Document:

DepoCyt Supply and Distribution Agreement

 Exhibit 10.12 
 Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. 
 EXECUTION COPY 
  
 DEPOCYT® 

SUPPLY AND DISTRIBUTION AGREEMENT 

BY AND BETWEEN 

SKYEPHARMA, INC. 

AND 
 ENZON PHARMACEUTICALS, INC. 

DATED AS OF 
 DECEMBER 31, 2002 

 TABLE OF CONTENTS 

 

									
	 	    	 	  	 	  	Page	 
	 1.
	    	 Definitions
	  	 	1	  
				
		    	 1.1
	  	 “AAA”
	  	 	1	  
				
		    	 1.2
	  	 “Additional Indication”
	  	 	1	  
				
		    	 1.3
	  	 “Affiliate”
	  	 	1	  
				
		    	 1.4
	  	 “Agreement”
	  	 	2	  
				
		    	 1.5
	  	 “Breaching Party”
	  	 	2	  
				
		    	 1.6
	  	 “Calendar Quarter”
	  	 	2	  
				
		    	 1.7
	  	 “CFR”.
	  	 	2	  
				
		    	 1.8
	  	 “cGMP”
	  	 	2	  
				
		    	 1.9
	  	 “Chiron”
	  	 	2	  
				
		    	 1.10
	  	 “Chiron Acquisition Agreement”
	  	 	2	  
				
		    	 1.11
	  	 “Commercially Reasonable Efforts”
	  	 	2	  
				
		    	 1.12
	  	 “Confidential Information”
	  	 	2	  
				
		    	 1.13
	  	 “Contract Year”
	  	 	2	  
				
		    	 1.14
	  	 “Disclosing Party”
	  	 	2	  
				
		    	 1.15
	  	 “Effective Date”
	  	 	2	  
				
		    	 1.16
	  	 “Enzon”
	  	 	2	  
				
		    	 1.17
	  	 “Executive Officers”
	  	 	3	  
				
		    	 1.18
	  	 “Failure to Supply”
	  	 	3	  
				
		    	 1.19
	  	 “FDA”
	  	 	3	  
				
		    	 1.20
	  	 “FDC Act”
	  	 	3	  
				
		    	 1.21
	  	 “Generic Event”
	  	 	3	  
				
		    	 1.22
	  	 “Gross Margin”
	  	 	3	  
				
		    	 1.23
	  	 “IND”
	  	 	3	  
				
		    	 1.24
	  	 “HPB”
	  	 	3	  
				
		    	 1.25
	  	 “Indemnitee”
	  	 	3	  
				
		    	 1.26
	  	 “Indemnitor”
	  	 	3	  
				
		    	 1.27
	  	 “Infringement”
	  	 	3	  
				
		    	 1.28
	  	 “Initial Term”
	  	 	3	  
				
		    	 1.29
	  	 “Laboratory”
	  	 	3	  
				
		    	 1.30
	  	 “Marketing Plan” and “Marketing Plans”
	  	 	3	  
				
		    	 1.31
	  	 “Minimum Annual Net Sales”
	  	 	3	  

  
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(CONTINUED) 
  

									
	 	    	 	  	 	  	Page	 
		    	 1.32
	  	 “Neo-plastic Indication”
	  	 	4	  
				
		    	 1.33
	  	 “Net Sales”
	  	 	4	  
				
		    	 1.34
	  	 “Net Unit Selling Price”
	  	 	4	  
				
		    	 1.35
	  	 “Non-breaching Party”
	  	 	4	  
				
		    	 1.36
	  	 “Party”
	  	 	4	  
				
		    	 1.37
	  	 “Phase IV Trial”
	  	 	4	  
				
		    	 1.38
	  	 “Product”
	  	 	4	  
				
		    	 1.39
	  	 “Product Specifications”
	  	 	4	  
				
		    	 1.40
	  	 “Q1”
	  	 	4	  
				
		    	 1.41
	  	 “Receiving Party”
	  	 	4	  
				
		    	 1.42
	  	 “Registration”
	  	 	4	  
				
		    	 1.43
	  	 “Registration Application”
	  	 	4	  
				
		    	 1.44
	  	 “Regulatory Authority”
	  	 	4	  
				
		    	 1.45
	  	 “Renewal Term”
	  	 	4	  
				
		    	 1.48
	  	 “Skye”
	  	 	4	  
				
		    	 1.47
	  	 “Skye Know-How”
	  	 	5	  
				
		    	 1.48
	  	 “Skye Patents”
	  	 	5	  
				
		    	 1.49
	  	 “Skye Technology”
	  	 	5	  
				
		    	 1.50
	  	 “Supply Price”
	  	 	5	  
				
		    	 1.51
	  	 “Term”
	  	 	5	  
				
		    	 1.52
	  	 “Territory”
	  	 	5	  
				
		    	 1.53
	  	 “Testing Methods”
	  	 	5	  
				
		    	 1.54
	  	 “Third Party”
	  	 	5	  
				
		    	 1.55
	  	 ‘Trademark(s)”
	  	 	5	  
				
		    	 1.56
	  	 “Unit”
	  	 	5	  
				
		    	 1.57
	  	 “United States” or “U.S.”
	  	 	5	  
			
	 2.
	    	 Representations, Warranties and Covenants
	  	 	5	  
				
		    	 2.1
	  	 Representations by Each Party
	  	 	5	  
				
		    	 2.2
	  	 Representations by Skye
	  	 	6	  
				
		    	 2.3
	  	 Representations by Enzon
	  	 	6	  
			
	 3.
	    	 Appointment; Rights and Obligations
	  	 	7	  
				
		    	 3.1
	  	 Appointment
	  	 	7	  
				
		    	 3.2
	  	 Right to Appoint Sub-distributors
	  	 	7	  

  
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(CONTINUED) 
  

									
	 	    	 	  	 	  	Page	 
		    	 3.3
	  	 Marketing Plan
	  	 	7	  
				
		    	 3.4
	  	 Maintenance of Registration(s); Additional Development Efforts
	  	 	7	  
			
	 4.
	    	 Sales and Marketing
	  	 	8	  
				
		    	 4.1
	  	 Obligations of Enzon
	  	 	8	  
				
		    	 4.2
	  	 Trademarks; Logos
	  	 	9	  
				
		    	 4.3
	  	 Extra-territorial Sales
	  	 	9	  
			
	 5.
	    	 Supply
	  	 	9	  
				
		    	 5.1
	  	 Generally
	  	 	9	  
				
		    	 5.2
	  	 Forecasts
	  	 	10	  
				
		    	 5.3
	  	 Orders
	  	 	10	  
				
		    	 5.4
	  	 Packaging
	  	 	10	  
				
		    	 5.5
	  	 Shipment
	  	 	10	  
				
		    	 5.6
	  	 Acceptance/Rejection
	  	 	10	  
				
		    	 5.7
	  	 Replacement Product
	  	 	11	  
				
		    	 5.8
	  	 Failure to Supply
	  	 	11	  
			
	 6.
	    	 Regulatory Matters
	  	 	12	  
				
		    	 6.1
	  	 Adverse Experience Reporting
	  	 	12	  
				
		    	 6.2
	  	 Recall Action
	  	 	12	  
				
		    	 6.3
	  	 Recall Expenses
	  	 	12	  
				
		    	 6.4
	  	 Debarment.
	  	 	13	  
			
	 7.
	    	 Manufacture
	  	 	13	  
				
		    	 7.1
	  	 Manufacturing Rights
	  	 	13	  
				
		    	 7.2
	  	 Manufacturing Obligations
	  	 	13	  
				
		    	 7.3
	  	 Inspections
	  	 	14	  
			
	 8.
	    	 Consideration; Payments; Reports.
	  	 	14	  
				
		    	 8.1
	  	 Supply Price; Minimums
	  	 	14	  
				
		    	 8.2
	  	 Milestones
	  	 	16	  
				
		    	 8.3
	  	 Transitional Services
	  	 	16	  
				
		    	 8.4
	  	 Mode of Payment
	  	 	17	  
				
		    	 8.5
	  	 Late Charges
	  	 	17	  
				
		    	 8.6
	  	 Records Retention
	  	 	17	  
				
		    	 8.7
	  	 Audit Rights
	  	 	17	  
				
		    	 8.8
	  	 Taxes
	  	 	17	  

  
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TABLE OF CONTENTS 

(CONTINUED) 
  

									
	 	    	 	  	 	  	Page	 
	 9.
	    	 Product Warranty
	  	 	18	  
				
		    	 9.1
	  	 Guaranty and Warranty
	  	 	18	  
				
		    	 9.2
	  	 Disclaimer
	  	 	18	  
			
	 10.
	    	 Confidentiality
	  	 	18	  
				
		    	 10.1
	  	 Confidential Treatment
	  	 	18	  
				
		    	 10.2
	  	 Exceptions
	  	 	18	  
				
		    	 10.3
	  	 Term of Obligation
	  	 	19	  
				
		    	 10.4
	  	 Return of Materials
	  	 	19	  
			
	 11.
	    	 Term and Termination
	  	 	19	  
				
		    	 11.1
	  	 Term
	  	 	19	  
				
		    	 11.2
	  	 Termination for Cause
	  	 	19	  
				
		    	 11.3
	  	 Termination by Skye
	  	 	19	  
				
		    	 11.4
	  	 Termination by Enzon
	  	 	19	  
				
		    	 11.5
	  	 Termination in the Generic Event
	  	 	20	  
				
		    	 11.6
	  	 Effect of Termination
	  	 	20	  
			
	 12.
	    	 Assignment
	  	 	20	  
			
	 13.
	    	 Indemnification
	  	 	20	  
				
		    	 13.1
	  	 Indemnification by Enzon
	  	 	20	  
				
		    	 13.2
	  	 Indemnification by Skye
	  	 	21	  
				
		    	 13.3
	  	 Procedure
	  	 	21	  
				
		    	 13.4
	  	 Complete Indemnification
	  	 	21	  
			
	 14.
	    	 Insurance
	  	 	21	  
			
	 15.
	    	 Enforcement of Intellectual Property Rights
	  	 	21	  
				
		    	 15.1
	  	 Notice to Skye
	  	 	21	  
				
		    	 15.2
	  	 Enforcement
	  	 	21	  
				
		    	 15.3
	  	 Infringement Action by Third Parties
	  	 	22	  
			
	 16.
	    	 Limitation on Liability
	  	 	22	  
			
	 17.
	    	 Dispute Resolution
	  	 	22	  
				
		    	 17.1
	  	 Referral to Executive Officers
	  	 	22	  
				
		    	 17.2
	  	 Arbitration
	  	 	23	  
				
		    	 17.3
	  	 Injunctive Relief
	  	 	23	  
			
	 18.
	    	 Force Majeure
	  	 	23	  
			
	 19.
	    	 Notice
	  	 	24	  

  
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TABLE OF CONTENTS 

(CONTINUED) 
  

									
	 	    	 	  	 	  	Page	 
	 20.
	    	 Books and Records
	  	 	24	  
			
	 21.
	    	 Governing Law
	  	 	24	  
			
	 22.
	    	 Miscellaneous
	  	 	25	  
				
		    	 22.1
	  	 Relationship of Parties
	  	 	25	  
				
		    	 22.2
	  	 Further Actions
	  	 	25	  
				
		    	 22.3
	  	 Use of Name; Publicity
	  	 	25	  
				
		    	 22.4
	  	 Waiver
	  	 	25	  
				
		    	 22.5
	  	 Severability
	  	 	25	  
				
		    	 22.6
	  	 Amendment
	  	 	25	  
				
		    	 22.7
	  	 Entire Agreement
	  	 	25	  
				
		    	 22.8
	  	 Parties in Interest
	  	 	25	  
				
		    	 22.9
	  	 Descriptive Headings
	  	 	25	  
				
		    	 22.10
	  	 Counterparts
	  	 	26	  

							
	
	LIST OF EXHIBITS
				
		    	 EXHIBIT 1.38
	    	THE PRODUCT	  	
				
		    	 EXHIBIT 1.39
	    	PRODUCT SPECIFICATIONS	  	
				
		    	 EXHIBIT 1.48
	    	PATENTS	  	
				
		    	 EXHIBIT 3.4
	    	CLINICAL PLAN	  	
				
		    	 EXHIBIT 8.1.1
	    	QUARTERLY PAYMENT RECONCILIATION	  	
				
		    	 EXHIBIT 8.3A
	    	TRANSITIONAL SERVICES REQUESTED AND APPROVED BY ENZON	  	
				
		    	 EXHIBIT 8.B
	    	TRANSITIONAL SERVICES	  	

  
 (v)

 DEPOCYT® SUPPLY AND DISTRIBUTION
AGREEMENT 
 THIS
DEPOCYT® SUPPLY AND DISTRIBUTION
AGREEMENT dated as of the 31st day of December, 2002, is entered into by and between ENZON PHARMACEUTICALS, INC., a corporation organized and existing under the laws of Delaware,
having offices located at 685 Route 202/206, Bridgewater, New Jersey 08807 (“Enzon”) and SKYEPHARMA, INC., a corporation organized and existing under the laws of the State of
California, having offices located at 1450 Science Center Drive, San Diego, California 92121 (“Skye”). 

PRELIMINARY STATEMENTS 

WHEREAS, Skye is in possession of proprietary know-how and technology and has the expertise and
skill needed to manufacture and further develop the Product (as defined below); and 

WHEREAS, Skye is party to certain agreements with Chiron Corporation
(“Chiron”), pursuant to which Skye has granted Chiron the exclusive marketing, sale and distribution rights for the Product in the United States; and 

WHEREAS, effective as of December 31, 2002, and subject to the terms of that
certain Acquisition Agreement dated November 22, 2002, by and between Skye and Chiron (the “Chiron Acquisition Agreement”), Chiron shall transfer, convey, assign and deliver to Skye all its rights to the Product in the United
States; and 
 WHEREAS, Enzon is interested in marketing the Product and
purchasing its supply of Product from Skye, and Skye is willing to grant Enzon an exclusive license to market and sell the Product in the Territory (as defined below) and supply Enzon with its requirements of Product, all upon the terms and
conditions recited hereinafter. 
 NOW, THEREFORE, in
consideration of the foregoing preliminary statements and the mutual agreements and covenants set forth herein, the Parties (as defined below) hereby agree as follows: 
 1. DEFINITIONS. 
 As used in this Agreement the following
terms shall have the meanings set forth in this Section 1 unless context dictates otherwise: 
 1.1
“AAA” shall have the meaning assigned to such term in Section 17.2. 
 1.2
“Additional Indication” shall have the meaning assigned to such term in Section 3.4.3. 

1.3 “Affiliate” shall mean, with respect to a Party, any entity controlling, controlled by, or under
common control with, such Party. For these purposes, “control” shall refer to (i) the possession, directly or indirectly, of the power to direct the management or policies of an entity, whether through the ownership of voting
securities, by contract or otherwise, or (ii) the ownership, directly or indirectly, of at least fifty percent (50%) of the voting securities or other ownership interest of an entity. 

 1.4 “Agreement” shall mean this supply and distribution
agreement together with the preliminary statements and all exhibits, schedules and attachments hereto. 
 1.5
“Breaching Party” shall have the meaning assigned to such term in Section 11.2. 
 1.6
“Calendar Quarter” shall mean a period of three (3) consecutive months ending at midnight, eastern time on the last day of March, June, September, or December, respectively. 

1.7 “CFR” shall mean the United Stales Code of Federal Regulations. 

1.8 “cGMP” shall mean current Good Manufacturing Practice as defined in Parts 210 and 211 of Title 21 of
the CFR, as may be amended from time to time, or any successor thereto. 
 1.9 “Chiron” shall
have the meaning assigned to such term in the second preliminary statement. 
 1.10 “Chiron Acquisition
Agreement” shall have the meaning assigned to such term in the third preliminary statement. 
 1.11
“Commercially Reasonable Efforts” shall mean, with respect to a Party, those commercially reasonable efforts by that Party similar to the efforts that Party in good faith believes it would make in similar circumstances for its own
operations at that time, it being understood that a Party’s Commercially Reasonable Efforts will not in any event require that Party to take any action that would be reasonably likely to result in a breach of any other provision of this
Agreement, or any other agreement between the Parties, or any other agreement between a Party, Affiliate of such Party and/or Third Parties existing as of the Effective Date, or that the Party in good faith believes may violate any applicable law,
regulation, rule, order, permit, direction or license of any court or governmental authority having appropriate jurisdiction over the Party and subject matter or would be reasonably likely to be disruptive of any material service conducted or
product made at or from any of its facilities or impair its ability to provide services or Product hereunder. 

1.12 “Confidential Information” shall mean, with respect to either Party, all confidential or
proprietary information and materials, patentable or otherwise, in any form (written, oral, photographic, electronic, magnetic, or otherwise) which is disclosed by or on behalf of such Party to the other Party pursuant to and in contemplation of
this Agreement, inducing, without limitation, information relating to the Product or any other product of either Party and the pricing thereof; provided that such Confidential Information is identified as confidential either: (i) at the
time of disclosure; or (ii) in writing, within thirty (30) days of disclosure. 
 1.13
“Contract Year” shall mean each calendar year period during the Term; provided, however, that the first such Contract Year shall commence on the Effective Date and end on December 31, 2003 and the last such
Contract Year shall end on the final day of the Term. “Contract Year One” shall mean the first such year; “Contract Year Two” shall mean the second such year, and so on, year-by-year. 

1.14 “Disclosing Party” shall have the meaning assigned to such term in Section 10.1. 

1.15 “Effective Date” shall mean the date of this Agreement as set forth in the Preamble. 

1.16 “Enzon” shall have the meaning assigned to such term in the preamble. 

  
 -2-

 1.17 “Executive Officers” shall have the meaning assigned
to such term in Section 17.1. 
 1.18 “Failure to Supply” shall have the meaning assigned
to such term in Section 5.8. 
 1.19 “FDA” shall mean the United States Food and Drug
Administration, or any successor agency having regulatory jurisdiction over the manufacture, distribution and sale of drugs in the United States, and its territories and possessions. 

1.20 “FDC Act” shall mean the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §321 et seq., as
amended, and the regulations promulgated thereunder from time to time. 
 1.21 “Generic Event”
shall mean when a generic pharmaceutical product that is therapeutically equivalent to the Product is sold in the Territory and Unit sales of the Product in the Territory in any subsequent [**] ([**]) sequential calendar quarters decrease by [**]
percent ([**]%) or more as compared to the prior [**] ([**]) sequential calendar quarters of sales. As used in this definition, “therapeutically equivalent” means that, for purposes of the United States, an AB rating is assigned to the
product’s entry in the list of drug products with effective approvals published in the then-current edition of FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations” and any current supplement to the
publication (also known as the “Orange Book”) referred to in 21 CFR 314.3 and such product is covered by an Abbreviated New Drug Application (as defined in the FDC Act). For purposes of other countries in the Territory, as used in this
definition, “therapeutically equivalent” means that a rating equivalent to the FDA’s AB rating is assigned to the product by that country’s Regulatory Authority. 

1.22 “Gross Margin” shall mean, with respect to a Unit of Product, the Net Unit Selling Price of such
Product less the minimum Supply Price with respect to such Product of [**] U.S. Dollars (US$[**]) per Unit. 

1.23 “IND” shall mean any filing made with an appropriate Regulatory Authority in the respective
jurisdiction within the Territory for initiating clinical trials in such jurisdiction with respect to the use of the Product in an Additional Indication. 
 1.24 “HPB” shall mean the Health Protection Branch of Health Canada, or any successor agency having regulatory jurisdiction over the manufacture, distribution and sale of drugs in Canada.

 1.25 “Indemnitee” shall have the meaning assigned to such term in Section 13.3.

 1.26 “Indemnitor” shall have the meaning assigned to such term in Section 13.3.

 1.27 “Infringement” shall have the meaning assigned to such term in Section 15.1.

 1.28 “Initial Term” shall have the meaning assigned to such term in Section 11.1.

 1.29 “Laboratory” shall have the meaning assigned to such term in Section 5.6.2.

 1.30 “Marketing Plan” and “Marketing Plans” shall have the meaning assigned
to such terms in Section 3.3. 
 1.31 “Minimum Annual Net Sales” shall have the meaning
assigned to such term in Section 8.1.2. 

  
 -3-

 1.32 “Neo-plastic Indication” shall mean the use of the
Product in the treatment of solid tumor neo-plastic meningitis. 
 1.33 “Net Sales” shall mean
the aggregate of all Net Unit Selling Prices for Units sold in the Territory by Enzon, its Affiliates and sub-distributors, if any. 
 1.34 “Net Unit Selling Price” shall mean, with respect to each Unit of the Product, the gross invoiced sales price with respect thereto, less the total value of the following deductions
to the extent included in the gross invoiced sales price for the Unit of Product or otherwise directly paid or incurred by Enzon, its Affiliates or sub-distributors, if any, with respect to the sale of such Unit of Product: (i) reasonable and
customary discounts, credits, rebates, allowances, and adjustments; (ii) price reductions or rebates retroactively or otherwise imposed by government authorities; (iii) sales, excise, turnover, value-added, and similar taxes assessed on
the sale of Product (but excluding income taxes); (iv) transportation and importation directly chargeable to the sale of Product; (v) credits or refunds actually allowed for returned Product; and (vi) reasonable and customary charge
backs granted to drug wholesalers based upon sales to their customers, if any; provided however, that total aggregate deductions per Unit shall be not more than what is reasonable and customary in the industry and consistent with Enzon’s
normal business practices. 
 1.35 “Non-breaching Party” shall have the meaning assigned to
such term in Section 11.2. 
 1.36 “Party” shall mean Skye or Enzon and, when used in the
plural, shall mean Skye and Enzon. 
 1.37 “Phase IV Trial” shall have the meaning assigned to
such term in Section 3.4.2. 
 1.38 “Product” shall mean the formulation of cytarabine
known as DTC 101 which is currently sold under the tradename DepoCyt as further described on Exhibit 1.38. 
 1.39 “Product Specifications” shall mean the specifications for the Product set forth on Exhibit 1.39 and such other packaging and labeling specifications as are approved by the
applicable Regulatory Authorities. 
 1.40 “Q1” shall have the meaning assigned to such term in
Section 5.2. 
 1.41 “Receiving Party” shall have the meaning assigned to such term in
Section 10.1. 
 1.42 “Registration” shall mean, with respect to each country in the
Territory, written approval of a Registration Application for the Product filed in such country, including pricing or reimbursement, where applicable, by the Regulatory Authority in such country. 

1.43 “Registration Application” shall mean a New Drug Application under the FDC Act and the regulations
promulgated thereunder, or a comparable filing for Registration in a country, in each case with respect to the Product in the Territory. 
 1.44 “Regulatory Authority” shall mean the FDA in the U.S., the HPB in Canada, and any successor(s) thereto as well as any other state or local health regulatory authorities having
jurisdiction for any activities contemplated by the Parties. 
 1.45 “Renewal Term” shall have
the meaning assigned to such term in Section 11.1. 
 1.46 “Skye” shall have the meaning
assigned to such term in the second preliminary statement. 

  
 -4-

 1.47 “Skye Know-How” shall mean all information and data,
which is not generally known, including formulae, procedures, protocols, techniques and results of experimentation and testing, which are necessary or useful to make, use, develop, sell or seek regulatory approval in the Territory to market the
Product, which Skye owns or controls and which is in the possession of Skye on the Effective Date or thereafter during the Term. 
 1.48 “Skye Patents” shall mean all patents (including, without limitation, all reissues, extensions, substitutions, re-registrations, re-examinations, re-validations, supplementary
protection certificates and patents of addition) and patent applications (including, without limitation, all provisional applications, continuations, continuations-in-part and divisions) which are useful or necessary for the development,
manufacture, use, marketing or sale of Product and which Skye owns, possesses or controls during the Term. A list of the Patents as of the Effective Date is attached as Exhibit 1.48. 

1.49 “Skye Technology” shall mean the Skye Know-How and the Skye Patents. 

1.50 “Supply Price” shall have the meaning assigned to such term in Section 8.1.1. 

1.51 “Term” shall have the meaning assigned to such term in Section 11.1. 

1.52 “Territory” shall mean the United States and Canada. 

1.53 “Testing Methods” shall have the meaning assigned thereto in Section 5.6. 

1.54 “Third Party” shall mean any person who or which is neither a Party nor an Affiliate of a Party.

 1.55 “Trademark(s)” shall mean the DepoCyt trademark that Skye has registered in the United
States and applied for registration in Canada in connection with the Product, or such other trademark that Skye registers for use with the Product. 
 1.56 “Unit” shall mean a vial of the Product as described in Exhibit 1.38. 
 1.57 “United States” or “U.S.” shall mean The United States of America, including its possessions and territories. 

2. REPRESENTATIONS, WARRANTIES AND COVENANTS. 

2.1 Representations by Each Party. Each Party hereby represents and warrants to the other Party, as of the
Effective Date, that: 
 2.1.1 such Party (i) is a corporation duly organized, validly existing and in good
standing under the laws of the jurisdiction in which it is incorporated; (ii) has the corporate power and authority and the legal right to own and operate its property and assets, to lease the property and assets it operates under lease, and to
carry on its business as it is now being conducted; and (iii) is in compliance with all requirements of applicable law, except to the extent that any noncompliance would not have a material adverse effect on the properties, business, financial
or other condition of such Party and would not materially adversely affect such Party’s ability to perform its obligations under this Agreement; 
 2.1.2 such Party (i) has the corporate power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder; and (ii) has taken all necessary corporate
action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. The Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding
obligation, enforceable against such Party in accordance with its terms; 

  
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 2.1.3 such Party has obtained all necessary consents, approvals and
authorizations of all governmental authorities and Third Parties required to be obtained by such Party in connection with this Agreement; and 
 2.1.4 the execution and delivery of this Agreement and the performance of such Party’s obligations hereunder (i) do not, to the best of such Party’s knowledge, conflict with or violate any
requirement of applicable laws or regulations; and (ii) do not conflict with, or constitute a default under, any contractual obligation of such Party. 
 2.2 Representations by Skye. Skye hereby represents, warrants and covenants to Enzon that: 
 2.2.1 Skye is the owner of, or has exclusive rights to, all of the Skye Patents in existence on the Effective Date, and has the exclusive right to grant the rights granted under this Agreement. Without
limiting the foregoing, Skye has made all payments necessary to effect the closing of the Chiron Acquisition Agreement on or before the Effective Date. No Skye Patent is, or during the Term of this Agreement will be, the subject of any lien or other
encumbrance that interferes or could in the future interfere with Enzon’s enjoyment of the rights granted to Enzon in this Agreement. To the knowledge of Skye, all of the issued Skye Patents as of the Effective Date are valid, in full force and
effect and have been maintained to date, and are not the subject of any interference or opposition proceedings; 

2.2.2 there is no pending or, to the knowledge of Skye, threatened claim, interference, opposition or demand of any Third
Party challenging the ownership, validity or scope of any of the Skye Patents in existence as of the Effective Date; 
 2.2.3 Skye is the owner of a Registration for the Product in the lymphomatous meningitis indication in the U.S. and in Canada and, to the knowledge of Skye, each of such Registrations is in full force and
effect and has been maintained to date; 
 2.2.4 Skye shall perform its obligations as set forth in this
Agreement, in compliance with good laboratory and clinical practices and cGMP, in each case as applicable under the laws and regulations of the Territory; 
 2.2.5 Skye has not entered into any agreement with any Third Party that is in conflict with the rights granted to Enzon pursuant to this Agreement; and 

2.2.6 as of the Effective Date, the amount of the Product in the distribution channel does not exceed a six (6) week
inventory of such Product based on historical, customary sales levels for the Product in the normal course of business. 
 2.3 Representations by Enzon. Enzon hereby represents, warrants and covenants to Skye that: 
 2.3.1 Enzon shall use Commercially Reasonable Efforts to market and sell the Product throughout the Territory; 
 2.3.2 Enzon shall comply with all applicable laws, rules and regulations (including, without limitation, those applicable to the importation and exportation of Product) in connection with the performance
of its obligations under this Agreement; 

  
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 2.3.3 Enzon is legally qualified to conduct the business contemplated herein
in all jurisdictions where such qualification is necessary to perform its obligations under this Agreement, except to the extent that failure to so qualify would not have a material adverse effect on its business or on its performance of such
obligations; and 
 2.3.4 Enzon shall make no warranty, guaranty or other assurance with regard to the Product
other than as set forth in Section 9. 
 3. APPOINTMENT; RIGHTS AND
OBLIGATIONS. 
 3.1 Appointment. Subject to the terms and conditions of this Agreement and
Chiron’s rights under the Chiron Acquisition Agreement to supply transitional services and use the Trademark in connection therewith, Skye hereby appoints Enzon as of the Effective Date to be its exclusive distributor for the sale of the
Product in the Territory. Enzon hereby accepts such appointment and agrees to fulfill its obligations and responsibilities as set forth in this Agreement. In connection with the appointment of Enzon set forth herein, and subject to Chiron’s
rights under the Chiron Acquisition Agreement to supply transitional services and use the Trademark in connection therewith, Skye hereby grants to Enzon as of the Effective Date: 

3.1.1 the exclusive right and license (including as to Skye) under the Skye Technology to use, market, sell, have sold
and distribute the Product in the Territory during the Term; and 
 3.1.2 the exclusive right and license to use
the Trademark(s) and Skye’s trade name in each country of the Territory during the Term in connection with the marketing and sale of Product as contemplated in this Agreement. 

3.2 Right to Appoint Sub-distributors. Enzon shall have the right to appoint sub- distributors of the Product in
the Territory; provided that no such appointment shall be valid unless: (i) Enzon shall guarantee and be responsible for the making of all payments due, and the making of any reports under this Agreement, with respect to sales of Product
by its sub- distributors and their compliance with all applicable terms of this Agreement; and (ii) each sub- distributor agrees in writing to maintain books and records and permit Skye to review such books and records pursuant to the relevant
provisions, and to observe all other applicable terms, of this Agreement. 
 3.3
Marketing Plan. Within forty-five (45) days of the Effective Date, and on or before
November 15th of each Contract Year during the Term,
Enzon shall provide to Skye, for its review and approval (which approval shall not be unreasonably withheld), Enzon’s marketing plan for the Product for the following Contract Year (each such plan a “Marketing Plan”, and
collectively, the “Marketing Plans”). Each Marketing Plan which shall include, without limitation, good faith purchase and distribution objectives, Net Sales targets and projections with respect to sales force staffing levels,
marketing research, physician education, advertising and detailing. 
 3.4 Maintenance of Registration(s);
Additional Development Efforts. 
 3.4.1 Skye shall use Commercially Reasonable Efforts to maintain in full
force and effect the Registrations for the Product, and to comply with all conditions attached to such Registrations. 
 3.4.2 The Parties acknowledge that Skye is currently conducting a phase IV clinical trial entitled Skye 0101-010 as set forth in Exhibit 3.4 (the “Phase IV Trial”). Skye shall at
its sole expense, use Commercially Reasonable Efforts to conduct the Phase IV Trial, as may be 

  
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amended by Skye from time to time in consultation with the FDA and Enzon, as may be applicable, and prepare and file any and all Registration Applications and other regulatory filings in the
Territory through and including Registration, and, thereafter shall use Commercially Reasonable Efforts to maintain any such Registrations. 
 3.4.2.1 For the avoidance of doubt, Skye shall not be required to (i) undertake any clinical trials not set forth in the clinical plan annexed hereto as Exhibit 3.4 unless required to do so by the
FDA to maintain the Registration of the Product in the lymphomatous meningitis indication or any other indication(s) that may be approved; and/or (ii) prepare or file any Registration Applications or other regulatory filings with respect to the
Neo-plastic Indication unless the clinical trials conducted by Skye pursuant to Section 3.4.2 produce statistically significant results sufficient to support such a filing. 

3.4.2.2 To better allow Enzon to prepare to market the Product in the Neo-plastic Indication following receipt of
Registration, Skye agrees to provide to Enzon copies of all protocols and other documentation related to the conduct of the clinical trials for Enzon’s review and comment and, to the extent reasonable, permit Enzon, at its sole cost and
expense, to participate in meetings with investigators and clinicians regarding such clinical trials. 
 3.4.3
The Parties also recognize that from time to time Skye may conduct research resulting in the discovery that the Product demonstrates utility outside the currently approved indication of lymphomatous meningitis and the Neo-plastic Indication (each
such use, an “Additional Indication”). In each such case, Skye shall, as may be appropriate, in its sole discretion, conduct all clinical trials and prepare and file any and all INDs, Registration Applications and other regulatory
filings for the use of the Product in any Additional Indication in the Territory through and including Registration, and, thereafter shall be responsible for maintaining such Registrations, as it may deem appropriate, in its sole discretion;
provided however, that in the event the Parties determine that there is an Additional Indication that they wish to develop together, they shall negotiate in good faith the funding responsibilities of the respective Parties as well as
appropriate changes to the financials regarding the supply and distribution of the Product for such Additional Indication(s), including but not limited to adjustments to the Supply Price, which shall be set forth in an amendment or addendum to this
Agreement, as may be appropriate. 
 3.4.4 Skye shall appoint, and hereby does appoint, Enzon as its exclusive
distributor under the Skye Technology to use, market, sell, have sold and distribute the Product in the Neo-plastic Indication and, subject to the provisions of Section 3.4.3, any Additional Indication(s) that may be developed by Skye during
the Term for which Registration may be obtained. 
 4. SALES AND MARKETING. 

4.1 Obligations of Enzon. During the term of this Agreement, Enzon shall use Commercially Reasonable Efforts to
promote, sell and distribute the Product to customers within the Territory as if Enzon were undertaking such efforts for a product of its own. Enzon shall be solely responsible for, and shall bear all costs associated with, all marketing activities
related to the Product in the Territory including, but not limited to, the development of advertising campaigns, sales material, trade show support and educational campaigns; provided, however, that to the extent that it is permitted to do
so, Skye shall provide to Enzon, free of charge, access to the marketing materials (including detail aids, promotional tools, graphics, slides and journal advertisements) used by Skye’s distributors of the Product outside the Territory. Any and
all costs associated with such access including, without limitation, copying and/or printing expenses or other costs of transferring such marketing materials to the Territory shall be the sole responsibility of Enzon. Furthermore, Enzon agrees that
it shall: 
 4.1.1 use Commercially Reasonable Efforts to satisfy the demand for the Product throughout the
Territory and attempt to increase the demand for such Product by, among other things, servicing substantially all customer accounts with reasonable frequency; 

  
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 4.1.2 maintain adequate sales and warehouse facilities and employ a
sufficient number of experienced and qualified personnel to promote the sale of the Product and perform the activities approved and set forth in the Marketing Plan; 

4.1.3 maintain a sufficient inventory of Product and support material to reasonably fulfill the requirements of its
customers in the Territory; 
 4.1.4 maintain adequate records concerning the sale of the Product as required by
any applicable Regulatory Authority in the Territory; 
 4.1.5 use only advertising literature approved by Skye;
provided that Enzon shall submit such advertising literature to Skye at least fifteen (15) business days in advance of its intended use of same and such advertising literature shall be deemed to have received Skye’s approval unless
Skye provides Enzon with written notice of rejection within fifteen (15) business days following submission by Enzon; 
 4.1.6 immediately forward to Skye information concerning any and all charges, complaints or claims reportable to any Regulatory Authority relating to the Product that may come to Enzon’s attention;
and 
 4.1.7 obtain and maintain in full force and effect all necessary licenses, permits, records and
authorizations required by law (excluding the Registrations for the Product) and fully observe and comply with all applicable laws, ordinances, rules and regulations including, but not limited to, those of the applicable Regulatory Authorities.

 4.2 Trademark; Logos. Enzon shall market the Product throughout the Territory under the Trademark(s)
and all marketing materials for the Product shall display the Trademark(s). In addition: (i) all marketing materials shall display the trade names and logos of Skye and Enzon, subject in all cases to the requirements of the applicable
Regulatory Authorities; and (ii) all labeling and packaging shall state that the Product is manufactured by Skye and distributed by Enzon. 
 4.3 Extra-territorial Sales. The Parties acknowledge that some of Enzon’s customers in the Territory may have facilities/operations located outside the Territory where Product may be shipped
for use. The Parties also acknowledge that Skye already has appointed, and/or intends to appoint, Third Parties to distribute Product outside the Territory. Therefore, during the Term, Enzon agrees to undertake in good faith and use Commercially
Reasonable Efforts not to market or sell Product to or for: 
 4.3.1 customers located entirely outside the
Territory; or 
 4.3.2 customers who Enzon reasonably believes intend to use Product purchased from Enzon
primarily outside the Territory. 
 5. SUPPLY. 

5.1 Generally. Subject to the terms and conditions of this Agreement, Skye shall supply Enzon, and Enzon shall
purchase from Skye, all of Enzon’s requirements of Product for sale in the Territory. Skye shall maintain sufficient inventory of the Product to fulfill its supply obligations under this Section 5. 

  
 -9-

 5.2 Forecasts. Enzon’s initial forecast of Units of Product
estimated to be required on; a quarterly basis during the first twelve (12) months after the Effective Date shall be provided by Enzon to Skye within ten (10) days after the Effective Date, and shall serve as the first firm commitment for
quantities of Product (for the current Calendar Quarter) and rolling written forecast required by this Section 5.2. Thereafter not later than ninety (90) days prior to the first day of each Calendar Quarter (“Q1”), Enzon
shall place a firm commitment for quantities of the Product, in writing, for Q1 and simultaneously indicate its estimated requirements for each of the following three (3) Calendar Quarters, 

5.3 Orders. All orders of Product shall be made on Enzon’s form of purchase order; however, each
purchase order or any acknowledgement thereof, whether printed, stamped, typed or written shall be governed by the terms of this Agreement and none of the provisions of such purchase orders or acknowledgements shall be applicable, except those
specifying the quantity of Product ordered or general delivery date and shipping instructions and other general non-contractual invoice information. 
 5.3.1 Enzon shall submit orders for Product at least ninety (90) days in advance of its requested delivery date. 

5.3.2 Said orders shall be consistent with Skye’s current minimum batch sizes for the Product, or multiples thereof,
currently estimated to be between [**] ([**]) and [**] ([**]) Units. 
 5.3.3 Notwithstanding the foregoing,
Skye will be required to accept firm orders for Product placed in Q1 only for quantities equal to the lesser of: (i) the quantities of such Product reflected in the most recent forecast for Q1, (ii) +/-[**]% of the quantities of such
Product reflected for Q2 in the forecast provided immediately preceding the most recent forecast, and (iii) +/-[**]% of the quantities of such Product reflected for Q3 in the forecast provided immediately preceding the forecast referred to in
subclause (ii). Skye will use Commercially Reasonable Efforts to supply quantities of Product exceeding the amounts set forth in this Section 5.3.3; provided however the Parties agree that Skye does not have an obligation to do so
pursuant to this Agreement. 
 5.4 Packaging. Enzon and Skye shall agree upon the secondary packaging of
the Product for the Territory. Skye shall be responsible for the content of the prescribing information and Enzon shall be responsible for correctly labeling and packaging the Product supplied by Skye hereunder, which labeling and packaging shall in
all cases be in compliance with all requirements of the applicable Regulatory Authorities. 
 5.5
Shipment. All Product shall be shipped FOB Skye’s facility in San Diego, United States, via the carrier specified in Enzon’s purchase order or, if not specified, by any commercially reasonable carrier, to the location specified by
Enzon in its purchase order. Freight and insurance shall be for the account of Enzon, and all risk of loss, delay or damage in transit shall be with Enzon from and after delivery to the carrier. Each shipment of Product hereunder shall be
accompanied by a certified quality control protocol and certificate of analysis for each lot of Product therein as set forth in Section 7.2.4, as well as such customs and other documentation as is necessary or appropriate. Enzon shall notify
Skye of any partial loss, damage, defect or non-delivery of any shipment, or part thereof within five (5) business days after delivery of such shipment to Enzon or, if such loss, damage or non-delivery is not evident at the time of delivery,
not later than thirty (30) days after delivery, or such longer period as may be agreed upon by the Parties. 
 5.6 Acceptance/Rejection. Within thirty (30) days from the date of receipt of each shipment of the Product, and prior to releasing such Product for sale to customers, Enzon shall

  
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conduct (i) a visual inspection of the Product for defects or damages; (ii) an inspection of all associated quality assurance documents, including, without limitation, the certificate
of analysis; and (iii) random testing of Units of Product which shall be done in accordance with the test procedures established by Skye from time to time (the “Testing Methods”). Enzon shall have the right to return any
Product to the extent Enzon determines that the Product fails to conform with the Product Specifications following such inspection. All or any part of any shipment may be held for Skye’s disposition and at Skye’s expense if found to be not
in conformance with the Product Specifications. 
 5.6.1 All Product delivered to Enzon hereunder shall be
deemed to materially conform with the Product Specifications unless Skye receives from Enzon written notice, not later than thirty (30) days after Enzon’s receipt of a given shipment, specifying the shipment, purchase order number and the
exact nature of the failure of such shipment to conform, along with reasonable evidence of such non-conformity (including a sample of the Product from the shipment analyzed); provided, however, that Enzon’s failure to advise Skye in a
timely manner that a shipment of the Product does not conform to the Product Specifications shall not prejudice Enzon’s right to reject or revoke acceptance of the Product if the defect or other non-conforming condition which justifies
rejection or revocation could not have been detected by Enzon’s inspection undertaken pursuant to Section 5.6. 
 5.6.2 If at any time Enzon does not accept, or revokes its acceptance of, all or any part of a shipment of the Product, then the Parties shall have sixty (60) days from the date of Skye’s
receipt of Enzon’s notification to resolve any dispute regarding whether all or any part of such shipment of the Product conforms with the Product Specifications. Disputes between the Parties as to whether all or any part of a shipment rejected
by Enzon conforms with the Product Specifications not resolved in the sixty (60) day period shall be resolved by an independent cGMP testing laboratory or consultant acceptable to both Enzon and Skye (the “Laboratory”). The
determination of the Laboratory with respect to all or part of any shipment of Product shall be final and binding upon the Parties. The fees and expenses of the Laboratory making such determination shall be paid by the Party against which the
determination is made. 
 5.7 Replacement Product. If any Product is determined not to conform to the
Product Specifications, upon Enzon’s request, Skye shall promptly deliver, or cause to be delivered, to Enzon conforming Product in the same quantity as the rejected Product. 

5.8 Failure to Supply. In the event that for a period of not less than [**] ([**]) consecutive months Skye has
shipped none of the quantities of Product ordered by Enzon during such [**] ([**]) month period (a “Failure to Supply”): 
 5.8.1 the Minimum Annual Net Sales requirements set forth in Section 8.1.2 shall be waived for the Contract Year(s) in which such Failure to Supply occurs and continues to occur; and 

5.8.2 in the event that such a Failure to Supply occurs during Contract Year One or Contract Year Two, Skye shall pay to
Enzon a one-time only payment of [**] U.S. Dollars (US$[**]) within thirty (30) days of the expiration of the [**] ([**]) month period as liquidated damages for such Failure to Supply and in lieu of any and all other payments (including, but
not limited to, damages or other relief in the event of a termination by Enzon for breach by Skye under Section 11.2) to Enzon. In the event that such a Failure to Supply occurs during Contract Year Three or thereafter, no payment shall be due
Enzon under this Section 5.8.2, provided however, that at such time and in the event of termination of this Agreement by Enzon pursuant to Section 11.2, Enzon shall be entitled to seek damages for such Failure to Supply. 

  
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 6. REGULATORY MATTERS. 

6.1 Adverse Experience Reporting. Skye and Enzon shall report to the other any information of which they have
knowledge concerning any adverse drug experience in connection with the use of the Product, including the incidence or severity thereof, associated with non-clinical toxicity studies, clinical uses, studies, investigations or tests, whether or not
determined to be attributable to the Product Reports of routine adverse drug experiences of the type defined in Section 214.80 of Title 21 of the CFR shall be exchanged by each Party on a Calendar Quarter basis. Reports of serious adverse drug
experiences of the type defined in Sections 312.32 and 314.80 of Title 21 of the CFR shall be made available to the other Party within twenty-four (24) hours after a Party becomes aware of such serious adverse drug experience. Upon receipt of
any such information concerning any serious adverse drug experience by either Skye or Enzon, the Parties shall promptly consult each other and use Commercially Reasonable Efforts to arrive at a mutually acceptable procedure for taking such possible
actions as appropriate or required under the circumstances; provided, however, that nothing contained herein shall be construed as restricting the right or duty of either Party to make a required report or submission to the FDA, or take any
other action that it deems to be appropriate or required by applicable law or regulation. Notwithstanding anything to the contrary contained in this Agreement, Skye shall be responsible for making all reports of adverse drug experience to the FDA
and/or any other applicable Regulatory Authority. 
 6.2 Recall Action. 

6.2.1 In the event Skye is required or voluntarily decides to initiate a recall, withdrawal, or field correction of the
Product, Skye shall notify Enzon and provide a copy of its proposal, including the recall letter, for review prior to initiation of such action and the Parties shall fully consult and cooperate with each other concerning the need for such a recall
and in order to develop and execute a recall plan, as necessary. In conjunction with such recall, Enzon shall assist, at Skye’s sole discretion and expense, in the investigation to determine the cause and extent of the problem. 

6.2.2 In the event that Enzon independently believes that a recall, withdrawal, or field correction of the Product may be
necessary or appropriate, Enzon shall notify Skye of Enzon’s belief, and the Parties shall fully cooperate with each other concerning the necessity and nature of such action. 

6.2.3 All coordination of any recall or field correction activities involving Product shall be handled by Skye, in
cooperation with Enzon, whether or not such action was initially requested by Enzon. 
 6.3 Recall
Expenses. In the event that any Product is recalled as a direct result of the negligent or intentionally wrongful acts or omissions of Enzon or its representatives, then Enzon shall bear all of the costs and expenses of such recall, including
expenses related to communications and meetings with all required regulatory agencies, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of recalled Product from customers and shipment of an equal
amount of replacement Product to those same customers. In the event that any Product is recalled as a direct result of the negligent or intentionally wrongful acts or omissions of Skye or its representatives or as result of Product misbranding or
failure to meet Product Specifications, then Skye shall bear all of the costs and expenses of such recall, including expenses related to communications and meetings with all required regulatory agencies, expenses of replacement stock, the cost of
notifying customers and costs associated with shipment of recalled Product from customers and shipment of an equal amount of replacement Product to those same customers. To the extent that the reason for any recall of Product hereunder is in part
the responsibility of Skye and in part the responsibility of Enzon or is not due to the fault of either Party, then the expenses shall be allocated in an equitable manner between the Parties. 

  
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 6.4 Debarment. Each of Enzon and Skye represent that it is not
debarred under the Generic Drug Enforcement Act of 1992 and that it does not employ or use the services of any person or entity who is debarred or has engaged in activity that could lead to debarment. 

7. MANUFACTURE. 
 7.1 Manufacturing Rights. Except as otherwise provided herein, Skye shall have the exclusive right to manufacture or have manufactured the Product in the Territory. 

7.2 Manufacturing Obligations. 

7.2.1 The Product shall be manufactured in accordance with cGMPs promulgated by the FDA, the Product Specifications and
in accordance with the regulatory specifications and methods described and approved in the Registration. 

7.2.2 For quality control, Skye shall conduct in-process and final controls in accordance with the Testing Methods. Skye
shall be responsible for the validation of all manufacturing processes and processing systems and shall maintain its programs for change control for the validated process, systems, and computer systems. 

7.2.3 Skye shall store for each shipment of manufactured Product the respective documentation as well as retain a sample
for one (1) year beyond expiration of the Product. Skye shall provide quality control examination of the retained sample representing the beginning, middle and end of the packaging operation prior to release to assure the Product’s
packaging is in accordance with the Product Specifications. 
 7.2.4 Skye shall provide a certificate of
analysis to Enzon for each batch of the Product delivered hereunder. 
 7.2.5 Skye will provide final reports,
including recommendation for the Product disposition for all investigations involving: 
 7.2.5.1 foreign
matter/particulate contamination; 
 7.2.5.2 initial sterility test failure (if applicable); and 

7.2.5.3 initial endotoxin test failure (if applicable). 

7.2.6 Skye shall be responsible for the investigation of any Product complaints arising from the manufacturing process,
packaging or labeling following notification from Enzon. 
 7.2.7 Skye will provide Enzon with annual product
reviews which will include complaint and stability analysis. Such reviews shall be available at time of audits or upon reasonable request. 
 7.2.8 Skye will provide Enzon with Material Safety Data Sheets as required for the Product, and updates as necessary. 

7.2.9 Skye shall be responsible for maintaining compliance with official compendia. 

  
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 7.3 Inspections. In performing its obligations hereunder, Skye shall:

 7.3.1 At any time during the Term, but not more than once per Contract Year, permit Enzon’s
representatives to inspect, upon reasonable prior notice, which shall in no case be less than fifteen (15) days, and during normal business hours, Skye’s facilities where the Product is manufactured or stored to review Skye’s
compliance with the Product Specifications, applicable environmental, health and safely regulations, cGMP and good laboratory practices, and to evaluate Skye’s capability for responding effectively to any spills or releases of hazardous
materials utilized or produced by Skye in the manufacture of the Product. In the event such representatives conclude that any non-conformity exists with respect to such Product Specifications or regulations: (i) the Parties, in addition to any
other rights or remedies available to such Parties, shall use their respective diligent efforts to resolve the issue as promptly as possible, and (ii) Skye shall permit Enzon’s representatives to re-inspect such facilities thereafter to
determine whether such non-conformity has been rectified. 
 7.3.2 Report to Enzon as soon as possible any of
the following incidents related to the manufacture of the Product: 
 7.3.2.1 fire; 

7.3.2.2 explosion; 
 7.3.2.3 environmental event; 
 7.3.2.4 serious injury; and/or

 7.3.2.5 physical damage. 

7.3.3 Permit Enzon to review Skye’s licenses and permits relating to the manufacture of the Product. 

7.3.4 Notify Enzon of any inspection by the FDA, or similar government regulatory entity, of any facility where the
Product is manufactured where such inspection could result in an adverse effect on the Product, and provide a copy of the results of that inspection and corrective actions taken or to be taken in response to their observations. 

8. CONSIDERATION; PAYMENTS; REPORTS. 

8.1 Supply Price; Minimums. 

8.1.1 In consideration of the Product supplied, licenses granted and the services provided by Skye under this Agreement,
Enzon shall pay to Skye the price (the “Supply Price”) for Product ordered and shipped hereunder equal to the greater of: (i) (A) [**] percent ([**]%) of the Net Unit Selling Price on annual Net Sales up to and including
[**] U.S. Dollars (US$[**]); and (B) [**] ([**]%) of the Net Unit Selling Price on incremental annual Net Sales in excess of [**] U.S. Dollars (US$[**]); or (ii) [**] U.S. Dollars (US$[**]) per Unit. The Supply Price shall be paid as
follows: 
 8.1.1.1 Skye shall submit invoices to Enzon for payment of [**] U.S. Dollars (US$[**]) per Unit for
quantities of Product ordered promptly after each shipment thereof. Payments shall be made by Enzon within forty-five (45) days of the invoice date; and 

  
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 8.1.1.2 within sixty (60) days after the end of each Calendar Quarter
during the Term, Enzon shall provide Skye with a quarterly reconciliation report, in the form attached hereto as Exhibit 8.1.1, that reflects (i) the calculation of the actual Net Unit Selling Price, (ii) aggregate Net Sales that
accrued during such Calendar Quarter, (iii) the amount previously invoiced by, and paid to, Skye, and (iv) the reconciliation amount to be paid to Skye. Each such statement shall also set forth any amounts to be reimbursed to Enzon under
Section 8.3 with respect to any discounts, chargebacks, returns or rebates relating to sales of Product that occurred prior to the Effective Date, and be accompanied by payment of the amount set forth in the reconciliation, calculated as set
forth on Exhibit 8.1.1 together with reasonable evidence of the discount, chargeback, return and/or rebate amounts being reimbursed. For purposes of this Agreement, the Net Unit Selling Price and Net Sales shall accrue when the Product is
shipped by Enzon, its Affiliates or sub-distributors, if any. 
 8.1.2 Notwithstanding anything contained herein
to the contrary, and subject to Section 5.8 and this Section 8.1.2, Enzon agrees that Enzon, together with its Affiliates and sub-distributors, if any, shall achieve minimum annual Net Sales of Product in the Territory (the
“Minimum Annual Net Sales”) which, in the aggregate, shall not be less than as follows: 

8.1.2.1 by the end of Contract Year One, [**] percent ([**]%) of aggregate Net Sales for the Product during calendar
year 2002. Skye shall provide a report to Enzon of Net Sales for the Product during calendar year 2002 by February 28, 2002; 
 8.1.2.2 unless otherwise provided in Section 8.1.2.3, for each Contract Year thereafter and throughout the Term, [**] U.S. Dollars (US$[**]); 

8.1.2.3 in the event that: (i) Enzon is acquired (whether through merger, sale of stock representing sixty percent
(60%) or more of the outstanding voting stock of Enzon, or sale of all or substantially all of Enzon’s assets or otherwise), or (ii) a sale of the division or portion of the business of Enzon which markets and distributes the Product
is consummated; then for each Contract Year thereafter and throughout the Term, the Net Sales of Product in the Territory for the four (4) sequential calendar quarters immediately prior to the consummation of such event: and 

8.1.2.4 notwithstanding the preceding, all such Minimum Annual Net Sales requirements shall cease commencing with the
calendar quarter following the calendar quarter in which a Generic Event occurs, and the Minimum Annual Net Sales shall be pro rated for the Contract Year in which such Generic Event occurs. 

In the event Enzon fails to achieve the Minimum Annual Net Sales requirements set forth in this Section 8.1.2 during any Contract
Year, Enzon shall pay to Skye, within sixty (60) days of the end of such Contract Year, the difference between: (i) the aggregate Supply Price actually owed and/or paid by Enzon to Skye during such Contract Year; and (ii) the
aggregate Supply Price that would have been paid to Skye for such Contract Year upon the achievement of the Minimum Annual Net Sales requirements set forth herein. In addition to the foregoing, commencing in Contract Year Two, in the event Enzon
fails to achieve the Minimum Annual Net Sales requirements set forth in this Section 8.1.2 in any two consecutive Contract Years, Skye shall, in addition to any other rights or remedies available hereunder, be entitled to terminate this
Agreement pursuant to Section 11.3. 
 8.1.3 In the event that a Generic Event occurs, the Parties shall
discuss in good faith, for a period of thirty (30) days thereafter, whether, and to what extent, if any, changes should be made to the Supply Price to fairly allocate the economic burdens of such Generic Event between the Parties. 

  
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 8.1.4 In the event that, as a result of changes in market conditions beyond
the reasonable control of Enzon, the average Gross Margin for the Product during any two (2) consecutive Calendar Quarters falls below [**] percent ([**]%), the Parties shall meet and discuss appropriate changes, if any, to the minimum Supply
Price; provided however, that in no case shall the Supply Price fall below Skye’s fully burdened manufacturing cost plus [**] percent ([**]%). If after ninety (90) days of negotiations, the Parties are unable to agree on appropriate
changes, if any, to the minimum Supply Price, the matter shall be resolved through arbitration in accordance with the provisions set forth in Section 17.2. 

8.2 Milestones. 
 8.2.1 In further consideration of the Product supplied, licenses granted and the services provided by Skye under this Agreement, Enzon shall pay to Skye a non-refundable, non-creditable up-front payment
of [**] U.S. Dollars (US$[**]) upon the execution of this Agreement. 
 8.2.2 In further consideration of the
Product supplied, licenses granted and the services provided by Skye under this Agreement, Enzon shall, within thirty (30) days of the first occurrence of each event set forth in the table below, pay to Skye the corresponding non-refundable
milestone payment: 
  

			
	 MILESTONE EVENT
	 	MILESTONE PAYMENT
	 [**] of [**] in the [**] in any [**] ([**])

consecutive [**] equals [**] U.S. Dollars

(US$[**])
	 	[**] U.S. Dollars (US$[**])
		
	 [**] of [**] in the [**] in any [**] ([**])

consecutive [**] equals [**] U.S. Dollars

(US$[**])
	 	[**] U.S. Dollars (US$[**])
		
	 [**] in the [**] of the [**] for the [**] on or [**]
	 	[**] U.S. Dollars (US$[**])
		
	 [**] in the [**] of the [**] for the [**] after [**]

but on or before [**]
	 	[**] U.S. Dollars (US$[**])
		
	 [**] in the [**] of the [**] for the [**] after [**]
	 	[**] U.S. Dollars (US$[**])

8.3 Transitional Services. In further consideration of the Product supplied, licenses granted and the services
provided by Skye under this Agreement, Enzon shall reimburse Skye for payments to Chiron for those transitional services provided by Chiron pursuant to the Chiron Acquisition Agreement in connection with the wind-down by Chiron and transition of
responsibility for such services to Enzon, solely to the extent that Enzon has requested and approved such transitional services as set forth on Exhibit 8.3A. The transition services to be provided by Chiron which Enzon may request and fees
therefor are set forth on Exhibit 8.3B 

  
 -16-

 
which is attached hereto and made a part hereof. Skye shall submit invoices to Enzon for the payment of such requested and approved transitional services promptly after receipt of same from
Chiron. Payments shall be made by Enzon to Skye within thirty (30) days of the invoice date. In addition, if during the period commencing as of the Effective Date and ending on May 15, 2003, Enzon is charged any discounts, chargebacks,
rebates or returns with respect to sales of the Product, Skye shall reimburse Enzon for such amounts as set forth in Section 8.1.1.2. 
 8.4 Mode of Payment. Enzon shall make all payments required under this Agreement as directed by Skye from time to time in U.S. Dollars. For the purposes of computing Net Sales of Product sold in a
currency other than U.S. Dollars, such currency shall be converted into U.S. Dollars at an exchange rate equal to the buy rate of U.S. dollars published in the East Coast Edition of The Wall Street Journal for the last business day of the
applicable Calendar Quarter. Such payments shall be without deduction of exchange, collection or other charges. 

8.5 Late Charges. Amounts not paid when due as set forth in this Section 8 shall be subject to a late charge
at a rate of interest equal to the base lending rate on corporate loans posted by at least [**] percent ([**]%) of the U.S.’s largest banks, as reported on the date such payment is due by the East Coast Edition of The Wall Street Journal
as the prime rate, plus [**] percent ([**]%), with daily compounding of interest. Payment by Enzon of such late charges shall not foreclose any other rights or remedies which Skye may have hereunder with respect to such late payments. 

8.6 Records Retention. Enzon shall keep true, accurate and complete records with respect to the calculation of the
Net Unit Selling Price, Net Sales and Supply Price paid under this Agreement for a period of three (3) years after the year in which the sale of the Product generating the same occurred, and in sufficient detail to allow Skye to confirm the
accuracy of all payments made hereunder. 
 8.7 Audit Rights. At the request of Skye, Enzon, its
Affiliates and sub-distributors, if any, shall permit an independent certified public accountant appointed by Skye, at reasonable times and upon reasonable notice (but in no event more than once per calendar year), to examine those records and all
other material documents relating to or relevant to the Net Unit Selling Price, Net Sales and Supply Price in the possession or control of Enzon, its Affiliates, and/or sub-distributors, if any, for a period of two (2) years after same have
accrued, as may be necessary: (i) to determine the correctness of any report or payment made under this Agreement; or (ii) to obtain information as to same with respect to any Calendar Quarter in the event of Enzon’s failure to report
or pay pursuant to this Agreement. Said accountant shall not disclose to Skye any information other than information relating to said reports and payments. The results of any such examination shall be made available to both Parties. Skye shall bear
the full cost of the performance of any such audit except as hereinafter set forth. If, as a result of any inspection of the books and records of Enzon, its Affiliates and/or sub-distributors, if any, it is shown that Enzon’s payments under
this Agreement were less than the amount which should have been paid, then Enzon shall make all payments required to be made to eliminate any discrepancy revealed by said inspection within forty-five (45) days after Skye’s demand therefor.
Furthermore, if the payments made by Enzon were less than [**] percent ([**]%) of the amount of payments that should have been paid with respect to the period in question, Enzon shall also reimburse Skye for the cost of such examination. 

8.8 Taxes. In the event that Enzon is required to withhold any tax to the tax or revenue authorities in the
Territory regarding any payment to Skye, such amount shall be deducted from the payment to be made by Enzon, and Enzon shall promptly notify Skye of such withholding and, within a reasonable amount of time after making such deduction, furnish Skye
with copies of any tax certificate or other documentation evidencing such withholding. Each 

  
 -17-

 
Party agrees to cooperate with the other Party in claiming exemptions from such deductions or withholding under any agreement or treaty from time to time in effect:. 

9. PRODUCT WARRANTY. 

9.1 Guaranty and Warranty. Skye guarantees and warrants to Enzon that the Product shipped to Enzon pursuant to this
Agreement shall: 
 9.1.1 at the time of shipment, not be adulterated or misbranded within the meaning of the
FDC Act, as such FDC Act is constituted and effective at the time of shipment, and shall not be an article which may not under the provisions of Section 404 and 505 of such FDC Act be introduced into interstate commerce; and 

9.1.2 conform with the Product Specifications throughout its shelf life and shall be in compliance with applicable laws
and regulations and all regulatory requirements of the applicable Regulatory Authorities in effect at the time of shipment. 
 9.2 Disclaimer. SKYE MAKES NO WARRANTIES, EXPRESS OR IMPLIED, OTHER THAN THOSE EXPRESSLY MADE HEREIN WITH RESPECT TO THE PRODUCT. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED BY SKYE. 
 10.
CONFIDENTIALITY. 
 10.1 Confidential Treatment. Any Party receiving any Confidential
Information (a “Receiving Party”) from the other Party (a “Disclosing Party”) in connection with the execution, delivery and performance of this Agreement agrees that all such Confidential Information:
(i) shall not be used by the Receiving Party except in connection with the activities contemplated by this Agreement or in order to further the purposes of this Agreement; (ii) shall be maintained in confidence by the Receiving Party; and
(iii) shall not be disclosed by the Receiving Party to any Third Party who is not a consultant of, or an advisor to, the Receiving Party or an Affiliate or sublicensee/sub-distributor, as applicable, of the Receiving Party, without the prior
written consent of the Disclosing Party. 
 10.2 Exceptions. The obligations of confidentiality and
non-use set forth in Section 10.1 shall not apply to any such Confidential Information which: 
 10.2.1
either before or after the date of the disclosure to the Receiving Party becomes published or otherwise part of the public domain through no fault or omission on the part of the Receiving Party or its Affiliates; 

10.2.2 either before or after the date of the disclosure to the Receiving Party is lawfully disclosed to the Receiving
Party or its Affiliates by sources other than the Disclosing Party rightfully in possession of the Confidential Information and without restriction as to confidentiality or use; 

10.2.3 was known or used by the Receiving Party or its Affiliates prior to its date of disclosure to the Receiving Party
as demonstrated by legally admissible evidence available to the Receiving Party or its Affiliates; 
 10.2.4 is
independently developed by or for the Receiving Party or its Affiliates without reference to or in reliance upon the Disclosing Party’s Confidential Information as demonstrated by competent written records; or 

  
 -18-

 10.2.5 is required to disclose under applicable laws or regulations or an
order by a court or other regulatory body having competent jurisdiction; provided, however, that except where impracticable, the Receiving Party shall give the Disclosing Party reasonable advance notice of such disclosure requirement (which
shall include a copy of any applicable subpoena or order) and shall cooperate with the Disclosing Party to oppose, limit or secure confidential treatment for such required disclosure. In the event of any such required disclosure, the Receiving Party
shall disclose only that portion of the Confidential Information of the Disclosing Party that the Receiving Party is legally required to disclose. 
 10.3 Term of Obligation. The obligations of the Parties under this Section 10 shall continue for a period of [**] ([**]) years after the date of disclosure with respect to any particular item
of Confidential Information. 
 10.4 Return of Materials. Upon expiration or termination of this
Agreement and the written request of the Disclosing Party, the Receiving Party shall return to the Disclosing Party all Confidential Information of the Disclosing Party that the Receiving Party possesses in tangible form and shall return to the
Disclosing Party, or destroy, at the Disclosing Party’s request, all Confidential Information of the Disclosing Party that the Receiving Party possesses in electronic form. Notwithstanding the foregoing, each Party may retain one copy of all
Confidential Information provided by the other Party solely for archival and legal purposes. 
 11. TERM
AND TERMINATION. 
 11.1 Term. This Agreement shall take effect on the
Effective Date and shall remain in force for ten (10) years unless earlier terminated pursuant to one of the other provisions of this Section 11 (the “Initial Term”). Following expiration of the Initial Term, this
Agreement shall be automatically renewed for successive two (2) year renewal periods (each, a “Renewal Term”); provided, however, that at any time following expiration of the Initial Term, Enzon shall have the right to
terminate this Agreement upon ninety (90) days prior written notice (the Initial Term and all Renewal Terms, or parts thereof, collectively, the “Term”). 

11.2 Termination for Cause. Either Party (the “Non-breaching Party”) may, without prejudice to
any other remedies available to it at law or in equity (except for a termination by Enzon hereunder during Contract Year One or Contract Year Two in the Event of a Failure to Supply as more fully set forth in Section 5.8), terminate this
Agreement, in whole or in part, in the event the other Party (the “Breaching Party”) shall have materially breached or defaulted in the performance of any of its material obligations hereunder, and such default shall have continued
for sixty (60) days after written notice thereof was provided to the Breaching Party by the Non-breaching Party (or, if such default cannot be cured within such sixty (60)-day period, if the Breaching Party does not commence and diligently
continue actions to cure such default during such sixty (60)-day period). Any such termination shall become effective at the end of such sixty (60)-day period unless the Breaching Party has cured any such breach or default prior to the expiration of
such sixty (60)-day period (or, if such default cannot be cured within such sixty (60)-day period, if the Breaching Party has commenced and diligently continued actions to cure such default). 

11.3 Termination by Skye. Skye may terminate this Agreement without penalty upon thirty (30) days prior
written notice in the event that Skye exercises its right to terminate this Agreement for Enzon’s failure to achieve the Minimum Annual Net Sales in accordance with and as set forth in Section 8.1.2. 

11.4 Termination by Enzon. In the event that a final decision is issued (including a decision to grant a permanent
injunction) by a court or other governmental agency of competent jurisdiction which is unappealable or unappealed within the time allowed for such appeal, or a 

  
 -19-

 
settlement is entered into by Skye pursuant to Section 13.2(ii), that prohibits the manufacture, use or sale of the Product in the U.S., Enzon shall have the right to terminate this
Agreement upon written notice of such event. 
 11.5 Termination in the Generic Event. In the event that
a Generic Event occurs and the thirty (30) day period set forth in Section 8.1.3 has expired without agreement between the Parties as to an equitable adjustment, if any, to the Supply Price, either Party shall have the right to terminate
this Agreement without penalty upon one hundred eighty (180) days prior written notice to the other Party. 

11.6 Effect of Termination. Upon termination, relinquishment or expiration of this Agreement the Parties hereto
shall have no further obligations towards each other, except the fulfillment of obligations that have accrued before the date of termination or expiration. Such termination, relinquishment or expiration shall not relieve either Party from
obligations which are expressly indicated to survive termination or expiration of this Agreement. 
 11.6.1 All
of the Parties’ rights and obligations under, and/or the provisions contained in, Sections 2, 3.2, 4.1.4, 4.1.6, 6.1, 6.3, 7.2.3, 8.1 (solely for payments due for sales before the expiration, termination or relinquishment of the Agreement or
pursuant to Section 11.6.2), 8.4, 8.5, 8.6, 8.7, 8.8, 9, 10, 11.6, 13, 16, 17, 19, 20, 21 and 22 shall survive termination, relinquishment or expiration of this Agreement. 

11.6.2 Following the termination of this Agreement, Enzon shall retain the right to distribute the quantity of the
Product that was purchased by Enzon prior to such termination for a period not to exceed [**] ([**]) months, subject to the terms and conditions of this Agreement, including without limitation, Enzon’s payment obligations under Section 8.

 12. ASSIGNMENT. 
 This Agreement shall not be assignable by either Party without the prior written consent of the other Party, which consent shall not be unreasonable withheld, except that either Party may assign its
rights and transfer its duties under this Agreement in whole or in part to any of its Affiliates or in the event of such Party’s merger, consolidation or sale of all or substantially all of its assets or a sale of the division or portion of the
business of such Party to which the Product relates, in which case such Affiliate or assignee shall thereafter be substituted directly for such Party hereunder. In connection with any such assignment, the assigning Parry hereby unconditionally
guarantees the performance of any of its Affiliates or assignees hereunder. In the event of a breach by an Affiliate or assignee in the observance of applicable terms of this Agreement, the non-assigning Party may proceed against the assigning Party
and/or such Affiliate or assignee in order to enforce this Agreement. No assignment and transfer shall be valid or effective unless done in accordance with this Section 12 and unless and until the assignee, transferee or successor-in-interest
shall agree in writing to be bound by the provisions of this Agreement, and upon such agreement, all references herein to the assignor, transferor or predecessor shall be deemed to refer and apply to the assignee, transferee or successor in
interest. 
 13. INDEMNIFICATION. 

13.1 Indemnification by Enzon. Enzon shall indemnify and hold Skye and its directors, officers, employees,
representatives and agents harmless from and against any and all liabilities, claims, demands, actions, suits, losses, damages, costs and expenses (including reasonable attorney’s fees and disbursements, but excluding any anticipated or actual
lost profits or revenues or other special, indirect, incidental or consequential damages), based upon any Third Party claims of death, actual bodily injury or physical property damage: (i) to the extent resulting from Enzon’s handling,
storage, promotion, testing, use, marketing, distribution or sale of the Product; 

  
 -20-

 
or (ii) otherwise resulting from Enzon’s negligence, willful misconduct or material breach of this Agreement (including, without limitation, of the representations, and warranties
hereunder); except to the extent covered by subclause (i) of Section 13.2. 
 13.2 Indemnification
by Skye. Skye shall indemnify and hold Enzon and its directors, officers, employees, representatives and agents harmless from and against any and all liabilities, claims, demands, actions, suits, losses, damages, costs and expenses (including
reasonable attorney’s fees and disbursements, but excluding any anticipated or actual lost profits or revenues or other special, indirect, incidental or consequential damages): (i) based upon Third Party claims of death, actual bodily
injury or physical property damage (A) to the extent resulting from Skye’s manufacture, handling, storage, packaging and labeling of the Product, or (B) to the extent otherwise resulting from Skye’s negligence, willful misconduct
or material breach of this Agreement (including, without limitation, of the representations and warranties hereunder); or (ii) which Enzon may incur, suffer or be required to pay by reason of any patent infringement suit or claim of violation
of any patents, trademarks, trade secrets or other intellectual property rights of any Third Party (including but not limited to Paul Capital Partners or any of its affiliates, successors or assigns) brought against Enzon and arising from the
manufacture, use or sale of the Product or the use of the Trademark. 
 13.3 Procedure. In the event that
any person entitled to indemnification under this Section 13 (an “Indemnitee”) is seeking such indemnification, such Indemnitee shall inform the other Party (the “Indemnitor”) of the claim as soon as reasonably
practicable after such Indemnitee receives notice of such claim, shall permit the Indemnitor to assume direction and control of the defense of the claim (including the sole right to settle it at the sole discretion of the Indemnitor, provided that
such settlement provides for the unconditional release of the Indemnitee and does not impose any obligation on the Indemnitee or the other Party) and shall cooperate as requested (at the expense of the Indemnitor) in the defense of the claim.

 13.4 Complete Indemnification. As the Parties intend complete indemnification, all costs and expenses
incurred by an Indemnitee in connection with enforcement of this Section 13 shall also be reimbursed by the Indemnitor. 

14. INSURANCE. 
 Each Party shall use Commercially Reasonable Efforts to maintain insurance (including general and product liability coverage) and upon such terms (including coverages, deductible limits and self-insured
retentions) as is customary for the activities to be conducted by it under this Agreement and is appropriate to cover its indemnification obligations hereunder (provided that product liability coverage shall be with limits of not less than $[**]).
Each Party shall furnish to the other Party evidence of such insurance, upon request. 
 15. ENFORCEMENT
OF INTELLECTUAL PROPERTY RIGHTS. 
 15.1 Notice to
Skye. If Enzon learns of an infringement, unauthorized use, misappropriation or ownership claim or threatened infringement or other such claim (any of the foregoing, an “Infringement”) by a Third Party with respect to any Skye
Technology or Trademark(s) within the Territory, Enzon shall promptly notify Skye and shall provide Skye with available evidence of such Infringement. 
 15.2 Enforcement. Skye shall have the first right, but not the duty, to institute Infringement actions against Third Parties based on any Skye Technology or Trademark(s) in the Territory. If Skye
does not secure actual cessation of such Infringement or institute an Infringement proceeding against an offending Third Party within one-hundred twenty (120) days of learning of such Infringement, Enzon shall have the right, but not the duty,
to institute such an action with respect: to any Infringement by such Third Party. The costs and expenses of any such 

  
 -21-

 
action (including fees of attorneys and other professionals) shall be borne by the Party instituting the action, or, if the Parties elect to cooperate in instituting and maintaining such action,
such costs and expenses shall be borne by the Parties in such proportions as they may agree in writing. Each Party shall execute all necessary and proper documents, take such actions as shall be appropriate to allow the other Party to institute and
prosecute such Infringement actions- and shall otherwise cooperate in the institution and prosecution of such actions (including, without limitation, consenting to being named as a nominal party thereto). Any award paid by Third Parties as a result
of such an Infringement action (whether by way of settlement or otherwise) shall be applied first to reimburse both Parties for all costs and expenses incurred by the Parties with respect to such action on a pro rata basis and, if after such
reimbursement any funds shall remain from such award they shall be allocated to Enzon to be included in Net Sales (and subject to payment to Skye of the Supply Price); provided however that to the extent that any damage award includes
specific damage awards to the individual Parties, the remaining funds shall be allocated between the Parties in the same proportion as the total damage award was allocated to each Party. 

15.3 Infringement Action by Third Parties. In the event of the institution or threatened institution of any suit
by a Third Party against Enzon for infringement of any patent, trademark or other intellectual property right involving the marketing or sale of the Product in the Territory where such infringement claim is a result of the manufacture, use or sale
of the Product, Enzon shall promptly notify Skye in writing of such suit. Skye agrees to indemnify and defend Enzon as more fully set forth in Section 13 hereof. 
 16. LIMITATION ON LIABILITY. 
 NOTWITHSTANDING ANY OTHER PROVISION OF THE AGREEMENT, NO PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT OR CONSEQUENTIAL DAMAGES HEREUNDER, SUCH AS LOSS OF REVENUE OR ANTICIPATED PROFITS OR
LOST BUSINESS, REGARDLESS OF WHETHER SUCH PARTY HAS NOTICE OR KNOWLEDGE THEREOF, AND NO PARTY SHALL BE LIABLE FOR ANY SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES HEREUNDER: EXCEPT WITH RESPECT TO ITS INDEMNIFICATION OBLIGATIONS UNDER SECTION 13.

 17. DISPUTE RESOLUTION. 

17.1 Referral to Executive Officers. The Parties recognize that disputes, as to certain matters may from time to
time arise during the Term which relate to a Party’s rights and/or obligations hereunder. If the Parties cannot resolve any such dispute within thirty (30) calendar days after notice of a dispute from one Party to the other, either Party
may, by notice to another, have such dispute referred to the Chief Executive Officer of SkyePharma, plc (having offices located at 105 Piccadilly, London W1J 7NJ, England), or such other person holding a similar position as designated by Skye from
time to time, and the Chief Executive Officer of Enzon, or such other person holding a similar position as designated by Enzon from time to time (such officers collectively, the “Executive Officers”). The Executive Officers shall
meet promptly to negotiate in good faith the matter referred and to determine a resolution. During such period of negotiations, any applicable time periods under this Agreement shall be tolled, if the Executive Officers are unable to determine a
resolution in a timely manner, which shall in no case be more than thirty (30) days after the matter was referred to them, the matter shall be resolved through arbitration in accordance with the provisions set forth in Section 17.2, upon
notice by either Party to the other specifically requesting such arbitration. 

  
 -22-

 17.2 Arbitration. Any dispute arising out of or relating to any
provisions of this Agreement shall be finally settled by arbitration to be held in New York, New York, under the auspices and then current Commercial Arbitration Rules of the American Arbitration Association (the “AAA”). The arbitration
shall be conducted by one arbitrator who is knowledgeable in the subject matter which is at issue in the dispute and who is selected by mutual agreement of the Parties or, failing such agreement, shall be selected according to the AAA rules. The
Parties shall have such discovery rights as the arbitrator may allow, but in no event broader than that discovery permitted under the Federal Rules of Civil Procedure, in conducting the arbitration, the arbitrator(s) shall apply the New York Rules
of Evidence and shall be able to decree any and all relief of an equitable nature, including but not limited to such relief as a temporary restraining order, a preliminary injunction, a permanent injunction, or replevin of property, as well as
specific performance. The arbitrator(s) shall also be able to award direct damages but shall not award any other form of damages (e.g., consequential, punitive or exemplary damages). The reasonable fees and expenses of the arbitrator(s), along with
the reasonable legal fees and expenses of the Parties (including all expert witness fees and expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, shall be paid as follows: (i) if the arbitrator(s) rule in
favor of one Party on all disputed issues in the arbitration, the losing Party shall pay one hundred percent (100%) of such fees and expenses; if the arbitrator(s) rule in favor of one Party on some issues and the other Party on other issues,
the arbitrators shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the Parties. The decision of the arbitrators shall be final and may be entered, sued on or enforced by the Party in
whose favor it runs in any court of competent jurisdiction at the option of such Party. Whether a claim, dispute or other matter in question would be barred by the applicable statute of limitations, which statute of limitations also shall apply to
any claim or disputes subject to arbitration under this Section 17, shall be determined by binding arbitration pursuant to this Section 17.2. 
 17.3 Injunctive Relief. Notwithstanding the foregoing, nothing contained herein shall prohibit a Party from seeking injunctive relief from a court of competent jurisdiction in the event of a breach
or prospective breach of this Agreement by the other Party which would cause irreparable harm to the Non-breaching Party. 
 18.
FORCE MAJEURE. 
 Any delay in the performance of any of the duties or obligations
of either Party hereto (except the payment of money due hereunder) shall not be considered a breach of this Agreement, and the time required for performance shall be extended for a period equal to the period of such delay, if such delay has been
caused by or is the result of acts of God; acts of public enemy; insurrections; riots; injunctions; embargoes; labor disputes, including strikes, lockouts, job actions, or boycotts; fires; explosions; earthquakes; floods; shortages of energy:
governmental prohibition or restriction; or other unforeseeable causes beyond the reasonable control and without the fault or negligence of the Party so affected. The Party so affected shall give prompt notice to the other Party of such cause, and
shall take whatever reasonable steps are necessary to relieve the effect of such cause as rapidly as reasonably possible. 

  
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 19. NOTICE. 

Any notice or communication required or permitted to be given under or in connection with this Agreement shall be deemed
to have been sufficiently given if in writing and personally delivered or sent by certified mail (return receipt requested), facsimile transmission (receipt verified), or overnight express courier service (signature required), prepaid, to the Party
for which such notice is intended as follows: 
  

					
	 (i)
	    	 If to Enzon, to:
	    	 Enzon Pharmaceuticals. Inc.
 685 Route 202/206
 Bridgewater, New Jersey 08807

Attention: Peter Cicala
 Facsimile: 908.541.8838
 Telephone: 908.541.8767

			
		    	 With a copy to:
	    	 Dorsey & Whitney LLP
 250 Park Avenue
 New York, New York 10177

Attention: Kevin T. Collins, Esq.
 Facsimile: 212.953.7201
 Telephone; 212.415.9200

			
	 (ii)
	    	 If to Skye, to:
	    	 SkyePharma. Inc.
 1450 Science Center Drive
 San Diego, California 92121

Attention: Mr. Steve Thornton
 Facsimile: 858.623.0376
 Telephone: 858.625.2424

			
		    	 With a copy to:
	    	 Skye-Pharma PLC
 105 Piccadilly
 London W1J 7NJ

England

Attention: Chief Executive Officer
 Facsimile: 011.44.20.7491.0452
 Telephone:
011.44.20.7491.1777

 or to such other address as the addressee shall have last furnished
in writing to the addressor; such notice shall be effective upon receipt by the addressee. If delivered personally or by facsimile transmission, the date of delivery shall be deemed to be the date on which such notice or request was given. If sent
by overnight express courier service, the date of delivery shall be deemed to be the next business day after such notice or request was deposited with such service. If sent by certified mail, the date of delivery shall be deemed to be the third
(3rd) business day after such notice or request was
deposited with the U.S. Postal Service. 
 20. BOOKS AND RECORDS. 

Any books and records to be maintained under this Agreement by a Party or its Affiliates shall be maintained in accordance
with U.S. generally accepted accounting principles, consistently applied. 
 21. GOVERNING LAW. 

This Agreement shall be governed by the laws of the State of New York, in all respects of validity, construction and
performance thereof, without regard to principles of conflicts of law. 

  
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 22. MISCELLANEOUS. 

22.1 Relationship of Parties. Nothing in this Agreement is intended or shall be deemed to constitute a partnership,
agency, employer-employee or joint venture relationship between the Parties. No Party shall incur any debts or make any commitments for the other, except to the extent, if at all, specifically provided herein. 

22.2 Further Actions. Each Party shall execute, acknowledge and deliver such further instruments, and do all such
other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement. 

22.3 Use of Name; Publicity. Except as otherwise provided herein, (i) neither Party shall have any right,
express or implied, to use in any manner the. name or other designation of the other Party or any other trade name, trademark or logos (including the Trademark) of the other Party for any purpose in connection with the performance of this Agreement;
and (ii) neither Party shall make any public announcement concerning this Agreement or the subject matter hereof without the prior written consent of the other Party; provided however, that nothing in this Section 22.3 shall prevent either
Party from issuing statements that such Party determines to be necessary to comply with applicable law (including the disclosure requirements of the U.S. Securities and Exchange Commission, Nasdaq or any other stock exchange on which securities
issued by such Party are traded). 
 22.4 Waiver. A waiver by either Party of any of the terms and
conditions of this Agreement in any instance shall not be deemed or construed to be a waiver of such term or condition for the future, or of any subsequent breach hereof. All rights, remedies, undertakings, obligations and agreements contained in
this Agreement shall be cumulative and none of them shall be in limitation of any other remedy, right, undertaking, obligation or agreement of either Party. 
 22.5 Severability. When possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is
held to be prohibited by or invalid under applicable law, such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement. 

22.6 Amendment. No amendment, modification or supplement of any provisions of this Agreement shall be valid or
effective unless made in writing and signed by a duly authorized officer of each Party. 
 22.7 Entire
Agreement. This Agreement together with the schedules and exhibits hereto, sets forth the entire agreement and understanding between the Parties as to the subject matter hereof and merges all prior discussions and negotiations between them, and
neither of the Parties shall be bound by any conditions, definitions, warranties, understandings or representations with respect to such subject matter other than as expressly provided herein or as duly set forth on or subsequent to the date hereof
in writing and signed by a proper and duly authorized officer or representative of the Party to be bound thereby. 
 22.8 Parties in Interest. All of the terms and provisions of this Agreement shall be binding upon, inure to the benefit of and be enforceable by the Parties hereto and their respective permitted
successors and assigns. 
 22.9 Descriptive Headings. The descriptive headings of this Agreement are for
convenience only, and shall be of no force or effect in construing or interpreting any of the provisions of this Agreement. 

  
 -25-

 22.10 Counterparts. This Agreement may be signed in counterparts,
each and every one of which shall be deemed an original, notwithstanding variations in format or file designation which may result from the electronic transmission, storage and printing of copies of this Agreement from separate computers or
printers. Facsimile signatures shall be treated as original signatures. 

*        *        * 

  
 -26-

 IN WITNESS
WHEREOF, the Parties hereto have caused this DepoCyt® Supply and Distribution
Agreement to be executed by their duly authorized representative as of the Effective Date. 
  

											
	 ENZON PHARMACEUTICALS, INC.
	 		 		 	 SKYEPHARMA, INC.

						
	 By:
	 	  
	 		 		 	 By:
	 	  

	 Name:
	 	 Arthur J. Higgins
	 		 		 	 Name:
	 	 Michael R.D. Ashton

	 Title:
	 	 Chairman and Chief Executive Officer
	 		 		 	 Title:
	 	 Chief Executive Officer of SkyePharma PLC

  
 -27-

 IN WITNESS
WHEREOF, the Parties hereto have caused this DepoCyt® Supply and Distribution
Agreement to be executed by their duly authorized representative as of the Effective Date. 
  

									
	 ENZON PHARMACEUTICALS, INC.
	  		  	SKYEPHARMA, INC.
					
	 By:
	 	 /s/ Arthur J. Higgins
	  		  	 By:
	 	  

	 Name:
	 	 Arthur J. Higgins
	  		  	 Name:
	 	 Michael R.D. Ashton

	 Title:
	 	 Chairman and Chief Executive Officer
	  		  	 Title:
	 	 Chief Executive Officer of SkyePharma PLC

  
 -28-

 IN WITNESS
WHEREOF, the Parties hereto have caused this DepoCyt® Supply and Distribution
Agreement to be executed by their duly authorized representative as of the Effective Date. 
  

									
	 ENZON PHARMACEUTICALS, INC.
	 	 	 	 SKYEPHARMA, INC.

					
	 By:
	 	  
	 		 	 By:
	 	 /s/ Michael R.D. Ashton

	 Name:
	 	 Arthur J. Higgins
	 		 	 Name
	 	 : Michael R.D. Ashton

	 Title:
	 	 Chairman and Chief Executive Officer
	 		 	 Title:
	 	 Chief Executive Officer of SkyePharma PLC

  
 -29-

 EXHIBIT 1.38 

THE PRODUCT 
 DepoCyt® in all dosage strengths and including all improvements and
line extensions. 
 DepoCyt® is a sterile, white to off-white [**]mL suspension of [**]mg [**] encapsulated into multivesicular lipid-based particles in a single-use glass vial. 

  

 EXHIBIT 1.39 

PRODUCT SPECIFICATIONS 
  

					
	         Test Parameter
 (and Method Type/Source
	  	Acceptance Limits
			
		  	 I. Shelf Life
	  	 II. Release

			
	 Appearance (Visual)
	  	 [**]
	  	 [**]

			
	 Identity (HPLC)
	  	 [**]
	  	 [**]

			
	 Total Cytarabine (HPLC)
	  	 [**]
	  	 [**]

			
	 % Free Cytarbine (HPLC)
	  	 [**]
	  	 [**]

			
	 Content Uniformity, USP (HPLC)
	  	 [**]
	  	 [**]

			
	 pH
	  	 [**]
	  	 [**]

			
	 Particle Size (Light Scattering, USP)
	  	 [**]
	  	 [**]

			
	 Uracil Arabinoside (HPLC)
	  	 [**]
	  	 [**]

			
	 Cytosine (HPLC)
	  	 [**]
	  	 [**]

			
	 Cytidine (HPLC)
	  	 [**]
	  	 [**]

			
	 Uridine (HPLC)
	  	 [**]
	  	 [**]

			
	 Uracil (HPLC)
	  	 [**]
	  	 [**]

			
	 Total Cytarabine related impurities not including Uracil Arabinoside
	  	 [**]
	  	 [**]

			
	 Cholesterol (HPLC)
	  	 [**]
	  	 [**]

					
	 Triolein (HPLC)
	  	 [**]
	  	 [**]

			
	 DPPG (HPLC)
	  	 [**]
	  	 [**]

			
	 DOPC (HPLC)
	  	 [**]
	  	 [**]

			
	 Lyso DOPC (HPLC)
	  	 [**]
	  	 [**]

			
	 Dextrose (HPLC)
	  	 [**]
	  	 [**]

			
	 L-Lysine (Capillary Electrophoresis)
	  	 [**]
	  	 [**]

			
	 Chloroform (GC)
	  	 [**]
	  	 [**]

			
	 Osmolality (Vapor Pressure)
	  	 [**]
	  	 [**]

			
	 Fill Volume
	  	 [**]
	  	 [**]

			
	 Particulates (Light Obscuration, USP)
	  	 [**]
	  	 [**]

			
	 In-Vitro Release Assay (HPLC)
	  		  	
			
	 Day 1
	  	[**]	  	[**]
			
		  	[**]	  	[**]
			
	 Day 2
	  	[**]	  	[**]
			
		  	[**]	  	[**]
			
	 Day 3
	  	[**]	  	[**]
			
		  	[**]	  	[**]
			
	 Day 4
	  	[**]	  	[**]
			
		  	[**]	  	[**]
			
	 Bacterial Endotoxins (USP)
	  	 [**]
	  	 [**]

			
	 Sterility (USP)
	  	 [**]
	  	 [**]

  

NOTE: The above table presents product specifications as approved in the product registrations for the two territories 

 EXHIBIT 1.48 

PATENTS 
 US Patent number [**] 
 US Patent number [**] 

US Patent number [**] 
 CA Patent number [**] 
 CA Patent number [**] (pending) 

 EXHIBIT 3.4 

CLINICAL PLAN 
 (See attached) 

 DepoCyt Study SKY0101-010 

23+ Study Sites in US & Canada 
  

							
	 Investigator
First Name
	    	 Investigator
 Last Name
	    	 Investigator’s Institution
	  	 Location

	 William
	    	 Shapiro
	    	 Barrow Neurological Institute
	  	 Phoenix

				
	 Pamela
	    	 New
	    	 University of Texas Health Science Center
	  	 San Antonio

				
	 Pamela
	    	 Khosla
	    	 Rush Cancer Institute
	  	 Chicago

				
	 Surasak
	    	 Phuphanich
	    	 H. Lee Moffitt Cancer Center and Research Inst.
	  	 Tampa

				
	 Glenn
	    	 Lesser
	    	 Comprehensive Cancer Center of Wake Forest Univ.
	  	 Winston-Salem

				
	 Erie
	    	 Wong
	    	 Beth Israel Deaconess Medical Center
	  	 Boston

				
	 Said
	    	 Baidas
	    	 Georgetown University Medical Center
	  	 Washington

				
	 Denise
	    	 Damek
	    	 University of Colorado
	  	 Aurora

				
	 Paul
	    	 Moots
	    	 Vanderbuilt University Medical Center
	  	 Nashville

				
	 Rena
	    	 Buckstein
	    	 Toronto Sunnybrook Regional Cancer Centre
	  	 Toronto

				
	 Kurt
	    	 Jaeckle
	    	 Mayo Clinic
	  	 Jacksonville

				
	 Stephen
	    	 Sagar
	    	 Case Western Reserve University
	  	 Cleveland

				
	 Deborah
	    	 Blumenthal
	    	 Huntsman Cancer Institute
	  	 Salt Lake City

				
	 Marc
	    	 Chamberlain
	    	 USC
	  	 Los Angeles

				
	 Subramanian
	    	 Hariharan
	    	 JFK Neuroscience Institute
	  	 Edison

				
	 Lynne
	    	 Taylor
	    	 Virginia Mason Medical Center
	  	 Seattle

				
	 Martin
	    	 Lee
	    	 Park Nicollet Health Services
	  	 Minneapolis

				
	 David
	    	 Eisenstat
	    	 CancerCare Manitoba
	  	 Winnipeg

				
	 Lynn
	    	 Ashby
	    	 Straub Clinic and Hospital
	  	 Honolulu

				
	 Jeffrey
	    	 Olson
	    	 Windship Cancer Institute
	  	 Atlanta

				
	 David
	    	 Irwin
	    	 Alta Bates Comprehensive Cancer Center
	  	 Berkeley

				
	 Thomas
	    	 Coyle
	    	 SUNY Upstate Medical University
	  	 Syracuse

24 Study Sites – EUSwitzerland – 1 site 

German – 6 sites total 
 Ireland – 3 sites 
 United Kingdom – 5 sites 

Belgium – 1 site 
 France – 5 sites 
 The Netherlands – 2 sites 

 FDA Agreements 

Post-Marketing Study (Sky0101-010) 

 

	 	•	 	 Objectives of Post-Marketing Study 

  

	 	•	 	 Fulfill FDA post-marketing requirement (all patients) 

 

	 	•	 	 NDA expedited review of surrogate endpoint pivotal LM study based on CSF clearance of malignant cells 

 

	 	•	 	 Patient population: lymphomatous meningitis and solid tumor 

 

	 	•	 	 Primary endpoint neurological progression free survival 

 

	 	•	 	 Expand label (STNM Subgroup of patients) 

  

	 	•	 	 Current NDA indication lymphomatous meningitis 

  

	 	•	 	 Add solid tumor neoplastic meningitis 

  

	 	•	 	 Expand study to include European study sites 

  

	 	•	 	 Improve enrollment 

  

	 	•	 	 Pooling of US and European data acceptable 

  

	 	•	 	 Differences in patient management acknowledged by FDA 

 

	 	•	 	 One significant pivotal study sufficient for STNM approval 

 

	 	•	 	 P<.0366 for each of two independent primary efficacy analysis 

 

	 	•	 	 Enroll patients until 72 events occur in STNM subgroup 

 

	 	•	 	 Event driven analysis 

  

	 	•	 	 Interim sample size adjustment net necessary 

  

	 	•	 	 67% of patient enrolled are STNM 

  

	 	•	 	 >90% of patients will have an event prior to 2-yr. follow-up 

 

	 	•	 	 Approximately 110 additional patients will be enrolled 

 

	 	•	 	 Enrollment complete 2H’04 

  

	 	•	 	 As of 18 December 2002 

  

	 	•	 	 42 Patients Randomized 

  

	 	•	 	 12 lymphoma patients 

  

	 	•	 	 30 solid tumor patients 

  

	 	•	 	 Regulatory Filings 

  

							
	 •   US
	 		    			
			
		 	 •   Pre-supplemental NDA meeting
	    	 	1Q2005	  
			
		 	 •   NDA
	    	 	2Q2005	  
			
	 •   Europe
	 		    			
			
		 	 •   Pre-MAA Meeting
	    	 	1Q2005	  
			
		 	 •   Scientific Advice
	    	 	1Q2005	  
			
		 	 •   MAA (EU)
	    	 	2Q2005	  

 EXHIBIT 8.1.1 

QUARTERLY PAYMENT RECONCILIATION 

Supply Price Calculation 
  

									
	 Gross invoiced sales price per Unit
	  	$	 	  	 			
			
	 Less Trade Discounts/Rebates, Etc.
	  	 	($        	) 	 			
		  	 	 	 	 			
			
	 Net Unit Selling Price
	  	$	 	  	 			
			
	 *  where X equals the total number of Units sold by Enzon, its Affiliates and sun-distributors, if any.
	  	 	x X	* 	 			
		  	 	 	 	 			
			
	 Net Sales
	  				 	$	 	  
		  				 	 	 	 
			
	 *  where Y equals either 35 or 30 depending on cumulative annual Net Sales to date.
	  				 	 	x Y	*% 
		  				 	 	 	 
			
	 Supply Price A
	  				 			
			
	 Minimum per Unit Supply Price
	  				 	$	[**]	  
			
	 *  where X equals the total number of Units sold by Enzon, its Affiliates and sun-distributors, if any.
	  				 	 	x X	* 
		  				 	 	 	 
			
	 Supply Price B
	  				 			
			
	 Total Supply Price (the greater of A or B)
	  				 	 	[**]	  
	
	Payment Reconciliation	  
			
	 Supply Price
	  				 	$	 	  
			
	 Less Amounts Previously Paid to Skye
	  				 	 	 ($        
	) 
		  				 	 	 	 
			
	 Net Supply Price
	  				 	 	 ($        
	) 
		  				 	 	 	 
			
	 Less Reimbursement due Enzon under Section 8.3
	  				 	 	 ($        
	) 
		  				 	 	 	 
			
	 Amount Payable to Skye:
	  				 	 	[**]	  

 EXHIBIT 8.3A 

TRANSITIONAL SERVICES 
 REQUESTED AND APPROVED BY ENZON 
 The following transitional services as described on Exhibit 8.3B are hereby requested and approved by Enzon for the period commencing as of the Effective Date and terminating on the date set forth next to
such services: 
 Marketing – March 31, 2003; 

Manufacturing – June 30, 2003; 
 Distribution – March 31, 2003; 
 Professional Services –
February 28, 2003; 
 Reimbursement Services – February 28, 2003; and 

Medical Affairs – February 28, 2003. 

 EXHIBIT 8.3B 

TRANSITIONAL SERVICES 
  

							
	 Transition Service
	  	 Description
	  	 Monthly
Cost +[**]%
	    	 Termination
Date

	 Marketing
	  	Consulting services as mutually agreed by the parties	  	$[**] per day plus out-of-pocket expenses	    	03/31/03
				
	 Manufacturing
	  	Labeling of finished Product	  	$[**] per lot	    	06/30/03
				
	 Sales
	  	Product details by field sales force ([**]% of available time); Field Operations ([**]% of available time); Field Management [**]% of available time	  	$[**]	    	03/31/03
				
	 Distribution
	  	Product warehousing; order taking; order fulfillment; invoicing; collections; returns processing	  	$[**] plus out-of-pocket costs of shipping	    	06/30/03
				
	 Professional Services
	  	Maintain toll-free number for receiving and responding to inquiries from health care professionals regarding the Product	  	$[**]	    	03/31/03
				
	 Reimbursement Services
	  	Reimbursement services provided by Quintiles	  	$[**] (at cost)	    	03/31/03
				
	 Medical Affairs
	  		  	$[**]	    	03/31/03

 INTERCOMPANY QUALITY AGREEMENT 

DepoCyt® 
 Revision: Original 

Enzon Pharmaceuticals Inc. 
 685 Route 202/206 
 Bridgewater, NJ 08807 

(hereinafter called “Enzon”) 
  

													
	 Approved by:
	  	 /s/ Ralph delCampo
	  		  	 	Date:	  	 	 11/3/03
	  	
					
	 Ralph delCampo
	  		  				 		  	
	 Senior Vice President Operations
	  		  				 		  	

 AND 
 SkyePharma, Inc. 
 10450 Science Center Drive 

San Diego, California 92121 
 (hereinafter called “SkyePharma”) 
 Approved by: 

 

													
	 Approved by:
	  	 /s/ Steve Thornton
	  		  	 	Date:	  	 	 11/6/03
	  	
					
	 Steve Thornton
	  		  				 		  	
	 President, SkyePharma Inc.
	  		  				 		  	

  

									
	 Section
	 	 	  	 TABLE OF CONTENTS
	  	Page	 
	 I.
	 		  	 QUALITY AGREEMENT
	  	 	4	  
		 	A.	  	 Purpose
	  	 	4	  
		 	B.	  	 Relationship to SUPPLY AGREEMENT
	  	 	4	  
				
	 II.
	 		  	 PRODUCTS
	  	 	4	  
				
	 IV.
	 		  	 ADMINISTRATIVE INFORMATION
	  	 	4	  
				
	 IV.
	 		  	 DURATION OF QUALITY AGREEMENT
	  	 	4	  
				
	 V.
	 		  	 MANUFACTURING cGMP COMPLIANCE
	  	 	5	  
		 	A.	  	 General
	  	 	5	  
		 	B.	  	 Premises
	  	 	5	  
		 	C.	  	 Personnel
	  	 	5	  
		 	D.	  	 cGMP Guidelines
	  	 	5	  
		 	E.	  	 Materials
	  	 	5	  
		 		  	 1.         Materials Procured by SkyePharma
	  	 	5	  
		 		  	 2.         Materials Procured by Enzon
	  	 	6	  
		 	F.	  	 Standard Operating Procedures
	  	 	6	  
		 	G.	  	 Methods Validation Certification
	  	 	6	  
		 	H.	  	 Batch Numbers
	  	 	7	  
		 	I.	  	 Dates of Manufacture and Expiration
	  	 	7	  
		 	J.	  	 Manufacturing and Equipment Data
	  	 	7	  
		 	K.	  	 Storage and Shipment
	  	 	7	  
				
	 VI.
	 		  	 PRODUCT TESTING
	  	 	8	  
		 	A.	  	 General
	  	 	8	  
		 	B.	  	 In-Process and Finished Product Testing
	  	 	8	  
		 	C.	  	 Retain Samples
	  	 	8	  
		 	D.	  	 Routine Stability Program
	  	 	9	  
		 	E.	  	 Out-of-Specification (OOS) Investigations
	  	 	9	  
				
	 VII.
	 		  	 QUALITY ASSURANCE
	  	 	9	  
		 	A.	  	 Investigations
	  	 	9	  
		 	B.	  	 Batch Disposition
	  	 	9	  
		 		  	 1.         Interim Release by SkyePharma
	  	 	9	  
		 		  	 2.         Batch Disposition by SkyePharma
	  	 	9	  
		 	C.	  	 Authorization for Distribution by Enzon
	  	 	10	  
		 	D.	  	 Product Complaints and Recalls
	  	 	10	  
		 	E.	  	 Records Retention
	  	 	10	  
		 	F.	  	 QA Presence in the Manufacturing Facility
	  	 	10	  

									
	 Section
	 	 	  	 TABLE OF CONTENTS
	  	Page	 
	 VIII.
	 		  	 REGULATORY
	  	 	10	  
		 	A.	  	 Regulatory Inspections
	  	 	10	  
		 	B.	  	 Regulatory Actions
	  	 	11	  
		 	C.	  	 Regulatory Affairs
	  	 	11	  
		 	D.	  	 Right to Audit
	  	 	11	  
		 	E.	  	 Audit Closeout
	  	 	11	  
				
	 IX.
	 		  	 DISPUTE RESOLUTION
	  	 	12	  
		 	A.	  	 Non-Conformity Dispute
	  	 	12	  
		 	B.	  	 Test Result Dispute
	  	 	12	  
				
	 X.
	 		  	 CHANGE MANAGEMENT
	  	 	12	  
		 	A.	  	 Changes for Commercial PRODUCTS
	  	 	12	  
		 	B.	  	 Control of Master Labels and Labeling
	  	 	12	  
		 	C.	  	 Changes to the Quality Agreement
	  	 	13	  
				
	 XI.
	 		  	 PRODUCT AND PROCESS VALIDATION/VERIFICATION
	  	 	13	  
		 	A.	  	 Process Verification/Validation
	  	 	13	  
		 	B.	  	 Cleaning Validation
	  	 	13	  
		 	C.	  	 Equipment, Computer, Facility and Utilities Qualification
	  	 	13	  
		 	D.	  	 Laboratory Qualification
	  	 	13	  
				
	 XII.
	 		  	 ANNUAL PRODUCT REVIEW, ANNUAL PRODUCT REPORT AND DRUG LISTING
	  	 	14	  
		 	A.	  	 Annual Product Review
	  	 	14	  
		 	B.	  	 Annual Product Report
	  	 	14	  
		 	C.	  	 Drug Listing
	  	 	14	  
		 	D.	  	 Adverse Drug Experience Reports
	  	 	14	  
				
		 		  	 APPENDIX I – Outline of Responsibilities
	  	 	15	  
		 		  	 APPENDIX II – List of Quality Contacts
	  	 	17	  
		 		  	 APPENDIX III – Release Documentation
	  	 	19	  
		 		  	 APPENDIX IV – SkyePharma Regulatory Specifications for SKY0101
	  	 	20	  

  

	I.	 QUALITY AGREEMENT 

  

	 	A.	 Purpose 

 This INTERCOMPANY QUALITY AGREEMENT (this “Quality Agreement”) defines the roles and responsibilities of SkyePharma and Enzon with respect to the quality assurance of the PRODUCTS referenced in
the DepoCyt® Supply and Distribution Agreement entered into by and between SkyePharma and Enzon dated as of
December 31, 2002 (the “SUPPLY AGREEMENT”). 
 This Quality Agreement also defines how SkyePharma’s Quality
Operations and Enzon’s Quality Department will interact with each other. 
  

	 	B.	Relationship to the SUPPLY AGREEMENT  

 This Quality Agreement shall be attached to and made a part of the SUPPLY AGREEMENT. 
 In the event of a conflict between any of the provisions of this Quality Agreement and the SUPPLY AGREEMENT, the provisions of this Quality Agreement shall govern. 

All capitalized terms, unless otherwise set forth below, shall have the meaning set forth in the SUPPLY AGREEMENT. 

 

	II.	 PRODUCTS 

 The PRODUCTS prepared for Enzon by SkyePharma are defined in the SUPPLY AGREEMENT including 
 DepoCyt®, (cytarabine liposome injection, SKY0101) Formulation 1.5
(US) 
  

	III.	 ADMINISTRATIVE INFORMATION 

 Enzon contact names: See Appendix II 
 SkyePharma contact
names: See Appendix II 
 Emergency contact names and numbers 

 

					
	 	  	 Enzon Pharmaceuticals, Inc.
	  	 SkyePharma

	 Name
	  	 K. Alice Preville
	  	 Patrick McCormick, Ph.D.

			
	 Title
	  	 Associate Director
 Quality Assurance
	  	 Senior Director
 Global Quality Assurance

			
	 Work
	  	 908 412-2331
	  	 858 625-2424, Extn. 3224

			
	 FAX
	  	 908 668-5997
	  	 858 625-2439

			
	 e-mail
	  	 alice.preville@enzon.com
	  	 patrick_mccormick@skyepharma.com

  

	IV.	 DURATION OF QUALITY AGREEMENT 

 The Quality Agreement will expire one (1) year after the expiration date of PRODUCTS associated with the SUPPLY AGREEMENT. The Quality Agreement will be reviewed annually to ensure that the roles and
responsibilities reflect current practice. This Quality Agreement can be modified as needed with the written approval of both parties. 

  

	V.	 MANUFACTURING cGMP COMPLIANCE 

  

	A.	 General  

 The manufacturing operations for the PRODUCTS to be performed by SkyePharma are defined in the SUPPLY AGREEMENT, and responsibilities are illustrated in Appendix I of this document. 

 

	B.	Premises 

 The premises
and equipment used to manufacture the PRODUCTS will be maintained according to current local state and federal regulatory requirements. 
 The manufacture of the PRODUCTS will be conducted by SkyePharma in a suitably controlled environment, and such facilities will be regularly monitored for parameters critical to the process to demonstrate
compliance with applicable cGMP guidelines and any conditions registered, in the manufacturing authorization (NDA or ANDA or investigational application). 
 SkyePharma will maintain controlled access to the premises. All visitors must sign in and be escorted during any visit to the area of the premises used to manufacture, test or store the PRODUCTS.

  

	C.	Personnel 

 Each PARTY
shall be responsible for providing documented training to each employee engaged in the manufacture and testing of PRODUCTS sufficient to ensure that the assigned function is performed correctly. Additionally each PARTY shall maintain documented
evidence demonstrating that all employees associated with PRODUCTS have received annual training on the principles of cGMP. This documentation will be available during facility audits. 

Both Parties hereby certify that neither they, or any employees, agents, officers, directors or consultants is debarred, or is under
threat of debarrment under the US Generic Drug Enforcement Act of 1992, or any other applicable statute, code or regulation. 

Use of subcontractors directly engaged in the manufacturing and testing of PRODUCTS not specified in this, or the SUPPLY AGREEMENT must be
disclosed prior to use. 
  

	D.	cGMP Guidelines 

 cGMP
guidelines shall include the principles detailed in the US Current Good Manufacturing Practices (21 CFR 210 and 211) that cover the standards of manufacture for any product intended for human use, as well as the Product Specifications and any
applicable product license, the NDA application, pharmacopoeia or formulary requirements. 
  

	E.	Materials 

  

	 	1.	Materials Procured by SkyePharma  

 SkyePharma will use only raw materials and components that have been tested in accordance with the NDA and applicable cGMP. 

 Prior to commercial use, all materials used in the PRODUCTS must meet SkyePharma’s
requirements for production use. 
 SkyePharma is responsible for auditing and qualifying vendors of actives and raw materials
used in PRODUCTS and will provide Enzon with a Certificate of Conformance statement for such vendors when requested. SkyePharma will audit raw material vendors / suppliers at regular intervals according to a defined program. The identity of the
vendors / suppliers audited and date of audit will be available for review by Enzon upon request. 
 SkyePharma is responsible
for ensuring that all materials procured by SkyePharma for use in the PRODUCTS are in compliance with the specifications listed in the product registration. Raw Materials are given a reassay date upon the satisfactory completion of all initial,
testing. Reassay testing will be performed at defined time intervals to ensure the chemical and physical stability of the raw materials. Reassay dates assigned by SkyePharma are not to exceed vendor assigned expiration or retest dates. 

SkyePharma is responsible for ensuring that all materials are stored properly, used correctly, appropriately tested upon receipt and
traceable to the relevant Certificate of Analysis for the materials. 
  

	2.	Materials Procured by Enzon  

 Enzon is responsible for auditing and qualifying vendors / suppliers of labels and labeling used with PRODUCTS and will provide SkyePharma with a Certificate of Conformance statement for such vendors when
requested. Enzon will audit vendors / suppliers at regular intervals according to a defined program. The identity of the vendors / suppliers audited and date of audit will be available for review by SkyePharma upon request. 

Enzon is responsible for assuring that labels and packaging are received, identified, stored, handled, sampled examined and/or tested
prior to use, to assure that labels and packaging are issued and controlled during use to prevent mix-up and to examine representative samples of labeled and packaged PRODUCTS to assure label correctness. 

 

	F.	Standard Operating Procedures  

 SkyePharma is responsible for maintaining any SOPs required to manufacture, test and store the PRODUCTS at SkyePharma and to support applicable cGMPs. 

 

	G.	Methods Validation Certification  

 SkyePharma is responsible for providing to Enzon a Certification of Methods Validation Compliance for all critical methods practiced by SkyePharma (raw materials testing, in-process product testing,
product batch release, drug and product stability and cleaning validation). The certifications should state, “The methods are appropriate for the intended purpose, are validated per relevant regulatory guidelines and are readily available in
case of a regulatory inspection.” 

  

	H.	 Batch Numbers 

 Enzon is responsible to code labels and packaging with an Enzon lot number and an expiration date provided, by SkyePharma. The batch number applied to the crimp cap will be in the SkyePharma format.

 SkyePharma Batch Number – A six digit number of the form WW-XYZZ. “WW” represents the last two digits of the
current year. “X” represents a one-digit code which is specific for the product by active ingredient, “Y” represents a one-digit code to differentiate the type of lot, e.g., commercial, process development clinical, etc.
“ZZ” represents a sequential number from 1 to 99. The batch number will be applied to the crimp cap of the vialed product immediately after filling. 
 Enzon Lot Number – A six digit alpha numeric code in the form A B CC DD where “A” represents the product, “B” represents the scheduled month of manufacture. “CC”
represents the last two digits of the year of manufacture and “DD” represents a sequential number from 1 to 99. The Enzon lot number will be applied to the product labeling. 

 

	I.	Dates of Manufacture and Expiration  

 The date of manufacture of a PRODUCT will be defined by SkyePharma as the date that active drug and excipients are first placed together into a mixing vessel. Expiration dates are computed from the date
of manufacture, and are listed in month/year format. 
 SkyePharma will calculate the expiry date from the date of manufacture
using the currently approved expiry period. The expiration date will be the last day of the month computed above. Changes to the expiration period will be handled by Change Management (see Section X) and SkyePharma will provide any necessary
notification to FDA. 
  

	J.	Manufacturing and Equipment Data  

 SkyePharma is responsible for keeping records of equipment usage (previous PRODUCT produced in non-dedicated equipment), cleaning and any maintenance and/or calibration performed. 

 

	K.	Storage and Shipment  

When the PRODUCTS are in the possession, custody or control of a Party, such Party will (i) store the PRODUCTS under cGMP conditions
with appropriate temperature control, and (ii) ensure that appropriate controls are in place to prevent interference, theft, product contamination and mixture with any other products or materials. 

SkyePharma will suitably pack the unlabeled PRODUCTS in validated shippers for transit. At least one(l) temperature monitor will be
included in each shipping container. Shipments will be arranged for next day delivery. Shipments will not be made on Thursday or Friday unless prior written approval from Enzon is received. 

Only interim approved, unlabeled PRODUCTS will be shipped by SkyePharma to Enzon in accordance with Appendix III attached hereto, except
as otherwise provided. 

 SkyePharma will not skip any PRODUCT that is unapproved or under quarantine, unless mutually
agreed by the parties. 
 When the PRODUCTS are in the possession, custody or control of a Party, such Party will maintain proper
segregation of the PRODUCTS. Each Party shall be permitted to review the other Party’s segregation systems. Different lots of a single PRODUCT or different types of products will not be mixed on a pallet. 

 

	VI.	PRODUCT TESTING 

  

	A.	General 

 The testing
activities for the PRODUCTS are to be performed by SkyePharma as set forth in the NDA and defined in the SUPPLY AGREEMENT. Following SkyePharma’s release of the PRODUCTS to Enzon, the Enzon Quality Unit will be responsible for authorization for
distribution based upon the full release documentation package provided by SkyePharma. 
 The DepoCyt final PRODUCT specification
is attached as Appendix IV. 
  

	B.	In-Process and Finished Product Testing  

 All testing must be done in accordance with the NDA and under cGMP guidelines. 
 At
the completion of each packaging operation (including partial sublot packaging) Enzon will provide SkyePharma with one packaged unit of PRODUCTS for the purposes of identity testing of the contents to assure correct labeling. SkyePharma will provide
the results of the identity test for inclusion in the Enzon labeling and packing records. 
  

	C.	Retain Samples 

 For each
lot of PRODUCT manufactured by SkyePharma. SkyePharma will retain samples of the active ingredients and excipients used in the manufacture of the PRODUCTS for a period of no less than three years following the labeled expiration or last retest date
determined, by SkyePharma for that component. The amount of sample retained will be at least twice the amount necessary to carry out all of the tests required to determine if the material meets its specifications, with the exception of sterility and
endotoxin testing. 
 For each lot of PRODUCTS manufactured by SkyePharma, Enzon will provide SkyePharma with packaged material.
SkyePharma will retain these samples for at least one year beyond the expiry period. The amount of sample retained will be twice the quantity required to carry out all of the tests required to determine if the material meets its specifications, with
the exception of sterility and endotoxin testing. SkyePharma will use these samples for annual visual inspection. 
 For each lot
of PRODUCTS manufactured by SkyePharma. Enzon will retain a sample of the commercial package under the proper storage conditions. 
 SkyePharma will notify Enzon prior to the destruction of any PRODUCTS designated as Clinical Trial Material involved in clinical trials in which Enzon was engaged. 

  

	D.	 Routine Stability Program  

 SkyePharma is responsible for maintaining a routine stability testing program for the PRODUCTS and will provide a formal stability report to Enzon annually and a data summary semi-annually. The stability
program will be in compliance with the NDA commitments. At a, minimum, one lot of each product, of each strength and in each package type (largest and smallest) will be placed on stability each year. The stability program will follow ICH guidelines
with the exception of humidity control and monitoring for products packaged in glass. SkyePharma will inform Enzon at the time of occurrence, of any material changes to the stability protocol for any PRODUCT. 

Any confirmed problems that arise as a result of the stability program will be promptly communicated by SkyePharma to Enzon. 

 

	E.	Out-of-Specification (OOS) Investigations  

 SkyePharma is responsible for investigating any testing performed by SkyePharma that fails to meet specifications. Each investigation will be reviewed by SkyePharma’s designated Quality person and
will follow internal procedures that are in accordance with regulatory guidelines. 
  

	VII.	QUALITY ASSURANCE 

  

	A.	Investigations  

 Any
deviation from the process or OOS result will be carefully documented and approved by SkyePharma Quality Assurance and appropriate area management, in accordance with controlling SkyePharma SOPs. In addition to the tracking number, a brief
description of each investigation, deviation from the process or OOS associated with, the batch will be provided to Enzon with the batch release documentation. 
 SkyePharma will notify Enzon if any problems are discovered that may impact PRODUCT batch(es) previously shipped to Enzon. 
 SkyePharma will perform any additional testing, stability and validation that is necessary as a result of any such investigation. SkyePharma will keep Enzon informed of the conduct and progress of such
work if shipping schedules will be impacted. 
  

	B.	Batch Disposition 

  

	 	1.	Interim Release by SkyePharma  

 To facilitate labeling and packaging by Enzon, SkyePharma will provide an interim release of unlabeled vials for shipment to Enzon after the tests specified for Interim Release in Appendix III have
been completed and results meet the criteria stated in the NDA and the SUPPLY AGREEMENT. 
  

	 	2.	Batch Disposition by SkyePharma  

 For each batch, SkyePharma will provide release documentation as defined in Appendix III, including a standard Certificate of Analysis indicating the test results and specification of each test
performed, as well as a signed Certificate of Compliance confirming that the PRODUCTS have been manufactured, tested and stored according to the requirements of the Master Production Record and cGMPs. 

  

	C.	 Authorization for Distribution by Enzon 

 Authorization for distribution of PRODUCTS, released by SkyePharma, is the responsibility of Enzon’s Quality Assurance department. Enzon’s authorization will be based on Enzon’s internal
procedures, and the full release documentation package provided by SkyePharma. 
 Upon review of SkyePharma documents and the
Enzon labeling and packaging records, the Enzon Quality Assurance department will issue authorization for distribution. 
 Any
problem discovered by Enzon likely to cause rejection of the PRODUCTS will be communicated to SkyePharma within 30 days from receipt of the full release documentation package (see Appendix III). 

 

	D.	Product Complaints and Recalls  

 Enzon is responsible for receiving and initially evaluating any PRODUCT complaints. Enzon will promptly notify SkyePharma of all complaints received. Recalls of the PRODUCTS will be conducted in
accordance with the appropriate SUPPLY AGREEMENT entered into by SkyePharma and Enzon. SkyePharma is responsible for reporting complaints to the appropriate regulatory authority, including adverse drug-events reports. Any complaint relating to any
PRODUCT received by SkyePharma will be promptly forwarded to Enzon. 
 SkyePharma, with data and assistance provided by Enzon, is
responsible for filing Field Alerts. 
  

	E.	Records Retention  

SkyePharma will retain, at a minimum, batch production records for the PRODUCTS and materials for seven (7) years from manufacture of
lots. Validation records may need to be held for longer than seven (7) years. 
 SkyePharma will retain batch records for
the expiry date of the Clinical Trial Material involved in clinical trials in which Enzon was engaged for a maximum of three (3) years, unless notified of a shorter retention period by Enzon, but at a maximum one (1) year past the stop use
date. 
  

	F.	QA Presence in the Manufacturing Facility  

 SkyePharma will maintain adequate QA presence in the manufacturing facility during the manufacture of the PRODUCTS to ensure compliance with cGMPs. 

VIII. REGULATORY 
  

	A.	Regulatory Inspections  

SkyePharma will promptly inform Enzon of any regulatory inspections that may involve the PRODUCTS and permit a representative from Enzon
Quality to be present; provided such inspection may proceed without the presence of a representative from Enzon Quality. 

 SkyePharma will promptly inform Enzon of all material manufacturing related commitments to
Regulatory Authorities regarding the PRODUCTS. 
 Enzon will promptly inform SkyePharma in writing of any regulatory issue that
may impact SkyePharma’s ability to manufacture the PRODUCTS. 
  

	B.	Regulatory Actions  

Enzon will notify SkyePharma of any regulatory actions on the PRODUCTS that may impact SkyePharma. Enzon will promptly forward any
regulatory correspondence on the PRODUCTS to SkyePharma. 
 SkyePharma is responsible for supporting all batch record
investigations associated with regulatory actions. 
  

	C.	Regulatory Affairs  

SkyePharma is responsible for ensuring all appropriate regulatory filings and import/export documentation are filed with Regulatory
Agencies prior to shipment/human administration. 
  

	D.	Right to Audit  

SkyePharma will allow representatives from Enzon Quality to perform one standard no-cause cGMP compliance audit per year, and will provide
access to their manufacturing, warehousing, and laboratory premises and associated records pertinent to PRODUCTS for audit purposes. In the event any non-conformity is identified, Enzon shall be permitted to re-inspect SkyePharma’s facilities
to determine whether such non-conformity has been rectified. Reasonable copying of records will be allowed. Enzon representatives will be escorted at all times by SkyePharma personnel. All such audits will be conducted at reasonable times and will
not unduly disrupt SkyePharma’s operations. 
 Enzon will allow representatives from SkyePharma Quality to perform one
standard no-cause cGMP compliance audit per year, and will provide access to their labeling and packaging area and associated records pertinent to PRODUCTS for audit purposes. In the event any non-conformity is identified, SkyePharma shall be
permitted to re-inspect Enzon’s facilities to determine whether such non-conformity has been rectified. Reasonable copying of records will be allowed. SkyePharma representatives will be escorted at all times by Enzon personnel. All such audits
will be conducted at reasonable times and will not unduly disrupt Enzon’s operations. 
  

	E.	Audit Closeout  

 An exit
meeting will be held with representatives from SkyePharma and Enzon to discuss significant audit observations. 
 The auditing
party will provide a written report of all observations within thirty (30) days to the audited party. Within 30 days of the audit report receipt, the audited party will provide a written response to all findings that details corrective action
to be implemented with follow up to ensure that all corrective actions are implemented. 

  

	IX.	 DISPUTE RESOLUTION 

  

	A.	 Non-Conformity Dispute  

 In the event that a dispute arises between SkyePharma and Enzon in the nonconformity of a batch of the PRODUCTS, the heads of the Quality departments from both companies will in good faith promptly
attempt to reach an agreement .Financial liability will be determined according to the Supply Agreement. 
  

	B.	Test Result Dispute  

 In
the event that a dispute arises between SkyePharma and Enzon in the testing performed by SkyePharma for the PRODUCTS, the resolution will proceed in stages. The first stage requires direct communication between analysts from both parties to
determine that the methods of analysis are the same and are being executed in the same manner at both sites. Second, carefully controlled and split samples should be sent from one site to another in an attempt to reach agreement. Should there be a
failure to achieve resolution, analysts from both parties will be required to meet to work through the analysis of a mutually agreeable sample. If these actions fail to achieve resolution, and only after these avenues have been exhausted, a
qualified referee laboratory will be used to achieve resolution. This laboratory must be agreeable to both parties prior to use. The results from this referee laboratory will be used as final authority to determine responsibilities, but whatever the
outcome, SkyePharma retains the right to determine product release status. Financial liability will be determined according to the SUPPLY AGREEMENT. 
 In the event that an independent third party laboratory must be retained to settle dispute between the Parties with respect to the conformity or nonconformity of a Product, SkyePharma will be responsible
for the technology transfer to such laboratory, and will confirm that the technology transfer had been successful, the laboratory was capable of reproducing SkyePharma laboratory results and that the laboratory was in compliance with cGMP.

  

	X.	CHANGE MANAGEMENT 

  

	A.	Changes for Commercial PRODUCTS – All material changes to the PRODUCTS will undergo a technical and cGMP impact assessment by SkyePharma’s expert
groups coordinated by SkyePharma’s Quality Operations’ Change Management personnel. Such changes will be communicated to Enzon Quality. 

  

	B.	Control of Master Labels and Labeling – Change control for each printed component accompanying PRODUCTS will be administered by both Enzon and SkyePharma
(an exception is made for SkyePharma supplied shipper and WTP labels) depending upon the change requested. This includes, but is not limited to, the vial label, the unit carton and the package insert. 

Both parties will be responsible for approval of master printed material including the respective Quality organizations. SkyePharma will
be solely responsible for technical, content, language and validity as it applies to PRODUCTS and PRODUCT characteristics or specifications. 

 
Enzon is responsible for supplying approved artwork for the purchase of printed packaging components. 
  

	C.	 Changes to the Quality Agreement  

 This Quality Agreement and any appendices attached hereto may be amended at anytime upon mutual written agreement between the Parties. 

Contact names may be changed by issuing a memo provided to both companies and attaching the memo to the original agreement. The updated
information will be incorporated into the next revision of the agreement. 
  

	XI.	PRODUCT AND PROCESS VERIFICATION/VALIDATION 

  

	A.	Process Verification – SkyePharma is responsible for the verification of the manufacturing process for the PRODUCTS, as might be required. The verification
should ensure that the process is capable of consistently achieving the PRODUCTS acceptance specification. 

Process Validation – SkyePharma is responsible for the validation of the manufacturing process for PRODUCTS, as might be
required. The validation, should ensure that the process is capable of consistently achieving the PRODUCTS acceptance specification. 
  

	B.	Cleaning Validation – SkyePharma is responsible for ensuring that adequate cleaning is carried out between batches of different products to prevent
contamination. Data should be available to support the campaign of batches of the same product, and the type of cleaning that will be performed in between manufacturing of the same product. 

 

	C.	Equipment, Computer, Facility and Utilities Qualification – SkyePharma is responsible for all equipment, computer, facility and utility qualification and
calibration activities associated with the manufacture of PRODUCTS. Such qualification/calibration should be in accordance with cGMP regulations. 

  

	D.	Laboratory Qualification – SkyePharma is responsible for ensuring that all laboratories are in compliance with applicable cGMP guidelines.

 If analytical work is subcontracted by SkyePharma, SkyePharma will be responsible for the technology transfer to
such laboratory and will confirm that the technology transfer had been successful, that the laboratory is capable of reproducing SkyePharma laboratory results and that the laboratory is in compliance with cGMP. SkyePharma will perform an audit on
such vendors to be used for analytical testing. SkyePharma will be responsible for ensuring that the vendor is practicing within cGMP compliance. 
 In the event that an ENZON quality control laboratory will perform analytical testing of a Product, SkyePharma will be responsible for the technology transfer to such laboratory and will confirm that the
technology transfer has been successful and that the laboratory is capable of reproducing SkyePharma laboratory results. 

  

	XII.	 ANNUAL PRODUCT REVIEW, ANNUAL PRODUCT REPORT AND DRUG LISTING 

 

	A.	 Annual Product Review  

 SkyePharma will perform an Annual Product Review which includes an executive summary for the PRODUCTS. This report will cover all manufacturing and testing performed by SkyePharma. It will be a review of
any changes at SkyePharma in the manufacturing, testing or validation of the PRODUCTS in the previous calendar year and a summary of lots made, released and rejected. Also, control charting or trend analysis of key product parameters will be
performed. Any abnormalities will be explained in the annual, product review. 
 The executive summary and documented evidence
that responsible officials of SkyePharma have reviewed and endorsed the Annual Product Review will be provided to Enzon during cGMP compliance audits. 
  

	B.	Annual Product Report  

SkyePharma is responsible for preparing and submitting an Annual Product Report to FDA as required by applicable regulations, including 21
CFR 314.70, 314.81, and/or 601.12. 
  

	C.	Drug Listing  

 SkyePharma
is responsible for drug listing domestic products as the manufacturer of the PRODUCTS, while Enzon is responsible for drug listing as the distributor of the PRODUCTS. Enzon and SkyePharma will provide each other with all required information needed
to register the PRODUCTS. 
  

	D.	Adverse Drug Experience Reports  

 SkyePharma is responsible for submitting Adverse Drug Experience reports. 

 APPENDIX I 
 OUTLINE OF RESPONSIBILITIES 
  

					
	 FUNCTION
	  	SkyePharma	  	Enzon
	 EXPIRATION DATE ASSIGNMENT
	  	X	  	
			
	 BATCH/LOT NUMBER ASSIGNMENT
	  	X	  	X
			
	 MANUFACTURING
	  	X	  	
			
	 IN-PROCESS TESTING (Physical, Chemical Microbial)
	  	X	  	
			
	 FINAL PRODUCT TESTING (Physical Chemical, Microbial)
	  	X	  	
			
	 ID TESTING POST LABELING
	  	X	  	
			
	 INVESTIGATIONS INTO DEVIATIONS AND NON-CONFORMANCES
	  	X	  	
			
	 BATCH RECORD REVIEW/SIGNOFF
	  	X	  	
			
	 FINAL PRODUCT RELEASE to ENZON
	  	X	  	
			
	 CERTIFICATE OF ANALYSIS
	  	X	  	
			
	 FINAL PRODUCT RETAINS
	  	X	  	
			
	 ANNUAL PRODUCT INSPECTION
	  	X	  	
			
	 FINAL PRODUCT STABILITY
	  	X	  	
			
	 FINAL PRODUCT RELEASE to MARKET
	  		  	X
			
	 DISTRIBUTION
	  		  	X
			
	 ADVERSE EVENT REPORTS
	  	X	  	X
			
	 COMPLAINT RECEIPTS
	  	X	  	X
			
	 COMPLAINT INVESTIGATIONS
	  	X	  	
			
	 RECALLS
	  	X	  	X
			
	 VALIDATION
	  	X	  	
			
	 FIELD ALERT REPORTS
	  	X	  	
			
	 CUSTOMER RETURNS
	  		  	X

 APPENDIX I continued 

OUTLINE OF RESPONSIBILITIES 
  

					
	 FUNCTION
	  	SkyePharma	  	Enzon
	 RAW MATERIAL (Active/ Inactives) PURCHASE
	  	X	  	
			
	 RAW MATERIAL (Active/ Inactives) TESTING and RELEASE
	  	X	  	
			
	 COMPONENTS (Printed Packaging Materials) PURCHASE
	  		  	X
			
	 COMPONENTS (Printed Packaging Materials) TESTS
	  		  	X
			
	 COMPONENTS (Printed Packaging Materials) RELEASE
	  		  	X
			
	 RAW MATERIAL/COMPONENT RETAINS
	  	X	  	X
			
	 MAINTENANCE OF VENDOR LISTS
	  	X	  	X
			
	 SUPPLIER AUDITS (Active / Inactives)
	  	X	  	
			
	 SUPPLIER AUDITS (Printed Packaging Materials)
	  		  	X
			
	 RECORD RETENTION
	  	X	  	X
			
	 DOCUMENT CHANGE CONTROL
	  	X	  	X
			
	 NOTICE OF PROPOSED CHANGES (either party may initiate)
	  	X	  	X
			
	 FINAL PRODUCT SPECIFICATION MAINTENANCE
	  	X	  	
			
	 ANNUAL PRODUCT REVIEW
	  	X	  	
			
	 DRUG LISTING
	  	X	  	X
			
	 ANNUAL PRODUCT REPORT TO FDA
	  	X	  	

 APPENDIX II 
 LIST OF QUALITY CONTACTS 
 (name, phone, fax, e-mail) 

 

					
	 ISSUE
	  	 Enzon
	  	 SkyePharma

	 Product Release
	  	 Kathy Buchanan
 Ph: (908) 412-2458
 Fax (908) 668-5997

kathy.buchanan@enzon.com
	  	 Russell Owen
 Ph: (858) 625-2424 X3260
 Fax (858) 625-0213

RussellO@skyepharma.com

			
	 Laboratory Testing
	  	 Beverly Wilson
 Ph: (908) 412-2338
 Fax (908) 668-5997

beverly.wilson@enzon.com
	  	 Lorie Opelanio
 Ph: (858) 625-2424 X3268
 Fax (858) 625-2439

LorieO@skyepharma.com

			
		  		  	 Rick Summers
 Ph: (858) 625-2424 X3103
 Fax (858) 625-2439

RickS@skyepharma.com

			
	 Investigations
	  	 Kathy Buchanan
 Ph: (908) 412-2458
 Fax (908) 668-5997

kathy.buchanan@enzon.com
	  	 Rick Summers
 Ph: (858) 625-2424 X3103
 Fax (858) 625-2439

RickS@skyepharma.com

			
		  		  	 Russell Owen
 Ph: (858) 625-2424 X3260
 Fax (858) 625-0213

RussellO@skyepharma.com

			
	 Regulatory Affairs
	  	 Kathryn Bishburg, PharmaD
 Ph: (732) 980-4755
 Fax: (732) 980-5991

kathryn.bushburg@enzon.com
	  	 Steve Jensen
 Ph: (858) 625-2424 X3227
 Fax (858) 625-0804

SteveJ@skyepharma.com

			
	 Pharmacovigilance
	  	 Anthony Killian, Ph.D., M.D.
 Ph: (732) 980-4523
 Fax: (732) 980-5991

anthony.killian@enzon.com
	  	 John Gait, M.D.
 Ph: (858) 625-2424 X3253
 Fax (858) 625-0804

JohnG@skyepharma.com

			
	 Stability
	  	 Not Applicable
	  	 Rick Summers
 Ph: (858) 625-2424 X3103
 Fax (858) 625-2439

RickS@skyepharma.com

 APPENDIX II continued 

LIST OF QUALITY CONTACTS 
 (name, phone, fax, e-mail) 
  

					
	ISSUE	  	Enzon	  	SkyePharma
	Validation	  	  
  
 Not Applicable
	  	 Nicole Plumb
 Ph: (858)
625-2424 X2259
 Fax (858) 625-0213 NicoleP@skyepharma.com

			
	Compliance Audits	  	 Alice Preville
 Ph: (908)
412-2331
 Fax: (908) 668-5997 alice.preville@enzon.com
  

Joel Schwartzman
 Ph: (908) 412-2321

Fax (908) 668-5997 joel.schwartzman@enzon.com
	  	 Russell Owen
 Ph: (858)
625-2424 X3260
 Fax (858) 625-0213 RussellO@skyepharma.com

			
	Product Complaints	  	 Kathy Buchanan
 Ph: (908)
412-2458
 Fax (908) 668-5997 kathy.buchanan@enzon.com
	  	 Russell Owen
 Ph: (858)
625-2424 X3260
 Fax (858) 625-0213 RussellO@skyepharma.com

			
	Change Management	  	 Dottie Sluzas
 Ph: (908)
412-2417
 Fax (908) 668-5997 dorothy.sluza@enzon.com
  

Kathy Welsch
 Ph: (908) 412-2342

Fax (908) 668-5997 kathy.welsch@enzon.com
	  	 Russell Owen
 Ph: (858)
625-2424 X3260
 Fax (858) 625-0213 RussellO@skyepharma.com

 
 Nicole Plumb
 Ph: (858) 625-2424 X2259
 Fax (858) 625-0213
NicoleP@skyepharma.com

 APPENDIX III 
 RELEASE DOCUMENTATION 
 The Batch/Lot Release Document Package will include a
batch, specific Certificate of Analysis, identity test results of PRODUCTS post-labeling/packaging and a Certificate of Compliance. 
 Interim Certificate of Analysis (Interim COA) 
 An Interim
COA, to support packaging and labeling, will be provided in SkyePharma standard format and will include the manufacturing address, the PRODUCTS name, SkyePharma batch number, Enzon assigned lot number, date of manufacture, date of expiration,
analytical specifications for the tests performed by SkyePharma laboratories, actual test results and a statement releasing the PRODUCTS for labeling and packaging. 

Testing to support interim release will include appearance, identity by HPLC, in-vitro release assay, total cytarabine, %
free cytarabine and content uniformity. 
 The batch specific SkyePharma Interim Release Checklist will be
attached. The Interim COA and Interim Release Checklist will be signed and dated by a responsible member of the SkyePharma Quality organization. 
 Certificate of Analysis (COA) 
 A COA will be provided in
SkyePharma standard format and will include the manufacturing address, PRODUCTS name, SkyePharma batch number, Enzon assigned lot number, date of manufacture, date of expiration and analytical specifications as provided in the NDA, the Supply
Agreement, and in SkyePharma product specification 006-40001 (refer to APPENDIX IV). The COA will list the Release tests performed by SkyePharma laboratories and actual test results. The COA will make reference to the product specification which
identifies the analytical methods used for product testing. 
 The batch specific SkyePharma QA Release Checklist
will be attached. The COA and the QA Release Checklist will be signed and dated by a responsible member of the SkyePharma Quality organization. 
 Certificate of Analysis for Identity Test – Post Labeling and Packaging 
 Test results with a statement that the conditions of the test were met. A COA will be provided in SkyePharma standard format and will include the manufacturing address, the PRODUCTS name, SkyePharma batch
number, Enzon assigned lot number, date of manufacture, and date of expiration. The test report and test results will be signed and dated by a responsible member of the SkyePharma Quality Control organization. The COA will be signed and dated by a
member of the SkyePharma Quality organization. 
 Certificate of Compliance (COC) 

This document will be provided in SkyePharma standard format and will certify that the batch of PRODUCTS was made in
accordance with all applicable regulations, licenses, and company policies and meets specifications as provided in the NDA, the Supply Agreement, and in SkyePharma product specification 006-40001 (refer to APPENDIX IV). This document will include
the PRODUCT’s SkyePharma batch number and Enzon lot number, batch yield (in vials), the quantity approved (in vials), and the expiration date. It will also include a listing of all deviations, OOSs and investigations associated with the batch
including a brief description of each. 
 The COC will be signed and dated by a responsible member of the
SkyePharma Quality organization. 

 APPENDIX IV 
 SkyePharma Regulatory Specification for SKY01001 – Formulation 1.5 (US) 
  

					
	 SkyePharma Inc.

Specifications
	  	OFFICIAL COPY	  	 Document Number: 006-40001.008
 PCDOC#:0085877.01         Page 1 of 3

Regulatory Specifications for SKY0101- Formulation 1.5 (US) 

 
  

					
	 	  	 	  	Effective Date: May 22, 2003        

 

					
	 1.    
	    	 Definitions:

			
		    	 1.1.
	    	 Regulatory Specifications - specifications approved by the regulatory agency to be applied to the product throughout its shelf life.

		
	 2.
	    	 Associated Documents:

			
		    	 2.1.
	    	 002-10005, “SKY0101. Formulation 1.5 (US)”

			
		    	 2.2.
	    	 002-10008, “SKY0101, Formulation 1.5. Interim Release (US)”

		
	 3.
	    	 References:

			
		    	 3.1.
	    	 005-00019. “Dextrose in SKY0101”

			
		    	 3.2.
	    	 005-00046. “Lyso-DOPC in SKY0101”

			
		    	 3.3.
	    	 005-01002. “Appearance Test for DepoFoamTM Suspension Final Product”

			
		    	 3.4.
	    	 005-01003, “Cholesterol in SKY0101”

			
		    	 3.5.
	    	 005-01010, “Total and Percent Free Cytarabine in SKY0101”

			
		    	 3.6.
	    	 005-01011. “Measurement of pH”

			
		    	 3.7.
	    	 005-01012. “Chloroform in SKY0101”

			
		    	 3.8.
	    	 005-01014. “Measurement of Osmolality”

			
		    	 3.9.
	    	 005-01016. “Particle Size Analysis of DSKY0101”

			
		    	 3.10.
	    	 005-01025. “DOPC in SKY0101”

			
		    	 3.11.
	    	 005-01029. “Fill Volume of Final Product”

			
		    	 3.12.
	    	 005-01054. “Triolein in SKY0101”

			
		    	 3.13.
	    	 005-01059. “Cytarabine Related Substances in SKY0101”

			
		    	 3.14.
	    	 005-01075. “DPPG in SKY0101”

			
		    	 3.15.
	    	 005-01076. “Content Uniformity of SKY0101”

			
		    	 3.16.
	    	 005-10003. “L-Lysine Level in SKY0101 Final Product by FSCE”

			
		    	 3.17.
	    	 005-10012. “HIAC/ROYCO Particulate Matter Test for DSKY0101 Final Product”

			
		    	 3.18.
	    	 005-90021. “In Vitro Release Assay for SKY0101”

 APPENDIX IV – continued 

SkyePharma Regulatory Specification for SKY01001 – Formulation 1.5 (US) 

 

					
	 SkyePharma Inc.

Specifications
	 		  	 Document Number: 006-40001.008
 PCDOC#:0085877.01         Page 2 of 3

 Regulatory Specifications for SKY0101- Formulation 1.5 (US) 
  

 

	4.	 Regulatory Specifications for SKY0101 – Formulation 1.5 (US)-: 

 

							
	 Test
	  	Method**	 	  	Specification
	 Appearance
	  	 	005-01002	  	  	[**]
			
	 Identity by HPLC
	  	 	005-01010	  	  	[**]
			
	 Total Cytarabine
	  	 	005-01010	  	  	[**]
			
	 % Free Cytarabine
	  	 	005-01010	  	  	[**]
			
	 Content Uniformity
	  	 	005-01076	  	  	[**]
			
	 pH
	  	 	005-01011	  	  	[**]
			
	 Particle Size
	  	 	005-01016	  	  	[**]
			
		  				  	[**]
			
	 Oracil Arabinoside
	  	 	005-01059	  	  	[**]
			
	 Cytosine
	  	 	005-01059	  	  	[**]
			
	 Cytidine
	  	 	005-01059	  	  	[**]
			
	 Uridine
	  	 	005-01059	  	  	[**]
			
	 Uracil
	  	 	005-01059	  	  	[**]
			
	 Total Cytarabine related imparities not including Uracil Arabinoside
	  	 	005-01059	  	  	[**]
			
	 Cholesterol
	  	 	005-01003	  	  	[**]
			
	 Triolein
	  	 	005-01054	  	  	[**]
			
	 DPPG
	  	 	005-01075	  	  	[**]
			
	 DOPC
	  	 	005-01025	  	  	[**]
			
	 Lyso-DOPC
	  	 	005-00046	  	  	[**]
			
	 Dextrose
	  	 	005-00019	  	  	[**]
			
	 L-Lysine
	  	 	005-10003	  	  	[**]
			
	 Chloroform
	  	 	005-01012	  	  	[**]
			
	 Osmolality
	  	 	005-01014	  	  	[**]
			
	 Fill Volume
	  	 	005-01029	  	  	[**]

 APPENDIX IV – continued 

SkyePharma Regulatory Specification for SKY01001 – Formulation 1.5 (US) 

 

					
	 SkyePharma Inc.

Specifications
	 		  	 Document Number: 006-40001.008
 PCDOC#:0085877.01         Page 3 of 3

 Regulatory Specifications for SKY0101- Formulation 1.5 (US) 
  

 

	4.	 Regulatory Specifications for SKY0101 – Formulation 1.5 (US)* (Continuation): 

 

					
	 Test
	  	Method**	  	Specification
	 Particulates
	  	 005-10012
	  	 [**]

		  	 or USP <788>
	  	 [**]

			
		  		  	
	 In-Vitro Release Assay (ACSF)

 
	  	 005-90021
	  	
	 Day-0
  

Day-1
  

Day-2
  

Day-3
  

Day-4
	  		  	 [**]

			
	 Bacterial Endotoxins
	  	 LAL Chromogenic
	  	 [**]

			
	 Sterility
	  	 USP
	  	 [**]

 

	*	 Revision of these tests and specifications will affect Referenced Documents. 

	**	 Latest revision level applies.Amended and Restated Strategic Licensing, Distribution and Marketing Agreement

 Exhibit 10.13 
 Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. 
 DATED: OCTOBER 15, 2009 
 PACIRA PHARMACEUTICALS, INC. 

and 

EKR THERAPEUTICS, INC. 
  

 
 AMENDED AND RESTATED

 STRATEGIC LICENSING, DISTRIBUTION AND MARKETING AGREEMENT 

 
  

 THIS AMENDED AND RESTATED STRATEGIC LICENSING, DISTRIBUTION AND MARKETING
AGREEMENT (the “Agreement”) is made on October 15, 2009 (the “Agreement Date”) and is effective as of the Effective Date (as defined below), between: 

PACIRA PHARMACEUTICALS, INC. (F/K/A SKYEPHARMA, INC.) a company incorporated in the state of California whose
principal place of business is 10450 Sciences Center Drive, San Diego, California 92121 USA (“PPI”); and 
 EKR THERAPEUTICS, INC., a company incorporated in the state of Delaware whose principal place of business is 1545 Route 206 South, Third Floor, Bedminster, New Jersey 07921
(“EKR”). 
 Recitals 

PPI owns and has all right title and interest in or has acquired exclusive rights to the PPI IP (as defined below), the
Trademark (as defined below) and the Product (as defined below). 
 EKR has, among other things, specialized
knowledge and expertise in relation to the marketing and sale of pharmaceutical products. 
 Pursuant to that
certain Strategic Licensing, Distribution and Marketing Agreement between EKR and PPI dated as of August 10, 2007 (the “Original Agreement”), PPI granted and EKR acquired the exclusive right and license to sell, offer to sell,
distribute and market the Product in the Territory (as defined below) in the Field (as defined below). 
 EKR
and PPI desire to amend and restate the Original Agreement in its entirety as set forth herein in order to provide for: (i) certain changes to the financial terms set forth in the Original Agreement, (ii) the transfer of Marketing
Authorizations (as defined below) from PPI to 

  
 -1-

 
EKR, and EKR’s assumption of obligations thereunder, (iii) the transfer of title to certain manufacturing equipment from PPI to EKR and the lease of such equipment back from EKR to PPI
and (iv) certain other changes as are set forth herein; all of the foregoing subject to and in accordance with the terms and conditions of this Agreement. 
 NOW THEREFORE, in consideration of the following mutual agreements and covenants set forth herein and intending to be legally bound hereby, PPI and EKR (each, a “Party” and
collectively, the “Parties”) acknowledge and agree that this Agreement shall amend and supersede in its entirety the Original Agreement and hereby agree as follows: 
 Operative Provisions 
  

	1.	 Definitions 

  

	1.1	 As used in this Agreement, the following words and expressions have the following meanings: 

 

			
	 “Affiliate”
	  	 With respect to any Party to this Agreement shall mean any company, corporation, firm, individual or other entity which Controls, is Controlled by or is under
common Control with such Party to this Agreement for only so long as such Control exists;

  
 -2-

			
	 “Applicable Laws”
	  	 Shall mean all laws, rules and regulations regarding the manufacture, packaging, labeling, import, export, storage, distribution, representation, promotion,
marketing and sale of the Products including but not limited to the Federal Food, Drug and Cosmetic Act of 1938, as amended (“FD&C Act”) and the Controlled Substances Act, as amended (21 U.S.C. §801 et seq.), or as defined
in attendant regulations promulgated under authorities granted by the FD&C Act, together with any equivalent laws, rules, regulations, codes or guidelines having effect in any jurisdiction in the Territory;

		
	 “Calendar Year”
	  	 Shall mean the period of twelve months commencing on 1st January in any year, and each consecutive period of twelve months thereafter during the
Term;

		
	 “cGMP”
	  	 Means Current Good Manufacturing Practices pursuant to 21 CFR Parts 210 and 211, as may be amended from time to time;

		
	 “Commercial Launch”
	  	 Shall mean the date of the first arm’s length sale by EKR to an unaffiliated Third Party customer for commercial use of Product in a country within the
Territory following the grant of Marketing Authorization and any necessary pricing approval in that country;

		
	 “Commercialization
Committee”
	  	 Shall mean the committee to be set up under the terms of Article 5;

  
 -3-

			
	 “Competing Product”
	  	 Means any [**] ([**] hours) [**] preparation (other than the Product) available in a country in the Territory which competes or would compete directly with the
Product. For the avoidance of doubt, the definition of “Competing Product” does not include Depobupivacaine or any improvement thereto;

		
	 “Confidential Information”
	  	 Means all confidential information, data and materials in whatever form disclosed by or on behalf of one Party or its
Affiliates to the other Party or its Affiliates including, without limitation, the terms of this Agreement, data, formulae, unpublished patent disclosures, processes, protocols, marketing studies, sales information, specifications and know-how,
(and, in the case of EKR’s Confidential Information, EKR’s marketing plans and EKR’s sales forecasts), but excluding information which either Party can establish by written documentation:

 

(i)        at the time of disclosure, is in the public
domain or is public knowledge;
  
 (ii)       after disclosure, becomes part of the public domain by publication, except by breach of any obligation of confidentiality by a Party hereto or an Affiliate of
such Party;
  
 (iii)      was already in its possession at the time of its receipt and was not acquired directly or indirectly from the other Party or its Affiliates; or

 

(iv)      received from Third Parties who were lawfully entitled to
disclose such information;

  
 -4-

			
	 “Control”
	  	 Means in relation to any Party or an Affiliate the possession directly or indirectly, of the power to direct or cause the direction of the management and
policies of such firm, person or entity, by contract or otherwise, or the ownership either directly or indirectly of 50% or more of the voting securities of such Party;

		
	 “Copyrights”
	  	 Means (i) the copyright registrations and applications for registration identified on Schedule III, (ii) works of authorship whether or not copyrightable
and (iii) any other copyrights and works, together with all common law rights, used or held for use by PPI or any of its Affiliates in connection with the Products in the Territory (including, but not limited to, any license or other rights of PPI
or any of its Affiliates, whether as a licensor, licensee or otherwise relation to any of the foregoing);

		
	 “Current Base Price”
	  	 Means the Product’s current (as of the Effective Date) net average selling price of $[**] ([**] mg) and $[**] ([**] mg);

		
	 “DEA”
	  	 Shall mean the United States Drug Enforcement Administration and any successor thereto performing similar functions;

		
	 “Distribution Rights”
	  	 Shall have the meaning set forth in Section 2.1 hereof;

		
	 “Domain Name”
	  	 Shall mean Depodur.com and any other domain names owned or licensed by PPI related to the Product set forth on Schedule IV
hereto;

  
 -5-

			
	“EKR Improvement”	  	 Means any Improvement generated, conceived, reduced to practice or other created during the Term by EKR or any of its Affiliates.

		
	Endo/PPI Unit Sales	  	 Shall have the meaning set forth in Section 3.19 hereof;

		
	Endo Product	  	 Means: (i) DepoDur Injectible Liposomal Epidural 10 mg/ml NDC # [**]; and (ii) DepoDur Injectible Liposomal Epidural 15 mg/1.5 ml NDC #
[**];

		
	“Effective Date”	  	 Means August 10, 2007;

		
	“FDA”	  	 Means the United States Food and Drug Administration or any successor thereto performing similar functions;

		
	“Field”	  	 Means the management of post-operative pain following major orthopedic, abdominal or pelvic
surgery;

  
 -6-

			
	“Force Majeure”	  	 Means in relation to either Party, any cause affecting the performance of this Agreement or the Supply Agreement arising from or attributable to any acts,
events, non-happenings, omissions or accidents beyond the reasonable control of the Party to perform and in particular but without limiting the generality thereof shall include strikes and labor disturbances, lock-outs, industrial action, civil
commotion, riot, invasion, war, threat of or preparation for war, terrorist activity, fire, explosion, storm, flood, earthquake, subsidence, epidemic or other natural physical disaster, impossibility of the use of railways, shipping, aircraft, motor
transport, or other means of public or private transport, failure or suspension of utilities, unavailability, shortage or interruption in the supply of raw material, and political interference with the normal operation of either
Party;

		
	“Improvements”	  	 Means any discovery, development, improvement, know-how or patent relating to the Product generated, conceived, reduced to practice or otherwise created during
the Term by PPI or EKR (or any Affiliate of PPI or EKR);

		
	“Joint Improvements”	  	 Means any Improvements generated, conceived, reduced to practice or other created jointly by EKR and PPI or their Affiliates.

		
	“Known In-Channel
Product Units”	  	 Shall have the meaning set forth in Section 3.19 hereof;

  
 -7-

			
	“Marketing Authorization”	  	 Means the new drug application (“NDA”) and all other necessary regulatory and governmental approvals by a Regulatory Authority or other
governmental body required to market and sell the Product in any country of the Territory, including, but not limited to, those set forth on Schedule V hereto;

		
	“Marketing Plan”	  	 Means the plan for the marketing, distribution and sale of the Product in the Territory submitted to the Commercialization Committee in accordance with
Section 5.4;

  
 -8-

			
	“Net Sales”	  	 Means total gross sales of Product invoiced by EKR, its Affiliates and sub-distributors in arms length sales to Third
Parties, less the following amounts actually incurred, deducted, accrued or allowed:
  

(i)        transport, freight and insurance costs which
are separately stated;
  
 (ii)       sales and excise taxes and duties;
  

(iii)      normal and customary trade, quantity and cash discounts,
rebates and chargebacks;
  
 (iv)      amounts repaid or credited for properly rejected, returned or recalled goods or resulting from retroactive price adjustments related to the Product;

 

(v)       amounts incurred or resulting from government (or an
agency thereof) mandated or managed care or other rebate programs now existing or implemented hereafter;
  

(vi)      any other identifiable amounts included in gross sales of
the Product that were or ultimately will be credited and that are substantially similar to those listed hereinabove; and
  

(vii)     any other deductions allowed by GAAP which effectively reduce
the net selling price of Product;

		
	“PPI Improvement”	  	 Means any Improvement generated, conceived, reduced to practice or otherwise created during the Term by PPI or any of its
Affiliates;

  
 -9-

			
	“PPI IP”	  	 Means the Copyrights, PPI Know-How, PPI Patents and PPI Improvements; and PPI’s interest in Joint Improvements;

		
	“PPI Know-How”	  	 Means all information, procedures, instructions, techniques, data, technical information, knowledge and experience (including, without limitation, toxicological,
pharmaceutical, clinical, non-clinical and medical data, health registration data and marketing data), designs, dossiers (including, without limitation, manufacturing assay and quality control dossiers) manufacturing formulae, processing
specifications, sales and marketing materials and technology relating to the Product;

		
	“PPI Patents”	  	 Means those patents set out in Schedule I which cover the Products and such other patents as PPI may include from time to time, including additions,
divisions, confirmations, continuations-in-part, substitutions, re-issues, re-examinations, extensions, registrations, patent terms extensions, supplementary protection certificates and renewals of any of the above or any other patents owned or
licensed by PPI subsequent to the Effective Date which cover the Products or any Improvements;

  
 -10-

			
	“Product(s)”	  	 Means: (i) DepoDur Injectible Liposomal Epidural [**] mg/ml [**]; (ii) DepoDur Injectible Liposomal Epidural [**] mg/[**] ml [**]; (iii) such other presentations
and dosages which hereafter receive Marketing Authorization in any country of the Territory; in each case for epidural administration presented in Vials or other approved vessels, appropriately packaged and labeled for sale to end users and (iv) any
and all Improvements of the items listed in clauses (i) through (iii).

		
	“Promotional Materials”	  	 Means promotional, sales, marketing, educational and training materials which are necessary to support the marketing of the Products;

		
	“Quarter”	  	 Means a three month period ending on the last day of March, June, September or December in any Calendar Year;

		
	“Regulatory Authority”	  	 Means any competent regulatory authority or other governmental body (for example, but not by way of limitation the FDA and DEA) responsible for granting a
Marketing Authorization in the Territory;

		
	“Royalty Cap”	  	 Shall have the meaning set forth in Section 6.4;

		
	“Supply Agreement”	  	 Means: (i) with respect to periods between the Effective Date and the Agreement Date, that certain Supply Agreement entered into by the Parties on the Effective
Date and (ii) with respect to periods on or after the Agreement Date, that certain Amended and Restated Supply Agreement entered into by the Parties on the Agreement Date (as may be amended from time to
time);

  
 -11-

			
	“Term”	  	 Means the term of this Agreement as set out in Section 15;

		
	“Territory”	  	 Means each of the countries and territories listed in Schedule VII;

		
	“Third Party”	  	 Means any company, corporation, firm, individual or other entity but excluding a Party to this Agreement or an Affiliate;

		
	“Trademarks”	  	 Means those Trademarks registered or applied for set out in Schedule II;

		
	“Transition Services and
Inventory Agreement”	  	 Means that certain Transition Services and Inventory Agreement entered into between the Parties on the Effective Date;

		
	“Vial”	  	 Means a vial containing the Product supplied to EKR in presentations and dosages and other relevant terms set out in the Supply Agreement;

		
	“Year”	  	 Means the period of twelve months commencing on the first Commercial Launch of the Product in the Territory, and each consecutive period of twelve months
thereafter during the Term.

  

	1.2	 In this Agreement, unless the context requires otherwise: 

 

	 	(a)	 the headings are included for convenience only and shall not affect the construction of this Agreement; 

 

	 	(b)	 references to “persons” includes individuals, bodies corporate (wherever incorporated), unincorporated associations and partnerships;

  

	 	(c)	 words denoting the singular shall include the plural and vice versa; 

 

	 	(d)	 words denoting one gender shall include each gender and all genders; and 

  
 -12-

  

	 	(e)	 any reference to an enactment or statutory provision is a reference to it as it may have been, or may from time to time be amended, modified,
consolidated or re-enacted. 

  

	1.3	 The Schedules comprise part of and shall be construed in accordance with the terms of this Agreement. In the event of any inconsistency between the
Schedules and the terms of this Agreement, the terms of this Agreement shall prevail. 

  

	2.	 Grant of Rights 

  

	2.1	 Retention of EKR. Subject to the terms of this Agreement, PPI hereby appoints EKR and EKR agrees to be retained as the exclusive distributor,
and Authorized Distributor of Record, of the Products in the Field in the Territory during the Term to market, distribute, warehouse and sell the Products. EKR shall have the right to appoint sub-distributors hereunder in each country of the
Territory. 

  

	2.2	 Grant of License and Distribution Rights. PPI hereby grants EKR the exclusive right and license (with the right to sublicense) to use,
market, promote, sell, distribute and warehouse the Products (the “Distribution Rights”) in the Field in the Territory during the Term, as well as to make or have made the Products anywhere in the world for import or sale in the
Field in the Territory in each case, under the PPI IP provided that PPI retains all rights necessary to manufacture and supply the Products to EKR in accordance with this Agreement and the Supply Agreement. Such grant by PPI shall include the right
of EKR to market the Product in the Territory during the Term as an EKR product using in addition to the Trademarks, EKR’s own trademarks, trade dress, trade names and other proprietary designations in combination with the Trademarks.

  

	2.3	 Grant of Trademark Rights. PPI hereby grants to EKR a royalty free and exclusive license (with the right to sublicense) to use the Trademarks
in the Territory solely in connection with the exercise of the Distribution Rights in the Territory during the Term (and thereafter as set forth in Section 17.4) and EKR shall market and sell the Products under the Trademarks. For the avoidance
of doubt, the term “exclusive” for the 

  
 -13-

	 	 
purposes of Sections 2.1, 2.2 and 2.3 means to the exclusion of all others, including PPI and its Affiliates, except to the extent necessary to enable PPI to perform its
specific obligations under this Agreement and the Supply Agreement. Notwithstanding the foregoing, nothing contained herein shall prohibit PPI from utilizing the Trademarks in the Territory in connection with its business for the sole purpose of
signifying that PPI is the manufacturer of the Products for EKR. 

  

	2.4	 Transfer of Domain Names. On the Effective Date, PPI has transferred the Domain Names to EKR for use in connection with the exercise of the
Distribution Rights. PPI has provided EKR with reasonable assistance as was necessary to effectuate the transfer of the Domain Names. Upon any termination or expiration of this Agreement, EKR shall promptly transfer the Domain Names back to PPI.

  

	2.5	 Condition of Appointment. The acceptance of forecasts and orders for the Products (as provided in the Supply Agreement), and PPI’s
obligation to supply the Product to EKR shall at all times be conditioned by the Marketing Authorization for the Product being in force in the country of Territory to which such acceptance and order relates. 

 

	3.	 Undertakings of PPI 

  

	3.1	 Manufacturing Activities. Subject to Section 17.5, PPI shall manufacture and supply, or procure the manufacture and supply of,
the Product in accordance with the terms and conditions of the Supply Agreement. 

  

	3.2	 Transfer of Transferred NDA. Effective as of the Agreement Date, PPI hereby sells, transfers, conveys and assigns to EKR all right, title and
interest in and to [**] (the “Transferred NDA”). Each Party shall, within five (5) business days after the Agreement Date, file with the FDA a notice letter, substantially in the form attached as Schedule XI(A) or
Schedule XI(B) (as applicable), regarding the transfer to EKR of the Transferred NDA. PPI represents, warrants and covenants that: (i) prior to the Agreement Date, it has provided EKR with complete, up-to-date copies of the Transferred
NDA and all material correspondence with Regulatory Authorities in the 

  
 -14-

	 	 
Territory in connection with the Transferred NDA (including, but not limited to, any periodic and annual report submissions, and all adverse event reports and data) and (ii) on the Agreement
Date, EKR shall receive sole ownership of, and good and valid title to, the Transferred NDA, free and clear of any liens and encumbrances. For the avoidance of doubt, nothing in this Agreement regarding the appointment of EKR as PPI’s
distributor of the Products shall be construed to diminish any rights of EKR as holder of the Transferred NDA. Upon termination of this Agreement for any reason except by EKR pursuant to Section 16.1(a), EKR shall promptly transfer the
Transferred NDA and related regulatory documentation to PPI in accordance with Section 17.1(e). 

  

	3.3	 Maintenance of Transferred NDA. The Parties acknowledge that prior to the Agreement Date, PPI was responsible at its own cost and expense for
maintaining and updating the Transferred NDA, and agree that PPI shall retain all liabilities with respect to the foregoing obligations to the extent relating to periods prior to the Agreement Date. Commencing as of the Agreement Date, EKR shall, at
its own cost and expense, maintain and update the Transferred NDA and be responsible for all liabilities with respect to the foregoing obligations to the extent relating to periods after the Agreement Date. 

 

	3.4	 Assistance. PPI shall, at EKR’s cost and expense, provide EKR with all assistance, information and guidance, including where appropriate
direct access to employees of and consultants to PPI and its Affiliates and shall use reasonable efforts to obtain such assistance and access from any sub-contractors of PPI and its Affiliates (including for the avoidance of doubt any manufacturers
of the Product) which is reasonably necessary in relation to the conduct of any post-marketing or Phase IV studies to be conducted by EKR in the Territory or otherwise in connection with the discharge of EKR’s obligations under the terms of
this Agreement (including, but not limited to, the maintenance of the Transferred NDA); provided, however, that any such post-marketing or Phase IV studies to be conducted by EKR shall be at EKR’s sole cost and expense. Any labor

  
 -15-

 
costs of PPI employees related to this assistance shall be reimbursed by EKR at a rate of [**] dollars ($[**]) per hour. PPI represents and warrants that as of the Agreement Date, except for the
studies set forth on Schedule X attached hereto (the “Required Studies”), no post-marketing or Phase IV studies are required by any applicable Regulatory Authority to be conducted with respect to the Product. EKR shall be
responsible for the conduct of the Required Studies after the Agreement Date, at its own expense, in accordance with the requirements of the applicable Regulatory Authorities. PPI shall be responsible for all costs and liabilities incurred prior to
the Agreement Date with respect to the Required Studies, and shall indemnify and hold harmless EKR from such costs and liabilities. Promptly after the Agreement Date, PPI shall provide EKR with copies of all agreements relating to the Required
Studies and shall assign such agreements to EKR if and to the extent (i) such agreements are assignable in accordance with their terms and (ii) requested by EKR. 

 

	3.5	 Adverse Events. PPI shall at its own cost and expense promptly provide EKR with all information in its possession or otherwise coming to its
attention relating to the occurrence of a serious adverse event or an adverse event (in any jurisdiction throughout the world) in connection with the Product. PPI shall be responsible, to the extent required by Applicable Laws, to report all
charges, complaints or claims reportable to the FDA relating to the Product, to the extent such charges, complaints or claims are made prior to the Agreement Date. EKR shall be responsible, to the extent required by Applicable Laws, to report all
charges, complaints or claims reportable to the FDA relating to the Product, to the extent such charges, complaints or claims are made after the Agreement Date. 

 

	3.6	 Reserved. 

  

	3.7	 Delivery of Materials. The Parties acknowledge that prior to the Agreement Date, PPI has delivered to EKR (i) all existing PPI produced
Promotional Materials (if any) and (ii) any existing market research in its possession related to the Product. 

  
 -16-

  

	3.8	 Customer Orders. PPI shall at its own cost and expense during the Term, promptly forward to EKR any customer orders or inquiries for the
Product within the Territory received after the Effective Date and shall inform any customers ordering the Product that EKR is now distributing the Product and provide such customers with EKR’s address and telephone number.

  

	3.9	 Payment of Third Party Royalties. During the Term, PPI shall be solely responsible for and pay any royalties or other amounts due to Third
Parties related to the Product and shall indemnify and hold EKR harmless from any claims arising from or related thereto. 

  

	3.10	 Customer Returns. PPI shall at its own cost and expense be responsible for all customer returns of Product sold prior to the Effective Date.

  

	3.11	 Governmental Rebates. PPI shall at its own cost and expense be responsible for all discounts, rebates, or promotional allowances/incentive
programs deemed to be “discount[s] or other reduction[s] in price” for purposes of 42 U.S.C. Section 1320a-7b(b)(3)(A) and may be subject to the reporting requirements under state and federal Medicaid and Medicare laws for sales of
Product prior to the Effective Date. PPI represents that it is aware of its obligations to report discounts resulting from this Agreement to the appropriate reimbursing agencies and authorities (including Medicaid and Medicare). PPI is responsible
for complying with and agrees to comply with all applicable requirements, if any, in respect of providing information on such discounts to reimbursing agencies (including Medicaid and Medicare) and other entities in accordance with Applicable Laws
and regulations for sales of Product prior to the Effective Date and for sales of any PPI labeled product subsequent the Effective Date. 

  

	3.12	 Chargebacks. PPI shall at its own cost and expense be responsible for all chargebacks for sales of Product prior to the Effective Date.

  

	3.13	 Exclusivity. During the Term, PPI and its Affiliates shall not: (i) file for Marketing Authorization with respect to any Competing
Product in any country in the Territory, (ii) manufacture or have manufactured any Competing Product in any country in the Territory, (iii) market or have marketed any Competing Product in any country in the Territory or (iv) license
any Third Party to do any of the foregoing. 

  
 -17-

  

	3.14	 Product Development. PPI shall at its own cost and expense cooperate fully and assist EKR with the preparation of any necessary submissions
to any of the Regulatory Authorities in the Territory for the development and approval or supplemental approval(s) of the Products, including, but not limited to, by providing access to all PPI Know-How, the drug master file and any other
information necessary for approval or supplemental approval of the Product in any country of the Territory. In addition, PPI shall cooperate fully in participating in interactions with the appropriate Regulatory Authorities including FDA related to
such product development so as to enable EKR to fully exploit the Distribution Rights granted hereunder. For purpose of this Section, the contact person for each of the parties is set forth below. 

EKR – [**], MD - CMO 

PPI – [**], MD - CMO 
  

	3.15	 Reserved. 

  

	3.16	 Recalls and PostMarket Notifications. All costs of safety alerts and all other forms of notifications regarding safety risks associated with
the Products in the United States shall be borne by PPI to the extent arising prior to the Agreement Date and by EKR to the extent arising after the Agreement Date. 

 

	3.17	 Compliance. During the Term PPI shall at its own cost and expense take all actions necessary to comply with all Applicable Laws and obtain
and maintain all necessary license, permits, records and authorizations PPI is required to obtain and maintain hereunder so as to enable PPI to perform its obligations hereunder and under the Supply Agreement so as to enable EKR to fully exercise
the Distribution Rights. 

  

	3.18	 Assignment of ICS Agreement. The Parties acknowledge that effective upon the termination or expiration of the Transition Services and
Inventory Agreement, PPI has 

  
 -18-

	 	 
assigned to EKR all of PPI’s right, title and interest under that certain Commercial Outsourcing Services Agreement between PPI (f/k/a SkyePharma, Inc.) and Integrated Commercialization
Solutions, Inc. (“ICS”) dated April 3, 2007 (the “ICS Agreement”), and EKR has assumed all obligations and liabilities under the ICS Agreement arising after the Effective Date. The Parties further acknowledge
that as of the Effective Date, the Parties have entered into an Assignment and Assumption Agreement to further evidence the foregoing assignment and assumption of the ICS Agreement. 

 

	3.19	 Product in Channel. All sales of Product conducted by PPI and its distributors and wholesalers (and, to the knowledge of PPI, by Endo
Pharmaceuticals and its distributors and wholesalers) during the six month period prior to the Effective Date have been conducted in the ordinary course upon standard payment terms. PPI has provided EKR: (i) all information regarding sales by
Endo Pharmaceuticals during the six month period prior to the Effective Date and (ii) all information regarding the number of units of Product and Endo Product that were in the possession or control of PPI or Endo Pharmaceuticals (and their
respective distributors or wholesalers) as of the Effective Date (the “Known In-Channel Product Units”). Within 10 days of the end of each month following the Effective Date, PPI shall provide EKR with copies of: (i) any
reports provided by Endo Pharmaceuticals of the number of units of Endo Product sold to hospitals or other customers during the preceding month by Endo, and (ii) information possessed by PPI of such sales by PPI or any of their respective
distributors or wholesalers (the “Endo/PPI Unit Sales”). 

  

	3.20	 Sale and Leaseback of Transferred Equipment. 

 

	 	(a)	 In consideration of and subject to EKR’s payment of the Equipment Purchase Price (as defined below), effective as of the Agreement Date, PPI
hereby sells, transfers, conveys and assigns to EKR all right, title and interest in and to the equipment described on Schedule XII (the “Transferred Equipment”). The

  
 -19-

	 	 
Parties shall share equally the responsibility for any and all sales, transfer and conveyance taxes occasioned by the sale of the Transferred Equipment by PPI to EKR. PPI represents and warrants
that: (i) on the Agreement Date, EKR shall receive sole ownership of, and good and valid title to, the Transferred Equipment, free and clear of any liens and encumbrances, (ii) the Transferred Equipment as of the Agreement Date is in good
operating condition, normal wear and tear excepted and (iii) the Transferred Equipment constitutes all specialized equipment that is used in the manufacture of Product by PPI as of the Agreement Date. For purposes of clarity, the Transferred
Equipment does not include any standard, non-specialized equipment generally found in manufacturing facilities or available to manufacturers of products similar to the Product (e.g., refrigerators, freezers, safes, incubators, stability chambers,
clean utilities, supportive utilities, temperature control units and other supportive equipment). On the Agreement Date, PPI shall execute and deliver to EKR a Bill of Sale with respect to the Transferred Equipment substantially in the form attached
hereto as Exhibit 3.20(a). 

  

	 	(b)	 EKR will pay PPI [**] Dollars ($[**]) for the Transferred Equipment (the “Equipment Purchase Price”) as follows:

  

	 	(i)	 within five (5) days after the Agreement Date, EKR will pay PPI [**] Dollars ($[**]) of the Equipment Purchase Price in cash; and

  

	 	(ii)	 concurrently with the execution of this Agreement, EKR will issue to PPI a promissory note in principal amount of [**] Dollars ($[**]), such note to
be substantially in the form attached hereto as Exhibit 3.20(b) (the “Promissory Note”). 

  

	 	(c)	 Commencing as of the Agreement Date, EKR agrees to lease the Transferred Equipment to PPI through the end of the then-current calendar quarter and,
subject to renewal as provided below, on a calendar quarter-to-calendar quarter 

  
 -20-

	 	 
basis thereafter (the “Lease Term”), for use solely in connection with the (i) performance of PPI’s obligations under the Supply Agreement, (ii) the supply of
Products to PPI’s other licensees and collaborators and (iii) the supply of placebo for PPI’s Exparel product to PPI’s other licensees and collaborators. The Lease Term shall automatically renew at the end of each calendar
quarter of the Lease Term. The Lease Term will automatically terminate immediately upon (i) any termination or expiration of this Agreement and/or the Supply Agreement or (ii) any exercise by EKR of the Step-in Right described in
Section 17.5 below. 

  

	 	(d)	 At any time between the Agreement Date and July 1, 2015, EKR shall have the right, exercisable upon sixty (60) days prior written notice
to PPI, to terminate the Lease Term and sell the Transferred Equipment back to PPI, subject to payment by PPI to EKR within five (5) days of such notice of $[**] in cash, which if exercised shall result in (i) an offset against the unpaid
balance of principal and interest under the Promissory Note pursuant to Section 3.20(f) below; and (ii) the termination of the Step-in Right described in Section 17.5. 

 

	 	(e)	 At any time after July 1, 2015, PPI shall have the right, exercisable upon sixty (60) days prior written notice to EKR, to terminate the
Lease Term and repurchase the Transferred Equipment from EKR, subject to payment by PPI to EKR within five (5) days of such notice of any principal paid by EKR under the Promissory Note, which if exercised shall result in the termination of the
Step-in Right set forth in Section 17.5. 

  

	 	(f)	 If, upon the expiration or earlier termination of the Lease Term (except as provided in Section 3.20(e) above), the aggregate amount of
repayments and Royalty Offsets (as defined below) earned by EKR pursuant to Section 6.3 below have not equaled or exceeded the Advanced Royalty Payment (as defined below), then EKR shall have the right, at its option, to offset against
the unpaid balance of principal and interest under the Promissory Note, by an amount equal to the 

  
 -21-

	 	 
then-current balance of the Advanced Royalty Payment that has not yet been recouped by EKR through repayments and Royalty Offsets pursuant to Section 6.3 below (the “Remaining
Balance”), in which event PPI’s obligations under Section 6.3 below with respect to repayment of the Advanced Royalty Payment shall be deemed to have been paid in full. 

 

	 	(g)	 In consideration of the foregoing lease, PPI shall pay EKR [**] lease payments in the amount of $[**]per calendar quarter, with the first lease
payment due on the Agreement Date and each subsequent lease payment due during the Lease Term on the first day of each calendar quarter thereafter. 

  

	 	(h)	 PPI shall not, without the prior, written consent of EKR, remove any of the Transferred Equipment from the locations within the Approved Facilities
(as defined in the Supply Agreement) where such Transferred Equipment is installed as of the Agreement Date. 

  

	 	(i)	 During the Lease Term, PPI shall: (i) assume the risk of loss or damage to the Transferred Equipment; (ii) maintain the Transferred
Equipment in good operating condition and appearance, ordinary wear and tear excepted; (iii) comply with all requirements necessary to enforce any warranty rights and to maintain eligibility for any manufacturer maintenance program;
(iv) promptly repair any repairable damage to the Transferred Equipment and (v) maintain property damage and liability insurance and insurance against loss or damage to the Transferred Equipment as part of PPI’s general liability
insurance. 

  

	 	(j)	 If any of the Transferred Equipment is lost, stolen, destroyed, damaged beyond repair or in the event of any condemnation, confiscation, seizure or
expropriation of any Transferred Equipment (“Casualty Transferred Equipment”), PPI shall promptly (i) notify EKR of the same, and (ii) pay to EKR an amount equal to the estimated in-place, fair market value of the Casualty
Transferred Equipment as of the date of the loss, as determined by a mutually agreed nationally recognized 

  
 -22-

	 	 
appraiser; provided that (i) in the event there are any amounts owed to PPI under the Promissory Note as of the date of such loss, PPI shall have the right, at its option, to
offset against the unpaid balance of principal and interest under the Promissory Note, the amounts owed to EKR pursuant to this Section 3.20(k), and (ii) in no event shall PPI be required to pay EKR an amount that exceeds [**]
Dollars ($[**]) plus the amounts paid by EKR pursuant to the Promissory Note. 

  

	 	(k)	 Subject to Sections 3.20(d) and (e) and Section 6.3(d) and PPI’s right to repurchase the Transferred Equipment
thereunder, upon the expiration or earlier termination of the Lease Term, EKR shall remove the Transferred Equipment from PPI’s premises (unless EKR at its option elects to retain the Transferred Equipment at PPI’s premises in connection
with EKR’s exercise of step-in rights under Section 17.5). PPI agrees to cooperate with EKR in the removal of the Transferred Equipment, including providing the necessary access to the Transferred Equipment and the facilities where
it is located at times mutually agreed by the Parties, such agreement not to be unreasonably withheld or delayed by either Party. 

  

	 	(l)	 Upon termination of the Lease Term, unless PPI has repurchased the Transferred Equipment, EKR will, at PPI’s request, use commercially
reasonable efforts to (i) supply the Product and (ii) supply placebo for [**], to PPI’s other licensees and collaborators outside the Territory, excluding PPI and any of its Affiliates (the “Other PPI Customers”), in
each case in accordance with the commercially reasonable requirements of any existing agreements between PPI and such Other PPI Customers, subject to EKR’s receipt of payment required under such agreements for supplying such Products and/or
other products. PPI will use commercially reasonable efforts to cooperate with EKR so as to enable EKR to supply Product and, if applicable, other products, to such Other PPI Customers. 

  
 -23-

  

	4.	 Undertakings of EKR. 

  

	4.1	 Marketing Authorizations. EKR shall, as determined in its sole discretion to be commercially reasonable, prepare studies of the markets and
sales potential of the Products for countries in the Territory other than the United States and present such studies to the Committee. EKR shall at its own cost and expense use commercially reasonable efforts to take those steps reasonably necessary
in order to obtain and thereafter maintain Marketing Authorizations (including pricing and reimbursement approvals) for the Product in those countries of the Territory other than the United States which the Committee determines to present
commercially viable opportunities for the Product. EKR shall provide PPI with a copy of any original certificates of approval/registration in each country in the Territory other than the United States. EKR shall provide PPI with a copy of any other
registration matters received from the appropriate Regulatory Authorities concerning maintenance, renewal or variations to the original certificates of approval/registration in each country in the Territory. Except as provided in
Section 3.17, EKR shall be solely responsible for, and shall bear all costs associated with, all regulatory activities related to the development and approval of the Product in the countries of the Territory (including, after the
Agreement Date, the United States) and shall own the Marketing Authorizations for the Product in each other country of the Territory. EKR will comply with all conditions and requirements attaching to such Marketing Authorizations.

  

	4.2	 Liaison with Regulatory Authorities. Pursuant to Section 4.1 above, EKR shall at its own cost and expense liaise with the
relevant Regulatory Authorities in respect of each Marketing Authorization and notify PPI of all material communications relating thereto. The cost of submitting any data generated by any Phase IV studies conducted by EKR which is required to be
filed with the FDA shall be borne by EKR and the cost of submitting any other data (including data submitted to support the use of the Product for additional indications) shall also be borne by EKR; 

  
 -24-

  

	4.3	 Submission of Promotional Materials. Pursuant to Section 4.1 above, EKR shall at its own cost and expense submit and obtain the
approvals of Regulatory Authorities in the Territory of Promotional Materials as required by Applicable Laws; 

  

	4.4	 Pre-Launch and Post Launch Activities. Pursuant to Section 4.1 above, EKR shall at its own cost and expense carry out reasonable
pre-launch market development and conduct such post-marketing clinical trials (as determined solely by EKR in its reasonable business judgment) in accordance with the Marketing Plan. Any data resulting from such trials shall be owned by EKR but
shall be provided on a royalty-free license to PPI for use outside of the Territory. PPI shall cooperate with EKR in connection with such pre-launch and post launch activities as provided in sections 3.3 and 3.14 hereof;

  

	4.5	 Launch of Products. Pursuant to Section 4.1 above, EKR shall at its own cost and expense launch and achieve Commercial Launch of
the Products in accordance with the Marketing Plan but no later than 18 months following receipt of Marketing Authorization in each country in the Territory provided however that EKR shall not be obligated to launch such Product in such country of
the Territory where the approved pricing in such country provides EKR a gross margin of less than [**]% (after payment of Royalties, Additional Royalties and Cost of Goods) or where the launch of the Product in such country of the Territory as
determined by EKR is not commercially reasonable. 

  

	4.6	 Marketing Activities. EKR shall at its own cost and expense, during the term of this Agreement, promote, market, sell and distribute the
Products to customers within the Territory and provided that PPI has supplied EKR with necessary quantities of Product, satisfy the demand for the Product throughout the Territory. EKR shall be solely responsible for, and shall bear all costs
associated with, all marketing and selling activities related to the Products in the Territory; 

  

	4.7	 SubDistributors. EKR shall at its own cost and expense maintain, or use reasonable commercial efforts to ensure that sub-distributors
maintain, adequate sales and, where 

  
 -25-

	 	 
appropriate, warehouse facilities and employ, or use reasonable commercial efforts to procure that sub-distributors employ, a sufficient number of experienced, trained and qualified personnel to
promote the sale of the Product in the Territory and perform, or procure the performance of the activities set forth in the Marketing Plan; 

  

	4.8	 Inventory and Promotional Materials. EKR shall maintain a sufficient inventory of Product and support material to reasonably fulfill the
requirements of its customers in the Territory provided that, subject to Section 17.5, PPI shall comply with the Supply Agreement; 

  

	4.9	 Records. EKR shall maintain adequate records concerning the sale of the Product as required by any applicable Regulatory Authority in the
Territory; 

  

	4.10	 Promotional Materials. EKR shall provide PPI with copies of the Promotional Materials proposed to be used in connection with the sale of the
Products in the United States for approval, solely with respect to Trademark usage, (such approval not to be unreasonably withheld, conditioned or delayed) to the extent such Promotional Materials include any Trademark. EKR shall submit such
Promotional Materials to PPI at least five (5) business days in advance of its intended use of the same and such Promotional Material shall be deemed to have received PPI’s approval unless PPI Provides EKR with written notice of rejection
within said five (5) business day period and EKR shall be authorized to finalize and use same. For the avoidance of doubt, any Trademark usage set forth on any Promotional Materials in use as of or prior to the Agreement Date are hereby deemed
to be approved by PPI. 

  

	4.11	 Adverse Events. Each Party shall promptly provide the other Party with all information in its possession or otherwise coming to its attention
relating to the occurrence of a serious adverse event or an adverse event (in any jurisdiction throughout the world) in connection with the Product, and promptly forward to such other Party information concerning any and all charges, complaints or
claims reportable to any Regulatory Authority relating to the Product that may come to the first Party’s attention, and 

  
 -26-

	 	 
otherwise comply in all respects with the adverse drug event reporting and recall procedures set out or referred to in the Supply Agreement from time to time. EKR shall be responsible, to the
extent required by Applicable Law, to report all charges, complaints or claims reportable to any Regulatory Authority outside of the United States relating to the Product, as well as any such charges, complaints or claims reportable to any
Regulatory Authority inside the United States to the extent such charges, complaints or claims are made after the Agreement Date. 

  

	4.12	 Permits. EKR shall obtain and maintain all necessary licenses, permits, records and authorizations required by Applicable Laws as holder of
the Transferred NDA after the Agreement Date and in order to exercise the Distribution Rights and observe and comply with all Applicable Laws, ordinances, rules and regulations including, but not limited to those of the applicable Regulatory
Authorities in the exercise of the Distribution Rights save insofar as PPI is required to obtain the same as holder of the Marketing Authorizations prior to the Agreement Date, or under the terms of this Agreement; 

 

	4.13	 Compliance. EKR shall conduct the promotion and marketing and sale of the Products in accordance with Applicable Laws and with all due care
and diligence. 

  

	4.14	 Sales and Promotional Activities. In connection with the promotion, marketing and sale of the Product, EKR shall, without limitation:

  

	 	(a)	 observe and comply with such storage, stock control and operational practices and procedures as may be legally required in the Territory and as
reasonably specified in writing by PPI from time to time; 

  

	 	(b)	 from time to time consult with PPI’s representatives for the purpose of assessing the state of the market in each country of the Territory and
permit representatives of PPI, on reasonable prior notice, to inspect any premises or documents used in connection with the marketing, distribution and sale of the Products; 

  
 -27-

	 	(c)	 provide PPI on reasonable prior notice but not more than once in any Calendar Year, copies of its up-to-date price list for the Product together
with full details of standard discounts and any special pricing arrangements entered into or proposed to be entered into; 

  

	 	(d)	 market the Product throughout the Territory under the Trademarks and any EKR trademarks and ensure that all marketing materials for the Product
shall display the Trademarks; and 

  

	 	(e)	 comply with all applicable regulatory and statutory requirements imposed in relation to the Product, including, without limitation, those imposed by
the US Drug Enforcement Agency (“DEA”) and other equivalent agencies in the Territory. 

  

	4.15	 Prohibition on Sales Outside the Territory. EKR shall not directly or indirectly market distribute and/or sell the Product outside the
Territory, or sell the product to any Third Party that EKR knows intends to sell or distribute the Product outside the Territory. In addition, the Parties acknowledge that since the Product is a controlled substance, the DEA and other law
enforcement agencies will not permit any sale outside the Territory without relevant clearances and approvals. 

  

	4.16	 Non-Compete. EKR shall not, during [**], market, distribute or sell a Competing Product in the Territory unless during such time an A/B rated
generic product of the Product(s) is launched in such country of the Territory or in the event this Agreement is terminated or EKR exercises its rights under Section 17.4 hereof. 

 

	4.17	 PPI as Exclusive Provider. During the Term, except if PPI is unable to supply Products (including, but not limited to, in connection with
EKR’s exercise of its rights under Section 17.5 below) or as provided in the Supply Agreement, EKR shall purchase all of its requirements for the Product from PPI. 

 

	4.18	 Packaging. During the Term, EKR shall not use in relation to the Product any packaging, labeling and Product inserts, nor any advertising
literature that has not been 

  
 -28-

	 	 
approved by PPI in writing with respect to Trademark usage (such approval not to be unreasonably withheld, conditioned or delayed) or deemed approved pursuant to Section 4.10, to the
extent such materials include any Trademark. EKR shall be responsible for insuring that any packaging, labeling and Product inserts, and advertising literature complies with Applicable Laws. 

 

	4.19	 Customer Orders. If EKR receives a request from a customer located outside the Territory for supply of the Product outside of the Territory,
EKR shall promptly forward such request to PPI. 

  

	4.20	 Governmental Rebates. Any discounts, rebates, or promotional allowances/incentive programs provided are “discount[s] or other
reduction[s] in price” for purposes of 42 U.S.C. Section 1320a-7b(b)(3)(A) and may be subject to the reporting requirements under state and federal Medicaid and Medicare laws. EKR represents that it is aware of its obligations to report
discounts resulting from this Agreement to the appropriate reimbursing agencies and authorities (including Medicaid and Medicare). EKR is responsible for complying with and agrees to comply with all applicable requirements, if any, in respect of
providing information on such discounts to reimbursing agencies (including Medicaid and Medicare) and other entities in accordance with Applicable Laws and regulations. 

 

	4.21	 Resale Pricing. In exercising the Distribution Rights, EKR shall determine resale pricing of the Products in its sole discretion.

  

	5.	 Commercialization Committee. 

  

	5.1	 Establishment of Committee. The Parties have established a Commercialization Committee (“Committee”) consisting of 4
individuals (“Committee Members”); 2 of whom were nominated by PPI; and 2 of whom were nominated by EKR. The Committee Members may be replaced by notice to the other Party and shall be appropriately qualified and experienced in
order to make a meaningful contribution to Committee meetings. 

  
 -29-

	5.2	 Purpose. The purpose of the Committee is to provide a forum for the Parties to share information and knowledge on the on-going
Commercialization of the Product including, but not limited to, monitoring progress on clinical studies, reviewing clinical trial programs, discussing the appropriate regulatory strategy for the Products in the Territory, considering proposed
marketing and promotional plans, reviewing competitor activity and discussing any regulatory, technical, quality assurance or safety issues in relation to the Product. The Committee shall conduct its discussions in good faith with a view to
operating to the mutual benefit of the Parties and in furtherance of the successful development and marketing of the Products. 

  

	5.3	 Meetings. The Committee shall meet as often as the Committee Members may determine, but in any event not less than 2 times per Calendar Year.
The Committee may invite individuals with special skills to attend such meetings where considered to be relevant and appropriate. The quorum for Committee meetings shall be 2 Committee Members, comprising 1 Committee Member from each Party.

  

	5.4	 Marketing Plan. The Parties acknowledge that EKR has provided the Committee with its Marketing Plans for Calendar Years 2008 and 2009
pursuant to the Original Agreement. EKR shall on or before October 15th 2009 and October 15 th of each Calendar Year thereafter provide the Committee with its Marketing Plan for the coming Calendar Year. Each Marketing Plan shall include, without limitation, Net Sales targets and projections with
respect to sales force staffing levels, market research, physician education, marketing expenditure, post-approval clinical trials and advertising. With regard to pre-marketing clinical trials, the design and conduct shall be subject to the written
approval of PPI, such approval not to be unreasonably withheld or delayed. 

  

	5.5	 Decision Making. Decisions of the Committee shall be made as follows: 

 

	 	(a)	 The Committee may make decisions with respect to any subject matter that is subject to the Committee's decision-making authority. Except as
expressly provided in this Agreement, all decisions of the Committee 

  
 -30-

	 	 
shall be made by unanimous vote or written consent, with EKR and PPI each having, collectively, one vote in all decisions. The Committee shall use commercially reasonable efforts to resolve the
matters within its roles and functions or otherwise referred to it. 

  

	 	(b)	 If, with respect to a matter that is subject to the Committee's decision-making authority, the Committee cannot reach consensus within 15 days after
it has met and attempted to reach such consensus or the Parties cannot reach consensus on whether the Committee has decision-making authority regarding a matter within 15 days after such matter was first raised by either Party, the dispute in
question shall be referred to the Chief Executive Officer of PPI, on behalf of PPI, or such other person holding a similar position designated by PPI from time to time, and the Chief Executive Officer of EKR, or such other person holding a similar
position designated by the EKR from time to time (such officers collectively, the “Executive Officers”), for resolution. The Executive Officers shall use reasonable efforts to resolve the matter referred to them.

  

	 	(c)	 If the Executive Officers cannot resolve the matter in accordance with Section 5.5(b) within 30 days of the reference of the matter to
them, then EKR shall have the final decision-making authority if the matter relates to the sale or marketing of the Product in any country of the Territory and PPI shall have the final decision-making authority if the matter relates to the
development, manufacture or Trademarks of the Product. 

  
 -31-

  

	6.	 Fees, Milestones and Royalties. 

  

	6.1	 Up-Front Payment. In consideration for work previously undertaken by PPI in respect of the Product, the Parties acknowledge that EKR has paid
a non-refundable, non-creditable up front payment of $[**] to PPI pursuant to the Original Agreement. 

  

	6.2	 Deferred Milestone Payments. As further consideration for the work previously undertaken by PPI and in consideration for the license and
grant of the Distribution Rights to EKR under this Agreement, EKR shall pay to PPI the following milestone payments (the “Deferred Milestone Payments”) on the date when due: 

 

			
	 Deferred Milestone
	  	 Due Date

	 $[**] (the “First Deferred Milestone”)
	  	 The Parties acknowledge that EKR has paid the First Deferred Milestone to PPI prior to the Agreement Date.

		
	 $[**] (the “Second Deferred Milestone”)
	  	 Within three (3) days of the Agreement Date, EKR shall pay the Second Deferred Milestone.

 

	6.3	 Advanced Royalty Payment to PPI. 

  

	 	(a)	 Within three (3) days of the Agreement Date, EKR shall make an advanced Royalty payment to PPI of $[**] (the “Advanced Royalty
Payment”), which will be offset against EKR’s payment obligations or otherwise repaid to EKR as set forth below in this Section 6.3. 

 

	 	(b)	 Offsets and/or repayment of the Advanced Royalty Payment shall commence on [**] and shall continue, unless sooner paid, through [**] (the
“Royalty Offset Period”) and such offsets will be taken by EKR (and such repayment will be made by PPI) as follows: 

  

	 	(i)	 by a reduction in Royalties due under Section 6.4 of this Agreement of $[**] for each [**] mg vial of Product sold during the Royalty
Offset Period and $[**] for each [**] mg Vial of Product sold during the Royalty Offset Period (collectively the “Royalty Offset”) which amounts shall be deducted by EKR from any Royalty payments due PPI and reflected in the
quarterly and annual reports required in Section 6.5 of this Agreement; 

  
 -32-

  

	 	(ii)	 by payment to EKR of [**] percent ([**]%) of any purchase price payments, license fees, other access fees or royalties received by PPI or any of its
Affiliates after the Agreement Date in connection with the license (to the extent permitted hereunder) or transfer of any rights to the Product (and/or any underlying intellectual property rights) in the Field in the Territory to a Third Party
(other than pursuant to any transaction described in Section 6.3(b)(iii) below), which payment shall be made by PPI to EKR within ten (10) days of PPI’s receipt of such payments; and 

 

	 	(iii)	 upon any Change of Control (as defined in Section 20.4) of PPI, by repayment to EKR in full of the balance of the Advanced Royalty
Payment not previously used for offsets, which payment shall be made to EKR by PPI within ten (10) days after the closing date (without any conditions) of any such Change of Control. 

  
 -33-

	 	(c)	 Notwithstanding Section 6.3(b), effective July 1, 2013, the balance of the Advanced Royalty Payment that is available for
subsequent offsets and/or repayments under Section 6.3(b) above shall be reduced to the lesser of (x) $[**] or (y) the actual amount of such balance as calculated based upon any payments and offsets deducted to date from the
beginning Advanced Royalty Payment balance of $[**], as outlined in clauses (i) and (ii) of Section 6.3(b) above. As of [**] the balance of the Advanced Royalty Payment shall have been deemed repaid in full by PPI and no
additional offsets to or repayments of the Royalties shall thereafter be applied for any reason. 

  

	 	(d)	 Notwithstanding anything to the contrary, in the event EKR exercises it right of termination pursuant to Section 16.3(b) of this
Agreement or PPI terminates this Agreement pursuant to Section 16.1(a): (i) EKR will sell the Transferred Equipment back to PPI, subject to payment by PPI to EKR (within five (5) days of the date of termination) of $[**] in
cash and cancellation of any remaining obligation of EKR under the Promissory Note, (ii) the Advanced Royalty Payment shall be deemed to have been repaid in full, and EKR shall not have the right to the Royalty Offset between the date of notice
of such termination and the termination date of the Agreement and (iii) EKR shall promptly transfer the Marketing Authorizations to PPI or its nominee in accordance with Section 17.1(e) below. 

  
 -34-

	 	(e)	 Notwithstanding anything to the contrary, during the Royalty Offset Period, or until such time that the Advanced Royalty Payment balance has been
fully repaid, the combined Royalty and Supply Price (as defined in the Supply Agreement) shall not exceed [**] percent ([**]%) of the net average selling price of the Product. 

 

	 	(f)	 For the avoidance of doubt, the Royalty Offset described in clause (i) of Section 6.3(b) shall not be applied against any
Additional Royalty due PPI pursuant to Section 6.4. 

  

	6.4	 Royalties. As further consideration for the license and grant of Distribution Rights and other rights under this Agreement, EKR shall pay to
PPI a royalty (“Royalty”) equal to (a) $[**] for each [**] mg Vial of Product sold during the Term and $[**] for each [**] mg Vial of Product sold during the Term (the “Minimum Royalty”) plus (b) an
additional [**]% of any post Effective Date incremental price increase implemented by EKR over the Current Base Price of $[**] for the [**] mg Vial and $[**] for the [**] mg Vial (the “Additional Royalty”); provided,
however, that Additional Royalty shall not be payable to the extent that the sum of (i) the Minimum Royalty and Additional Royalty payable hereunder and (ii) the Supply Price (as defined in the Supply Agreement) shall at any time
during the Term exceed [**] percent ([**]%) of the net average selling price of the Product (the “Royalty Cap”); provided, however, that the Royalty Cap shall be [**] percent ([**]%) of the net average selling price of
the Product during certain periods as described in Section 6.3(e) above. EKR shall be entitled to offset certain amounts from Royalties payable hereunder as set forth in Section 6.3(b) above. Royalties on other presentations
and dosages which hereafter receive Marketing Authorization in any country of the Territory shall be negotiated in good faith by the parties in a manner consistent with the Royalty currently being paid by EKR as of the date of the receipt of
Marketing Authorization for such new presentations and dosages. 

  
 -35-

	6.5	 Quarterly Reports and Annual Reports. Within 30 days of the end of each Quarter and within sixty (60) days of the end of each Calendar
Year during the Term of this Agreement EKR shall send to PPI a statement setting out in respect of each country in the Territory in which Product is sold, details of Product sold during the previous Quarter or Calendar Year, as applicable, itemized
by presentation form, quantity, total gross receipts, itemized deductions which are applied to achieve the Net Sales figure, and Net Sales of Product. The statement shall (where appropriate) show: 

 

	 	(a)	 the total Net Sales for each country expressed both in local currency and in Dollars and the conversion rate used; 

 

	 	(b)	 the total number of Vials sold in each country (less properly rejected, returned or recalled Vials) for each of the [**] mg Product and the [**] mg
Product (the “Unit Sales”); 

  

	 	(c)	 the applicable Royalty rate multiplied by the Unit Sales for each of the [**]mg and [**] mg Products in that Quarter (“Prepayment”)
(or in that Calendar Year, as applicable); 

  

	 	(d)	 any Additional Royalties due in that Quarter (or for such Calendar Year); 

 

	 	(e)	 the total Royalties payable on those Unit Sales (subject to the Royalty Cap) in accordance with Section 6.4, and any deductions taken
pursuant to Section 6.3. 

  

	6.6	 Payment. EKR shall pay to PPI, any Minimum Royalties and Additional Royalties due within forty-five (45) days of the end of each Quarter
as the case may be subject to reconciliation at the end of each Calendar Year as set forth in Section 6.9. 

  

	6.7	 Reserved. 

  

	6.8	 Reserved. 

  

	6.9	 Reconciliation. Within forty-five (45) days of the end of each Contract Year, there shall be a reconciliation between the sums paid
under Section 6.6 and the Royalties payable under Section 6.4, and any payment due (or in the event of an overpayment by EKR to PPI) such amounts shall be paid by one Party to the other within thirty (30) days of the
resolution of such reconciliation. 

  
 -36-

  

	6.10	 Withholdings. In the event that a Party is required under the laws of a country or other political subdivision of competent jurisdiction to
withhold any tax to the tax or revenue authorities in such jurisdiction in connection with any payment to the other Party, such amount shall be deducted from the payment to be made by such withholding Party; provided that the withholding Party shall
take reasonable and lawful actions to avoid and minimize such withholding and promptly notify the other Party so that the other Party may take lawful actions to avoid and minimize such withholding. The withholding Party shall promptly furnish the
other Party with copies of any tax certificate or other documentation evidencing such withholding as necessary to satisfy the requirements of the appropriate regulatory authority related to any application by such other Party for foreign tax credit
for such payment. Each Party agrees to reasonably cooperate with the other Party in claiming exemptions from such deductions or withholdings under any agreement or treaty from time to time in effect. 

 

	7.	 Payment, Accounting, Audit Rights. 

  

	7.1	 Currency. Unless otherwise agreed between the Parties, all payments to be made hereunder shall be made in US Dollars. Net Sales shall be
determined in the currency in which the Product was sold and shall, if necessary, be converted into US Dollars using the noon buying rate as published in the Wall Street Journal for the last day of the Quarter for which such payment is being
determined. 

  

	7.2	 Maintenance of Records. EKR shall maintain and shall procure the maintenance of accurate and up to date records and books of account showing
the quantity, description and value of the Products supplied in each country of the Territory during the previous six (6) Calendar Years. 

  

	7.3	 Inspection. EKR shall during business hours, on no less than 14 day’s notice from PPI and not more than once in any Calendar Year, make
available for inspection the records 

  
 -37-

	 	 
and books referred to in Section 7.2. Such inspection shall be undertaken by an independent auditor appointed by PPI and reasonably acceptable to EKR for the purpose of verifying the
accuracy of any statement or report given by EKR to PPI and/or the amount of Royalties due. Upon completion of such inspection, PPI shall not be entitled to inspect nor shall EKR be required to make available the records and books for any Calendar
Year for which such inspection was previously undertaken. 

  

	7.4	 Confidentiality. PPI shall procure that any independent auditor appointed under Section 7.4 shall maintain all information and
materials received, directly or indirectly, by it from EKR in strict confidence and shall not use or disclose the same to any Third Party nor to PPI save for the sole purpose of conducting the audit pursuant to this Section.

  

	7.5	 Audit. In the event that an auditor appointed pursuant to this Section concludes that there has been an underpayment or overpayment, PPI
shall deliver to EKR a copy of such auditor’s report. Any deficit payable by EKR or any excess refundable by PPI shall be payable within 30 days of EKR’s receipt of such report. The fees charged by such auditor shall be payable by
PPI, provided that if the audit reveals that payments due to PPI for any Calendar Year have been understated by more than [**]%, the fees charged by such auditor shall be payable by EKR. 

 

	7.6	 Interest. Should any amount not be paid by either Party on or before the due date for payment interest on such unpaid amount at the rate of
[**]% above the prime lending rate of Citibank, N.A. (or its successor in interest) in effect from time to time and such interest shall be calculated and payable in respect of the period from the date such amount is due until the date payment in
full is received in cleared funds. 

  

	8.	 Intellectual Property and Trademarks. 

 

	8.1	 Limitation of License. Except as set out in this Agreement, all right, title and interest in the PPI IP or Trademarks shall belong to PPI and
EKR shall not have any right, title or interest in the PPI IP or Trademarks. 

  
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	8.2	 Trademark Standards. EKR shall use the Trademarks in a manner which conforms to the reasonable directions and standards notified to it by PPI
from time to time and not do anything which could, in the PPI’s reasonable opinion, bring the Trademarks or PPI into disrepute or otherwise damage the goodwill attaching to the Trademarks. 

 

	8.3	 Maintenance of Trademarks. PPI shall, at its own cost, take all steps required to maintain those registrations for the Trademarks subsisting
at the Effective Date, and prosecute any applications subsisting at the Effective Date for registration of the Trademarks through to grant (including oppositions thereto) in each country of the Territory. 

 

	8.4	 Additional Trademark Registrations. EKR may request that PPI use reasonable efforts to obtain Trademark registrations in respect of the
Trademarks, in classifications which cover the Product, in any countries in the Territory. PPI shall promptly notify EKR if it does not intend to make or pursue any such Trademark registration in any of the countries in the Territory and EKR shall
thereafter be entitled to make applications for such Trademark registrations in its own name. 

  

	8.5	 Domain Names. EKR shall have the right during the Term to register domain names in its own name specific to the countries comprised in the
Territory that incorporate the Trademark. 

  

	8.6	 Improvements. PPI Improvements shall be owned by PPI and be licensed to EKR hereunder. EKR Improvements shall be owned by EKR and upon
termination of this Agreement by PPI pursuant to Section, shall be deemed be licensed to PPI on a worldwide, non-exclusive, irrevocable basis, at a royalty or for such other consideration as may be mutually agreed upon by the parties in writing.
Joint Improvements shall be owned jointly by the Parties, and PPI’s interest therein shall be licensed to EKR hereunder. 

  
 -39-

  

	9.	 Representations and Warranties. 

  

	9.1	 Representations and Warranties of Both Parties. Each Party represents and warrants to the other Party as of the Effective Date, that:

  

	 	(a)	 Organization. Such Party is duly organized and validly existing and in good standing of the laws of the jurisdiction of its incorporation and
it has full power and authority and legal right to enter into this Agreement and perform the obligations under it; 

  

	 	(b)	 Authorization. Such Party has taken all corporate action such that the execution and delivery of this Agreement and the consummation of the
transaction contemplated hereby has been duly authorized by all necessary actions; 

  

	 	(c)	 Valid Obligation. This Agreement is a legal and valid obligation of such Party, binding on each of the Parties and enforceable in accordance
with its terms; 

  

	 	(d)	 Execution and Delivery. The execution and entry into and exercise of the respective rights and obligations under this Agreement including the
granting of rights to the other Party pursuant to this Agreement do not, and will not conflict with, or violate any provision of any agreement or other instrument or document to which it is Party or affect or be in conflict with or result in the
breach of or constitute a default under any such agreement, instrument or document or conflict with any rights granted by such Party to any Third Party or breach any obligation that such Party has to any Third Party; and

  

	 	(e)	 Debarment. It is not currently debarred, suspended or otherwise excluded by the United States, under any Federal law, including, without
limitation, the Generic Drug Enforcement Act of 1992, or by any other country in the Territory under any analogous law, rule or regulation, and does not and will not use in any capacity the services of any person debarred under applicable law, rule
or regulation, in the Territory in the performance of its obligations under this Agreement. 

  
 -40-

  

	9.2	 Representations and Warranties of PPI. PPI hereby represents and warrants to EKR as of the Effective Date that: 

 

	 	(a)	 Ownership; Validity. It is the owner of, or has exclusive rights to, all of the PPI IP and Trademarks in existence on the Effective Date, and
has the exclusive right to grant the Distribution Rights and other rights granted under this Agreement. All of the PPI Patents in existence on the Effective Date are valid, enforceable, in full force and effect and have been maintained to date and
are not the subject to any interference or opposition procedures. All of the PPI Patents listed in the Orange Book are properly filed in accordance with Applicable Laws; 

 

	 	(b)	 Third Party Interests. There are no Third Party interests or rights in the PPI IP or Trademarks that may prevent, encumber or restrict the
exercise by EKR of the Distribution Rights or other rights granted under this Agreement. 

  

	 	(c)	 Third Party Infringement. No Third Party is infringing or has infringed the intellectual property rights of PPI in any of the PPI IP or
Trademarks; 

  

	 	(d)	 Distribution Rights and other Rights. That neither the Products, the exercise of EKR’s Distribution Rights and other rights granted
under this Agreement or the manufacture of the Products as contemplated by this Agreement or the Supply Agreement do not and will not infringe or conflict with any Third Party intellectual property rights and EKR will not incur any obligation to any
Third Party by the exercise of the rights granted hereunder; 

  

	 	(e)	 Renewal and Maintenance Fees. All renewal and maintenance fees and all steps necessary for the filing, prosecution and maintenance of the PPI

  
 -41-

	 	 
Patents and Trademarks due and payable as of the Effective Date have been paid or taken and there are no actions due within 180 days of the Effective Date; 

 

	 	(f)	 Trademarks. The Trademarks are the only trademarks, trade dress or service marks related to the Product that are owned by PPI or licensed by
PPI (with the right to sublicense); 

  

	 	(g)	 Adverse Events. To its knowledge and belief all information, data and Third Party notices in relation to adverse events serious adverse
events or recalls with respect to the Product and of which PPI is aware have been disclosed by PPI to EKR; 

  

	 	(h)	 Access to Documents. PPI has provided EKR or given EKR access to true, complete and unredacted copies of all (i) regulatory
documentation or (ii) material agreements between PPI and any Third Party including all effective amendments to any such agreements which in any event (A) affects or may affect EKR’s rights under this Agreement or (B) relates to
the Product; 

  

	 	(i)	 No Brokers. Neither PPI nor any office, director or agent of PPI has employed any broker, finder or agent with respect to this Agreement or
the transactions contemplated hereby; 

  

	 	(j)	 Right to License. PPI has the right to use and license PPI IP and Trademarks free and clear of any material liens, security, interests,
licenses, obligations, transfer agreements, enforceable claims or encumbrances; 

  

	 	(k)	 Litigation. There is no litigation, arbitration, proceeding, governmental investigation, action or claim of any Third Party or to the
knowledge of PPI threatened by or against PPI relating specifically to the PPI IP, or the Trademarks which would impede, impair, restrict or interfere with the rights granted EKR hereunder or the ability of PPI to perform its obligations hereunder;
and 

  
 -42-

  

	 	(l)	 Customer Lists. PPI has or prior to the Effective Date will have provided EKR with complete and accurate lists of the names and addresses of
all material customers and suppliers of the Products. 

  

	 	(m)	 Permits. PPI has and shall maintain at all times during the Term all necessary license, permits, records and authorizations required by
Applicable Laws necessary to perform its obligations hereunder and shall observe and comply with all Applicable Laws, ordinances, rules and regulations including those of the applicable Regulatory Authorities and governmental entities including but
not limited to DEA in the performance of its obligations hereunder. 

  

	 	(n)	 ICS Agreement. All amounts due under the ICS Agreement as of or prior to the Effective Date have been paid in full. PPI is not in, nor has
PPI given or received notice of, any default or claimed, purported or alleged default, or facts that, with notice or lapse of time, or both, would constitute a default (or give rise to a termination right) on the part of any person in the
performance of any obligation to be performed under the ICS Agreement. A true and complete copy of the ICS Agreement, including any amendments thereto, has been delivered to EKR. 

 

	10.	 Liability, Insurance and Indemnities 

 

	10.1	 Indemnification of EKR. PPI shall be liable for and shall defend, indemnify and hold harmless EKR and its Affiliates and their officers,
directors, agents, representatives, consultants and employees (individually an “EKR Indemnified Party” and collectively the “EKR Indemnified Parties”) and any of them from and against any and all Claims (as defined
below), arising in connection with or relating to: 

  

	 	(a)	 The development, manufacture, sale and supply of the Product prior to the Effective Date (including Claims arising after the Effective Date to the
extent they are based on events occurring prior to the Effective Date); 

  
 -43-

  

	 	(b)	 The manufacture of the Product by or on behalf of PPI (including, but not limited to, any manufacture of Product or any other product by EKR for the
Other PPI Customers pursuant to Section 3.20(l)) except to the extent that such Claims arise from (i) the negligence or willful misconduct of EKR or its Affiliates, (ii) the breach by EKR of the terms of this Agreement or
(iii) the manufacture of Product by EKR in accordance with EKR’s exercise Step-in Right for supply of Product to EKR or its Affiliates; 

  

	 	(c)	 Claims which arise outside the Territory (except to the extent that the Claim has arisen from any act or omission by EKR);

  

	 	(d)	 A breach by PPI of any representation, warranty, covenant or agreement contained in this Agreement, the Supply Agreement or the Transition Services
and Inventory Agreement; 

  

	 	(e)	 PPI’s failure to comply with any Applicable Law in connection with the performance of its obligations hereunder or under the Supply Agreement
or the Transition Services and Inventory Agreement, or prior to the Effective Date; and 

  

	 	(f)	 Any Claims related to Product sold by parties other than EKR prior or subsequent to the Effective Date. 

 

	 	(g)	 Liabilities arising under the ICS Agreement prior to the Effective Date and subsequent to the Effective Date for Products sold by parties other than
EKR or under the direction of EKR or arising under the Transition Services and Inventory Agreement. 

  
 -44-

  

	10.2	 Indemnification of PPI. EKR shall be liable for and shall defend, indemnify and hold harmless PPI from and against any and all Claims arising
from (i) EKR’s exercise of the Distribution Rights or arising under the Transition Services and Inventory Agreement, (ii) a breach by EKR of any representation, warranty, covenant or agreement contained in this Agreement, the Supply
Agreement or the Transitions Services and Inventory Agreement, or (iii) EKR’s failure to comply with Applicable Laws in connection with its performance of its obligations hereunder, or (iv) Claims related to the manufacture of
Products by EKR or by a Third Party Manufacturer designated by EKR pursuant to Section 11.5 of the Supply Agreement, except to the extent that such Claims: 

 

	 	(a)	 relate to any act or circumstance occurring prior to the Effective Date; 

 

	 	(b)	 relate to Intellectual Property infringement proceedings with Third Parties in connection with the PPI IP and Trademarks (except to the extent that
the Claim has arisen from EKR’s use of the PPI IP or Trademarks other than in accordance with this Agreement); 

  

	 	(c)	 arise outside the Territory (except to the extent that the Claim has arisen from any act or omission by EKR); 

 

	 	(d)	 relate to the development or manufacture of the Product by PPI or its Affiliates or its or their agents or sub-contractors;

  

	 	(e)	 Arise under the ICS Agreement after the Effective Date for Products sold by EKR. 

 
  

	 	(f)	 result from the negligence, willful default or material breach of any representation or warranty given under this Agreement, the Supply Agreement,
or the Transition Services and Inventory Agreement by PPI, its Affiliates or sub-contractors; or 

  

	 	(g)	 are the responsibility of PPI under Section 10.1 above. 

  
 -45-

  

	10.3	 Conditions to Indemnification. Promptly after receipt by a Party of any Claim or alleged claim or notice of the commencement of any action,
administrative or legal proceeding, or investigation as to which the indemnity provided for in this Section 10 may apply, the indemnified Party shall give written notice to the indemnifying Party of such fact. The indemnifying Party shall have
the option to assume the defense thereof by election in writing within thirty (30) days of receipt of such notice. If the indemnifying Party fails to make such election, the indemnified Party may assume such defense and the indemnifying Party
will be liable for reasonable legal and other expenses subsequently incurred in connection with such defense. The Parties will co-operate in good faith in the conduct of any defense, provide such reasonable assistance as may be required to enable
any Claim to be properly defended, and the Party with conduct of the action shall provide promptly to the other Party copies of all proceedings relating to such action. 

 

	10.4	 Assumption of Defense. Should the indemnifying Party assume conduct of the defense: 

 

	 	(a)	 the indemnified Party may retain separate legal advisors in the event that it reasonably concludes that it may have defenses available to it which
are additional to, different from or inconsistent with those available to the indemnifying Party, in which case the indemnifying Party shall not be liable for the indemnified Party’s reasonable costs and expenses so incurred; and

  

	 	(b)	 the indemnifying Party will not, except with the consent of the indemnified Party (such consent not be unreasonably withheld or delayed), consent to
the entry of any judgment or enter into any settlement (other than for the payment of damages by the indemnifying Party, which includes as an unconditional term a release from the claimant to the indemnified Party from all liability in respect of
all claims). 

  
 -46-

  

	10.5	 Settlement of Claims. The indemnified Party shall not admit liability in respect of, or compromise or settle any such action without the
prior written consent of the indemnifying Party, such consent not to be unreasonably withheld or delayed. 

  

	10.6	 Insurance. Each Party shall maintain, at its own cost, comprehensive product liability insurance, general commercial liability insurance and
business interruption insurance at a level which is reasonable and customary taking into account the nature of the Product but which shall have combined limits of not less than $[**] per occurrence. Such insurance shall be with a reputable insurance
company and where reasonably possible (taking into account the availability of such insurance) shall be maintained for not less than [**] ([**]) years following the expiry or termination of this Agreement. During the Term, neither Party shall do or
omit to do any act, matter or thing which could prejudice or render voidable any such insurance. Each Party will provide to the other Party evidence of its insurance and thirty (30) days prior written notice of any cancellation of its coverage
or reduction in coverage from the requirements stated herein. 

  

	10.7	 Third Party Liability. Each of the Parties shall be liable to the other for legal liability to Third Parties in respect of all claims,
actions, judgments, damages, lawsuits, costs or expenses or professional fees for death or personal injury incurred by such other Party in relation to or arising out of any breach of this Agreement, the Transition Services and Inventory Agreement or
the Supply Agreement by the first Party or of any gross negligence or willful act of the first Party, or its employees in the course of their employment. 

 

	10.8	 PPI Liability Limitation. Any and all liability of PPI to EKR howsoever arising in respect of this Agreement, the Transition Services and
Inventory Agreement or the Supply Agreement and their performance, in contract tort or otherwise, shall be limited (except for death or personal injury caused by the negligence of PPI or its employees while acting in the course of their employment)
to [**] US Dollars ($[**]); provided 

  
 -47-

	 	 
however that such limitation shall not apply to the extent that EKR or any EKR Indemnified Party is required to pay in excess of such amount to a third party in respect of a final judgment or
order obtained by the third party or as a result of PPI’s breach of Section 7.2.12 of the Supply Agreement. 

  

	10.9	 EKR Liability Limitation. Any and all liability of EKR to PPI howsoever arising in respect of this Agreement, the Transition Services and
Inventory Agreement or the Supply Agreement and their performance in contract tort or otherwise shall be limited (except for death or personal injury caused by the negligence of EKR or its employees while acting in the course of their employment,
and except in relation to any specified payment, lump sum, milestone or royalty payment unpaid) to [**] US Dollars ($[**]); provided however that such limitation shall not apply to the extent that PPI or any PPI Indemnified Party is required to pay
in excess of such amount to a third party in respect of a final judgment or order obtained by the third party. 

  

	10.10	 Limitation of Damages. Notwithstanding anything contained in this Agreement or the Transition Services and Inventory Agreement or the Supply
Agreement in no circumstance shall either Party be liable to the other in contract, tort (including negligence or breach of statutory duty) or otherwise howsoever, and whatever the cause thereof, for any special, indirect or consequential loss or
damage of any nature whatsoever except in the cases of fraud or intentional misconduct or in the case of PPI as a result of PPI’s breach of Section 7.2.12 of the Supply Agreement. 

 

	10.11	 Definition of Claims. In this Section 10, “Claims” shall mean any and all claims, actions, demands, losses,
damages, costs and reasonable expenses (including, without limitation, reasonable legal and expert fees) made or brought by Third Parties. 

  

	11.	 Confidentiality, Press Releases and Publications 

 

	11.1	 Confidential Information. PPI and EKR undertake to each other to keep confidential, and to procure that their respective Affiliates,
employees, directors, officers, contractors, lawyers and accountants (including those of their Affiliates) keep confidential, Confidential Information disclosed to it by or belonging to the other Party. 

  
 -48-

  

	11.2	 Third Party Disclosure. Any Confidential Information received from the other Party shall not be disclosed to any Third Party or used for any
purpose other than as provided or specifically envisaged by this Agreement or as required in connection with any securities offering, financing, merger, acquisition or other corporate transaction involving such Party provided that any Party to whom
such disclosure is made is bound by obligations as to confidentiality that are at least as protective of Confidential Information as those contained herein. 

 

	11.3	 Duration. The confidentiality and non-use obligations contained in this Agreement shall continue for the duration of this Agreement and for a
period of [**] ([**]) years after termination for any reason of this Agreement. 

  

	11.4	 Public Announcements. The Parties shall consult with each other, in advance, with regard to the terms of all proposed press releases, public
announcements and other public statements with respect to the transactions contemplated under this Agreement. The Parties acknowledge that they have issued a joint press release in the form set out in Schedule VI of this Agreement.

  

	11.5	 Exceptions to Disclosure of Confidential Information. The Confidential Information may be disclosed by the other Parties to the extent that
such disclosure has been ordered by a court of law or directed by a governmental authority, provided that, wherever practicable, the Party disclosing the Confidential Information has been given sufficient written notice in advance to the other Party
to enable it to seek protection or confidential treatment of such Confidential Information, and may be disclosed only to the extent that such disclosure has been so ordered or directed. 

 

	12.	 Patents 

  

	12.1	 Maintenance. PPI shall pay all costs and expenses of the filing, prosecution and maintenance of the PPI Patents in each country of the
Territory so as to maintain the 

  
 -49-

	 	 
PPI Patents in full force and effect. PPI will consult with EKR with respect to any notice from or correspondence with the USPTO or any other governmental entity with respect thereto and the
development, filing and prosecution of any subdivisions, continuations, continuations in part or additional applications related to the Product for use in the Field in the Territory. 

 

	13.	Infringement of Third Party Rights 

  

	13.1	 Notice of Infringement. In the event of a Party becoming aware that the exercise of either Party’s rights and obligations pursuant to
this Agreement are infringing or may infringe the rights of a Third Party, it will promptly notify the other Party and provide it with such details of the Third Party rights and the extent of the infringement as are known to it.

  

	13.2	 Infringement of Third Party IP. In the event a claim of infringement of a Third Party’s intellectual property rights arising out of the
manufacture, use, sale, promotion or distribution of the Products is brought against either Party, PPI shall defend such action at its cost and expense and take one or more of the following actions simultaneously or sequentially:

  

	 	(a)	 Defend the claim and indemnify and hold harmless EKR, its Affiliates, officers, directors, shareholders, employees, representations, consultants and
agents (the “EKR Infringement Indemnitees”) as set forth in Section 13.3 below. 

  

	 	(b)	 Obtain for itself as the benefit of EKR the right through license or otherwise to utilize the technology upon which the claim of infringement was
based. Such rights obtained by PPI from a Third Party under this Section 13.2 shall be licensed or sublicensed to EKR at no additional cost to EKR. 

 

	13.3	 Infringement Indemnification. Notwithstanding any other provisions of this Agreement, PPI will defend, indemnify and hold harmless the EKR
Infringement 

  
 -50-

	 	 
Indemnitees from and against all liabilities, losses, damages, actions, claims and expenses suffered or incurred by the EKR Infringement Indemnitees (including reasonable attorneys fees, court
costs and expert witnesses’ fees) resulting from any claims by any Third Party that EKR’s exercise during the Term of the rights granted under this Agreement infringes or violates any license, patent, copyright, trademark or other
intellectual property right of that Third Party. 

  

	14.	Infringement of PPI IP 

  

	14.1	 Notice of Infringement. In the event that either Party becomes aware of any actual or suspected infringement or misuse of the PPI IP or
Trademarks in the Territory by a Third Party (“Third Party Infringement”), it shall promptly notify the other Party and provide it with all details thereof in its possession. 

 

	14.2	 Infringement Action. Within a reasonable time of becoming aware of such Third Party Infringement, the Parties shall consult with each other
and their respective counsel to develop a strategy for addressing the Third Party Infringement. In the event the Parties agree to the legal action to stop the Third Party Infringement, they shall agree upon legal counsel to prosecute such action and
unless the Parties otherwise agree, PPI shall prosecute the action at its cost and expense. EKR shall provide all such assistance at PPI’s cost and expense as PPI may reasonably require in the prosecution or defense of any such proceedings.

  

	14.3	 Awards. Any damages, award or settlement monies actually received by PPI in respect to such infringement and paid in compensation for sales
lost by EKR shall be deemed Net Sales and be paid to EKR, subject to PPI deducting its costs and expenses in pursuing such infringement from such damages, award or settlement actually received. Any damages, award or settlement monies actually
received by PPI in respect to such infringement and not paid in compensation for sales lost by EKR shall be shared equally by the Parties. 

  
 -51-

	14.4	 Non Participation. Should in accordance with Section 14.2, PPI decide not to participate in any such infringement action, EKR may
require PPI to bring the action, subject to reimbursement by EKR for reasonable out-of-pocket expenses incurred by PPI in connection with such action. The selection of counsel and all other material decisions with respect to such action shall be
subject to EKR’s prior, written approval, such approval not to be unreasonably withheld. In addition, EKR shall have the right to discontinue the prosecution of any such action at any time upon written notice to PPI. Except as provided above in
this Section 14.4, PPI shall have control of such action but shall consult with EKR regarding the conduct of such action and shall not settle such action without the prior written consent of EKR, which consent shall not be unreasonably
withheld, and EKR may, in such instance, retain any award or settlement in its entirety. Notwithstanding the foregoing, PPI shall offer reasonable assistance to EKR at no charge except for reimbursement of reasonable out of pocket expense including
reasonable attorneys fees. 

  

	14.5	 Cooperation. Each Party shall keep the other Party reasonably informed and consult with the other Party with regard to any infringement
action under this Article 14. 

  

	15.	 Term 

  

	15.1	 This Agreement shall commence on the Effective Date and, subject to earlier termination in accordance with the provisions of Section 16,
shall continue in force for a period being the longer of fifteen (15) years from first Commercial Launch of the Product in the Territory or until the expiration of the last valid claim in the PPI Patents covering the Product in any country of
the Territory (the “Initial Term”). Thereafter the term of this Agreement shall automatically renew for consecutive periods of two (2) years each. Notwithstanding the foregoing, this Agreement can be terminated by EKR at the
end of the Initial Term by delivery of written notice to PPI at least one hundred eighty (180) days prior to the end of the Initial Term or any renewal term. As used herein “Term” refers to the Initial Term and any renewal
terms. 

  
 -52-

  

	16.	 Termination 

  

	16.1	 Prior Termination by Either Party. Either Party shall be entitled forthwith to terminate this Agreement by notice to the other if:

  

	 	(a)	 the other Party commits a material breach of any material obligation under this Agreement or the Supply Agreement, and in the case of a breach which
is capable of remedy fails to remedy it within sixty (60) days of receipt of notice from the first Party of such breach and of its intention to exercise its rights under this Section; or 

 

	 	(b)	 any representation or warranty made herein or in the Supply Agreement by such other Party proves to be incorrect when made which has a material
adverse effect on the performance of the other Party’s obligations hereunder and in the case of a breach which is capable of remedy fails to remedy it within sixty (60) days of receipt of notice from the first Party of such breach and of
its intention to exercise its rights under this Section; or 

  

	 	(c)	 the entry of a decree or order for relief by a court having jurisdiction in the premises in respect of the other Party in an involuntary case under
the United States Bankruptcy Code, as now constituted or hereafter amended, or any other applicable foreign, federal or state insolvency or other similar law and the continuance of any such decree or order unstayed and in effect for a period of
sixty (60) consecutive days; or 

  

	 	(d)	 the filing by the other Party of a petition for relief under the United States Bankruptcy Code, as now constituted or hereafter amended, or any
other applicable foreign, federal or state insolvency law or other similar law; or 

  

	 	(e)	 the other Party becomes insolvent or takes the benefit of any statute for insolvent debtors or any steps are taken or proceedings commenced by any
person for the dissolution, winding-up or other termination of such other Party’s existence or the liquidation of its assets; or 

  
 -53-

	 	(f)	 a trustee, receiver, receiver-manager or like person is appointed with respect to the business or assets of the other Party; or

  

	 	(g)	 the other Party proposes or makes any composition or arrangement or composition with, or any assignment for the benefit of, its creditors; or

  

	 	(h)	 anything analogous to any of the events described in Sections 16.1(c)-(k) – 16.1.6, inclusive, occurs under the laws of any
applicable jurisdiction; or 

  

	 	(i)	 the other Party ceases or threatens to cease to carry on the whole or any material part of its business; or 

 

	 	(j)	 for reasons unrelated to any breach of either Parties’ duties or obligations under or in connection with this Agreement, the other Party is
prevented from performing any of its material obligations hereunder by any law, governmental or other action (other than laws of general application) and has not resumed performance in compliance with all Applicable Laws within one hundred twenty
(120) days following the date on which such performance was first provided; or 

  

	 	(k)	 in accordance with Section 18.2 below. 

 

	16.2	 Prior Termination by PPI. 

  

	 	(a)	 Reserved. 

  

	 	(b)	 PPI may terminate this Agreement with immediate effect in any country of the Territory where EKR is obligated to launch the Product pursuant to
Section 4.5 if within [**] months of the receipt of the Marketing Authorization for such country, EKR has not made its first Commercial Launch of the Product in that country. 

 

	 	(c)	 In the event PPI has terminated the Supply Agreement pursuant to Section 10.2 thereof and EKR or its designee is manufacturing Products
pursuant to Section 11.5 of the Supply Agreement, PPI shall have the right to terminate such rights of manufacture and this Agreement upon thirty (30)

  
 -54-

	 	 
days prior, written notice to EKR only in the event Royalties and Additional Royalties paid hereunder in any one year period following the date of such termination are less than $[**], unless the
difference between $[**] and the actual Royalties and Additional Royalties paid by EKR is paid to PPI within thirty (30) days of notice of such termination. 

 

	16.3	 Prior Termination by EKR. 

  

	 	(a)	 EKR may terminate this Agreement with immediate effect in any country of the Territory if the Products are withdrawn from the market in such country
of the Territory as a result of regulatory action by FDA or other governmental entities or there are significant adverse reactions from use of the Products. 

 

	 	(b)	 EKR may terminate this Agreement for convenience at any time upon [**] ([**]) days prior, written notice to PPI. 

 

	16.4	 Effect of Termination. The termination or expiration of this Agreement shall not release either of the Parties from any liability which at
the time of termination or expiry has already accrued to the other Party, nor affect in any way the survival of any other right, duty or obligation of the Parties which is expressly stated elsewhere in this Agreement to survive such termination or
expiry. 

  

	17.	 Consequences of Termination 

  

	17.1	 Upon termination of this Agreement for any reason except as set forth in Section 17.4 below (and, if applicable, in respect of that
country in respect of which termination occurs): 

  

	 	(a)	 the licenses and rights granted and appointments made under Sections 2.1, 2.2 and 2.3 shall terminate and EKR shall (and shall
procure that its Affiliates, sub-distributors and sub-licensees shall) cease all activities licensed or appointed hereunder, subject to Sections 17.2 and 17.3; 

  
 -55-

	 	(b)	 the following provisions of this Agreement shall continue in full force and effect: Article 1 (“Definitions”),
Section 3.20(k), Section 3.20(l), Article 9 (“Representations and Warranties”), Article 10 (“Liability, Insurance and Indemnities”) (excluding Section 10.6
(“Insurance”)), Article 11 (“Confidentiality, Press Releases and Publications”), Article 13 (“Infringement of Third Party Rights”), Section 16.4 (“Effect of Termination”), Article
17 (“Consequences of Termination”), Article 18 (“Force Majeure”), Article 19 (“Notices”), Article 20 (“Assignment and Change of Control”) and Article 21 (“General
Provisions”); 

  

	 	(c)	 EKR shall return to PPI all PPI IP in its possession; 

 

	 	(d)	 EKR shall assign to PPI free of charge any domain name registrations it has registered pursuant to Section 8.5; and

  

	 	(e)	 Except in the event of termination of this Agreement by EKR pursuant to Section 16.1(a), EKR shall promptly transfer to PPI or its
nominee, each and every Marketing Authorization (to the extent not held by PPI) relating to the Product, together with all communications with the relevant Regulatory Authorities, and all notes and record thereof. 

 

	17.2	 Sale of Remaining Inventory. Where this Agreement has expired or has been terminated for any reason other than by PPI in accordance with
Section 16.1 or EKR in accordance with Section 16.3(b), EKR and its Affiliates and sub-distributors and sales agents shall be entitled to continue to sell existing stocks of the Product in the Territory for a period of not
longer than 12 months following the date of termination, provided that, EKR continues to make any Royalty payments due to PPI in respect of such sales in accordance with the provisions of this Agreement. 

 

	17.3	 Other Rights upon Termination. In the event that this Agreement is terminated by PPI in accordance with Section 16.1 or EKR in
accordance with Section 16.3(b), EKR and its Affiliates, sub-distributors and sub-licensees shall be entitled to continue to sell 

  
 -56-

	 	 
existing stocks of the Product in the Territory for so long as PPI deems necessary to ensure that sale of the Product is not disrupted provided that EKR and its Affiliates shall cease such sale
immediately upon notification from PPI and in any event EKR shall not so sell for a period of longer than three (3) months following the date of termination. Immediately upon notification from PPI, such post termination sales shall cease.

  

	17.4	 Other Remedies of EKR. Notwithstanding anything contained herein to the contrary, in the event that EKR is entitled to exercise its right to
terminate this Agreement pursuant to Section 16.1(a), in addition to the right to terminate as provided therein and any other remedies EKR may have hereunder, PPI shall assist EKR in the transfer of the manufacture of the Products,
including the Specifications from PPI to EKR or EKR’s designee. In such event, the Royalty payments payable hereunder shall continue to be paid; provided, however, that all costs incurred by EKR in the transfer of manufacturing
information from PPI and obtaining FDA approval of the manufacture of the Products by EKR or EKR’s designee, and any other amounts due to EKR, shall be deducted from any royalties payable to PPI. In addition, PPI shall during the remainder of
the Term and for a period of up to [**] ([**]) years thereafter continue to manufacture and supply the Product to EKR at cost without mark-up until such time that EKR can secure an FDA approved manufacturing facility for the Product. PPI shall
provide such advice as necessary for EKR to arrange for an alternative manufacturer and shall provide EKR with access to all relevant PPI Know-How, and any other information necessary for EKR to transfer such manufacturing to an alternate
manufacturer. In addition, (i) PPI shall transfer to EKR any Marketing Authorizations held by PPI and (ii) the Trademark license granted under Section 2.3 shall continue in effect following such termination on a perpetual basis and
EKR shall be responsible for all costs associated with the maintenance of such Trademark. 

  
 -57-

  

	17.5	 EKR Step-In Rights. 

  

	 	(a)	 During the Term, in the event EKR has the right to terminate this Agreement under Section 16.1(a) – (i) hereof (the
“Step-in Right Trigger Event”), and EKR does not exercise its right to terminate this Agreement under such Section, EKR shall have the option to exercise step-in rights to manufacture the Product for the remainder of the Term (the
“Step-in Right”) by providing PPI written notice of such election within ninety (90) days after the Step-in Right Trigger Event (or such longer period as mutually agreed by the Parties) (the “Step-in Right
Notice”); provided that in the event such Step-in Right Trigger Event has been cured prior to EKR’s exercise of the Step-in Right, the Step-in Right shall terminate with respect to such Step-in Right Trigger Event. The Step-in
Right Notice shall specify the date which EKR intends to exercise the rights associated with the Step-in Right. 

  

	 	(b)	 In the event EKR exercises the Step-in Right, PPI shall, at EKR’s cost and expense, cooperate in the exercise of such rights and EKR shall
reimburse PPI for the reasonable costs PPI incurs in assisting EKR in the exercise of such rights within thirty (30) days of EKR’s receipt of invoice. 

 

	 	(c)	 The Step-in Right shall include, without limitation, and to the extent allowable under Applicable Law, PPI’s grant to EKR of such additional
license rights, rights of access, rights of observation and rights of management, direction and control, in each case solely with respect to the manufacture and supply of Product and as reasonably necessary to enable and permit EKR (or EKR’s
designee) to ensure that the supply of Product shall continue to be available to EKR under this Agreement and the Supply Agreement; provided that EKR in exercising the Step-in Right shall not (i) unreasonably interfere with PPI’s other
activities at the facilities at which the Product is manufactured, tested, labeled, stored or 

  
 -58-

	 	 
otherwise handled (“Product Facilities”) or (ii) require PPI to take any action or fail to take any action that does or could reasonably be expected to interfere with
PPI’s other activities at the Product Facilities. The foregoing rights shall apply with respect to any Product Facility to the extent necessary for EKR to preserve and protect supply of the Product as contemplated by this Agreement and the
Supply Agreement. For the avoidance of doubt, (i) upon termination of the Lease Term, PPI shall maintain responsibility and control over all other products manufactured by PPI and nothing in this Section 17.5 shall give EKR any
rights to direct, manage or control the manufacture of such products (ii) PPI shall maintain responsibility and control over the facilities where Product is manufactured, tested, labeled, stored or otherwise handled and nothing in this
Section 17.5 shall give EKR general oversight or control of the facilities where Product is manufactured, tested, labeled, stored or otherwise handled. 

 

	 	(d)	 In the event EKR exercises the Step-in Right, EKR shall comply with all policies applicable to the facilities where Product is manufactured, tested,
labeled, stored or otherwise handled and all Applicable Laws with respect to the manufacture of the Product. 

  

	18.	 Force Majeure 

  

	18.1	 Obligation to Perform. Except for payment obligations which shall not be excused or affected by any Force Majeure, neither Party shall be
entitled to terminate this Agreement or shall be liable to the other under this Agreement for loss or damages attributable to any Force Majeure, provided the Party affected shall give prompt notice thereof to the other Party. Subject to
Section 18.2, the Party giving such notice shall be excused from such of its obligations hereunder for so long as it continues to be affected by Force Majeure. 

  
 -59-

	18.2	 Duration. If such Force Majeure continues unabated for a period of at least ninety (90) days, the Parties will meet to discuss in good
faith what actions to take or what modifications should be made to this Agreement as a consequence of such Force Majeure in order to alleviate its consequences on the affected Party. If the affected Party is prevented by reason of any circumstances
referred to in this Section of this Agreement from performing any of its obligations hereunder for a continuous period of six (6) months the other Party may terminate this Agreement. 

 

	19.	 Notices 

  

	19.1	 Form. Any notice or other document given under this Agreement shall be in writing in the English language and shall be given by hand or sent
by U.S. prepaid first class registered or certified mail, return receipt requested, recognized national overnight courier service, or by fax transmission to the address of the receiving Party as set out in Section 19.3 below unless a
different address or fax number has been notified to the other in writing for this purpose. 

  

	19.2	 Delivery. Each such notice or document shall: 

 

	 	(a)	 if sent by hand, be deemed to have been given when delivered at the relevant address; 

 

	 	(b)	 if sent by prepaid airmail, be deemed to have been given 7 days after posting; or 

 

	 	(c)	 if sent by fax transmission be deemed to have been given when transmitted provided that a confirmatory copy of such facsimile transmission shall
have been sent by hand, U.S. prepaid first class registered or certified mail, return receipt requested, or recognized national overnight courier service within 24 hours of such transmission. 

  
 -60-

  

	19.3	 Notice of Parties. The address for services of notices and other documents on the Parties shall be: 

 

							
	To EKR	  	To PPI	  	
				
	 Address:
	  	 1545 Route 206 South
 Third Floor
 Bedminster, NJ 07921
	  	 Address:
	  	 10450 Science Center
 Drive, San Diego,
 California 92121 USA

				
	 Fax:
	  		  	 Fax:
	  	 858 623 0376

				
	 Attention:
	  	 Chairman & CEO
	  	 Attention:
	  	 President

		
	 With a copy to:
	  	 With a copy to:

		
	 Lowenstein Sandler
 65 Livingston Avenue
 Roseland, New Jersey 07068
	  	 Wilmer Cutler Pickering Hale & Dorr LLP

1117 S California Avenue
 Palo Alto, CA 94304 USA

				
	 Fax: 
	  	 973-597-6395
	  	 Fax:
	  	 650-858-6100

	 Attention:
	  	 Michael J. Lerner
	  	 Attention:
	  	 Joseph K. Wyatt

  

	20.	 Assignment and Change of Control 

  

	20.1	 Assignment. Subject to Section 20.2, neither Party shall, nor shall it purport to, assign, license, transfer or change any of its
rights or obligations under this Agreement without the prior written consent of the other, such consent not to be unreasonably withheld conditioned or delayed; provided, however, that except as provided in Section 20.4
either Party may assign its rights hereunder to an Affiliate or to any successor by merger, consolidation, sale of stock or other equity interests or the sale of substantially all of the assets of such Party without the consent of the other Party.
For the avoidance of doubt, either Party may grant a security interest with respect to its rights under this Agreement in connection with a secured financing or similar transaction. 

 

	20.2	 Sub-Distribution. EKR may appoint sub-distributors under this Agreement provided that EKR: 

 

	 	(a)	 informs PPI of the identity of any Third Party sub-distributor (other than Affiliate companies) prior to the execution of any sub-distribution
agreement; 

  
 -61-

	 	(b)	 obtain a confidential nondisclosure agreement with the prospective Sub-Distributor in a form acceptable to PPI, which acceptance shall not be
unreasonably withheld or delayed and containing terms at least as stringent as those terms included in Article 11 of this Agreement; 

  

	 	(c)	 deliver to the prospective Sub-Distributor a redacted copy of this Agreement (“Redacted Agreement”). Any sub-distribution agreement
shall provide that such agreement is subject and subordinate to the rights of PPI under this Agreement; and 

  

	 	(d)	 provides PPI with a copy of written sub-distribution agreement as soon as reasonably practicable after the execution thereof by EKR.

  

	20.3	 Responsibility of EKR. Notwithstanding any such sub-distribution agreement, EKR shall remain primarily liable to PPI for its obligations
hereunder, and for any act or omission of any sub-distributor. 

  

	20.4	 Change of Control. Should there be a Change of Control of either Party resulting in the control of such Party by a Third Party which markets
or sells a Competing Product in any part of the Territory, then the rights under this Agreement may not be assigned without the express consent of the other Party which consent shall not be unreasonably withheld. “Change of Control”
shall mean (a) the sale, lease, exchange, license or disposition of all or substantially all of the Party’s assets in one transaction or series of related transactions or (b) a merger or consolidation with an unaffiliated Third Party
as a result of which the holders of the Party’s issued and outstanding voting securities immediately before such transaction own or control less than a majority of the voting securities of the continuing or surviving entity immediately after
such transaction. The issuance by either Party of securities in connection with any financing transaction or 

  
 -62-

	 	 
public offering shall not be deemed a Change of Control under this Agreement. Notwithstanding the foregoing, for the purposes of Section 6.3(b)(iii): (i) references to a
“Party” in the above definition of Change of Control shall be deemed to include PPI as well as any Affiliate of PPI and (ii) a Change of Control shall also include (in addition to any of the transactions described above in the
definition of Change of Control), any sale of securities of PPI or its Affiliates directly by the holder (the "Holder") of such securities (other than to an Affiliate of such Holder) in which such sale results in a transfer of more than 50% of the
outstanding voting stock of PPI or its Affiliates. 

  

	21.	 General Provisions 

  

	21.1	 Relationship of the Parties. Nothing in this agreement is deemed to constitute a partnership, agency, employer-employee or joint venture
relationship between the Parties. No Party shall incur any debts or make any commitments for the other, except to the extent, if at all, specifically provided herein. 

 

	21.2	 Dispute Resolution. If there is a disagreement between the PPI and EKR on the interpretation of this Agreement or any aspect of the
performance by either Party of its obligations under this Agreement, the Parties shall resolve the dispute in accordance with the dispute resolution procedure set out in Schedule VIII. 

 

	21.3	 Cooperation. Each of the Parties shall do execute and perform and shall procure to be done executed and performed all such further acts deeds
documents and things as the other Party may reasonably require from time to time to give full effect to the terms of this Agreement. 

  

	21.4	 Expenses. Each Party shall pay its own costs, charges and expenses incurred in connection with the negotiation, preparation and completion of
this agreement. 

  

	21.5	 Entire Agreement. This Agreement (together with the Transition Services and Inventory Purchase Agreement and the Supply Agreement) sets out
the entire agreement and understanding between the Parties in respect of the subject matter hereof and thereof. This Agreement supersedes the Original Agreement and any heads of agreement which shall cease to have any further force or effect. It is
agreed that: 

  

	 	(a)	 no Party has entered into this Agreement in reliance upon any representation, warranty or undertaking of the other Party which is not expressly set
out in this Agreement; 

  
 -63-

  

	 	(b)	 no Party shall have any remedy in respect of misrepresentation or untrue statement made by the other Party or for any breach of warranty which is
not contained in this Agreement; 

  

	 	(c)	 this Section shall not exclude any liability for, or remedy in respect of, fraudulent misrepresentation. 

 

	21.6	 Amendment. No amendment, change or modification of any of the terms, provisions or conditions of this Agreement shall be valid unless it is
in writing and signed by or on behalf of both Parties. 

  

	21.7	 Waiver. Unless expressly agreed, no waiver of any term, provision or condition of this Agreement shall constitute a general waiver of any
provisions of this Agreement, nor shall it affect any rights, obligations or liabilities under or pursuant to this Agreement which have already accrued up to the date of variation, and the rights and obligations of the Parties under or pursuant to
this Agreement shall remain in full force and effect, except and only to the extent that they are so waived. 

  

	21.8	 Unenforceability. If and to the extent that any provision of this Agreement is held to be illegal, void or unenforceable, such provision
shall be given no effect and shall be deemed not to be included in this Agreement but without invalidating any of the remaining provisions of this Agreement. 

 

	21.9	 Delay. No failure or delay by either Party in exercising any right or remedy provided by law under or pursuant to this Agreement shall impair
such right or remedy or operate or be construed as a waiver or variation of it or preclude its exercise at any subsequent time and no single or partial exercise of any such right or remedy shall preclude any other or further exercise of it or the
exercise of any other right or remedy. 

  
 -64-

  

	21.10	 Cumulative Rights. The rights and remedies of each of the Parties under or pursuant to this Agreement are cumulative, may be exercised as
often as such Party considers appropriate and are in addition to its rights and remedies under general law. 

  

	21.11	 Counterparts. This Agreement may be executed in any number of counterparts and by the Parties on separate counterparts, each of which is an
original but all of which together constitute one and the same instrument. 

  

	21.12	 Reserved. 

  

	21.13	 Governing Law. This Agreement and the relationship between the Parties shall be governed by, and interpreted in accordance with New York law
without regard to provisions related to conflicts of laws, and, except as provided in Section 21.2 above, the Parties agree to submit any dispute to the exclusive jurisdiction of the federal and state courts sitting in New York.

  

	21.14	 Successors and Assigns. Subject to Section 20.1, this Agreement shall be binding upon and shall inure to the benefit of the
Parties hereto and their respective successors and assigns permitted under this Agreement. 

  

	21.15	 Systems. Immediately upon the Effective Date, or as soon thereafter as practicable, the Parties shall implement a mutually acceptable
operation plan to transfer the processing of chargebacks, federal releases, state releases and customer services from PPI to EKR. 

 (signature page follows) 

  
 -65-

 AS WITNESS the hands of the Parties or their duly authorized
representatives effective as of the Effective Date. 
  

							
	 SIGNED for and by behalf of
	 	 )
	 	 By:
	 	 /s/ David Stack

	PACIRA PHARMACEUTICALS, INC.	 		 		 	
		 	 )
	 		 	
		 		 	 David Stack

		 		 	 Print Name

				
	 SIGNED for and by behalf of
	 	 )
	 	 By:
	 	 /s/ Richard DeSimone

	EKR THERAPEUTICS, INC.	 		 		 	
		 		 	 Richard DeSimone, CFO

		 		 	 Print Name

  
 -66-

 SCHEDULE I 
 PATENTS 
  

															
	[**]
	 Attorneys’
 Ref:
	 	 Country
	 	 Application
 date
	 	 Application
 no.
	 	 Patent/
Publication no.
	 	 Grant date
	 	 Expiry date
	 	 Status

	 [**]
	 	 [**]
	 	 [**]
	 	 [**]
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	 	 [**]
	 	 [**]
	 	 [**]

	 [**]
	 	 [**]
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	 [**]
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	 	 [**]

	 [**]
	 	 [**]
	 	 [**]
	 	 [**]
	 	 [**]
	 	 [**]
	 	 [**]
	 	 [**]

	
	[**]
	 Attorneys’
 Ref:
	 	 Country
	 	 Application
 date
	 	 Application
 no.
	 	 Patent/
Publication no.
	 	 Grant date
	 	 Expiry date
	 	 Status

	 [**]
	 	 [**]
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	 [**]
	 	 [**]
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	 	 [**]
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	 	 [**]

	
	[**]
	 Attorneys’
 Ref:
	 	 Country
	 	 Application
 date
	 	 Application
 no.
	 	 Patent/
 Publication
 no.
	 	 Grant date
	 	 Expiry date
	 	 Status

	 [**]
	 	 [**]
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	[**]
	 Attorneys’
 Ref:
	 	 Country
	 	 Application
 date
	 	 Application
 no.
	 	 Patent/
Publication no.
	 	 Grant date
	 	 Expiry date
	 	 Status

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 -67-

  

															
	[**]
	 Attorneys’
 Ref:
	 	 Country
	 	 Application
 date
	 	 Application
 no.
	 	 Patent/
 Publication
 no.
	 	 Grant date
	 	 Expiry date
	 	 Status

	 [**]
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	 [**]
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	*	 Publication date of Application – 13 Apr 06. 

 

															
	[**]
	 Attorneys’
 Ref:
	 	 Country
	 	 Application
 date
	 	 Application
 no.
	 	 Patent/
Publication no.
	 	 Grant date
	 	 Expiry date
	 	 Status

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 -68-

 SCHEDULE II 
 TRADEMARKS 
  

					
	 File Date:
 Serial No.:
 International Class:

First Use:
 First Use
in Commerce:
 Registration Date:
 Registration No.:
 Mark:
	  	 [**]
	  	
			
	 File Date:
 Serial No.:
 International Class:

First Use:
 First Use
in Commerce:
 Registration Date:
 Registration No.:
 Mark:
	  	 [**]
  
	  	
			
	 File Date:
 Serial No.:
 International Class:

First Use:
 First Use
in Commerce:
 Registration Date:
 Registration No.:
 Mark:
	  	 [**] 
  
	  	
		
	*[**] Trademark Application 	  	
			
	 File Date:
 Serial No.:
 International Class:

Mark:
	  	 [**]
	  	

 [**] – Owner of Record, United States Patent Trademark Office website. Record of Assignment
from [**]. to [**] is in process. 

  
 -69-

 SCHEDULE III 
 COPYRIGHTS 
 There are no recorded copyrights 

  
 -70-

 SCHEDULE IV 
 DOMAIN NAMES 
 DepoDur.com 

  
 -71-

 SCHEDULE V 
 MARKETING AUTHORIZATIONS 
 United States Food and Drug Administration
New Drug Application: [**] 

  
 -72-

  

					
	

	 	SCHEDULE VI	 	
	 	PRESS RELEASE	 	

  
  

News Release 
 EKR Therapeutics Achieves Key Growth Milestone with the 
 Acquisition of
Rights to DepoDur®, a Novel Extended-Release Opioid 
 Analgesic for Post Operative Pain 

Cedar Knolls, N.J., August X, 2007 – EKR Therapeutics, Inc., a specialty pharmaceutical company focused
on acquiring, developing, and commercializing proprietary products to enhance patient quality-of-life in the acute care setting, today announced it has acquired exclusive marketing and distribution rights to DepoDur® for the Americas from San Diego-based Pacira Pharmaceuticals who retains manufacturing rights to the product.

 Formerly a business unit of SkyePharma, plc, Pacira Pharmaceuticals is an independent private company focused on developing
and manufacturing controlled-release injectable products based on their DepoFoamTM and BiosphereTM drug delivery platforms. 
 DepoDur, which utilizes the DepoFoam technology, is a sterile injectable suspension of multivesicular liposomes formulated to provide extended release of morphine sulfate. It is the only extended-release
opioid that is approved by the Food and Drug Administration for epidural use. A single injection of DepoDur into the lumbar epidural space may provide pain relief for up to 48 hours following major surgery without the restrictions and potential
complications associated with an indwelling epidural catheter. 
 “The product characteristics of DepoDur fit exceptionally
well with EKR’s acquisition model,” said Howard Weisman, EKR’s Chairman & CEO. “DepoDur is patent protected, addresses an important medical need in our market space, and has growth prospects that can be fully exploited
through the application of EKR’s expertise and strengths in the acute care market.” 
 Mr. Weisman further noted,
“EKR is commencing a number of pre-launch activities, including interacting with opinion leaders, and we expect to fully deploy our sales force in support of DepoDur early next year.” He concluded, “We are very optimistic about
EKR’s growth prospects in 2008 as we foresee a ramp up in sales for both DepoDur and Gelclair® and anticipate favorable market synergies between these products.” Gelclair, which is marketed to acute care facilities and cancer centers,
is indicated for the management of pain associated with oral lesions of various etiologies, including chemotherapy and radiation induced oral mucositis/stomatitis. 
 Tong Zhang, Ph.D., Director of Business Development for EKR, added, “Acquiring the rights to DepoDur exemplifies EKR’s strategy of focusing on building a portfolio of premier products in the
acute care space.” He further noted, “Our strict acquisition criteria center on high-margin, innovative products that offer value to healthcare providers and their patients, thus, representing excellent opportunities for EKR to realize
strong returns on investment.” 

  
 -73-

 “Pacira Pharmaceuticals is delighted to have EKR Therapeutics as our marketing and
commercialization partner for DepoDur in the Americas,” commented Fred Middleton, Pacira’s Chairman of the Board. “This product was clinically developed as a proprietary treatment by Pacira R&D and it received FDA approval in 2004
for long-acting post surgical pain management, for which it is known to be effective.” 
 Mr. Middleton further noted,
“EKR Therapeutics has demonstrated in the past that they possess the strengths to successfully bringing a focused marketing and clinician targeting approach to DepoDur to help it reach its full commercial potential. We look forward to working
with EKR, as our partner on the expanded commercial marketing of DepoDur.” 
 Detailed terms of the transaction were not
disclosed. However, EKR did note that in addition to royalty payments on net sales, it has agreed to an upfront payment amounting to somewhat more than [**] times DepoDur’s 2006 U.S. sales. EKR has also agreed to certain milestone payments with
the sum of upfront and milestone payments potentially worth up to $[**]. 
 About EKR Therapeutics 

EKR Therapeutics is a privately held specialty pharmaceutical company that has brought together a highly seasoned team of industry
professionals The Company focuses on the acquisition, development and commercialization of proprietary products for the acute care segment of the healthcare market, including oncology supportive care therapeutics. From its inception in late 2005,
EKR has been organized to be a class leader in commercializing products to address unmet and under-satisfied medical needs or to otherwise enhance the therapeutic value of acute-care prescription products. EKR’s goal is to be the pre-eminent
provider of acute-care specialty products, backed by a commitment to excellence in customer service. For additional information about EKR visit the Company’s website at http://www.ekrtx.com. 

About Pacira Pharmaceuticals, Inc. 
 Pacira Pharmaceuticals, Inc. is a wholly owned subsidiary of Pacira Inc., a Delaware corporation, which is controlled and funded by a group of financial investors including Sanderling Ventures, HBM
Bioventures (Cayman) Ltd, OrbiMed Advisors, and MPM Capital. This business is based in San Diego, CA, and focuses on formulating, developing and manufacturing controlled-release injectable products based on two proprietary drug delivery platforms:
DepoFoamTM and BiosphereTM. Revenues are generated from two marketed products: DepoCyt® for lymphomatous meningitis and DepoDur® for the treatment of post-surgical pain. For additional information about Pacira visit the Company’s website at http://www.pacira.com 

#### 
 Contact
for EKR Therapeutics 
 Stuart Z. Levine, Ph.D. 
 Corporate Communications 
 877-435-2524 

s.levine@ekrtx.com 

  
 -74-

 SCHEDULE VII 
 THE TERRITORY 
 all countries in North America including the United States,
its territories as possessions including Puerto Rico, South America and Central America 

  
 -75-

 SCHEDULE VIII 
 DISPUTE RESOLUTION 
  

	1.1	 Representatives of the Parties will, within 14 days of receipt of a written request from either Party to the other, convene a meeting of the
Committee to discuss in good faith and try to resolve the disagreement without recourse to legal proceedings. 

  

	1.2	 If resolution does not occur within 7 days after meeting, the matter shall be escalated for determination by the respective Chief Executive Officer
of the Parties who may resolve the matter themselves or jointly appoint a mediator or independent expert to do so. 

  

	1.3	 Nothing in this Agreement restricts either Party’s freedom to seek urgent relief to preserve a legal right or remedy, or to protect a
proprietary, trade secret or other right. 

 Appointment of an Expert 

 

	1.4.1	 In the event that the Chief Executive Officers are unable to resolve the dispute and the dispute has a monetary value of cost of [**] dollars
($[**]) or more, the dispute shall be submitted to the federal or state courts located in the State of California, which shall have exclusive jurisdiction over such dispute. 

 

	1.4.2	 In the event that the Chief Executive Officers are unable to resolve the dispute and the dispute has a monetary value of cost of less than [**]
dollars ($[**]), and the Parties do not agree on the appointment of an expert to resolve the dispute, or mediation has failed to resolve the dispute, one Party shall serve on the other a written Referral Notice requesting that the matter be referred
to an expert for resolution, and the following procedure shall be followed. 

  

	 	1.4.1	 The dispute shall be determined by a single independent impartial expert who shall be agreed between the Parties or, in the absence of agreement
between the Parties within 30 days of the service of a Referral Notice, be appointed by the American Arbitration Association or any successor thereto, or such other competent body agreed by the Parties. 

 

	 	1.4.2	 30 days after the appointment of the expert pursuant to paragraph 1.4.1 both Parties shall exchange simultaneously statements of case in no more
than 10,000 words, in total, and each side shall simultaneously send a copy of its statement of case to the expert. 

  

	 	1.4.3	 Each Party may, within 30 days of the date of exchange of statement of case pursuant to paragraph 1.4.2, serve a reply to the other side's statement
of case in no more than 10,000 words. A copy of any such reply shall be simultaneously sent to the expert. 

  

	 	1.4.4	 Subject to paragraph 1.4.6, there shall be no oral hearing. The expert shall issue his decision in writing to both Parties within 30 days of
the date of service of the last reply pursuant to paragraph 1.4.3 above or, in the absence of receipt of any replies, within 60 days of the date of exchange pursuant to paragraph 1.4.2. 

  
 -76-

  

	 	1.4.5	 The seat of the dispute resolution shall be the normal place of residence of the expert. 

 

	 	1.4.6	 The expert shall not have power to alter, amend or add to the provisions of this Agreement, except that the expert shall have the power to decide
all procedural matters relating to the dispute, and may call for a one day hearing if desirable and appropriate. 

  

	 	1.4.7	 The expert shall have the power to request copies of any documents in the possession and/or control of the Parties which may be relevant to the
dispute. The Parties shall forthwith provide to the expert and the other Party copies of any documents so requested by the expert. 

  

	 	1.4.8	 The decision of the expert shall be final and binding upon both Parties except in the case of manifest error. The Parties hereby exclude any rights
of application or appeal to any court, to the extent that they may validly so agree, and in particular in connection with any question of law arising in the course of the reference out of the award. 

 

	 	1.4.9	 The expert shall determine the proportions in which the Parties shall pay the costs of the expert's procedure. The expert shall have the authority
to order that all or a part of the legal or other costs of a Party shall be paid by the other Party. 

  

	 	1.4.10	 All documents and information disclosed in the course of the expert proceedings and the decision and award of the expert shall be kept strictly
confidential by the recipient and shall not be used by the recipient for any purpose except for the purposes of the proceedings and/or the enforcement of the expert’s decision and award. 

  
 -77-

 SCHEDULE IX 
 SALES FORECAST 
 

 
  

	Date:	 July 25, 2007 

	From:	 [**], EKR Therapeutics, Inc. 

	To:	 [**], Pacira 

	Re:	 DepoDur Unit Sales Forecast, as of July 25, 2007 

 While we continue to work on our marketing plan and forecast, based on the current run rate of approximately [**] to [**] units per month, you can expect that our plan will call for the following
forecast: 
  

					
	                            
Period	  	Unit Sales Forecast	 
	 August 1 – December 31, 2007
	  	 	[	**] 
	 January 1 – December 31, 2008
	  	 	[	**] 
	 January 1 – December 31, 2009
	  	 	[	**] 

  
 -78-

 SCHEDULE X 
 PHASE IV STUDIES 
 A DepoDur study in pediatric patients. Pacira has
requested a waiver and is awaiting a response from the FDA 

  
 -79-

 SCHEDULE XI 
 NDA TRANSFER LETTERS 
 A. Transfer Letter to be Filed by PPI 

[PACIRA PHARMACEUTICALS, INC. LETTERHEAD] 
                     , 2009 
 VIA OVERNIGHT MAIL 
 [NAME AND ADDRESS OF APPROPRIATE FDA CONTACT TO BE PROVIDED]

  

	Re:	 DepoDur® NDA [**] 

 General Correspondence: Transfer of NDA Ownership 
 Dear
                        : 
 Effective                     , 2009, pursuant to 21 CFR 314.72, DepoDur® NDA [**] is hereby transferred from Pacira Pharmaceuticals, Inc. to EKR Therapeutics, Inc., 1545 Route 206 South,
Third Floor, Bedminster, New Jersey 07921 (Regulatory Contact:                             , telephone
                ). 
 As a condition of
this transfer of ownership, Pacira will provide to EKR Therapeutics all available information pertaining to the above-referenced NDA to be kept under 21 CFR 314.70, including all previous correspondence to and from the Agency. A signed 356h form is
attached 
 If you have any questions or require any additional information, please do not hesitate to contact me at
                            . 
 Sincerely, 
 PACIRA PHARMACEUTICALS, INC. 

  
 -80-

 B. Transfer Letter to be Filed by EKR 

[EKR THERAPEUTICS, INC. LETTERHEAD] 
                     , 2009 
 VIA OVERNIGHT MAIL 
 [NAME AND ADDRESS OF APPROPRIATE FDA CONTACT TO BE PROVIDED]

  

	RE:	 NDA No. [**] 

 DepoDur® 
 General Correspondence: Transfer of NDA Ownership

 Dear                     :

 Pursuant to 21 CFR 314.72 the above-mentioned NDA has been transferred from Pacira Pharmaceuticals, Inc. to
EKR Therapeutics, Inc. effective                     , 2009. EKR has received a complete copy of the approved application, including all
supplements and records that are required to be kept under 21 CFR 314.81. EKR agrees to abide by all agreements, promises and conditions made by the former owner, which are contained in the application. EKR will advise the FDA about any changes in
the conditions in the approved application as required by 21 CFR 314.70, or in the next annual report, if appropriate. EKR will consider the date of transfer to be the new date for annual reporting purposes. A new signed 356h form is attached.

 Please contact me by phone at
                , by email at                      or
by fax at                         , if you have any questions or if you require additional information. 

 

	
	 Sincerely,

	
	 [Name / Title]

  
 -81-

 SCHEDULE XII 
 TRANSFERRED EQUIPMENT 
 DepoDur processing equipment: 

1. ST-01 ([**], [**] rated to [**], equipped with agitator used in preparation of [**] prior to [**]) 

2. ST-02 ([**], [**] rated to [**], equipped with agitator used in preparation of [**] [**] prior to [**]) 

3. ST-03 ([**], [**] rated to [**], equipped with agitator used in preparation of [**] prior to [**]) 

4. ST-04 ([**], [**] rated to [**], equipped with agitator used in preparation of [**] [**] prior to [**]) 

5. ST-22 ([**], [**] rated to [**], [**]) 
 6. EV-01 ([**], [**] rated to [**], equipped with [**] used to produce [**] [**]) 
 7. EV-02 ([**], [**] rated to [**], equipped with [**] and [**] [**] used to produce [**]) 
 8. FV-01 ([**], [**] rated to [**], used [**] during [**]) 
 9. [**]
skid, including [**] lobe pumps, [**] manifold system, and [**] flometers 
 10. Interconnective valves and piping between
vessels 
 11. Pressure gauges, temperature probes, other small instrumentation for in-process measurements. 

12. HMI / PLC / automation 

  
 -82-

 Exhibit 3.20(a) 

Form of Bill of Sale 
 BILL OF SALE 
 THIS BILL OF SALE, dated October
    , 2009 (this “Bill of Sale”), is made by Pacira Pharmaceuticals, Inc. (“Seller”), in favor of EKR Therapeutics, Inc. (“Purchaser”). 

WHEREAS, Purchaser and Seller have entered into that certain Amended and Restated Strategic Licensing,
Distribution and Marketing Agreement, dated as of the date hereof (the “Agreement”), providing, among other things, for the sale of the Transferred Equipment (as defined therein) by Seller to Purchaser. 

NOW, THEREFORE, for good and valuable consideration, the receipt of which is hereby acknowledged, Seller and
Purchaser agree as follows: 
 1. Definitions. Capitalized terms used in this Bill of Sale and not otherwise
defined in this Bill of Sale shall have the respective meanings assigned to them in the Agreement. 
 2.
Conveyance. In accordance with the terms of the Agreement, Seller hereby sells, transfers, conveys and assigns to Purchaser all right, title and interest in and to the Transferred Equipment. A list of the Transferred Equipment is set
forth on Schedule A to this Bill of Sale. 
 3. Further Assurances. At any time and from time to
time after the date of this Bill of Sale, Seller, at the Purchaser’s request and subject to reimbursement by Purchaser of any out-of-pocket expenses, will do, execute, acknowledge and deliver, or will cause to be done, executed, acknowledged
and delivered, any and all further acts, conveyances, transfers, assignments and assurances as may be reasonably required by Purchaser to further evidence and effectuate the sale, transfer, conveyance and assignment to the Purchaser of the
Transferred Equipment. 
 4. Relationship With Agreement. The provisions of this Bill of Sale are subject,
in all respects, to the terms and conditions of the Agreement and all of the representations, warranties, covenants and agreements contained in the Agreement. Nothing contained in this Bill of Sale shall be deemed to modify, limit or amend any such
rights and obligations of the parties hereto under the Agreement. In the event of any conflict or inconsistency between this Bill of Sale and the Agreement, the Agreement shall govern. 

5. Successors and Assigns. This Bill of Sale shall be binding upon and inure to the benefit of and be enforceable by
Seller and Purchaser and their respective successors and assigns. 
 6. Governing Law. This Bill of Sale shall be
governed by, and construed in accordance with, the laws of the State of New York, without regard to the conflicts of law principles thereof. 
 7. Counterparts; Facsimile Signature Pages. This Bill of Sale may be executed by each of Seller and Purchaser in separate counterparts, each of which when so executed and delivered
shall be deemed to be an original and which together shall constitute one and the same instrument. Any signed counterpart of this Bill of Sale which is delivered by facsimile or other printable electronic transmission shall be deemed to be executed
and delivered for all purposes. 
 [Signature Page Follows] 

  
 -83-

 IN WITNESS WHEREOF, Seller has executed and delivered this Bill of Sale on the date first above
written. 
  

			
	 Pacira Pharmaceuticals, Inc.

			
		
	 By:
	 	
 

			
	 Print Name:
	 	
 

			
	 Title:
	 	  

Acknowledged and Agreed to as 
 of the date
first above written. 
  

			
	 EKR Therapeutics, Inc.

			
		
	 By:
	 	  

			
	 Print Name:
	 	  

			
	 Title:
	 	  

  
 -84-

 Schedule A to Bill of Sale 

Transferred Equipment 
 DepoDur processing equipment: 
 1. ST-01 ([**], [**] rated to [**], equipped
with agitator used in preparation of [**] prior to [**]) 
 2. ST-02 ([**], [**] rated to [**], equipped with agitator used
in preparation of [**] [**] prior to [**]) 
 3. ST-03 ([**], [**] rated to [**], equipped with agitator used in
preparation of [**] prior to [**]) 
 4. ST-04 ([**], [**] rated to [**], equipped with agitator used in preparation of
[**] [**] prior to [**]) 
 5. ST-22 ([**] [**], [**] rated to [**], [**] [**]) 

6. EV-01 ([**], [**] rated to [**], equipped with [**] used to produce [**] [**]) 

7. EV-02 ([**], [**] rated to [**], equipped with [**] and [**] [**] used to produce [**]) 

8. FV-01 ([**], [**] rated to [**], used [**] during [**]) 
 9. [**] skid, including [**] lobe pumps, [**] manifold system, and [**] flometers 
 10. Interconnective valves and piping between vessels 
 11. Pressure gauges,
temperature probes, other small instrumentation for in-process measurements. 
 12. HMI / PLC / automation 

  
 -85-

 Exhibit 3.20(b) 

Form of Promissory Note 
 PROMISSORY NOTE 
  

			
	 $900,000
	  	October     , 2009

 FOR VALUE RECEIVED, EKR Therapeutics, Inc. (“Maker”), having an address at 1545 Route 206 South, Third Floor, Bedminster, New Jersey 07921, hereby promises to pay to Pacira
Pharmaceuticals, Inc. (“Payee”), having an address at 10450 Sciences Center Drive, San Diego, California 92121, the principal sum of NINE HUNDRED THOUSAND DOLLARS ($900,000.00), plus interest computed at the rate of FIVE PERCENT
(5%) per annum, in accordance with the terms and conditions set forth in this Promissory Note (this “Note”). 
 1. Payments. On the fifth anniversary of the date of this Note, all principal and interest (calculated according to Paragraph 3 below) accrued on this Note and not sooner paid in accordance
with the terms hereof shall be payable in full (the “Payment”). 
 2. Place of Payment.
The entire amount due hereunder shall be payable to Payee at the address set forth above, or at such other place as Payee may designate in writing to Maker at the address set forth above. 

3. Interest Calculation: Interest shall be calculated on the basis of a 360 day year based on the number of days
elapsed. 
 4. Optional Prepayment. Maker may, at its option, prepay the entire amount due hereunder in
whole at any time or in part from time to time without penalty or premium. At the option of Maker, prepayments pursuant to this Paragraph 4 shall (a) be applied to the outstanding principal balance in reverse order of maturity or
(b) reduce the Payment installments set forth above for the balance of the term of this Note. In the event that Maker elects to reduce the Payment installments, Maker agrees to provide to Payee written notice of its election to do so at least
thirty (30) days prior to making any prepayment and to execute and deliver to Payee an amendment to this Note setting forth a revised payment schedule. 
 5. Defaults. At the option of Payee, the entire amount due hereunder shall immediately become due and payable on any of the following events of default: 

(a) Maker fails to make Payment as provided for in this Note and such failure to make Payment continues
for thirty (30) days after Maker’s receipt of written notice from Payee that such Payment is due; 
 (b) Maker makes a general assignment for the benefit of creditors; 

  
 -86-

 (c) A receiver is appointed for the assets of Maker upon
request by any Person(s) other than Maker, or Maker makes a formal request for appointment of a receiver; or 
 (d) Any proceeding is brought by Maker in any court or under supervision of any court-appointed officer under any federal or state bankruptcy, reorganization, rearrangement, insolvency or debt
readjustment law, or if any such proceedings are instituted against Maker and Maker fails to obtain dismissal of such proceeding within ninety (90) days after the same has been instituted. 

6. Agreement. This Note is made pursuant to that certain Amended and Restated Strategic Licensing, Distribution
and Marketing Agreement dated as of October     , 2009 by and between Maker and Payee (the “Agreement”) and is subject to the terms thereof. This Note is subject to offset as expressly provided for in the
Agreement. 
 7. Nonnegotiability, Nontransferability. This Note shall be nonnegotiable. Further, this
Note may not be transferred by either party except to a permitted transferee under the Agreement. 
 8.
Governing Law. This Note shall be governed by and construed in accordance with the laws of the State of New York, excluding any conflict-of-laws rule or principle that may refer the governance, construction or interpretation of this Note to
the laws of another State. 
 IN WITNESS WHEREOF, the Maker has executed this promissory note as of
                        . 

 

			
	  
	 	
	
                        
                            , Maker
	 	

  
 -87-

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