 OR DAMAGES AVAILABLE FOR BREACH OF ARTICLE 11.
14.5Insurance.  Each Party shall procure and maintain insurance, including comprehensive or commercial general liability insurance (including contractual liability and product liability), in amounts that are commercially reasonable in light of the activities and obligations undertaken by such Party pursuant to this Agreement, which amounts shall be 
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consistent with normal business practices of prudent companies similarly situated.  It is understood that such insurance shall not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this Article 14 or otherwise.  Each Party shall provide the other Party with written evidence of such insurance upon request.  Each Party shall provide the other Party with written notice at least [***] days prior to the cancellation or nonrenewal of such insurance.
15.Dispute Resolution
15.1Disputes.  It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation.  In the event of any disputes, controversies or differences which may arise between the Parties out of or in relation to or in connection with this Agreement (other than disputes arising from the JDC or JCC that are subject to the final decision making authority set forth in Section 3.4(b) and other than disputes that are subject to Third Party resolution as set forth in Section 4.1(a)(ii), Section 4.2(d)(iv), Section 5.4(c)(iv), Section 5.4(c)(v) or Section 15.3, each of which shall be resolved as described therein), including, without limitation, any alleged failure to perform, or breach, of this Agreement, or any issue relating to the interpretation or application of this Agreement (each, a “Dispute”), then upon the request of either Party by written notice, the Parties agree to meet and discuss in good faith a possible resolution thereof, which good faith efforts shall include at least one in-person meeting between the Parties’ respective Executive Officers.  If the matter is not resolved within [***] days following the written request for discussions, either Party may then invoke the provisions of Section 15.2.
15.2Arbitration.  
(a)ICC Arbitration.  Any Dispute that is not resolved pursuant to Section 15.1 or required to be resolved in accordance with Section 3.4(b), Section 4.1(a)(ii), Section 4.2(d)(iv), Section 5.4(c)(iv), Section 5.4(c)(v) or Section 15.3, except for a dispute, claim or controversy under Section 15.3, shall be finally settled by arbitration in accordance with the Rules of Arbitration of the International Chamber of Commerce (“ICC Rules”).  The number of arbitrators shall be three (3), of whom each Party shall appoint one (1).  The two arbitrators so appointed will select the third and final arbitrator in accordance with the ICC Rules.  The seat of arbitration shall be located in New York, New York, United States.  The Parties each consent to the personal jurisdiction of the U.S. federal courts for any case arising out of or otherwise related to this arbitration, its conduct and its enforcement.  The language to be used in the arbitral proceedings will be English.  Any situation not expressly covered by this Agreement shall be decided in accordance with the ICC Rules.  
(b)Decision.  The arbitrators shall issue a reasoned opinion following a full comprehensive hearing, no later than [***] months following the selection of the arbitrators as provided for in Section 15.2(a) unless the Parties jointly request an extension or the arbitrators determine, in a reasoned decision that the interest of justice or the complexity of the case requires that such limit be extended.
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(c)Award.  Any award shall be promptly paid in Dollars free of any tax, deduction or offset; and any costs, fees or taxes incident to enforcing the award shall, to the maximum extent permitted by Applicable Law, be charged against the Party resisting enforcement.  Each Party agrees to abide by the award rendered in any arbitration conducted pursuant to this Section 15.2, and agrees that, subject to the Federal Arbitration Act, judgment may be entered in any court of competent jurisdiction and that other courts may award full faith and credit to such judgment in order to enforce such award.  The award shall include interest from the date of any damages incurred for breach of this Agreement, and from the date of the award until paid in full, at a rate fixed by the arbitrators.
(d)Costs.  Except as set forth in Section 15.2(c), each Party shall bear its own legal fees.  The arbitrators shall assess their costs, fees and expenses against the Party losing the arbitration unless they believe that neither Party is the clear loser, in which case the arbitrators shall divide their fees, costs and expenses according to their sole discretion.  
(e)Confidentiality.  The arbitration proceeding shall be confidential and the arbitrators shall issue appropriate protective orders to safeguard each Party’s Confidential Information.  Except as required by Applicable Law, no Party shall make (or instruct the arbitrators to make) any public announcement with respect to the proceedings or decision of the arbitrators without prior written consent of the other Party.  The existence of any dispute submitted to arbitration, and the award, shall be kept in confidence by the Parties and the arbitrators, except (i) as required in connection with the enforcement of such award, (ii) as otherwise required by Applicable Law or required of a Party to fulfill a legal duty or protect or pursue a legal right, (iii) with the consent of both Parties, (iv) where such information is already in the public domain other than as a result of a breach of this clause, or (v) by order of the arbitrators upon application of a Party.  
(f)Survivability.  Any duty to arbitrate under this Agreement shall remain in effect and be enforceable after termination of this Agreement for any reason.
15.3Court Actions.  Nothing contained in this Agreement shall deny either Party the right to seek injunctive or other equitable relief, including specific performance, from a court of competent jurisdiction in the context of a bona fide emergency or prospective irreparable harm, including with respect to any breach of Article 11 or the ownership provisions of Section 10.1 in order to preserve the status quo pending resolution of the Dispute between the Parties under Sections 15.1 and 15.2, and such an action may be filed and maintained notwithstanding any ongoing discussions between the Parties or any ongoing arbitration proceeding.  In addition, either Party may bring an action in any court of competent jurisdiction to resolve disputes pertaining to the validity, construction, scope, enforceability, infringement or other violations of Patent Rights or other intellectual property rights, and no such claim shall be subject to arbitration pursuant to Section 15.2.
16.General Provisions
16.1Entire Agreement; Amendments.  This Agreement, including the Exhibits hereto, and the Supply Agreement, Safety Exchange Agreement and Quality Agreement sets 
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forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto with respect to the subject matter hereof and supersedes, as of the Restatement Effective Date, all prior and contemporaneous agreements and understandings between the Parties with respect to the subject matter hereof, including the Confidentiality Agreement and the Original License Agreement; provided that (a) the Original License Agreement shall have been in effect and shall govern the Parties’ rights and obligations with respect to the subject matter of this Agreement between the Effective Date and the Restatement Effective Date; and (b) this Agreement shall govern the Parties’ rights and obligations with respect to the subject matter of this Agreement from and after the Restatement Effective Date.  The foregoing shall not be interpreted as a waiver of any remedies available to either Party as a result of any breach, prior to the Effective Date, by the other Party of its obligations under the Confidentiality Agreement or the Original License Agreement.  There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth in this Agreement.  No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.
16.2Governing Law.  This Agreement shall be governed by and construed in accordance with the laws of the State of New York, USA, excluding its conflicts of laws principles with the exception of sections 5-1401 and 5-1402 of New York General Obligations Law.  Subject to Article 15 above, each Party hereby consents to the venue and jurisdiction of state and federal courts located in the State of New York (U.S.).
16.3Rights in Bankruptcy.
(a)All rights and licenses granted under or pursuant to this Agreement by PharmaMar to Jazz are, for all purposes of Title 11 of the United States Code (“Title 11”), licenses of rights to “intellectual property” as defined in Title 11, and, in the event that a case under Title 11 is commenced by or against PharmaMar, Jazz shall have all of the rights set forth in Section 365(n) of Title 11 to the maximum extent permitted thereby.  During the Term, PharmaMar shall create and maintain current copies to the extent practicable of all such intellectual property.  Without limiting the Parties’ rights under Section 365(n) of Title 11, if a case under Title 11 is commenced by or against PharmaMar, Jazz shall be entitled to a copy of any and all such intellectual property and all embodiments of such intellectual property, and the same, if not in the possession of Jazz, shall be promptly delivered to it (i) before this Agreement is rejected by or on behalf of PharmaMar, within [***] days after Jazz’s written request, unless PharmaMar, or its trustee or receiver, elects within [***] days to continue to perform all of its obligations under this Agreement, or (ii) after any rejection of this Agreement by or on behalf of PharmaMar, if not previously delivered as provided under clause (i) above.  All rights of the Parties under this Section 16.3 and under Section 365(n) of Title 11 are in addition to and not in substitution of any and all other rights, powers, and remedies that each Party may have under this Agreement, Title 11, and any other Applicable Laws.  Jazz shall have the right to perform the obligations of PharmaMar hereunder with respect to such intellectual property, but neither such 
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provision nor such performance by Jazz shall release PharmaMar from any such obligation or liability for failing to perform it.  
(b)The Parties agree that they intend the foregoing Jazz rights to extend to the maximum extent permitted by law and any provisions of applicable contracts with Third Parties, including for purposes of Title 11, (i) the right of access to any intellectual property (including all embodiments thereof) of PharmaMar or any Third Party with whom PharmaMar contracts to perform an obligation of PharmaMar under this Agreement, and, in the case of the Third Party, which is necessary for the Development, Regulatory Approval and manufacture of Licensed Products and (ii) the right to contract directly with any Third Party described in (i) in this sentence to complete the contracted work.  
(c)Any intellectual property provided pursuant to the provisions of this Section 16.3 shall be subject to the licenses set forth elsewhere in this Agreement and the payment obligations of this Agreement, which shall be deemed to be royalties for purposes of Title 11.
(d)Notwithstanding anything to the contrary in Article 10, in the event that a case under Title 11 is commenced by or against PharmaMar, Jazz may take appropriate actions in connection with the filing, prosecution, maintenance and enforcement of any PharmaMar Patent Rights in the Jazz Territory licensed to Jazz under this Agreement without being required to consult with PharmaMar before taking any such actions, provided that such actions are consistent with this Agreement.
16.4Assignment.  Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other, except that a Party may make such an assignment or transfer without the other Party’s consent to its Affiliates or to a Third Party successor to substantially all of the business of such Party to which this Agreement relates, whether in a merger, sale of stock, sale of assets or other transaction.  Any permitted assignment shall be binding on the successors of the assigning Party.  Any assignment or attempted assignment by either Party in violation of the terms of this Section 16.4 shall be null, void and of no legal effect.
16.5Force Majeure.  Each Party shall be excused from liability for the failure or delay in performance of any obligation under this Agreement by reason of any event beyond such Party’s reasonable control, including but not limited to Acts of God, fire, flood, explosion, earthquake, or other natural forces, war, civil unrest, acts of terrorism, accident, destruction, epidemic, pandemic or other casualty, any lack or failure of transportation facilities, any lack or failure of supply of raw materials, any strike or organized labor disturbance, or any other event similar to those enumerated above (“Force Majeure”).  Such excuse from liability shall be effective only to the extent and duration of the event(s) causing the failure or delay in performance and provided that the Party has not caused, in whole or in part, such event(s) to occur.  The affected Party shall notify the other Party of such Force Majeure as soon as reasonably practical, and shall promptly undertake all reasonable efforts necessary to cure such Force Majeure.  
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16.6Non-Waiver.  The failure of a Party to insist upon strict performance of any provision of this Agreement or to exercise any right arising out of this Agreement shall neither impair that provision or right nor constitute a waiver of that provision or right, in whole or in part, in that instance or in any other instance.  Any waiver by a Party of a particular provision or right shall be in writing, shall be as to a particular matter and, if applicable, for a particular period of time and shall be signed by such Party.  
16.7Severability.  If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties.  The Parties shall in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.
16.8Further Actions.  Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
16.9Notices.  Any notice to be given under this Agreement must be in writing and delivered either in person, by internationally-recognized express courier, to the Party to be notified at its address(es) given below, or at any address such Party has previously designated by prior written notice to the other.  Notice shall be deemed sufficiently given for all purposes upon the earliest of:  (a) the date of actual receipt; or (b) if delivered by express courier, the second Business Day the express courier regularly makes deliveries following deposit.  
						
	If to Jazz, to:	Jazz Pharmaceuticals Ireland Limited
		Fifth Floor, Waterloo Exchange
		Waterloo Road, Dublin 4, Ireland
		Attention: General Counsel
		Fax:  [***]
		
		With copy to:
		Jazz Pharmaceuticals, Inc.
		3170 Porter Drive
		Palo Alto, CA 94304
		Attention: General Counsel
		Fax:  [***]
		
		With copy to:
		[***]
		Attention: Legal Department

89

						
	If to PharmaMar, to:	PharmaMar SA
		Avda. De los Reyes no 1

		28770 Colmenar Viejo, Madrid
		Spain
		Attn. Business Development, Director
		Fax: [***]
		E-mail address: [***]
		
		With a copy to:
		
		PharmaMar SA
		Avda. De los Reyes no 1

		28770 Colmenar Viejo, Madrid
		Spain
		Attn. Legal Director – Business

		Email: [***]

16.10Interpretation.  The headings of clauses contained in this Agreement preceding the text of the sections, subsections and paragraphs hereof are inserted solely for convenience and ease of reference only and shall not constitute any part of this Agreement, or have any effect on its interpretation or construction.  All references in this Agreement to the singular shall include the plural where applicable.  The term “including” or “includes” as used in this Agreement means including, without limiting the generality of any description preceding such term, and the word “or” has the inclusive meaning represented by the phrase “and/or.”  Unless otherwise specified, references in this Agreement to any section shall include all subsections and paragraphs in such Section and references in this Agreement to any subsection shall include all paragraphs in such subsection.  All references to days in this Agreement shall mean calendar days, unless otherwise specified.  Ambiguities and uncertainties in this Agreement, if any, shall not be interpreted against either Party, irrespective of which Party may be deemed to have caused the ambiguity or uncertainty to exist.  This Agreement has been prepared in the English language, and the English language shall control its interpretation.  In addition, all notices required or permitted to be given hereunder, and all written, electronic, oral or other communications between the Parties regarding this Agreement shall be in the English language.  
16.11Relationship between the Parties.  The Parties’ relationship, as established by this Agreement, is solely that of independent contractors.  This Agreement does not create any partnership, joint venture or similar business relationship between the Parties.  Neither Party is a legal representative of the other Party, and neither Party may assume or create any obligation, representation, warranty or guarantee, express or implied, on behalf of the other Party for any purpose whatsoever.
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16.12No Third Party Rights.  The provisions of this Agreement are for the exclusive benefit of the Parties, and no other person or entity shall have any right or claim against any Party by reason of these provisions or be entitled to enforce any of these provisions against any Party.
16.13HSR Clearance.  The Parties acknowledge that the Original License Agreement obtained HSR Clearance on January 21, 2020.
16.14Personal Data Protection
(a)General.  Both Parties undertake to comply with any Applicable Law regarding protection of personal data, including but not limited to the European General Data Protection Regulation 2016/679 of 8 April 2016 (“GDPR”). 
(b)Purpose.  The Parties acknowledge that personal data of each Party’s officers, agents, Affiliates, partners, employees, subcontractors, consultants, customers, partners, investigators, physicians, and authorities ́ staff may become part of data files property of PharmaMar or Jazz, as appropriate, for the only purpose of managing the contractual relationship between the Parties, including regulatory matters, operational matters and financial relationship derived from this Agreement, control of the execution of the activities to be performed by the Parties under this Agreement, contact maintenance and compliance with all Applicable Laws, regulations and codes of practices.  Both Parties shall be considered independent data controllers (as that term is defined in the GDPR) of such personal data exchanges according to Applicable Law.  The Parties do not operate as joint data controllers. 
(c)Recipients.  The Parties agree that each Party may transfer personal data of the other Party for the same purpose to the respective Affiliates, Sublicensees, Third Party Partners, each Party’s subcontractors and to Regulatory Authorities as provided by Applicable Law.
(d)Legitimation of the treatment of personal data.  The Parties agree that the legitimation for the collection, processing and transfer of personal data of the other Party is based in the existing contractual relationship under this Agreement and subsequently once purpose for its collection, processing and transfer has been completed, in the need to comply and/or verify compliance with contractual and legal obligations and possible liabilities derived from this Agreement.  In the case of opposing the processing of personal data, PharmaMar and/or Jazz would not be able to continue maintaining the Agreement, having to make the necessary modifications or even having to cancel it.  The maintenance of contact, even by electronic means, on matters relating to the activities to be performed under the Agreement is based on the legitimate interest respectively of both PharmaMar and Jazz.
(e)Limited storage periods.  Subject to Applicable Law, each Party may store personal data of the other Party during the Term of the Agreement and thereafter during the time necessary to assure the compliance with any contractual and legal obligation or as necessary to determine any liability of the Parties derived from the contractual relationship and the processing of personal data.  In this regard, financial data will be gathered according to 
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Applicable Laws and regulations in this subject matter - for the time tax and accounting regulations provide such information could be required from Regulatory Authorities, such as tax agencies or courts. 
(f)Rights.  To the extent a Party receives a request from each of the aforementioned persons in 16.15(b) to exercise his/her rights (including requests of access, rectification, cancellation, portability or/and opposition to his data being processed) under Applicable Law with respect to personal data under the Agreement gathered in PharmaMar or Jazz files, as appropriate, the receiving Party will respond to the extent required under Applicable Law, and each Party shall reasonably cooperate with the other Party to assist the other Party with such required response. 
(g)Data Protection Officer.  In case of data gathered in PharmaMar files, to execute any of the previously mentioned rights, data subjects must provide written notice in this regard to the Legal Department of PharmaMar to its address at Avda. De los Reyes no 1, 28770 Colmenar Viejo (Madrid), Spain or by email to dpo@pharmamar.com.  Jazz and its staff can access the full information on the privacy and data protection policy on PharmaMar ́s website www.pharmamar.com. 
In case of data gathered in Jazz ́s files, to execute any of the previously mentioned rights, data subjects must provide written notice in this regard to the Privacy Office of Jazz Pharmaceuticals to its address at 3170 Porter Drive, Palo Alto, CA 94303, U.S., or by email to dpo@jazzpharma.com.  PharmaMar and its staff can access the privacy statement on Jazz’s website www.jazzpharma.com.
(h)Other Obligations.  Likewise, PharmaMar and Jazz, as independent data controllers, compromise to:
(i)reasonably cooperate with the other Party to enable such Party to fulfill its obligations under Applicable Laws;
(ii)have in place appropriate technical and organizational measures to protect the personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorized disclosure or access, and which provide a level of security appropriate to the risk represented by the processing and the nature of the data to be protected;
(iii)subject to Applicable Laws, comply with its secrecy obligations with regard to all personal data gathered in their file; this obligation to remain indefinitely in place after the end of this Agreement;
(iv)all personal involved in this Agreement must be aware of the obligation to confidentially and security;
(v)have in place procedures so that any third party they authorize to have access to the personal data, including processors, will respect and maintain the confidentiality and security of the personal data;
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(vi)process the personal data for purposes described in this Agreement, and have the legal authority to give the warranties and fulfil the undertakings set out in these clauses; 
(vii)to the extent a Party receives a request from supervisory authority with respect to personal data for which another Party is also a data controller, the other Party shall reasonably cooperate with the receiving Party’s efforts to respond to such a request;
(viii)to the extent a Party needs to conduct a data protection impact assessment (“DPIA”), including prior consultation with a supervisory authority, the other Party shall reasonably cooperate with the Party conducting the DPIA to assist with its completion of the DPIA; and
(ix)in the event that for the performance of activities set forth in this Agreement any Party should provide personal data of natural persons to the other Party, such Party providing such personal data should inform, in advance, to such natural person about the processing of such personal data as contemplated by this Agreement.
16.15Counterparts.  This Agreement may be executed in counterparts, each of which shall be deemed an original document, and all of which, together with this writing, shall be deemed one instrument.  This Agreement may be executed by facsimile or PDF signatures, which signatures shall have the same force and effect as original signatures.  
[Signature page follows.]
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In Witness Whereof, the Parties have duly executed this Amended and Restated License Agreement as of the Restatement Effective Date.
						
	Jazz Pharmaceuticals Ireland Limited	Pharma Mar S.A.
		
	By: /s/ Patricia Carr
Name: Patricia Carr
Title: Director
	By:  /s/ Jose María Fernandez Sousa-Faro     
Name: Jose María Fernandez Sousa-Faro
Title: President

[Signature Page to Amended and Restated License Agreement]

Exhibit A
Licensed API
[***]

EXHIBIT B
PharmaMar Patents 
[***]

EXHIBIT C
Third Party Partners 
                                                               [***]

EXHIBIT D
Atlantis Trial Development Plan
[***]

Exhibit E
Sample Royalty Calculation for Jazz Territory 
[***]
{3 pages omitted}

Exhibit F
U.S. Co-Promotion Terms 
1.[***] will have the right and obligation to provide (a) [***] and (b) [***] (the “Co-Promotion Activities”).  The [***] will be agreed upon by the JCC as part of the Co-Promotion Plan. Each Party’s [***] shall be [***].  Each Party shall [***].  
2.The [***] shall be [***].  
3.[***] shall [***] in the Jazz U.S. Territory.  [***] shall [***] in the Jazz U.S. Territory.  
4.To [***], [***] will [***] starting on [***] and ending upon [***].
5. Other terms included in this Agreement shall be mutatis mutandi applied to the Co-Promotion Agreement to the extent such terms are applicable to a Co-promotion Agreement.

229793363 v14

Exhibit G
Product Trademark 
[***]

EXHIBIT H

Press Release
PharmaMar signs an agreement with Jazz Pharmaceuticals for lurbinectedin in Canada
•PharmaMar is eligible to receive up to US $5 million between the upfront payment and regulatory milestone payments.
•PharmaMar is also entitled to receive tiered royalties on future net sales of lurbinectedin in Canada, ranging from high teens to 30% as well as sales milestone payments. 
Madrid, October XXth, 2020. – PharmaMar (MSE:PHM) has announced today that Pharma Mar, S.A. and Jazz Pharmaceuticals Ireland Limited have entered into an amended and restated license agreement of the US lurbinectedin license agreement signed in December 2019 for the purpose of granting Jazz an exclusive license for ZepzelcaTM (lurbinectedin) in Canada. 
Under the terms of this amended agreement, and with respect to the license granted for Canada, PharmaMar is eligible to receive up to US $5 million between an upfront payment and regulatory milestone payments in Canada.
PharmaMar is also eligible to receive incremental tiered royalties on future net sales of lurbinectedin in Canada, ranging from the high teens up to 30%, in addition to up to US $3 million as potential sales milestone payments. PharmaMar retains production rights for lurbinectedin and will supply the product to Jazz.
The terms of the license agreement signed in December 2019 with respect to the exclusive license granted to Jazz in US (including Jazz ́ payment obligations) remain unchanged.  
ZepzelcaTM (lurbinectedin) was approved by US FDA for the treatment of metastatic Small Cell Lung Cancer on June 15th, 2020, and has been submitted to health agencies in Australia, Switzerland, Israel and Singapore under accelerated approval pathways. PharmaMar and Jazz are working together to determine the lurbinectedin regulatory filing strategy for Canada.

Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

About PharmaMar
Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.
PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis® in Europe and has other clinical-stage programs under development for several types of solid cancers: ZepzelcaTM (lurbinectedin, PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.
About lurbinectedin
Lurbinectedin (ZepzelcaTM), also known as PM1183, is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinacidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets.
Media Contact:
Alfonso Ortín – Communications Director aortin@pharmamar.com Mobile: +34 609493127
Miguel Martínez-Cava – Communication Manager mmartinez-cava@pharmamar.com Mobile: +34 606597464
Álvaro Mateo - Communication Manager amateo@pharmamar.com Mobile: +34 650726009
Phone: +34 918466000

Capital Markets & Investor Relations:
José Luis Moreno– Capital Markets & Investor Relations Director
María Marín de la Plaza – Capital Markets & Investor Relations
investorrelations@pharmamar.com
Phone: +34 914444500

Or please visit our website at www.pharmamar.com

EXHIBIT I

Regulatory Filings in Jazz Territory 

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