Document:

EX-10.21

 Exhibit 10.21 

December 28, 2011 

 
 STRAKAN
INTERNATIONAL S.À R.L. 
 PROSTRAKAN INC. 

(For the Purposes of Sections 5.1 and 11.1.2) 

– and – 

APTALIS PHARMA US, INC. 
  

 

Commercialization and License Agreement 
  

 
  

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	 ARTICLE 1 DEFINITIONS
	  	 	1	  
			
	 1.1
	    	 Definitions
	  	 	1	  
			
	 1.2
	    	 Additional Definitions
	  	 	10	  
		
	 ARTICLE 2 GRANT OF RIGHTS
	  	 	11	  
			
	 2.1
	    	 Licenses to Aptalis
	  	 	11	  
			
	 2.2
	    	 Trade Dress License
	  	 	11	  
			
	 2.3
	    	 Right to Grant Sublicenses
	  	 	11	  
			
	 2.4
	    	 Product Promotional Materials License
	  	 	11	  
			
	 2.5
	    	 Know-How Transfer
	  	 	11	  
			
	 2.6
	    	 [*]
	  	 	12	  
			
	 2.7
	    	 No Implied Licenses
	  	 	12	  
			
	 2.8
	    	 Liability for Affiliates and Subcontractors
	  	 	12	  
			
	 2.9
	    	 Retained Rights
	  	 	12	  
			
	 2.10
	    	 Exclusivity
	  	 	12	  
		
	 ARTICLE 3 MANAGEMENT OF COLLABORATION WITH RESPECT TO THE PRODUCT
	  	 	13	  
			
	 3.1
	    	 General
	  	 	13	  
			
	 3.2
	    	 Operating Committee
	  	 	13	  
			
	 3.3
	    	 Operating Committee Membership and Procedures
	  	 	14	  
			
	 3.4
	    	 Decision-Making
	  	 	15	  
		
	 ARTICLE 4 DEVELOPMENT OF THE PRODUCT
	  	 	16	  
			
	 4.1
	    	 Development Plan for the Supplemental Studies
	  	 	16	  
			
	 4.2
	    	 Phase 4 Studies
	  	 	17	  
			
	 4.3
	    	 Lifecycle Management
	  	 	17	  
			
	 4.4
	    	 Assistance
	  	 	17	  
			
	 4.5
	    	 Compliance with Laws
	  	 	18	  
			
	 4.6
	    	 Right to Audit
	  	 	18	  
			
	 4.7
	    	 Other Development Activities
	  	 	18	  
		
	 ARTICLE 5 REGULATORY MATTERS
	  	 	19	  
			
	 5.1
	    	 Transfer of Product IND and Product NDA
	  	 	19	  
			
	 5.2
	    	 Filing & Maintenance of Regulatory Approvals
	  	 	19	  
			
	 5.3
	    	 Appearances Related to the Product
	  	 	19	  

  
  

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	 5.4
	    	 Step-In Rights in Relation to Regulatory Approvals for the Product
	  	 	19	  
			
	 5.5
	    	 Right of Reference
	  	 	20	  
			
	 5.6
	    	 Advance Notice
	  	 	20	  
			
	 5.7
	    	 Product Quality Agreement
	  	 	21	  
			
	 5.8
	    	 Safety Data Exchange Agreement
	  	 	21	  
		
	 ARTICLE 6 COMMERCIALIZATION OF THE PRODUCT
	  	 	21	  
			
	 6.1
	    	 Principles of Commercialization
	  	 	21	  
			
	 6.2
	    	 Launch and Commercialization; General
	  	 	21	  
			
	 6.3
	    	 Summary of Launch and Commercialization Plan; [*] Submission of Commercialization Plan; No Commitment
	  	 	22	  
			
	 6.4
	    	 Promotional Materials
	  	 	22	  
			
	 6.5
	    	 Compliance with Laws
	  	 	23	  
		
	 ARTICLE 7 MANUFACTURE OF THE PRODUCT
	  	 	23	  
			
	 7.1
	    	 Development and Commercial Supply by Strakan
	  	 	23	  
		
	 ARTICLE 8 FINANCIAL TERMS; PAYMENT TERMS
	  	 	23	  
			
	 8.1
	    	 Upfront Payment
	  	 	23	  
			
	 8.2
	    	 Milestones
	  	 	23	  
			
	 8.3
	    	 Royalties
	  	 	24	  
			
	 8.4
	    	 Payment Method
	  	 	25	  
			
	 8.5
	    	 Taxes
	  	 	25	  
			
	 8.6
	    	 Records Retention; Financial Audit
	  	 	26	  
		
	 ARTICLE 9 CONFIDENTIALITY
	  	 	27	  
			
	 9.1
	    	 Confidential Information
	  	 	27	  
			
	 9.2
	    	 Publicity; Filing of this Agreement
	  	 	29	  
			
	 9.3
	    	 Use of Names
	  	 	29	  
			
	 9.4
	    	 Confidentiality of this Agreement
	  	 	29	  
			
	 9.5
	    	 Survival
	  	 	29	  
		
	 ARTICLE 10 INTELLECTUAL PROPERTY
	  	 	30	  
			
	 10.1
	    	 Inventions Related to the Product
	  	 	30	  
			
	 10.2
	    	 Specified Patent Maintenance
	  	 	31	  
			
	 10.3
	    	 Patents Covering Joint Inventions
	  	 	31	  
			
	 10.4
	    	 Patents Covering Aptalis Inventions
	  	 	32	  

  
  

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	 10.5
	    	 Patents Covering Strakan Inventions
	  	 	32	  
			
	 10.6
	    	 Enforcement of Patent Rights
	  	 	33	  
			
	 10.7
	    	 Trademark
	  	 	36	  
		
	 ARTICLE 11 REPRESENTATIONS AND WARRANTIES
	  	 	37	  
			
	 11.1
	    	 Representations, Warranties and Covenants
	  	 	37	  
			
	 11.2
	    	 Disclaimer of Warranty
	  	 	41	  
			
	 11.3
	    	 Limitation of Liability
	  	 	41	  
			
	 11.4
	    	 Death or Personal Injury Liability
	  	 	42	  
			
	 11.5
	    	 Essential Basis
	  	 	42	  
		
	 ARTICLE 12 TERM AND TERMINATION
	  	 	42	  
			
	 12.1
	    	 Term
	  	 	42	  
			
	 12.2
	    	 Termination for Breach
	  	 	42	  
			
	 12.3
	    	 Termination by Either for Safety Concerns
	  	 	42	  
			
	 12.4
	    	 Patent Challenge
	  	 	42	  
		
	 ARTICLE 13 EFFECTS OF TERMINATION
	  	 	43	  
			
	 13.1
	    	 Expiration of the Agreement or Termination Pursuant to Articles 12 or 16
	  	 	43	  
			
	 13.2
	    	 [*]
	  	 	44	  
			
	 13.3
	    	 Accrued Rights
	  	 	44	  
			
	 13.4
	    	 Survival
	  	 	45	  
		
	 ARTICLE 14 INDEMNIFICATION; INSURANCE
	  	 	45	  
			
	 14.1
	    	 Indemnification
	  	 	45	  
			
	 14.2
	    	 Notice of Claim
	  	 	45	  
			
	 14.3
	    	 Control of Defense
	  	 	46	  
			
	 14.4
	    	 Right to Participate in Defense
	  	 	46	  
			
	 14.5
	    	 Settlement
	  	 	46	  
			
	 14.6
	    	 Cooperation
	  	 	47	  
			
	 14.7
	    	 Expenses of the Indemnified Party
	  	 	47	  
			
	 14.8
	    	 Product Claims
	  	 	47	  
			
	 14.9
	    	 Insurance
	  	 	48	  
		
	 ARTICLE 15 GOVERNING LAW; DISPUTE RESOLUTION
	  	 	48	  
			
	 15.1
	    	 Governing Law
	  	 	48	  
			
	 15.2
	    	 Dispute Resolution
	  	 	48	  

  
  

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	 ARTICLE 16 BANKRUPTCY
	  	 	49	  
			
	 16.1
	    	 Termination
	  	 	49	  
			
	 16.2
	    	 Effect on Licenses
	  	 	49	  
			
	 16.3
	    	 Rights to Intellectual Property
	  	 	50	  
			
	 16.4
	    	 Additional Rights
	  	 	50	  
		
	 ARTICLE 17 MISCELLANEOUS
	  	 	51	  
			
	 17.1
	    	 Notices
	  	 	51	  
			
	 17.2
	    	 Independent Status
	  	 	51	  
			
	 17.3
	    	 Force Majeure
	  	 	51	  
			
	 17.4
	    	 Entire Agreement; Amendment and Waiver
	  	 	52	  
			
	 17.5
	    	 Headings; Construction; Certain Conventions
	  	 	52	  
			
	 17.6
	    	 Assignment
	  	 	52	  
			
	 17.7
	    	 Severability
	  	 	53	  
			
	 17.8
	    	 Further Assurances
	  	 	53	  
			
	 17.9
	    	 Counterparts
	  	 	53	  
			
	 17.10
	    	 [*]
	  	 	53	  

  
  

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 COMMERCIALIZATION AND LICENSE AGREEMENT 

This COMMERCIALIZATION AND LICENSE AGREEMENT (this “Agreement”) is dated as of December 28, 2011 (the “Signing
Date”), but shall not be effective until the Effective Date, by and among STRAKAN INTERNATIONAL S.À R.L., a company incorporated under the Laws of Luxembourg having a principal place of business at Galabank Business Park, Galashiels,
Scottish Borders, TD1 1QH UK (“Strakan”), and PROSTRAKAN INC., for the purposes of Sections 5.1 and 11.1.2, a company incorporated under the Laws of Delaware having a principal place of business at 1430 State Highway 206, Suite 101,
Bedminster, NJ 07921, US (“ProStrakan”), on the one hand, and APTALIS PHARMA US, INC. a company incorporated under the Laws of the State of Delaware and having a principal place of business at 22 Inverness Center Parkway,
Birmingham, Alabama 35242, United States (“Aptalis”) on the other hand. Strakan and Aptalis are sometimes referred to herein individually as a “Party” and collectively as the “Parties”. 

BACKGROUND 
 (A)
ProStrakan has acquired rights to, and has obtained an NDA in the Territory for, the pharmaceutical product that will be marketed as RectivTM; 

(B) Aptalis has significant experience in the development, marketing and promotion of pharmaceutical products in the Territory; 

(C) Aptalis and Strakan desire to establish a relationship for the Commercialization of the Product in the Territory; and 

(D) Strakan desires to license to Aptalis, and Aptalis desires to license from Strakan, certain other rights in the Territory. 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the Parties, intending to be
legally bound, agree as follows: 
 ARTICLE 1 

DEFINITIONS 
 1.1
Definitions. The following terms shall have the following meanings as used in this Agreement: 
 “Affiliate” means
any individual, corporation, company, partnership, trust, limited liability company, association or other business entity (“Person”) which directly or indirectly is controlled by, in the case of Aptalis, Aptalis Holdings, Inc. (or
any entity which is a successor to Aptalis Holdings Inc) or, in the case of Strakan, Prostrakan Group Plc (or any entity which is a successor to ProStrakan Group Plc). As used in this definition of “Affiliate” and the definition of
“Greater Affiliate”, the term “controlled” means, as to any Person, (a) direct or indirect ownership of fifty percent (50%) (or such lesser percentage which is the maximum allowed to be owned by a foreign
corporation in a particular jurisdiction) or more of the voting interests or other ownership 

 
interests in the Person in question; (b) direct or indirect ownership of fifty percent (50%) or more of the interest in the income of the Person in question; or (c) possession,
directly or indirectly, of the power to direct or cause the direction of management or policies of the Person in question (whether through ownership of securities or other ownership interests, by contract or otherwise). 

“Business Day” means any Monday, Tuesday, Wednesday, Thursday or Friday that is not a day on which banking institutions in
Scotland or the State of New Jersey are authorized by Law, regulation or executive order to close. 
 “Calendar Quarter”
means that period of each Calendar Year ending March 31, June 30, September 30 and December 31; provided, however, that the calendar quarter in which this Agreement expires or is terminated shall extend from the first
day of such calendar quarter until the effective date of such expiration or termination of this Agreement. 
 “Calendar
Year” means (a) for the first Calendar Year, the period commencing on the Effective Date and ending on December 31 of the same year, (b) for each successive period beginning on January 1 and ending twelve consecutive
calendar months later on December 31, and (c) for the calendar year in which this Agreement expires or is terminated, the period beginning on January 1 of such calendar year and ending on the effective date of the expiration or
termination of this Agreement. 
 “Canada” means Canada including its territories and possessions. 

“cGCP” or “current Good Clinical Practices” means a set of ethical and scientific quality requirements as
provided in the Laws of the United States, including C.F.R. Parts 50, 56 and 312 et seq., each as amended from time to time, and all FDA and ICH guidelines related thereto, including the ICH Consolidated Guidelines on Good Clinical Practices, all of
which must be observed in the designing, conducting, recording and reporting of clinical trials that involve the participation of human subjects and relating to the implementation of good clinical practice in the conduct of clinical trials on
medicinal products for human use, laying down the principles and detailed guidelines for good clinical practice as regards investigational medicinal products, as well as the requirements for authorization of the manufacturing and importation of such
products and any subsequent modifications or amendments thereto and any Laws that apply in the location of performance of the clinical trial. 

“cGLP” means current good laboratory practices as stated in applicable Law, including 21 C.F.R. Part 58 et seq., each as
amended from time to time and all FDA and Council of the Organization for Economic Cooperation and Development (OECD) guidelines related thereto. 

“cGMP” or “current Good Manufacturing Practices” means all applicable standards relating to manufacturing
practices for fine chemicals, active pharmaceutical ingredients, intermediates, bulk products or finished pharmaceutical products, including current good 

  
  

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manufacturing practices and standards as provided for (and as amended or superseded from time to time) in 21 C.F.R. Parts 210 and 211, each as amended from time to time, all ICH guidelines
related thereto, the practices set out in the guidelines published as the Volume 4 of “The rules governing medicinal products in the European Union” laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC and
91/412/EEC, respectively, and other such relevant good manufacturing practices as required by applicable Laws of other jurisdictions of the world. 

“Clinical Data” means all information relating to a drug product made, collected or otherwise generated in the performance of
or in connection with any clinical trials, including any data, reports and results relating thereto. 
 “Commercialization
Plan” means a plan prepared by Aptalis that summarizes the efforts Aptalis, its Affiliates, sublicensees, distributors and subcontractors intend to use in respect of Commercialization of the Product in the Territory, and containing at a
minimum the types of information set out in Exhibit E excluding that information which is specific to the launch of the Product. 

“Commercialization” or “Commercialize” means activities directed to the marketing, promotion, selling, or
offering for sale of a product for an indication, including pre-marketing, advertising, educating, planning, marketing, promoting, distributing and post-marketing safety surveillance and reporting. For purposes of clarity, subject to
Section 2.1, Commercialization shall not include any activities related to research or the Manufacturing or Development of the Product. 

“Commercially/Commercial Launch” means initiating a communication campaign for the Product with the target prescribing
customers for the approved indication(s) to educate them concerning the Product with the aim of encouraging the prescription of the Product through various aspects of sales, marketing, advertising and medical affairs resources. 

“Commercially Reasonable Efforts” means [*]. 

“Competing Product” means [*]. 

“Compound” means nitroglycerin. 

“Control” means, with respect to any Intellectual Property Right or other intangible property, that a Party or one of its
Affiliates owns or has a license or sublicense to such item or right, and has the ability to grant access, license or sublicense in or to such right, without violating the terms of any agreement or other arrangement with any Third Party. 

“Development” means clinical research and drug development activities, including toxicology, test method development and
stability testing, process development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, clinical studies (including pre- and post-approval studies), regulatory affairs,
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(excluding regulatory activities directed to obtaining pricing and reimbursement approvals). For purposes of clarity, subject to Section 2.1, Development shall not include any activities
related to non-clinical research or the Manufacturing of the Product. 
 “Dollar” or “$” means United
States dollars (i.e., the legal currency authorized by the United States of America). 
 “FDA” means the United States Food
and Drug Administration and any successor entity thereto. 
 “First Commercial Sale” means, with respect to a Product that
has received Regulatory Approval for Commercialization in the Territory, the first Sale by Aptalis after such Regulatory Approval, the date of which Aptalis shall promptly notify to Strakan in writing. 

“GAAP” means United States generally accepted accounting principles consistently applied. 

“Generic Product” means any product that contains the same active ingredient as the Product and has been approved for sales
introduction into interstate commerce pursuant to Section 505(b)(2) or Section 505(j) of the United States Food, Drug and Cosmetic Act. 

“Governmental Authority” means any court, tribunal, arbitrator, agency, legislative body, commission, official or other
instrumentality of (a) any government of any country, (b) a federal, state, province, county, city or other political subdivision thereof or (c) any supranational body. 

“ICH Consolidated Guidelines on Good Clinical Practices” means the Guidance For Industry, E6 Good Clinical Practice:
Consolidated Guidance issued by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 

“Intellectual Property Rights” means, collectively, all intellectual property rights and other similar proprietary rights in
any jurisdiction throughout the world, whether owned, used or held for use under license, whether registered or unregistered, including such rights in and to: (a) trademarks, service marks, brand names, certification marks, trade dress, logos,
trade names and corporate names and other indications of origin, and the goodwill associated with any of the foregoing; (b) patents and patent applications, and any and all divisions, continuations, continuations-in-part, reissues, continuing
patent applications, provisional patent applications, re-examinations, and extensions thereof, any counterparts claiming priority therefrom, utility models, patents of importation/confirmation, certificates of invention, certificates of registration
and like rights, and inventions, invention disclosures, discoveries and improvements, whether or not patentable; (c) trade secrets (including, those trade secrets defined in the Uniform Trade Secrets Act and under corresponding foreign
statutory Law and common Law), business, technical and know-how information, non-public information, and confidential information and rights to limit 

  
  

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the use or disclosure thereof by any person; (d) all works of authorship (whether copyrightable or not), copyrights and proprietary rights in copyrighted works including writings, and
databases (or other collections of information, data, works or other materials); (e) software, including data files, source code, object code, firmware, mask works, application programming interfaces, computerized databases and other
software-related specifications and documentation; (f) designs and industrial designs; (g) Internet domain names; (h) rights of publicity and other rights to use the names and likeness of individuals; (i) claims, causes of action
and defenses relating to the past, present and future enforcement of any of the foregoing; in each case of clauses (a) to (i) above, including any registrations of, applications to register and renewals and extensions of, any of the
foregoing with or by any Governmental Authority in any jurisdiction; and (j) tangible embodiments of the foregoing. 

“Know-How” means any information, results and data of any type whatsoever, in any tangible or intangible form whatsoever,
including databases, ideas, discoveries, inventions, trade secrets, practices, methods, tests, assays, techniques, specifications, processes, formulations, formulae, knowledge, know-how, skill, experience, materials, including pharmaceutical,
chemical and biological materials, products and compositions, scientific, technical or test data (including pharmacological, biological, chemical, biochemical, toxicological and clinical test data), analytical and quality control data, stability
data, studies and procedures, drawings, plans, designs, diagrams, sketches, technology, documentation or descriptions. 

“Law” or “Laws” means the laws, statutes, rules, codes, regulations, orders, judgments and/or ordinances of a
Governmental Authority. 
 “Maintain” or “Maintenance” means, with respect to a Patent, the payment of all
maintenance, renewal and any other fees necessary to keep such Patent in force. 
 “Manufacture” or
“Manufacturing” means all activities related to the manufacturing of the Product, including manufacturing supplies for Development, manufacturing supplies for commercial sale, packaging, in-process and finished Product testing, all
in accordance with cGMP. 
 “Material Adverse Event” means [*]. 

“Net Sales” means the gross invoiced Sales by Aptalis, its Affiliates or its sublicensees to Third Parties for Products Sold,
less deductions, consistent with GAAP used in the applicable reporting period for Aptalis’s consolidated financial reporting purposes, which shall be limited to: (a) price adjustments, chargeback payments, credits, or rebates (or the
equivalent thereof), allowances allowed and taken, quantity or other trade discounts and other amounts paid on sale of Products, including those granted to and actually used by group purchasing organizations or other buying groups, managed
healthcare organizations, pharmacy benefit management companies, health maintenance organizations and any other providers of health insurance coverage, health care organizations or other healthcare 

  
  

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institutions (including hospitals), Third Party health care administrators or patient assistance or other similar program, or to federal, state / provincial, local and other governments,
including their agencies, or to wholesalers, distributors and other trade customers; (b) sales, use, tariffs, value-add, and/or excise taxes, or other governmental charges and tariffs incurred in connection with exportation or importation
directly imposed and with reference to particular Sales; (c) reasonable and customary freight, postage, shipping, insurance and other transportation expenses and delayed ship order credits reflected in the applicable invoice and paid by the
customer; and (d) amounts allowed, repaid or credited due to defects, returns, rejections, recalls, rebates and replacements and allowances of goods or because of retroactive price reductions; (e) normal and customary rebates, trade, cash
or quantity discounts; billing errors; coupons for price reductions; (f) required distribution commissions / fees payable to Third Party wholesalers for distribution of the Products; (g) allowance and write-offs for bad debt made in
accordance with generally accepted accounting principles, consistently applied to all of Aptalis’s products; (h) discounts pursuant to indigent patient programs and patient discount programs including “Together Rx” and coupon
discounts; and (i) any item, substantially similar in character or substance to any of the foregoing permitted by GAAP and customary in the pharmaceutical industry. Net Sales also includes the fair market value of any non-cash consideration
received in connection with the Sale of the Products. In the case of any sale of Product for value other than in an arm’s length transaction exclusively for cash, Net Sales shall be determined by referencing Net Sales at which substantially
similar quantities of such Product are sold in an arm’s length transaction for cash. 
 “Patent” means (a) any
patent, re-examination, reissue, renewal, extension, supplementary protection certificate and term restoration, any confirmation patent or registration patent or patent of addition based on any such patent, (b) any pending application for
patents, including continuations, continuations-in-part, divisional, provisional and substitute applications, and inventors’ certificates, (c) all foreign counterparts of any of the foregoing, and (d) all priority applications of any
of the foregoing. 
 “PDE” shall mean [*]. 

“Phase 4 Study” means a clinical study which is carried out after Commercialization of the Product (i.e., a study that is not
carried out at the request of any Regulatory Authority or in connection with obtaining or maintaining any Regulatory Approval). 

“Product” means (a) the pharmaceutical product containing the Compound as its sole active ingredient, currently approved
by the FDA pursuant to the Product NDA and any supplements or amendments to the foregoing prepared and submitted in accordance with the terms of this Agreement, and (b) any lifecycle improvements, line extensions, enhanced or modified
presentations or formulations thereof or indications therefor in each case under the Product NDA and any supplements or amendments thereto. 

“Product IND” means IND number 45,326. 

  
  

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 “Product Label” or “Product Labeling” means, with respect to a
particular pharmaceutical product and a particular country, (a) the full prescribing information for the product approved by the applicable Regulatory Authorities in such country, including any required patient information; and (b) all
labels and other written, printed or graphic matter physically upon a container, wrapper or any package insert utilized with or for the product in such country. 

“Product NDA” means all Regulatory Approvals granted by any Regulatory Authority in the Territory relating to the
Commercialization of the Product and any applications for the same consisting of NDA 21-359 and any supplements or amendments to the foregoing prepared and submitted in accordance with the terms of this Agreement. 

“Product Promotional Materials” means all Promotional Materials (other than the Product Label and package insert for the
Product) for marketing, advertising and promotion of the Product, including copyrights in any such materials and all designs, industrial designs, design patents, design registrations, and design patent applications developed in connection with such
materials, for use in Commercialization, in the case of Aptalis in the Territory and in the case of Strakan outside the Territory (to the extent the rights to such materials are Controlled by Strakan). 

“Product Quality Agreement” means the product quality agreement to be entered into by the Parties on the Signing Date, to be
effective as of the Effective Date, in the form set out in Exhibit A. 
 “Product Trade Dress” means any trade dress
used in relation to the Product at or prior to the Signing Date. 
 “Promotional Materials” means, all sales representative
training materials with respect to the Product and all written, printed, graphic, electronic, audio or video matter, including advertising materials, sales visual aids, direct mail, medical information and education monographs, direct-to-consumer
advertising, Internet postings and advertisements, broadcast advertisements and sales reminder aids (for example, scratch pads, pens and other such items) intended for use or used in connection with any promotion of the product, except Product
Labeling. 
 “Regulatory Approval” means all approvals (including, where applicable, pricing and reimbursement approval and
schedule classifications), product and/or establishment licenses, registrations or authorizations of any supranational, regional, federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the
Development, Manufacture, use or Commercialization of the Product for an indication in the Territory, including any label expansions. 

“Regulatory Authority” means a Governmental Authority with the authority to grant any Regulatory Approvals in the Territory,
including the FDA. 

  
  

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 “Regulatory Documentation” means, in respect of the Product, (a) the trial
master file and all regulatory files relating to the Development, Regulatory Approval, Manufacture or Commercialization of the product, minutes of meetings and telephone conferences with any Regulatory Authorities, validation data, preclinical and
clinical studies and tests related to the product (including all audit reports of clinical studies and all other clinical data), all applications (and amendments thereto) for Regulatory Approvals, annual reports and safety reports associated
therewith, and all correspondence with Regulatory Authorities regarding the marketing status of the product; and (b) all records maintained under Current Good Manufacturing Practices or other applicable Laws, including record keeping or
reporting requirements of Regulatory Authorities, all correspondence and communications with Regulatory Authorities in connection with the product, including those relating to any Product Labeling or Promotional Materials, adverse event files,
complaint files or manufacturing records. 
 “Sale” means a transfer for profit to a Third Party in an arm’s length
transaction, but excluding sales for clinical studies, compassionate use, named patient programs or any similar instance, none of which shall constitute a Sale. 

“SDEA” or “Safety Data Exchange Agreement” means the safety data exchange agreement to be entered into by the
Parties on the Signing Date, to be effective as of the Effective Date, in the form set out in Exhibit B. 
 “Specified
Patent” means United States Patent No. [*] 
 “Strakan Know-How” means any Know-How that is necessary or useful for
the Development or Commercialization of the Products in the Territory pursuant to this Agreement that is Controlled by Strakan or any of its Affiliates at any time during the Term. 

“Strakan Patents” means any Patent that is necessary or useful for the Development or Commercialization of the Products in the
Territory pursuant to this Agreement, that is Controlled by Strakan or any of its Affiliates at any time during the Term, including the Specified Patent. 

“Supplemental Studies” means the clinical studies which are required to be conducted in relation to the Product by the FDA in
relation to pediatric use of the Product including the post Regulatory Approval pediatric clinical commitments described in Exhibit C. 

“Supply Agreement” means the supply agreement for the Product to be entered into by the Parties on the Signing Date, to be
effective as of the Effective Date, in the form set out in Exhibit D. 
 “Territory” means United States of America
including its commonwealths, territories and possessions. 

  
  

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 8 

 “Third Party” means any Person other than Strakan or Aptalis or their respective
Greater Affiliates. 
 “Third Party Losses” means any and all amounts paid or payable to Third Parties with respect to a
Third Party claim, including damages (including all incidental and consequential damages), deficiencies, defaults, awards, settlement amounts, assessments, fines, dues, penalties, costs, liabilities, obligations, taxes, liens, losses, lost profits,
fees and expenses (including court costs, interest and reasonable fees of attorneys, accountants and other experts). 

“Trademark” means the mark RECTIV, which is the subject of United States trademark application Serial No. 85/330,038,
currently pending before the United States Patent and Trademark Office, for use in connection with “Pharmaceutical and veterinary preparations and substances, namely, pharmaceutical preparations for the treatment of pain; pharmaceutical
preparations and ointments for the treatment of rectal conditions, diseases and disorders; medicines, namely, medicines for the treatment of rectal conditions, diseases and disorders; sanitary preparations for medical purposes; dietetic foods and
beverages adapted for medical use; medical plasters; medical and surgical dressings”. 

  
  

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 1.2 Additional Definitions. Each of the following definitions is set forth on the page of
this Agreement indicated below: 

 

					
	 Term and Location (by Page) of Definition
  
	  			
	Additional Development Data	  	 	18	  
	[*]	  	 	[*]	  
	Adverse Events	  	 	39	  
	Agreement	  	 	1	  
	Aptalis	  	 	1	  
	Aptalis Inventions	  	 	29	  
	Aptalis Know-How	  	 	43	  
	Aptalis Patents	  	 	31	  
	Aptalis Press Release	  	 	28	  
	Assignment	  	 	36	  
	Bankruptcy Event	  	 	48	  
	Breaching Party	  	 	42	  
	Clinical Studies	  	 	40	  
	Confidential Information	  	 	26	  
	Controlled	  	 	1	  
	Controlling Party	  	 	35	  
	Data License	  	 	16	  
	Debtor Party	  	 	48	  
	[*]	  	 	[*]	  
	Designated Senior Officer	  	 	15	  
	Development Data	  	 	16	  
	Development Plan	  	 	16	  
	Disclosing Party	  	 	26	  
	Dispute	  	 	48	  
	[*]	  	 	[*]	  
	[*]	  	 	[*]	  
	Force Majeure Event	  	 	51	  
	Greater Affiliate	  	 	[*]	  
	[*]	  	 	[*]	  
	ICC	  	 	48	  
	Indemnification Claim Notice	  	 	45	  
	Indemnified Party	  	 	45	  
	Indemnifying Party	  	 	45	  
	Indemnitee	  	 	45	  
	Indemnitees	  	 	45	  
	Interim Period	  	 	36	  
	Joint Inventions	  	 	29	  

 

					
	 Term and Location (by Page) of Definition
  
	  			
	Joint Patents	  	 	30	  
	Launch Plan Summary	  	 	21	  
	Milestone	  	 	23	  
	[*]	  	 	[*]	  
	Non-Debtor Party	  	 	48	  
	OC	  	 	13	  
	[*]	  	 	[*]	  
	Parties	  	 	1	  
	Party	  	 	1	  
	Patent Challenge	  	 	42	  
	Person	  	 	1	  
	Product Claim	  	 	47	  
	ProStrakan	  	 	1	  
	Protocol	  	 	17	  
	Receiving Party	  	 	26	  
	[*]	  	 	[*]	  
	Sales Milestone Payment	  	 	23	  
	Sales Reports	  	 	24	  
	[*]	  	 	[*]	  
	Signing Date	  	 	1	  
	Strakan	  	 	1	  
	Strakan Inventions	  	 	29	  
	Strakan Patents	  	 	32	  
	Strakan Press Release	  	 	28	  
	Subject Documentation	  	 	39	  
	[*]	  	 	[*]	  
	[*]	  	 	[*]	  
	Term	  	 	41	  
	[*]	  	 	[*]	  
	Third Party Claim	  	 	44	  
	[*]	  	 	[*]	  
	Third-Party License	  	 	35	  
	Third-Party Payment	  	 	35	  
	Title 11	  	 	48	  
	USPTO	  	 	36	  
	Withholding Taxes	  	 	24	  

  

 

  
  

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 ARTICLE 2 

GRANT OF RIGHTS 
 2.1
Licenses to Aptalis. Strakan grants to Aptalis during the Term: 
 2.1.1 an exclusive (even as to Strakan), royalty-bearing license,
with the right to grant sublicenses, subject to Section 2.3, through multiple tiers, to the Strakan Know-How and under the Strakan Patents to Commercialize the Product in the Territory and to make (inside or outside the Territory), have made
(inside or outside the Territory), Manufacture (inside or outside the Territory) and import into the Territory, the Product subject to the royalty obligations in Section 8.3 provided that Strakan shall retain the right to make or have made the
Product in the Territory solely for the purpose of supplying its customers or those of its licensees outside the Territory; and 
 2.1.2 a
non-exclusive, royalty-free, license, with the right to grant sublicenses, subject to Section 2.3, through multiple tiers, to the Strakan Know-How and under the Strakan Patents to conduct Development of the Product in accordance with the
Development Plans and this Agreement. 
 2.2 Trade Dress License. Subject to terms and conditions of this Agreement, Strakan hereby
grants to Aptalis an exclusive (even as to Strakan) royalty-free license, with the right to grant sublicenses, subject to Section 2.3, through multiple tiers, to use the Product Trade Dress, solely with respect to the Product, solely for the
purpose of Commercializing the Product in the Territory. 
 2.3 Right to Grant Sublicenses. From the Effective Date through [*]. 

2.4 Product Promotional Materials License. Subject to the terms and conditions of this Agreement, Strakan hereby grants to Aptalis an
exclusive (even as to Strakan) royalty-free license to the Product Promotional Materials Controlled by Strakan at any time during the Term for the purpose of Commercialization of the Product in the Territory. 

2.5 Know-How Transfer Promptly following the Effective Date Strakan will transfer to Aptalis any Strakan Know-How used in connection
with the Development, Commercialization and Manufacture of the Product. Such transfer shall be effected by the delivery of documents, to the extent such Strakan Know-How is embodied in documents, and to the extent that such Strakan Know-How is not
fully embodied in documents, Strakan shall, at Aptalis’s reasonable request and Strakan’s reasonable cost, make its employees and agents who have knowledge of such Strakan Know-How in addition to that embodied in documents available to
Aptalis at Aptalis’s premises for interviews, demonstrations and training to effect such transfer in manner sufficient to enable Aptalis to practice such Strakan Know-How. The Parties agree to use video and telephone conferencing where
reasonably appropriate for the purposes of enabling Strakan to comply with its obligations under this Section. 

  
  

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 2.6 [*]. 

2.6.1 [*] 
 2.6.2 [*] 

2.7 No Implied Licenses. Except as expressly provided in this Agreement, neither Party grants to the other Party any right or license
in any Intellectual Property Right, whether by implication, estoppel or otherwise. No implied licenses are granted under this Agreement. Each Party hereby covenants and agrees not to use or sublicense any of its rights under the licenses set forth
in this Article 2 except as expressly permitted in this Agreement. 
 2.8 Liability for Affiliates and Subcontractors. 

2.8.1 Performance by Affiliates. The Parties recognize that each may perform some or all of its obligations under this Agreement
through Affiliates; provided, however, [*]. Each Party hereby expressly waives any requirement that the other Party exhaust any right, power or remedy, or proceed against an Affiliate, for any obligation or performance hereunder prior to proceeding
directly against such Party. Wherever in this Agreement the Parties delegate responsibility to Affiliates or local operating entities, the Parties agree that such entities may not make decisions inconsistent with this Agreement, amend the terms of
this Agreement or act contrary to its terms in any way. 
 2.8.2 Other Subcontractors. The Parties recognize that each may perform
some or all of its obligations under this Agreement through subcontractors; provided, however, that each Party [*] and shall use Commercially Reasonable Efforts to cause its subcontractors to comply with the provisions of this Agreement in
connection with such performance. For the avoidance of doubt, (a) Aptalis will remain directly responsible for all amounts owed to Strakan under this Agreement and (b) subject to the provisions of Section 7.1 Strakan shall be
responsible for the Manufacture and supply of all Product to Aptalis pursuant and subject to the terms of the Supply Agreement. Each Party hereby expressly waives any requirement that the other Party exhaust any right, power or remedy, or proceed
against a subcontractor, for any obligation or performance hereunder prior to proceeding directly against such Party. 
 2.9 Retained
Rights. Any rights of Strakan not expressly granted to Aptalis under the provisions of this Agreement shall be retained by Strakan. 

2.10 Exclusivity. 

2.10.1 Aptalis. During the Term, neither Aptalis nor its Affiliates shall directly or indirectly sell, have sold or otherwise
Commercialize, either itself or with a Third Party, any Competing Product in the Territory, except as authorized under this Agreement or any other agreement with Strakan or its successors in interest. Such restriction shall continue until [*]. To
the extent permitted by applicable Law Aptalis shall: 
 (a) distribute, promote, offer for sale and sell the Product only in the
Territory; and 

  
  

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 (b) shall not knowingly distribute, promote, offer for sale or sell the Product directly or
indirectly (i) to any person outside the Territory or (ii) to any person inside the Territory that has or is reasonably likely to directly or indirectly distribute, promote, offer for sale or sell the Product outside the Territory. 

2.10.2 Strakan. During the Term, neither Strakan nor its Affiliates shall directly or indirectly sell, have sold or otherwise
Commercialize, either itself or with a Third Party, any Competing Product or any Product in the Territory, except as authorized under any other agreement with Aptalis or its successors in interest. To the extent permitted by applicable Law Strakan
shall not knowingly distribute, promote, offer for sale or sell a Competing Product or Product directly or indirectly (a) to any person inside the Territory or (b) to any person outside the Territory that has or is reasonably likely to
directly or indirectly distribute, promote, offer for sale or sell a Competing Product inside the Territory. 
 2.10.3 [*] 

2.10.4 Anti-Avoidance. The Parties agree that they will act in good faith in relation to this Section 2.10 and will not attempt to
circumvent the provisions of this Section by [*]. 
 ARTICLE 3 

MANAGEMENT OF COLLABORATION WITH RESPECT TO THE PRODUCT 

3.1 General. The Parties wish to create a specialized committee to monitor the Parties’ activities under this Agreement, and to
facilitate communications between the Parties, with respect to the Manufacturing, Development and Commercialization of the Product within the Territory. Such committee shall have the responsibilities and authority allocated to it in this Article 3.
The committee shall have the obligation to exercise its authority consistent with the provisions of this Agreement. 
 3.2 Operating
Committee. 
 3.2.1 Formation and Purpose. Promptly following the Effective Date (but in no event later than thirty
(30) days thereafter) the Parties shall create a joint operating committee (the “OC”) to manage the overall relationship between the Parties pursuant to the terms of this Agreement. 

3.2.2 Specific Responsibilities of the OC. Subject to Section 3.4, the OC shall, among other things: 

(a) subject to Article 4, facilitate the exchange of information and data related, and decision-making with respect, to the Development of
the Product, including lifecycle strategies with respect to the Product; 

  
  

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 (b) subject to Article 6, facilitate the exchange of information and data related to the
Commercialization of the Product, it being understood that Aptalis shall, subject to Article 6, have sole control, in its discretion, of all matters relating to the Commercialization of the Product in the Territory, including the right to determine
the price of the Product within the Territory; and 
 (c) subject to Article 7 and the terms and conditions of the Supply Agreement,
facilitate the exchange of information and data related, and decision-making with respect, to the Manufacture of the Product, excluding, for the avoidance of doubt, any determinations with respect to any breach or alleged breach of the Supply
Agreement. 
 3.3 Operating Committee Membership and Procedures. 

3.3.1 Membership. For the OC the Parties shall each designate an equal number of representatives who are employees of such Party or an
Affiliate of such Party with appropriate expertise to serve as members of OC. The OC shall be comprised of three (3) senior decision making representatives of each Party with relevant expertise. Each Party may replace its OC representatives at
any time upon written notice to the other Party, provided that the Parties will use reasonable endeavors to keep such replacements to a minimum. Each Party shall have one vote on the OC. [*]. The chairperson of the OC shall be responsible for
calling meetings, preparing and circulating an agenda in advance of each meeting of such committee, and preparing and issuing minutes of each meeting within thirty (30) days thereafter; provided, however, that the chairperson shall call a
meeting of the OC promptly upon the written request of a representative of the other Party to convene such a meeting. The minutes of the OC meeting will not be deemed finalized until Aptalis has approved such minutes in writing. Aptalis shall
endeavor to review and approve the minutes prepared by Strakan’s chairperson within thirty (30) days of its receipt thereof from Strakan. 

3.3.2 Meetings. OC shall hold meetings at such times as it elects to do so; provided, however that the OC shall hold meetings no less
frequently than once every six (6) months in the first year following First Commercial Sale of the Product and, thereafter, once every twelve (12) months. Meetings of the OC may be held in person or by means of telecommunication
(telephone, video, or web conferences). The Parties will alternate in designating the location for in-person meetings, with Strakan selecting the first meeting location. Other employees of each Party or any of its Affiliates involved in the
Development or Commercialization of the Product may attend meetings of such OC as nonvoting participants, and, with the consent of each Party, consultants, representatives, or advisors involved in the Development or Commercialization of the Product
may attend meetings of OC as nonvoting observers; provided, however, that such Third Party representatives are under obligations of confidentiality and non-use applicable to the Confidential Information of each Party and that are at least as
stringent as those set forth in Article 9. Each Party shall be responsible for all of its own expenses of participating in OC. 
 3.3.3
Meeting Agendas. Each Party will disclose to the other proposed agenda items along with appropriate information at least seven (7) Business Days in advance of each 

  
  

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meeting of the OC; provided, however, that under exigent circumstances requiring OC input, a Party may provide its agenda items to the other Party within a lesser period of time in advance of the
meeting, or may propose that there not be a specific agenda for a particular meeting, so long as such other Party consents to such later addition of such agenda items or the absence of a specific agenda for such OC meeting. 

3.3.4 Limitations of Committee Powers. The OC shall have only such powers as are specifically delegated to it hereunder and shall not
be a substitute for the rights of the Parties. Without limiting the generality of the foregoing, the OC shall not have any power to amend this Agreement. Any amendment to the terms and conditions of this Agreement shall be implemented pursuant to
Section 17.4 below. 
 3.4 Decision-Making. The members of the OC shall endeavor to reach a consensus on all decisions within
its jurisdiction (which, for the avoidance of doubt, does not include Commercialization of the Product). If the members of the OC cannot reach consensus with respect to any action, decision or ruling related to the Manufacture or Development of the
Product within ten (10) days (or such shorter time as may be reasonable under the circumstances) following the day that the OC first considers such matter, then the issue shall be referred to the Designated Senior Officers of the Parties who
will use good faith efforts to resolve the dispute within thirty (30) days of the dispute being referred to them. The “Designated Senior Officer” of each Party shall mean such official (who is sufficiently senior and is an
executive officer of the Party) designated by each Party from time to time with appropriate expertise for the issue in dispute. If the Designated Senior Officers cannot resolve the dispute related to the Manufacture or Development of the Product the
dispute shall be submitted to the procedure set forth in Section 3.4.1. 
 3.4.1 Non-Binding Mediation. Within thirty
(30) days of referral in accordance with this Section, or if the Designated Senior Officers fail to meet within such thirty (30) days, either Party may initiate a non-binding mediation procedure within fifteen (15) days of written
notice to the other Party. The non-binding mediation shall be administered by (a) the Centre for Dispute Resolution in London, England in accordance with its commercial mediation procedures if such mediation is initiated by Aptalis and
(b) JAMS in New York, New York if such mediation is initiated by Strakan, and in either event shall not last longer than thirty (30) days after commencement. The Parties agree that they shall share equally the cost of the mediation,
including filing and hearing fees, and the cost of the mediator(s). Each Party shall have the right, at its own expense, to be represented by counsel in such a proceeding. 

3.4.2 Commercialization by Aptalis. For the avoidance of doubt, Aptalis shall, subject to Article 6, have sole control in its
discretion of all matters relating to the Commercialization of the Product in the Territory, including the right to determine the price of the Product within the Territory. 

3.4.3 Commercialization by Strakan. For the avoidance of doubt, Strakan shall have sole control in its discretion of all matters
relating to the Commercialization of the Product outside the Territory, including the right to determine the price of the Product outside the Territory. 

  
  

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 ARTICLE 4 

DEVELOPMENT OF THE PRODUCT 

4.1 Development Plan for the Supplemental Studies. 

4.1.1 Scope. The Development of the Product in the Territory in connection with the Supplemental Studies shall be governed by a
development plan (the “Development Plan”). The Development Plan shall describe the proposed overall program for such Development, including clinical studies, proposed end points, regulatory strategies and other relevant elements
relating the such Development, as well as timelines with respect to key Regulatory Authority meetings, submissions to Regulatory Authorities and Regulatory Approvals. 

4.1.2 Preparation and Approval of Development Plan. The Development Plan, together with any updates thereto, shall be prepared,
approved and implemented as follows: 
 (a) Development Plan. Aptalis will be responsible for designing and implementing the
Development Plan and shall prepare a draft of the Development Plan. Such preparation shall include good faith consultation with Strakan. Aptalis shall submit the draft Development Plan to Strakan for its review and prompt approval, such draft
Development Plan to be finalized and implemented in sufficient time to ensure that Aptalis meets key timelines, as set out by the Regulatory Authorities, for submission of study protocols and any other related regulatory submissions. The draft
Development Plan shall include all the recommendations of such Regulatory Authorities. Aptalis shall be solely responsible for all costs associated with the Supplemental Studies up to a maximum of [*] Dollars ($[*]) in total for all such
Supplemental Studies. The Parties shall [*] the costs associated with the Supplemental Studies in excess of [*] Dollars [*] provided that any such excess shall be first approved by Strakan in writing, such consent not to be unreasonably withheld,
conditioned or delayed. 
 (b) Amendments to the Development Plan. From time to time during the Term, the OC shall have the right to
amend the Development Plan. 
 4.1.3 Diligence. Aptalis will use Commercially Reasonable Efforts to carry out the Development Plan
(including seeking applicable Regulatory Approvals). 
 4.1.4 Reporting and Data. 

(a) Reporting. At each meeting of the OC, Aptalis will present a report describing its activities under the Development Plan since the
last such report. 
 (b) Development Data. Aptalis shall provide to Strakan copies of all substantive or material information with
respect to its activities under the Development Plan, including clinical data compiled with respect to the Product and all information and data filed with any Regulatory Authority relating to the Supplemental Studies, as soon as reasonably
practicable after such information, data or results become available or compiled, including any drafts and final versions of any study reports (the “Development Data”). 

  
  

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 (c) License to Development Data. Strakan shall have the exclusive right to use the
Development Data (or any portion thereof) solely to the extent necessary for Developing and Commercializing the Product outside the Territory during the Term and inside the Territory after the Term, and shall have the right to grant sublicenses
(“Data License”). 
 4.2 Phase 4 Studies. 

4.2.1 Aptalis Phase 4 Studies. Aptalis shall prepare a design and protocol(s) for any Phase 4 Study it or its sublicensees may propose
(collectively, regardless of the preparer, including those prepared under Section 4.2.2, a “Protocol”) to carry out, and will submit each such Protocol to Strakan for its review, comment and approval. Aptalis shall, and shall
use Commercially Reasonable Efforts to cause its sublicensees to, consider in good faith any comments submitted by Strakan, including comments regarding the impact of such Protocol on the regulatory and commercial status of the Product outside the
Territory. Strakan shall provide its comments to Aptalis within fifteen (15) days after receiving a single Protocol for a Phase 4 Study and thirty (30) days after receiving multiple Protocols for a Phase 4 Study, and shall notify Aptalis
within such time period(s) whether or not it approves the respective Protocol(s), provided that such approval will not be unreasonably withheld, conditioned or delayed. Aptalis shall use its Commercially Reasonable Efforts to cause its sublicensees
to comply or carry out, as applicable, with such Protocol(s) as approved. 
 4.2.2 Strakan Phase 4 Studies. During the Term, Strakan
will submit each Protocol for a Phase 4 Study it or its licensees may propose to carry out in respect of the Product outside of the Territory to Aptalis for its review, comment and approval. Strakan shall, and shall use Commercially Reasonable
Efforts to cause its licensees to, consider in good faith any comments submitted by Aptalis, including comments regarding the impact of such Protocol on the regulatory and commercial status of the Product inside the Territory. Aptalis shall provide
its comments to Strakan within fifteen (15) days after receiving a single Protocol for a Phase 4 Study and thirty (30) days after receiving multiple Protocols for a Phase 4 Study, and shall notify Strakan within such time period(s) whether
or not it approves the respective Protocol(s), provided that such approval will not be unreasonably withheld, conditioned or delayed. Strakan shall use its Commercially Reasonable Efforts to cause its licensees to comply or carry out, as applicable,
with any such Protocol(s) as approved. 
 4.3 Lifecycle Management. Aptalis shall consider commercially reasonable strategies in
respect of prolonging the lifecycle of the Product, and shall use Commercially Reasonable Efforts to evaluate and implement such strategies, provided, however, that the foregoing obligations shall not extend to pursuing new indications for the
Product. 
 4.4 Assistance. Subject to the terms of this Article 4, each Party agrees to provide the other with all reasonable
assistance and take all actions reasonably requested by the other Party 

  
  

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that are necessary or desirable to enable the other Party to comply with any Law applicable to the Development of the Product, including meeting, reporting and other obligations to maintain and
update any Regulatory Approvals for the Product at the requesting Party’s expense. 
 4.5 Compliance with Laws. Each Party and
its permitted Third Party contractors shall perform its responsibilities under this Article 4, including those set forth in a Development Plan, in accordance with all applicable Laws, including cGCPs. 

4.6 Right to Audit. Subject to the next sentence, Aptalis shall use Commercially Reasonable Efforts to ensure that Strakan’s
authorized representatives, and any Regulatory Authorities to the extent required by applicable Law, may, during regular business hours (giving, if reasonably possible, at least five (5) Business Days prior written notice) (a) examine and
inspect its facilities or, subject to any Third Party confidentiality restrictions and obligations, the facilities of any subcontractor or any investigator site used by Aptalis in the performance of Development or Commercialization of the Product
hereunder, and (b) subject to applicable Law and any Third Party confidentiality restrictions and obligations, inspect all data, documentation and work products relating to the activities performed by Aptalis, the subcontractor or investigator
site, including, the anonymous medical records of any patient participating in any clinical study, in each case generated pursuant to the Development and Commercialization activities hereunder. The right to inspect the facilities under clause
(a) above shall be unlimited in the case of inspections by Regulatory Authorities and in the case of Strakan shall be limited to once per calendar year of the Term, unless Strakan reasonably determines that a material safety or quality issue
exists with respect to the Product, in which case the number of inspections shall be limited to the number that are reasonably necessary to resolve such issues. The right to inspect all data, documentation, and work product relating to the Product
under clause (b) above may be exercised at any time during the Term, or such longer period as shall be required by applicable Law. 

4.7 Other Development Activities. Except for the Development activities contemplated by Section 4.1, and subject to compliance
with the provisions of the other foregoing Sections of this Article 4, all Development related to the Products or otherwise may be conducted by the Parties as they see fit and in their sole discretion, provided, however, that each Party shall
provide to the other (a) information regarding any protocols for any clinical studies such Party may propose to carry out, and such Party shall consider in good faith any comments received from the other Party with respect to such protocols and
clinical studies, and (b) copies of all substantive or material information with respect to its and its Third Party licensees or sublicensees Development activities for products that correspond to the Product, including clinical data compiled
with respect to such products and all information and data filed with any Regulatory Authority relating to such products, as soon as reasonably practicable after such information, data or results become available or compiled, including any drafts
and final versions of any study reports (the “Additional Development Data”). Aptalis shall have the exclusive right to use the Additional Development Data created by or on behalf of Strakan (or any portion thereof) solely to the
extent necessary for Developing, Commercializing or Manufacturing the Product (and, for the sake of clarity, for no other pharmaceutical product) in or for the Territory during the Term, and shall have the right to grant sublicenses. Strakan shall
have the exclusive right to use the Additional Development Data created by or on behalf of Aptalis (or any portion 

  
  

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thereof) solely to the extent necessary for Developing, Commercializing or Manufacturing the Product (and, for the sake of clarity, for no other pharmaceutical product) outside the Territory
including the right to make or have made the Product in the Territory solely for the purpose of supplying its customers or those of its licensees outside the Territory and shall have the right to grant sublicenses. Subject to this Section 4.7,
the Parties agree to exchange information related to any planned, in-progress and/or completed clinical studies that may be relevant to the other Party’s Development activities, including information with respect to Phase 4 Studies. 

ARTICLE 5 
 REGULATORY
MATTERS 
 5.1 Transfer of Product IND and Product NDA. Effective as of the Effective Date, ProStrakan hereby assigns the Product
NDA and the Product IND to Aptalis. To the extent required by applicable Laws, and at such time as Aptalis shall direct, ProStrakan shall notify the FDA of the transfer of such Product NDA and Product IND. Notwithstanding anything to the contrary in
this Agreement, except in connection with the assignment of this Agreement in accordance with Section 17.6, Aptalis shall not be entitled to transfer, assign, encumber (other than in connection with general liens as part of financing
arrangements in the ordinary course) or convey such Product NDA and Product IND to any Third Party. 
 5.2 Filing & Maintenance
of Regulatory Approvals. From the Effective Date, Aptalis shall, at its sole expense, support and maintain all Regulatory Approvals in the Territory (including the Product IND and Product NDA assigned to Aptalis by ProStrakan under
Section 5.1 above and any future Regulatory Approvals obtained by Aptalis or its Affiliates for the Product in the Territory), including filing reports or regulatory variations with the applicable Regulatory Authorities (subject to the
provisions of Sections 5.4 and 5.6). Aptalis shall provide Strakan with drafts of all documents or correspondence to be submitted to any Regulatory Authority in the Territory that pertains to the Product at least one (1) week (or such lesser
period of time as may be necessitated by the circumstances) prior to the proposed filing date, if possible. Aptalis will consult in advance with Strakan with respect to any substantive or material filings to be made in accordance with both the terms
of this Section 5.2 and the Supply Agreement, including Regulatory Approval applications, and shall take into consideration all reasonable comments made by Strakan in respect of such filings. Strakan shall provide Aptalis with drafts of any
documents or correspondence related to the Manufacture of the Product reasonably requested by Aptalis (and in the timeframe reasonably requested by Aptalis), and shall provide Aptalis with any information, data or documentation that Aptalis requests
with respect to the Manufacture of the Product, but Aptalis shall be responsible for all regulatory filings related to the Manufacture of the Product in the Territory. 

5.3 Appearances Related to the Product. Aptalis shall be the Party that is responsible for communicating directly with and appearing
before the FDA or any other Regulatory Authority with respect to the Development or Commercialization of the Product in the Territory. 

5.4 Step-In Rights in Relation to Regulatory Approvals for the Product. In the event that Aptalis fails to maintain any Regulatory
Approval for the Product in the Territory, in addition 

  
  

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to any other rights or remedies that Strakan may have, Strakan shall have the right to seek or maintain such Regulatory Approval, either in Aptalis’s or its own name upon thirty
(30) days prior written notice to Aptalis. In such event, Aptalis shall cooperate with Strakan’s efforts to seek or maintain such Regulatory Approval. 

5.5 Right of Reference. 

5.5.1 Strakan shall, for the purpose of Aptalis exercising its rights under this Agreement, permit Aptalis to have access to and grant it the
right to reference and use all regulatory filings and regulatory communications associated with any submissions for Regulatory Approval and Regulatory Approvals for the Product outside the Territory to the extent permitted under applicable Laws.
Where required in order for Aptalis to obtain such access, Strakan shall, as soon as reasonably possible (no later than thirty (30) days from Aptalis’s request), provide the applicable Regulatory Authorities with notice of its consent to
such access by Aptalis in the appropriate form. 
 5.5.2 Upon transfer of the Product IND and Product NDA to Aptalis, Aptalis shall, upon
Strakan’s reasonable request which shall be accompanied by a reasonable explanation of the reason for such request, permit Strakan to have access to and grant it the right to reference and use all regulatory filings and regulatory
communications associated with the Product IND and Product NDA and any other Regulatory Approvals for the Product held by Aptalis or an Aptalis Affiliate. Such right shall include, without limitation, access to the original documentation and file
source data submitted to the Regulatory Authorities in respect of the Product NDA application as well as to any updates made to such documentation and data since the original filing, and permission to cross refer to and make copies of all such data
and documentation for the purposes of future regulatory filings in respect of indications outside the Territory or Development activities by Strakan (or its designee). Where required in order for Strakan to obtain such access, Aptalis shall, as soon
as reasonably possible (no later than thirty (30) days from Strakan’s request), provide the applicable Regulatory Authorities with notice of its consent to such access by Strakan in the appropriate form. 

5.6 Advance Notice. Subject to applicable Laws, Aptalis shall provide Strakan with reasonable advance notice (no less than ten
(10) Business Days, if feasible) of any meeting or substantive or material conference call with any Regulatory Authority relating to any regulatory filing, regulatory communication or Regulatory Approval for the Product in the Territory.
Strakan has no right to initiate or appear at any meetings or participate on such calls. If it is not possible to provide Strakan notice of any such meeting or conference call, Aptalis shall immediately thereafter provide Strakan with a summary of
any such meeting or conference call. Aptalis shall promptly, but in no event more than fifteen (15) Business Days after receipt, furnish Strakan with copies of all substantive or material documents or correspondence Aptalis has had with or
receives from any Regulatory Authority, and contact reports concerning substantive or material conversations or meetings with any Regulatory Authority, in each case relating to the Product in the Territory (including any minutes from a meeting with
respect thereto). 

  
  

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 5.7 Product Quality Agreement. Upon the Signing Date, and subject to Section 17.10,
the Parties shall enter into the Product Quality Agreement. 
 5.8 Safety Data Exchange Agreement. Upon the Signing Date, and subject
to Section 17.10, the Parties shall enter into the SDEA. 
 ARTICLE 6 

COMMERCIALIZATION OF THE PRODUCT 

6.1 Principles of Commercialization. Aptalis will be solely responsible for Commercializing the Product in the Territory during the
Term in accordance with the Commercialization Plan and this Agreement, including [*] percent ([*]%) of the expenses (including pre-marketing and detailing expenses) incurred by Aptalis in connection with the Commercialization of the Product in the
Territory. 
 6.2 Launch and Commercialization; General. 

6.2.1 Launch. Aptalis shall use its Commercially Reasonable Efforts to Commercially Launch the Product in the Territory [*]. 

6.2.2 Commercialization Efforts. Aptalis shall use Commercially Reasonable Efforts to Commercialize the Product in the Territory,
subject to and in accordance with the provisions of this Agreement. 
 6.2.3 [*] 

(a) [*] 
 (b) [*] 

[*] 
 Commercialization Efforts
During the [*] Period Following Subject Period (the “Second Subject Period”). In its second Commercialization Plan (which will be developed by Aptalis during the first year of the Term) Aptalis shall include (a) specific target
numbers of PDEs to be completed for the Product in the Territory by Aptalis’s sales force during the Second Subject Period and (b) a target incentive compensation plan for the Second Subject Period for Aptalis’s sales force who are
employees of Aptalis, with each element to be determined by Aptalis in its sole discretion, except that the exact performance measures are to be determined by Aptalis in good faith and acting reasonably. Aptalis agrees that it will commit
(i) to achieving seventy percent (70%) of the PDEs set forth in such Commercialization Plan during the Second Subject Period and (ii) that Aptalis’s sales force’s target incentive compensation plan for the Second Subject
Period will be at least seventy percent (70%) of the target incentive compensation plan stated in such Commercialization Plan for the Second Subject Period. For the avoidance of doubt, Aptalis’s commitments regarding the target incentive
compensation plan for Aptalis’s sales force who are employees of Aptalis in this Section 6.2.4 and Section 6.2.3(b), above, are not intended, and shall not be deemed, to be a guaranty that such sales force will achieve their sales
targets 
 6.2.4 [*] 

  
  

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 6.3 Summary of Launch and Commercialization Plan; [*] Submission of Commercialization
Plan; No Commitment. Attached hereto as Exhibit E is an initial draft summary of Aptalis’s launch and Commercialization plan for the Product (the “Launch Plan Summary”) for the [*] period following the Commercial
Launch of the Product. [*] For purposes of this Agreement, the commencement of the Commercial Launch shall be deemed to occur on the date specified in the Launch Plan Summary or, if later, as specified by Aptalis by notice to Strakan, which date
shall not be unreasonably delayed. Aptalis shall submit to Strakan a Commercialization Plan for the Product in the Territory [*] and may amend and/or update any such Plan, subject to notice to Strakan. For the avoidance of doubt, it is understood
and agreed by the Parties that (a) the contents of the Launch Plan Summary and the Commercialization Plans submitted by Aptalis as provided for herein, as amended, updated, etc., and including future [*] Commercialization Plans, shall not be
considered a commitment or obligation of any kind on the part of Aptalis, but represents only a good faith estimate of Aptalis’s anticipated Commercialization efforts for the Product, (b) Aptalis’s failure to actually achieve such
Commercialization efforts shall not be deemed a breach of this Agreement and (c) the contents of the Launch Plan Summary and the Commercialization Plans submitted by Aptalis as provided for herein, as updated, amended, etc., shall not be
considered in any way in determining whether Aptalis has exercised Commercially Reasonable Efforts to Commercialize the Product. For clarity the above provisions of Section 6.3 shall not derogate from the obligations of Aptalis set out in
Section 6.2. 
 6.4 Promotional Materials 

6.4.1 Aptalis Promotional Materials. As soon as practicable after the Effective Date, Aptalis will create and develop Promotional
Materials for the Territory in accordance with Regulatory Approvals and applicable Laws. Prior to making a claim with respect to the Product that has not been sent to Strakan previously, Aptalis shall submit to Strakan such claim for information
purposes. If Strakan has any concern as to whether any claim is in accordance with any applicable Regulatory Approval in the Territory or applicable Law in the Territory, it shall raise the matter with Aptalis within ten (10) Business Days of
receiving the claim from Aptalis. If Aptalis does not agree with Strakan’s concern, then an ad hoc meeting of the OC will take place as soon as reasonably possible to resolve the matter in dispute. If the matter is not resolved by the OC then
the dispute shall be subject to the procedures in Section 15.2. Copies of all Promotional Materials used in the Territory will be archived by Aptalis in accordance with applicable Laws. 

6.4.2 Other Promotional Materials. Strakan will from time to time, upon the reasonable request of Aptalis, but in any event at least
annually, provide copies of its Promotional Materials used outside the Territory to Aptalis, and subject to any Third Party rights, grant Aptalis the right to use such materials in the Territory. Strakan will bear the cost of obtaining any
reasonably necessary Third Party consents to the use of Promotional Materials in existence as of the Signing Date by Aptalis in the Territory. 

  
  

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 6.4.3 Aptalis Ownership of Promotional Materials. During the Term Aptalis shall own all
right, title and interest in and to any Promotional Materials relating to the Product in the Territory, including applicable copyrights and trademarks, but excluding copyrights and trademarks owned by Strakan or Third Parties as contemplated by
Sections 6.4.2, 10.7.1 and 10.7.2. 
 6.5 Compliance with Laws. Each Party or its permitted Third Party contractors shall perform its
responsibilities under this Article 6 in accordance with all applicable Laws. 
 ARTICLE 7 

MANUFACTURE OF THE PRODUCT 

7.1 Development and Commercial Supply by Strakan. Subject to the terms of the Supply Agreement, during the Term Strakan shall
Manufacture, or arrange for a Third Party to Manufacture, and supply exclusively to Aptalis in the Territory all of Aptalis’s requirements of the Product for Development and Commercialization in accordance with the terms of the Supply Agreement
[*]. 
 ARTICLE 8 

FINANCIAL TERMS; PAYMENT TERMS 

8.1 Upfront Payment. As partial payment for the rights and licenses granted by Strakan pursuant to this Agreement, Aptalis shall,
within [*] Business Days of the Effective Date, pay to Strakan a non-creditable and non-refundable amount of Twenty Million Dollars ($20,000,000). 

8.2 Milestones. As further payment for the rights and licenses granted by Strakan to Aptalis pursuant to this Agreement: 

8.2.1 Commercialization Milestone. Within [*] following the date that is [*] following the First Commercial Sale of the Product, but in
any event before [*], Aptalis shall pay to Strakan a non-creditable and non-refundable amount of Twenty Million Dollars ($20,000,000). 

  
  

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 8.2.2 Sales Milestone Payments. 

(a) Aptalis shall notify Strakan as soon as practicable upon achievement of each milestone set forth below (each, a
“Milestone”). In further consideration of the rights granted to Aptalis hereunder, no later than [*] days after receiving Strakan’s invoice following Aptalis’s achieving each Milestone, Aptalis shall pay to Strakan the
corresponding non-creditable and non-refundable milestone payment set forth below (each, a “Sales Milestone Payment”). 
  

					
	 Milestone
	  	Product Sales Milestone
Payment	 
		
	 Net Sales of Product in any [*] during the Term equal to or greater than [*] Dollars ($[*])
	  	$	[*]	  
		
	 Net Sales of Product in any [*] during the Term equal to or greater than [*] Dollars ($[*])
	  	$	[*]	  
		
	 Net Sales of Product in any [*] during the Term equal to or greater than [*] Dollars ($[*])
	  	$	[*]	  
		
	 Net Sales of Product in any [*] during the Term equal to or greater than [*] Dollars ($[*])
	  	$	[*]	  
		
	 Net Sales of Product in any [*] during the Term equal to or greater than [*] Dollars ($[*])
	  	$	[*]	  

 (a) For the avoidance of doubt each Sales Milestone Payment shall be payable only once upon achievement of
the applicable Milestone by the Product, regardless of the number of times such Milestone may be achieved and regardless of the achievement thereof separately by an extension, enhanced or modified presentation or formulation thereof; and 

(b) If more than one Milestone is achieved [*] then the aggregate of the applicable Sales Milestone Payments will be payable. For example if
[*]. 
 8.3 Royalties. 

8.3.1 Royalty Rate. From the Effective Date, as further consideration for Strakan’s grant of the rights and licenses to Aptalis
hereunder, Aptalis will pay to Strakan a royalty on Net Sales of the Products in the Territory, subject to the deduction of (a) [*], as follows: 
  

					
	Aggregate Net Sales [*]	  	Product Royalty Rate	 
		
	 For that portion of Net Sales in [*] which is less than or equal to [*] Dollars ($[*])
	  	 	[*]	% 
		
	 For that portion of Net Sales in [*] which is greater than [*] Dollars ($[*]) up to [*] Dollars ($[*])
	  	 	[*]	% 
		
	 For that portion of Net Sales in [*] which is greater than [*] Dollars ($[*])
	  	 	[*]	% 

  
  

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 8.3.2 Royalty Term. Royalties due under this Section 8.3 will commence upon the First
Commercial Sale of the Product in the Territory after the date of this Agreement and will continue during the Term. 
 8.3.3 Royalty
Payments and Sales Reporting. Within forty-five (45) days following [*] Aptalis shall provide Strakan a report setting forth, the amount of gross sales of the Products in the Territory for [*], a calculation of Net Sales, and a calculation
of the amount of royalty payments due on such Net Sales after deducting [*] (“Sales Reports”). Royalty payments due pursuant to this Section 8.3 are due and payable within [*] Business Days of receipt of an invoice from
Strakan. Each Sales Report will be considered Confidential Information of Aptalis subject to the obligations of Article 9 of this Agreement. 

8.4 Payment Method. All undisputed amounts due to either Party hereunder will be paid in Dollars by wire transfer in immediately
available funds to an account designated by such Party. Any payments or portions thereof due hereunder that are not subject to good faith dispute and not paid by the date such payments are due under this Agreement will bear simple interest at the
lower of (a) United States Prime Rate, as reported in the Wall Street Journal, Eastern Edition, on the due date (or, if the due date is not a Business Day, on the last Business Day prior to such due date) plus two percent (2%), or (b) the
maximum rate permitted by applicable Law, calculated on the number of days such payment is delinquent. 
 8.5 Taxes. 

8.5.1 Withholding Taxes. Strakan will be responsible for any and all income or other taxes owed by Strakan and required by applicable
Law to be withheld or deducted from any of the royalty and other payments made by or on behalf of Aptalis to Strakan hereunder (“Withholding Taxes”), and Aptalis may deduct from any amounts that Aptalis is required to pay hereunder
an amount equal to such Withholding Taxes. Aptalis will provide Strakan with reasonable advance notice of tax withholding obligations to which it reasonably believes that it is subject. Strakan will provide Aptalis any reasonable information
available to Strakan that is necessary to determine the Withholding Taxes. Such Withholding Taxes will be paid to the proper taxing authority for Strakan’s account and evidence of such payment will be secured and sent to Strakan within one
(1) month of such payment. The Parties will do all such lawful acts and things and sign all such lawful deeds and documents as either Party may reasonably request from the other Party to enable Strakan and Aptalis or its Affiliates to take
advantage of any applicable legal provision or any treaty provisions with the object of paying the sums due to Strakan hereunder with the lowest legal amount of Withholding Taxes. 

8.5.2 Additional Withholding Taxes. If, as a result of any change in the corporate status or location of Aptalis, or the permitted
assignment of this Agreement by Aptalis, in each case where Strakan’s prior consent has not been sought and obtained, additional Withholding Taxes become due on payments from Aptalis or its permitted assignee to Strakan that would not have been
due, solely as a result of the difference in tax treatment of the changed corporate status or under applicable Law of or treaty with the taxing jurisdiction of the changed location, as compared to the United States absent such change in corporate
status or location or permitted 

  
  

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assignment where Strakan’s prior consent has not been sought and obtained, and Strakan is permanently unable to claim a credit or reimbursement for such tax, in whole or in part, then
Aptalis will deduct Withholding Taxes in accordance with this Section 8.5, but will, in addition to the sums otherwise payable under this Agreement, pay to Strakan such further sum as will ensure that, after deduction of Withholding Taxes on
all such sums, the net amount received by Strakan equals the amount that Strakan would have received had the non-creditable or non-reimbursable excess portion of such additional Withholding Taxes not been deducted. 

8.6 Records Retention; Financial Audit. 

8.6.1 Record Retention. Each Party will maintain complete and accurate books, records and accounts used for the determination of
expenses incurred in connection with the performance of Development or Commercialization activities or otherwise relevant for the calculation of Net Sales, in sufficient detail to confirm the accuracy of any payments required under this Agreement,
which books, records and accounts will be retained by such Party for five (5) years after the end of the period to which such books, records and accounts pertain, or longer as is required by applicable Law. 

8.6.2 Financial Audit. Each Party will have the right to have an independent certified public accounting firm of internationally
recognized standing, reasonably acceptable to the other Party, to have access during normal business hours, and upon reasonable prior written notice, to such of the records of the other Party as may be reasonably necessary to verify the accuracy of
any expenses shared or paid by the other Party under this Agreement or the calculation of Net Sales for any Calendar Year ending not more than five (5) years prior to the date of such request; provided, however, that, (a) no Party will
have the right to conduct more than one such audit in any twelve (12) month period and that (b) the auditing Party shall not be permitted to audit the same period of time more than once, unless evidence of fraud or gross negligence arises
in a subsequent audit and the auditing Party reasonably believes that such evidence indicates the reasonable possibility of fraud or gross negligence in any such prior period. The accounting firm will disclose to the Parties only whether the various
expenses subject to being shared by this Agreement, Net Sales reported by the audited Party are correct or incorrect and the specific details concerning any discrepancies. The auditing Party will bear all costs of such audit, unless the audit
reveals a discrepancy in the auditing Party’s favor of more than ten percent (10%), in which case the audited Party will bear the cost of the audit. The result of the audit shall, in the absence of manifest error, be final and binding on the
Parties. Aptalis shall obtain from any subcontractor, as applicable, audit rights at least as favorable as the audit rights set forth in this Section 8.6.2 and the right to share the results of any such audit with Strakan. In the event that
Strakan reasonably believes that there is a material inaccuracy in the reporting by a subcontractor, as applicable, of the Net Sales of such subcontractor, then Strakan may direct Aptalis to exercise such audit rights in accordance with procedures
reasonably requested by Strakan. 
 8.6.3 Payment of Additional Amounts. If, based on the results of any audit, additional payments
are owed to either Party under this Agreement, then the paying Party will make such additional payments within thirty (30) days (provided that the paying Party has received an invoice in respect of the same) after the accounting firm’s
written report is delivered to the Parties. The provisions of Section 8.5 shall apply to such payment. 

  
  

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 8.6.4 Confidentiality. Each Party will treat all information subject to review under this
Section 8.6 in accordance with the provisions of Article 9. Prior to conducting any audit hereunder, the Party conducting such audit will cause its accounting firm to enter into a reasonably acceptable confidentiality agreement with the audited
Party obligating such accounting firm to maintain all such financial information in confidence with standards no less stringent that the terms of Article 9 of this Agreement. 

ARTICLE 9 

CONFIDENTIALITY 
 9.1
Confidential Information. 
 9.1.1 Confidential Information. As used in this Agreement, the term “Confidential
Information” means all secret, confidential or proprietary information or data, whether provided in written, oral, graphic, video, computer, electronic or other form, provided pursuant to this Agreement by one Party (the “Disclosing
Party”) to the other Party (the “Receiving Party”), including information relating to the Disclosing Party’s existing or proposed research, development efforts, Know-How, Development Data, patent applications, business
or products, and any other materials that have not been made available by the Disclosing Party to the general public. Notwithstanding the foregoing sentence, Confidential Information shall not include any information or materials that: 

(a) were already known to the Receiving Party (other than under an obligation of confidentiality), at the time of disclosure by the
Disclosing Party, to the extent such Receiving Party has documentary evidence to that effect; 
 (b) were generally available to the public
or otherwise part of the public domain at the time of disclosure thereof to the Receiving Party; 
 (c) became generally available to the
public or otherwise part of the public domain after disclosure or development thereof, as the case may be, and other than through any act or omission of a Party in breach of such Party’s confidentiality obligations under this Agreement; 

(d) were disclosed to a Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing
Party not to disclose such information to others; or 
 (e) were independently discovered or developed by or on behalf of the Receiving
Party without the use of the Confidential Information belonging to the other Party, to the extent such Receiving Party has documentary evidence to that effect. 

  
  

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 9.1.2 Confidentiality Obligations. Each of Strakan and Aptalis shall keep all Confidential
Information received from the other Party with the same degree of care it maintains the confidentiality of its own Confidential Information, but in no event less than a reasonable degree of care. Neither Party shall use such Confidential Information
for any purpose other than in performance of this Agreement or disclose the same to any other person other than to such of its and its Affiliates’ or sub-licensees, directors, officers, managers, employees, independent contractors, agents or
consultants who have a need to know such Confidential Information to implement the terms of this Agreement or enforce its rights under this Agreement; provided, however, that a Receiving Party shall advise any of its and its Affiliates’,
sub-licensees, directors, officers, managers, employees, independent contractors, agents or consultants who receives such Confidential Information of the confidential nature thereof and of the obligations contained in this Agreement relating
thereto, and the Receiving Party shall ensure (including, in the case of a Third Party, by means of a written agreement with such Third Party having terms at least as protective as those contained in this Article 9) that all such directors,
officers, managers, employees, independent contractors, agents or consultants comply with such obligations as if they had been a Party hereto. Upon termination of this Agreement, the Receiving Party shall return or destroy all documents, tapes or
other media, other than the Receiving Party’s back-up or archival media (which media shall be destroyed in the normal course of the Receiving Party’s document retention program), containing Confidential Information of the Disclosing Party
that remain in the possession of the Receiving Party or its directors, managers, employees, independent contractors, agents or consultants, except that the Receiving Party may keep one copy of the Confidential Information in the legal department
files of the Receiving Party, solely for archival purposes. Such archival copy shall be deemed to be the property of the Disclosing Party, and shall continue to be subject to the provisions of this Article 9. 

9.1.3 Permitted Disclosure and Use. Notwithstanding Section 9.1.2, a Party may disclose Confidential Information belonging to the
other Party to the extent such disclosure is reasonably necessary to: (a) obtain Regulatory Approval of the Product to the extent such disclosure is made to a Regulatory Authority; (b) comply with or enforce any of the provisions of this
Agreement; or (c) comply with applicable Laws, including a filing with the Securities and Exchange Commission or other listing authority, provided, that, the disclosing Party shall provide copies of the disclosure reasonably in advance of such
filing or other disclosure for the non-disclosing Party’s prior review and comment. If a Party deems it necessary to disclose Confidential Information of the other Party pursuant to this Section 9.1.3, such Party shall, if reasonably
possible and permissible, give reasonable advance notice of such disclosure to the other Party to permit such other Party sufficient opportunity to object to such disclosure or to take measures to ensure confidential treatment of such information.
In addition, notwithstanding Section 9.1.2, the Parties shall prepare standardized responses to anticipated inquiries from the public or press, stockholders, investors and/or analysts with respect to the Product or other activities hereunder
that may be disclosed. 

  
  

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 9.1.4 Notification. The Receiving Party shall notify the Disclosing Party promptly upon
discovery of any unauthorized use or disclosure of the Disclosing Party’s Confidential Information, and will cooperate with the Disclosing Party in any reasonably requested fashion to assist the Disclosing Party to regain possession of such
Confidential Information and to prevent its further unauthorized use or disclosure. 
 9.2 Publicity; Filing of this Agreement. The
Parties agree that the public announcement of the execution of this Agreement by (a) Strakan shall be substantially in the form of the press release attached as Exhibit F-1 (the “Strakan Press Release”) and
(b) Aptalis shall be substantially in the form of the press release attached as Exhibit F-2 (the “Aptalis Press Release”). Any other publication, news release or other public announcement relating to this Agreement or to
the performance hereunder, shall first be reviewed and approved by both Parties; provided, however, that any disclosure which is required by applicable Law as advised by the disclosing Party’s counsel may be made without the prior consent of
the other Party. To the extent practicable and permissible, the disclosing Party shall be given at least three (3) Business Days advance notice of any such legally required disclosure, and the other Party shall provide any comments on the
proposed disclosure during such period. To the extent that either Party determines that it or the other Party is required to file or register this Agreement or a notification thereof to comply with the requirements of an applicable stock exchange or
NASDAQ regulation or any Governmental Authority, including the United States Securities and Exchange Commission, the Competition Directorate of the Commission of the European Communities or the United States Federal Trade Commission, such Party
shall promptly inform the other Party thereof. Prior to making any such filing, registration or notification, the Parties shall agree on the provisions of this Agreement for which the Parties shall seek confidential treatment, it being understood
that if one Party determines to seek confidential treatment for a provision for which the other Party does not, then the Parties will use reasonable efforts in connection with such filing to seek the confidential treatment of any such provision. The
Parties shall cooperate, each at its own expense, in such filing, registration or notification, including such confidential treatment request, and shall execute all documents reasonably required in connection therewith. 

9.3 Use of Names. Subject to Sections 9.1.3 and 9.2 neither Party shall use the name of the other Party in relation to this transaction
in any public announcement, press release or other public document without the prior, written consent of such other Party, which consent shall not be unreasonably withheld; provided, however, that either Party may use the name of the other Party in
any document filed with any Regulatory Authority, including FDA, or with the Securities and Exchange Commission or otherwise as required by applicable Law. 

9.4 Confidentiality of this Agreement. The terms of this Agreement shall be Confidential Information of each Party and, as such, shall
be subject to the provisions of this Article 9; provided, however, that either Party may disclose the terms of this Agreement to any Third Party with which it is proposing to merge or which might be proposing to acquire or invest in the relevant
Party provided that such Third Party agrees to keep the terms of this Agreement confidential. 
 9.5 Survival. The obligations and
prohibitions contained in this Article 9 shall survive the expiration or termination of this Agreement. 

  
  

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 ARTICLE 10 

INTELLECTUAL PROPERTY 

10.1 Inventions Related to the Product. 

10.1.1 Ownership. 
 (a)
Strakan. Subject to this Article 10, Strakan shall solely own within and outside of the Territory any invention that is created by employees of Strakan (or of its Affiliates, subcontractors, distributors or sublicensees) jointly (other than
jointly with Aptalis) or severally, (x) as a result of Strakan carrying out any of its obligations under this Agreement, and (y) pertaining to the Product (“Strakan Inventions”). Aptalis shall have an exclusive (even as to
Strakan), royalty-free, irrevocable, sublicensable license to make, use and sell Strakan Inventions in order to research, Develop, Commercialize and Manufacture the Product in or for the Territory. 

(b) Aptalis. Subject to this Article 10, Aptalis shall solely own within and outside of the Territory any invention created by
employees of Aptalis (or of its Affiliates, subcontractors, distributors or sublicensees) jointly (other than jointly with Strakan) or severally, (x) as a result of Aptalis carrying out any of its obligations under this Agreement, and
(y) pertaining to the Product (“Aptalis Inventions”). Strakan shall have an exclusive (even as to Aptalis), royalty-free, irrevocable, sublicensable license to make, use and sell Aptalis Inventions in order to research,
Develop, Commercialize and Manufacture the Product (i) outside the Territory and (ii) in the Territory, provided, however, that the license that is the subject of this clause (ii) shall not be effective until after the Term except
that Strakan shall be entitled to make or have made the Product in the Territory solely for the purpose of supplying its customers or those of its licensees outside the Territory. 

(c) Joint. The Parties shall jointly own any invention that is created by employees of Strakan (or of its Affiliates, subcontractors,
distributors or sublicensees) jointly or severally together with employees of Aptalis (or of its Affiliates, subcontractors, distributors or sublicensees) as a result of their carrying out any of their respective obligations under this Agreement
(“Joint Inventions”). Except as expressly provided in this Agreement and subject to Section 10.3 and the next succeeding sentence, neither Party shall exploit any Joint Invention without the prior written approval of the other
Party, it being understood that such approval may be conditioned on agreement after good faith negotiations. Aptalis shall have the exclusive (even as to Strakan), irrevocable, worldwide, sublicensable right, without any accounting to Strakan as to
any profits or other returns derived therefrom, to make, use and sell any Joint Invention in order to research, Develop, Commercialize and Manufacture the Product in the Territory. Strakan shall have an exclusive (even as to Aptalis), royalty-free,
irrevocable, sublicensable right, without any accounting to Aptalis as to any profits or other returns derived therefrom, to make, use and sell any Joint Invention in order to research, Develop, 

  
  

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Commercialize and Manufacture the Product (i) outside the Territory and (ii) in the Territory, provided, however, that the right that is the subject of this clause (ii) shall not
be effective with regard to the Product in the Territory until after the Term except that Strakan shall be entitled to make or have made the Product in the Territory solely for the purpose of supplying its customers or those of its licensees outside
the Territory. 
 10.2 Specified Patent Maintenance. Strakan shall Maintain the Specified Patent during the Term. 

10.3 Patents Covering Joint Inventions. 

10.3.1 Strategy. The Parties shall discuss in good faith, and if agreed upon, implement, a mutually agreeable patent strategy with
respect to all Joint Inventions that may be patentable, and, in any event, shall cause their respective patent counsel to communicate regularly regarding the prosecution and Maintenance of any Patents covering any Joint Invention in the Territory
and outside the Territory. 
 10.3.2 Aptalis. Aptalis shall be responsible for the prosecution (including filing applications for
Patents) and Maintenance of any Patents covering any Joint Invention (“Joint Patents”), the costs of which shall be borne by Aptalis with respect to the Territory and Strakan with respect to jurisdictions outside of the Territory,
unless otherwise agreed by the Parties. Aptalis shall provide to Strakan copies of all communications sent to and received from patent offices pertaining to the prosecution of such Joint Patents, including draft patent applications, filing receipts,
office actions, information disclosure statements (including cited art/material), responses and/or amendments, and notices of allowance. Furthermore, the Parties shall cause their patent counsel to communicate regularly in advance regarding the
prosecution of such Joint Patents. Strakan shall be given at least fifteen (15) Business Days prior to the earlier of the expiration of any shortened statutory period for response or anticipated filing to review and comment upon the text of any
such communication. Aptalis also shall keep Strakan advised on the Maintenance of any such Joint Patents and provide Strakan with a reasonable opportunity to comment on matters related to Maintenance. In the event that the Parties, after good faith
discussions, cannot agree with respect to any decision to be made regarding the prosecution and Maintenance of any Joint Patent (including decisions relating to interference, opposition, revocation, reissue, reexamination and similar proceedings
related to such Patents), Aptalis shall make such decision with respect to the Territory and Strakan shall make such decision with respect to all jurisdictions outside of the Territory. In all cases, each Party shall provide reasonable assistance to
the other Party, at Aptalis’s expense with respect to such Joint Patents in the Territory and at Strakan’s expense with respect to such Joint Patents outside the Territory, with respect to any activities determined by the other Party to be
necessary or desirable to obtain and Maintain such Patent protection. 
 10.3.3 Strakan. In the event Aptalis elects not to prepare,
file, prosecute or Maintain any such Joint Patents, it shall give Strakan notice to this effect, sufficiently in advance to permit Strakan to undertake such filing, prosecution and Maintenance without a loss of rights, and, thereafter, Strakan may,
upon written notice to Aptalis, file and prosecute such Joint Patents 

  
  

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applications and Maintain such Joint Patents in Aptalis’s name, the costs of which shall be borne by Aptalis in the Territory and Strakan outside of the Territory, unless otherwise agreed by
the Parties, provided that Strakan shall provide to Aptalis, for Aptalis’s review and comment, copies of all communications sent to and received from any patent office pertaining to such Joint Patents, including draft patent applications,
filing receipts, office actions, information disclosure statements (including cited art/material), responses and/or amendments, and notices of allowance. 

10.4 Patents Covering Aptalis Inventions. Aptalis shall be solely responsible for the prosecution (including filing applications for
Patents) and Maintenance of any Patents covering the Aptalis Inventions (“Aptalis Patents”) at Aptalis’s expense. Aptalis shall provide to Strakan copies of all communications sent to and received from patent offices pertaining
to the prosecution of such Aptalis Patents, including draft patent applications, filing receipts, office actions, information disclosure statements (including cited art/material), responses and/or amendments, and notices of allowance. Furthermore,
the Parties shall cause their patent counsel to communicate regularly in advance regarding the prosecution of such Aptalis Patents. With respect to Aptalis Patents outside of the Territory or in the Territory after the Term, Strakan shall be given
at least fifteen (15) Business Days prior to the earlier of the expiration of any shortened statutory period for response or anticipated filing to review and comment upon the text of any such communication. Aptalis also shall keep Strakan
advised on the maintenance of any such Aptalis Patents and provide Strakan with a reasonable opportunity to comment on matters related to Maintenance. In the event that the Parties, after good faith discussions, cannot agree with respect to any
decision to be made with respect to the preparation, filing, prosecution and maintenance of any such Aptalis Patents (including decisions relating to interference, opposition, revocation, reissue, reexamination and similar proceedings), Aptalis
shall make such decision. With respect to Aptalis Patents outside of the Territory or in the Territory after the Term, in the event Aptalis elects not to prepare, file, prosecute or Maintain any such Aptalis Patents, it shall give Strakan notice to
this effect, sufficiently in advance to permit Strakan to undertake such filing, prosecution and Maintenance without a loss of rights, and, thereafter, Strakan may, upon written notice to Aptalis, file and prosecute such Patent applications and
Maintain such Patents in Aptalis’s name, all at Strakan’s expense, provided that Strakan shall provide to Aptalis, for Aptalis’s review and comment, copies of all communications sent to and received from any patent office pertaining
to such Aptalis Patents, including draft patent applications, filing receipts, office actions, information disclosure statements (including cited art/material), responses and/or amendments, and notices of allowance. 

10.5 Patents Covering Strakan Inventions. Strakan shall be solely responsible for the prosecution (including filing applications for
Patents) and Maintenance of any Patents covering the Strakan Inventions (“Strakan Patents”) at Strakan’s expense. Strakan shall provide to Aptalis copies of all communications sent to and received from patent offices pertaining
to the prosecution of such Strakan Patents, including draft patent applications, filing receipts, office actions, information disclosure statements (including cited art/material), responses and/or amendments, and notices of allowance. Furthermore,
the Parties shall cause their patent counsel to communicate regularly in advance regarding the prosecution of such Strakan Patents. With respect to Strakan Patents in the Territory, Aptalis shall be given at least fifteen (15) Business Days
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or anticipated filing to review and comment upon the text of any such communication. Strakan also shall keep Aptalis advised on the Maintenance of any such Strakan Patents and provide Aptalis
with a reasonable opportunity to comment on matters related to Maintenance. In the event that the Parties, after good faith discussions, cannot agree with respect to any decision to be made with respect to the preparation, filing, prosecution and
Maintenance of any such Patents (including decisions relating to interference, opposition, revocation, reissue, reexamination and similar proceedings), Strakan shall make such decision. With respect to Strakan Patents in the Territory, in the event
Strakan elects not to prepare, file, prosecute or Maintain any such Strakan Patents, it shall give Aptalis notice to this effect, sufficiently in advance to permit Aptalis to undertake such filing, prosecution and Maintenance without a loss of
rights, and, thereafter, Aptalis may, upon written notice to Strakan, file and prosecute such Patent applications and Maintain such Patents in Strakan’s name, all at Aptalis’s expense, provided that Aptalis shall provide to Strakan, for
Strakan’s review and comment, copies of all communications sent to and received from any patent office pertaining to such Patents, including draft patent applications, filing receipts, office actions, information disclosure statements
(including cited art/material), responses and/or amendments, and notices of allowance. 
 10.6 Enforcement of Patent Rights. 

10.6.1 Notice. If a Party becomes aware of any infringement, anywhere in the world, of any issued Patent covering the Strakan
Inventions, the Aptalis Inventions and/or any Joint Inventions, such Party will notify the other Party in writing to that effect. Any such notice shall include any available evidence to support an allegation of such infringement. 

10.6.2 Enforcement of Strakan Patents and Joint Patents in the Territory. Except as otherwise provided in this Section 10.6.2,
Aptalis shall, as between Strakan and Aptalis, have the first right but not the obligation, at its own expense, to take action (or cause or permit to be taken action) to obtain a discontinuance of infringement or bring suit against a Third Party
infringer in the Territory of any Strakan Patents or any Joint Patents. Such right shall remain in effect until thirty (30) days after the date of notice given under Section 10.6.1. Aptalis, at its own expense, may require Strakan to join
as a party plaintiff to any action or suit resulting from Aptalis’s exercise of such rights. Strakan may participate, and be represented by independent counsel, in such litigation at its own expense. Aptalis shall not consent to the entry of
any judgment or enter into any settlement with respect to such an action or suit without the prior written consent of Strakan (not to be unreasonably withheld or delayed) if such judgment or settlement includes a finding or agreement that any
Strakan Patent or Joint Patent is invalid, unenforceable, or not infringed or would enjoin or grant other equitable relief against Strakan. Aptalis shall bear all the expenses of any such action or suit brought by Aptalis under this first right
claiming infringement of any Strakan Patent or Joint Patent. If, after the expiration of the thirty (30) day period, Aptalis has not obtained a discontinuance of the infringement of any Strakan Patent or Joint Patent or filed suit against any
such Third Party infringer of any Strakan Patent or Joint Patent, or provided Strakan with information and arguments demonstrating to Strakan’s reasonable satisfaction that there is insufficient basis for the allegation of such infringement of
the Strakan Patents or Joint Patents, then Strakan shall have the second right, but not the obligation, at its own expense, to bring suit against such Third Party infringer in the 

  
  

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Territory. Strakan may require Aptalis to join as a party plaintiff to any action or suit resulting from Strakan’s exercise of such rights. Strakan shall not consent to the entry of any
judgment or enter into any settlement with respect to such an action or suit without the prior written consent of Aptalis (not to be unreasonably withheld or delayed) if such judgment or settlement includes a finding or agreement that any Strakan
Patent or Joint Patent is invalid, unenforceable, or not infringed, grants a Third Party license, or would enjoin or grant other equitable relief against Aptalis. Strakan shall bear all the expenses of any such action or suit brought by Strakan
under this second right claiming infringement of any Strakan Patent or Joint Patent. Each Party shall cooperate with the other Party (including by executing any documents required to enable the other Party to initiate such litigation) in any action
or suit for infringement of any Strakan Patent or Joint Patent brought by a Party in accordance with this Section 10.6.2 and shall have the right to consult with the other. Neither Party shall incur any liability directly to the other Party as
a consequence of such action or suit or any unfavorable decision resulting therefrom, including any decision holding any Strakan Patent or Joint Patent invalid or unenforceable. However, the Party exercising the right to bring an action or suit
shall indemnify and hold the other Party harmless from any liability to a Third Party as a consequence of such action or suit or any unfavorable decision resulting therefrom. Any recovery obtained by either Party as a result of any such action or
suit against a Third Party infringer shall be allocated as follows: 
 (a) Such recovery shall first be used to reimburse each Party for
all litigation costs in connection with such action or suit paid by that Party; 
 (b) If Aptalis brought the infringement action or suit,
Aptalis shall remit a portion of the remainder of the recovery equal to the applicable royalty rate to Strakan; and 
 (c) If Strakan
brought the infringement action or suit, the remainder of the recovery shall be shared equally by the Parties. 
 10.6.3 Enforcement of
Aptalis Patents. Except as otherwise provided in this Section 10.6.3, Aptalis shall, as between Aptalis and Strakan, have the first right but not the obligation, at its own expense, to take action (or cause or permit to be taken action) to
obtain a discontinuance of infringement or bring suit against a Third Party infringer of any Aptalis Patents. Such right shall remain in effect until ninety (90) days after the date of notice given under Section 10.6.1. Aptalis, at its own
expense, may require Strakan to join as a party plaintiff to any action or suit resulting from Aptalis’s exercise of such rights. Strakan may participate, and be represented by independent counsel, in such litigation at its own expense with
respect to any such litigation that is outside of the Territory or in the Territory after the Term. Aptalis shall not consent to the entry of any judgment or enter into any settlement with respect to such an action or suit without the prior written
consent of Strakan (not to be unreasonably withheld or delayed) if such judgment or settlement includes a finding or agreement that any Aptalis Patent is invalid, unenforceable, or not infringed, grants a Third Party license, or would enjoin or
grant other equitable relief against Strakan. Aptalis shall bear all the expenses of any such action or suit brought by Aptalis under this first right claiming infringement of any Aptalis Patent. If, with respect to an alleged infringement of the
Aptalis Patents outside of the Territory or in the Territory after the Term, after the expiration of the ninety (90) day period, Aptalis has not obtained a discontinuance of the 

  
  

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infringement of any Aptalis Patent or filed suit against any such Third Party infringer of any Aptalis Patent, or provided Strakan with information and arguments demonstrating to Strakan’s
reasonable satisfaction that there is insufficient basis for the allegation of such infringement of the Aptalis Patent, then Strakan shall have the second right, but not the obligation, at its own expense, to bring suit against such Third Party
infringer (x) outside the Territory or (y) in the Territory after the Term. Strakan may require Aptalis to join as a party plaintiff to any action or suit resulting from Strakan’s exercise of such rights. Strakan shall not consent to
the entry of any judgment or enter into any settlement with respect to such an action or suit without the prior written consent of Aptalis (not to be unreasonably withheld or delayed) if such judgment or settlement includes a finding or agreement
that any Aptalis Patents are invalid, unenforceable, or not infringed, grants a Third Party license, or would enjoin or grant other equitable relief against Aptalis. Strakan shall bear all the expenses of any such action or suit brought by Strakan
under this second right claiming infringement of any Aptalis Patent. Each Party shall cooperate with the other Party (including by executing any documents required to enable the other Party to initiate such litigation) in any action or suit for
infringement of any Aptalis Patent brought by a Party in accordance with this Section 10.6.3 and shall have the right to consult with the other. Neither Party shall incur any liability directly to the other Party as a consequence of such action
or suit or any unfavorable decision resulting therefrom, including any decision holding any Aptalis Patent invalid or unenforceable. However, the Party exercising the right to bring an action or suit shall indemnify and hold the other Party harmless
from any liability to a Third Party as a consequence of such action or suit or any unfavorable decision resulting therefrom. Any recovery obtained by either Party as a result of any such action or suit against a Third Party infringer shall be
allocated as follows: 
 (a) Such recovery shall first be used to reimburse each Party for all litigation costs in connection with such
action or suit paid by that Party; 
 (b) If Aptalis brought the infringement action or suit, Aptalis shall remit a portion of the
remainder of the recovery equal to the applicable royalty rate to Strakan; and 
 (c) If Strakan brought the infringement action or suit,
the remainder of the recovery shall be shared equally by the Parties. 
 10.6.4 Enforcement of Joint Patents Outside of the
Territory. Strakan shall, as between Aptalis and Strakan, have the right but not the obligation, at its own expense, to take action (or cause or permit to be taken action) to obtain a discontinuance of infringement or bring suit against a Third
Party infringer of any Joint Patents outside of the Territory. Aptalis shall provide such assistance as Strakan shall reasonably require in connection with such enforcement at Strakan’s cost. 

10.6.5 Appeal. In the event that a judgment is entered against a Party exercising a rights pursuant to this Section 10.6 (the
“Controlling Party”) and an appeal is available, the Controlling Party shall have the first right, but not the obligation, to file such appeal. In the event the Controlling Party does not desire to file such an appeal, it will
promptly, in a reasonable time period (i.e., with sufficient time for the non-Controlling Party to 

  
  

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take whatever action may be necessary) prior to the date on which such right to appeal will lapse or otherwise diminish, permit the non-Controlling Party to pursue such appeal at such
non-Controlling Party’s own cost. If the Law requires the Controlling Party’s involvement in such appeal, the Controlling Party shall be a nominal party of the appeal and shall provide reasonable cooperation with the other Party at the
other Party’s expense. 
 10.6.6 Third Party Licenses. If Aptalis enters into a commercially reasonable agreement with a Third
Party to license any Patent in the Territory that would, but for such license, be, in the written opinion of a patent counsel selected by Aptalis that doesn’t regularly represent either of the Parties and is reasonably acceptable to Strakan,
infringed by the Development, Manufacture, use, sale, offering for sale, importation, exportation or other Commercialization or exploitation of the Product in the Territory in accordance with this Agreement (“Third-Party License”),
then Strakan shall be responsible for all payments, one hundred percent (100%) on par, with respect to the Third Party License (subject to the proviso to this sentence) and Aptalis and its Affiliates and subcontractors may deduct [*] of the
payments actually made to such Third Party pursuant to such Third Party License with respect to the Product from the next payment due to Strakan under Article 8 hereof (the “Third-Party Payment”); [*]. In no event, however, shall
Strakan have any liability to (a) [*] or (b) Aptalis with respect to [*]. Aptalis shall not enter into a Third-Party License without first obtaining the prior written consent of Strakan which consent shall not be unreasonably withheld,
conditioned or delayed. 
 10.7 Trademark. 

10.7.1 Ownership of Names. Each Party and its Affiliates shall retain all right, title and interest in and to its and their respective
corporate names and logos. 
 10.7.2 Acknowledgment of Ownership. Each Party acknowledges the sole ownership by the other Party and
validity of all trademarks, trade dress, logos and slogans owned by the other Party and used or intended to be used on or in connection with the Commercialization of the Product in the Territory. Each Party agrees that it will not at any time during
or after the Term assert or claim any interest in or do anything which may adversely affect the validity or enforceability of any trademark, trade dress, logo or slogan owned by the other Party and used or intended to be used on or in connection
with the marketing or sale of the Product. Neither Party will register, seek to register or cause to be registered any trademarks, trade dress, logos or slogans owned by the other Party and used or intended to be used on or in connection with the
marketing or sale of the Product or any variation thereof, under any applicable Law providing for registration of trademarks, service marks, trade names, fictitious names or similar Laws, as an Internet domain name, or in the name of a corporation,
partnership, limited liability company or other entity, without the other Party’s prior written consent. 
 10.7.3 Assignment of
Trademark. Within five (5) business days after the Effective Date, Strakan shall file a statement of use with the United States Patent and Trademark Office (the “USPTO”), along with a declaration, proof of use, the required
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use, Strakan will execute an assignment of the Trademark and any related domain names, in substantially the same form as shown in Exhibit G (“Assignment”), transferring,
as of the Effective Date, all right title and interest in and to the Trademark and the domain names which contain the Trademark, listed in Exhibit G throughout the world, to Aptalis. Strakan will cooperate with Aptalis in filing all documents
required by the USPTO, any domain name registrar and any other entity to effectuate the assignment of the Trademark and the domain names, and any recordal thereof. Upon execution of the Assignment, the Trademark will be solely owned by Aptalis and
Strakan will be bound by the terms of Section 10.7.2 herein, with respect to such ownership by Aptalis. 
 10.7.4 Infringement and
Enforcement. In the event that either Party becomes aware of any infringement of the Trademark by a Third Party prior to execution of the Assignment, such Party shall promptly notify the other Party. In such event of a Third Party infringement
of the Trademark, Strakan will cooperate with Aptalis, at its own expense, in providing any assistance necessary if Aptalis chooses, in its sole discretion and at its own expense, to take legal action with respect to such infringement of the
Trademark. 
 10.7.5 License of Trademark. During the period between the Effective Date and the execution of the Assignment
(“Interim Period”), Strakan grants Aptalis a royalty free, exclusive right and license (even as to Strakan) to use the Trademark in connection with the Product. Any such use of the Trademark by Aptalis during the Interim Period and
pursuant to this license shall be of a quality at least equal to and substantially consistent with Strakan’s use of the Trademark prior to the Effective Date. Aptalis agrees that it will not, during the Interim Period, engage in any commercial
act or other practice that could reasonably be anticipated to disparage, injure or impair the value of the reputation and goodwill associated with Strakan or the Trademark. Upon reasonable request and reasonable prior notice during the Interim
Period, Strakan may inspect during regular business hours all facilities operated by Aptalis Licensee solely to verify proper use of the Trademark. 

ARTICLE 11 

REPRESENTATIONS AND WARRANTIES 

11.1 Representations, Warranties and Covenants. 

11.1.1 Mutual Representations. Each of the Parties hereby represents and warrants to the other Party that, as of the Signing Date and
the Effective Date: 
 (a) Such Party has full corporate right, power and authority to enter into this Agreement and to perform its
respective obligations under this Agreement and that it has the right to grant the licenses and sublicenses granted pursuant to this Agreement. 

(b) This Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms. The execution,
delivery and performance of this Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a Party or by which it is bound, nor violate any applicable Law of any Governmental Authority
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 (c) Such Party has not granted any right to any Third Party that would conflict with the rights
granted to the other Party hereunder. 
 (d) Except for Regulatory Approvals, manufacturing approvals and/or similar approvals necessary
for the Development, Manufacture or Commercialization of the Product (and the components thereof), such Party has obtained all necessary consents, approvals and authorizations of all Government Authorities and other Persons required to be obtained
by it as of the Signing Date and the Effective Date in connection with the execution, delivery and performance of this Agreement. 
 (e)
There is no action or proceeding pending against such Party or, to such Party’s knowledge, threatened against such Party that questions the validity of this Agreement or any action taken by such Party in connection with the execution of this
Agreement. 
 11.1.2 Additional Representations of Strakan and ProStrakan. As of the Signing Date and the Effective Date, Strakan
represents and warrants in accordance with Sections 11.1.2(a)-(n) and 11.1.2(p), ProStrakan represents and warrants in accordance with Section 11.2.2(o) and Strakan and ProStrakan jointly and severally represent and warrant in accordance
with Section 11.1.2(q) to Aptalis, , that: 
 Accuracy of Information and Intellectual Property Rights 

(a) No statement made by Strakan in this Agreement contains any untrue material statement or omits to state a material fact necessary to make
such statement, in light of the circumstances in which it was made, not misleading. Strakan does not have knowledge of any fact that has specific application to the Compound or the Product that may materially adversely affect the commercial
prospects for the Product in the Territory. 
 (b) Strakan is the exclusive owner, free and clear of any liens, claims, and encumbrances of
any Person, of the Strakan Patents, the Strakan Know-How, the Trademark, the Product Trade Dress and the Promotional Materials in existence on the Signing Date and the Effective Date. 

(c) As far as Strakan is aware, none of the Strakan Patents, the Strakan Know-How, the Trademark, the Product Trade Dress or the Promotional
Materials to be made available by Strakan to Aptalis pursuant to this Agreement infringe, dilute, misappropriate or otherwise violate the Intellectual Property Rights of any Third Party, nor would as far as Strakan is aware, the Commercialization of
the Product in the Territory infringe, dilute, misappropriate or otherwise violate the Intellectual Property Rights of any Third Party. 

(d) There are no pending proceedings in any court, arbitration, administrative or other tribunal in the Territory which are concerned with
the validity or ownership of any of any Strakan Patent or the Trademark or Product Trade Dress. 

  
  

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 (e) Strakan has not, and no Strakan Affiliate, has received any complaints and there are no
pending proceedings or claims in any court, alleging that the exploitation of any Strakan Patent or that the use of the Trademark or Product Trade Dress infringe or would infringe the Intellectual Property Rights of any person in the Territory. 

(f) The Strakan Patents and the Trademark (to the extent they are granted) are subsisting and all applications or registrations for the
Strakan Patents and Trademark are pending in the United States. The legal and beneficial owner or applicant for registration of each of the Strakan Patents and the Trademark is Strakan. 

(g) The Strakan Patents, the Trademark, the Strakan Know-How and the Product Trade Dress are the only Intellectual Property Rights owned by,
licensed to or used by Strakan or its Affiliates in relation to the Product in the Territory; and as far as Strakan is aware, no Intellectual Property Rights other than the Strakan Patents, the Trademark, the Strakan Know-How, and the Product Trade
Dress are required in order to Manufacture, Develop, use, import and/or sell or Commercialize the Product in the Territory. 
 (h) All
actions required to be taken before the Signing Date and the Effective Date for the Maintenance of the Strakan Patents and the Trademark (including all applicable fees due and payable before such date) have been taken or paid provided that foregoing
is given to the best of Strakan’s knowledge in relation to Strakan Patent which have been licensed to it and are not owned by it. 

(i) None of the Strakan Patents or Strakan Know-How arose from work funded in whole or in part by United States or other governmental
funding. 
 Product NDA /Regulatory 

(j) Product NDA 21-359 is the only Regulatory Approval held by Strakan or its Affiliates in relation to the marketing and sale of the Product
in the Territory. ProStrakan is an Affiliate of Strakan within the meaning of the definition thereof in this Agreement. 
 (k) Strakan has
not, and no Strakan Affiliate has, received any notice from any Governmental Authority in the Territory or in any jurisdiction in which the Product is Manufactured for Aptalis pursuant to the Supply Agreement claiming that the Product is not
currently in compliance with any relevant requirement of such Governmental Authority. 
 (l) Strakan does not know, and no Strakan
Affiliate has knowledge, of anything that is reasonably likely to result in the revocation, suspension or modification of the Product NDA. 

(m) Neither Strakan nor any Strakan Affiliate has entered into any agreement or understanding with FDA with respect to the conduct of any
Supplemental Studies except as set out in Exhibit C and Strakan has made available to Aptalis all material correspondence and notes of all phone calls related thereto. 

  
  

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 (n) Neither Strakan nor any Strakan Affiliate is engaged in any litigation, opposition or
arbitration proceedings affecting or relating to the Product (including claims relating to product liability or any clinical trial) as plaintiff or defendant and there are no such proceedings pending or threatened by or against Strakan or any
Strakan Affiliate and Strakan is not aware of facts or circumstances likely to give rise to any such proceedings. 
 (o) In respect of the
Compound and Product, ProStrakan has prepared, maintained and retained in all material respects all Regulatory Documentation prepared by or for ProStrakan for filing in the Territory (the “Subject Documentation”) that is required to
be maintained or reported pursuant to and in accordance with cGCP, cGLP and all other material applicable Law in the Territory or in any jurisdiction in which the Product is Manufactured for Aptalis pursuant to the Supply Agreement and all such
information is true, complete and correct in all material respects. 
 (p) The information provided by Strakan to Aptalis in connection
with the negotiation of this Agreement fairly describes all Adverse Events of which Strakan has knowledge in respect of the Product. “Adverse Events” means (i) any finding from tests in laboratory animals or in vitro that
suggests a significant risk for human subjects including reports of mutagenicity, teratogenicity or carcinogenicity and (ii) any undesirable, untoward or noxious event or experience associated with the clinical, commercial or other use or
occurring following administration, of a product in humans, occurring at any dose, whether expected or unexpected and whether or not considered related to or caused by a product, including such an event or experience as occurs in the course of the
use of a product in professional practice, in a clinical trial, from overdose, whether accidental or intentional, from abuse, from withdrawal or from a failure of expected pharmacological or biological therapeutic action of a product, and including
those events or experiences that are required to be reported to the FDA under 21 C.F.R. Sections 312.32 or 314.80 or to Regulatory Authorities under corresponding applicable Law outside the United States. 

(q) As far as Strakan and ProStrakan are aware Strakan or its Affiliates and licensees have conducted or are conducting those Clinical
Studies with respect to the Compound and those Clinical Studies with respect to Product set forth on Exhibit H. As far as Strakan is aware Strakan and its Affiliates have conducted, and have caused their respective contractors and consultants
to conduct, the aforesaid studies and any and all other preclinical and Clinical Studies related to the Product conducted by any such Person in accordance in all material respects with applicable cGCP, cGLP and all other applicable Law. As far as
Strakan and ProStrakan are aware all Clinical Data resulting from the Clinical Studies set forth on Exhibit H and any other Clinical Studies conducted by Strakan, its Affiliates or its licensees in respect of the Compound or Product has been
or will be collected or acquired, maintained and used in compliance with applicable Law and the transfer of all such Clinical Data to Aptalis, or the making available of the same to Aptalis, as contemplated hereby will comply with all requirements
of applicable Law. For the purposes of this Section 11.1.2(q), “Clinical Studies” means clinical investigations as defined in 21 C.F.R. 312.3(b) and clinical trials governed by Directive 2001/20/EC. 

  
  

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 11.1.3 Additional Representations of Aptalis and Compliance with Applicable Law. 

(a) Aptalis hereby represents and warrants to Strakan that, as of the Signing Date and the Effective Date, Aptalis has the ability to perform
all of its obligations under this Agreement. 
 (b) Aptalis hereby represents and warrants to Strakan that, as of the Signing Date and the
Effective Date, neither it nor its Affiliates has been debarred or is subject to debarment and neither it nor any of its Affiliates will use in any capacity, in connection with the Development or Commercialization of the Product, any Person who has
been debarred pursuant to Section 306 of the United States Federal Food, Drug and Cosmetic Act, or who is subject of a conviction described in such section. Further, Aptalis agrees to inform Strakan in writing immediately if it or any Person
who is performing services hereunder is debarred or is the subject of a conviction described in Section 306, or if any action, suit, claim, investigation or legal administrative proceeding is pending or, to the best of Aptalis’s knowledge,
is threatened, relating to the debarment of Aptalis, its Affiliates or any Person used in any capacity by Aptalis or its Affiliates in connection with the Development or Commercialization of the Product. 

(c) Aptalis hereby represents, warrants and covenants that it and its Affiliates will not Commercialize the Product outside the Territory,
except as explicitly authorized by Strakan. 
 (d) Aptalis hereby represents, warrants and covenants that as at the Signing Date and the
Effective Date it and its Affiliates are not aware of any Patent that would need to be the subject of a Third Party License as envisaged by Section 10.6.6. 

11.2 Disclaimer of Warranty. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN SECTION 11.1 OF THIS AGREEMENT, NEITHER PARTY MAKES ANY
REPRESENTATIONS AND GRANTS NO WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND STRAKAN AND APTALIS EACH SPECIFICALLY DISCLAIM ANY OTHER REPRESENTATIONS AND WARRANTIES, WHETHER WRITTEN OR ORAL,
EXPRESS, STATUTORY OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES. 
 11.3 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY LOST PROFITS (EXCEPT AS OTHERWISE PROVIDED
FOR IN SECTION 13.2), SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, HOWEVER CAUSED, ON ANY THEORY OF LIABILITY AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, ARISING UNDER ANY CAUSE OF ACTION
AND ARISING IN ANY WAY OUT OF THIS AGREEMENT. THE FOREGOING LIMITATIONS WILL NOT LIMIT EITHER PARTY’S OBLIGATIONS TO THE OTHER PARTY UNDER ARTICLE 9 AND ARTICLE 14. 

  
  

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 11.4 Death or Personal Injury Liability. Nothing in this Agreement shall limit any
Party’s liability for death or personal injury caused by negligence or for fraudulent misrepresentation. 
 11.5 Essential
Basis. The Parties acknowledge and agree that the disclaimers, exclusions and limitations of liability set forth in this Article 11 form an essential basis of this Agreement, and that, absent any of such disclaimers, exclusions or limitations of
liability, the terms of this Agreement, including the economic terms, would be substantially different. 
 ARTICLE 12 

TERM AND TERMINATION 
 12.1
Term. Unless sooner terminated as provided herein, this Agreement shall continue in effect in the Territory for as long as Aptalis, its Affiliates, distributors, subcontractors or sublicensees continues to sell the Product (the
“Term”), it being understood that any temporary suspension in Sales that is not intended by Aptalis, its Affiliates, distributors, subcontractors or sublicensees to be permanent shall not be considered a cessation of sales provided
that Aptalis is using its Commercially Reasonable Efforts to recommence Sales of Product as soon as reasonably possible. 
 12.2
Termination for Breach. Either Party may, without prejudice to any other remedies available to it at Law or in equity, terminate this Agreement in the event that the other Party (the “Breaching Party”) shall have committed a
material breach of this Agreement. The Breaching Party shall have sixty (60) days after written notice thereof was provided to the Breaching Party by the non-breaching Party to remedy such default. 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. If there is a dispute between the Parties regarding any amounts due hereunder,
Aptalis may withhold payment with respect to those amounts that Aptalis believes in good faith are inaccurate or are otherwise not in accordance with the terms of this Agreement until resolution in accordance with the procedures set forth in Article
15, and any such withholding shall not be considered a breach of this Agreement. 
 12.3 Termination by Either for Safety Concerns.
Either Party may terminate this Agreement as to the Product, to the extent that there is a permanent recall or withdrawal of the Product in the Territory. 

12.4 Patent Challenge. Strakan will be permitted to terminate this Agreement by written notice effective upon receipt if Aptalis or its
Affiliates directly, or indirectly through assistance granted to a Third Party (save where such assistance is ordered by a court, patent office or other tribunal), commence any interference or opposition proceeding, challenge the validity or
enforceability in any patent office or court proceedings of, or oppose any extension of or the grant 

  
  

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of a supplementary protection certificate with respect to, the Strakan Patent (each such action, a “Patent Challenge”) provided that if the Strakan Patent is asserted against
Aptalis or its Affiliate or its subcontractors under the direction of Strakan for activities authorized under this Agreement, then such Party is entitled to all and any defenses available to it including challenging the validity or enforceability of
such patent without enabling Strakan to terminate this Agreement. 
 ARTICLE 13 

EFFECTS OF TERMINATION 

13.1 Expiration of the Agreement or Termination Pursuant to Articles 12 or 16. In the event that the Term of this Agreement expires as
contemplated by Section 12.1 or is terminated pursuant to Sections 12.2, 12.3, 12.4 or Article 16, or is terminated by Aptalis pursuant to Section 2.10.3(a) then the following provisions, subject to Section 13.2, will apply: 

13.1.1 Assignments. Aptalis will promptly (and in each case within sixty (60) days after receipt of Strakan’s request): 

(a) upon Strakan’s request, assign to Strakan all of Aptalis’s right, title and interest in and to any agreements between Aptalis
and Third Parties that are freely assignable by Aptalis and that relate to the Development Plan or Commercialization of the Product in the Territory. If any such agreements do not relate exclusively to the Development Plan or Commercialization of
the Product will, if reasonably possible, assign the relevant part of the agreement to Strakan. 
 (b) assign to Strakan all of
Aptalis’s right, title and interest in and to any (i) Promotional Materials and (ii) the Trademark and trade dress, (including any goodwill associated therewith), any registrations and design patents for the foregoing and any Internet
domain name registrations for such trademarks and slogans, all to the extent solely related to the Product in any territory for which such termination is effective; 

(c) assign to Strakan the management and continued performance of any clinical trials for the Product pursuant to any Supplemental Studies
ongoing as of the effective date of such termination in any territory for which such termination is effective; 
 (d) transfer to Strakan
all of Aptalis’s right, title and interest in and to any and all regulatory filings and Regulatory Approvals for the Product (including Product NDA number 21-359 and the Product IND and supplements to the foregoing) in the Territory. 

(e) return all Confidential Information of Strakan in accordance with the provisions of Section 9.1.2; 

(f) to the extent that any agreement or other asset described in this Section 13.1.1 is not assignable by Aptalis, then such agreement
or other asset will not be assigned, and upon the request of Strakan, Aptalis will take such steps as may be necessary to allow Strakan to obtain and to enjoy the benefits of such agreement or other asset, without additional payment therefor, in the
form of a license or other right to the extent Aptalis has the right and ability to do so; and 

  
  

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 (g) provide copies of any other books, records, documents and instruments to the extent related
to the Product. 
 Strakan shall pay the reasonable and actually incurred expenses associated with the transfers described in this Section 13.1.1 but
except for such expenses such transfers shall be for nil consideration. 
 13.1.2 Disclosure and Delivery. Aptalis will promptly
transfer to Strakan at Strakan’s reasonable cost any Aptalis Know-How Controlled by Aptalis (“Aptalis Know-How”), to the extent then used exclusively in connection with the Development or Commercialization of the Product; such
transfer shall be effected by the delivery of documents, to the extent such Know-How is embodied in documents, and to the extent that Aptalis Know-How is not fully embodied in documents, Aptalis shall, at Strakan’s reasonable cost, make its
employees and agents who have knowledge of such Aptalis Know-How in addition to that embodied in documents available to Strakan at Aptalis’s premises for interviews, demonstrations and training to effect such transfer in manner sufficient to
enable Strakan to practice such Aptalis Know-How as theretofore practices by Aptalis. Subject to Section 13.1.1(b), Aptalis shall also promptly transfer to Strakan all Promotional Materials. 

13.1.3 Disposition of Inventory. Strakan shall have the option, exercisable within thirty (30) days following the effective date
of such termination, to purchase any inventory of Products affected by such termination at the price for which the Product was sold to Aptalis by Strakan hereunder. Strakan may exercise such option by written notice to Aptalis during such thirty
(30)-day period. Upon such exercise, the Parties will establish mutually agreeable payment and delivery terms for the sale of such inventory. If Strakan does not exercise such option during such thirty (30)-day period, or if Strakan provides Aptalis
with written notice of its intention not to exercise such option, then Aptalis and its Affiliates will be entitled, during the period ending on the last day of the sixth (6th) full month following the effective date of such termination, to sell
any inventory of Products affected by such termination that remain on hand as of the effective date of the termination, so long as Aptalis pays to Strakan the royalties applicable to said subsequent sales, with respect to sales in the Territory, as
applicable, in accordance with the terms and conditions set forth in this Agreement. 
 13.1.4 [*] 

13.2 Accrued Rights. Termination of this Agreement for any reason will be without prejudice to any rights that will have accrued to the
benefit of a Party prior to the effective date of such termination. Such termination will not relieve a Party from obligations that are expressly indicated to survive the termination of this Agreement. 

  
  

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 13.3 Survival. The following Articles and Sections, together with any definitions used or
exhibits referenced therein, will survive any expiration or termination of this Agreement: Sections 2.8, 4.1.4(c), Section 4.7 (with regard to the license granted to Strakan under Additional Development Data), 5.4, 5.5, 8.6 and Articles 1, 9,
10 (excluding 10.6.6), 11, 13, 14, 15, 17. 
 ARTICLE 14 

INDEMNIFICATION; INSURANCE 

14.1 Indemnification. 

14.1.1 Indemnification by Aptalis. Aptalis hereby agrees to save, defend and hold Strakan, its Affiliates, and their respective
directors, agents and employees harmless from and against any and all Third Party Losses arising in connection with any and all charges, complaints, actions, suits, proceedings, hearings, investigations, claims, demands, judgments, orders, decrees,
stipulations or injunctions by a Third Party (each a “Third Party Claim”) resulting from (a) any material breach by Aptalis of any of its representations, warranties or covenants pursuant to this Agreement, (b) the gross
negligence or willful misconduct by Aptalis or its Affiliates or their respective officers, directors, employees, agents or consultants in performing any obligations under this Agreement, (c) any research and Development activities conducted by
Aptalis; (d) any alleged violation of any applicable Laws by Aptalis, its Affiliates or their subcontractors, including Laws relating to the Commercialization of the Products in the Territory; in each case except to the extent that such Third
Party Losses are subject to indemnification by Strakan pursuant to Section 14.1.2. 
 14.1.2 Indemnification by Strakan. Strakan
hereby agrees to save, defend and hold Aptalis, its Affiliates, and their respective directors, agents and employees harmless from and against any and all Third Party Losses arising in connection with any and all Third Party Claims resulting from
(a) any material breach by Strakan of any of its representations, warranties or covenants pursuant to this Agreement or (b) the gross negligence or willful misconduct by Strakan or its Affiliates or their respective officers, directors,
employees, agents or consultants in performing any obligations under this Agreement; and (c) any research and Development activities conducted by Strakan, and (d) any alleged violation by Strakan, its Affiliates or their sublicensees or
subcontractors, of any applicable Laws; in each case except to the extent that such Third Party Losses are subject to indemnification by Aptalis pursuant to Section 14.1.1. 

14.1.3 Other Provisions. The rights of indemnification under this Section 14.1 shall be subject to the provisions of Sections 14.2
through 14.8. 
 14.2 Notice of Claim. All indemnification claims in respect of any indemnitee seeking indemnity under
Section 14.1 (collectively, the “Indemnitees” and each an “Indemnitee”) will be made solely by the corresponding Party (the “Indemnified Party”). The Indemnified Party will give the
indemnifying Party (the “Indemnifying Party”) prompt written notice (an “Indemnification 

  
  

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Claim Notice”) of any Third Party Losses or the discovery of any fact upon which such Indemnified Party intends to base a request for indemnification under Section 14.1, but in
no event will the Indemnifying Party be liable for any Third Party Losses that result from any delay in providing such notice which materially prejudices the defense of such Third Party Claim. Each Indemnification Claim Notice must contain a
description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss are known at such time). Together with the Indemnification Claim Notice, the Indemnified Party will furnish promptly to the
Indemnifying Party copies of all notices and documents (including court papers) received by any Indemnitee in connection with the Third Party Claim. The Indemnifying Party shall not be obligated to indemnify the Indemnified Party to the extent any
admission or statement made by the Indemnified Party materially prejudices the defense of such Third Party Claim. 
 14.3 Control of
Defense. At its option, the Indemnifying Party may assume the defense of any Third Party Claim subject to indemnification as provided for in Sections 14.1.1 and 14.1.2 by giving written notice to the Indemnified Party within thirty
(30) days after the Indemnifying Party’s receipt of an Indemnification Claim Notice. Upon assuming the defense of a Third Party Claim, the Indemnifying Party may appoint as lead counsel in the defense of the Third Party Claim any legal
counsel it selects. Should the Indemnifying Party assume the defense of a Third Party Claim, the Indemnifying Party will not, except as provided in Sections 14.4 below, be liable to the Indemnified Party or any other Indemnitee for any legal
expenses subsequently incurred by such Indemnified Party or other Indemnitee in connection with the analysis, defense or settlement of the Third Party Claim. 

14.4 Right to Participate in Defense. Without limiting Section 14.3, any Indemnitee will be entitled to participate in, but not
control, the defense of a Third Party Claim for which it has sought indemnification hereunder and to employ counsel of its choice for such purpose; provided, however, that such employment will be at the Indemnitee’s own expense unless
(a) the employment thereof has been specifically authorized by the Indemnifying Party in writing, or (b) the Indemnifying Party has failed to assume the defense and employ counsel in accordance with Section 14.3 (in which case the
Indemnified Party will control the defense). 
 14.5 Settlement. With respect to any Third Party Losses relating solely to the
payment of money damages in connection with a Third Party Claim and that will not result in the Indemnitee’s becoming subject to injunctive or other relief or otherwise adversely affect the business of the Indemnitee in any manner, and as to
which the Indemnifying Party will have acknowledged in writing the obligation to indemnify the Indemnitee hereunder, the Indemnifying Party will have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise
dispose of such Third Party Loss, on such terms as the Indemnifying Party, in its reasonable discretion, will deem appropriate (provided, however that such terms shall include a complete and unconditional release of the Indemnified Party from all
liability with respect thereto), and will transfer to the Indemnified Party all amounts which said Indemnified Party will be liable to pay prior to the time of the entry of judgment. With respect to all other Third Party Losses in connection with
Third Party Claims, where the Indemnifying Party has assumed the defense of the Third Party Claim in accordance with Section 14.3, the Indemnifying Party will 

  
  

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have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Third Party Loss; provided, however, it obtains the prior written consent of the
Indemnified Party (which consent will be at the Indemnified Party’s reasonable discretion). The Indemnifying Party that has assumed the defense of the Third Party Claim in accordance with Section 14.3 will not be liable for any settlement
or other disposition of a Third Party Loss by an Indemnitee that is reached without the written consent of such Indemnifying Party. Regardless of whether the Indemnifying Party chooses to defend or prosecute any Third Party Claim, no Indemnitee will
admit any liability with respect to, or settle, compromise or discharge, any Third Party Claim without first offering to the Indemnifying Party the opportunity to assume the defense of the Third Party Claim in accordance with Section 14.3. 

14.6 Cooperation. If the Indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party will, and will
cause each other Indemnitee to, cooperate in the defense or prosecution thereof and will furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may
be reasonably requested in connection with such Third Party Claim. Such cooperation will include access during normal business hours afforded to the Indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information
that are reasonably relevant to such Third Party Claim, and making Indemnitees and other employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the
Indemnifying Party will reimburse the Indemnified Party for all its reasonable out-of-pocket expenses incurred in connection with such cooperation. 

14.7 Expenses of the Indemnified Party. Except as provided above, the reasonable and verifiable costs and expenses, including fees and
disbursements of counsel, incurred by the Indemnified Party in connection with any Third Party Claim will be reimbursed on a Calendar Quarter basis by the Indemnifying Party, without prejudice to the Indemnifying Party’s right to contest the
Indemnified Party’s right to indemnification and subject to refund in the event the Indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party. 

14.8 Product Claims. 

14.8.1 Allocation of Third Party Losses. Subject to Sections 14.1.1 and 14.1.2 and the terms of the Supply Agreement, with respect to
Third Party Losses from Third Party Claims resulting directly or indirectly from the Development, Manufacture, use, handling, storage, sale or other disposition of the Product (including those Third Party Claims that involve death or bodily injury
(or allegations thereof) to any individual or any property other than Intellectual Property Rights) in the Territory (each, a “Product Claim”), Aptalis shall be responsible for such Third Party Losses to the extent the Product Claim
relates to the Territory. 
 14.8.2 Defense of Product Claims. Each Party shall give the other prompt written notice of any Product
Claim (actual or potential), but the omission of such notice shall not relieve either Party from its obligations under this Section 14.8, except to the extent the other Party can establish actual prejudice and direct damages as a result
thereof. Aptalis shall assume the lead role in the defense of such Product Claim. Aptalis shall consult with Strakan on all material aspects of 

  
  

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any material decisions to be taken with regard to, the defense, including settlement of such Product Claim, and Strakan shall have a full opportunity to participate in decision-making process
with respect to the strategy of such defense, and the Parties shall cooperate fully with each other in connection therewith. Aptalis will use its Commercially Reasonable Efforts to ensure that any Third Party with which it is proposing to settle a
Product Claim will agree to keep the terms of the settlement confidential. If such Third Party is not prepared to agree to keep the settlement terms confidential, Aptalis will notify Strakan before entering into such settlement and further shall not
enter into such settlement agreement for a period of two (2) Business Days from such notification. Strakan shall also have the right to participate in the defense of any Product Claim utilizing attorneys of its choice, at its own expense. In
furtherance of the Parties’ cooperation, Aptalis will consult with Strakan regarding strategic decisions, including the retention of counsel and defense of each Product Claim. Aptalis will otherwise keep Strakan fully informed of the status and
progress of the defense and any settlement discussions concerning the Product Claim. 
 14.9 Insurance. Each Party will obtain and
keep in force, through self-insurance or otherwise, in a form reasonably acceptable to the other Party hereto, insurance in scope and amount as required by Law applicable to a Party’s activities hereunder and such additional amounts as may be
reasonably necessary to cover such Party’s indemnity obligations under this Agreement with scope and coverage as is normal and customary in the biotechnology/pharmaceutical industry generally for parties similarly situated. It is understood
that such insurance will not be construed to limit a Party’s liability with respect to its indemnification obligations under this Article 14. Each Party will, except to the extent self-insured, provide to the other Party upon request a
certificate evidencing the insurance such Party is required to obtain and keep in force under this Article 14. Such certificate will provide that such insurance will not expire or be cancelled or modified without at least thirty (30) days’
prior notice to the other Party. 
 ARTICLE 15 

GOVERNING LAW; DISPUTE RESOLUTION 

15.1 Governing Law. This Agreement shall be governed by and interpreted in accordance with the Laws of the State of New York without
giving effect to any conflict of Laws provisions, except matters of Intellectual Property Rights that will be determined in accordance the Intellectual Property Rights Laws relevant to the Intellectual Property Rights in question. The UNICITRAL
Convention for the International Sale of Goods, as well as any other unified Laws relating to the conclusion and implementation of contracts for the international sale of goods, will not apply. 

15.2 Dispute Resolution. In the event of a dispute, controversy or claim arising from this Agreement (including non-contractual
disputes) other than claims relating solely or principally to the ownership of Intellectual Property Rights (“Dispute”), the Parties will submit such Dispute to arbitration under the Rules of Arbitration of International Chamber of
Commerce (“ICC”). Unless, the Parties agree otherwise, the number of arbitrators shall be three. One arbitrator shall be appointed by each Party and the third arbitrator shall be appointed by the International Court of Arbitration
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New York if Strakan initiates arbitration proceedings or London, England if Aptalis initiates the arbitration proceedings. The language of the arbitration will be in English. Prior to the
commencement of hearings, each of the arbitrators appointed must provide an oath of undertaking of impartiality. Judgment upon the award rendered by the arbitrators may be entered into any court having jurisdiction thereof. The cost of any such
arbitration will be divided equally between the Parties, with each Party bearing its own attorneys’ fees and costs. The arbitration proceedings and the decision of the arbitrators will be kept confidential by the Parties and the arbitrators.

 ARTICLE 16 

BANKRUPTCY 
 16.1
Termination. This Agreement may be terminated by written notice by either Party (the “Non-Debtor Party”) at any time during the Term of this Agreement (a) upon the declaration by a court of competent jurisdiction
that the other Party (the “Debtor Party”) is bankrupt and, pursuant to the U.S. Bankruptcy Code, the Debtor Party’s assets are to be liquidated, (b) upon the filing or institution of bankruptcy, liquidation or receivership
proceedings (other than reorganization proceedings under Chapter 11 of the U.S. Bankruptcy Code) with respect to the Debtor Party, (c) upon an assignment of a substantial portion of the assets for the benefit of creditors by the Debtor Party,
(d) in the event a receiver or custodian is appointed for the Debtor Party’s business, or (e) if a substantial portion of the Debtor Party’s business is subject to attachment or similar process (each a “Bankruptcy
Event”); provided, however, that in the case of any involuntary bankruptcy proceeding such right to terminate shall become effective only if the proceeding is not dismissed within sixty (60) days after the filing thereof. 

16.2 Effect on Licenses. All rights and licenses granted under or pursuant to this Agreement are licenses of rights to
“intellectual property” as defined in Section 365(n) of Title 11 of the United States Code (“Title 11”). Provided that the Non-Debtor Party does not terminate this Agreement pursuant to this Article 16, each Party
agrees that the other Party, as licensee of such rights under this Agreement shall retain and may fully exercise all of its rights and elections under Title 11. Each Party agrees during the Term of this Agreement, to create and maintain current
copies or, if not amenable to copying, detailed descriptions or other appropriate embodiments, to the extent feasible, of all such intellectual property. If a case is commenced by or against the Debtor Party under Title 11, the Debtor Party (in any
capacity, including debtor-in-possession) and its successors and assigns (including a Title 11 trustee) shall, as the Non-Debtor Party may elect in a written request, immediately upon such request: 

16.2.1 perform all of the obligations provided in this Agreement to be performed by the Debtor Party including, where applicable and without
limitation, providing to the Non-Debtor Party portions of such intellectual property (including embodiments thereof) held by the Debtor Party and such successors and assigns or otherwise available to them; or 

16.2.2 provide to the Non-Debtor Party all such intellectual property (including all embodiments thereof) held by the Debtor Party and such
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 16.2.3 not interfere with the rights of the Non-Debtor Party under this Agreement, or any
agreement supplemental hereto, to such intellectual property (including such embodiments), including any right to obtain such intellectual property (or such embodiments) from another entity, to the extent provided in Section 365(n) of Title 11.

 16.3 Rights to Intellectual Property. If (a) a Title 11 case is commenced by or against the Debtor Party, (b) this
Agreement is rejected as provided in Title 11, and (c) the Non-Debtor Party elects to retain its rights under this Agreement as provided in Title 11, then the Debtor Party (in any capacity, including debtor-in-possession) and its successors and
assigns (including a Title 11 trustee) shall provide to the Non-Debtor Party all such intellectual property (including all embodiments thereof) held by the Debtor Party and such successors and assigns, or otherwise available to them, immediately
upon the Non-Debtor Party’s written request. Whenever the Debtor Party or any of its successors or assigns provides to the Non-Debtor Party any of the intellectual property licensed under this Agreement (or any embodiment thereof) pursuant to
this Article 16, the Non-Debtor Party shall have the right to perform the obligations of the Debtor Party under this Agreement with respect to such intellectual property, but neither such provision nor such performance by the Non-Debtor Party shall
release the Debtor Party from any such obligation or liability for failing to perform it. The Parties hereto acknowledge and agree that, other than the milestones to be paid under Section 8.2 and royalties to be paid pursuant to
Section 8.3, no other payments to be made pursuant this Agreement constitute “royalties” within the meaning of Title 11 or relate to licenses of intellectual property under this Agreement. 

16.4 Additional Rights. All rights, powers and remedies of the Non-Debtor provided herein are in addition to and not in substitution
for any and all other rights, powers and remedies now or hereafter existing at Law or in equity (including Title 11) in the event of the commencement of a Title 11 case by or against the Debtor Party. The Non-Debtor Party, in addition to the rights,
power and remedies expressly provided herein, shall be entitled to exercise all other such rights and powers and resort to all other such remedies as may now or hereafter exist at Law or in equity (including Title 11) in such event. The Parties
agree that they intend the foregoing rights to extend to the maximum extent permitted by Law, including for purposes of Title 11, the right of access to any intellectual property (including all embodiments thereof) of the Debtor Party, or any Third
Party with whom the Debtor Party contracts to perform an obligation of the Debtor Party under this Agreement, and, in the case of the Third Party, which is necessary for the research, development, manufacture and Commercialization of Products. 

  
  

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 ARTICLE 17 

MISCELLANEOUS 
 17.1
Notices. All notices or other communications that are required or permitted under this Agreement will be in writing and delivered personally, sent by facsimile (and promptly confirmed by personal delivery or overnight courier as provided in
this Agreement), or sent by internationally-recognized overnight courier to the addresses below. Any such communication will be deemed to have been given (a) when delivered, if personally delivered or sent by facsimile on a Business Day (so
long as promptly confirmed by personal delivery or overnight courier as provided in this Agreement), and (b) on the second Business Day after dispatch, if sent by internationally-recognized overnight courier. Unless otherwise specified in
writing, the mailing addresses of the Parties shall be as described below: 
 If to Strakan, to: 

Strakan International S.a r.l. 

Galabank Business Park 

Galashiels, Scottish Borders, TD1 1QH UK 

ATTN: General Counsel 
 Facsimile:
44 (0)1896 664001 
 If to Aptalis, to: 

Aptalis Pharma US, Inc. 
 22
Inverness Center Parkway 
 Birmingham, Alabama 35242 

ATTN: General Counsel 
 Facsimile:
908-927-9648 
 With a copy, which shall not constitute notice, to: 

Dewey & LeBoeuf LL 

1301 Avenue of the Americas 
 New
York, NY 10019 
 ATTN: Stanton J. Lovenworth, Esq, 

Facsimile: 212-632-0175 
 17.2
Independent Status. Neither Party is an agent, employee or representative of the other. Neither Party shall have the authority to make any statements, representations or commitments of any kind, nor to take any action, which shall be binding
on the other Party, except as may be explicitly authorized by the other Party in writing. This Agreement shall not constitute, create or in any way be interpreted as a joint venture, partnership or formal business organization of any kind. 

17.3 Force Majeure. Neither Party shall be liable to the other for any failure or delay in the fulfillment of its obligations under
this Agreement (other than the payment of monies due and owing to a Party under this Agreement), when any such failure or delay is caused by fire, flood, earthquakes, locusts, explosions, sabotage, terrorism, strikes, lockouts, lack of adequate raw
materials (caused by matters beyond the reasonable control of the performing Party or its subcontractors), civil commotions, riots, invasions, wars, peril of the sea, acts, restraints, requisitions, regulations, or directions of government
authorities (caused by matters beyond the reasonable control of the performing Party or its subcontractors), acts of God, or any similar cause beyond the reasonable control of the performing Party or its subcontractors (each, a “Force
Majeure Event”). In the event that either Party is prevented from discharging its obligations under this Agreement on account of a Force Majeure Event, the performing Party will notify the other Party forthwith, and will nevertheless make
every endeavor, in the utmost good faith, to discharge its obligations, even if in a partial or compromised manner. 

  
  

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 17.4 Entire Agreement; Amendment and Waiver. This Agreement, including the Exhibits and
Schedules attached hereto (each of which is hereby and thereby incorporated herein and therein by reference) between the Parties shall constitute the entire agreement and understanding of the Parties relating to the subject matter of this Agreement
and supersedes all prior oral or written agreements, representations, understandings or arrangements between the Parties relating to the subject matter of this Agreement. No amendment, supplement or other modification to any provision of this
Agreement shall be binding unless in writing and signed by both Parties. No waiver of any rights under this Agreement shall be effective unless in writing signed by the Party to be charged. A waiver of a breach or violation of any provision of this
Agreement will not constitute or be construed as a waiver of any subsequent breach or violation of that provision or as a waiver of any breach or violation of any other provision of this Agreement. 

17.5 Headings; Construction; Certain Conventions. The headings used in this Agreement have been inserted for convenience of reference
only and do not define or limit the provisions hereof. The Exhibits and Schedules to this Agreement are incorporated herein by reference and will be deemed a part of this Agreement. Unless otherwise expressly provided herein or the context of this
Agreement otherwise requires, (a) words of any gender include each other gender, (b) words such as “herein”, “hereof”, and “hereunder” refer to this Agreement as a whole and not merely to the particular
provision in which such words appear, (c) words using the singular will include the plural, and vice versa, (d) the words “include,” “includes” and “including” will be deemed to be followed by the phrase
“but not limited to”, “without limitation”, “inter alia” or words of similar import, (e) the word “or” will be deemed to include the word “and” (e.g., “and/or”) and (f) references
to “Article,” “Section,” “subsection”, “clause” or other subdivision, or to a Schedule or Exhibit, without reference to a document are to the specified provision, Schedule or Exhibit of this Agreement. This
Agreement will be construed as if it were drafted jointly by the Parties and shall not be strictly construed against either Party. 
 17.6
Assignment. Subject to Sections 2.10, none of the Parties herein shall assign or transfer any of their rights or obligations under this Agreement without the prior written consent of the other Party. Each Party shall be entitled (without the
consent of the other Party) to assign this Agreement (or any of its rights or obligations under this Agreement) to (a) its Affiliate (as long as such entity remains an Affiliate of the relevant Party) provided that the assigning Party shall be
responsible for the performance of this Agreement by such Affiliate; or (b) to any corporation to which it has sold all or substantially all of its assets relating to this Agreement provided that the acquiring corporation agrees in writing to
be bound by the terms of this Agreement. If a Party delegates all or any of its obligations under this Agreement to any Third Party, the Party delegating shall be fully responsible to the other Party for the proper performance of those obligations
and for any negligent act or omission made by the Third Party or its staff in relation thereto. For purposes of clarity, any change of control or merger, consolidation, initial public offering or other financing activity of a Party shall not be
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 17.7 Severability. If any provision of this Agreement or application thereof to anyone is
adjudicated to be invalid or unenforceable in any jurisdiction, such invalidity or unenforceability shall not affect any provision or application of this Agreement which can be given effect without the invalid or unenforceable provision or
application and shall not invalidate or render unenforceable such provision or application in any other jurisdiction. Further, the judicial or other competent authority making such determination shall have the power to limit, construe or reduce the
duration, scope, activity and/or area of such provision, and/or delete specific words or phrases as necessary to render, such provision enforceable in such jurisdiction. 

17.8 Further Assurances. Each Party shall, as and when requested by the other Party, do all acts and execute all documents as may be
reasonably necessary to give effect to the provisions of this Agreement. 
 17.9 Counterparts. This Agreement may be executed in one
or more counterparts, each of which shall be deemed to be an original but all of which together shall constitute one and the same instrument. 

17.10 [*] 
  

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 IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate originals by
their proper officers as of the Effective Date. 
  

													
	STRAKAN INTERNATIONAL S.À R.L.	 		 	APTALIS PHARMA US, INC.
					
	By:	 	 /s/ Adam McLean
	 		 	By:	 	 /s/ Frank Verwiel

		 	Name:	 	Adam McLean	 		 		 	Name:	 	Frank Verwiel, MD
		 	Title:	 	Director & General Counsel	 		 		 	Title:	 	President and Chief Executive Officer
						
		 		 		 		 	By:	 	 /s/ Steve Gannon

		 		 		 		 		 	Name:	 	Steve Gannon
		 		 		 		 		 	Title:	 	Senior Vice President, Finance, Chief Financial Officer and Treasurer
					
	PROSTRAKAN INC.	 		 		 		 	
	(For the Purposes of Sections 5.1 and 11.1.2)	 		 		 		 	
						
	By:	 	 /s/ Andrew McLean
	 		 		 		 	
		 	Name:	 	Andrew McLean	 		 		 		 	
		 	Title:	 	Director and General Counsel	 		 		 		 	

  
  

	[*]	Confidential treatment requested. 

 EXHIBIT A 

PRODUCT QUALITY AGREEMENT 

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit A-1 

 Execution Version 

 
 

 
 EXHIBIT A 

THE PRODUCT QUALITY AGREEMENT 

BETWEEN 
 APTALIS PHARMA
US, INC. 
 100 Somerset Corporate Boulevard, 

Bridgewater, NJ 08807 USA 

AND 
 STRAKAN
INTERNATIONAL S.À R.L. 
 (a member of the ProStrakan group of companies) 

Galabank Business Park 

Galashiels TD1 1QH 

United Kingdom 
 For the
Distribution of Rectiv 
 TECHNICAL AGREEMENT REFERENCE NUMBER: CTA1119 

Effective Date: Refer to approval signature. 

  
  

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 Exhibit A-1 

 TABLE OF CONTENTS 
  

							
	 Page
	 	 	  	 	 
			
	 Article 1
	 	SCOPE OF THIS AGREEMENT	  	 	1	  
			
	 Article 2
	 	DEFINITIONS	  	 	2	  
			
	 Article 3
	 	AUTHORIZATIONS	  	 	4	  
			
	 Article 4
	 	MANUFACTURE & SUPPLY OF PRODUCTS	  	 	4	  
			
	 Article 5
	 	CERTIFICATION OF FINISHED PRODUCTS FOR SHIPPING	  	 	5	  
			
	 Article 6
	 	FINAL RELEASE TO MARKET OF FINISHED PRODUCTS	  	 	6	  
			
	 Article 7
	 	DOCUMENTATION	  	 	6	  
			
	 Article 8
	 	ADDITIONAL MATERIAL SOURCING	  	 	7	  
			
	 Article 9
	 	TESTING	  	 	9	  
			
	 Article 10
	 	PRINTED PACKAGING ADDITIONAL MATERIALS CONTROL	  	 	9	  
			
	 Article 11
	 	NOTIFICATION AND APPROVAL OF DEVIATIONS AND NON-CONFORMANCE	  	 	10	  
			
	 Article 12
	 	REFERENCE AND RETENTION SAMPLES	  	 	12	  
			
	 Article 13
	 	STORAGE OF PRODUCT / ENVIRONMENTAL MONITORING	  	 	12	  
			
	 Article 14
	 	COMPLAINTS	  	 	13	  
			
	 Article 15
	 	CHANGE CONTROL	  	 	13	  
			
	 Article 16
	 	REPROCESSING AND REWORK	  	 	14	  
			
	 Article 17
	 	SUB-CONTRACTING	  	 	14	  
			
	 Article 18
	 	REGULATORY INSPECTIONS	  	 	14	  
			
	 Article 19
	 	PERIODIC QUALITY REVIEWS	  	 	15	  
			
	 Article 20
	 	ON-GOING GMP STABILITY	  	 	15	  
			
	 Article 21
	 	ANNUAL REPORT	  	 	15	  

  
  

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 Exhibit A-1-i 

							
	 Article 22
	  	CHANNELS OF COMMUNICATION	  	 	15	  
			
	 Article 23
	  	REVIEW	  	 	15	  

  

					
			
	 APPENDIX 1
	  	FINISHED PRODUCT LISTING	  	1-1
			
	 APPENDIX 2
	  	CONTRACT MANUFACTURER AUTHORIZATION TO MANUFACTURE	  	2-1
			
	 APPENDIX 3
	  	SUMMARY OF MARKETING AUTHORIZATION	  	3-1
			
	 APPENDIX 4
	  	DIVISION OF PHARMACEUTICAL RESPONSIBILITIES CHECKLIST	  	4-1
			
	 APPENDIX 5
	  	CONTACT NAMES	  	5-1
			
	 APPENDIX 6
	  	LIST OF CURRENT SUBCONTRACTORS	  	6-1
			
	 APPENDIX 7
	  	CHANGE HISTORY LOG	  	7-1
			
	 APPENDIX 8
	  	LIST OF APPROVED SUPPLIERS	  	8-1

  
  

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 Exhibit A-1-ii 

 Article 1 SCOPE OF THIS AGREEMENT 

This Product Quality Agreement (this “Agreement”), dated as of the Effective Date, defines the roles and responsibilities for the Manufacture,
assembly, quality control, release, storage and distribution of the medical product(s) listed in Appendix 1. 
 For the avoidance of doubt, the commercial
arrangements relating to the storage and distribution of the Product are addressed in the commercialization and license agreement (the “License Agreement”) and the supply agreement (the “Supply Agreement”) each
entered into between the Parties and both of even date to this Agreement and in the event of any inconsistency between the terms and conditions of this Agreement and the terms and conditions of the License Agreement or the Supply Agreement between
the parties, the terms and conditions of this Agreement shall have precedence over the License Agreement and the Supply Agreement with respect to quality and cGMP aspects unless specific reference is made to this Agreement in connection with such
inconsistency. 
 This Agreement is made between: 
 Aptalis
Pharma US, Inc., whose principal place of business is at: 
 100 Somerset Corporate Boulevard, 

Bridgewater, NJ 08807 USA. 
 Hereinafter referred to as
“Aptalis”, and 
 Strakan International S.à r.l. (a member of the ProStrakan group of companies) - a company incorporated in
Luxembourg with offices at: 
 Galabank Business Park, 

Galashiels, 
 TD1 1QH, Scotland

 Hereinafter referred to as “Strakan”. 

  
  

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 Exhibit A-1-1 

 Points to note: 
  

	 	•	 	Strakan has audited the Manufacturing Facilities of its Contract Manufacturer(s) to ensure that the systems were in compliance with cGMP. Strakan will routinely audit its Contract Manufacturer(s) to ensure acceptable
cGMP standards are maintained. 

  

	 	•	 	Following receipt of finished Product Aptalis will be responsible for final release of finished packs for sale and supply in the Territory. 

 

	 	•	 	Each party undertakes to provide the other with all reasonable information and assistance such party requires to discharge their responsibilities under this Agreement. 

Communication 
 Strakan and Aptalis have identified key
contact personnel for critical quality processes to ensure responsible individuals are contacted to address issues that may arise. 
 Aptalis may, upon
notice to Strakan, designate its own employee or an employee of any of its Affiliates to act as a contact person with regard to the responsibilities and obligations of Aptalis hereunder or to fulfill the duties or exercise the rights of Aptalis set
out herein. 
 Article 2 DEFINITIONS 

For purposes of this Agreement, in addition to the other terms defined elsewhere in this Agreement, the following initially capitalized terms, whether used in
the singular or plural, will have the following meanings. Other capitalized terms that are used in this Agreement and not defined in this Agreement will have the meaning set forth in the License Agreement or the Supply Agreement. To the extent that
any terms are defined in this Agreement and the License Agreement or the Supply Agreement, for purposes of this Agreement such defined terms will have the meaning set forth in this Agreement. 

The term Marketing Authorization is a defined term used in this Agreement to cover a regulatory approval to market the Product in a specific country, e.g. New
Drug Applications (NDA) in the USA. 
 Other definitions in this Agreement are those detailed or construed from the “Rules”,
“Guidelines” and “Directives” as applied to the control of medicines in the United States. 
 “Batch” shall mean a
specific quantity of Additional Material expected to be homogeneous within specified limits produced or packaged in a process or series of processes; 

  
  

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 Exhibit A-1-2 

 “Batch Record” shall mean Manufacturing documentation, packaging documentation, and exception
documentation, such as a non-conformance report, Deviation Report and Certificate of Analysis, and additional documentation, which may have been processed as part of the production and packaging records of the
Batch; 
 “Bulk Product” shall mean any Product, which has completed all Manufacturing stages up to, but not including packaging in a
primary container; 
 “Deviation” is a temporary modification or exception to usual operating, Manufacturing, packaging, testing
instructions, test results or procedures; 
 “Deviation Report” shall mean a report used to obtain approvals to temporarily modify or to
document exceptions to usual operating, Manufacturing, packaging, testing instructions, test results or procedures. A Deviation Report does not permanently change existing instructions or standard operation procedures, it is intended to be a
specific, “one-time-use” document; 
 “Master Manufacturing Document” shall have the meaning given in Section 7.1; 

“Master Packaging Document” shall have the meaning given in Section 7.2; 

“Product” shall have the meaning given in the Supply Agreement; 

“Quality of the Product” shall mean the quality of the Product described in Appendix 4; 

“Reinspection” shall mean a visual or mechanical evaluation performed to remove/correct defective units and for which the process is not
expected to have an adverse effect on product quality. Reinspection shall involve the use of a Deviation, except where standard procedure allows for such routine activity in the course of normal processing; 

“Reprocessing” shall mean reprocessing all or part of a Lot of a Bulk Product or Product to a previous step in the Manufacturing Process due
to a failure to meet the Specifications for such Bulk Product or Product. Reprocessing procedures are foreseen as occasionally necessary and pre-approved by the quality assurance departments of Strakan and
Aptalis; and 
 “Reworking” shall mean reworking a Bulk Product or Product of a single Lot that failed to meet predetermined Specifications
using an alternative Manufacturing Process. Reworking is an unexpected occurrence and rework must be pre-approved by Strakan and Aptalis and documented per approved Rework documentation requirements and
appended to a Deviation Report. 

  
  

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 Exhibit A-1-3 

 Article 3 AUTHORIZATIONS 

 

	3.1	Marketing Authorization 

  

	 	3.1.1	Subject to assignment thereof by Strakan to Aptalis, Aptalis will provide Strakan with a copy of the Product NDA or a suitable extract or summary of the relevant sections of the Product NDA, upon request, in order for
Strakan to be able to discharge its responsibilities. 

  

	 	3.1.2	Aptalis will be responsible for informing the appropriate authorities of any future variation to the Product NDA and informing Strakan of the same. 

 

	3.2	Authorization to Manufacture 

 Strakan will be responsible for ensuring that it or its Contract
Manufacturer(s) obtains authorization to Manufacture and for ensuring that any necessary variations to the authorization to Manufacture are obtained to allow continued production of the Products. A copy of the authorization to Manufacture is
provided in Appendix 2. 
 Article 4 MANUFACTURE & SUPPLY OF PRODUCTS 

 

	4.1	Strakan will undertake to ensure that production control complies with: 

  

	 	a.	The principles and guidelines of cGMP. 

  

	 	b.	The requirements of the Product NDA summarized in Appendix 3. 

  

	 	c.	The Specifications. 

  

	 	d.	Applicable Laws. 

  

	 	e.	The requirements of this Agreement. 

  

	 	f.	The requirements of the License Agreement and the Supply Agreement. 

  

	4.2	Strakan shall, and shall cause its Contract Manufacturer(s), to Manufacture the Product in accordance with the approved Specifications and will provide the following documents to Aptalis for each Lot of Product:

  

	 	a.	The executed Manufacturing Batch Record. 

  

	 	b.	The executed packaging Batch Record. 

  

	 	c.	Certificate of Manufacture (QP Release Certificate). 

  
  

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 Exhibit A-1-4 

	 	d.	Certificates of Analysis for API, excipients, tubes and Product. 

  

	 	e.	Specimen of any controlled printed component (tube, insert, box) as scanned copies to be included in executed packaging records. 

  

	 	f.	Deviation Reports (if applicable). 

  

	 	g.	Investigation reports (if applicable). 

 Article 5 CERTIFICATION OF FINISHED PRODUCTS FOR
SHIPPING 
  

	5.1	Strakan will assess the batch documentation for compliance with cGMP and with the Product NDA Summary provided in Appendix 3 for the Product. 

 

	5.2	Strakan will authorize shipment of finished Product for Product which complies with cGMP and with the Product NDA. 

  

	5.3	Strakan will arrange shipment of the Product to Aptalis and will send electronic copies of the following documents to Aptalis unless otherwise instructed by Aptalis: 

 

	 	a.	The executed Manufacturing Batch Record. 

  

	 	b.	The executed packaging Batch Record. 

  

	 	c.	Certificate of Manufacture (QP Release Certificate). 

  

	 	d.	Certificate of Analysis (for API, excipients, tubes and Product). 

  

	 	e.	Specimen of any controlled printed component (tube, insert, box) as scanned copies to be included in executed packaging records. 

  

	 	f.	Deviation Reports (if applicable). 

  

	 	g.	Investigation reports (if applicable). 

  
  

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 Exhibit A-1-5 

	5.4	Any deviations from Specifications and agreed requirements outlined in Appendix 3 shall be reported in writing to Aptalis, prior to shipment and Strakan shall await Aptalis’ approval before shipment.

  

	5.5	Strakan shall, or shall cause its Contract Manufacturer(s) to, investigate any out of specification “OOS” results under the direction of Strakan and cause such results to be communicated in writing to Aptalis
by Strakan for Aptalis’ approval or comment. 

  

	5.6	Strakan shall not ship any Product until all the elements described in this Article are reviewed to the satisfaction of Strakan’s or its Contract Manufacturer’s QA department, and with respect to Sections 5.4
and 5.5, until receipt of Aptalis’ written approval. 

 Article 6 FINAL RELEASE TO MARKET OF FINISHED
PRODUCTS 
 Aptalis will carry out the final release of finished packs of the Product for sale and supply in compliance with cGMP and the
Product NDA. 
 Article 7 DOCUMENTATION 
  

	7.1	Master Manufacturing Document 

 The master manufacturing document specifies the
Manufacturing Process and Additional Materials used to Manufacture a specific Bulk Product (“Master Manufacturing Document”). Strakan shall, or shall cause its Contract Manufacturer(s), to develop and maintain the Master
Manufacturing Documents, and Strakan shall supply such Master Manufacturing Documents to Aptalis. Strakan shall notify Aptalis in accordance with the provisions of Section 17.1 of the License Agreement and Aptalis shall approve, in writing, all
modifications to the Master Manufacturing Document. Aptalis, with the assistance of Strakan, shall ensure that those documents are consistent with the Marketing Authorization file of the relevant Product. Strakan shall provide Aptalis with copies of
all revised Master Manufacturing Documents on a timely basis. Aptalis shall retain a copy of the Master Manufacturing Documents. 
  

	7.2	Master Packaging Document 

  

	 	7.2.1	 The master packaging document specifies the packaging process and packaging Additional Materials used to package a specific Product (“Master
Packaging Document”). Strakan shall, or shall cause its Contract Manufacturer(s), to develop and maintain the Master Packaging Documents, and Strakan shall supply 

  
  

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 Exhibit A-1-6 

	 	
such Master Packaging Documents to Aptalis. Strakan shall notify Aptalis in accordance with the provisions of Section 17.1 of the License Agreement and Aptalis shall approve in writing all
modifications to the Master Packaging Document. Aptalis, with the assistance of Strakan, shall ensure that those documents are consistent with the Marketing Authorization file of the Product. Strakan shall provide Aptalis with copies of all revised
Master Packaging Documents on a timely basis. Aptalis shall retain a copy of the Master Packaging Document. 

  

	 	7.2.2	Strakan shall, or shall cause its Contract Manufacturer(s), to maintain the Batch Records consisting of Manufacturing, packaging, quality control, quality assurance and delivery documentation for each Lot of Product
(including any supporting documentation) for a period required by Law. 

  

	 	7.2.3	Strakan will maintain copies of documents provided for batch review together with certificates and the Batch release register used to document the authorization for shipping of each Lot of the Product.

  

	 	7.2.4	Aptalis will maintain all documentation for final release to market for finished packs. 

 Article 8
ADDITIONAL MATERIAL SOURCING  
  

	8.1	All Additional Materials used to Manufacture a Product shall be sourced as per this Agreement unless otherwise specified in writing and with the agreement of both Strakan and Aptalis. Strakan hereby undertakes, and
shall cause its Contract Manufacturer(s) to undertake, to enter into a separate quality agreement with all of its suppliers with terms consistent with the terms hereof and of the Supply Agreement. The procurement of such Additional Materials shall
be pursuant to Section 2.1.5 of the Supply Agreement. 

  

	8.2	API 

 Strakan shall, or shall cause its Contract Manufacturer(s), to utilize only API
meeting Specifications and sourced from approved suppliers listed in Appendix 8. API shall be ordered from approved suppliers as per Strakan’ requirements. API ordered will be delivered to Strakan’s or its Contract Manufacturer’s
Manufacturing Facility with a Certificate of Analysis. Strakan shall not use an alternate source of API without the written consent of Aptalis, which consent shall not be unreasonably withheld. Strakan shall supply a controlled copy of the
Specifications for every Batch of API used in the Product for review and approval by Aptalis. 

  
  

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 Exhibit A-1-7 

	8.3	Excipients 

 Strakan shall, or shall cause its Contract Manufacturer(s), to utilize only
excipients defined in the Master Manufacturing Document. Excipients shall either comply with the most recent Pharmacopoeia monograph (EP and USP) or Strakan’ Specifications where such excipients are not included in a Pharmacopoeia monograph. In
all cases, Strakan shall supply to Aptalis a control copy of the Specifications of each excipient for review and approval. Strakan shall, or shall cause its Contract Manufacturer(s), to source excipients from reputable companies previously approved
by Strakan. 
  

	8.4	Packaging Additional Materials (Unprinted) 

  

	 	8.4.1	Primary packaging component: Strakan shall, or shall cause its Contract Manufacturer(s), to utilize only primary packaging components meeting Specifications and sourced from approved suppliers listed in Appendix 8.
Primary packaging component shall be ordered from approved suppliers as per Strakan’ requirements and will be delivered to Strakan’s or its Contract Manufacturer’s Manufacturing Facility with a Certificate of Analysis. Strakan shall
not use an alternate source of primary packaging component without the written consent of Aptalis, which consent shall not be unreasonably withheld. Strakan shall supply a control copy of the Specifications for every primary packaging component used
in the Product for review and approval by Aptalis. 

  

	 	8.4.2	Strakan shall, or shall cause its Contract Manufacturer(s), to utilize only those unprinted packaging Additional Materials as defined in the Master Packaging Document. Strakan shall supply to Aptalis a control copy of
the Specifications of such packaging Additional Materials for review and approval. Strakan shall order packaging Additional Materials only from reputable companies. 

 

	8.5	Packaging Additional Materials (Printed) 

 Strakan shall, or shall cause its Contract
Manufacturer(s), to utilize only those printed packaging Additional Materials that meet Specifications and are approved by Aptalis (such as artwork validation). Strakan shall supply to Aptalis a control copy of the Specifications of such packaging
Additional Materials for review and approval. Strakan shall, or shall cause its Contract Manufacturer(s), to order packaging Additional Materials only from reputable companies. 

  
  

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 Exhibit A-1-8 

 Article 9 TESTING 

 

	9.1	Strakan shall, or shall cause its Contract Manufacturer(s), to develop and maintain Specifications used for API, Bulk Products and Products, and Strakan shall supply the same to Aptalis. 

 

	9.2	Strakan shall notify Aptalis in accordance with the provisions of Section 17.1 of the License Agreement and Aptalis shall approve, in writing, all modifications to the analytical methods and Specifications prior to
implementation. 

 Article 10 PRINTED PACKAGING ADDITIONAL MATERIALS CONTROL 

 

	10.1	Strakan shall, or shall cause its Contract Manufacturer(s), to maintain a formal system for printed packaging Additional Materials control that shall ensure, inter alia, that only those labels, graphics, printed
matter and other packaging Additional Materials that have been approved or provided by Aptalis shall be used. Strakan shall ensure that its or its Contract Manufacturer’s control measures with respect to printed packaging Additional Materials
shall include, but shall not be limited to: (i) secure storage of all packaging Additional Materials; (ii) accountability records; and (iii) packaging line clearance of labeling. Strakan shall, or shall cause its Contract
Manufacturer(s), to ensure that a sample of all printed packaging Additional Materials used in respect of a Product will be included in the Batch/packaging record of the Product. 

 

	10.2	Strakan shall, or shall cause its Contract Manufacturer(s), to ensure that samples, examines and releases all printed packaging Additional Materials prior to use in accordance with their documented procedures and
policies. Aptalis shall provide, in writing, approved proof copy for all printed packaging Additional Materials used by Strakan. Strakan shall supply to Aptalis a controlled copy of its Specification for the Additional Materials for review and
approval. Any proposed change to such Specifications of the printed packaging Additional Material shall be communicated to Aptalis for approval prior to implementation. Strakan shall provide Aptalis with samples of all new or revised printed
packaging components. Strakan shall maintain, or shall ensure that its Contract Manufacturer(s) maintains, adequate control over the printing plates and packaging components as scanned copies to be included in executed packaging records.

  
  

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 Exhibit A-1-9 

	10.3	Temperature Management. Strakan shall, and shall cause its Contract Manufacturer(s), to store Product under the appropriate temperature conditions to maintain the Product’s stability, integrity and
effectiveness while minimizing the risks of tampering or theft. The Product must also be kept free of contamination, deterioration and adulteration. 

Article 11 NOTIFICATION AND APPROVAL OF DEVIATIONS AND NON-CONFORMANCE 

 

	11.1	Deviations 

  

	 	11.1.1	Strakan shall have, or shall ensure that its Contract Manufacturer(s) has, a written procedure in place to perform a systematic investigation in the event that (i) any Product or process fails to meet
Specifications; or (ii) any process Deviation occurs in respect of any Product. 

  

	 	11.1.2	Strakan shall not, or shall ensure that its Contract Manufacturer shall not, void out-of-specification (“OOS”) results by
retesting unless the investigation determines that laboratory error caused the OOS results and shall retain all OOS data and investigation results, whether or not the OOS results are voided. Upon completion of the OOS investigation, all OOS data and
investigation results of confirmed OOS results shall be communicated to Aptalis by Strakan for review and approval prior to initial Product release. Strakan shall notify Aptalis within two (2) Business Days of the occurrence of any OOS results
or unapproved Deviation in respect of any Product. 

  

	 	11.1.3	Strakan shall ensure that all process Deviations are approved by Aptalis prior to implementation unless the Deviation is such that it is not reasonable to do so. Strakan shall, or shall ensure that its Contract
Manufacturer(s), investigates and fully documents all Deviations. This documentation shall be retained as part of the Batch documentation for the Lot of Product affected. When deemed necessary, Strakan shall ensure that Aptalis has the right to
request additional or more in-depth investigation by Strakan or its Contract Manufacturer(s) of any Deviation. 

  
  

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 Exhibit A-1-10 

	11.2	Non-Conformance 

  

	 	11.2.1	Additional Material or Product that do not meet established Specifications shall be handled as Non-conformities and documented as such, in accordance with Strakan’s or its
Contract Manufacturer’s standard operating procedures. Actions taken to investigate Non-conformity and to justify the release of the Lot of Product or Batch shall be fully documented. 

 

	 	11.2.2	Aptalis and Strakan shall approve the Non-conformity document as stated below prior to initial release. Any resulting corrective actions shall be followed through timely closure.

  
  

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 Exhibit A-1-11 

			
	 Non-conformance
	  	 Approval Requirements

		
	API	  	Aptalis and Strakan
		
	excipient	  	Strakan
		
	Product	  	Aptalis and Strakan
		
	primary packaging Additional Material manufacturer	  	Aptalis and Strakan
		
	printed packaging Additional Material	  	Aptalis and Strakan

 Article 12 REFERENCE AND RETENTION SAMPLES 

 

	12.1	Strakan shall, or shall ensure that its Contract Manufacturer(s), retains reference samples for Additional Material in accordance with EU and US FDA cGMP requirements or, if longer, for a minimum of one (1) year
following the expiration of the last Lot of Product containing said Additional Material and in an amount sufficient to comply with any specific regulatory requirements applicable to the Additional Material and, in any case, sufficient to allow at
least two (2) full rounds of release tests. 

  

	12.2	Strakan shall, or shall ensure that its Contract Manufacturer(s), retains reference samples and samples of finished Product in an amount sufficient to allow at least two (2) full rounds of release tests, stored in
a secure location at the recommended and approved storage conditions for the Product for a period of five (5) years or one (1) year after the expiry date of the Product, whichever is the longer. As the reference samples are kept as fully
packaged units, reference samples and retain samples may be regarded as interchangeable. 

 Article 13 STORAGE OF PRODUCT /
ENVIRONMENTAL MONITORING 
  

	13.1	Strakan shall, or shall ensure that its Contract Manufacturer(s), agrees to store the Bulk Product and/or Product under appropriate product label storage conditions and in a secure area to ensure that they comply with
all the quality Specifications and attributes and all applicable Laws and regulations. 

  

	13.2	 Under no circumstances shall any other products which may present a potential hazard to Bulk Products, and/or Products, such as beta-lactam and
cephalosporin antibiotics, potent hormones, cytotoxic compounds, highly potent drugs, biological preparations or non-pharmaceutical chemicals be Manufactured, processed or packaged in the same Manufacturing
Facilities at the time used for the Manufacture of Bulk Product, and/or 

  
  

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 Exhibit A-1-12 

	 	
Product. Strakan shall make Aptalis immediately aware of the presence of any potentially hazardous products in its or its Contract Manufacturer’s Manufacturing Facilities during production
or the proposed production period and if Strakan or its Contract Manufacturer(s) contemplate handling other products of the classes mentioned in this Article, Strakan shall so inform Aptalis in advance so that Aptalis may determine whether or not
such handling is acceptable during production of the Product. 

 Article 14 COMPLAINTS 

 

	14.1	Aptalis shall be responsible for handling Product complaints from the Territory and shall reply to inquiries as promptly as possible. Aptalis shall provide the necessary information to Strakan and render assistance to
Strakan as required. 

  

	14.2	Strakan will investigate technical complaints or other concerns with respect to the quality of the Product in consultation with Strakan’s Contract Manufacturer(s) and report results to Aptalis within fifteen
(15) Business Days at the latest or sooner if agreed to by the parties or if a more urgent need is recognized. Strakan shall assist Aptalis by testing Product samples and reviewing Batch Manufacturing and analytical records. If the test period
is unable to be met, Strakan will notify Aptalis to agree on a new timeframe. Strakan is responsible for implementation of the corrective actions agreed with Aptalis. 

 

	14.3	Complaints received by Strakan relating to the Product shall be immediately drawn to the attention of Aptalis. 

  

	14.4	In addition on an annual basis each Party will exchange a summary of all complaints received, including complaints from other territories. 

 

	14.5	No matter which Party receives the initial contact from any competent authority regarding the Product, they will immediately inform the other Party. Aptalis will liaise with Strakan to agree who will respond/correspond
with the competent authority. 

 Article 15 CHANGE CONTROL 

 

	15.1	Strakan will notify Aptalis of any proposed changes that may affect the Product, including, but not limited to, changes that may impact Specifications and/or the validation status of the production process or quality
control test procedures. Aptalis shall assess and approve, in writing, any and all such changes prior to implementation. 

  
  

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 Exhibit A-1-13 

	15.2	Any modification to Specifications shall be pursuant to Section 5.4 of the Supply Agreement. 

 Article
16 REPROCESSING AND REWORK 
  

	16.1	It is agreed between the parties that reprocessing shall be exceptional. Reprocessing of Additional Material or Bulk Product or Products must be fully documented to state reason and justification for reprocessing.

  

	16.2	Rework activity can only be performed as per agreement between both Strakan and Aptalis. 

 Article 17
SUB-CONTRACTING 
  

	17.1	Strakan will not subcontract to a Third Party other than its Contract Manufacturer(s) any of the work entrusted under this Agreement without the prior, written approval of Aptalis, such approval not to be unreasonably
withheld, conditioned or delayed. Where Strakan subcontracts such a Third Party in accordance with the terms of this Agreement Strakan shall ensure that such contract or agreement is on terms which are consistent with this Agreement and Strakan
shall remain liable for the performance of the obligations under this Agreement by the Contract Manufacturer(s). 

  

	17.2	In the event that Strakan, with the written permission of Aptalis, subcontracts any operation under this Agreement to a Third Party, Strakan shall ensure that it enters into an agreement with the Third Party setting out
the respective technical responsibilities of each party. 

 Article 18 REGULATORY INSPECTIONS 

 

	18.1	Any serious deficiencies noted during an inspection of Strakan or its Contract Manufacturer’s premises, which relate directly or indirectly to the Product must be brought to the attention of Aptalis, including any
vendor of Additional Materials or any external testing laboratory. 

  

	18.2	Any serious deficiencies noted during an inspection of Aptalis’ premises, which relate directly or indirectly to the Product must be brought to the attention of Strakan. 

  
  

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 Exhibit A-1-14 

 Article 19 PERIODIC QUALITY REVIEWS 

Strakan shall, or shall ensure that its Contract Manufacturer(s), carry out a periodic Product quality review according to a program agreed between the
Parties. A responsibilities checklist is presented as Appendix 4. 
 Article 20 ON-GOING GMP
STABILITY 
 Strakan shall, or shall ensure that its Contract Manufacturer(s), carry out stability testing according to a program agreed
between the Parties, on one Lot of the Product per calendar year. The protocol will be agreed between the Parties and approved by Aptalis. Stability data interpretation and reporting shall be Aptalis’s responsibility and Aptalis shall update
stability information in the regulatory documents for the Product. 
 Article 21 ANNUAL REPORT 

 

	21.1	Aptalis will provide Strakan with Aptalis’s request for chemistry, Manufacturing and control data and other information required for submission in the Annual Report with FDA, at least sixty (60) calendar days
before Annual Report due date. 

  

	21.2	Strakan will provide Aptalis with the required data and information within thirty (30) days of the request. 

Article 22 CHANNELS OF COMMUNICATION 

Contact lists are provided in Appendix 5. The Parties will ensure that contact lists are kept up to date. 

Article 23 REVIEW 
  

	23.1	Changes or supplements to this Agreement and to the Appendices and enclosures can only be made by mutual consent in writing. Such changes will be recorded in the Change History Log (Appendix 7). The appendices and
enclosures to this Agreement are part of this Agreement and may be updated separately from the main body of the agreement provided written approval is given by both Parties. 

 

	23.2	This Agreement will be formally reviewed every two (2) years. Strakan will initiate this process. 

  
  

	*	Confidential treatment requested. 

 Exhibit A-1-15 

									
	 SIGNED for and on behalf of

Aptalis Pharma US, Inc.:
	 	 	 	 SIGNED for and on behalf of

Strakan International S.à r.l:

			
	 /s/    Steve Gannon
	 		 	 /s/    Andrew McLean

	Signature	 		 		 	Signature	 	
					
	Date:	 	December 28, 2011	 		 	Date:	 	December 28, 2011
					
	Name:	 	Steve Gannon	 		 	Name:	 	Andrew McLean
					
	Title:	 	Senior Vice President, Finance, Chief Financial Officer and Treasurer	 		 	Title:	 	Director and General Counsel

  
  

	*	Confidential treatment requested. 

 APPENDIX 1 

FINISHED PRODUCT LISTING 
  

							
	 Product Description
	  	 Pack Size
	  	 Storage Conditions
	  	 Territory

	Rectiv TM (nitroglycerin) Ointment 0.4%	  	1 x 30g	  	Store at [*]; excursions permitted between [*]. Keep the tube tightly closed. Use within [*] weeks of first opening.	  	US

	

  
  

	*	Confidential treatment requested. 

 Appendix 1 - 1 

 APPENDIX 2 

CONTRACT MANUFACTURER AUTHORIZATION TO MANUFACTURE 

[*] 

  
  

	*	Confidential treatment requested. 

 Appendix 2 - 1 

 APPENDIX 3 

PRODUCT NDA SUMMARY 
 [*]

  
  

	*	Confidential treatment requested. 

 Appendix 3 - 1 

 APPENDIX 4 

DIVISION OF PHARMACEUTICAL RESPONSIBILITIES CHECKLIST 
  

					
	 Topic
	  	Aptalis	  	Strakan
	Marketing Authorization	  		  	
	Holder	  	X	  	
	Maintenance of MA (preparing and submitting variations)	  	X	  	
			
	Manufacturing Authorization	  		  	
	Ensuring Strakan or its Contract Manufacturer(s) has a licence to allow Manufacturing and packaging and testing of products.	  		  	X
			
	Authorisation for Shipping of Product	  		  	
	Review of Batch Records and authorisation for shipping of product.	  		  	X
			
	Shipping of Product	  		  	
	Ship Product to Aptalis Incoterms 2010: ExWorks	  		  	X
			
	Release of Finished Packs	  		  	
	Final Release to market of Finished Packs	  	X	  	
			
	Documentation	  		  	
	Ensuring Strakan or its Contract Manufacturer(s) retains all documentation relating to the Manufacture, packaging and testing packaging of the products in accordance with cGMP requirements.	  		  	X
	Retaining copies of Batch Records, packaging records, Certificates of Analysis and certification documents.	  	X	  	X
			
	Reference and Retention Samples	  		  	
	Ensuring Storage of Reference Samples of starting materials and finished packs at Strakan or its Contract Manufacturer(s)	  		  	X
			
	Complaints	  		  	
	Maintain customer complaint file	  	X	  	X
	Notify Strakan of complaints requiring investigation	  	X	  	
	Investigate complaint in collaboration with the Contract Manufacturer(s)	  		  	X
	Prepare investigation report and circulate to Aptalis.	  		  	X
	Final review and assessment of complaint.	  	X	  	
	Feedback to complainant	  	X	  	
	Notify Aptalis of complaints received directly from customers.	  		  	X

  
  

	*	Confidential treatment requested. 

 Appendix 4 - 1 

 APPENDIX 4 

DIVISION of PHARMACEUTICAL RESPONSIBILITIES CHECKLIST (cont’d) 

 

					
	 Topic
	  	Aptalis	  	Strakan
	Product Recall	  		  	
	Initiate recall procedure	  	X	  	
	Investigate the requirement to recall	  	X	  	X
	Notify Regulatory Authorities of decision to recall	  	X	  	
	Conduct recall	  	X	  	
	Ensure corrective and preventative action plans are implemented	  	X	  	X
			
	Change Control	  		  	
	Notification of changes to Specifications to Strakan	  	X	  	
	Notification to Aptalis of proposed changes to Specifications	  		  	X
			
	Auditing	  		  	
	Auditing of Strakan or its Contract Manufacturer(s) for compliance with cGMP	  	X	  	X
	Auditing of supplier of active ingredients, excipients, packaging components for compliance with cGMP	  	X	  	X
	Auditing Supplier of Product (Strakan) for Compliance with cGMP	  	X	  	

  
  

	*	Confidential treatment requested. 

 Appendix 4 - 2 

 APPENDIX 5 

CONTACT NAMES 
 For Strakan
International S.à r.l. : 
  

			
	Responsibility:	  	[*]
	Name:	  	[*]
	Job Title:	  	[*]
	Address:	  	[*]
	Telephone Number:	  	[*]
	Fax Number:	  	[*]
	E-mail:	  	[*]
	Responsibility:	  	[*]
	Name:	  	[*]
	Job Title:	  	[*]
	Address:	  	[*]
	Telephone Number:	  	[*]
	Fax Number:	  	[*]
	E-mail:	  	[*]
	Responsibility:	  	[*]
	Name:	  	[*]
	Job Title:	  	[*]
	Address:	  	[*]
	Telephone Number:	  	[*]
	Fax Number:	  	[*]
	 E-mail:

Complaints:
	  	[*]

  
  

	*	Confidential treatment requested. 

 Appendix 5 - 1 

 APPENDIX 5 

CONTACT NAMES (cont’d) 
  

 For Strakan International S.à r.l.: 

 

			
	Responsibility:	  	[*]
	Name:	  	[*]
	Job Title:	  	[*]
	Address:	  	[*]
	Telephone Number:	  	[*]
	Fax Number:	  	[*]
	E-mail:	  	[*]
	Deputy Name:	  	[*]
	Job Title:	  	[*]
	Address:	  	[*]
	Telephone Number:	  	[*]
	Fax Number:	  	[*]
	E-mail:	  	[*]

  
  

	*	Confidential treatment requested. 

 Appendix 5 - 2 

 APPENDIX 5 

CONTACT NAMES (cont’d) 
  

 For Aptalis Pharma US, Inc.: 

 

			
	Responsibility:	  	[*]
	Name:	  	[*]
	Job Title:	  	[*]
	Address:	  	[*]
	Telephone Number:	  	[*]
	Fax Number:	  	[*]
	E-mail:	  	[*]
		
	Responsibility:	  	[*]
	Name:	  	[*]
	Job Title:	  	[*]
	Address:	  	[*]
	Telephone Number:	  	[*]
	Fax Number:	  	[*]
	E-mail:	  	[*]
		
	Responsibility:	  	[*]
	Name:	  	[*]
	Job Title:	  	[*]
	Address:	  	[*]
	Telephone Number:	  	[*]
	Fax Number:	  	[*]
	E-mail:	  	[*]

  
  

	*	Confidential treatment requested. 

 Appendix 5 - 3 

 APPENDIX 6 

LIST OF CURRENT SUBCONTRACTORS 
  

			
	 Name & Address
	  	 Activity

	[*]	  	Manufacture, assembly, QC testing and QP Release of Product
	Suppliers used by NextPharma:	  	
		
	[*]	  	API Supplier
		
	[*]	  	
		
		  	Aluminium Tubes and Caps
		
		  	Microbiology testing

  
  

	*	Confidential treatment requested. 

 Appendix 6 - 1 

 APPENDIX 7 

CHANGE HISTORY PAGE 
 On receipt of a
revised/new page set the document holder must replace or insert the appropriate pages and destroy the originals. The document holder must then return the acknowledgement slip duly signed to confirm that their document has been updated. It is the
document holder’s responsibility to ensure that staff are adequately briefed and any procedural, documentary changes consequent upon the updating are effected in their areas. 

 

							
	 Date
	  	 Page Number
	  	 Section Number
	  	 Summary of Change

		  		  		  	
		  		  		  	
		  		  		  	

  
  

	*	Confidential treatment requested. 

 Appendix 7 - 1 

 APPENDIX 8 

LIST OF APPROVED SUPPLIERS 
  

			
	 Material
	  	 Approved Supplier Name

	Diluted Nitroglycerin ([*])	  	[*]
	White Petrolatum	  	[*]
	Lanolin	  	[*]
	Paraffin	  	[*]
	Sorbitan Sesquioleate	  	[*]
	Aluminium tubes and caps	  	[*]

  
  

	*	Confidential treatment requested. 

 Appendix 8 - 1 

 EXHIBIT B 

SAFETY DATA EXCHANGE AGREEMENT 

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit B-1 

 Execution Version 

EXHIBIT B 
 Safety Data
Exchange Agreement (Pharmacovigilance Agreement) 
 For Rectiv (nitroglycerin) Ointment 0.4% 

between 
 Aptalis Pharma
US, Inc. 
 100 Somerset Corporate Boulevard, 

Suite 2000, Bridgewater, 
 New
Jersey 08807 USA 
 and 

Strakan International S.à r.l. 

Galabank Business Park 
 Galashiels
TD1 1QH, UK 

  
  

	*	Confidential treatment requested. 

 Exhibit B-1 

	1.	INTRODUCTION 

 THIS IS A SAFETY DATA EXCHANGE AGREEMENT (hereinafter “SDEA”) by and between
Strakan International S.à r.l. (hereinafter referred to as “Strakan”), and Aptalis Pharma US, Inc. (hereinafter “Aptalis”). Strakan and Aptalis may be referred to herein individually as a “Party” or collectively
as the “Parties.” 
 WHEREAS, Strakan and Aptalis entered into a commercialization and license agreement (the “License Agreement”) and a
supply agreement (the “Supply Agreement”) relating to the Product in the Territory, both of even date to this SDEA; 
 WHEREAS, the Parties desire
to set forth the pharmacovigilance responsibilities of each of the Parties with respect to the Product; 
 WHEREAS, this SDEA sets forth the terms under
which Strakan Global Pharmacovigilance (hereinafter “GPV”) and the Pharmacovigilance Department of Aptalis shall exchange safety data and collaborate on related safety surveillance activities concerning the Product in the pre-marketing (clinical trial) and post-marketing phases; and 
 WHEREAS, this SDEA applies to pharmacovigilance for the
Product as well as adverse event data relating to the Product and any other glyceryl trinitrate ointment and glyceryl trinitrate unknown obtained from any source, including information derived from any clinical, post-marketing surveillance or
epidemiological investigations, commercial marketing experience, reports in the scientific literature and unpublished scientific papers, as well as any reports from regulatory authorities, whether inside or outside the Territory. 

NOW THEREFORE, in accordance with each company’s Standard Operating Procedures (SOPs) and in consideration of the mutual promises and covenants set forth
below, the Parties agree as follows: 
 Strakan and Aptalis are also parties to the product quality agreement executed by the Parties with even date to this
SDEA (the “Product Quality Agreement”). This SDEA and the Product Quality Agreement shall be read together. Notwithstanding anything to the contrary in the Product Quality Agreement, in the event of a conflict between this SDEA and the
Product Quality Agreement, this SDEA shall take precedence. Except as expressly provided in this SDEA, the Product Quality Agreement shall remain in full force and effect, unaffected hereby. The provisions of this SDEA shall not be construed to
restrict either Party’s ability to take action that it deems to be appropriate or required of it under any applicable Laws. 
  

	2.	DEFINITIONS 

 All definitions relating to this SDEA on adverse event reporting and related terminologies
are consistent with the International Conference on Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH); the United States Code of Federal Regulations (CFR), Title 21; Directive 2001/83/EC of the European Parliament and of
the Council of 6 November 2001 on the Community code relating to the Product’s medicinal use for humans; and Volume 9A of The Rules Governing Medicinal Products in the European Union (EU). See Appendix B for all standard definitions. 

  
  

	*	Confidential treatment requested. 

 Exhibit B-1-2 

 Other capitalized terms that are used in this SDEA and not otherwise defined in this SDEA will have the meanings
set forth in the License Agreement, the Supply Agreement or the Product Quality Agreement. 
  

	 	2.1	RECEIPT DATE 

 The Receipt Date is defined as the date any personnel/Affiliates/partners
of Strakan or personnel/Affiliates/partners of Aptalis or any of its Affiliates or agents, is first aware of an adverse event (AE) or other safety-related report associated with the Product or any other glyceryl trinitrate ointment and glyceryl
trinitrate unknown obtained from any source anywhere in the world. Regulatory reporting will be as defined in each Party’s respective Standard Operating Procedures. 
  

	3.	REGULATORY STATUS 

 As of the Effective Date Strakan’s Affiliate, ProStrakan Inc., holds the Product
NDA in the Territory and shall transfer such Product NDA to Aptalis as provided in the License Agreement. 
  

	4.	LANGUAGE 

 All reports and documentation must be provided in English. Adverse Event (AE) reports and
relevant information from source documents should be translated into English as necessary. 
  

	5.	RESPONSIBILITIES 

 This section describes the Parties’ responsibilities for exchange of AE reports
regarding the Product and collaborations on related pharmacovigilance including Safety Surveillance or Risk Management activities both in the pre- and post-marketing phases, to meet global regulatory
requirements. 
  

	 	5.1	GENERAL 

 The Parties shall meet and agree upon a written plan for exchanging adverse
event and other pharmacovigilance and safety information relating to the Product (with respect to the Territory) and products that correspond to the Product (with respect to territories outside of the Territory) Commercialized by Strakan or its
Third Party licensees (together with the Product, the “Subject Products”) within thirty (30) days of the Effective Date. Such written plan shall ensure that adverse event and other pharmacovigilance and safety information is exchanged
according to a schedule that will permit Aptalis to comply with applicable Laws and regulations throughout the Territory. 
  

	 	5.2	SAFETY DATABASE 

 Each Party shall maintain a validated safety database for reporting and
safety surveillance activities for the Subject Product in accordance with applicable regulations. Strakan shall maintain a validated global safety database for reporting and safety surveillance activities for the Subject Product worldwide in
accordance with applicable regulations. 
  

	 	5.3	AE/ADVERSE DRUG REACTION (ADR) DATA COLLECTION AND EXCHANGE 

  

	 	5.3.1	General Overview 

 Aptalis shall hold the Product NDA in the Territory and Strakan, or
its Affiliates or licensees shall act as MAH for the Subject Product in its respective territories and each Party may perform any clinical development or post-marketing safety surveillance activities accordingly to applicable local safety
regulations and applicable contractual agreements. 

  
  

	*	Confidential treatment requested. 

 Exhibit B-1-3 

 Spontaneous Adverse Events, both serious and non-serious,
originating from all sources, will be exchanged pursuant to this SDEA including: 
  

	 	•	 	Healthcare professionals 

  

	 	•	 	Consumers, or other non-healthcare professionals including legal sources 

  

	 	•	 	Literature 

  

	 	•	 	Regulatory Authorities 

  

	 	•	 	Third Party licensee AE/ADR reports. 

 Spontaneous AE(s)/ADR(s) shall be processed by Aptalis in
accordance with the relevant Law applicable in the Territory, and by Strakan in accordance with the relevant Laws applicable outside of the Territory, and in accordance with the Parties’ SOPs and/or written agreed upon practices. 

Such SOPs shall cover AE reporting and follow-up practices, and, if applicable, handling of Subject
Product complaints, Subject Product recalls and investigations. Each Party shall ensure that the responsible personnel handling AE reporting and Subject Product complaints are trained on these SOPs, as documentation will be required during
inspections or audits. 
  

	 	5.3.1.1	Expectedness Assessment 

 Aptalis shall determine expectedness for AE reports of
spontaneous origin using the applicable locally-approved labelling or global core labelling document in accordance with the local reporting requirements in the Territory. 

Strakan shall determine expectedness for AE reports of spontaneous origin using the applicable locally-approved labelling or global core
labelling document in accordance with the local reporting requirements outside the Territory. 
  

	 	5.4	EXCHANGE OF SPONTANEOUS ADVERSE EVENT REPORTS 

 Serious Reports: 

 

	 	•	 	All serious adverse event reports received directly by each Party from all sources including literature relating to the Subject Product or glyceryl trinitrate ointment or glyceryl trinitrate unknown will be exchanged by
the Parties by Calendar Day 7 from Receipt Date on FDA 3500 A MedWatch form or Council for International Organizations of Medical Sciences’ (CIOMS) I form via designated e-mail. Such designated e-mail shall be provided promptly by each Party. 

  

	 	•	 	If Strakan receives serious adverse event reports originating directly from a customer in the United States of America, they should exchange the case with Aptalis by Calendar Day 5. 

Non-Serious Adverse Event Reports 

 

	 	•	 	All non-serious adverse event reports relating to the Subject Product or glyceryl trinitrate ointment, or glyceryl trinitrate unknown received directly by each Party from all
sources will be forwarded to the other Party by Calendar Day 30 from Receipt Date on FDA 3500 A MedWatch form or Council for International Organizations of Medical Sciences’ (CIOMS) I form via designated
e-mail. 

 Alternative means of data transfer may be used upon mutual agreement between
the Parties. 

  
  

	*	Confidential treatment requested. 

 Exhibit B-1-4 

	 	5.4.1	Adverse Events of Special Interest (AESI) 

 Reports concerning an AESI communicated to
Strakan by Aptalis (serious or non-serious regardless of source) or to Aptalis by Strakan will be exchanged by the Parties by Calendar Day 7 from Receipt Date on an FDA 3500 A MedWatch form or Council for
International Organizations of Medical Sciences’ (CIOMS) I form via designated e-mail. 
  

	 	5.4.2	Follow-Up Reports 

 Aptalis shall be responsible
for obtaining further information on AE reports occurring in the Territory and Strakan shall be responsible for obtaining further information on AE reports occurring outside the Territory. Specifically, the Parties’ respective responsibilities
shall be for critical data elements that ensure a comprehensive AE description and a true clinical understanding of the case or to ensure sufficient data to secure a “valid” case (a patient with at least one patient identifier, a reporter,
an event, where the product is identified as the Product or glyceryl trinitrate unknown). Additional information may include laboratory data, biopsy results, hospital discharge summaries, etc. Each Party will transmit
follow-up information received within the timeframe and by the methods described above for serious and non-serious cases. 

 

	 	5.4.3	Pregnancy Exposure Reports 

 While exposure via pregnancy itself is not a serious adverse
event, Aptalis and Strakan will exchange all reports of exposure via pregnancy by Calendar Day 7 from Receipt Date preferably using on FDA 3500 A MedWatch form or Council for International Organizations of Medical Sciences’ (CIOMS) I form via
designated e-mail. Both Parties shall perform due diligence to obtain follow-up information regarding the course and outcome of the pregnancy and condition of the
infant. All follow-up reports concerning the outcome of the pregnancy shall be forwarded as indicated previously for initial reports (see above). 

 

	 	5.4.4	Overdose/Misuse/Abuse/Medication error/Lack of effect/ Exposure via lactation 

Definition of overdose/misuse/abuse/medication error/lack of effect shall be based on definitions in Appendix C. Aptalis and Strakan will
exchange all cases of overdose/misuse/abuse/medication error/lack of effect/exposure via lactation within the same timelines as above according to whether the report is classified as serious or non-serious or
involves a pregnancy. 
  

	 	5.4.5	Literature Reports 

 Aptalis will monitor local US literature and Strakan will monitor
global literature. Each Party will generate individual case safety reports (ICSR) accordingly. All AE/ADR reports will be processed and exchanged in the same manner as spontaneous reports as described in Section 5.3 above. An abstract of the
article in English shall be provided with the report. Such abstract shall contain sufficient information to determine case reportability and provide a quality ICSR. 
  

	6.	RECONCILIATION OF CASE EXCHANGE 

 Each Party shall acknowledge receipt of all ICSRs received by providing
their database case ID by the next Business Day to aid timely and on-going reconciliation. 

  
  

	*	Confidential treatment requested. 

 Exhibit B-1-5 

 Both Parties will maintain a log of all initial and follow-up reports
received. Aptalis and Strakan shall exchange a quarterly listing of all case reports sent to Strakan and Aptalis. The list shall include case tracking numbers, database case ID, whether initial or follow-up
and date sent. Aptalis and Strakan will reconcile each listing by the end of the following month. If discrepancies are noted, either during reconciliation or by other means, the Parties shall handle the issues to resolution within a reasonable time.

 If there have been no cases exchanged during the period, this should be confirmed between the Parties. 

 

	7.	REGULATORY SUBMISSION 

 Aptalis shall be responsible for fulfilling Spontaneous AE reporting obligations
to the Competent Authorities or Regulatory Agency in the Territory and Strakan shall be responsible for fulfilling Spontaneous AE reporting obligations to the Competent Authorities or Regulatory Agency outside the Territory. Strakan and Aptalis will
make every effort to ensure that their respective partners are accountable for the regulatory submission where neither Party is the MA holder for the Subject Product. 
  

	8.	REGULATORY AUTHORITY SAFETY REQUESTS 

 Aptalis will be responsible for preparing a response to any safety
requests/queries from the FDA concerning the Product. Strakan will assist Aptalis in the preparation of a response to such safety requests/queries concerning the Subject Product, as deemed necessary. Aptalis shall be responsible for submitting the
regulatory safety response. 
 Strakan or its licensees will be responsible for preparing a response to any safety requests/queries from any Regulatory
Authorities in their respective territories concerning the Subject Product. Aptalis will assist Strakan in the preparation of a response to such safety requests/queries concerning the Subject Product, as deemed necessary. Strakan shall be
responsible for submitting the regulatory safety response. 
  

	9.	Actions taken for Safety Reasons: 

 The Parties shall promptly exchange information on regulatory
actions, pending actions that might result in a labelling change, health authority inquiries for safety and/or efficacy reason(s), which may significantly affect safety profile or benefit/risk balance of the Subject Product or market restriction due
to issues including but not limited to: 
  

	 	•	 	Marketing Authorisation withdrawal or suspension; 

  

	 	•	 	failure to obtain a Marketing Authorisation renewal, restrictions on distribution; 

  

	 	•	 	clinical trial suspension, or protocol amendment; 

  

	 	•	 	health providers and/or Public Communications; 

  

	 	•	 	dosage modification; 

  

	 	•	 	changes in target population or indications, formulation changes; or 

  

	 	•	 	modification of the investigator brochure and/or core safety data sheet and/or labelling, etc. 

 Regulatory
correspondence concerning the Subject Product safety shall be promptly exchanged by the Parties via designated e-mail. 
  

	10.	SAFETY SURVEILLANCE ACTIVITIES 

 Each Party shall be responsible for signal detection and risk
assessment. If a detected signal has an impact on the established safety profile of the Subject Product, and/or new significant risk factors are identified, each Party shall expeditiously communicate that information to the other Party. 

  
  

	*	Confidential treatment requested. 

 Exhibit B-1-6 

 Aptalis shall not make any major specific safety interventions involving communications with physicians or
healthcare providers such as “Dear Healthcare Professional Letters” or any other Risk Evaluation and Mitigation Strategies (REMS) without prior consultation with Strakan to the extent practicable but consistent with applicable Law. Strakan
shall also promptly inform Aptalis of significant changes to the safety profile of the product. The respective heads of the pharmacovigilance of each of the Parties shall facilitate such collaboration through joint periodic safety meeting. 

 

	11.	PERIODIC SAFETY UPDATE REPORTS (PSURS) 

 Aptalis will be responsible for the preparation and submission
of Periodic Adverse Drug Experience Reports (PADERs) for the Territory and shall provide them to Strakan within two (2) weeks of submission. 
 Strakan
will be responsible for the preparation and submission of Periodic Safety Update Reports (PSURs) outside the Territory and shall provide them to Aptalis within two (2) weeks of submission. Specific safety concerns documented in a Regulator
Authority’s PADER/PSUR Assessment Report will be exchanged by the Parties in order to facilitate any collaboration on proactive or due diligent medical safety surveillance practices of a safety concern. 

 

	12.	Reference Safety Information 

 Both Parties are responsible for establishing and maintaining Reference
Safety Information in their respective territories based on the accumulated safety information of the Subject Product. However, since Strakan maintains the global safety database for the Product, Strakan shall be responsible for the development and
maintenance of the Core Safety Information (CSI) for the Product in accordance with international safety standards. Strakan shall advise Aptalis when the CSI for the product is available or updated. 

Aptalis may not use the Product CSI as the Reference Safety Information for purpose of listedness determination or aggregrate safety reporting but other
standard RSI as deemed appropriate. Both Parties shall exchange their respective Reference Safety Information upon the written request of the other Party. 
  

	13.	RISK MANAGEMENT ACTIVITIES 

 Strakan shall advise Aptalis on any EU Risk Management Plan (RMP) or Aptalis
shall inform US Risk Evaluation and Mitigation Strategies (REMS) program for the Subject Product. Both Parties shall consult on the request for any Local RMP for the Subject Product. 

 

	14.	CLINICAL TRIALS 

 Each Party shall inform the other of any planned clinical trials involving the Subject
Product, especially post-marketing safety surveillance studies, and investigator sponsored studies supported by such Party, and will provide a copy of the protocol to the other Party, if deemed appropriate. 

 

	15.	MEDICAL INFORMATION 

 Aptalis shall be responsible for answering enquiries relating to the Product
received from members of the public or healthcare professionals in the Territory. Such responses shall be provided in accordance with applicable Laws in the Territory governing information to consumers concerning medicinal products. 

Strakan shall be responsible for answering enquiries relating to the Subject Product received from members of the public or healthcare professionals outside
the Territory. Such responses shall be provided in accordance with applicable Laws governing information to consumers concerning medicinal products. 

  
  

	*	Confidential treatment requested. 

 Exhibit B-1-7 

 Both parties shall have systems in place to review medical information queries that may have direct or indirect
effect on the product safety. Heads of Pharmacovigilance or their designees shall, as practicable, discuss or share these concerns to facilitate the safety monitoring of the product. 

 

	16.	TRAINING 

 Strakan and Aptalis shall retain responsibility for the pharmacovigilance training of their
respective staff. Such training may cover but is not limited to any applicable guidelines relating to the pharmacovigilance activities in this SDEA. 
  

	17.	ARCHIVING 

 Both Parties shall maintain a record of each AE, overdose, misuse, abuse, medication error,
lack of effect, AESI, lactation report or pregnancy report indefinitely, in accordance with current regulatory requirements and each Party’s respective procedures. Such maintenance will include: 

a) a copy of the report (standardized AE collection form, including relevant source documentation) 

b) the date of the initial receipt or creation of the report 

c) the date of provision of the report to the other Party. 
  

	18.	AUDITING 

 Either Party may perform a pharmacovigilance audit of the other Party’s pharmacovigilance
functions if announced a minimum of four (4) weeks in advance. Such audit shall take place during normal business hours and shall be conducted in a manner intended to minimize any disruption to the business of the Party being audited. Each
Party will be able to request an audit of the other Party’s partners either directly or through independent auditors. The results of the audit shall be made available to the audited Party within a reasonable time of the audit being completed.

  

	19.	TERM AND TERMINATION 

 This SDEA and the respective responsibilities of the Parties shall continue in
effect until the latest of (a) the expiration or earlier termination of the License Agreement, (b) the first anniversary of the latest expiration date of any quantity of the Product distributed under the License Agreement, and
(c) with respect to all ongoing clinical trials, until such clinical trials are completed. In any event, if the Subject Product is subsequently divested or discontinued by any of the Parties, this SDEA will be terminated as soon as the Product
is no longer registered anywhere in the Territory. 
 The expiration or termination of this SDEA shall be without prejudice to any rights or obligations of
the Parties that may have accrued prior to the termination and, except as otherwise expressly provided herein, shall not limit any rights or remedies that may be available by Law or otherwise. Upon the termination or expiration of this SDEA, each
Party shall, at its expense, promptly return to the other Party all of such other Party’s Confidential Information, in the possession of, or under the control of, such first Party. 

 

	20.	ENTIRE AGREEMENT; AMENDMENT 

 This SDEA, in conjunction with the Product Quality Agreement, contains the
entire agreement and understanding between the Parties and shall supersede all prior oral or written agreements and understandings between the Parties with respect to the subject matter contained herein. This SDEA may be amended solely by mutual
written agreement of the Parties. In the case of a change of the Product NDA holder, this SDEA will be renegotiated. 

  
  

	*	Confidential treatment requested. 

 Exhibit B-1-8 

	21.	ASSIGNMENT 

 Neither of the Parties shall assign or transfer any of their rights or obligations under
this Agreement without the prior written consent of the other Party, provided, that in the event the License Agreement is assigned by Aptalis to any Person, Aptalis shall be permitted to assign this Agreement to the same Person to which the License
Agreement is assigned without the prior written consent of Strakan. Each Party shall be entitled (without the consent of the other Party) to assign this Agreement (or any of its rights or obligations under this Agreement) to (a) its Affiliate
(as long as such entity remains an Affiliate of the relevant Party) provided that the assigning Party shall be responsible for the performance of this Agreement by such Affiliate; or (b) to any corporation to which it has sold all or
substantially all of its assets relating to this Agreement provided that the acquiring corporation agrees to be bound by the terms of this Agreement. In addition, Strakan may assign this SDEA, in whole or in part, to an entity to whom it transfers
ownership of the Product. If a Party delegates all or any of its obligations under this Agreement to any Third Party, the Party delegating shall be fully responsible to the other Party for the proper performance of those obligations and for any
negligent act or omission made by the Third Party or its staff in relation thereto. For purposes of clarity, any change of control or merger, consolidation, initial public offering or other financing activity of a Party shall not be deemed an
assignment of this Agreement. 
  

	22.	GOVERNING LAW 

 This Agreement shall be governed by and interpreted in accordance with the Laws of the
State of New York without giving effect to any conflict of Laws provisions. In the event of a Dispute, the Parties will submit such Dispute to arbitration under the Rules of Arbitration of ICC. Unless, the Parties agree otherwise, the number of
arbitrators shall be three. One arbitrator shall be appointed by each Party and the third arbitrator shall be appointed by the International Court of Arbitration of the ICC. The place of arbitration will be New York, New York if Strakan initiates
arbitration proceedings or London, England if Aptalis initiates the arbitration proceedings. The language of the arbitration will be in English. Prior to the commencement of hearings, each of the arbitrators appointed must provide an oath of
undertaking of impartiality. Judgment upon the award rendered by the arbitrators may be entered into any court having jurisdiction thereof. The cost of any such arbitration will be divided equally between the Parties, with each Party bearing its own
attorneys’ fees and costs. The arbitration proceedings and the decision of the arbitrators will be kept confidential by the Parties and the arbitrators. 
  

	23.	THIRD PARTIES 

 Except as otherwise provided herein, nothing in this SDEA shall confer any benefits or
rights on any person or entity other than the Parties to this SDEA. 
  

	24.	LIMITED LIABILITY 

 To the extent permitted by applicable law, in no event shall either Party be liable
to the other Party for any indirect, special, incidental, consequential or punitive damages, whether any claim for such recovery is based upon theories of contract, negligence, or tort (including strict liability), and even if either Party has
knowledge of the possibility of the potential damage or loss. 
  

	25.	CONFIDENTIALITY 

 The provisions of this SDEA shall be subject to the confidentiality provisions set out
in Article 9 of the License Agreement. 
  

	26.	COUNTERPARTS 

 This SDEA may be executed in two or more counterparts, each of which shall be deemed an
original but all of which together shall constitute one and the same instrument. 

  
  

	*	Confidential treatment requested. 

 Exhibit B-1-9 

 IN WITNESS WHEREOF, this SDEA has been signed by the authorized representatives of the Parties on the day and
year first written below. 
  

									
	Strakan International S.à r.l.	 		 	Aptalis Pharma US, Inc.
			
		 		 	
			
		 		 	
			
	 /s/    Andrew McLean
	 		 	 /s/    Ruth Thieroff-Ekerdt, M.D.

			
		 		 	
			
		 		 	
					
	By:	 	 Andrew McLean
	 		 	By:	 	Ruth Thieroff-Ekerdt, M.D.
			
	 Director and General Counsel
	 		 	Chief Medical Officer
					
	Date:	 	 December 28, 2011
	 		 	Date:	 	 December 28, 2011

 Appendices: 
 Appendix A:
Contact Persons and Details 
 Appendix B: Definitions 

  
  

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 Appendix A - CONTACT DETAILS 

The following points of contact are to be used for all reports of suspected Adverse Events or Adverse Drug Reactions, or for discussion of specific issues
pertaining to this SDEA. 
 Strakan 
  

			
	Name: [*]	  	Tel: [*]
	Job Title: [*]	  	Mob: [*]
		  	Fax: [*]
	Department: [*]	  	E-mails: [*]
		
		  	[*]
		  	[*]
		
	Name: [*]	  	
		
		  	Tel: [*]
		  	Mob: [*]
	Office hours: 08:30 to 17:30	  	Fax: [*]
	Out-of-hours contact:	  	E-mail:
	[*]	  	[*]
		  	[*]
		
		  	Address: ProStrakan
		  	1430 US Highway 206, Suite 110
		  	Bedminster, NJ 07921, USA
		  	And as of January 1, 2012,
		  	685 Rt 202/206
		  	Suite 101
		  	Bridgewater, NJ 08807

  
  

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 Appendix A - 1 

 Aptalis 
  

			
	Name: [*]	  	Tel: [*]
	Job Title: [*]	  	Fax: [*]
		  	E-mail: [*]
	Department: [*]	  	
		
	Name: [*]	  	
		
	Department: [*]	  	Tel: [*]
		  	Fax: [*]
	Office hours: 08:00 to 17:00	  	E-mail: [*]
		
	Tel [*]	  	
	Fax # [*]	  	
		  	Address:
		  	Aptalis Pharma
		  	597, Boul. Laurier,
		  	Mont-Saint-Hilaire, Qc,
		  	Canada, J3H 6C4

  
  

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 Appendix A - 2 

 Appendix B – DEFINITIONS AND GLOSSARY 

Abuse 
 Any persistent or
sporadic intentional excessive use of a medicinal product or investigational product accompanied by harmful physical and/or psychological effects. 

Adverse Drug Reaction (ADR) 

All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. 

The phrase “responses to a medicinal product” means that a causal relationship between a medicinal product and an adverse event is at
least a possibility (refer to ICH E2A). 
 A reaction, in contrast to an event, is characterized by the fact that a causal relationship
between the drug and the occurrence is suspected. If an event is spontaneously reported, even if the relationship is unknown or unstated, it meets the definition of an adverse drug reaction. 

Adverse Event (or Adverse Experience) 

An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to
have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (for example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product,
whether or not considered related to this medicinal product. 
 Adverse Event of Special Interest 

An Adverse Event of Special Interest (AESI) (serious or non-serious) is one of scientific and medical
concern specific to the sponsor’s product or programme, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate. Such an event might require further investigation in order to characterize and
understand it. Depending on the nature of the event, rapid communication by the trial sponsor to other parties (e.g. regulators) might also be warranted. 

Calendar Day 
 Any and
each day of the calendar year. 
 Consumers 

A consumer is defined as a person who is not a healthcare professional. 

Core Safety Information (CSI): 

All relevant safety information contained in core data sheet (CDS) prepared by the MAH, and which the MAH requires to be listed in all
countries where the company markets the drug, except when the local regulatory authority specifically requires a modification. It is the reference information by which listed and unlisted are determined for the purpose of periodic reporting for
marketed products, but not by which expected and unexpected are determined for expedited reporting. 
 Consumer reports 

Consumer adverse reaction reports should be handled as spontaneous reports irrespective of any subsequent “medical confirmation”, a
process required by some authorities for reportability. Even if reports received from consumers do not qualify for regulatory reporting, the cases should be retained. Emphasis should be placed on the quality of the report and not on its source. 

  
  

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 Appendix B - 1 

 Data lock point 

The data cut-off date for data to be included in regulatory report as required by Applicable law. This
applies to any report required to be submitted to a Regulatory Authority. 
 Healthcare Professionals 

Healthcare professionals are medically-qualified persons such as physicians, dentists, pharmacists, nurses, coroners, or as otherwise specified
by local regulations. Preferably, information about the case should be collected from the healthcare professionals who are directly involved in the patient’s care. In some regions, the healthcare professional status of the reporter is
immaterial to reporting practices. 
 Identified risk 

An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest. 

Examples of identified risks include: 

-an adverse reaction adequately demonstrated in non-clinical
studies and confirmed by clinical data; 
 -an adverse reaction observed in well designed clinical
trials or epidemiological studies for which the magnitude of the difference compared with the comparator group (placebo or active substance or unexposed group) on a parameter of interest suggests a causal relationship; an adverse reaction suggested
by a number of well documented spontaneous reports where causality is strongly supported by temporal relationship and biological plausibility, such as anaphylactic reactions or application site reactions. 

Internet 
 MAHs are not
expected to screen external websites for ADR information. However, if an MAH becomes aware of an adverse reaction on a website that it does not manage, the MAH should review the adverse reaction and determine whether it should be reported.
Unsolicited cases from the Internet should be handled as spontaneous reports. 
 MAHs should regularly screen their websites for potential
ADR case reports. MAHs and regulators should consider utilising their websites to facilitate ADR data collection, e.g. by providing ADR forms for direct reporting or by providing appropriate contact details for direct communication. For the
determination of reportability the same criteria should be applied as for cases provided via other ways. 
 Lack of Efficacy 

Reports of lack of efficacy should not normally be expedited, but should be discussed in the relevant periodic safety update report. However,
in certain circumstances reports of lack of efficacy should be treated as expedited cases for reporting purposes. Medicinal products used for the treatment of life-threatening or serious diseases, vaccines, and contraceptives are examples of classes
of medicinal products where lack of efficacy should be considered for expedited reporting. Clinical judgment should be used in reporting, with consideration of the approved product labeling/prescribing information. 

  
  

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 Appendix B - 2 

 Literature 

The Marketing Authorisation Holder (MAH) is expected to regularly screen the worldwide scientific literature, by accessing widely used
systematic literature reviews or reference databases. Cases of ADRs from the scientific and medical literature, including relevant published abstracts from meetings and draft manuscripts, might qualify for expedited reporting. A regulatory reporting
form with relevant medical information should be provided for each identifiable patient. The publication reference(s) should be given as the report source; additionally a copy of the article might be requested by the local regulatory authority to
accompany the report. All company offices are encouraged to be aware of publications in their local journals and to bring them to the attention of the company safety department as appropriate. 

The regulatory reporting time clock starts once it is determined that the case meets minimum criteria for reportability. MAHs should search the
literature according to local regulation or at least once a month. If the product source, brand, or trade name is not specified, the MAH should assume that it was its product, although reports should indicate that the specific brand was not
identified. 
 Worldwide Medical and Scientific literature – means literature available from internationally recognized scientific
databases (such as Embase, Medline, and where applicable, Aidsline, and Derwent Drug File) and journals (such as “Reactions”) and relevant abstracts presented at major internationally attended conferences. 

Marketing Authorization 

With respect to any medicinal product, any indications for which such medicinal product is to be used and any country or other jurisdiction,
the authorization required to be granted by the applicable Regulatory Authority in that country or jurisdiction in order for a party to commercially market and sell such medicinal product therein for such indications. 

Minimum Criteria for Reporting 

Minimum required data elements for an ADR case are: an identifiable reporter, an identifiable patient, an adverse reaction, and a suspect
product. Lack of any of these four elements means that the case is incomplete; however, MAHs are expected to exercise due diligence to collect the missing data elements. It is recommended that as much information as possible be collected at the time
of the initial first report. 
 Misuse 

Use of a medicinal product in a way that is not in accordance with its Regulatory Authorization or Marketing Authorization and that is
accompanied by harmful physical and/or psychological effects. 
 Non-serious ADRs 

Cases of non-serious ADRs are not normally reportable on an expedited basis. The spontaneous reports of
non-serious ADRs should be reported in the periodic safety update report. 
 Other Sources

 If MAHs become aware of a case report from non-medical sources, it should be handled as a
spontaneous report. 

  
  

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 Appendix B - 3 

 Overdose 

Reports of overdose with no associated adverse outcome should not be reported as adverse reactions. They should be routinely followed up to
ensure that information is as complete as possible with regard to symptoms, treatment, and outcome. The MAH should collect any available information related to its products on overdose, and report cases of these that lead to serious adverse
reactions according to expedited reporting criteria. 
 Parent-child/fetus exposure report (Pregnancy Exposure Report) 

A parent-child/fetus exposure report (pregnancy exposure report) is any report where a fetus/breast-feeding infant/child is at risk of
experiencing an adverse reaction/event as a result of being exposed to the product via mother and/or father. 
 Periodic Safety Update
Report 
 The periodic reports contained the records referred to in Article 104 of Council Directive 2001/83/EC and in Article 24(3) of
Regulation (EC) No 726/2004 (Volume 9A), and similar reports required under Applicable Law in the United States. 
 The PSUR is a practical
and achievable mechanism for summarizing interval safety data, especially covering short periods (e.g., 6 months or 1 year), and for conducting an overall safety evaluation. 

Potential risk 
 An
untoward occurrence for which there is some basis for suspicion of an association with the 
 medicinal product of interest but where this
association has not been confirmed. 
 Examples of potential risks include: 

 

	 	•	 	Non-clinical safety concerns that have not been observed or resolved in clinical studies; 

  

	 	•	 	Adverse events observed in clinical trials or epidemiological studies for which the magnitude of the difference, compared with the comparator group (placebo or active substance, or unexposed group), on the parameter of
interest raises a suspicion of, but is not large enough to suggest, a causal relationship; 

  

	 	•	 	A signal arising from a spontaneous adverse reaction reporting system; 

  

	 	•	 	An event which is known to be associated with other products of the same class or which could be expected to occur based on the properties of the medicinal product 

Product Quality Complaints 

Any inquiry from a third party that questions the purity, identity, potency, or quality of any product(s). 

Receipt Date 
 The meaning
is set forth in Section 2.1 of this SDEA. 
 Regulatory Authority Sources 

Individual serious unexpected adverse drug reaction reports originating from foreign regulatory authorities are always subject to expedited
reporting. Re-submission of serious ADR cases without new information to the originating regulatory authority is not usually required, unless otherwise specified by local regulation. 

  
  

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 Appendix B - 4 

 Reporting Guidelines for Other Observations 

In addition to single case reports, any safety information from other observations that could change the risk-benefit evaluation for the
product should be promptly communicated to the regulatory authorities. 
 Reporting Time Frames 

In general, expedited reporting of serious and unexpected ADRs refers to 15 calendar days. Time frames for other types of reports vary among
countries. 
 Regulatory Authority means, with respect to any country or other jurisdiction, any regulatory authority or other government
agency with competent jurisdiction in that country or jurisdiction over the development or commercialization of the product(s) contemplated by the Transaction Agreement and the pharmacovigilance and safety data management, exchange and reporting
activities in respect by this Agreement. 
 Safety signal 

An unexpected observation of an event in relation to treatment with a medicinal product or investigational medicinal product that deviates so
much from expectations that it calls for immediate and greater attention, including (but not limited to) unlabeled suspected adverse drug reactions, increased frequency or severity of labeled suspected adverse reaction, and any change in the
risk/benefit profile of the medicinal product or investigation medicinal product. 
 Seriousness Criteria 

The most internationally agreed seriousness criteria appear in ICH guideline E2A. A serious adverse event (experience) or reaction is any
untoward medical occurrence that at any dose: 
 * results in death 

* is life-threatening 
 (NOTE: The
term “life-threatening” in the definition of “serious” refers to an event/a reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/a reaction which hypothetically might
have caused death if it were more severe), 
 * requires inpatient hospitalisation or results in prolongation of existing hospitalisation, *
results in persistent or significant disability/incapacity, 
 * is a congenital anomaly/birth defect, 

* is a medically important event or reaction. 

Medical and scientific judgment should be exercised in deciding whether other situations should be considered as serious such as important
medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the patient or may require intervention to prevent one of the other outcomes listed in the definition above. These should also be
considered serious. 
 Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm; blood
dyscrasias or convulsions that do not result in hospitalisation; or development of drug dependency or drug abuse. 
 Any suspected
transmission via a medicinal product of an infectious agent is also considered a serious adverse reaction. 

  
  

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 Appendix B - 5 

 Single Cases of Serious ADRs (expedited reporting) 

Cases of adverse drug reactions from all sources that are both serious and unexpected are subject to expedited reporting. The reporting of
serious expected reactions in an expedited manner varies among countries. Non-serious adverse reactions, whether expected or not, would normally not be subject to expedited reporting. 

For reports from studies and other solicited sources, all cases judged by either the reporting healthcare professional or the MAH as having a
possible causal relationship to the medicinal product qualify as ADRs. For the purposes of reporting, spontaneous reports associated with approved drugs imply a possible causality. 

Solicited Sources 

Solicited reports are those derived from organized data collection systems, which include clinical trials, post-approval named patient use
programs, other patient support and disease management programs, surveys of patients or healthcare providers, or information gathering on efficacy or patient compliance. Adverse event reports obtained from any of these should not be considered
spontaneous. 
 For the purposes of safety reporting, solicited reports should be handled as if they were study reports, and therefore should
have an appropriate causality assessment. Further guidance on study-related issues such as managing blinded therapy cases can be found in ICH E2A. 

Spontaneous Reports 
 A
spontaneous report is an unsolicited communication by healthcare professionals or consumers to a company, regulatory authority or other organization (e.g. WHO, Regional Centers, Poison Control Center) that describes one or more adverse drug
reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme. 

Stimulated reporting may occur in certain situations, such as a notification by a “Dear Healthcare Professional” letter, a
publication in the press, or questioning of healthcare professionals by company representatives. These reports should be considered spontaneous. 

Suspect Drug 
 A generic
or brand name of a product administered and considered by the reporter to be potentially related to the occurrence of a specific adverse event. For spontaneous reports, a causal relationship is always assumed. 

Time Clock Start Point (Regulatory Clock Start Date) 

The regulatory reporting time clock (in calendar days) starts on the date when any personnel of the MAH first receive a case report that
fulfills minimum criteria as well as the criteria for expedited reporting. In general, this date should be considered as day 0. 
 When
additional medically significant information is received for a previously reported case, the regulatory reporting time clock begins again for submission of the follow-up report. 

Unexpected Adverse Drug Reactions 

An ADR whose nature, severity, specificity, or outcome is not consistent with the term or description used in the official product information
should be considered unexpected. 

  
  

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 Appendix B - 6 

 An ADR with a fatal outcome should be considered unexpected, unless the official product
information specifies a fatal outcome for the ADR. In the absence of special circumstances, once the fatal outcome is itself expected, reports involving fatal outcomes should be handled as for any other serious expected ADR in accord with
appropriate regulatory requirements. 
 Please note that the term “listedness” is not applicable for expedited reporting (refer to
ICH E2C for definition). 
 Additional considerations: 

“Class ADRs” should not automatically be considered to be expected for the subject drug. “Class ADRs” should be considered
to be expected only if described as specifically occurring with the product in the official product information, as illustrated in the following examples: 
  

	 	•	 	“As with other drugs of this class, the following undesirable effect occurs with Drug X.” 

  

	 	•	 	Drugs of this class, including Drug X, can cause...” 

 If the ADR has not been
documented with Drug X, statements such as the following are likely to appear in the official product information: 
  

	 	•	 	“Other drugs of this class are reported to cause...” 

  

	 	•	 	“Drugs of this class are reported to cause..., but no reports have been received to date with Drug X.”. 

In these situations, the ADR should not be considered as expected for Drug X. 

In the absence of sufficient documentation and in the face of uncertainty, a reaction should be regarded as unexpected. 

  
  

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 Appendix B - 7 

 EXHIBIT C 

SUPPLEMENTAL STUDIES 
 [*] 

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit C-1 

 EXHIBIT D 

SUPPLY AGREEMENT 

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit D-1 

 Execution Version 

SUPPLY AGREEMENT 
 by
and between 
 STRAKAN INTERNATIONAL S.À R.L. 

and 
 APTALIS PHARMA US,
INC. 
  
  

DATE: December 28, 2011 

  
  

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 TABLE OF CONTENTS 
  

							
	 Page
	    	 	  	 	 
			
	Article 1	    	DEFINITIONS	  	 	1	  
			
	Article 2	    	MANUFACTURE AND SUPPLY	  	 	4	  
			
	Article 3	    	FORECAST, ORDERING AND DELIVERY	  	 	8	  
			
	Article 4	    	PRICE AND PAYMENT	  	 	11	  
			
	Article 5	    	QUALITY CONTROL OF THE PRODUCT/AUDITS AND INSPECTIONS	  	 	12	  
			
	Article 6	    	REGULAR BUSINESS REVIEWS	  	 	16	  
			
	Article 7	    	REPRESENTATIONS AND WARRANTIES	  	 	17	  
			
	Article 8	    	DEFECTS, INDEMNIFICATION AND INSURANCE	  	 	20	  
			
	Article 9	    	FORCE MAJEURE	  	 	23	  
			
	Article 10	    	TERM AND TERMINATION	  	 	24	  
			
	Article 11	    	MISCELLANEOUS	  	 	27	  
			
	Article 12	    	ASSIGNMENT	  	 	29	  
			
	Article 13	    	ENTIRE AGREEMENT; AMENDMENT AND WAIVER	  	 	29	  
			
	Article 14	    	GOVERNING LAW AND DISPUTES	  	 	30	  
			
	Article 15	    	COUNTERPARTS	  	 	31	  

 Schedule 1: Product and Product Specifications 

Schedule 2: Price and Payment 
 Schedule 3: Supplier Scorecard

  
  

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 i 

 SUPPLY AGREEMENT 

This Supply Agreement (the “Agreement”) is made on December 28, 2011 by and between 

 

	 	(1)	Strakan International S.à r.l., a company incorporated in Luxembourg with offices at Galabank Business Park, Galashiels, TD1 1QH, Scotland (“Strakan”); and 

 

	 	(2)	Aptalis Pharma US, Inc., whose principal place of business is at 100 Somerset Corporate Boulevard, Bridgewater, NJ 08807 USA (“Aptalis”). 

Recitals 
  

	 	(A)	WHEREAS, Strakan and Aptalis are parties to that certain Commercialization and License Agreement of even date (the “License Agreement”), whereby Aptalis has licensed the rights to Develop, Commercialize
and Manufacture the Product in the Territory; and 

  

	 	(B)	WHEREAS, in accordance with the License Agreement, the Parties agreed to contemporaneously with such License Agreement enter into this Agreement pursuant to which, and subject to the conditions set forth below, Strakan
is to supply all of Aptalis’ requirements of Product in order to commercialize such Product in the Territory, except as otherwise provided in this Agreement. 

NOW, THEREFORE, the Parties, intend to be legally bound, agree as follows: 

Article 1 DEFINITIONS 
 For purposes of this
Agreement, in addition to the other terms defined elsewhere in this Agreement, the following initially capitalized terms, whether used in the singular or plural, will have the following meanings. Other capitalized terms that are used in this
Agreement and not defined in this Agreement will have the meaning set forth in the License Agreement. In the event that any terms are defined in both this Agreement and the License Agreement, such terms shall have the meaning as defined in this
Agreement only for purposes of this Agreement. 

  
  

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 1 

 “Additional Materials” shall mean all raw materials, Active Pharmaceutical Ingredients,
intermediates, components, excipients, other ingredients, packaging materials and supplies, including Printed Matters, required to Manufacture the Product. 

“API” or “Active Pharmaceutical Ingredient” shall mean the substance in a Product that is pharmaceutically active. 

“Breaching Party” shall have the meaning given in Section 10.2.1 of this Agreement. 

“Certificate of Analysis” means a document identified as such and provided by Strakan or Strakan’s Contract Manufacturer(s) to Aptalis
that sets forth the analytical test results against the Specifications as agreed to in writing between the Parties for a given Lot of Product delivered to Aptalis hereunder. 

“Certificate of Compliance” means a document identified as such and provided by Strakan or Strakan’s Contract Manufacturer(s) to Aptalis
that certifies that each Lot of Product was Manufactured and tested in compliance with Specifications, cGMPs, the Master Batch Records and other applicable regulatory documents. 

“Contract Manufacturer” shall mean [*] and, subject to Section 2.1.3, any other manufacturers operating under contract to Strakan in the
Manufacture of the Product. 
 “Contract Year” shall mean, for the first Contract Year, the period from the Effective Date to
December 31, 2012, and for each subsequent Contract Year shall be the subsequent consecutive 12- month periods of each relevant calendar year (January
1st until December 31st). 

“Effective Date” means the date on which the License Agreement becomes effective in accordance with its terms. 

“Fixed Period” shall have the meaning given in Section 3.2 of this Agreement. 

“Forecast” shall have the meaning given in Section 3.1 of this Agreement. 

“Indemnitee(s)” shall have the meaning given in Section 8.7 of this Agreement. 

“Indemnification Claim Notice” shall have the meaning given in Section 8.7 of this Agreement. 

“Indemnified Party” shall have the meaning given in Section 8.7 of this Agreement. 

  
  

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 2 

 “Indemnifying Party” shall have the meaning given in Section 8.7 of this Agreement. 

“Lot” an aliquot of Product in the same package size produced in a discrete Manufacturing run that is identifiable by a unique number. 

“Manufacturing Facilities” shall mean the facilities utilized in the Manufacture of the Product that have been designated as an approved
manufacturing facility in the Product NDA. 
 “Manufacturing Process” with respect to each Product, means process and methods (or step in
any process, including packaging, quality control and quality assurance) used or planned to be used by a manufacturer (or any of its permitted Affiliates or sub contractors) in the Manufacturing of such Product in accordance with the Product Quality
Agreement. 
 “Master Batch Record” means a detailed,
step-by-step description of the entire Manufacturing Process for a specific Product, which explains exactly how the product is Manufactured, indicating specific types
and quantities of components and raw materials, Additional Materials, processing parameters, in-process quality controls, and other relevant controls. 

“MOQ” shall mean the minimum order quantities of Product at SKU level, as set out in Schedule 2 and as may be adjusted in accordance with
Article 6 of this Agreement. 
 “Non-conforming Product” shall have the meaning given in Section 5.5 of this Agreement. 

“Non-conformity” shall have the meaning given in Section 5.5 of this Agreement. 

“Open Period” shall have the meaning given in Section 3.2 of this Agreement. 

“Price” with respect to the Product, means the amount in the applicable currency payable for the Product, as determined in accordance with
the terms hereof and Schedule 2. 
 “Printed Matter” shall mean printed matter that accompanies the Product in the market and identifies it
in any way; therefore, label includes immediate container label, printed primary, secondary and tertiary packaging, including package inserts but exclusive of promotional materials. 

“Product” means the finished product to be Manufactured pursuant to the Product NDA and supplied in accordance with the terms of this
Agreement including the product profile set forth in Schedule 1. 

  
  

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 3 

 “SKU” shall mean stock keeping unit as applied to the Product. 

“Specifications” shall mean the processes, methods, formulae, analyses, instruction, standards, know – how, testing and control
procedures, information and specifications relating to (a) the Manufacture of the Product in accordance with the Product NDA and this Agreement, including Schedule 1 and (b) the supply of Additional Materials in accordance with the Product
Quality Agreement. 
 “Termination Assistance Period” shall have the meaning given in Section 10.4.5 of this Agreement. 

“Termination Assistance Services” shall have the meaning given in Section 10.4.5 of this Agreement. 

“Trading Period” shall have the meaning given in Section 3.2 of this Agreement. 

Article 2 MANUFACTURE AND SUPPLY 
  

	2.1	Manufacture. 

  

	 	2.1.1	Strakan shall, or shall cause its Affiliates and Contract Manufacturer(s), to Manufacture the Product exclusively for Aptalis in the Territory in accordance with the Specifications, cGMP, the Product Quality Agreement,
the License Agreement and applicable Laws, and deliver it to Aptalis in accordance with Article 3 of this Agreement. 

  

	 	2.1.2	 Manufacturing Facilities: Strakan and its Contract Manufacturer(s) shall Manufacture the Product only at the Manufacturing Facilities. Without
limiting the foregoing, neither Strakan nor its Contract Manufacturer(s) shall change Manufacturing Facilities except with the prior written approval of Aptalis such approval not to be unreasonably withheld, conditioned or delayed and the
authorisation of all applicable Regulatory Authorities (if required) and the change control procedures set forth in this Section 2.1.2. A copy of the project plan relating to any proposed change of Manufacturing Facility (together with a copy
of updates to such plan) shall be submitted to Aptalis for approval (such approval not to be unreasonably withheld, conditioned or delayed) and, if Aptalis approves 

  
  

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 4 

	 	
such plan, then following receipt of Aptalis’ approval, Aptalis shall be kept regularly informed as to Strakan’s and its Contract Manufacturer(s)’ progress against the plan.
Aptalis shall not be obliged to purchase any Product from any changed Manufacturing Facility until such time as Regulatory Approval to use such facility is obtained. The Parties will cooperate to receive Regulatory Approval with respect to using any
additional Manufacturing Facilities. Aptalis will notify Strakan promptly, in writing, after any such Regulatory Approval is obtained. Before initiating such change in Manufacturing Facilities, Strakan shall, and shall cause its Affiliates and
Contract Manufacturer(s), to take all reasonable precautions to mitigate the risk to Aptalis of any supply interruption, including maintaining an appropriate level of safety stock as agreed to by Aptalis (it being recognized by Aptalis that there
may be a commensurate reduction in the shelf life for such safety stock which shall not be a breach of Section 3.5.2, provided however that Strakan will replace any stock that becomes unsaleable due to obsolescence with saleable stock) during
the period during which such change in Manufacturing Facility is taking place. The Parties agree, in relation to costs associated with any change of, or to, the Manufacturing Facilities, that (a) where a change in the Manufacturing Facility
(i) is required by a change in Law outside the Territory, (ii) is required by an applicable Regulatory Authority outside the Territory, (iii) is required by a change in Law inside the Territory alone or by an applicable Regulatory
Authority inside the Territory, or (iv) is required by a change in Law both inside and outside the Territory or by applicable Regulatory Authorities both inside and outside the Territory, such costs shall be the responsibility of [*], and
(b) where a change in the Manufacturing Facility is mutually agreed to in order to mitigate supply risk and qualify an alternate Manufacturing site (not due to Strakan’s failure to Manufacture and supply in accordance with Specifications,
including, cGMP or due to Supplier’s failure to comply with any Law in force at the Effective Date or as updated, amended or replaced from time to time pursuant to terms of this Section where the allocation of such costs for such update has
been in accordance with the terms of this Section 2.1.2 and not due to Aptalis’ decision to elect to manufacture the Product 

  
  

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in accordance with Section 2.1.7), such costs shall be allocated [*] percent ([*]%) to Strakan and [*] percent ([*]%) to Aptalis. Nothing in this Section or this Agreement shall prevent
Strakan from qualifying another Third Party (other than the Contract Manufacturer, subject to Section 2.1.7) as a supplier of the Product for the Territory, provided that Aptalis’ prior written approval (such approval not to be
unreasonably withheld, conditioned or delayed) has first been obtained by Strakan. 

  

	 	2.1.3	Right to Engage Contract Manufacturers. From the Effective Date through the term of this Agreement Strakan shall only exercise its right to enter into a contract with a Contract Manufacturer with the prior,
written approval of Aptalis, such approval not to be unreasonably withheld, conditioned or delayed. Where Strakan enters into a contract with a Contract Manufacturer in accordance with the terms of this Agreement Strakan shall ensure that such
contract or agreement is on terms which are consistent with this Agreement and Strakan shall remain liable for each Contract Manufacturer’s performance under this Agreement. 

 

	 	2.1.4	Maintenance of Manufacturing Facilities. During the term of this Agreement, Strakan shall, and shall cause its Affiliates and Contract Manufacturer(s), to maintain the Manufacturing Facilities, all personal
property and Additional Materials, equipment, machinery, Product, systems (including quality assurance and control systems), intangibles, Intellectual Property Rights and contract rights in use at the Manufacturing Facilities during the term of this
Agreement in the ordinary course of business, in compliance with cGMP and applicable Law and, in the case of tangible equipment and materials, in good working order. 

 

	 	2.1.5	Procurement of Materials and Inventory. 

  

	 	2.1.5.1	Strakan or its Contract Manufacturer(s) shall timely procure, at [*] expense, all Additional Materials necessary for the Manufacture of Product. Title to all such Additional Materials shall reside with Strakan or its
Contract Manufacturer(s) until such time as such Additional Materials are incorporated into the Product and such Product is delivered to Aptalis in accordance with Section 3.5. 

  
  

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	 	2.1.5.2	Strakan or its Contract Manufacturer(s) shall maintain commercially reasonable inventories of Additional Materials (excluded printed materials) and Third Party APIs required to Manufacture the Product and ensure timely
delivery, provided that such inventories shall be sufficient to Manufacture the Product for at least [*] weeks in accordance with the current Forecast at any time and further provided that any obsolescence of such Additional Material or Third Party
APIs caused by Aptalis changing the Specification or the Manufacturing Facility shall be at Aptalis’ cost. 

  

	 	2.1.5.3	Strakan shall, promptly upon becoming aware of any actual or anticipated shortages of or changes to the supply of Additional Materials, notify, and provide Aptalis with any information, data and documentation, related
to any such actual or anticipated shortages of or changes to the supply of Additional Materials experienced by Strakan or its Contract Manufacturer(s). 

  

	 	2.1.6	Records, Retained Samples and Storage. Strakan shall, and shall cause its Affiliates and Contract Manufacturer(s), to retain samples and maintain records from each Lot of Product for a period required by Law for
record keeping, testing and regulatory purposes or specified in the Product Quality Agreement and shall make the same available to Aptalis at Aptalis’ request to address any issues raised by any Regulatory Authority relating to the Manufacture
of the Product in the Territory or any other reasonable request of Aptalis. When storing Product, Strakan shall, and shall cause its Affiliates and Contract Manufacturer(s) to, comply with and maintain all storage facilities in compliance with
Specifications and in accordance with cGMP and Law. 

  

	 	2.1.7	Aptalis’ Right to Manufacture. Aptalis shall have the right to take over responsibility for Manufacture of the Product by either making the Product itself or appointing a Third Party to do so on its behalf,
in each case for sale in the Territory, provided that Aptalis shall not have the right to appoint the Contract Manufacturer directly unless [*]. If Aptalis wishes to exercise this right it will 

  
  

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provide Strakan [*] months’ notice in writing, provided that such notice is not required if Strakan has breached this Agreement or experienced a Bankruptcy Event. Following receipt of such
notice and subject to the Parties agreeing in good faith any consequential changes required to the License Agreement or Product Quality Agreement, Strakan shall and shall use its Commercially Reasonable Efforts to procure that its Contract
Manufacturer(s) shall provide such Termination Assistance Services as Aptalis shall reasonably require (and at [*] cost) in order to transfer Manufacture of the Product to Aptalis or its nominated Third Party contract manufacturer. For the avoidance
of doubt, Aptalis shall be entitled to undertake any necessary activities in order to qualify a new manufacturer prior to taking over responsibility for Manufacturing pursuant to this Section 2.1.7 

Article 3 FORECAST, ORDERING AND DELIVERY. 
  

	3.1	Rolling Forecasts. 

 Commencing no later than the Effective Date, each month Aptalis
shall submit to Strakan, within six (6) Business Days after the first Business Day of each month, written or electronic forecasts of the quantities of the Product that it desires or expects to order from Strakan during each of the succeeding
[*] months (“Forecast”). 
  

	3.2	Firm Commitment and Estimates 

  

	 	3.2.1	Pharmaceutical Dosage Form 

  

	 	3.2.1.1	The first [*] weeks (“Fixed Period”) covered by each Forecast shall constitute a binding commitment by Aptalis to purchase the quantities of Product covered thereby. Any variation to this will be
managed by exception and agreed between the Parties. 

  

	 	3.2.1.2	 With respect to months [*] to [*] covered by each Forecast (“Trading Period”), although such quantities shall not constitute a
binding commitment by Aptalis to purchase such quantities, unless the quantity Forecast is otherwise consumed by later orders Aptalis shall 

  
  

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be obliged and committed to reimburse the costs for the Additional Materials and Third Party APIs for such Product quantities, provided that such reimbursement shall only be required to the
extent that Strakan has actually purchased such Additional Materials and Third Party APIs. For purposes of clarity, the Trading Period Forecast can be adjusted without limitation at Aptalis’ sole discretion. 

 

	 	3.2.1.3	With respect to month [*] through month [*] of the Forecast (“Open Period”) these quantities shall constitute a non binding Forecast of Aptalis orders, presented solely for the purpose of enabling
Strakan to schedule the use of facilities and resources and plan the production of Product. 

  

	3.3	Purchase Orders 

 All purchase of Product shall be pursuant to written purchase orders
which shall include all of the Forecast quantities in the Fixed Period. Purchase orders shall be placed by Aptalis at least [*] weeks prior to the due date by which the Product shall be delivered or made available by Strakan. Strakan shall
acknowledge receipt of each purchase order within five (5) Business Days of receipt. Confirmation of the purchase order within ten (10) Business Days shall include a written confirmation of the due date, which shall be the requested
delivery date unless otherwise agreed to between the Parties. Strakan may reject a purchase order only if that order is not in compliance with the then applicable Forecasts, sets forth incorrect Prices, or specifies a quantity that is inconsistent
with the MOQ of the Product, provided that if the purchase order exceeds the Fixed Period Forecast Strakan will use its Commercially Reasonable Efforts to supply the excess. To the extent that any order by Aptalis provides for a due date that is
less than [*] weeks after the date of the purchase order, Strakan shall be entitled to request that the due date be postponed to [*] weeks after the date of the order but not to reject the order. The Parties agree to use Commercially Reasonable
Efforts to define a mutually acceptable expedited delivery process, which provides for a due date that is less than [*] weeks after the applicable order. This process is to be used only in exceptional circumstances, including as set forth in
Section 8.2.1, and is subject to the terms of Strakan’s contract with its Contract Manufacturer. Nothing contained in any purchase order or confirmation thereof shall supersede the terms and conditions of this Agreement. 

  
  

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	3.4	MOQs and Deviation from MOQs 

 MOQs and Prices for the Product are set out in Schedule 2.

 In the event that Aptalis desires to purchase a quantity of the Product not in accordance with the MOQ then the Parties shall negotiate in
good faith any necessary adjustments to be made in the planning, Manufacture and delivery of Product. 
  

	3.5	Delivery 

  

	 	3.5.1	The Product hereunder shall be delivered according to the following Incoterms 2010: Ex-works Strakan’s nominated Contract Manufacturer or warehousing facility. Where
appropriate to and required by the specified Incoterms 2010 Aptalis shall designate the carrier that will take delivery of the Product. For purposes of clarity the actual reasonable Third Party logistical expenses, including sea freight costs,
incurred by Aptalis to deliver Product to its Third Party logistics provider in the United States from the Contract Manufacturer [*]. In addition, Aptalis may use, and [*] under the License Agreement, air freight to ship the Product from the
Contract Manufacturer to its United States logistics provider if the shelf life of the Product is less than [*] months. 

  

	 	3.5.1.1	Aptalis shall be responsible for logistical expenses in connection with the delivery of any Product already located in the Territory as of the Effective Date. 

 

	 	3.5.2	The quantity of Product delivered by Strakan with respect to each confirmed order shall be in accordance with Schedule 2. The Product shall have a shelf life on delivery of not less than [*] percent ([*]%) of the
shelf-life specified in the Product NDA for as long as the shelf life specified is [*] months and [*] percent ([*]%) of the shelf life specified in the Product NDA as long as the shelf life specified is [*] months or longer. Aptalis agrees to
purchase Lots [*] and [*] of Product which have been manufactured prior to the Effective Date if (i) the next scheduled stability data is provided to Aptalis by [*], (ii) in Aptalis’ sole discretion such data 

  
  

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supports a shelf life of [*] months, and (iii) in Aptalis’ reasonable discretion there is no other reason Aptalis cannot sell such Lots in the Territory, including any regulatory or
legal barriers. Delivery documents shall include purchase order number, quantity, copy of Certificate of Analysis, Certificate of Compliance, item codes and description, lot number, number of shippers (or other specified containers) weight and
number of pallets. 

  

	 	3.5.3	Each order shall be delivered not more than five (5) Business Days earlier or later than the date agreed upon for the confirmed order unless otherwise agreed to by the Parties, and Strakan shall immediately notify
Aptalis of any change to the agreed upon delivery date. 

  

	3.6	Samples. Strakan shall supply Aptalis with sample packs of the Product, the details and price of which shall be agreed between the Parties. Otherwise, supply of such sample packs shall be subject to the same
terms as supply of the Product. 

  

	3.7	Shelf Life Reduction. If the shelf life of the Product approved by the FDA is reduced below [*] months Strakan will reimburse Aptalis for the cost of any Product which is returned to Aptalis by its wholesalers
because such wholesalers are unable to sell such Product as a result of such reduction in the approved shelf life. 

 Article 4 PRICE
AND PAYMENT 
  

	4.1	Price 

 For the duration of the License Agreement, Aptalis shall pay to Strakan the
amount set forth in Schedule 2 for each unit of the Product Manufactured and supplied under the terms of this Agreement. For purposes of clarity, amounts paid [*]. 
  

	4.2	Invoices - Payment conditions 

  

	 	4.2.1	Upon delivery of each order, Strakan shall issue an invoice to Aptalis for the applicable Price for all Product delivered to Aptalis. The invoice shall contain a reference identifying the Aptalis purchase order.

  

	 	4.2.2	Aptalis shall pay all undisputed invoices in full within forty-five (45) days from the date of the relevant invoice. 

  
  

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 Article 5 QUALITY CONTROL OF THE PRODUCT/AUDITS AND INSPECTIONS 

 

	5.1	Product Quality Agreement 

 The Parties have entered into a Product Quality Agreement of
even date. To the extent that there are any inconsistencies or conflicts between this Agreement and the Product Quality Agreement then the terms of this Agreement shall govern with respect to supply aspects and the Product Quality Agreement shall
govern with respect to quality and cGMP aspects. 
  

	5.2	Testing and Release 

 Testing and release of the Product shall be undertaken in
accordance with the terms of the Product Quality Agreement. Aptalis shall be responsible for final release of the Product, which shall be in accordance with the Product Quality Agreement. 

 

	5.3	Records 

 At its own cost Strakan shall cause the Contract Manufacturer(s) to keep and
accurately maintain documents and records in accordance with applicable Laws and as specified in the Product Quality Agreement. 
  

	5.4	Modification of Specifications 

  

	 	5.4.1	Strakan shall not make any modification to the Specifications without first giving prior written notification to Aptalis and obtaining Aptalis’s approval of such modifications. 

 

	 	5.4.2	For all changes to the Specifications made at Aptalis’ reasonable request and to which Strakan has consented in writing (such consent not to be unreasonably withheld, conditioned or delayed), [*] shall be solely
responsible for and pay any and all Specifications change implementation costs. [*] agrees to use Commercially Reasonable Efforts to implement such changes to the Specifications and minimize the costs associated with any Specifications change.

  

	 	5.4.3	 The Parties will cooperate to amend or supplement the Specifications where the OC requests in writing to implement a discretionary modification to the
Specifications which is not necessary to comply with applicable Law or the 

  
  

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requirements of a Regulatory Authority. For such Specification changes the Parties shall share the Specifications change implementation costs as follows: Strakan shall pay [*] percent ([*]%) and
Aptalis shall pay [*] percent ([*]%). [*] agrees to use Commercially Reasonable Efforts to implement such changes to the Specifications and minimise the costs associated with any Specifications change. 

 

	 	5.4.4	The Parties will cooperate to amend or supplement the Specifications (a) to the extent reasonably necessary to comply with applicable Law or the requirements of a Regulatory Authority in the Territory, (b) to
the extent reasonably necessary to comply with applicable Law or the requirements of Regulatory Authorities that are effective both in the Territory and outside the Territory, or (c) to the extent reasonably necessary to comply with applicable
Law or the requirements of a Regulatory Authority outside the Territory. For all changes to the Specifications made in accordance with this Section 5.4.4, [*] shall be solely responsible for and pay any and all Specifications change
implementation costs. [*] may, upon obtaining written approval from the OC, impose any changes in connection with clause (c) of this Section 5.4.4 to the Specifications for the Product in the Territory to the extent that such changes are
permitted by the applicable Regulatory Authorities. For purposes of clarity, where any modification to the Specifications is required outside the Territory, [*] shall not change the Specifications with respect to the Product unless it has received
[*] prior written approval not to be unreasonably withheld, conditioned or delayed. 

  

	5.5	Non-conformity 

 If Aptalis determines that any Product does not comply with the
Specifications and the Product Quality Agreement and Strakan agrees or if Strakan does not agree but the expert appointed in accordance with Section 8.3 determines that the Product does not comply with the Specifications or the Product Quality
Agreement (“Non-conformity”) then such Product shall be considered “Non-conforming Product”. The consequences of Non-conformity are set out in Article 8 of this Agreement. The
provisions of the Product Quality Agreement shall also apply to the determination of the Non-conformity of any Product. 

  
  

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	5.6	Recall 

 In the event any Product recall in the Territory is required by any Regulatory
Authority, or if recall is jointly deemed to be required by the Parties, or deemed to be required by Aptalis such recall shall promptly be administered by [*] at [*]’ cost in a manner reasonable under the circumstances and in line with accepted
trade practice and regulatory requirements; provided, that [*] will be reimbursed by [*] for all reasonable costs and expenses incurred in connection with such recall if such recall results from [*]. [*] shall have sole discretion for determining
whether and when to recall any Lot in the Territory and for all matters relating to such recall’s implementation, for any reason whatsoever. 
  

	5.7	Reporting of Adverse Events 

 The Parties shall promptly provide each other with
necessary information and data relating to adverse events associated with the Manufacture of the Product, received by or reported to the Parties from any sources in accordance with the Safety Data Exchange Agreement. 

 

	5.8	Audit and Inspection Rights. 

  

	 	5.8.1	Audit Rights. Strakan shall grant to authorized representatives of Aptalis (or at Aptalis’ sole discretion, a Third Party hired on behalf of Aptalis who is reasonably acceptable to Strakan) or cause its
Contract Manufacturer(s) to grant to such persons, upon reasonable notice, during regular business hours and no more than once per Calendar Year with respect to clause (a) below (unless an audit has determined, or Aptalis reasonably believes,
that material safety or quality issues exist with respect to the Product delivered to Aptalis hereunder, in which case the number of audits shall be limited to the number of audits that are reasonably necessary to resolve such issues), access to the
Manufacturing Facilities where the Product is Manufactured, tested or stored for the sole purpose of (a) allowing Aptalis to conduct audits of the Manufacturing Facilities as they relate to any matters arising under this Agreement, the Product
Quality Agreement or the Safety Data Exchange Agreement or (b) subject to applicable 

  
  

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Law and any Third Party confidentiality restrictions and obligations, inspecting all data, documentation and work products relating to the activities performed by Strakan or the Contract
Manufacturer(s) under this Agreement, the Product Quality Agreement or the Safety Data Exchange Agreement. The right to inspect all data, documentation and work products relating to the Product under clause (b) above may be exercised at any
time during the Term, or such longer period as shall be required by applicable Law. Strakan will comply with all reasonable requests and assist in any audit initiated by Aptalis personnel or a person designated by Aptalis. Aptalis shall provide
Strakan with, if reasonably possible, at least fifteen (15) Business Days’ notice in writing of the date on which Aptalis shall conduct any audit hereunder and Strakan shall use its Commercially Reasonable Efforts to ensure that the
Contract Manufacturer provides such access as requested by Aptalis, but in any event Strakan shall cause the Contract Manufacturer to provide such access within thirty (30) Business Days. An exit meeting will be held with representatives from
Aptalis and Strakan to discuss any significant audit observations. In the event that, as a result of any such audit Aptalis reasonably believes that Strakan or its Contract Manufacturer is not in compliance with Law, Specifications or any other
agreed upon requirement of Aptalis and/or has not met its obligations under this Agreement, the Product Quality Agreement or the Safety Data Exchange Agreement, Strakan shall respond to Aptalis within thirty (30) days following receipt of
Aptalis’s audit report with a proposed written plan for corrective action and shall execute such corrective action plan as may be reasonably agreed by Aptalis. 

 

	 	5.8.2	 Inspection Rights. Each Party shall notify the other Party as soon as possible of any notification received by it or otherwise notified to it
from a Regulatory Authority (including those outside the Territory) to conduct an inspection of the Manufacturing Facilities and if such request is received by Aptalis, upon notification, Strakan shall ensure that the Manufacturing Facilities where
the Product is Manufactured, tested or stored, including all records and reference samples are available for inspection by the applicable Regulatory Authority. Subject to applicable confidentiality obligations, each Party shall, within ten
(10)

  
  

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Business Days, provide to the other Party copies of all correspondence relating thereto with a Regulatory Authority to the extent that such correspondence relates to the Product. To the extent
reasonably practicable, Strakan shall inform Aptalis within ten (10) Business Days of any inspection of the Manufacturing Facilities by a relevant Regulatory Authority and of the results of any such inspection and provide the inspection report
and response. 

  

	 	5.8.3	Strakan shall provide Regulatory Authorities access to the Manufacturing Facilities as required by such Regulatory Authorities. Aptalis reserves the right to be on site at Strakan’s or its Contract
Manufacturer’s Manufacturing Facility during pre-approval or general inspections of Products or Manufacturing Facilities by Regulatory Authorities. 

 

	 	5.8.4	Strakan shall cause it Contract Manufacturer(s) to grant Aptalis and Regulatory Authorities the audit and inspection rights set forth in Sections 5.8.1, 5.8.2 and 5.8.3. 

 

	 	5.8.5	Strakan will be responsible for auditing its Contract Manufacturer(s) and the supplier(s) of Additional Materials on behalf of Aptalis. 

 

	5.9	Regulatory Approvals for Manufacturing. 

 Strakan shall, or shall cause its Affiliates
and Contract Manufacturer(s), to provide all data, information or other documentation in the possession or control of Strakan or the Contract Manufacturer as requested by Aptalis to respond to any inquiry by any Regulatory Authority. 

Article 6 REGULAR BUSINESS REVIEWS 
  

	6.1	The Parties will discuss matters regarding Manufacture of the Product in the OC in accordance with Section 3.2 of the License Agreement. The Parties will ensure that at least one of its members of the OC is
reasonably experienced in the manufacture of pharmaceutical products. 

  

	6.2	Strakan will use its Commercially Reasonable Efforts to provide or cause to be provided the information (to the extent reasonably available to Strakan) necessary to populate the information in the Supplier Scorecard set
out in Schedule 3 on a quarterly basis, and such information will be provided within thirty (30) days of the last day of such quarter. 

  
  

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 Article 7 REPRESENTATIONS AND WARRANTIES 

 

	7.1	Representations, Warranties and Covenants. 

  

	 	7.1.1	Each Party represents and warrants to the other that, as of the Effective Date: 

  

	 	7.1.1.1	It is a corporation or entity duly organized and validly existing under the laws of the state of incorporation; 

  

	 	7.1.1.2	It has full corporate right, power and authority to enter into and deliver this Agreement and to perform its respective obligations under this Agreement; 

 

	 	7.1.1.3	This Agreement is a legal and valid obligation binding upon it and enforceable in accordance with its terms. The execution, delivery and performance of this Agreement by it does not conflict with or result in a breach
of any other agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any applicable Laws; 

  

	 	7.1.1.4	It has not granted any right to any Third Party that would conflict with the rights granted to the other Party hereunder; and 

  

	 	7.1.1.5	It has obtained all necessary consents, approvals and authorizations of all Governmental Authorities and other persons or entities required to be obtained by it as of the Effective Date in connection with the execution,
delivery and performance of this Agreement. 

  

	 	7.1.2	Strakan represents, warrants and covenants to Aptalis that: 

  

	 	7.1.2.1	All Product delivered to Aptalis by Strakan or its designee shall be Manufactured, stored and tested in accordance with and conform to the Specifications, cGMPs, all applicable Law, and the Product Quality Agreement as
of the time of delivery by Strakan to Aptalis; 

  
  

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	 	7.1.2.2	The ownership and operation of the Manufacturing Facilities shall be in material compliance with cGMPs and all applicable Law; 

  

	 	7.1.2.3	All Product delivered to Aptalis will be free and clear of all liens and encumbrances at the time at which title transfers to Aptalis; 

 

	 	7.1.2.4	It has not, none of its Affiliates has, and to its knowledge after due inquiry no Contract Manufacturer has, received any notice from any Governmental Authority in the Territory or in any jurisdiction in which the
Product is to be Manufactured for Aptalis pursuant to this Agreement claiming that the Product (or a product that corresponds to the Product in the relevant jurisdiction) or any Manufacturing Facility is not currently in compliance with any relevant
requirement of such Governmental Authority; 

  

	 	7.1.2.5	It and its Affiliates are and shall remain, and shall cause its Contract Manufacturer(s) to be, in compliance with any and all Laws of any Governmental Authority having jurisdiction over the Manufacture of the Product,
including without limitation fulfilling any reporting requirements to any such Governmental Authority, and including the Physician Payments Sunshine Act, as applicable; 

 

	 	7.1.2.6	It (a) is not in breach of any of its contracts or arrangements with a Contract Manufacturer, (b) knows of no event or circumstance which would constitute a breach of any contract or arrangement with a
Contract Manufacturer; 

  

	 	7.1.2.7	To its knowledge after due inquiry, there are no outstanding orders, judgments or settlements against or owed by Strakan, any of its Affiliates or its Contract Manufacturer(s), nor any pending or threatened claims or
litigation, in either case relating to the Manufacturing Process or Additional Materials for Product used or practiced by Strakan or its Contract Manufacturer(s); and 

  
  

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	 	7.1.2.8	As of the Effective Date, neither Strakan nor its Affiliates has been debarred or is subject to debarment and neither Strakan nor any of its Affiliates will use in any capacity, in connection with the Manufacture of the
Product, any Person who has been debarred pursuant to Section 306 of the United States Federal Food, Drug and Cosmetic Act, or who is subject of a conviction described in such section. Further, Strakan agrees to inform Aptalis in writing
immediately if it or any Person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306, or if any action, suit, claim, investigation or legal administrative proceeding is pending or, to the
best of Strakan’s knowledge, is threatened, relating to the debarment of Strakan, its Affiliates or any Person used in any capacity by Strakan or its Affiliates in connection with the Manufacture of the Product. 

 

	7.2	Disclaimers. STRAKAN MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, AND SUCH WARRANTIES ARE HEREBY SPECIFICALLY DISCLAIMED BY STRAKAN. 

  

	7.3	Exceptions to Warranties. The warranties as applied to each Party set forth in Section 7.1.2.1 shall not apply to any Product that (a) has been tampered with or otherwise altered other than by Strakan,
its Affiliates or a Contract Manufacturer, (b) has been subjected to misuse, negligence or accident other than by Strakan, its Affiliates or a Contract Manufacturer, (c) has been stored, handled or used by others in a manner contrary to
Law other than by Strakan, its Affiliates or a Contract Manufacturer, or (d) has expired its stated shelf life other than due to an act or omission by Strakan, its Affiliates or a Contract Manufacturer. 

  
  

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 Article 8 DEFECTS, INDEMNIFICATION AND INSURANCE 

 

	8.1	If any delivery of Product delivered or Manufactured by or on behalf of Strakan contains any damage, quantity deviation or defect of the Product due to Strakan, the Contract Manufacturer(s) or circumstances which
Strakan is responsible for, Aptalis shall notify Strakan (a) within sixty (60) days of Aptalis taking title to the Product if such damage, deviation or defect can be ascertained by the exercise of reasonable diligence upon examination by
Aptalis on receipt of the Product, or (b) within sixty (60) days after discovery of the same if such damage, deviation or defect cannot be ascertained by the exercise of reasonable diligence upon examination by Aptalis on receipt of such
delivery arriving at Aptalis’ warehouse. For the avoidance of doubt it is understood between the Parties that any minor deviation between ordered and delivered quantity that falls within applicable industry standards shall be accepted.

  

	8.2	If there is any damage, shortage and/or defect, as defined in Section 8.1 above, such that any Product delivered by Strakan or its Contract Manufacturer(s) is Non-conforming
Product, Strakan shall at Aptalis’ option without any undue delay, either: 

  

	 	8.2.1	replace the Non-conforming Product within [*] weeks with conforming Product, at Strakan’s expense, or, if necessary for Aptalis to avoid a stock out risk, replace such Non-conforming Product in accordance with the expedited delivery process set forth in Section 3.3 and use Commercially Reasonable Efforts to place the order of such replacement Product for Aptalis ahead of any
other purchase orders; 

  

	 	8.2.2	refund to Aptalis the cost paid to Strakan by Aptalis for such Non-conforming Product, or, if the invoice has not been paid, cancel the invoice; and 

 

	 	8.2.3	in either case, compensate Aptalis for any costs, losses and damages incurred as a result of such damage, shortage and/or defect, including but not limited to the costs, losses and damages related to any withdrawal,
recall, removal and/or disposal of any Non-conforming Product in each case as agreed by Strakan or determined by the arbitrators in accordance with Section 14.2. 

 

	8.3	 If a dispute arises between the Parties as to whether any Product is a Non-conforming Product or shortage of
Products delivered, which cannot be resolved by the Parties within 

  
  

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thirty (30) days of a claim being notified by Aptalis to Strakan, either Party may require that the matter in dispute be referred to an independent expert (such as an independent testing
laboratory) selected by agreement of the Parties, or, failing agreement, appointed by JAMS, or if JAMS is unwilling or unable to make such appointment, by the President of the International Court of Arbitration of the ICC. Such referral will be
solely for the purpose of establishing whether or not there is any Non-conformity in the relevant Product delivered by Strakan or its Contract Manufacturer(s) to Aptalis. Except in the case of fraud or
manifest error on the part of such independent expert, the decision of such independent expert will be binding upon the Parties. If the independent expert decides there was no Non-conformity in the Product in
question, the costs of the independent expert will be borne by [*]. In all other circumstances, the costs of the independent expert will be borne by [*]. 

  

	8.4	All or part of any shipment of the Product determined to have been rightfully rejected by Aptalis as provided herein shall be held by Aptalis for a period of up to [*] days or such lesser period as agreed to by the
Parties following notice to Strakan for proper disposal by Strakan, at [*] expense. If Strakan does not provide instructions for disposal of the Product within such period, then Aptalis may dispose of such Product and Strakan shall [*], or Aptalis
shall have the right to [*]. All or part of any Lot of Product determined to have been rightfully rejected by Aptalis prior to its release for shipment shall be properly disposed of by Strakan, at [*] expense. 

 

	8.5	 Strakan shall fully indemnify and at all times keep Aptalis, its Affiliates, and their respective directors, officers, employees and agents fully
indemnified against any and all Third Party Losses resulting from (a) any material breach by Strakan or its Affiliates of any of its or their representations, warranties or covenants pursuant to this Agreement, (b) the gross negligence or
wilful misconduct by Strakan or its Affiliates or Contract Manufacturer(s) or their respective officers, directors, employees, agents or consultants in performing any obligations under this Agreement, (c) the failure of the Product to be
stored, handled or Manufactured in accordance with cGMP, the Specifications or Law, (d) any violations of applicable Laws and regulations or Regulatory Approvals for the Product by Strakan in the performance of its obligations under this
Agreement, (e)

  
  

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adulteration of the product while in Strakan’s or its Contract Manufacturer’s possession; in each case except to the extent that such Third Party Losses result from the negligence or
wilful misconduct of, or breach of this Agreement by Aptalis and except to the extent that such Third Party Losses are subject to indemnification by Aptalis pursuant to Section 8.6. 

 

	8.6	Aptalis shall fully indemnify and at all times keep Strakan, its Affiliates, and their respective directors, officers, employees, and agents fully indemnified against any and all Third Party Losses resulting from
(a) any material breach by Aptalis of any of its representations, warranties or covenants pursuant to this Agreement, (b) the gross negligence or wilful misconduct by Aptalis or its Affiliates or their respective officers, directors,
employees, agents or consultants in performing any obligations under this Agreement, or (c) any action or inaction of Aptalis (or its Affiliates, agents, contractors or other designees, other than Strakan) or its failure to store, handle or use
the Product in accordance with cGMP, the Specifications or Law; in each case except to the extent that such Third Party Losses result from the negligence or wilful misconduct of, or breach of this Agreement by Strakan and except to the extent that
such Third Party Losses are subject to indemnification by Strakan pursuant to Section 8.5. 

  

	8.7	All indemnification claims in respect of any indemnitee seeking indemnity under Section 8.1 (collectively, the “Indemnitees” and each an “Indemnitee”) will be made solely by the
corresponding Party (the “Indemnified Party”). The Indemnified Party will give the indemnifying party (the “Indemnifying Party”) prompt written notice (an “Indemnification Claim Notice”) of any
claims or the discovery of any fact upon which such Indemnified Party intends to base a request for indemnification under Section 8.5 or 8.6, but in no event will the Indemnifying Party be liable for any claims that result from any delay in
providing such notice which materially prejudices the defence of such claim. 

  

	8.8	 Each Party will obtain and keep in force insurance in scope and amount as required by Law with respect to a Party’s activities hereunder and such
additional amounts as may be reasonably necessary to cover such Party’s indemnity obligations under this Agreement with scope and coverage as is normal and customary in the pharmaceutical industry generally for parties similarly situated. It is
understood that such insurance will not be 

  
  

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construed to limit a Party’s liability with respect to its indemnification obligations under this Article 8. Each Party will provide to the other Party upon request a certificate evidencing
the insurance such Party is required to obtain and keep in force under this Article 8. Such certificate will provide that such insurance will not expire without renewal or be cancelled or modified without at least ninety (90) days’ prior
notice to the other Party. 

  

	8.9	EXCEPT FOR EITHER PARTY’S INDEMNITY OBLIGATIONS UNDER THIS AGREEMENT, AND SUBJECT TO SECTION 13.2 OF THE LICENSE AGREEMENT, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY LOST PROFITS OR REVENUE, LOSS OF USE,
SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, HOWEVER CAUSED, ON ANY THEORY OF LIABILITY AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, ARISING UNDER ANY CAUSE OF ACTION AND ARISING IN ANY WAY
OUT OF THIS AGREEMENT. 

  

	8.10	Nothing in this Agreement shall limit any Party’s liability for death or personal injury caused by negligence or for fraudulent misrepresentation. 

Article 9 FORCE MAJEURE. 
  

	9.1	Subject to Section 9.2, a Party’s obligations under this Agreement will be suspended to the extent and for the duration that its performance is delayed, hindered or prevented by a Force Majeure Event.

  

	9.2	A Party affected by a Force Majeure Event shall: 

  

	 	9.2.1	promptly in writing notify the other Party, explaining the nature, details and expected duration of such event. Such Party shall also notify the other Party from time to time as to when the affected Party reasonably
expects to resume performance in whole or in part of its obligations hereunder, and notify the other Party of the cessation of any such event; 

  
  

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	 	9.2.2	use its reasonable efforts to resume full performance of its obligations under this Agreement as soon as reasonably practical; and 

  

	 	9.2.3	pending such resumption, use its reasonable efforts to facilitate any efforts that the other Party may make to procure an alternative method by which its obligations under this Agreement may be performed.

  

	9.3	If a Party anticipates that a Force Majeure Event may occur, such Party shall notify the other Party of the nature, details and expected duration of such event. 

 

	9.4	If a Force Majeure Event prevails for a continuous period in excess of [*] months, the Party which is to be notified of such circumstances in accordance with Section 9.2.1 may terminate this Agreement, by giving
written notice of termination with immediate effect to the Party affected by the Force Majeure Event. 

 Article 10 TERM AND
TERMINATION. 
  

	10.1	This Agreement shall commence as of the Effective Date and, unless sooner terminated as provided herein, shall expire upon the expiration or termination of the License Agreement. 

 

	10.2	Termination by Either Party 

  

	 	10.2.1	Termination for Breach. Either Party may, without prejudice to any other remedies available to it at Law or in equity, terminate this Agreement in the event that the other Party (the “Breaching
Party”) shall have committed a material breach of this Agreement. The Breaching Party shall have sixty (60) days after written notice thereof was provided to the Breaching Party by the
non-breaching Party to remedy such default. 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. If there is a dispute between the Parties regarding any amounts due hereunder, Aptalis may withhold payment with respect to those amounts that Aptalis believes in good faith are inaccurate or are
otherwise not in accordance with the terms of this Agreement until resolution in accordance with the procedures set forth in Article 14, and such withholding shall not be considered a breach hereunder. 

  
  

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	 	10.2.2	Termination for Insolvency. Either Party may terminate this Agreement upon written notice to other Party at any time, to the extent permitted by applicable Law, if the other Party shall become insolvent, or shall
make or seek to make or arrange an assignment for the benefit of creditors, or if proceedings in voluntary or involuntary bankruptcy shall be initiated by, on behalf of or against such Party (and, in the case of any such involuntary proceeding, not
dismissed within ninety (90) days), or if a receiver or trustee of such Party’s property shall be appointed and not discharged within ninety (90) days. 

 

	10.3	Termination by Aptalis. Without limiting the generality of Aptalis’s rights under Section 10.2.1, if: 

  

	 	10.3.1	Strakan delivers [*] or more consecutive orders with less than [*] percent ([*]%) of the amount set forth in the purchase order submitted and accepted pursuant to Section 3.3, it being understood that Non-conforming Product shall not be included in such [*]%-amount; 

  

	 	10.3.2	Strakan delivers [*] or more consecutive orders more than [*] days after the agreed upon delivery date as set forth in a purchase order submitted and accepted pursuant to Section 3.3; or 

 

	 	10.3.3	the shelf life approved by the Regulatory Authority is reduced to less than [*] months as a result of Strakan’s or the Contract Manufacturer’s failure to make the Product in accordance with the Specification
or cGMP; 

 and as a consequence of Sections 10.3.1 or 10.3.2 Aptalis is unable to supply customers of the Product in the
Territory or as a consequence of Section 10.3.3 Aptalis can demonstrate a material detrimental effect on the market potential for the Product in the Territory, then Aptalis may terminate this Agreement effective immediately by giving notice to
Strakan in writing. 

  
  

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	10.4	Upon expiration or termination of this Agreement: 

  

	 	10.4.1	All representations and warranties and indemnities contained in Section 7.1 shall, insofar as appropriate, remain in full force and effect; 

 

	 	10.4.2	Strakan shall deliver to Aptalis the Product requested in each accepted purchase order submitted prior to the date of expiration or termination; 

 

	 	10.4.3	Upon delivery of Product pursuant to such confirmed written purchase orders, Aptalis shall pay in full all undisputed sums due in relation to such delivery; 

 

	 	10.4.4	Each Party shall return to the other all confidential records and documents relating to this Agreement; 

  

	 	10.4.5	In the event the License Agreement remains in effect, Strakan shall, upon the written request of Aptalis, which notice shall contain information sufficient for Strakan to determine the scope of the Termination
Assistance Services required by Aptalis, perform the Termination Assistance Services for up to [*] months following the expiration or termination of this Agreement (the “Termination Assistance Period”). “Termination
Assistance Services” means such services and cooperation with Aptalis or its Third Party designee as may be reasonably necessary to effect the orderly transfer of the Manufacturing to Aptalis or a Third Party. Such Termination Assistance
Services may include continuing to provide the Manufacturing on a transitional basis, assisting Aptalis with Strakan’s Contract Manufacturer(s) for the purposes of enabling Aptalis to enter into its own contracts with such Contract
Manufacturer(s), and the provision of Manufacturing technology, and knowledge transfer of Know-How, in each case, to Aptalis or a replacement manufacturer or other Third Party, including the grant to Aptalis of a sublicensable license to all
Intellectual Property Rights owned by Strakan necessary for Aptalis or a sublicensee to Manufacture the Product as theretofore Manufactured for the duration of the License Agreement . For the avoidance of doubt, the Parties acknowledge that not
all of the foregoing services will be applicable in every situation, but that the Termination Assistance Services shall include all of those services necessary to transition Aptalis with minimal 

  
  

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disruption to its business and operations. In the event Strakan has terminated this Agreement pursuant to Section 10.2.1 or 10.2.2, Termination Assistance Services provided during the
Termination Assistance Period shall be provided at Aptalis’s cost. In the event Aptalis has terminated this Agreement pursuant to Section 10.2.1, 10.2.2 or 10.3, all Termination Assistance Services provided by Strakan shall be
provided free of charge. 

  

	10.5	In the event of a material breach of this Agreement by Strakan resulting in a shortage of supply of Product to Aptalis, Strakan shall use its Commercially Reasonable Efforts to mitigate such supply shortage by
appropriately managing supply of the Product inside and outside the Territory in order to supply Aptalis with as much of the Product ordered as possible, provided that Strakan shall not be obliged to place itself in breach of any agreement with its
other licensees or customers of the Product outside the Territory. 

  

	10.6	In the event that Strakan receives a notice of default under any contract or arrangement, including with its Contract Manufacturer(s), that in any way has a detrimental effect on the ability of Strakan to fulfill its
obligations under this Agreement, Strakan shall use Commercially Reasonable Efforts to provide a copy of such notice of default to Aptalis as soon as possible after Strakan’s receipt of such notice of default. 

 

	10.7	Termination of this Agreement for any reason will be without prejudice to any rights that will have accrued to the benefit of a Party prior to the effective date of such termination. Such termination will not relieve a
Party from obligations that are expressly indicated to survive the termination of this Agreement. 

  

	10.8	Survival. The following Articles and Sections, together with any definitions used or Schedules referenced therein, will survive any expiration or termination of this Agreement: Sections 2.1.6, 2.1.7, 5.3, 5.6,
5.8 and Articles 1, 7, 8, 10, 11, 13 and 14. 

 Article 11 MISCELLANEOUS. 

 

	11.1	Confidentiality. The terms and conditions of Article 9 of the License Agreement regarding confidentiality will be applicable to this Agreement. 

  
  

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	11.2	Notices. 

 All notices or other communications that are required or permitted under this
Agreement shall be in accordance with Section 17.1 of the License Agreement. 
  

	11.3	Independent Status. Neither Party is an agent, employee or representative of the other. Neither Party shall have authority to make any statements, representations nor commitments of any kind, nor to take any
action, which shall be binding on the other Party, except as may be explicitly authorized by the other Party in writing. This Agreement shall not constitute, create or in any way be interpreted as a joint venture, partnership or formal business
organization of any kind. 

  

	11.4	Severability. If any provision of this Agreement or application thereof to anyone is adjudicated to be invalid or unenforceable in any jurisdiction, such invalidity or unenforceability shall not affect any
provision or application of this Agreement which can be given effect without the invalid or unenforceable provision or application and shall not invalidate or render unenforceable such provision or application in any other jurisdiction. Further, the
judicial or other competent authority making such determination shall have the power to limit, construe or reduce the duration, scope, activity and/or area of such provision, and/or delete specific words or phrases as necessary to render, such
provision enforceable in such jurisdiction. 

  

	11.5	Headings; Construction; Certain Conventions. The headings used in this Agreement have been inserted for convenience of reference only and do not define or limit the provisions hereof. The Schedules to this
Agreement are incorporated herein by reference and will be deemed a part of this Agreement. Unless otherwise expressly provided herein or the context of this Agreement otherwise requires, (a) words of any gender include each other gender,
(b) words such as “herein”, “hereof”, and “hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear, (c) words using the singular will include the
plural, and vice versa, (d) the words “include,” “includes” and “including” will be deemed to be followed by the phrase “but not limited to”, “without limitation”, “inter alia” or
words of similar import, (e) the word “or” will be deemed to include the word “and” (e.g., “and/or”) and (f) references to “ARTICLE,” “Section,” “subsection”, “clause”
or other subdivision, or to a Schedule, without reference to a document are to the specified provision or Schedule of this Agreement. This Agreement will be construed as if it were drafted jointly by the Parties and shall not be strictly construed
against either Party. 

  
  

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	11.6	Further Assurances. Each Party shall, as and when requested by the other Party, do all acts and execute all documents as may be reasonably necessary to give effect to the provisions of this Agreement.

 Article 12 ASSIGNMENT. 
  

	12.1	Assignment and Subcontracting. Neither of the Parties shall assign or transfer any of their rights or obligations under this Agreement without the prior written consent of the other Party, provided, that in the
event the License Agreement is assigned by Aptalis to any Person, Aptalis shall be permitted to assign this Agreement to the same Person to which the License Agreement is assigned without the prior written consent of Strakan. Each Party shall be
entitled (without the consent of the other Party) to assign this Agreement (or any of its rights or obligations under this Agreement) to (a) its Affiliate (as long as such entity remains an Affiliate of the relevant Party) provided that the
assigning Party shall be responsible for the performance of this Agreement by such Affiliate; or (b) to any corporation to which it has sold all or substantially all of its assets relating to this Agreement provided that the acquiring
corporation agrees to be bound by the terms of this Agreement. If a Party delegates all or any of its obligations under this Agreement to any Third Party, the Party delegating shall be fully responsible to the other Party for the proper performance
of those obligations and for any negligent act or omission made by the Third Party or its staff in relation thereto. For purposes of clarity, any change of control or merger, consolidation, initial public offering or other financing activity of a
Party shall not be deemed an assignment of this Agreement. 

 Article 13 ENTIRE AGREEMENT; AMENDMENT AND WAIVER. 

 

	13.1	 This Agreement, the Product Quality Agreement, the Safety Data Exchange Agreement and the License Agreement, including the Exhibits and Schedules
attached hereto and thereto (each of which is hereby and thereby incorporated herein and therein by reference) between the Parties shall constitute the entire agreement and understanding of the Parties relating to the subject matter of this
Agreement and supersedes all prior oral or 

  
  

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written agreements, representations, understandings or arrangements between the Parties relating to the subject matter of this Agreement. No amendment, supplement or other modification to any
provision of this Agreement shall be binding unless in writing and signed by both Parties. No waiver of any rights under this Agreement shall be effective unless in writing signed by the Party to be charged. A waiver of a breach or violation of any
provision of this Agreement will not constitute or be construed as a waiver of any subsequent breach or violation of that provision or as a waiver of any breach or violation of any other provision of this Agreement. 

Article 14 GOVERNING LAW AND DISPUTES. 
  

	14.1	This Agreement shall be governed by and interpreted in accordance with the Laws of the State of New York without giving effect to any conflict of Laws provisions, except matters of Intellectual Property that will be
determined in accordance the Intellectual Property Laws relevant to the Intellectual Property in question. The UNICITRAL Convention for the International Sale of Goods, as well as any other unified Laws relating to the conclusion and implementation
of contracts for the international sale of goods, will not apply. 

  

	14.2	In the event of a Dispute except for a dispute set out in Section 8.3, the Parties will submit such Dispute to arbitration under the Rules of Arbitration of ICC. Unless, the Parties agree otherwise, the number of
arbitrators shall be three. One arbitrator shall be appointed by each Party and the third arbitrator shall be appointed by the International Court of Arbitration of the ICC. The place of arbitration will be New York, New York if Strakan initiates
arbitration proceedings or London, England if Aptalis initiates the arbitration proceedings. The language of the arbitration will be in English. Prior to the commencement of hearings, each of the arbitrators appointed must provide an oath of
undertaking of impartiality. Judgment upon the award rendered by the arbitrators may be entered into any court having jurisdiction thereof. The cost of any such arbitration will be divided equally between the Parties, with each Party bearing its own
attorneys’ fees and costs. The arbitration proceedings and the decision of the arbitrators will be kept confidential by the Parties and the arbitrators. 

  
  

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 Article 15 COUNTERPARTS. 
  

	15.1	This Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original but all of which together shall constitute one and the same instrument. 

[Signature page follows] 

  
  

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 EXECUTION. 

THIS AGREEMENT IS EXECUTED by the authorised representatives of the Parties as of the date first written above. 

 

									
	SIGNED for and on behalf of	 		 	SIGNED for and on behalf of
	Strakan International S.à.r.l.	 		 	Aptalis Pharma US, Inc.
			
		 		 	
			
		 		 	
			
		 		 	
			
	 /s/    Andrew McLean
	 		 	 /s/    Frank Verwiel

	Signature	 		 	Signature
					
	Name:	 	 Andrew McLean
	 		 	Name:	 	 Frank Verwiel, MD

					
	Title:	 	 Director and General Counsel
	 		 	Title:	 	 President and Chief Executive Officer

				
		 		 		 	
				
		 		 		 	
				
		 		 		 	
				
		 		 		 	 /s/    Steve Gannon

		 		 		 	Signature	 	
					
		 		 		 	Name:	 	 Steve Gannon

					
		 		 		 	Title:	 	Senior Vice President, Finance, Chief Financial Officer and Treasurer

  
  

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 EXHIBIT E 

LAUNCH PLAN SUMMARY 
 [*]

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit E-1 

 EXHIBIT F-1 

STRAKAN PRESS RELEASE 
 ProStrakan
Partners with Aptalis Pharma for RectivTM in the US 
 Galashiels, UK. 9 January 2012
– ProStrakan Group plc, a subsidiary of Kyowa Hakko Kirin Co. Ltd. (KHK), and an international specialty pharmaceutical company, today announces that it has signed an exclusive licensing and distribution agreement with Aptalis Pharma Inc
(Aptalis) for RectivTM (nitroglycerin) Ointment 0.4%, for the treatment of moderate to severe pain associated with chronic anal fissure. 

Rectiv will be the only FDA-approved prescription product in the United States for patients with this condition and is already marketed by ProStrakan as
Rectogesic® in 20 countries worldwide including Europe where, in 2011, it is expected to have achieved €11m in sales. 

Rectiv will be marketed exclusively by Aptalis in the US, where the company has a strong specialist gastrointestinal sales team. Aptalis plans to launch
Rectiv as soon as possible in 2012. The availability of an FDA approved prescription product across the US is expected to make the therapy available to many more patients. 

Under the terms of the agreement, Aptalis will make an upfront license fee payment to ProStrakan, a commercialisation payment, and payment upon the
achievement of certain sales milestones and royalties on sales of Rectiv. ProStrakan will exclusively supply Rectiv to Aptalis in the US. 
 Tom Stratford
PhD, Chief Executive of ProStrakan, said: 
 “Rectiv sits outside our core focus in the US, and that of our parent company, KHK, which is on oncology,
immunology and nephrology, so it is strategically appropriate for ProStrakan to out-license Rectiv in the US. We are delighted to be partnering with such a highly regarded gastrointestinal specialty company as Aptalis for this important launch. 

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit F-1-1 

 “Chronic anal fissure can cause significant pain for patients, and Aptalis’ team will work to get the
message to physicians across the US of the launch of the only FDA approved prescription product for patients with this condition. This deal allows ProStrakan to continue to focus on our oncology franchise in the US, while ensuring that we fully
capitalise on the potential of Rectiv.” 
 Frank Verwiel, M.D., President and Chief Executive Officer of Aptalis Pharma, said: 

“This agreement will add strength and breadth to Aptalis’ portfolio of products. With Aptalis’ commercial expertise and infrastructure in the
US, and our deep knowledge of and experience in the GI space, we believe Aptalis is positioned to make a positive impact in the lives of patients diagnosed and treated for this condition.” 

Important Safety Information 
 Rectiv is
contraindicated in patients taking phosphodiesterase type 5 (PDE5) inhibitors (eg, sildenafil, vardenafil, and tadalafil), which can potentiate the hypotensive effect of nitrate, and in patients with severe anemia, increased intracranial pressure,
or known hypersensitivity to nitroglycerin, other nitrates and nitrites, or any components of the ointment. The most common adverse reactions are headache and dizziness. For full US prescribing information please see:
www.accessdata.fda.gov/drugsatfda_docs/label/2011/021359s000lbl.pdf 
 About Anal Fissures 

An anal fissure is a small tear in the skin that lines the anus, which typically causes severe pain and bleeding with bowel movements. When anal fissures do
not heal with interventions such as diet and lifestyle changes, fissures may become chronic. The pain associated with chronic anal fissure has been shown to have a significant impact on patients’ quality of life. (Source: i – x) 

  
  

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 Exhibit F-1-2 

 Enquiries: 

ProStrakan 
 Callum Spreng, 

Corporate Communications 
 Tel: +44 (0)1896 664000 

Mobile: +44 (0)7803 970103 
 Notes to Editors: 

About ProStrakan: 
 ProStrakan Group plc is a
rapidly growing specialty pharmaceutical company engaged in the development and commercialisation of prescription medicines for the treatment of unmet therapeutic needs in major markets. 

ProStrakan is a subsidiary of Kyowa Hakko Kirin Co. Ltd., the Japan-based global specialty pharmaceutical company. 

ProStrakan’s head office is located in Galashiels in Scotland. The company’s development capabilities are centered in Galashiels and Bedminster, New
Jersey, USA. Sales and marketing of ProStrakan’s portfolio of products are handled by commercial subsidiaries in the UK, US, France, Germany, Spain, Italy and other EU countries. 

You can learn more about the business at: www.prostrakan.com 

Sources: 
  

	 	i. 	1Gearhart SL. Diverticular disease and common anorectal disorders. In: Fauci AS, et al. Harrison’s Principles of Internal Medicine. 17th ed. New York, N.Y.: McGraw-Hill; 2008.
http://www.accessmedicine.com/content.aspx?aID=2881328. Accessed July 28, 2010. 

  

	 	ii.	Lacy BE, et al. Common anorectal disorders: Diagnosis and treatment. Current Gastroenterology Reports. 2009;11:413. 

  

	 	iii.	Herzig D. Anal fissure. Surgical Clinics of North America. 2010;90:33. 

  

	 	iv.	Greenwald DA. Common disorders of the anus and rectum: Hemorrhoids and fissures. American College of Gastroenterology. http://www.acg.gi.org/patients/gihealth/hemorrhoids.asp. Accessed July 28, 2010.

  

	 	v.	Yamada T, et al. Anorectal diseases. In: Yamada T, et al. Textbook of Gastroenterology. 4th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2003. http://ovidsp.tx.ovid.com/sp-2.3.1b/ovidweb.cgi. Accessed
July 28, 2010. 

  

	 	vi.	Breen E, et al. Anal fissures. http://www.uptodate.com/home/index.html. Accessed July 28, 2010. 

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit F-1-3 

	 	vii.	Anal fissure. American Society of Colon & Rectal Surgeons. http://www.fascrs.org/patients/conditions/anal_fissure. Accessed July 28, 2010. 

 

	 	viii.	Anal fissure. The Merck Manuals: The Merck Manual for Healthcare Professionals. http://www.merck.com/mmpe/print/sec02/ch020/ch020.html. Accessed July 28, 2010. 

 

	 	ix.	Gil J, et al. Screening for the effectiveness of conservative treatment in chronic anal fissure patients using anorectalmanometry. International Journal of Colorectal Disease. 2010;25:649. 

 

	 	x.	Klein MD, et al. Surgical conditions of the anus, rectum, and colon. In: Kliegman RM, et al. Nelson Textbook of Pediatrics. 18th ed. Philadelphia, Pa: Saunders Elsevier; 2007.
http://www.mdconsult.com/das/book/body/212152969-3/1032016749/1608/827.html#4-u1.0-B978-1-4160-2450-7..50343-1—cesec13_6840. Accessed July 28, 2010. 

  

	 	xi.	Rectiv prescribing information at FDA.gov: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021359s000lbl.pdf 

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit F-1-4 

 EXHIBIT F-2 

APTALIS PRESS RELEASE 

Aptalis Pharma Announces Agreement to Market RECTIVTM in the U.S. 

BRIDGEWATER, NJ—(Marketwire – January 9, 2012) - Aptalis Pharma, a global specialty pharmaceutical company focused on gastrointestinal diseases
and cystic fibrosis, today announced that it has signed an exclusive license agreement with ProStrakan Group plc to market RECTIVTM (nitroglycerin) Ointment 0.4 % in the U.S. for the
treatment of moderate to severe pain associated with chronic anal fissure. ProStrakan Group, a subsidiary of Kyowa Hakko Kirin Co. Ltd., and an international specialty pharmaceutical company, received Food and Drug Administration (FDA) approval for
RECTIV on June 21, 2011. 
 Financial terms of Aptalis’s transaction with ProStrakan include an upfront license fee, a commercialization payment,
and payment upon the achievement of certain sales milestones and royalties on sales of RECTIV. 
 RECTIV is the first and only medication approved by the
U.S. FDA for the treatment of moderate to severe pain associated with chronic anal fissure. The product is already marketed by ProStrakan under the name RECTOGESIC® in 20 countries worldwide,
including all major European markets. 
 Frank Verwiel, M.D., President and Chief Executive Officer of Aptalis Pharma, stated, “RECTIV provides
physicians with an FDA-approved treatment option for moderate to severe pain associated with chronic anal fissure. We expect that this agreement will add strength and breadth to Aptalis’ portfolio of products. With Aptalis’ commercial
expertise and infrastructure in the U.S., and our deep knowledge of and experience in the GI space, we believe that we are positioned to make a positive impact in the lives of patients diagnosed and treated for this condition.” 

Tom Stratford, Chief Executive of ProStrakan, said, “We are delighted to be partnering with such a highly regarded gastrointestinal specialty pharma
company as Aptalis for this important launch. Chronic anal fissure can cause significant pain for patients, and Aptalis’ team will work to inform physicians across the U.S. of the availability of the only FDA approved prescription product for
patients with this condition.” 
 Aptalis and ProStrakan expect the deal to close by the end of January. 

Important Safety Information 
 RECTIV is contraindicated
in patients taking phosphodiesterase type 5 (PDE5) inhibitors (e.g., sildenafil, vardenafil, and tadalafil), which can potentiate the hypotensive effect of nitrate, and in patients with severe anemia, increased intracranial pressure, or known
hypersensitivity to nitroglycerin, other nitrates and nitrites, or any components of the ointment. The most common adverse reactions are headache and dizziness. For full U.S. prescribing information please see
www.accessdata.fda.gov/drugsatfda_docs/label/2011/021359s000lbl.pdf (i) 

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit F-2-1 

 About Anal Fissures 

An anal fissure is a small tear in the skin that lines the anus, which typically causes severe pain and bleeding with bowel movements. When anal fissures do
not heal with interventions such as diet and lifestyle changes, fissures may become chronic. The pain associated with chronic anal fissure has been shown to have a significant impact on patients’ quality of life. (ii–xi) 

About Aptalis 
 Aptalis Pharma Inc. is a privately held,
leading specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal disorders. Aptalis, formed from the recent combination of Axcan Pharma and Eurand, has
manufacturing and commercial operations in the United States, the European Union and Canada, and its products include ZENPEP®, CANASA®, CARAFATE®, PYLERA®, LACTEOL®, DELURSAN®, PANZYTRAT® and SALOFALK®. Aptalis also
formulates and clinically develops enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary technology platforms including bioavailability enhancement of poorly soluble drugs, custom release profiles, and
taste-masking/orally disintegrating tablet (ODT) formulations. For more information, visit www.aptalispharma.com. 
 FOR FURTHER INFORMATION PLEASE
CONTACT: 
 Steve Gannon 
 Senior Vice President, Chief
Financial Officer and Treasurer 
 Aptalis Pharma 

+1-450-467-5138 
 (i) RECTIV prescribing information at FDA.gov:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021359s000lbl.pdf 
 (ii) Gearhart SL. Diverticular disease and common anorectal disorders. In:
Fauci AS, et al. Harrison’s Principles of Internal Medicine. 17th ed. New York, N.Y.: McGraw-Hill; 2008. http://www.accessmedicine.com/content.aspx?aID=2881328. Accessed July 28, 2010. 

(iii) Lacy BE, et al. Common anorectal disorders: Diagnosis and treatment. Current Gastroenterology Reports. 2009;11:413. 

(iv) Herzig D. Anal fissure. Surgical Clinics of North America. 2010;90:33. 

(v) Greenwald DA. Common disorders of the anus and rectum: Hemorrhoids and fissures. American College of Gastroenterology.
http://www.acg.gi.org/patients/gihealth/hemorrhoids.asp. Accessed July 28, 2010. 
 (vi) Yamada T, et al. Anorectal diseases. In: Yamada T, et al.
Textbook of Gastroenterology. 4th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2003. http://ovidsp.tx.ovid.com/sp-2.3.1b/ovidweb.cgi. Accessed July 28, 2010. 

(vii) Breen E, et al. Anal fissures. http://www.uptodate.com/home/index.html. Accessed July 28, 2010. 

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit F-2-2 

 (viii) Anal fissure. American Society of Colon & Rectal Surgeons.
http://www.fascrs.org/patients/conditions/anal_fissure. Accessed July 28, 2010. 
 (ix) Anal fissure. The Merck Manuals: The Merck Manual for
Healthcare Professionals. http://www.merck.com/mmpe/print/sec02/ch020/ch020.html. Accessed July 28, 2010. 
 (x) Gil J, et al. Screening for the
effectiveness of conservative treatment in chronic anal fissure patients using anorectalmanometry. International Journal of Colorectal Disease. 2010;25:649. 

(xi) Klein MD, et al. Surgical conditions of the anus, rectum, and colon. In: Kliegman RM, et al. Nelson Textbook of Pediatrics. 18th ed. Philadelphia, Pa:
Saunders Elsevier; 2007. http://www.mdconsult.com/das/book/body/212152969-3/1032016749/1608/827.html#4-u1.0-B978-1-4160-2450-7..50343-1—cesec13_6840. Accessed July 28, 2010. 

Forward-Looking Statements 
 This release contains
forward-looking statements within the meaning of the U.S. federal securities laws, including statements regarding the transaction, its timing and terms and statements regarding the expectations for the commercialization and marketing of
Rectiv. Forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. The words “expects”,
“potentially”, “anticipates”, “could”, “calls for” and similar expressions also identify forward-looking statements. These statements are based upon Aptalis’ current expectations and are subject to
risks and uncertainties which could cause actual results and developments to differ materially from those expressed or implied in such statements. Factors that could affect actual results and developments include successful consummation of the
transaction on a timely basis, the impact of regulatory reviews, the satisfaction of customary conditions, the ability of Aptalis to achieve the anticipated benefits of commercializing and marketing Rectiv in the territory, the results,
consequences, effects or timing of any inquiry or investigation by any regulatory authority or any legal or administrative proceedings, the successful preparation and implementation of an effective marketing plan, and any other risks set forth in
Aptalis’ filings with the SEC, including Aptalis Pharma Inc.’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, in each case together with all amendments thereto. Investors should evaluate any
statement in light of these important factors. Forward-looking statements contained in this press release are made as of this date, and, other than as required by applicable law, Aptalis undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information, future events or otherwise. Actual events could differ materially from those anticipated in the forward-looking statements. 

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit F-2-3 

 EXHIBIT G 

FORM OF TRADEMARK AND DOMAIN NAME ASSIGNMENT 

THIS TRADEMARK AND DOMAIN NAME ASSIGNMENT AGREEMENT is effective as of [DATE]1 (the “Effective
Date”) by and between STRAKAN INTERNATIONAL S.À R.L., a company incorporated under the Laws of Luxembourg having a principal place of business at Galabank Business Park, Galashiels, Scottish Borders, TD1 1QH UK (hereinafter referred
to as “Assignor”), and APTALIS PHARMA US, INC. a company incorporated under the Laws of the State of Delaware and having a principal place of business at 22 Inverness Center Parkway, Birmingham, Alabama 35242, United States
(hereinafter referred to as “Assignee”). 
 WHEREAS, Assignor is the owner of all right, title and interest in and to the
(a) trademarks and trademark applications and registrations identified on Schedule 1 (collectively, the “Trademarks”), together with the goodwill appurtenant to all such Trademarks and (b) domain name registrations
identified on Schedule 2 (the “Domain Names”); and 
 WHEREAS, Assignor intends to assign to Assignee the Trademarks and Domain
Names. 
 NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Assignor does hereby sell,
transfer, convey and assign unto Assignee Assignor’s entire right, title and interest in and to the Trademarks and Domain Names, together with the goodwill of the business appurtenant thereto and which is symbolized thereby, including the right
to apply for trademark registration in the United States based in whole or in part upon the Trademarks, and the right to renew the trademark registrations and any trademark registrations which shall issue from the applications included in the
Trademarks, and every priority right that is or may be predicated upon or arise from the Trademarks, to be held and enjoyed by Assignee for its own use and benefit and for the use and benefit of its successors, assigns and legal representatives, to
be used as fully and entirely as said rights would have been held and enjoyed by Assignor had this assignment and sale not been made, together with all claims for damages by reason of past infringement of the Trademarks with the right to sue and
collect the same for its own use or for the use of its successors, assigns or other legal representatives. 
 Assignor hereby authorizes the Commissioner of
Patents and Trademarks of the United States and other empowered officials of the United States Patent and Trademark Office to transfer the ownership of all registrations and applications for the Trademarks to Assignee as owner of the entire right,
title and interest therein or otherwise as Assignee may direct, in accordance with this instrument of assignment, and to issue to Assignee all registrations which may issue with respect to any applications for a trademark or service mark included in
the Trademarks, in accordance with this Trademark and Domain Name Assignment Agreement. Assignee shall bear the costs and fees associated with recording the transfer of ownership. 

 

	1 	[Note: To be executed when contemplated by Section 10.7.] 

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit G-1 

 Assignor will take, or cause to be taken, all such other and further action as may reasonably be required by
Assignee at Assignee’s cost in order to effect the assignment contemplated hereby. 
 IN WITNESS WHEREOF, the Parties have caused this Trademark and
Domain Name Assignment Agreement to be executed as of the Effective Date. 
  

									
	STRAKAN INTERNATIONAL S.À R.L.	 		 	APTALIS PHARMA US, INC.
					
	By:	 	  
	 		 	By:	 	  

					
	Name:	 	  
	 		 	Name:	 	  

					
	Title:	 	  
	 		 	Title:	 	  

  

					
	STATE OF	  	}	 	
		  	}	 	ss:
	COUNTY OF	  	}	 	

 Before me, the undersigned, a Notary Public personally appeared
                                        , having
been sworn by me according to law did depose and say [s]he was the
                                         of
STRAKAN INTERNATIONAL S.À R.L. (the “Assignor”) and did acknowledge the execution of the foregoing Trademark Assignment on behalf of said Assignor. 

WITNESS my hand and notarial seal this [DAY] of [MONTH], 201    . 

 

	
	  

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit G-2 

 Schedule 1 

Trademarks 
 RECTIV (Serial
No. 85/330,038) 
 1-800-6RECTIV 

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit G-3 

 Schedule 2 

Domain Names 
 www.rectiv.com 

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit G-4 

 EXHIBIT H 

CLINICAL STUDIES 
 Rectiv/Rectogesic
Studies 
  

											
	 Study
	  	 Study Design
	  	 Total

Patients/Subjects

Enrolled

(Safety Set)
	  	 Patients/Subjects
	  	 Treatment Dose
(Regimen)
	  	 Treatment
Duration (Days)

	 Phase III Studies

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

  
  

	[*]	Confidential treatment requested. 

  
 Exhibit H-1EX-10.27

 Exhibit 10.27 

SHARE PURCHASE AGREEMENT 
 by and
among 
 AXCAN HOLDINGS INC., 

AXCAN PHARMA HOLDING B.V. 
 and

 EURAND N.V. 
 Dated as of
November 30, 2010 

 TABLE OF CONTENTS 

 

							
	 	 	 	  	Page	 
		
	 ARTICLE I DEFINITIONS
	  	 	2	  
			
	 SECTION 1.01.
	 	 Definitions.
	  	 	2	  
		
	 ARTICLE II THE OFFER
	  	 	12	  
			
	 SECTION 2.01.
	 	 The Offer.
	  	 	12	  
			
	 SECTION 2.02.
	 	 Company Action.
	  	 	14	  
			
	 SECTION 2.03.
	 	 Company Options.
	  	 	15	  
			
	 SECTION 2.04.
	 	 EGM.
	  	 	16	  
		
	 ARTICLE III POST CLOSING MATTER
	  	 	17	  
			
	 SECTION 3.01.
	 	 Restructuring.
	  	 	17	  
			
	 SECTION 3.02.
	 	 Co-Operation of the Company.
	  	 	17	  
		
	 ARTICLE IV REPRESENTATIONS AND WARRANTIES OF THE COMPANY
	  	 	18	  
			
	 SECTION 4.01.
	 	 Organization and Qualification; Subsidiaries.
	  	 	18	  
			
	 SECTION 4.02.
	 	 Articles of Association; Etc.
	  	 	18	  
			
	 SECTION 4.03.
	 	 Capitalization.
	  	 	18	  
			
	 SECTION 4.04.
	 	 Authority Relative to This Agreement.
	  	 	20	  
			
	 SECTION 4.05.
	 	 No Conflict; Required Filings and Consents.
	  	 	20	  
			
	 SECTION 4.06.
	 	 SEC Filings; Financial Statements.
	  	 	21	  
			
	 SECTION 4.07.
	 	 Disclosure Controls and Procedures.
	  	 	21	  
			
	 SECTION 4.08.
	 	 Absence of Certain Changes or Events.
	  	 	22	  
			
	 SECTION 4.09.
	 	 Compliance with Laws.
	  	 	22	  
			
	 SECTION 4.10.
	 	 Absence of Litigation.
	  	 	22	  
			
	 SECTION 4.11.
	 	 Employee Benefit Plans.
	  	 	22	  
			
	 SECTION 4.12.
	 	 Labor and Employment Matters.
	  	 	24	  
			
	 SECTION 4.13.
	 	 Property and Leases.
	  	 	25	  
			
	 SECTION 4.14.
	 	 Intellectual Property.
	  	 	26	  
			
	 SECTION 4.15.
	 	 Taxes.
	  	 	27	  
			
	 SECTION 4.16.
	 	 Environmental Matters.
	  	 	27	  
			
	 SECTION 4.17.
	 	 Material Contracts.
	  	 	28	  
			
	 SECTION 4.18.
	 	 Insurance.
	  	 	29	  

  
 i 

 TABLE OF CONTENTS 

(continued) 
  

							
	 	 	 	  	Page	 
			
	 SECTION 4.19.
	 	 Regulatory Compliance.
	  	 	30	  
			
	 SECTION 4.20.
	 	 Brokers.
	  	 	31	  
			
	 SECTION 4.21.
	 	 Opinion of Financial Advisor.
	  	 	31	  
		
	 ARTICLE V REPRESENTATIONS AND WARRANTIES OF PARENT AND BUYER
	  	 	32	  
			
	 SECTION 5.01.
	 	 Corporate Organization.
	  	 	32	  
			
	 SECTION 5.02.
	 	 Authority Relative to this Agreement.
	  	 	32	  
			
	 SECTION 5.03.
	 	 No Conflict; Required Filings and Consents.
	  	 	32	  
			
	 SECTION 5.04.
	 	 Absence of Litigation.
	  	 	33	  
			
	 SECTION 5.05.
	 	 Financing.
	  	 	33	  
			
	 SECTION 5.06.
	 	 Lack of Ownership of Shares.
	  	 	34	  
			
	 SECTION 5.07.
	 	 Brokers.
	  	 	34	  
			
	 SECTION 5.08.
	 	 Solvency.
	  	 	34	  
			
	 SECTION 5.09.
	 	 SEC Filings; Financial Statements.
	  	 	35	  
		
	 ARTICLE VI CONDUCT OF BUSINESS PENDING THE Closing
	  	 	35	  
			
	 SECTION 6.01.
	 	 Conduct of Business by the Company Pending the Closing.
	  	 	35	  
		
	 ARTICLE VII ADDITIONAL AGREEMENTS
	  	 	38	  
			
	 SECTION 7.01.
	 	 Appropriate Action; Consents; Filings.
	  	 	38	  
			
	 SECTION 7.02.
	 	 Access to Information; Confidentiality.
	  	 	41	  
			
	 SECTION 7.03.
	 	 No Solicitation of Transactions.
	  	 	41	  
			
	 SECTION 7.04.
	 	 Directors’ and Officers’ Indemnification and Insurance.
	  	 	43	  
			
	 SECTION 7.05.
	 	 Notification of Certain Matters.
	  	 	45	  
			
	 SECTION 7.06.
	 	 Public Announcements.
	  	 	45	  
			
	 SECTION 7.07.
	 	 Comparability of Employee Benefits.
	  	 	46	  
			
	 SECTION 7.08.
	 	 Financing.
	  	 	47	  
		
	 ARTICLE VIII TERMINATION, AMENDMENT AND WAIVER
	  	 	52	  
			
	 SECTION 8.01.
	 	 Termination:
	  	 	52	  
			
	 SECTION 8.02.
	 	 Effect of Termination.
	  	 	54	  
			
	 SECTION 8.03.
	 	 Termination Fees and Expenses.
	  	 	54	  
			
	 SECTION 8.04.
	 	 Amendment.
	  	 	57	  
			
	 SECTION 8.05.
	 	 Waiver.
	  	 	57	  

  
 ii 

 TABLE OF CONTENTS 

(continued) 
  

							
	 	 	 	  	Page	 
		
	 ARTICLE IX GENERAL PROVISIONS
	  	 	58	  
			
	 SECTION 9.01.
	 	 Nonsurvival of Representations and Warranties.
	  	 	58	  
			
	 SECTION 9.02.
	 	 No Additional Representations.
	  	 	58	  
			
	 SECTION 9.03.
	 	 Counterparts.
	  	 	58	  
			
	 SECTION 9.04.
	 	 Costs and Expenses.
	  	 	59	  
			
	 SECTION 9.05.
	 	 Notices.
	  	 	59	  
			
	 SECTION 9.06.
	 	 Severability.
	  	 	61	  
			
	 SECTION 9.07.
	 	 Entire Agreement; Assignment.
	  	 	61	  
			
	 SECTION 9.08.
	 	 Parties in Interest.
	  	 	62	  
			
	 SECTION 9.09.
	 	 Specific Performance.
	  	 	62	  
			
	 SECTION 9.10.
	 	 Time is of the Essence.
	  	 	64	  
			
	 SECTION 9.11.
	 	 Governing Law.
	  	 	64	  
			
	 SECTION 9.12.
	 	 Waiver of Jury Trial.
	  	 	64	  
			
	 SECTION 9.13.
	 	 Interpretation and Disclosure Schedule.
	  	 	65	  
			
	 SECTION 9.14.
	 	 Negotiated Agreement.
	  	 	65	  
			
	 ANNEX I
	 	 Conditions of the Offer
	  			

  
 iii 

 SHARE PURCHASE AGREEMENT 

This SHARE PURCHASE AGREEMENT, dated as of November 30, 2010 (this “Agreement”), by and among Axcan Holdings Inc., a
Delaware corporation (“Parent”), Axcan Pharma Holding B.V., a private limited liability company (besloten vennootschap met beperkie aansprakelijkheid) organized under the laws of The Netherlands (“Buyer”),
and Eurand N.V., a public limited liability company (naamloze vennootschap) organized under the laws of The Netherlands (the “Company”). 

Background 

(a) It is proposed that Buyer will make a tender offer (as such offer may be amended from time to time as permitted under this
Agreement, the “Offer”) to purchase all outstanding ordinary shares, par value €0.01 per share, of the Company (the “Company Shares”), for US$12.00 per Company Share, without interest (such amount, or any
greater amount per share offered pursuant to the Offer in accordance with the terms of this Agreement, being hereinafter referred to as the “Per Share Amount”), net to each holder of Company Shares in cash, in accordance with the
terms and subject to the conditions set forth in this Agreement and the Offer Documents. 
 (b) The Board has determined that
the acquisition of the Company by Buyer, upon the terms and subject to the conditions set forth herein, is fair to, and in the best interests of the Company’s shareholders and other stakeholders, its Subsidiaries and the enterprises carried on
by the Company and its Subsidiaries. 
 (c) Pursuant to the Offer each issued and outstanding Company Share properly tendered
and not withdrawn will be purchased by Buyer at a price per share equal to the Per Share Amount, net to each holder of Company Shares in cash, without interest, in accordance with the terms and subject to the conditions set forth in this Agreement
and the Offer Documents. 
 (d) As a condition to its willingness to enter into this Agreement, Buyer has required Warburg,
Pincus Equity Partners, L.P., Warburg, Pincus Ventures International, L.P., Warburg, Pincus Netherlands Equity Partners I C.V., and Warburg, Pincus Netherlands Equity Partners III C.V., significant shareholders of the Company, and Gearóid M.
Faherty, a member of senior management of the Company, to enter into tender agreements, dated as of the date hereof, pursuant to which each such shareholder has agreed, among other things, to tender all of the Company Shares held by such shareholder
into the Offer. 
 (e) Parent, Buyer and the Company desire to make certain representations, warranties, covenants and
agreements in connection with the Offer and also to prescribe various conditions to the Offer. 

  
 1 

 Terms and Conditions 

NOW, THEREFORE, in consideration of the foregoing and the mutual representations, warranties, covenants and agreements herein contained, and
intending to be legally bound hereby, Parent, Buyer and the Company hereby agree as follows: 
 ARTICLE I 

DEFINITIONS 
 SECTION
1.01. Definitions. (a) For purposes of this Agreement: 
 “Acceptance Time” means the time at which Buyer
becomes obligated in accordance with the terms and conditions of this Agreement, the Offer Documents and applicable Laws to accept all Company Shares validly tendered and not withdrawn pursuant to the Offer. 

“Access Parties” means the Commitment Parties (as such term is defined in the Debt Financing Commitments) and their
respective advisors (and their respective equivalents in the case of an Alternative Financing). 
 “Acquisition Proposal”
means any bona fide proposal or offer from any third party, including shareholders of the Company and their respective affiliates, relating to (i) a direct or indirect sale, lease, license, exchange, mortgage, pledge, transfer or other
acquisition or assumption of 25% or more of the fair market value of the assets of the Company and its Subsidiaries, taken as a whole, in one or a series of related transactions, (ii) a direct or indirect purchase, tender offer, exchange offer
or other acquisition (including by way of merger, consolidation, share exchange or otherwise), in one or a series of related transactions, of beneficial ownership of equity securities representing 25% or more of the voting power in ordinary
elections of directors of the Company or 25% or more of the outstanding shares of any class of capital stock of the Company, or (iii) any reorganization, recapitalization, liquidation, dissolution or any other similar transaction involving the
Company or any of its material Subsidiaries which would result in a direct or indirect acquisition or distribution of 25% or more of the fair market value of the assets of the Company and its Subsidiaries, taken as a whole, or 25% or more of the
voting power in ordinary elections of directors of the Company or 25% or more of the outstanding shares of any class of capital stock of the Company; provided, however, that the term “Acquisition Proposal” shall not include
the Offer or the other transactions contemplated by this Agreement. 
 “affiliate” of a specified Person means a Person
who, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with, such specified Person. 

  
 2 

 “Antitrust Laws” means the antitrust, competition or foreign investment Laws of
any Governmental Authority. 
 “beneficial owner” and “beneficial ownership”, with respect to any Company
Shares, shall have the meanings assigned thereto in Section 13(d) of the Exchange Act. 
 “Board” means the board of
directors of the Company. 
 “business day” has the meaning set forth in Rule 14d-1(g)(3) promulgated under the Exchange
Act. 
 “Code” means the Internal Revenue Code of 1986, as amended from time to time, and the rules and regulations
promulgated thereunder. 
 “Company Equity Compensation Plan” means the Eurand N.V. Equity Compensation Plan (as amended,
restated and adopted on August 29, 2007, as amended). 
 “Company Intellectual Property” means any material
Intellectual Property, owned by the Company or any of its Subsidiaries, that is used in the business of the Company or any of its Subsidiaries. 

“Company Option” means each stock option (whether vested or unvested) to purchase Company Shares under the Company Equity
Compensation Plan or otherwise that is outstanding and unexercised immediately prior to the Closing. 
 “Company Personnel”
means any former or current director, officer, employee, or individual acting as an independent contractor or consultant of the Company or any of its Subsidiaries. 

“Company MBO Bonus Program” means the Eurand MBO Bonus Program, in the form provided to Buyer. 

“Company Registered Intellectual Property” means Company Intellectual Property consisting of (i) patents, patent
applications (including provisional applications), (ii) registered trademarks applications to register trademarks (including intent-to-use applications), and (iii) registered copyrights and applications for copyright registration. 

“Contract” means any written contract, lease, permit, authorization, indenture, note, bond, mortgage, franchise or other
agreement or instrument, commitment, obligation or binding arrangement, with respect to which there are continuing rights, liabilities or obligations. 

“control” (including the terms “controlling,” “controlled by” and “under common
control with”) means the possession, directly or indirectly, or as trustee or executor, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, as trustee
or executor, by contract or credit arrangement or otherwise. 

  
 3 

 “Disclosure Schedule” means the disclosure schedule referred to herein and
delivered by the Company to Buyer as of the date hereof. 
 “Environmental Laws” means any federal, state, local or foreign
Laws relating to (i) releases or threatened releases of Hazardous Substances or materials containing Hazardous Substances, (ii) the manufacture, handling, transport, use, treatment, storage or disposal of Hazardous Substances or materials
containing Hazardous Substances, or (iii) pollution or protection of the environment. 
 “ERISA” means the Employee
Retirement Income Security Act of 1974, as amended. 
 “ERISA Affiliate” means any Person that is, or at any relevant time
was, required to be treated as a single employer with the Company or any of its Subsidiaries under Section 414(b), (c), (m) or (o) of the Code or Section 4001(b)(1) of ERISA. 

“Evaluation Material” has the meaning set forth in the Nondisclosure Agreement. 

“Exchange Act” means the Securities Exchange Act of 1934, as amended from time to time, and the rules and regulations
promulgated thereunder. 
 “FDA” means the United States Food and Drug Administration. 

“Governmental Authority” means any (i) nation, principality, state, commonwealth, province, territory, county,
municipality, district or other governmental jurisdiction of any nature, (ii) federal, state, local, municipal, foreign or other government, (iii) governmental or quasi-governmental authority of any nature (including any governmental
division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or entity and any court or other tribunal), or (iv) individual, entity
or body exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature. 

“Hazardous Substances” means any substance, material or waste, including medical waste and petroleum, regulated as a
hazardous or toxic substance, material or waste by any Environmental Laws. 
 “HSR Act” means the Hart-Scott-Rodino
Antitrust Improvements Act of 1976, as amended from time to time, and the rules and regulations promulgated thereunder. 

“Indebtedness” means, with respect to any Person, without duplication, (A) all indebtedness of such Person for borrowed
money (including the aggregate principal amount thereof, the aggregate amount of any accrued but unpaid interest thereon and penalties, fees, and premiums with respect thereto), whether secured or unsecured, (B) all obligations of such Person
under conditional sale or other title retention agreements relating to property purchased by such 

  
 4 

 
Person, (C) all capitalized lease obligations of such Person, (D) all obligations of such Person under interest rate or currency hedging transactions or arrangements (valued at the
termination value thereof), including those with respect to interest rate and currency obligation swaps, hedges, collars or similar arrangements, (E) all obligations evidenced by bonds, notes, debentures, letters of credit or similar
instruments, (F) all obligations for the deferred purchase of property, goods or services (other than trade payables or accruals in the ordinary course of business, consistent with past practice), (G) obligations of any Person in which
such Person or any of its Subsidiaries beneficially owns equity interests that are intended to function primarily as a borrowing of funds by such Person or any of its Subsidiaries (such as receivables financing transactions and minority interest
transactions) that are not included as a liability on such Person’s consolidated balance sheet in accordance with GAAP and (H) all guarantees of such Person of any such Indebtedness of any other Person. 

“Initial Purchasers” means the initial purchasers in the high yield bond offering contemplated by the Debt Financing
Commitments. 
 “Intellectual Property” means any or all of the following and all rights in, arising out of, or associated
therewith: (i) patents and applications therefor and all reissues, divisions, renewals, extensions, provisionals, continuations and continuations-in-part thereof; (ii) all inventions (whether patentable or not), trade secrets, proprietary
information, know how, technology and technical data, and all documentation relating to any of the foregoing; (iii) all copyrights, copyright registrations and applications therefor and all other rights corresponding thereto; (iv) all
trade names, trademarks and service marks; trademark and service mark registrations and applications therefor and all associated goodwill; (v) all know-how, notebooks, work-product, databases and data collections and all rights therein; and
(vi) all Web addresses, sites and domain names. 
 “IRS” means the United States Internal Revenue Service. 

“Key Employee” has the meaning ascribed thereto in the Company’s Insider Trading Policy. 

“Knowing and Material Breach” means a material breach of this Agreement that is a consequence of an act undertaken by the
breaching party with the actual knowledge that the taking of such act would, or would be reasonably expected to, cause a material breach of this Agreement. 

“knowledge of the Company” means the actual knowledge (without having conducted or being deemed to have conducted any
investigation or inquiry) of each of the individuals set forth in Schedule 1.01. 
 “Lien” means, with respect to any
property or asset, any mortgage, lien, pledge, charge, security interest or other encumbrance in respect of such property or asset. 

  
 5 

 “Marketing Period” means the first period of 15 consecutive business days
commencing on or after January 3, 2011 throughout and at the end of which, (a) Buyer shall have the Required Information, and (b) all the Offer Conditions (other than (x) conditions which by their terms can only be satisfied at
the Closing itself and (y) the Minimum Condition so long as there shall be validly tendered in accordance with the terms of the Offer, prior to the expiration of the Offer, and not withdrawn, at least a number of Company Shares that, together
with the Company Shares beneficially owned by Buyer, represents 50.1% of the Company Shares outstanding (the “Majority Requirement”)) have been satisfied and nothing has occurred and no condition exists that would cause any of the
Offer Conditions (other than the Minimum Condition so long as the Majority Requirement shall be satisfied) to fail to be satisfied assuming the Closing were to be scheduled for any time during such 15-consecutive-business day period; provided, that
if the Company shall in good faith reasonably believe it has delivered the Required Information and that the requirements in clauses (a) and (b) are satisfied, it may deliver to Buyer a written notice to that effect (stating when it
believes it completed such delivery), in which case the Marketing Period shall be deemed to have commenced on the date of such notice unless Buyer in good faith reasonably believes the Company has not completed delivery of the Required Information
or that the requirements in clauses (a) and (b) are not satisfied or Buyer cannot obtain from the Financing Sources confirmation that the Required Information has been provided and, within three business days after the delivery of such
notice by the Company, delivers a written notice to the Company to that effect (stating to the extent reasonably possible and as applicable (1) which Required Information the Company has not delivered, (2) which Offer Condition has not
been satisfied, or (3) what has occurred or which condition exists that would cause any of the Offer Conditions to fail to be satisfied assuming that that the Closing were to be scheduled for any time during the 15-consecutive-business day
period following the date of the written notice by the Company); and provided, further, that in the event that the requirements in clauses (a) and (b) above are satisfied as of the date that is 25 business days prior to the
Termination Date (other than the Offer Conditions specified in clauses (ii) or (iii) of the first paragraph of Annex I hereto), then the Marketing Period shall commence or shall be deemed to have commenced not later than 25 business days
prior to the Termination Date, provided, further, that the Marketing Period shall not commence and shall be deemed not to have commenced if, prior to the completion of any such 15-consecutive-business day period, (1) the
Company’s independent registered accounting firm shall have withdrawn its audit opinion with respect to any financial statements contained in the Required Information, in which case the Marketing Period shall be deemed not to commence until the
time at which a new unqualified audit opinion is issued with respect to the consolidated financial statements for the applicable periods by the Company’s independent registered accounting firm or another independent registered accounting firm
reasonably acceptable to Buyer, (2) the Company shall have publicly announced any intention to restate any of its material financial information contained in the SEC Reports in which case the Marketing Period shall be deemed not to commence
until the time at which such restatement has been completed and the SEC Reports have been amended or the Company has announced that it has concluded that no restatement shall be required, or (3) the Company shall have failed to file any report
with the SEC by the date required under the Exchange Act containing any financial information that would be required to be contained therein or incorporated therein by reference, in which case the Marketing Period shall be deemed

  
 6 

 
not to commence until the time at which all such reports have been filed, provided, further, that the Marketing Period shall end on the date on which the Debt Financing is
consummated; and provided, further, that clause (a) of the definition of Marketing Period shall be deemed not to be satisfied if one or more of the conditions set forth in paragraphs (5), (6) and (10) of Exhibit D to the
Debt Financing Commitments has not been satisfied as a result of a deficiency in the information relating to, and provided by, the Company and its Subsidiaries. 

“Material Adverse Effect” means any change, effect, event, occurrence, state of facts or development that individually or in
the aggregate has had or would reasonably be expected to have a material adverse effect on the business, operations, results of operations or financial condition of the Company and its Subsidiaries, taken as a whole; provided that none
of the following shall be deemed, either alone or in combination, to constitute, and none of the following shall be taken into account in determining whether there has been, a Material Adverse Effect: (i) any change, effect, event, occurrence,
state of facts or development (a) in the financial, capital, securities or credit markets or the economy in general, (b) in general political or business conditions (including the commencement, continuation or escalation of war, armed
hostilities or other international or national calamity, acts of terrorism, earthquakes, hurricanes or other natural disasters, or acts of God), or (c) in or affecting the industries in which the Company or any of its Subsidiaries are involved,
(ii) any changes or proposed changes in applicable Laws, GAAP or other accounting standards or authoritative interpretations thereof, or stock exchange rules, regulations or listing standards, or the effects thereof, (iii) any change,
effect, event, occurrence, state of facts or development resulting from the announcement of this Agreement, the announcement of the Offer or the taking of any action consented to or requested by Buyer (including any cancellations of or delays in
customer offers, any reduction in sales, any disruption in supplier, distributor, partner or similar relationships or any loss of employees), (iv) any failure by the Company to meet any internal or published projections, forecasts, or revenue
or earnings predictions for any period ending on or after the date of this Agreement, provided that the exception in this clause shall not prevent or otherwise affect a determination that any change, effect, event, occurrence, state of facts or
development underlying such failure has resulted in, or contributed to, a Material Adverse Effect, (v) any shareholder or derivative litigation relating to the execution, delivery and performance of this Agreement and the transactions
contemplated hereby by the Company, (vi) any introduction of new or improved products (including any porcine derived pancreatic replacement therapy products, such as Ultrase® or UltresaTM) or generic equivalents of the Company’s
products, or services, or other changes to business strategy, by competitors of the Company or any of its Subsidiaries, (vii) any change arising from or as a result of Buyer, Parent, Axcan Pharma Inc. or their respective affiliates obtaining or
achieving, or the failure (other than as a result of a material breach by the Company under its contractual obligations with Parent and its Subsidiaries relating to the products currently identified as Ultrase® and UltresaTM, in which case
failure to obtain or achieve marketing or commercialization may be considered in determining whether a Material Adverse Effect has occurred) by Buyer, Parent, Axcan Pharma Inc. or their respective affiliates to obtain or achieve, marketing approval
or commercialization for a porcine derived pancreatic replacement therapy product, including, without limitation, the products currently identified as Ultrase® or UltresaTM, or (viii) any change in the market price or trading volume of
Company 

  
 7 

 
Shares, provided that the exception in this clause shall not prevent or otherwise affect a determination that any change, effect, event, occurrence, state of facts or development underlying such
failure has resulted in, or contributed to, a Material Adverse Effect, except that any change, effect, event, occurrence, state of facts or development set forth in sub-clause (i) or (ii) may be taken into account in determining whether
there has been or is a Material Adverse Effect to the extent such change, effect, event, occurrence, state of facts or development has a materially disproportionate adverse effect on the Company and its Subsidiaries, taken as a whole, as compared to
other participants in the industries in which the Company and its Subsidiaries operate. 
 “NASDAQ” means The Nasdaq Stock
Market. 
 “Nondisclosure Agreement” means that certain letter agreement, dated July 13, 2010, between the Company,
TPG Capital, L.P. and Axcan Pharma Inc. 
 “Permitted Liens” means (i) Liens for Taxes, assessments and governmental
impositions, charges or levies not yet due and payable or that are being contested in good faith and by appropriate proceedings and for which adequate reserves have been set aside if required by and in accordance with GAAP,
(ii) mechanics’, carriers’, workmen’s, repairmen’s, materialmen’s, landlord’s and similar statutory liens that secure amounts incurred in the ordinary course of business and not yet due and payable or that are
being contested in good faith and by appropriate proceedings and for which adequate reserves have been set aside in accordance with GAAP, (iii) pledges or deposits to secure obligations under workers’ compensation Laws or similar
legislation or to secure public or statutory obligations, (iv) pledges and deposits to secure the performance of bids, trade contracts, leases, surety and appeal bonds, performance bonds and other obligations of a similar nature, in each case
in the ordinary course of business, (v) Liens of public record (including Liens resulting from zoning, building and other similar ordinances, regulations, variances and restrictions) that do not materially interfere with the use and operation
of the related property or asset as currently used and operated by the Company or any of its Subsidiaries or materially reduce the value of such property or asset, (vi) unrecorded easements, encroachments, declarations, covenants, conditions,
reservations, and limitations and rights of way and other similar restrictions or immaterial defects, imperfections or irregularities in title that do not materially interfere with the use and operation of the related real property as currently used
and operated by the Company or any of its Subsidiaries or materially reduce the value of such real property, (vii) as to leased real property, all Liens of whatsoever nature created or incurred by any owner, landlord, sublandlord or other
Person in title that do not materially interfere with the use and operation of such leased real property as currently used and operated by the Company or any of its Subsidiaries, and (viii) any other Liens that do not materially interfere with
the use and operation of the related property or asset as currently used and operated by the Company or any of its Subsidiaries or materially reduce the value of such property or asset. 

“Person” means an individual, corporation, partnership, limited partnership, limited liability company, syndicate, Person
(including a “Person” as defined in Section 13(d)(3) of the Exchange Act), trust, association, entity or Governmental Authority. 

  
 8 

 “Representatives” means, with respect to any Person, the respective directors,
officers, employees, counsel, accountants, agents, advisors and other representatives of such Person and its Subsidiaries. 

“Required Information” means (a) all financial and other information relating to the Company and its Subsidiaries
required to be delivered pursuant to paragraph (5) of Exhibit D to the Debt Financing Commitments and all financial and other information relating to the Company and its Subsidiaries necessary to prepare the items required to be delivered
pursuant to paragraphs (6) and (10) of Exhibit D to the Debt Financing Commitments, including all financial statements, audit reports, pro forma financial statements, business and other financial data and disclosures and other information
reasonably requested by Buyer to prepare the offering memoranda required to be delivered pursuant to paragraph (10) of Exhibit D to the Debt Financing Commitments, or as otherwise reasonably required in connection with the Debt Financing and
the transactions contemplated by this Agreement or as otherwise necessary in order to assist in receiving customary “comfort” (including “negative assurance” comfort) from independent accountants in connection with the
offering(s) of debt securities contemplated by the Debt Financing Commitments and (b) receipt of drafts of customary comfort letters, including, without limitation, as to customary negative assurances and change period, by the independent
auditors of the Company. For the avoidance of doubt, (i) Required Information shall not include any information relating to the Buyer or its affiliates (including any post-Closing pro forma cost savings, synergies, capitalization, ownership or
other pro forma adjustments desired to be incorporated into any pro forma financial information (other than to the extent solely relating to the Company and its Subsidiaries as to which the Company will provide information reasonably requested by
Buyer) that may be required to satisfy paragraph (6) and (10) of Exhibit D to the Debt Financing Commitments and (ii) upon receipt of the Required Information from the Company, Buyer shall be responsible for timely preparation of any
pro forma financial information required to be delivered pursuant to the Debt Financing Commitments. 
 “SEC” means the
United States Securities and Exchange Commission. 
 “SEC Reports” means all forms, reports, statements and other documents
required to be filed by the Company with the SEC pursuant to the Securities Act and the Exchange Act since January 1, 2008. 

“Securities Act” means the Securities Act of 1933, as amended from time to time, and the rules and regulations promulgated
thereunder. 
 “Subsidiary” or “Subsidiaries” of the Company, Buyer or any other Person means any Person
of which an aggregate of more than 50% of the total voting power of equity securities in ordinary elections of directors, managers or other controlling Persons is controlled by such Person, directly or indirectly, through one or more intermediaries.

 “Tax” or “Taxes” means all taxes, fees, levies, tariffs, imposts and other similar charges, however
denominated and whether disputed or not, including any interest, penalties or other additions to tax that may become payable in respect thereof, imposed by any federal, state, 

  
 9 

 
local or foreign government or any agency or political subdivision of any such government, which taxes shall include all income or profits taxes (including federal income taxes, state income
taxes and foreign income taxes), escheat taxes, severance taxes, payroll and employment taxes, withholding taxes, unemployment insurance, social security taxes (or similar, including FICA), value added, sales and use taxes, ad valorem taxes, excise
taxes, pharmaceutical publicity taxes, franchise taxes, gross receipts taxes, license taxes, occupation taxes, real and personal property taxes, stamp taxes, custom duties, environmental taxes, transfer taxes, workers’ compensation, capital
stock and profits taxes, and other obligations of the same or of a similar nature to any of the foregoing, which are required to be paid, withheld or collected. 

“Tax Group” means, collectively, the Company and its Subsidiaries. 

“Tax Returns” means all reports, estimates, claims for refund, declarations of estimated Tax, information statements and
returns relating to, or required to be filed in connection with, any Taxes, including information returns or reports with respect to backup withholding and other payments to third parties and including any schedule or attachment thereto or
amendments thereof. 
 “Termination Date” means August 31, 2011. 

“Transaction Bonus Plan” means a pool not exceeding US$1,000,000 which the Company’s Chief Executive Officer, with the
approval of the Company’s Compensation Committee, can direct be paid out by the Company to those of its employees who have provided assistance in connection with the transactions contemplated hereby. 

(b) The following terms have the meaning set forth in the Sections set forth below: 

 

			
	 Defined Term
	  	 Location of Definition

		
	Action	  	4.10
	Agreement	  	Preamble
	Alternative Financing	  	7.08(b)
	Asset Sale	  	2.04
	Asset Sale Agreement	  	2.04
	Assumed Employees	  	7.07(a)
	Board Approvals	  	3.02(b)
	Board Recommendation	  	2.02(a)
	Borrower	  	5.05
	Bridge Financing	  	5.05
	Bridge Take Down	  	7.08(d)
	Buyer	  	Preamble
	Buyer Fee	  	8.03(d)/8.03(h)
	Buyer Representatives	  	8.03(j)
	Buyer SEC Reports	  	5.09(a)

  
 10 

			
	Buyer Termination Fee	  	8.03(d)
	Change in Recommendation	  	7.03(c)(ii)
	Closing	  	2.01(d)
	Company	  	Preamble
	Company Representatives	  	8.03(j)
	Company Required Approvals	  	4.05(b)
	Company Shares	  	Background
	Company Termination Fee	  	8.03(a)
	Covered Employees	  	7.07(e)
	Debt Financing	  	5.05
	Debt Financing Commitments	  	5.05
	Debt Offering Documents	  	7.08(c)(iii)
	DCC	  	3.01(a)
	Divestiture Action	  	7.01(e)
	EGM	  	2.04
	Equity Financing	  	5.05
	Equity Financing Commitment	  	5.05
	Executive Agreements	  	7.07(e)
	Financing	  	5.05
	Financing Commitments	  	5.05
	Financing Sources	  	5.05
	GAAP	  	4.06(b)
	Guarantee	  	Background
	Indemnified Parties	  	7.04(b)
	Initial Expiration Time	  	2.01(c)
	International Plans	  	4.11(a)
	Laws	  	4.05(a)
	Leased Real Property	  	4.13(b)
	Leases	  	4.13(b)
	Majority Requirement	  	1.01 (“Marketing Period”)
	Material Contracts	  	4.17(a)
	Minimum Condition	  	2.01(a)
	New Debt Financing Commitments	  	7.08(b)
	Nonclearance Termination Fee	  	8.03(h)
	Note Payable	  	2.04(c)(i)
	Offer	  	Background
	Offer Conditions	  	2.01(a)
	Offer Documents	  	2.01(b)
	Owned Real Property	  	4.13(a)
	Parent	  	Preamble
	Per Share Amount	  	Background
	Plans	  	4.11(a)
	Post-Closing Reorganization	  	3.01
	Real Property	  	4.13(b)

  
 11 

			
	Schedule 14D-9	  	2.02(b)
	Schedule TO	  	2.01(b)
	Section 7.03(c)(ii) Notice	  	7.03(c)(ii)
	Solvent	  	5.08
	Stockholder Approvals	  	2.04
	Subsequent Offering Period	  	2.01(c)
	Superior Proposal	  	7.03(e)
	U.S. Plans	  	4.11(a)

 ARTICLE II 

THE OFFER 
 SECTION 2.01.
The Offer. 
 (a) If this Agreement has not been terminated in accordance with Article VIII, as soon as practicable
after the public announcement of the execution of this Agreement, but in any event within 15 business days after the date hereof, Buyer shall commence (within the meaning of Rule 14d-2 under the Exchange Act) the Offer. The consummation of the Offer
shall be subject only to (i) the condition that there shall be validly tendered in accordance with the terms of the Offer, prior to the expiration of the Offer, and not withdrawn, at least a number of Company Shares that, together with the
Company Shares beneficially owned by Buyer, represents 80% of the Company Shares outstanding (the “Minimum Condition”); and (ii) the other conditions set forth in Annex I hereto (together with the Minimum Condition, the
“Offer Conditions”). Buyer expressly reserves the right to waive any Offer Conditions and to make any change in the terms of the Offer or the Offer Conditions; provided that (A) Buyer may not, without the prior written
consent of the Company, waive the satisfaction of the Minimum Condition, or accept for payment any Company Shares tendered pursuant to the Offer if the Minimum Condition has not been met and (B) no change may be made without the prior written
consent of the Company that (1) changes the form of consideration payable in the Offer, (2) decreases the Per Share Amount, (3) reduces the maximum number of Company Shares to be purchased in the Offer, (4) extends the Offer
other than in accordance with Section 2.01(c), (5) imposes conditions to the Offer in addition to those set forth in Annex I or which otherwise modifies the conditions set forth in such Annex I, or (6) amends any other term of the
Offer in a manner adverse to the holders of Company Shares. 
 (b) As soon as reasonably practicable after the commencement
of the Offer, Buyer shall file with the SEC a Tender Offer Statement on Schedule TO (“Schedule TO,” and such Schedule TO and any documents included therein pursuant to which the Offer will be made, together with any amendments or
supplements thereto, the “Offer Documents”). The Offer Documents shall comply in all material respects with the requirements of applicable federal securities Laws, and, on the date first filed with the SEC and on the date first
published, sent or given to the holders of Company Shares, shall not contain any untrue 

  
 12 

 
statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they
were made, not misleading, except that in complying with the foregoing commitments, Buyer may rely on the accuracy of any information supplied by the Company or any holders of Company Shares specifically for inclusion or incorporation by reference
in the Offer Documents. The Company shall promptly furnish to Buyer all information concerning the Company that may be reasonably requested by Buyer in connection with any action contemplated by this Section 2.01(b). Each of Buyer and the
Company shall promptly correct any information provided by it for use in the Offer Documents if and to the extent that such information shall have become false or misleading in any material respect and shall promptly supplement the Offer Documents
to include any information that shall become necessary to include in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Buyer shall take all steps necessary to cause the Offer Documents as
so corrected to be filed with the SEC and, at such time as reasonably agreed by Buyer and the Company, disseminated to holders of Company Shares, in each case as and to the extent required by applicable federal securities Laws. The Company and its
counsel shall be given an opportunity to review and comment on the Offer Documents at least three calendar days (or such shorter period if three calendar days is not possible but not less than 24 hours) prior to their being filed with the SEC or
disseminated to the holders of Company Shares. Buyer shall provide the Company and its counsel with any comments or other communications, whether written or oral, Buyer or their counsel may receive from the SEC or its staff with respect to the Offer
Documents promptly after the receipt of such comments or other communications and shall provide the Company and its counsel an opportunity to participate in the response of Buyer to such comments or other communications. 

(c) Unless extended as provided in this Agreement, the Offer shall be open for a period of 20 consecutive business days and
shall be scheduled to expire at 12:01 a.m., New York City time, immediately following the 20th business day of such period (calculated as set forth in Rule 14d-1(g)(3) under the Exchange Act) (the “Initial Expiration Time”). If any
Offer Condition is not satisfied (other than conditions which by their terms can only be satisfied at the Closing itself) and has not been waived or (i) the Closing has not occurred and (ii) the Marketing Period plus a period of 5 business
days thereafter has not elapsed, in each case at the Initial Expiration Time or any subsequent time as of which the Offer is then scheduled to expire, then on each such scheduled expiration date Buyer may, or at the Company’s written request,
Buyer shall, extend the Offer for a period of up to ten consecutive business days (or any such longer period as the parties may agree in writing); provided that the foregoing shall not be deemed to impair, limit or otherwise restrict the
right of any party to terminate this Agreement pursuant to the terms of Section 8.01 hereof; provided further, that notwithstanding the satisfaction or waiver of the Offer Conditions, if the Marketing Period has not ended at the
Initial Expiration Time or any subsequent time as of which the Offer is scheduled to expire, then on each such scheduled expiration date Buyer may extend the Offer for a period of up to ten consecutive business days (but in no event past the date
which is five business days following the expiration of the Marketing Period). Each extension requested by the Company pursuant to this Section 2.01(c) shall be made in writing and delivered to Buyer

  
 13 

 
no less than one business day prior to the expiration of the Offer (as it may have previously been extended pursuant to this Section 2.01(c)). Following the Closing, Buyer shall provide for
a subsequent offering period in accordance with Rule 14d-11 under the Exchange Act of at least ten business days (the “Subsequent Offering Period”). 

(d) Subject to the foregoing and upon the terms of the Offer and subject to satisfaction or waiver of the Offer Conditions and,
to the extent applicable, to the provisions of Rule 14d-11 under the Exchange Act, Buyer shall accept for payment and pay for, as promptly as practicable (and in any event within two business days) after the expiration of the Offer (as the same may
be extended pursuant to Section 2.01(c)), all Company Shares validly tendered and not withdrawn pursuant to the Offer (the “Closing”). Buyer shall provide on a timely basis the funds necessary to purchase any and all Company
Shares that Buyer becomes obligated to purchase pursuant to the Offer. The Closing shall occur at a place and time mutually agreed by the parties. Notwithstanding anything to the contrary set forth herein, Buyer shall be entitled to deduct and
withhold from amounts paid by Buyer for Company Shares validly tendered and not withdrawn such amounts as Buyer is required to deduct and withhold with respect to the making of such payments pursuant to applicable Laws. 

SECTION 2.02. Company Action. 

(a) The Company hereby approves of and consents to the Offer and represents that the Board, at a meeting duly called and held,
has (i) determined that this Agreement and the transactions contemplated hereby, including the Offer, are fair to, and in the best interests of the Company’s shareholders and other relevant stakeholders, its Subsidiaries and the
enterprises carried on by the Company and its Subsidiaries, (ii) approved this Agreement and the transactions contemplated hereby, including the Offer, in accordance with applicable law, and (iii) resolved to recommend acceptance of the
Offer by the holders of Company Shares (collectively, the “Board Recommendation”); provided that the Board Recommendation may be withdrawn, modified or amended in accordance with Section 7.03. The Company hereby
consents to the inclusion in the Offer Documents of the recommendation of the Board. 
 (b) The Company shall file with the
SEC as soon as practicable following the day that the Offer is commenced (but in no event shall the Company be required to file with the SEC earlier than the later of (i) 15 business days after the date hereof or (ii) the date the Schedule
TO is filed) and disseminate to holders of Company Shares, in each case as and to the extent required by applicable federal securities Laws, a Solicitation/Recommendation Statement on Schedule 14D-9 (together with any amendments or supplements
thereto, the “Schedule 14D-9”) that, subject to Section 7.03, shall reflect the recommendation of the Board referred to in Section 2.02(a) above and include a copy of the written opinion of Goldman Sachs International as
described in Section 4.21. The Schedule 14D-9 shall comply in all material respects with the requirements of applicable federal securities Laws. Buyer and its counsel shall be given an opportunity to review and comment on the Schedule 14D-9 at
least three calendar days (or such shorter period if three calendar days is not possible but not less than 24 hours) prior to its being filed with the SEC or disseminated to holders of Company 

  
 14 

 
Shares. The Company shall provide Buyer and its counsel with any comments that the Company or its counsel may receive from the SEC or its staff with respect to the Schedule 14D-9 promptly after
the receipt of such comments and shall provide Buyer and its counsel with an opportunity to participate in the response of the Company to such comments. Buyer shall promptly furnish to the Company all information concerning Buyer that may reasonably
be requested by the Company in connection with any action contemplated by this Section 2.02(b). Each of the Company and Buyer shall promptly correct any information provided by it for use in the Schedule 14D-9 if and to the extent that it shall
have become false or misleading in any material respect and shall promptly supplement the Schedule 14D-9 to include any information that shall become necessary to include in order to make the statements therein, in light of the circumstances under
which they were made, not misleading. The Company shall take all steps necessary to cause the Schedule 14D-9 as so corrected to be filed with the SEC and to be, at such time as reasonably agreed by Buyer and the Company, disseminated to holders of
Company Shares, in each case as and to the extent required by applicable federal securities Laws. 
 (c) The Company shall
promptly furnish Buyer with mailing labels containing the names and addresses of all record holders of Company Shares and with security position listings of Company Shares held in stock depositories, each as of a recent date, together with all other
available listings and computer files containing names, addresses and security position listings of record holders and beneficial owners of Company Shares as Buyer may reasonably request. The Company shall promptly furnish Buyer with such additional
information, including updated listings and computer files of holders of Company Shares, mailing labels and security position listings, and such other assistance in disseminating the Offer Documents to holders of Company Shares as Buyer may
reasonably request. Subject to the requirements of applicable Laws, and except for such steps as are necessary to disseminate the Offer Documents and any other documents necessary to consummate the Offer, Buyer and each of its affiliates, agents and
advisors shall hold in confidence the information contained in such labels, listings and files, shall use such information only in connection with the transactions contemplated in this Agreement, and, if this Agreement shall be terminated, shall
deliver to the Company, and shall use its reasonable best efforts to cause its affiliates, agents and advisors to deliver, all copies and any extracts or summaries from such information then in their possession. 

SECTION 2.03. Company Options. Immediately prior to the Closing, all outstanding and unexercised Company Options other than those
Company Options issued on or after the date of this Agreement shall become fully vested. At the Closing, all outstanding and unexercised Company Options shall be canceled and the holders thereof shall cease to have any rights with respect thereto,
excepting only the right, in respect of each such canceled Company Option other than those Company Options issued on or after the date of this Agreement, to receive an amount in cash from the Company, on the Company’s regular payroll date
occurring on or next following the date of the Closing and in accordance with the Company’s regular payroll practices, equal to the result of multiplying the total number of Company Shares previously subject to such vested Company Option by the
excess, if any, of the Per Share Amount over the 

  
 15 

 
per share exercise price of such unexercised Company Option, subject to applicable Tax withholding. No Company Options shall be outstanding from and after the Closing. The Company shall take such
actions as may be necessary with respect to the Company Options to effectuate the foregoing provisions of this Section 2.03. 
 SECTION
2.04. EGM. At any time following the execution of this Agreement, but in any event prior to the Initial Expiration Time, the Company shall hold an extraordinary meeting of shareholders (the “EGM”) to (a) provide
information regarding the Offer and approve this Agreement, (b) accept the resignation from the Board of the existing members thereof and appoint the new members of the Board in accordance with the designation of Buyer set out below;
(c) approve the sale by the Company effective as of the Closing, pursuant to a sale and purchase agreement (an “Asset Sale Agreement”), of all or substantially all of the assets of the Company (including the Company’s
Subsidiaries) to Buyer or one or more of its designees for aggregate consideration of (i) a note payable (the “Note Payable”) from Buyer or one or more of its designees in an aggregate principal amount equal to the Per Share
Amount multiplied by the total number of outstanding Company Shares as of the Closing (which Note Payable shall be prepayable without penalty or premium but shall require the Buyer to repay to the Company, on or prior to the completion of the
Subsequent Offering Period, an amount of the Note Payable equal to the Per Share Amount multiplied by the number of Shares not tendered in the Tender Offer or the Subsequent Offering Period), and (ii) the assumption by Buyer or its designees of
all liabilities and obligations of the Company, whether actual, contingent or otherwise, including the express assumption of all contractual obligations (and also including the related obligation of Buyer or its designees to fully indemnify and hold
harmless the Company with respect to all such assumed liabilities and obligations) (the transaction described in this clause (c), the “Asset Sale”); and (d) resolve upon the liquidation and dissolution of the Company following
such Asset Sale and completion of the Subsequent Offering Period with the aim that the proceeds of such sale will be paid by means of a liquidation distribution to the shareholders of the Company such that (i) each holder of Company Shares that
were not tendered in the Offer or during the Subsequent Offering Period shall receive cash in an amount equal to the Per Share Amount multiplied by the number of Company Shares then held by such holder, less any applicable withholding taxes and
(ii) Buyer shall receive (in kind) the Note Payable. In connection with the Asset Sale, the Buyer shall provide a guarantee to the liquidator as to any deficit in the estate of the Company, so as to enable the liquidator to pay the Per Share
Amount per Company Share (less withholding taxes, if any) by means of an advance liquidation distribution to holders of Company Shares that were not tendered in the Offer or during the Subsequent Offering Period. The resignations and appointments
and the approval of the sale of the Company’s assets, the liquidation and dissolution of the Company and the distribution of the liquidation proceeds referred to in the preceding sentence (the “Stockholder Approvals”) will be
effective as of, and conditional upon the occurrence of, the Closing. As soon as practicable after the date of execution of this Agreement and no later than 20 calendar days prior to the date of the EGM, Buyer shall designate in writing to the
Company the new members for the Board and furnish the Company with all information with respect to those new members that is required to be disclosed to the Company shareholders under the Laws of The Netherlands. At the EGM, the Company shall use
its reasonable best efforts to secure the Stockholder Approvals, such Stockholder 

  
 16 

 
Approvals to be effective as of, and conditional upon, the occurrence of the Closing, as aforesaid. Buyer and the Company shall consummate the Asset Sale simultaneously with the Closing. 

ARTICLE III 
 POST
CLOSING MATTER 
 SECTION 3.01. Restructuring. Buyer shall, simultaneously with or as soon as possible after the Closing,
effectuate a corporate reorganization (the “Post-Closing Reorganization”) of the Company and its Subsidiaries, which may include, in addition to the Asset Sale, without limitation, (a) the commencement of a compulsory
acquisition by Buyer of Company Shares from any remaining minority shareholder in accordance with Section 2:92a of the Dutch Civil Code (the “DCC”), (b) the amendment of the Articles of Association of the Company to permit
the creation, among other things, of separate classes of shares, (c) making a liquidation distribution to each holder of Company Shares that were not tendered in the Offer or during the Subsequent Offering Period, (d) the effectuation by
the Company and one or more Dutch Subsidiaries of Buyer of a legal merger within the meaning of Section 2:309 of the DCC, (e) the termination of the listing of the Company Shares on the NASDAQ, (f) the deregistration of the Company
under the Exchange Act and the cessation of the Company’s reporting obligations thereunder, or (g) any one or more combinations of any of the foregoing actions; all of which shall be conducted in accordance with applicable Laws and which
will in any case result in the holders of Company Shares that were not tendered in the Offer or during the Subsequent Offering Period being offered or receiving in any such Post-Closing Reorganization for each of such Company Shares cash in an
amount equal to the Per Share Amount, less applicable withholding taxes, as soon as reasonably possible after the Closing. 
 SECTION 3.02.
Co-Operation of the Company. The Company and Buyer shall take as of the date of this Agreement or as soon thereafter as is reasonably practical, but effective no earlier than the consummation of the Offer, all actions reasonably necessary or
desirable to accomplish the Asset Sale and, to the extent requested by Buyer, the Post-Closing Reorganization including, without limitation, (a) in the case of the Company, the convening of the necessary meetings of the Company shareholders and
the Board (including, without limitation, the EGM referenced in Section 2.04), (b) in the case of the Company, the consideration of any and all necessary or desirable resolutions by the Board for the purpose of the corporate
reorganizations and the consideration and approval (including approval by a majority of disinterested directors) of any board resolutions (the “Board Approvals”) necessary or desirable to convene the EGM referenced in
Section 2.04 and approve the Asset Sale to Buyer or its designee, the liquidation and dissolution of the Company (unless the Board elects to defer the matter to a later separate EGM), in each case as set forth in Section 2.04, and
(c) in the case of the Buyer and the Company, the execution of any and all reasonably requested documents, agreements or deeds that are necessary or desirable to effectuate any of the corporate reorganizations and the filing or registration of
any or all of such documents, agreements or deeds with the appropriate authorities or agencies. In addition, at the request of Buyer, the 

  
 17 

 
Company shall take any and all other actions that are reasonably necessary or desirable to accomplish the corporate reorganization of the Company and its Subsidiaries, so long as such actions are
reasonable based on the relative detriment or inconvenience to the Company and the relative benefit to Buyer from such action. With respect to all actions taken by the Company pursuant to this Section 3.02, Buyer shall reimburse the Company for
its reasonable out-of-pocket costs and expenses regardless of whether or not the Offer is consummated except where Buyer has terminated this Agreement pursuant to Section 8.01(d) or Section 8.01(h), in which case Buyer shall not be
obligated so to reimburse the Company. 
 ARTICLE IV 

REPRESENTATIONS AND WARRANTIES OF THE COMPANY 

The Company represents and warrants to Buyer that the statements contained in this Article IV are true and correct, except as set forth in
(i) the Disclosure Schedule or (ii) the SEC Reports (but excluding from the SEC Reports (x) any risk factor disclosures contained under the heading “Risk Factors,” (y) any disclosure of risks included in any
“forward-looking statements” disclaimer and (z) any other forward-looking statements of risk that do not contain a reasonable level of detail about the risks of which the statements warn). 

SECTION 4.01. Organization and Qualification; Subsidiaries. Each of the Company and its Subsidiaries is duly formed, validly existing
and (to the extent the concept of good standing exists in the applicable jurisdiction) in good standing under the Laws of the jurisdiction of its formation and has the requisite power and authority to own, lease and operate its properties and to
carry on its business as it is now being conducted, except where the failure to be so organized, existing and in good standing or to have such power and authority would not have a Material Adverse Effect. The Company and each of its Subsidiaries is
duly qualified or licensed to do business, in each jurisdiction where the character of the properties owned, leased or operated by it or the nature of its business makes such qualification or licensing necessary, except where the failure to be so
duly qualified or licensed would not have a Material Adverse Effect. 
 SECTION 4.02. Articles of Association; Etc. The Company has
heretofore made available to Buyer a complete and correct copy of the articles of association, deed or certificate of incorporation, by-laws or equivalent organizational documents, each as amended to date, of the Company and each of its
Subsidiaries. Such articles of association, deed or certificates of incorporation, bylaws or equivalent organizational documents are in full force and effect. 

SECTION 4.03. Capitalization. 

(a) The authorized capital stock of the Company consists of 130,000,000 Company Shares. As of November 29, 2010,
(i) 48,014,947 Company Shares were issued and outstanding, (ii) no Company Shares were held in the treasury of the Company, (iii) no Company Shares were held by any Subsidiaries of the Company and (iv) there were such number of
Company Options to purchase Company Shares as is set forth on Section 4.03 of the Disclosure Schedule. The Company has not issued any Company Shares or Company 

  
 18 

 
Options to purchase Company Shares from and including November 29, 2010 to and including the date hereof, other than the issuance of Company Shares pursuant to the exercise of Company
Options. As of the date hereof, no warrants to purchase shares of capital stock of the Company are outstanding. All outstanding Company Shares and shares of capital stock (or, where applicable, other comparable equity interests) of each Subsidiary
of the Company have been, and all shares of capital stock of the Company that may be issued pursuant to the Company Equity Compensation Plan will be, when issued in accordance with the respective terms thereof, duly authorized, validly issued, fully
paid and nonassessable. Section 4.03(a) of the Disclosure Schedule sets forth the authorized and, as of November 26, 2010, 2010, issued and outstanding capital stock (or, where applicable, other comparable equity interests) of each
Subsidiary of the Company. Except as set forth in Section 4.03(a) of the Disclosure Schedule, all outstanding shares of capital stock or comparable equity interests in the Subsidiaries of the Company are owned by the Company or a Subsidiary of
the Company, free and clear of all Liens other than transfer restrictions pursuant to the federal securities Laws and any similar state or foreign securities Laws. 

(b) Except as set forth in Section 4.03(a) above, there are no outstanding (i) shares of capital stock or voting
securities of the Company or any of its Subsidiaries, (ii) securities of the Company or any of its Subsidiaries convertible into or exchangeable for shares of capital stock or voting securities of the Company or any of its Subsidiaries,
(iii) options or other rights to acquire from the Company or any of its Subsidiaries or other obligations (including obligations arising out of preemptive rights or other similar rights) of the Company or any of its Subsidiaries to issue any
capital stock, voting securities or securities convertible into or exchangeable for capital stock or voting securities of the Company or any of its Subsidiaries, or (iv) contractual obligations that would otherwise entitle any other Person to
share in the equity, profits, earnings, losses or gains of the Company or any of its Subsidiaries (including stock appreciation, phantom stock, profit participation or other similar rights). No depositary receipts (“certificaten”)
have been issued for any Company Shares. 
 (c) Except as set forth in Section 4.03(a) above, there are no outstanding
obligations of the Company or any of its Subsidiaries to repurchase, redeem, otherwise acquire or make any payment (including any dividend or distribution) in respect of any (i) shares of capital stock or voting securities of the Company or any
of its Subsidiaries, (ii) securities of the Company or any of its Subsidiaries convertible into or exchangeable for shares of capital stock or voting securities of the Company or any of its Subsidiaries, or (iii) options or other rights to
acquire from the Company or any of its Subsidiaries, or other obligations of the Company or any of its Subsidiaries, to issue any capital stock, voting securities or securities convertible into or exchangeable for capital stock or voting securities
of the Company or any of its Subsidiaries. To the knowledge of the Company, there are no Liens on, or other contractual obligations relating to, the ownership, transfer or voting of any Company Shares or any shares of capital stock (or, where
applicable, other comparable equity interests) of each Subsidiary of the Company. 

  
 19 

 (d) Each Company Option was granted in compliance with all applicable Laws and
all of the terms and conditions of the Company Equity Compensation Plan and at all relevant times has qualified for exemption from Section 409A of the Code under Section 1.409A-1(b)(5)(i)(A) or Section 1.409A-1(b)(5)(ii) of the
regulations thereunder. 
 (e) As of the date hereof, the Company had outstanding indebtedness for borrowed money (including
the aggregate principal amount thereof, the aggregate amount of any accrued but unpaid interest thereon and penalties, fees, and premiums with respect thereto), whether secured or unsecured, in an amount as set forth in Section 4.03(e) of the
Disclosure Schedules. 
 SECTION 4.04. Authority Relative to This Agreement. The Company has all necessary corporate power and
authority to execute and deliver this Agreement and to perform its obligations hereunder. The execution and delivery of this Agreement by the Company have been duly and validly authorized by all necessary corporate action, and no other corporate
proceedings on the part of the Company are necessary to authorize this Agreement. This Agreement has been duly executed and delivered by the Company and, assuming the due authorization, execution and delivery hereof by Buyer and Parent, constitutes
the legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except that (a) such enforcement may be subject to applicable bankruptcy, insolvency, reorganization, moratorium or other
similar Laws, now or hereafter in effect, affecting creditors’ rights generally and (b) the remedy of specific performance and injunctive and other forms of equitable relief may be subject to equitable defenses and to the discretion of the
court before which any proceeding therefor may be brought. 
 SECTION 4.05. No Conflict; Required Filings and Consents. 

(a) The execution and delivery of this Agreement by the Company do not, and the performance of this Agreement by the Company
will not, (i) conflict with or violate the articles of association, certificate of incorporation or bylaws or equivalent organizational documents of the Company or any of its Subsidiaries, (ii) subject to obtaining the Company Required
Approvals, conflict with or violate any treaty, statute, law, ordinance, regulation, rule, code, executive order, injunction, judgment, decree or other order of or by any Governmental Authority (“Laws”) applicable to the Company or
any of its Subsidiaries or by which any property or asset of the Company or any of its Subsidiaries is bound or affected or (iii) subject to obtaining the consents listed in Section 4.05(a) of the Disclosure Schedule, result in any breach
of or constitute a default (or an event which, with notice or lapse of time or both, would become a default) under, or give to others any right of termination, amendment, acceleration or cancellation of, or result in the creation of a Lien other
than a Permitted Lien on any property or asset of the Company or any of its Subsidiaries, except, with respect to clauses (ii) and (iii), for any such conflicts, violations, breaches, defaults or other occurrences that would not prevent or
materially delay consummation of the Offer and would not have a Material Adverse Effect. 

  
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 (b) The execution and delivery of this Agreement by the Company do not, and the
performance of this Agreement by the Company will not, require any consent, approval, authorization or permit of, or filing with or notification to, any Governmental Authority, except (i) for applicable requirements, if any, of the Exchange
Act, state takeover and state securities or “blue sky” Laws, the rules or regulations of NASDAQ, the HSR Act and other Antitrust Laws, and Environmental Laws (the foregoing, together with those items listed on Section 4.05(b) of the
Disclosure Schedule, collectively, the “Company Required Approvals”), and (ii) any actions, licenses, consents, permits, orders, approvals or filings the absence of which would not prevent or materially delay consummation of
the Offer and would not have a Material Adverse Effect. 
 SECTION 4.06. SEC Filings; Financial Statements. 

(a) The SEC Reports (i) complied, at the time they were filed, as to form in all material respects with the applicable
requirements of the Securities Act or the Exchange Act and (ii) did not, at the time they were filed, or, if amended, as of the date of such amendment, contain any untrue statement of a material fact or omit to state a material fact required to
be stated therein or necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading. No Subsidiary of the Company is, or has been since May 17, 2007, required to file any
form, report or other document with the SEC. 
 (b) The condensed consolidated financial statements (including, in each case,
any notes thereto) contained in the SEC Reports when filed complied as to form in all material respects with the published rules and regulations of the SEC with respect thereto, were prepared in accordance with United States generally accepted
accounting principles (“GAAP”) applied on a consistent basis throughout the periods indicated (except as may be indicated in the notes thereto) and each fairly presents, in all material respects, the consolidated financial position,
results of operations and cash flows of the Company and its Subsidiaries as at the respective dates thereof and for the respective periods indicated therein (subject, in the case of unaudited statements, to normal and recurring year-end adjustments) in accordance with GAAP. 
 SECTION 4.07. Disclosure Controls and Procedures.
The Company has established and maintains disclosure controls and procedures and internal control over financial reporting (as such terms are defined in paragraphs (e) and (f), respectively, of Rule 13a-15 under the Exchange Act) as required by
Rule 13a-15 under the Exchange Act. The Company’s disclosure controls and procedures are reasonably designed to ensure that all material information required to be disclosed by the Company in the reports that it files or furnishes under the
Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that all such material information is accumulated and communicated to the Company’s management as appropriate
to allow timely decisions regarding required disclosure and to make the certifications required pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act. The Company’s management has completed an assessment of the effectiveness of the
Company’s internal control over financial reporting and of the Company’s 

  
 21 

 
disclosure controls and procedures in compliance with the requirements of Section 404 of the Sarbanes-Oxley Act for the year ended December 31, 2009, and such assessment concluded that
such controls were effective. 
 SECTION 4.08. Absence of Certain Changes or Events. Since the date of the latest audited financial
statement included in the SEC Reports through the date hereof, (a) the Company and its Subsidiaries have conducted their respective businesses in all material respects in the ordinary course and consistent with past practice, (b) there has
not been any Material Adverse Effect, and (c) there has not occurred any action or event that would have been prohibited by (assuming Buyer did not consent thereto) the provisions of Section 6.01 had such action or event occurred after the
date of this Agreement and prior to the earlier of the date of the Closing or the termination of this Agreement. 
 SECTION 4.09.
Compliance with Laws. The Company and its Subsidiaries are, and since May 17, 2007 have been, in material compliance with all applicable Laws and have all licenses, certificates, permits, consents, orders, approvals and authorizations
from any Governmental Authority that are necessary to the ownership of their property or to the conduct of their businesses in the manner and to the extent now conducted by the Company and its Subsidiaries, except where any failure to comply with
any such laws or failure to have any such license, certificate, permit, consent, order, approval or authorization would not have a Material Adverse Effect. This Section 4.09 includes all subject matters except those covered by Sections 4.01,
4.06, 4.07, 4.11, 4.15, 4.16 and 4.19. 
 SECTION 4.10. Absence of Litigation. There is no litigation, suit, claim, action,
arbitration or proceeding (each, an “Action”) pending or, to the knowledge of the Company, threatened, nor, to the knowledge of the Company, is any investigation or audit pending or threatened in writing, against the Company or any
of its Subsidiaries, or any property or asset of the Company or any of its Subsidiaries, by or before any court, other Governmental Authority or arbitrator that, if adversely determined, would have a Material Adverse Effect. 

SECTION 4.11. Employee Benefit Plans. 

(a) Section 4.11 of the Disclosure Schedule lists each material plan, arrangement or policy (written or oral), whether
covering a single individual or group of individuals, relating to stock options, stock purchases, deferred compensation, bonus, severance, retention, fringe benefits or other employee benefits (collectively, the “Plans”), including,
without limitation, each material employee benefit plan (as defined in Section 3(3) of ERISA) (such Plans, the “U.S. Plans”), in each case that is maintained or contributed to, or required to be maintained or contributed to, by
the Company or any ERISA Affiliate or under which the Company or any ERISA Affiliate has or may have any liability for contributions, premiums or benefits. Each Plan that has been maintained or contributed to by the Company or any of its
Subsidiaries, or with respect to which the Company or any of its Subsidiaries will or may have any liability, for the benefit of employees of the Company or its Subsidiaries, or any of them, who perform services outside the United States shall be
collectively referred to as the “International Plans.” 

  
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 (b) The Company has made available to Buyer true and complete copies of each U.S.
Plan and, for each U.S. Plan (i) if the Plan has been reduced to writing, the plan document and all amendments thereto, (ii) if the Plan has not been reduced to writing, a written summary of all material Plan terms, (iii) any related
trust agreements, custodial agreements, insurance policies or contracts, administrative agreements and similar agreements, and investment management or investment advisory agreements, (iv) any summary plan descriptions, employee handbooks or
similar employee communications, (v) in the case of any Plan for which Forms 5500 are required to be filed, the Form 5500 and accompanying schedules, if any, for the most recent two (2) years for which such Forms have been filed, and
(vi) in the case of any Plan that is intended to be qualified under Code Section 401(a), the most recent determination letter (and, if applicable, opinion letter) from the Internal Revenue Service. 

(c) Neither the Company nor any ERISA Affiliate has ever maintained, contributed to, or been required to contribute to a plan
subject to Title IV of ERISA or Section 412 of the Code, including any multiemployer plan (within the meaning of Section 3(37) or 4001(a)(3) of ERISA) or single employer pension plan (within the meaning of Section 4001(a)(15) of
ERISA) for which the Company or any of its Subsidiaries could incur liability under Section 4063 or 4064 of ERISA. None of the Plans (i) provides for the payment of separation, severance, termination or
similar-type benefits to any Person, (ii) obligates the Company or any of its Subsidiaries to pay or accelerate the vesting of any payment or funding of any separation, severance, termination or other
payment or benefits solely or partially as a result of any transaction contemplated by this Agreement, or (iii) obligates the Company or any of its Subsidiaries to make any payment or provide any benefit as a result of a change in the ownership
or control of the Company or the change in the ownership of a substantial portion of the Company’s assets. None of the Plans provides for or promises retiree medical, disability or life insurance benefits to any current or former employee,
officer or director of the Company or any of its Subsidiaries, except as required by Section 601 et seq. of ERISA. 

(d) To the knowledge of the Company, each Plan is now and always has been maintained and administered in all material respects
in accordance with its terms and the requirements of all applicable Laws, including ERISA and the Code, where applicable. Neither the Company nor any of its Subsidiaries could reasonably be subject to a liability under Sections 409 or 502(i) of
ERISA or to a tax under Section 4975 of the Code. The Company and its Subsidiaries have performed all obligations required to be performed by them under the Plans in all material respects and are not in any material respect in default under or
in violation of, and the Company has no knowledge of any material default or violation by any party to, any Plan. No Action is pending or, to the knowledge of the Company, threatened with respect to any Plan (other than claims for benefits in the
ordinary course) and, to the knowledge of the Company, no fact or event exists that is reasonably likely to give rise to any such Action. No Plan is or, within the last six (6) years, has been the subject of an examination or audit by any
Governmental Authority or the subject of an application or filing under or a participant in, a government-sponsored amnesty, voluntary compliance, self-correction or similar program. 

  
 23 

 (e) For each U.S. Plan that is intended to be qualified under Section 401(a)
of the Code or Section 401(k) of the Code, the Company and/or its Subsidiaries have adopted a prototype plan that has received a favorable opinion letter from the IRS and, to the knowledge of the Company, no fact or event has occurred to
adversely affect the qualified status of any such Plan. 
 (f) The Company and its Subsidiaries have timely paid all amounts
that each, as applicable, is required to pay as contributions to, or premiums or benefits under, the Plans in all material respects, or have accrued such amounts in accordance with GAAP. 

(g) Neither the execution of this Agreement nor the consummation of the transactions contemplated hereby (whether alone or in
connection with any other events) will result in any payment that, separately or in the aggregate, would constitute an “excess parachute payment” within the meaning of Section 280G of the Code or that would not be deductible under
Section 162 of the Code. 
 (h) Each International Plan has been established, maintained and administered in material
compliance with its terms and conditions and with the requirements prescribed by any and all Laws that are applicable to such International Plan. Furthermore, no International Plan has material unfunded liabilities that, as of the Closing, will not
be offset by insurance or fully accrued or disclosed in the Company’s financial statements. 
 (i) Prior to the
execution of this Agreement, the Company (acting through the Compensation Committee and the Special Committee of the Board) has taken all such steps as may be required to cause any and all employment compensation, severance and employee benefit
agreements and arrangements entered into by the Company or its Subsidiaries or contemplated hereby with any of their respective officers, directors or employees (including those agreement and arrangements listed in Schedule 4.11(i)) to be approved
as an “employment compensation, severance or other employee benefit arrangement” within the meaning of Rule 14d-10(d)(1) under the Exchange Act and to satisfy the requirements of the non-exclusive safe harbor set forth in Rule
14d-10(d) under the Exchange Act. 
 SECTION 4.12. Labor and Employment Matters. 

(a) Neither the Company nor any of its Subsidiaries are party to, or otherwise bound by, any collective bargaining or other
agreement with a labor union, and no such agreement is being negotiated by the Company or any of its Subsidiaries. None of the employees of the Company or any of its Subsidiaries are represented by a labor union. To the knowledge of the Company,
there is no effort by or on behalf of any labor union to organize any employees of the Company or any of its Subsidiaries and there have been no such efforts for the past three years. No petition has been filed or proceedings instituted by an
employee or group of employees of the Company or any of its Subsidiaries with any labor relations board seeking recognition of a bargaining representative. There is no labor dispute, work slowdown, picketing or strike pending, or to the knowledge of
the Company, threatened against the 

  
 24 

 
Company or any of the Subsidiaries and there have been no such disputes or activities for the past three years. Except as would not have a Material Adverse Effect, there are no unfair labor
practice complaints pending against the Company or any of its Subsidiaries before the National Labor Relations Board or any other labor relations tribunal or authority. 

(b) True and complete information as to the name, current job title and compensation for each of the last three years of all
current executive officers of the Company and its Subsidiaries has been provided to Buyer. As of the date hereof, to the knowledge of the Company, except as set forth in Section 4.12(b) of the Disclosure Schedule, no current executive officer
or Key Employee of the Company or any of its Subsidiaries has given written notice of termination of employment with the Company or any Subsidiary. 

(c) As of the date of this Agreement, except as set forth in Section 4.12(c) of the Disclosure Schedule or as would not
materially affect the Company, (i) there is no investigation or audit pending (or, to the knowledge of the Company, threatened) by any Governmental Authority with respect to the Company or any of its Subsidiaries concerning employment-related
matters, and (ii) no current or former employee or independent contractor of the Company or any of the Subsidiaries has brought any Action (or, to the knowledge of the Company, has threatened to bring any Action) against or affecting the
Company or any of its Subsidiaries. 
 (d) The Company and each of its Subsidiaries is in compliance in all material respects
with all Laws respecting employment, employment practices and terms and conditions of employment, including but not limited to wages and hours and the classification of employees and independent contractors, and have not been and are not engaged in
any unfair labor practice as defined in the National Labor Relations Act. 
 SECTION 4.13. Property and Leases. 

(a) Section 4.13 of the Disclosure Schedule contains a list of all real property owned by the Company or any of its
Subsidiaries (the “Owned Real Property”). The Company or a Subsidiary of the Company has good and marketable fee title to each parcel of Owned Real Property and all improvements located thereon, free and clear of all Liens other
than Permitted Liens. 
 (b) Section 4.13 of the Disclosure Schedule contains a list of all leases and subleases under
which the Company or any of its Subsidiaries is either lessor or lessee of real property (the “Leased Real Property,” and together with the Owned Real Property, the “Real Property”). The Company or one of its
Subsidiaries has a good and valid leasehold interest in each Leased Real Property, free and clear of all Liens other than Permitted Liens, except where the failure to have such leasehold interest would not have a Material Adverse Effect. The Company
has delivered to Buyer or its counsel a true and complete copy of every lease and sublease with respect to the Leased Real Property (the “Leases”). Except where such failure to be valid and enforceable in accordance with its terms
would not have a Material Adverse Effect, each Lease is valid and enforceable in accordance with its terms except that (a) such 

  
 25 

 
enforcement may be subject to applicable bankruptcy, insolvency, reorganization, moratorium or other similar Laws, now or hereafter in effect, affecting creditors’ rights generally and
(b) the remedy of specific performance and injunctive and other forms of equitable relief may be subject to equitable defenses and to the discretion of the court before which any proceeding therefor may be brought. 

(c) To the knowledge of the Company, none of the Real Property is the subject of any material condemnation or eminent domain
proceeding. The Real Property is served by all water, electric, gas, telephone, sewer and other utilities reasonably necessary for the conduct of business of the Company and its Subsidiaries as currently conducted. 

(d) The Company and the Subsidiaries of the Company have good and marketable title to all material personal property owned by
them, in each case free and clear of all Liens other than Permitted Liens. 
 SECTION 4.14. Intellectual Property. 

(a) The Company or one or more of its Subsidiaries owns, or has the right to use, all material Intellectual Property necessary
to the conduct of the business of the Company or any of its Subsidiaries as now conducted, except as would not, individually or in the aggregate, have a Material Adverse Effect. Section 4.14(a) of the Disclosure Schedule lists all proceedings
or actions before any court, tribunal (including the European Patent Office, the United States Patent and Trademark Office or equivalent authority elsewhere in the world) related to any of the Company Registered Intellectual Property which, if
adversely determined, would have a Material Adverse Effect. 
 (b) Each item of Company Intellectual Property, is, to the
knowledge of the Company, free and clear of any Liens other than Permitted Liens and Liens that would restrict the use of such Company Intellectual Property in such a manner that would not have a Material Adverse Effect. To the knowledge of the
Company, (i) the operation of the businesses of the Company and its Subsidiaries as they currently are conducted does not infringe the Intellectual Property of any Person in any material respect, (ii) no Person is infringing any Company
Intellectual Property in any material respect, and (iii) (x) none of the claims of patents constituting Company Intellectual Property are unenforceable or invalid, and (y) none of the claims of patent applications constituting Company
Intellectual Property would be unenforceable or invalid if issued as patents. 
 (c) The Company and its Subsidiaries have
taken commercially reasonable actions to maintain and preserve any Company Intellectual Property, including requiring, through signed written agreement or binding employment policy, all Company Personnel who develop or receive trade secret or
confidential or proprietary data or information or Intellectual Property of the Company or any of its Subsidiaries not to disclose such trade secrets, data, information or Intellectual Property to any third party, not to use such trade secrets, data
or information for any purpose other than the purposes of the Company and its Subsidiaries, and to assign their rights in such trade secrets, data, information or Intellectual Property to the Company or a Subsidiary of the Company. 

  
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 SECTION 4.15. Taxes. 

(a) (i) All income and other material Tax Returns required to be filed by or on behalf of the Tax Group have been duly filed on
a timely basis (taking into account applicable extensions) and such Tax Returns (taking into account all amendments thereto) are complete and accurate in all material respects, (ii) all income and other material Taxes whether or not shown to be
payable on the Tax Returns have been paid in full on a timely basis, except with respect to matters contested in good faith or for which adequate reserves have been established in accordance with GAAP in the financial statements of the Company
included in the SEC Reports, and (iii) the Tax Group has withheld and timely paid over to the appropriate authorities all Taxes required to have been withheld and paid over, and in all material respects has complied with all information
reporting and backup withholding requirements. 
 (b) To the knowledge of the Company, there are no binding agreements
relating to any prior formal audit of the Tax Group with the IRS or any other Governmental Authority that have or are reasonably likely to have a material and adverse impact on the Tax Group’s Taxes for which adequate reserves have not been
established in accordance with GAAP in the financial statements of the Company included in the Company SEC Documents. 
 (c)
The Tax Returns of the Tax Group have never been audited by a Governmental Authority, nor is any such audit in process, pending or, to the knowledge of the Company, threatened; no deficiencies exist or have been asserted with respect to Taxes of the
Tax Group which have not been fully paid or adequately reserved for in accordance with GAAP in the financial statements of the Company included in the Company SEC Documents, and the Tax Group is neither a party to any action or proceeding for
assessment or collection of material Taxes, nor has such event been asserted or, to the knowledge of the Company, threatened against the Tax Group or any of its assets or properties. No waiver or extension of any statute of limitations is in effect
with respect to Taxes or Tax Returns of the Tax Group. 
 (d) There are no Liens for Taxes on any of the assets of the Tax
Group other than Permitted Liens. 
 (e) The Tax Group does not have any liability for the Taxes of any other person that is
not a member of the Tax Group, including under Treasury Regulations Section 1.1502-6 (or any similar provision of state, local or foreign law), as transferee or successor, by contract or otherwise. No member of the Tax Group has participated in
any “reportable transaction” within the meaning of Treasury Regulations Section 1.6011-4(b). 
 SECTION 4.16.
Environmental Matters. Except as would not have a Material Adverse Effect, to the knowledge of the Company, (a) the Company and its Subsidiaries are in compliance with all applicable Environmental Laws, and have obtained and maintained
all permits and consents required for the operation of their business pursuant to applicable 

  
 27 

 
Environmental Laws, (b) except for matters that have been fully resolved and that impose no continuing obligations or liabilities on the Company or any of its Subsidiaries, neither the
Company nor any of its Subsidiaries has received any written notice, claim, demand or request for information with respect to the business of, or any real property of, the Company or any of its Subsidiaries from any Governmental Authority or third
party alleging or suggesting that the Company or any of its Subsidiaries is not in material compliance with any Environmental Laws or has liability under any Environmental Laws, and (c) neither the Company nor any of its Subsidiaries nor, to
the knowledge of the Company, any third party has caused any “release” (as defined in the Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. § 9601 et seq.) of a Hazardous Substance in excess of a
reportable quantity (or otherwise in a manner giving rise to a requirement for response actions) on any real property currently or formerly owned or leased by the Company or any of its Subsidiaries. 

SECTION 4.17. Material Contracts. 

(a) Section 4.17 of the Disclosure Schedule contains a list, as of the date hereof, of each contract or agreement that is
a “material contract” (as such term is defined in Item 601(b) (10) of Regulation S-K of the SEC) and each of the following types of contracts and agreements to which the Company or any of its Subsidiaries is a party (such
contracts and agreements as are required to be set forth in Section 4.17 of the Disclosure Schedule being the “Material Contracts”): 

(i) each contract and agreement that (A) is reasonably likely to involve consideration of more than US$500,000 during the calendar year
ending December 31, 2010, or (B) is reasonably likely to involve consideration of more than US$1,000,000, in the aggregate, over the remaining term of such contract, except any such contract that can be canceled by the Company or any of
its Subsidiaries for any reason without penalty or further payment and without more than 90 days’ notice; 
 (ii) any material license
or similar agreement, including any contracts involving the payment of royalties or other amounts calculated based upon the revenues or income of the Company or any of its Subsidiaries, or income or revenues related to any product of the Company or
any of its Subsidiaries, to which the Company or any of its Subsidiaries is a party, that (A) is reasonably likely to involve consideration of more than US$500,000 during the calendar year ending December 31, 2010, or (B) is
reasonably likely to involve consideration of more than US$1,000,000, in the aggregate, over the remaining term of such agreement, payable by the Company or any of its Subsidiaries to any third party; 

(iii) all contracts and agreements evidencing Indebtedness in excess of US$1,000,000; 

(iv) all contracts and agreements with any Governmental Authority, to which the Company or any of its Subsidiaries is a party, that are
material to the Company and its Subsidiaries taken as a whole; 

  
 28 

 (v) all distributor agreements material to the Company and its Subsidiaries taken as a whole;

 (vi) all Leases material to the Company and its Subsidiaries taken as a whole; 

(vii) all contracts and agreements that limit, or purport to limit, in any material respect the ability of the Company or any of its
Subsidiaries to compete in any line of business or with any Person or entity or in any geographic area or during any period of time; 

(viii) any partnership, joint venture or similar agreement or arrangement; 

(ix) all agreements obligating the Company or any of its Subsidiaries to make any individual payment in excess of US$25,000, or aggregate
payments in excess of US$250,000, as a result of a change in control; 
 (x) any non-compete, non-solicitation or similar agreement with
any director, officer or employee of the Company or its Subsidiaries; and 
 (xi) any agreement relating to the prospective acquisition or
disposition of any material portion of the businesses of the Company and its Subsidiaries taken as a whole (whether by merger, sale of stock, sale of assets or otherwise). 

(b) Except as would not prevent or materially delay consummation of the Offer or the Closing or would not have a Material
Adverse Effect, (i) each Material Contract is a legal, valid and binding obligation of the Company or a Subsidiary of the Company, the Company or a Subsidiary of the Company, as the case may be, is not in material default under any Material
Contract, and none of the Material Contracts has been canceled by the other party, (ii) to the knowledge of the Company, no other party is in breach or violation of, or default under, any Material Contract, (iii) the Company and its
Subsidiaries are not in receipt of, nor has the Company or any of its Subsidiaries sent, any written claim of default under any Material Contract and (iv) neither the execution of this Agreement nor the consummation of the Offer or the Closing
shall constitute a default, give rise to cancellation rights, or otherwise adversely affect any rights under any Material Contract. 

SECTION 4.18. Insurance. The Company and its Subsidiaries maintain and have since May 17, 2007 maintained with the insurers listed
in Section 4.18 of the Disclosure Schedule insurance with respect to their assets, employees, officers and directors (or equivalent) and business, in such amounts and against such losses and risks as is customarily carried by Persons engaged in
the same or similar business and as is required under the terms of any applicable Leases or other contractual obligations. Except as disclosed on Section 4.18 of the Disclosure Schedule, no insurer (a) has questioned, denied or disputed
coverage of any claim pending under any insurance policy or (b) has threatened to cancel any insurance policy. 

  
 29 

 SECTION 4.19. Regulatory Compliance. 

(a) Since May 17, 2007, neither the Company nor any of its Subsidiaries has voluntarily or involuntarily initiated,
conducted, or issued any recall, market withdrawal, safety alert, warning, “dear doctor” letter, investigator notice, or other notice relating to an alleged material lack of safety or efficacy of any manufactured, packaged, labeled,
imported, exported, stored, distributed, sold (whether or not for consideration), advertised or marketed product of the Company or any of its Subsidiaries. Neither the Company nor any of its Subsidiaries are currently contemplating such actions.

 (b) Except as would not have a Material Adverse Effect, to the knowledge of the Company, all material approvals,
registrations, authorizations, clearances, reports, documents, claims and notices required to be filed, maintained, or furnished to any Governmental Authority by the Company or any of its Subsidiaries with respect to products that are currently
manufactured, packaged, labeled, imported, exported, stored, distributed, sold (whether or not for consideration), advertised or marketed have been so filed, maintained or furnished and were complete and correct in all material respects on the date
filed (or were corrected in or supplemented by a subsequent filing). 
 (c) The Company and all of its Subsidiaries are in
material compliance with all applicable Laws (including Laws regarding the manufacturing, packaging, labeling, importation, export, storage, distribution, sale, advertising, marketing, pricing of the currently marketed products of the Company),
regulatory or warning letters, notices of adverse findings, and any other similar letters or notices issued by any Governmental Authority as well as with all terms and conditions imposed in any licenses, permits or approvals issued in respect of the
products of the Company. Since May 17, 2007, neither the Company nor any of its Subsidiaries have received notice of any threatened or pending investigation, hearing, finding of deficiency or non-compliance, adverse inspection report, penalty,
fine, sanction, request for recall, relabeling or other remedial action, audit or other regulatory action (other than non-material routine or periodic inspections or reviews) by any Governmental Authority against any of the Company, its Subsidiaries
or, with respect to the currently or heretofore marketed products of the Company, to the knowledge of the Company, any person that manufactures, packages, labels, imports, exports, stores, distributes or sells such products of the Company or its
Subsidiaries pursuant to a commercialization, manufacturing, supply or other collaboration arrangement with the Company or any of its Subsidiaries by any Governmental Authority which would have a Material Adverse Effect. 

(d) The Company and its Subsidiaries have not received any information (e.g., adverse event reports or complaints) and are
otherwise not aware of any information concerning any pending or threatened regulatory action by any Governmental Authority, which would have a Material Adverse Effect. 

(e) To the knowledge of the Company, the manufacture of the currently marketed products of the Company and its Subsidiaries is
being conducted in material compliance with current “good manufacturing practices” as defined by the applicable Governmental Authority. 

  
 30 

 (f) None of the Company, its Subsidiaries or, to the knowledge of the Company,
any of their respective agents or subcontractors, has been convicted of any crime. To the knowledge of the Company, none of the Company, its Subsidiaries or any of their respective agents or subcontractors has engaged in any conduct which would
reasonably be expected to result in debarment or disqualification by any Governmental Authority. There are no proceedings pending or threatened against the Company, its Subsidiaries or, to the knowledge of the Company, any of their respective agents
or subcontractors, that reasonably might be expected to result in criminal liability or debarment or disqualification by any Governmental Authority. 

(g) All studies, tests, and preclinical and clinical trials being conducted by the Company or its Subsidiaries are being
conducted in material compliance with applicable Laws, including “good laboratory practices,” and “good clinical practices,” each as defined by the applicable Governmental Authority. Neither the Company nor its Subsidiaries have
received any written notices from any Governmental Authority requiring the termination or suspension of any clinical trials conducted by the Company or its Subsidiaries since May 17, 2007. 

(h) As at the date of this Agreement, the Company has made available to Buyer copies of all (i) material warning letters
and untitled letters, notices of adverse findings and similar correspondence received since May 17, 2007, (ii) material 483s and other audit reports received since May 17, 2007 and (iii) material documents concerning any material
oral or written communication received from the FDA since May 17, 2007. The Company has provided to Buyer all material FDA correspondence and minutes from meetings with respect to the developmental and material currently marketed products of
the Company and its Subsidiaries, whether in person, by telephone, or otherwise, with FDA since May 17, 2007. 
 SECTION 4.20.
Brokers. No broker, finder or investment banker (other than Goldman Sachs International and Jefferies International Limited) is entitled to any brokerage, finder’s or other fee or commission in connection with the Offer based upon
arrangements made by or on behalf of the Company or any of its Subsidiaries. 
 SECTION 4.21. Opinion of Financial Advisor. The Board
of Directors of the Company has received an oral opinion of Goldman Sachs International (to be confirmed in writing) to the effect that, as of the date of this Agreement, and based upon and subject to the factors and assumptions set forth therein
(a) the Per Share Amount to be paid in the Offer to the holders of Company Shares pursuant to this Agreement is fair to such holders from a financial point of view and (b) the consideration contemplated by Section 2.04 of the
Agreement to be paid to the Company pursuant to the Asset Sale is fair to the Company from a financial point of view. The Special Committee of the Board of Directors of the Company has received an oral opinion of Jefferies International Limited (to
be confirmed in writing) to the effect that, as of the date of this Agreement, and based upon and subject to the factors and assumptions set forth therein (a) the Per Share Amount to be paid in the Offer to the holders of Company Shares (other
than Warburg, Pincus Equity Partners, L.P., Warburg, Pincus Ventures International, L.P., Warburg, Pincus Netherlands Equity Partners I C.V., and Warburg, Pincus Netherlands Equity Partners III C.V. 

  
 31 

 
and their affiliates) pursuant to this Agreement is fair, from a financial point of view, to such holders and (b) the consideration contemplated by Section 2.04 of the Agreement to be
paid to the Company pursuant to the Asset Sale is fair, from a financial point of view, to the Company. 
 ARTICLE V 

REPRESENTATIONS AND WARRANTIES OF PARENT AND BUYER 

Each of Buyer and Parent hereby jointly and severally represents and warrants to the Company that the statements contained in this Article V
are true and correct. 
 SECTION 5.01. Corporate Organization. Each of Buyer and Parent is duly formed, validly existing and (to the
extent the concept of good standing exists in the applicable jurisdiction) in good standing under the Laws of the jurisdiction of its formation and has the requisite power and authority to own, lease and operate its properties and to carry on its
business as it is now being conducted, except where the failure to be so organized, existing and (if applicable) in good standing or to have such power and authority would not prevent or materially delay consummation of the Offer or the Closing.

 SECTION 5.02. Authority Relative to this Agreement. Each of Buyer and Parent has all necessary power and authority to execute and
deliver this Agreement, to perform its obligations hereunder and to consummate the Offer. The execution and delivery of this Agreement by Buyer and Parent and the consummation by Buyer of the Offer have been duly and validly authorized by all
necessary corporate action, and no other corporate proceedings on the part of Buyer and Parent are necessary to authorize this Agreement or to consummate the Offer. This Agreement has been duly and validly executed and delivered by each of Buyer and
Parent and, assuming the due authorization, execution and delivery hereof by the Company, constitutes the legal, valid and binding obligation of each of Buyer and Parent, enforceable against Buyer and Parent in accordance with its terms, except that
(a) such enforcement may be subject to applicable bankruptcy, insolvency, reorganization, moratorium or other similar Laws, now or hereafter in effect, affecting creditors’ rights generally and (b) the remedy of specific performance
and injunctive and other forms of equitable relief may be subject to equitable defenses and to the discretion of the court before which any proceeding therefor may be brought. 

SECTION 5.03. No Conflict; Required Filings and Consents. 

(a) The execution and delivery of this Agreement by each of Buyer and Parent does not, the performance of this Agreement by
Buyer and Parent and the incurrence of Indebtedness as contemplated by the Financing by Buyer will not, (i) conflict with or violate the articles of association, certificate of incorporation or bylaws or equivalent organizational documents of
Buyer and Parent, (ii) conflict with or violate any Laws applicable to Buyer or Parent or by which any property or asset of Buyer or Parent is bound or affected or (iii) result in any breach of or constitute a default (or an event which,
with notice or lapse of time or both, would become a default) under, or give to others any right of termination, amendment, acceleration or cancellation of, or result in the creation of a Lien other than a Permitted Lien

  
 32 

 
pursuant to any material agreement, contract or understanding, except, with respect to clauses (ii) and (iii), for any such conflicts, violations, breaches, defaults or other occurrences
which would not prevent or materially delay consummation of the Offer or the Closing. 
 (b) The execution and delivery of
this Agreement by Buyer and Parent do not, and the performance of this Agreement by Buyer and Parent will not, require any consent, approval, authorization or permit of, or filing with or notification to, any Governmental Authority, except
(i) for applicable requirements, if any, of the Exchange Act, the HSR Act and other Antitrust Laws and (ii) any actions, licenses, consents, permits, orders, approvals or filings the absence of which would not prevent or materially delay
consummation of the Offer or the Closing. 
 SECTION 5.04. Absence of Litigation. There are no Actions pending, or, to the knowledge
of Buyer or Parent, threatened against Buyer, Parent or any of their respective Subsidiaries, or any of the executive officers or directors of Buyer or Parent, except, in each case, for those that do not seek to prevent or that would not be
reasonably likely to delay the consummation of the Offer or the Closing. 
 SECTION 5.05. Financing. At the time of the consummation
of the Offer and assuming the satisfaction of the Offer Conditions, the net proceeds from the Financing will, together with unrestricted cash or cash equivalents available to Buyer, in the aggregate be sufficient for Buyer to (i) pay the
aggregate consideration payable in respect of the Company Shares and in respect of Company Options pursuant to the Offer and this Agreement, (ii) pay or refinance all Company Indebtedness that is required to be paid or refinanced upon
consummation of the Offer pursuant to the Debt Financing Commitments, (iii) pay all fees and expenses incurred by Buyer in connection with this Agreement and the Offer upon the terms and conditions contemplated by this Agreement and
(iv) satisfy all other payment obligations of Buyer and the Company required to be satisfied at the Closing in connection with the consummation of the transactions contemplated hereby. Buyer has delivered to the Company, as of the date of this
Agreement, true, complete and correct copies of (i) executed commitment letters (the “Debt Financing Commitments”), pursuant to which the lender parties thereto and the Investment Banks (as defined in the Debt Financing
Commitments) (together with their respective officers, employees, directors, affiliates, partners, controlling parties, advisors, agents and representatives, the “Financing Sources”) have agreed, subject to the terms and conditions
thereof, to provide or cause to be provided the debt amounts contemplated thereby (which includes up to US$445.0 million in bridge financing (the “Bridge Financing”)) (the “Debt Financing”), and (ii) an
executed equity commitment letter (the “Equity Financing Commitment”, and together with the Debt Financing Commitments, the “Financing Commitments”), pursuant to which TPG Partners V, L.P. and TPG Biotechnology
Partners II, L.P. have committed, subject to the terms and conditions thereof, to invest through Parent the amounts set forth therein (the “Equity Financing”, and together with the Debt Financing, the “Financing”).
The Financing Commitments are in full force and effect as of the date of this Agreement, and are legal, valid and binding obligations of Parent or Axcan Intermediate Holdings Inc. (“Borrower”), as applicable, and, to the knowledge
of Buyer, the other parties thereto. As of the date hereof, no 

  
 33 

 
amendment or modification of the Financing Commitments has been made and the respective commitments contained in the Financing Commitments have not been withdrawn, terminated or rescinded in any
respect. Borrower has fully paid any and all commitment fees or other fees in connection with the Debt Financing Commitments that are payable on or prior to the date hereof. As of the date hereof, there are no side letters or other agreements,
contracts or arrangements (except for customary fee letters and engagement letters, true and correct copies of which have been furnished to the Company, in redacted form in the case of the fee letters) relating to the Financing other than the
Financing Commitments. There are no conditions precedent or other contingencies related to the funding of the full amount of the Financing other than as expressly set forth in the Financing Commitments. As of the date of this Agreement, assuming the
accuracy of the representations and warranties of the Company set forth in Article IV hereof, no event has occurred which, with or without notice, lapse of time or both, would constitute a default or breach on the part of Buyer, Parent or any holder
of equity interests in Parent under any term of the Financing Commitments, or a failure of any condition of the Financing Commitments or would otherwise be reasonably likely to result in any portion of the Financing contemplated thereby to be
unavailable. 
 SECTION 5.06. Lack of Ownership of Shares. None of Buyer, Parent, any director or officer of Parent, any Person
controlled by Parent, or any “associate” (as such term is defined in Rule 12b-2 under the Exchange Act) of Buyer beneficially owns any Company Shares or other securities convertible into, exchangeable into or exercisable for Company
Shares. Except as contemplated by this Agreement and except for the tender agreements entered into by Buyer with the Persons listed in Schedule 5.06 in connection with the transactions contemplated hereby, there are no voting trusts or other
agreements or understandings to which Buyer, Parent, any director or officer of Parent, any Person controlled by Parent, or any “associate” of Buyer is a party with respect to the voting of the capital stock or other equity interest of the
Company or any of its Subsidiaries. 
 SECTION 5.07. Brokers. No broker, finder or investment banker (other than Bank of America
Merrill Lynch) is entitled to any brokerage, finder’s or other fee or commission in connection with the Offer based upon arrangements made by or on behalf of Buyer or Parent. 

SECTION 5.08. Solvency. Assuming satisfaction of the Offer Conditions and that any estimates, projections or forecasts of the Company
and its Subsidiaries have been prepared in good faith based upon assumptions that were and continue to be reasonable as of the Closing, and after giving effect to the transactions contemplated by this Agreement, including the Financing and the
consummation of the Offer at the Acceptance Time, any repayment or refinancing of debt contemplated in this Agreement or the Financing Commitments, payment of all amounts required to be paid in connection with the consummation of the transactions
contemplated hereby, and payment of all related fees and expenses, Buyer will be Solvent as of the Acceptance Time and immediately after the consummation of the transactions contemplated hereby. For the purposes of this Agreement, the term
“Solvent” when used with respect to any Person, means that, as of any date of determination (a) the amount of the “fair saleable value” of the assets of such Person will, as of such date, exceed (i) the value of
all “liabilities of such 

  
 34 

 
Person, including contingent and other liabilities,” as of such date, as such quoted terms are generally determined in accordance with applicable Laws governing determinations of the
insolvency of debtors, and (ii) the amount that will be required to pay the probable liabilities of such Person on its existing debts (including contingent and other liabilities) as such debts become absolute and mature, (b) such Person
will not have, as of such date, an unreasonably small amount of capital for the operation of the businesses in which it is engaged or proposed to be engaged following such date, and (c) such Person will be able to pay its liabilities, including
contingent and other liabilities, as they mature. For purposes of this definition, “not have an unreasonably small amount of capital for the operation of the businesses in which it is engaged or proposed to be engaged” and “able
to pay its liabilities, including contingent and other liabilities, as they mature” means that such Person will be able to generate enough cash from operations, asset dispositions or refinancing, or a combination thereof, to meet its
obligations as they become due. 
 SECTION 5.09. SEC Filings; Financial Statements. 

(a) All forms, reports, statements and other documents filed by Borrower with the SEC pursuant to the Securities Act and the
Exchange Act since January 1, 2008 (collectively, the “Buyer SEC Reports”) (i) complied, at the time they were filed, as to form in all material respects with the applicable requirements of the Securities Act or the
Exchange Act and (ii) did not, at the time they were filed, or, if amended, as of the date of such amendment, contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order
to make the statements made therein, in the light of the circumstances under which they were made, not misleading. 
 (b) The
condensed consolidated financial statements (including, in each case, any notes thereto) contained in the Buyer SEC Reports when filed complied as to form in all material respects with the published rules and regulations of the SEC with respect
thereto, were prepared in accordance with GAAP applied on a consistent basis throughout the periods indicated (except as may be indicated in the notes thereto) and each fairly presents, in all material respects, the consolidated financial position,
results of operations and cash flows of Borrower as at the respective dates thereof and for the respective periods indicated therein (subject, in the case of unaudited statements, to normal and recurring
year-end adjustments) in accordance with GAAP. 
 ARTICLE VI 

CONDUCT OF BUSINESS PENDING THE CLOSING 

SECTION 6.01. Conduct of Business by the Company Pending the Closing. Between the date hereof and the earlier of (i) the Closing
or (ii) the termination of this Agreement, (A) the Company shall cause the businesses of the Company and its Subsidiaries to be conducted only in the ordinary course of business and in a manner consistent with past practice, and the
Company shall not, and shall cause its Subsidiaries not to, take any action except in the ordinary course of business and in a manner consistent with past practice and (B) the Company shall use its

  
 35 

 
reasonable best efforts to preserve substantially intact the business organization of the Company and its Subsidiaries and maintain existing relations and goodwill with Governmental Authorities,
customers, suppliers, employees and business associates, other than, in the case of clauses (A) and (B), as (1) required or expressly contemplated by this Agreement, (2) set forth in Schedule 6.01, (3) required under applicable
Laws, or (4) consented to in writing by Buyer, which consent shall not be unreasonably withheld, conditioned or delayed. By way of amplification and not limitation, neither the Company nor any of its Subsidiaries shall, between the date hereof
and the earlier of (I) the Closing or (II) the termination of this Agreement, directly or indirectly, do any of the following, except as (w) required or expressly contemplated by this Agreement, (x) set forth in Schedule 6.01,
(y) required under applicable Laws, or (z) consented to in writing by Buyer, which consent shall not be unreasonably withheld, conditioned or delayed: 

(a) issue, sell or contract for the issuance or sale, of any of the capital stock of the Company or any securities convertible
into or exchangeable for shares of capital stock of the Company or any securities, warrants, options or rights to purchase any of the foregoing, other than (i) Company Option grants to new employees in the ordinary course and in a manner
consistent with past practices, provided that the award agreements for Company Options issued on or after date hereof shall provide that the Company Options will not accelerate and vest in connection with the transaction contemplated by this
Agreement and that such Company Options will be canceled in accordance with Section 2.03 or (ii) pursuant to the exercise of Company Options; 

(b) other than as contemplated by Section 2.03, amend the terms of any outstanding security or option; 

(c) purchase or redeem any shares of capital stock of the Company other than the purchase or redemption of shares of capital
stock of the Company from a holder of an option outstanding on the date hereof in connection with the satisfaction of Tax withholding obligations or the payment of the exercise price thereof; 

(d) split, combine or reclassify any shares of the Company’s capital stock; 

(e) form any Subsidiary or enter into any joint venture or partnership; 

(f) declare, set aside, make or pay any dividend or other distribution, payable in cash, stock or other securities, property or
otherwise, with respect to any of the Company’s capital stock; 
 (g) amend any of the charter documents, bylaws or
other organizational documents of the Company or any of its material Subsidiaries; 
 (h) transfer, lease or license to any
third party, or materially encumber, any material assets of the Company or any of its Subsidiaries, except in the ordinary course of business consistent with past practice; 

  
 36 

 (i) enter into, materially amend or terminate any Material Contract or waive,
release or assign any material rights or claims under any Material Contract, except in the ordinary course of business and in a manner consistent with past practice; 

(j) enter into any agreement or arrangement that limits or otherwise restricts in any material respect the Company or any of
its Subsidiaries or any successor thereto or that would, after the Closing, limit or restrict in any material respect the Company or any of its Subsidiaries, from competing in any manner that is material to the Company in any location or with any
Persons; 
 (k) incur Indebtedness, other than Indebtedness not in excess of US$250,000 in any three month period after the
date hereof; 
 (l) grant any Lien upon any of its material assets other than Permitted Liens and to secure any permitted
Indebtedness; 
 (m) acquire any Person or property for a purchase price exceeding US$250,000 individually or US$500,000 in
any three month period after the date hereof, except for acquisitions of property in the ordinary course of business consistent with past practice; 

(n) make any capital expenditure exceeding US$250,000 individually or US$500,000 in any three month period after the date
hereof, except in the ordinary course of business to maintain and operate manufacturing facilities in an efficient manner consistent with past practices; 

(o) settle (i) any material litigation, investigation, arbitration, proceeding, or other material claim involving or
against the Company or any of its Subsidiaries, (ii) any stockholder litigation or dispute against the Company or any of its officers or directors, or (iii) any legal proceeding or dispute that relates to the transactions contemplated
hereby; 
 (p) fail to maintain any Company Registered Intellectual Property in the ordinary course of business consistent
with past practices; 
 (q) except as required by the terms of a Plan in effect on the date hereof or as required pursuant to
applicable Laws, (i) increase compensation, bonuses or other benefits payable to any director, employee or independent contractor of the Company or any Subsidiary or (ii) enter into, adopt or amend in any material respect any employment,
change of control, severance, compensation, retention, bonus, profit-sharing, stock option or other stock related rights or other forms of incentive or deferred compensation, retirement benefits or other benefit agreement, plan, arrangement or
policy applicable to any director, employee or independent contractor of the Company or any Subsidiary; 
 (r) change any of
the accounting methods used by the Company or any of its Subsidiaries (or change an annual accounting period), unless required by generally accepted accounting principals of relevant jurisdictions or applicable Law (in which case prompt written
notice shall be provided to Buyer prior to such change); 

  
 37 

 (s) change any Tax accounting period, make, change or revoke any material Tax
election, adopt or change any Tax accounting method, file any amended Tax Return, settle a material Tax claim or assessment or surrender any claim for a refund of a material amount of Taxes, enter into any closing agreement relating to Taxes, or
waive or extend any statute of limitations in respect of Taxes, in each case, relating to the Company or its Subsidiaries, unless required by GAAP or applicable Law (in which case prompt written notice shall be provided to Buyer); 

(t) sell or lease any of the Real Property or modify, amend, terminate or waive any material rights under any material Lease;

 (u) except as may be required by applicable Law, enter into any collective bargaining agreement or other agreement with a
labor union, works council or other employee representative; 
 (v) adopt a plan of complete or partial liquidation,
dissolution, merger, consolidation, restructuring, recapitalization or other reorganization of the Company or any of its Subsidiaries; or 

(w) agree to do any of the foregoing. 

ARTICLE VII 
 ADDITIONAL
AGREEMENTS 
 SECTION 7.01. Appropriate Action; Consents; Filings. 

(a) Subject to the terms and conditions of this Agreement, the Company, Buyer and Parent shall use their reasonable best
efforts to (i) take, or cause to be taken, all appropriate action, and do, or cause to be done, all things necessary, proper or advisable under applicable Laws or otherwise to consummate the Offer, the Closing and the Post-Closing
Reorganization (including the actions and transactions contemplated by the Stockholder Approvals) as promptly as practicable, (ii) obtain the Company Required Approvals; provided that Buyer, Parent and the Company shall cooperate with
each other in connection with the making of all such filings, including providing copies of all such documents to the non-filing party and its advisors prior to filing, and incorporating all reasonable additions, deletions or changes suggested by
the other party in connection therewith. Buyer, Parent and the Company shall furnish to each other all information required for any application or other filing to be made pursuant to the rules and regulations of any applicable Laws in connection
with the transactions contemplated by this Agreement. 

  
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 (b) Each of Buyer, Parent and the Company shall give (or shall cause its
respective Subsidiaries to give) any required notices to third parties, and use, and cause its respective Subsidiaries to use, their reasonable best efforts to obtain the third party consents listed on Schedule 7.01(b). 

(c) From the date of this Agreement until the Closing, each party shall promptly notify the other party in writing of any
pending or, to the knowledge of the first party, threatened Action or investigation by any Governmental Authority or any other Person (i) challenging or seeking material damages in connection with the Offer, the Closing or the Post-Closing
Reorganization (including the actions and transactions contemplated by the Stockholder Approvals) or (ii) seeking to restrain or prohibit the consummation of the Offer, the Closing or the Post-Closing Reorganization (including the actions and
transactions contemplated by the Stockholder Approvals) or otherwise limit the right of Buyer or Parent or, to the knowledge of such party, Subsidiaries of Buyer or Parent to own or operate all or any portion of the businesses or assets of the
Company or its Subsidiaries. 
 (d) Each party shall use its reasonable best efforts to file the appropriate
“Notification and Report Form” pursuant to the HSR Act with respect to the transactions contemplated hereby as promptly as the parties agree is advisable after the date hereof and, in any event, within 15 days after the date hereof, unless
the parties mutually agree to a later date, and to supply promptly any additional information and documentary material that may be requested pursuant to the HSR Act. In addition, each party shall promptly, and prior to the expiration of any legal
deadline, make any other filing that may be required under any other applicable Antitrust Laws. Each party shall bear its respective filing fees associated with the HSR filings and any other filings required under any other applicable Antitrust
Laws. Buyer, Parent and the Company shall, and shall instruct their respective counsel to, cooperate with each other and use their reasonable best efforts, in consultation with one another, to facilitate and expedite the HSR process and the
identification and resolution of any issues relating to the HSR filings and any other filings under any other applicable Antitrust Laws (including, meeting (either in person or by telephone) with the other party as promptly as practicable after the
date hereof to determine when to file the appropriate “Notification and Report Form” pursuant to the HSR Act, keeping each other appropriately informed of, and promptly providing each other copies of, all communications from and to
personnel of the reviewing antitrust authority, conferring regularly with each other regarding appropriate contacts with and response to personnel of said antitrust authority, including attending meetings, promptly furnishing to the other such
information and assistance as the other may reasonably request in connection with its preparation of any notifications or other submissions to Governmental Authorities, and permitting the other party to review, and incorporating the other
party’s reasonable comments, in any communication to be given by it to any Governmental Authority with respect to obtaining the necessary approvals for the transactions contemplated by this Agreement) and, consequently, facilitate expiration of
the applicable HSR Act waiting period and obtain clearance under any other applicable Antitrust Laws at the earliest practicable date. In all cases Buyer shall be entitled to direct the antitrust defense of the transactions contemplated by this
Agreement in any investigation or litigation by, or negotiations with, any 

  
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Governmental Authority or other Person relating to the Offer or regulatory filings under applicable Antitrust Laws, including any communications with any Governmental Authority relating to any
contemplated or proposed Divestiture Action. Subject to applicable legal limitations and the instructions of any Governmental Authority, the parties agree that they shall consult with each other in advance of and not participate in any meeting or
discussion expected to address substantive matters related to the transactions contemplated hereby, either in person or by telephone, with any Governmental Authority in connection with the proposed transactions unless, to the extent not prohibited
by such Governmental Authority, it gives the other party the opportunity to attend and observe; provided that, Buyer and Parent shall have no obligation to include the Company in any meeting or discussion with any Governmental Authority
relating to any contemplated or proposed Divestiture Action, only, in each case, following receipt of the prior consent of the Special Committee of the Board; provided, however, that Buyer or Parent shall provide the Company with a
summary of any such meeting or discussion. 
 (e) Notwithstanding anything in this Section 7.01 to the contrary, in
connection with obtaining clearance or any approval of any antitrust authority under the HSR Act or any other Antitrust Laws or the expiration of any waiting period thereunder, Buyer and Parent shall not, and shall not be required to cause any of
their respective Subsidiaries to, (i) sell or otherwise dispose of, or hold separate or agree to sell or otherwise dispose of, assets, categories of assets or businesses; (ii) terminate existing relationships, contractual rights or
obligations; (iii) terminate any venture or other arrangement; (iv) create any relationship, contractual right or obligation or (v) effectuate any other change or restructuring (or, in each case, enter into agreements or stipulate to
the entry of an order or decree or file appropriate applications with any antitrust authority in connection with any of the foregoing) (each a “Divestiture Action”). At the written request of Buyer, the Company shall, and shall
cause its Subsidiaries to, consummate a Divestiture Action in connection with obtaining clearance from or approval of any Governmental Authority under applicable Antitrust Laws; provided that, without the consent of the Company, no such
Divestiture Action will be effective prior to the Closing. Subject to Buyer’s right to direct the antitrust defense of the transactions contemplated by this Agreement, (i) in the event that any action is threatened or instituted
challenging the Offer as violative of the HSR Act or any other Antitrust Laws, the Company, Buyer and Parent shall use their reasonable best efforts to avoid or resolve such action, and (ii) in the event that any permanent or preliminary
injunction or other order is entered or becomes reasonably foreseeable to be entered in any proceeding that would make consummation of the transactions contemplated hereby, including the Offer, in accordance with the terms of this Agreement unlawful
or that would restrain, enjoin or otherwise prevent or materially delay the consummation of the transactions contemplated by this Agreement, the Company, Buyer and Parent shall use their reasonable best efforts to vacate, modify or suspend such
injunction or order so as to permit such consummation. The parties shall take reasonable efforts to share information protected from disclosure under the attorney-client privilege, attorney work product immunity, joint defense privilege or any other
privilege pursuant to this section so as to preserve any applicable privilege. 

  
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 (f) The Company, Buyer and Parent shall not take any action with the intention to
hinder or delay the obtaining of clearance or any necessary approval of any antitrust authority under the HSR Act or any other Antitrust Laws or the expiration of the required waiting period thereunder; provided that Buyer may withdraw the
filing of its Notification and Report Form pursuant to the HSR Act if, in the good faith judgment of the board of directors of Buyer, such withdrawal is unlikely to delay in any material respect consummation of the Offering. 

SECTION 7.02. Access to Information; Confidentiality. 

(a) From the date hereof until the Closing, the Company shall, and shall cause its Subsidiaries and the officers, directors,
employees, auditors and agents of the Company and its Subsidiaries to, afford the officers, employees and agents of Buyer reasonable access at all reasonable times to the officers, agents, properties, offices, plants and other facilities, books and
records of the Company and each of its Subsidiaries, and shall furnish Buyer with such financial, operating and other data and information as Buyer, through their officers, employees or agents, or the Access Parties may reasonably request; provided,
however, (i) that the officers, employees and agents of Buyer, and the Access Parities, shall not be permitted to conduct invasive environmental investigation or testing at any properties, offices, plants and other facilities at which the
Company conducts or has conducted operations and (ii) that the Company may restrict the foregoing access and information to the extent that the Company, in its reasonable judgment, determines that not doing so would (A) violate applicable
Laws, (B) result in a risk of the loss of attorney-client privilege with respect to such information provided that the Company shall use reasonable best efforts to disclose such information in a way that would not waive such privilege, or
(C) result in a violation of an agreement to which the Company or any of its Subsidiaries is a party; provided that the Company shall use reasonable best efforts to give prompt notice to Buyer any time the Company restricts access or
information pursuant to sub-clauses (ii)(A), (ii)(B) or (ii)(C). Any investigation pursuant to this Section 7.02 shall be conducted in a manner as not to interfere unreasonably with the conduct of the business of the Company or its
Subsidiaries. 
 (b) With respect to all information furnished by or on behalf of the Company to Buyer or any of its
representatives or agents under this Agreement, Buyer shall comply with, and shall cause its representatives and agents to comply with, all of their respective obligations under the Nondisclosure Agreement relating thereto. 

SECTION 7.03. No Solicitation of Transactions. 

(a) Subject to Section 7.03(c)(i), the Company will not, and (A) will cause its Subsidiaries and its and their
respective officers, directors and employees, and (B) will use its reasonable best efforts to cause its and its Subsidiaries respective investment bankers, attorneys and other representatives and agents retained by the Company or any of its
Subsidiaries not to (i) solicit, initiate or knowingly encourage the making of any Acquisition Proposal or any inquiries that would reasonably be expected to lead to any Acquisition Proposal; (ii) engage in negotiations or discussions
with, or furnish any information or data to, 

  
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any Person relating to an Acquisition Proposal; (iii) enter into any agreement or agreement in principle with respect to any Acquisition Proposal or waive any standstill provision; or
(iv) otherwise cooperate with or assist or participate in, or knowingly facilitate any Acquisition Proposal or any inquiry that would reasonably be expected to lead to an Acquisition Proposal. Promptly following the execution of this Agreement,
the Company shall, and shall direct or cause its Subsidiaries and its and their officers, directors, employees and investment bankers, attorneys and other representatives and agents to, immediately cease and cause to be terminated any discussions or
negotiations with any parties that may be ongoing with respect to any Acquisition Proposal as of the date hereof; provided, however, that the obligations set forth in this Section 7.03(a) shall not prohibit the Company from
entertaining an Acquisition Proposal in accordance with Section 7.03(c)(i) that may be made by any such Person after the date hereof, provided, further, that the Company’s release or waiver, in response to an unsolicited
inquiry, of any “standstill” to which it is a party shall not violate this Section 7.03(a). 
 (b) Subject to
Section 7.03(c)(ii), neither the Board nor any committee thereof shall (i) withdraw or modify in a manner adverse to Buyer, the approval or recommendation by the Board or any committee of the Board, of the Offer or this Agreement, or
(ii) approve or recommend any Acquisition Proposal of any Person other than Buyer. It being understood that a “stop, look and listen” statement or similar communication of the type contemplated by Rule 14d-9(f) under the Exchange Act
shall not be deemed a breach of this Section 7.03(b). 
 (c) Notwithstanding any other provision of this Agreement: 

(i) the Company and the Board may participate in discussions or negotiations with or furnish information to any Person if either (A) the
Board determines in good faith, after consultation with its financial advisors, that such Person is reasonably likely to submit to the Company an Acquisition Proposal that is a Superior Proposal, or (B) the Board determines in good faith, after
consultation with its legal counsel, that the failure to participate in such discussions or negotiations or to furnish such information would constitute a breach of the directors’ fiduciary duties under applicable Laws of The Netherlands;
provided that any such Person to whom information is furnished shall be required to execute a confidentiality agreement with the Company on terms no less favorable in the aggregate to the Company than those contained in the Nondisclosure
Agreement, except that such confidentiality agreement (x) may contain a less restrictive or no standstill restriction and may specifically release such Person from any existing standstill restriction, and (y) shall expressly not prohibit,
or adversely affect the rights of the Company thereunder upon, compliance by the Company with any provision of this Agreement; and 
 (ii)
the Board may be permitted to (A) withdraw or modify in a manner adverse to Buyer, its approval or recommendation of the Offer or this Agreement and make disclosure thereof to the holders of Company Shares, (B) take and disclose to the
holders of Company Shares a favorable position with respect to a Superior Proposal (each a “Change in Recommendation”) or (C) make “stop, look and listen” statements or similar communications of

  
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the type contemplated by Rule 14d-9(f) under the Exchange Act or disclosure in favor of the Offer to the holders of Company Shares, in each case either with respect to or as a result of a
Superior Proposal, if the Board determines in good faith, after consultation with its legal counsel, that the failure to take such action would constitute a breach of the Company’s disclosure obligations or the directors’ fiduciary duties
under applicable Laws of The Netherlands, as applicable; provided, however, that the Board shall not be entitled to make a Change in Recommendation until three full business days following delivery of written notice to Buyer (a
“Section 7.03(c)(ii) Notice”) from the Board advising Buyer that the Board intends to take such action, including the identity of the Person making the Superior Proposal, a description of the terms and conditions of any such
Superior Proposal and a copy of the proposed transaction agreement for any such Superior Proposal in the form to be entered into (it being understood and agreed that, in the event of an amendment to the financial terms or other material terms of
such Superior Proposal, the Board shall not be entitled to exercise such right based on such Superior Proposal, as so amended, until three full business days following delivery of written notice to Buyer of a Section 7.03(c)(ii) Notice with
respect to such Superior Proposal as so amended). In determining whether to terminate this Agreement in response to a Superior Proposal or to make a Change in Recommendation, the Board shall take into account any proposals made by Buyer to amend the
terms of this Agreement. 
 (d) Subject to the foregoing, the Company shall promptly (and in any event within two calendar
days) notify Buyer after receipt of any Acquisition Proposal or any request for nonpublic information relating to the Company in connection with an Acquisition Proposal or for access to the properties, books or records of the Company by any Person
that informs the Board that it is considering making, or has made, an Acquisition Proposal. Such notice to Buyer shall indicate in reasonable detail the identity of the offeror and the terms and conditions of such proposal, offer or request. 

(e) For purposes of this Agreement, a “Superior Proposal” means any Acquisition Proposal, not solicited or
initiated in violation of this Section 7.03, made by a Person other than Buyer, Parent or any affiliate of the Company which the Board determines in good faith, after consultation with its financial advisor, to be more favorable to the Company
and its stakeholders than the transactions contemplated by this Agreement. For purposes of the definition of Superior Proposal, the term “Acquisition Proposal” shall have the meaning assigned to such term in Section 1.01, except that
all references to 25% therein shall be deemed to be references to 50%. 
 SECTION 7.04. Directors’ and Officers’
Indemnification and Insurance. 
 (a) For six years from and after the date of the Closing, the indemnification
provisions then set forth in the articles of association of the Company shall not be amended, repealed or otherwise modified in any manner that would affect adversely the rights thereunder of individuals who, at or prior to the Closing, were
directors, officers or Key Employees of the Company or any of its Subsidiaries, unless such modification shall be required by applicable Laws. 

  
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 (b) From and after the Closing, Buyer and the Company shall jointly and
severally, to the fullest extent permitted under applicable Laws, indemnify, defend and hold harmless, each present and former director, officer or Key Employee of the Company or any of its Subsidiaries (collectively, the “Indemnified
Parties”) against any costs or expenses (including reasonable attorneys’ fees), judgments, fines, losses, claims, damages, liabilities and amounts paid in settlement in connection with any actual or threatened claim, action, suit,
proceeding or investigation, whether civil, criminal, administrative or investigative, (i) arising out of or pertaining to the Offer or this Agreement or (ii) otherwise with respect to any acts or omissions or any alleged acts or omissions
occurring prior to, on or after the Closing, in each case to the same extent and subject to any limitations as provided in the Company’s articles of association or any agreement set forth in Schedule 7.04(b) as in effect on the date hereof, in
each case for a period of six years after the date hereof. From and after the Closing, in the event of any such claim, action, suit, proceeding or investigation brought against any Indemnified Party (other than in the case of sub-clause
(B) below by Buyer, Parent or the Company), to the same extent and subject to any limitations provided in any such articles of association or agreement set forth in Schedule 7.04(b) (A) Buyer or the Company, as the case may be, shall pay
the reasonable fees and expenses of counsel selected by the Indemnified Parties and (B) Buyer and the Company shall cooperate in the defense of any such matter as reasonably requested by such Indemnified Party, and without Buyer, Parent and/or
the Company, as the case may be, being required to disclose any information or materials protected by attorney-client privilege, attorney work product doctrine or other immunities from disclosure; provided, however, that neither Buyer
nor the Company shall be liable for any settlement effected without the written consent of Buyer or the Company (which consent shall not be unreasonably conditioned, withheld or delayed); provided further, that in the event that any
claim for indemnification is asserted or made within such six-year period, all rights to indemnification in respect of such claim shall continue until the disposition of such claim. 

(c) From and after the Closing, Buyer shall cause the Company to maintain in effect for six years from the Closing, the current
directors’ and officers’ liability insurance policies maintained by the Company with respect to matters occurring prior to the Closing; provided that the Company may substitute therefor a policy or policies of at least the same
coverage containing terms and conditions that in the aggregate are not materially less favorable; provided further, that in no event shall the Company be required to expend pursuant to this Section 7.04(c) more than an amount
equal to 250% of current annual premiums paid by the Company for such insurance. 
 (d) From and after the Closing, Buyer and
the Company jointly and severally agree to pay all expenses, including reasonable attorneys’ fees, that may be incurred by the Indemnified Parties in enforcing the indemnity and other obligations provided for in this Section 7.04. 

(e) The provisions of this Section 7.04, (i) are intended to be for the benefit of, and will be enforceable by, each
Indemnified Party, his or her heirs and his or her representative or agent and (ii) are in addition to, and not in substitution for, any other rights to indemnification or contribution that any such person may have by contract or otherwise.

  
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 (f) In the event Buyer or the Company or any of their respective successors or
assigns (i) consolidates with or merges into any other Person and shall not be the continuing or surviving corporation or entity of such consolidation or merger or (ii) transfers all or substantially all of its properties and assets to any
Person, then, and in each such case, proper provision shall be made so that the successors and assigns of Buyer or the Company, as the case may be, shall assume the obligations set forth in this Section 7.04. 

(g) The rights and obligations under this Section 7.04 shall survive consummation of the Offer and the Closing and shall
not be terminated or amended in a manner that is adverse to any Indemnified Party without the written consent of such Indemnified Party; provided that if this Agreement is terminated prior to the Closing in accordance with Section 8.01,
this Section 7.04 shall not survive and shall be of no further effect. It is expressly agreed that the Indemnified Parties to whom this Section 7.04 applies shall be third party beneficiaries of this Section 7.04 and shall be entitled
to enforce the covenants and agreements contained herein. 
 SECTION 7.05. Notification of Certain Matters. From and after the date
of this Agreement until the earlier to occur of (i) the Closing and (ii) the termination of this Agreement pursuant to Section 8.01, the Company shall give prompt notice to Buyer, and Buyer shall give prompt notice to the Company, of
(a) the occurrence, or non-occurrence, of any event the occurrence, or non-occurrence, of which would be likely to cause any condition to the obligations of the
other party to consummate the Offer and other the transactions contemplated by this Agreement not to be satisfied, and (b) any failure of the Company, Buyer or Parent, as the case may be, to comply with or satisfy any covenant or agreement to
be complied with or satisfied by it hereunder that would reasonably be expected to result in any condition to the obligations of the other party to consummate the Offer and the other the transactions contemplated by this Agreement not to be
satisfied; provided, however, that the delivery of any notice pursuant to this Section 7.05 shall not cure any breach of any representation or warranty, the failure to comply with any covenant, the failure to meet any condition or
otherwise limit or affect the remedies available hereunder to the party receiving such notice. 
 SECTION 7.06. Public Announcements.
No public release or announcement concerning the Offer or this Agreement shall be issued by either party without the prior consent of the other party (which consent shall not be unreasonably conditioned, withheld or delayed), except as such release
or announcement may be required by applicable Laws, stock exchange or self-regulatory organization, in which case the party required to make the release or announcement shall use its reasonable best efforts to allow the other party reasonable time
to comment on such release or announcement in advance of such issuance. 

  
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 SECTION 7.07. Comparability of Employee Benefits. 

(a) For the one (1) year period following the date of the Closing, Buyer shall provide, or shall cause the relevant
Subsidiary of Buyer to provide, all individuals who are employees of the Company or any of its Subsidiaries immediately prior to the Closing, and whose employment by Buyer or a Subsidiary of Buyer continues following the Closing (the
“Assumed Employees”) with compensation and employee benefits (excluding equity or other incentive compensation) that are substantially comparable to those received by the Assumed Employees prior to the Closing. Following the
Closing, each Assumed Employee shall receive service credit under the employee benefit plans of Buyer and its Subsidiaries, for purposes of eligibility to participate and vesting (but not for benefit accrual purposes) for their service with the
Company and its Subsidiaries prior to the Closing. Each Assumed Employee shall also receive service credit for purposes of calculating the levels of benefits with respect to severance, vacation, personal days off and any other welfare-type benefits
where service is a factor in calculating benefits. Buyer and the Company will also cause all (i) pre-existing conditions and proof of insurability provisions for all conditions that all Assumed Employees and their covered dependents have as of
the Closing and (ii) waiting periods under each benefit plan that would otherwise be applicable to newly hired employees to be waived to the same extent waived or satisfied under the Plans. In addition, Buyer and the Company will honor or cause
to be honored any deductible, co-payment and out-of-pocket maximums incurred by Assumed Employees and their covered dependents under the Plans during the portion of the applicable plan year prior to the date of the Closing in satisfying any
deductibles, co-payments or out-of-pocket maximums under any plans of Buyer or the Company in which they are eligible to participate after the Closing for such plan year. Notwithstanding anything in this Section 7.07 to the contrary, none of
the provisions contained in this Section 7.07 shall operate to duplicate any benefit provided to any Assumed Employee. 

(b) Buyer and the Company will give each Assumed Employee credit, for purposes of Buyer’s and the Company’s vacation
and/or other paid leave benefit programs, for such Assumed Employee’s accrued and unpaid vacation and/or paid leave balance as of the Closing. 

(c) Notwithstanding anything herein to the contrary, the Assumed Employees shall be eligible to participate in Buyer’s
severance plan to the same extent as similarly-situated employees of Buyer in the same jurisdiction as such Assumed Employees; provided, that this provision shall not apply to the extent that an Assumed Employee is entitled to severance payments or
benefits pursuant to applicable Law. 
 (d) Those executive officers and other employees of the Company eligible to receive
bonus payments under the Company MBO Bonus Program shall receive, immediately prior to the Closing, (i) bonus payments for fiscal year 2010 in the amounts set forth on Schedule 7.07(d) and labeled “2010” to the extent such amounts have not
previously been paid, and (ii) pro rata bonus payments for fiscal year 2011 in an amount equal to the amounts set forth on Schedule 7.07(d) and labeled “2011” multiplied by a fraction, the numerator of which is the number of days in
2011 preceding and including the date of the Closing and the denominator of which is 365. 

  
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 (e) Buyer and the Company acknowledge and agree that the consummation of the
Offer shall constitute a “Change in Control” as defined in the executive change in control agreements and retention plan agreements (collectively, “Executive Agreements”) entered into between the Company and certain of its
employees (all of the employees covered by any of the foregoing agreements, the “Covered Employees”) (all of such Executive Agreements and Covered Employees being listed in Schedule 7.07(e)), and that upon and following the
consummation of the Offer, the Covered Employees shall have the rights and the Company shall have the obligations arising under such Executive Agreements upon a “Change in Control.” 

(f) Nothing in this Section 7.07, express or implied, is intended to confer upon any person not a party hereto any right,
benefit or remedy of any nature whatsoever, including any right to employment or continued employment for any period of time by reason of this Agreement, or any right to a particular term or condition of employment. Notwithstanding anything to the
contrary contained in this Agreement, no provision of this Agreement is intended to, or does, constitute the establishment of, or an amendment to, any Plan or any other employee benefit plan of the Company, Buyer or any of respective Subsidiaries or
will limit the rights of Buyer, the Company or their respective Subsidiaries to amend, terminate, or otherwise modify any benefit plan of Buyer, the Company or their respective Subsidiaries following the Closing. 

(g) The Company will, and will cause its Subsidiaries to, comply with any required notifications to, and any required
consultation with, the employees, employee representatives, works council, unions, labor boards and relevant labor Governmental Authorities in respect of the transactions contemplated hereby with respect to employees of the Company and its
Subsidiaries. 
 (h) The Company shall, at or prior to the Closing, award to employees bonuses under its Transaction Bonus
Plan, subject to the terms and conditions of the Transaction Bonus Plan. One-third of each employee bonus award shall be paid to the applicable employee not later than five business days after the Closing, and two-thirds of each such employee bonus
award shall be held in escrow at the Closing and released to the applicable employee not later than 60 calendar days following the Closing, in each case subject to the terms and conditions of the Transaction Bonus Plan and less any withholding
required by applicable Law. 
 SECTION 7.08. Financing. 

(a) Parent and Buyer shall, and shall cause their respective Subsidiaries to, use their reasonable best efforts to take, or
cause to be taken, all actions and to do, or cause to be done, all things necessary, proper or advisable to arrange and obtain the proceeds of the Financing on the terms and conditions described in the Financing Commitments, including using
reasonable best efforts to (i) maintain in effect the Financing and the Financing Commitments, (ii) enter into definitive financing agreements with respect to the Financing on the terms and conditions specified in the Financing Commitments
(subject to any related flex 

  
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provisions), so that such agreements are in effect as promptly as practicable but in any event no later than the Closing, (iii) enforce its rights under the Financing Commitments (including
through litigation), (iv) consummate the Financing at the Closing on the terms and conditions (including the flex provisions) specified in the Financing Commitments, (v) satisfy all conditions (including the provision of information
relating to the Buyer and its affiliates that is required to satisfy paragraphs (6) and (10) of Exhibit D to the Debt Financing Commitments) to such definitive agreements that are applicable to Buyer, Parent and its subsidiaries, and
(vi) to comply with its obligations under the Financing Commitments. It is understood that it is not a condition to Closing under this Agreement for Buyer to obtain the Financing or any Alternative Financing. Buyer shall provide to the Company
copies of all final documents relating to the Financing and shall keep the Company fully informed of material developments in respect of the financing process relating thereto. Without limiting the generality of the foregoing, Buyer shall give the
Company prompt notice (i) of any material breach or default by any party to any Financing Commitments or definitive document related to the Financing of which Buyer becomes aware; and (ii) of the receipt of any written notice or other
written communication from any Financing Source with respect to any: (A) material breach, default, termination or repudiation by any party to any Financing Commitments or any definitive document related to the Financing of any provisions of the
Financing Commitments or any definitive document related to the Financing or (B) material dispute or disagreement between or among any parties to any Financing Commitments or any definitive documents related to the Financing; provided, that
none of Buyer, Parent or any of their affiliates shall be under any obligation to disclose any information that is subject to attorney client or similar privilege; provided, further, that Buyer shall use reasonable best efforts to disclose
such information in a way that would not waive such privilege. As soon as reasonably practicable, but in any event within five (5) business days of the date the Company delivers to Buyer a written request, Buyer shall provide any information
reasonably requested by the Company relating to any circumstances referred to in clause (i) or (ii) of the immediately preceding sentence. Prior to the Closing, Buyer and Parent shall not, and shall cause Borrower and its affiliates, not
to agree to, or permit, any amendment or modification of, or waiver under, the Financing Commitments or other final documentation relating to the Financing without the prior written consent of the Company, except Parent or Borrower, as applicable,
may amend, modify, supplement, restate or replace the Financing Commitments, in whole or part, if such amendment, modification, supplement, restatement or replacement (w) does not reduce the aggregate amount of the Financing (including by
changing the amount of fees to be paid or original issue discount of the Debt Financing unless either the Debt Financing or the Equity Financing or both are increased by a corresponding amount), (x) does not impose new or additional conditions
or otherwise expand the conditions to the Financing, (y) does not amend or modify any other term of the Financing in a manner that would reasonably be expected to (I) make the timely funding of the Financing (or satisfaction of the
conditions to obtaining the Financing) less likely to occur or (II) adversely impact the ability of Buyer to enforce its rights against other parties to the Financing Commitments or the definitive agreements with respect thereto and (z) is not
reasonably expected to hinder or delay the Closing. Notwithstanding anything contained in this Section 7.08 or in any other provision of this Agreement, in no event shall Buyer be required to consummate the Closing any earlier than the fifth
business 

  
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day following the expiration of the Marketing Period. Buyer shall deliver to the Company copies of any such amendment, modification or replacement. For purposes of this Section 7.08,
references to “Financing” shall include the financing contemplated by the Financing Commitments as permitted to be amended, modified, supplemented, restated or replaced by this Section 7.08(a) and references to “Debt Financing
Commitments” and “Financing Commitments” shall include any amendment, modification, restatement, supplement and replacement permitted by this Section 7.08(a). 

(b) If, notwithstanding the use of reasonable best efforts by Buyer and Parent to satisfy their obligations under
Section 7.08(a), any of the Financing Commitments (or any definitive financing agreement relating thereto) becomes unavailable, in whole or in part, for any reason, (i) Buyer shall promptly notify the Company of such unavailability and the
reasons therefor and (ii) Buyer and Parent shall use their reasonable best efforts to arrange to obtain alternative debt financing from other financing sources on terms and conditions that are not materially less favorable to Buyer and its
affiliates than those contained in the Financing Commitments (including flex provisions) and in an amount sufficient to replace the Financing or the unavailable portion thereof, as the case may be (the “Alternative Financing”), and
to obtain a new financing commitment letter with respect to such Alternative Financing (the “New Debt Financing Commitments”) which shall replace the existing Debt Financing Commitments, a true, complete and correct copy of which
shall be promptly provided to the Company; provided that (i) none of Parent, Buyer, Borrower or any of their Affiliates shall be required to execute any New Debt Financing Commitments and (ii) neither Buyer nor Parent shall be
required to arrange for such Alternative Financing, in the case of both (i) and (ii) on terms and conditions (including flex provisions) which are materially less favorable (unless otherwise determined by Buyer), in the aggregate, to
Buyer, Parent and their respective Subsidiaries than those included in the Debt Financing Commitments that such New Debt Financing Commitments are replacing. In the event any New Debt Financing Commitments are obtained, (i) any reference in
this Agreement to the “Financing” or the “Debt Financing” shall mean the debt financing contemplated by the Debt Financing Commitments as modified pursuant to clause (ii) below, and (ii) any reference in this Agreement
to the “Financing Commitments” or the “Debt Financing Commitments” shall be deemed to include the Debt Financing Commitments that are not superseded by New Debt Financing Commitments at the time in question and the New Debt
Financing Commitments to the extent then in effect. 
 (c) In the period between the date hereof and the Closing, upon
request of Buyer, the Company shall, and shall cause its Subsidiaries to, at Buyer’s sole expense, use reasonable best efforts to cause its and their affiliates and its and their representatives (including legal and accounting) to, cooperate in
connection with the arrangement and obtaining of the Financing, including (i) using reasonable best efforts to provide to Buyer from time to time information regarding the Company reasonably requested by the lenders providing the Financing and
identifying any portion of such information that constitutes material non-public information, (ii) participating in a reasonable number of meetings, road shows presentations, drafting sessions, due diligence sessions with prospective lenders
and sessions with rating agencies in connection with the Financing, including direct contact (to the 

  
 49 

 
extent consistent with their obligations to the Company) between senior management and representatives (including accounting) of the Company and its Subsidiaries, on the one hand, and the
financing sources, potential lenders and investors for the Financing, on the other hand, (iii) assisting with the preparation of materials for rating agency presentations, offering and syndication documents (including prospectuses, private
placement memoranda and lender and investor presentations), business projections and similar marketing documents required in connection with the Financing (all such documents and materials, collectively the “Debt Offering
Documents”) and other materials to be used in connection with obtaining the Debt Financing and all documentation and other information required by Governmental Entities under applicable “know your customer” and anti-money
laundering rules and regulations, including U.S.A. Patriot Act of 2001, but in each case, solely with respect to the information relating to the Company and its Subsidiaries (iv) as promptly as practical after Buyer’s request, furnishing
Buyer and its Financing Sources all Required Information of the Company and its Subsidiaries, including all information and disclosures relating to the Company and its Subsidiaries reasonably requested by Buyer to assist with preparation of the Debt
Offering Documents, including customary authorization and management representation letters, (v) cooperating to a reasonable extent in satisfying the conditions precedent set forth in the Financing Commitments or any definitive document
relating to the financing (to the extent the satisfaction of such condition requires the cooperation of, and is within the control of, the Company), including but not limited to permitting the Access Parties reasonable access in accordance with
Section 7.02 to evaluate the Company’s and its Subsidiaries’ current assets, cash management and accounting systems, policies and procedures relating thereto for the purposes of establishing collateral arrangements, to the extent such
collateral arrangements are required by the terms of the Debt Financing, (vi) issuing customary representation letters to auditors and using reasonable best efforts to obtain (A) accountants’ comfort letters and consents to the use of
accountants’ audit reports relating to the Company, (B) corporate, credit and facility ratings from rating agencies, (C) consents and waivers and legal opinions reasonably required by Buyer, and (D) other documentation and items
contemplated by the Financing Commitments or any definitive document relating to the Financing as reasonably requested by Buyer, (vii) promptly providing monthly financial statements (excluding footnotes) to the extent available and prepared by
the Company in the ordinary course of business consistent with past practice, and (viii) executing and delivering, as of the Closing, any pledge and security documents, other definitive financing documents, or other certificates or documents
contemplated by the Financing Commitments and hedging agreements as may be reasonably requested by Buyer (including a certificate of the chief financial officer of the Company or any of its Subsidiaries with respect to financial matters for purposes
of Borrower’s certification with respect to solvency matters and consents of accountants for use of their reports in any materials relating to the Financing) and otherwise reasonably facilitating the pledging of collateral (including requesting
payoff letters, releases, terminations, waivers, consents, estoppels and approvals as may be required in connection therewith) contemplated by the Financing. The Company hereby consents to the use of its and its Subsidiaries’ logos in
connection with the Financing. Notwithstanding anything in this Section 7.08 to the contrary, none of the Company or any of its Subsidiaries shall be required to pay any commitment or other similar fee or incur any other liability in connection
with the Financing prior to the 

  
 50 

 
consummation of the Offer and Buyer shall, promptly upon written request by the Company, reimburse the Company for all reasonable documented out-of-pocket costs incurred by the Company or its
Subsidiaries in connection with any actions taken pursuant to this Section 7.08 if the Offer does not occur; provided that, notwithstanding anything to the contrary contained in this Agreement (including this Section 7.08)
(1) nothing in this Agreement (including this Section 7.08) shall require any such cooperation to the extent that it would (a) require the Company or any of its Subsidiaries or Representatives, as applicable, to waive or amend any
terms of this Agreement or agree to pay any commitment or other fees or reimburse any expenses prior to the Closing, or incur any liability or give any indemnities or otherwise commit to take any action that is not contingent upon the Closing,
(b) unreasonably interfere with the ongoing business or operations of the Company and its Subsidiaries, (c) require the Company or any of its Subsidiaries to take any action that will conflict with or violate the Company’s
organizational documents or any Laws or result in the contravention of, or that would reasonably be expected to result in a violation or breach of, or default under, any Contract to which the Company or any of its Subsidiaries is a party,
(d) require the Company or any of its Subsidiaries to enter into or approve any financing or purchase agreement for the Financing, (e) prevent the prompt and timely discharge in all material respects of the duties of any of the
Company’s executive officers, or (f) result in any officer or director of the Company or any of its Subsidiaries incurring any personal liability with respect to any matters relating to the Financing, (2) no action, liability or
obligation of the Company or any of its Subsidiaries or any of their respective Representatives under any certificate, agreement, arrangement, document or instrument relating to the Debt Financing shall be effective until the Closing, (3) any
bank information memoranda and high-yield offering prospectuses or memoranda required in relation to the Debt Financing need not be issued by the Company or any of its Subsidiaries, (4) notwithstanding anything to the contrary, the parties
agree that any road shows, ratings agencies presentations, preparation of documents (including rating agency presentation, bank information memoranda or other offer documents in connection with the Debt Financing) and provision of information with
respect to the prospects and plans for the Company’s business and operations, in each case under this clause (4), in connection with the Debt Financing remains the sole responsibility of Buyer and Parent and none of the Company or any of its
Subsidiaries or any of their respective Representatives shall have any liability or incur any losses, damages or penalties with respect thereto or be required to provide any information or make any presentations with respect to the manner in which
Buyer or Parent intends to operate, or cause to be operated, the business of the Company and its Subsidiaries after the Closing. Buyer shall indemnify and hold harmless the Company and its Representatives from and against any and all liabilities,
losses, damages, claims, costs, expenses, interest, awards, judgments and penalties suffered or incurred by them in connection with the arrangement of the Financing (including actions taken at the request of Buyer in accordance with this
Section 7.08) and any information (other than information furnished by or on behalf of the Company or its Subsidiaries) utilized in connection therewith, except to the extent such liabilities, losses, damages, claims, costs, expenses,
interests, awards, judgments and penalties arise out of or in connection with (i) the gross negligence, willful misconduct, bad faith or fraud by the Company or any of its Subsidiaries or Affiliates or any Representative of any of the
foregoing, or (ii) solely in the case of Buyer’s indemnification of the Company, breach of this Agreement by the Company. 

  
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 (d) Notwithstanding anything in this Section 7.08 to the contrary, and
without regard to the then market conditions or other general economic conditions, including the interest rate and cost of the Debt Financing, and, for the avoidance of doubt, regardless of whether or not commercially reasonable, if all of the Offer
Conditions (other than the conditions which by their terms can only be satisfied at the Closing itself) have been satisfied or waived, in the event that as of the date which is five business days following the expiration of the Marketing Period all
or any portion of the Debt Financing has not been consummated, Buyer shall use, and cause its affiliates to use, reasonable best efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary, proper or
advisable to consummate, or cause to be consummated, and shall use, or cause to be used, the proceeds of the Bridge Financing (or any Alternative Financing) to cause the Closing to occur within five (5) business days of such date. The
obligation to use the Bridge Financing (or any Alternative Financing) as set forth in this Section 7.08(d) is referred to as the “Bridge Take-Down”. Notwithstanding the foregoing, if it shall not be reasonably possible to
complete the Bridge Take-Down by such fifth (5th) business day, Buyer shall continue to use, and cause its affiliates to continue to use, reasonable best efforts to take, or cause to be taken, all actions and to do, or cause to be done, all
things necessary, proper or advisable to consummate, or cause to be consummated, and shall use, or cause to be used, the proceeds of such Bridge Financing (or such Alternative Financing) as soon as reasonably practicable thereafter. 

(e) Notwithstanding anything to the contrary contained in this Agreement, in no event shall Buyer or Parent be required to seek
the Equity Financing from any source other than those counterparty to, or in an amount in excess of that contemplated by, the Equity Financing Commitments. 

ARTICLE VIII 

TERMINATION, AMENDMENT AND WAIVER 

SECTION 8.01. Termination. This Agreement may be terminated at any time prior to the Acceptance Time by: 

(a) mutual written consent of the Company and Buyer duly authorized by the Board and the board of directors of Buyer; 

(b) either Buyer or the Company on or after the Termination Date if the Offer has not been consummated prior to such date; 

(c) either Buyer or the Company, (i) if there shall be any applicable treaty, statute, law, ordinance, regulation, rule or
code of any Governmental Authority that makes consummation of the Offer illegal or otherwise prohibited, or (ii) if a Governmental Authority shall have issued an order, decree, judgment, injunction, executive order or ruling or taken any other
action enjoining or otherwise prohibiting the Offer and such order, decree, judgment, injunction, executive order, ruling or other action shall have become final and nonappealable; 

  
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 (d) Buyer, in the event that any of the following shall have occurred:
(i) the Board shall have made a Change in Recommendation, (ii) the Company fails to include the Board Recommendation in the Solicitation/Recommendation Statement on Schedule 14D-9 filed with the SEC in respect of the Offer,
(iii) following the disclosure or announcement of any Acquisition Proposal (other than a Superior Proposal), the Board fails to reaffirm publicly the Board Recommendation within ten business days after Buyer requests in writing that such Board
Recommendation under such circumstances be reaffirmed publicly (which request may only be made once with respect to such Acquisition Proposal and once with respect to each material modification thereto), or (iv) a tender or exchange offer
relating to securities of the Company other than the Offer shall have commenced and the Company shall not have announced, within ten business days after the commencement of such tender or exchange offer, a statement disclosing that the Company
recommends rejection of such tender or exchange offer; 
 (e) the Company or Buyer, if all the Offer Conditions have been
satisfied or waived and Buyer shall have failed to consummate the Offer in accordance with the terms of this Agreement within ten business days following the expiration of the Marketing Period; provided that Buyer shall not be entitled to
terminate this Agreement pursuant to this Section 8.01(e) for so long as the Company is seeking to cause Buyer to comply with its obligations to consummate the transactions contemplated hereby, it being understood that if any such remedy is
sought by the Company, the Company shall be deemed to be seeking such enforcement unless all such remedies have been denied and such decisions have become final and nonappealable; provided, further, that Buyer shall only be entitled to
terminate this Agreement pursuant to this Section 8.01(e) upon five business days written notice to the Company (which notice Buyer shall only be entitled to give as from the tenth business day following the expiration of the Marketing Period);

 (f) the Company, if the Board has authorized entering into a definitive agreement with respect to a Superior Proposal;
provided, however, that the Company has provided Buyer a Section 7.03(c)(ii) Notice and at the end of the applicable three full business day period following delivery of the applicable Section 7.03(c)(ii) Notice, the Board
determines, in its good faith judgment, after consultation with its financial advisor, that such Superior Proposal is more favorable to the Company and the holders of Company Shares than this Agreement and the Offer, after taking into account any
adjustments to this Agreement and/or the Offer by Buyer; 
 (g) the Company, if Buyer or Parent shall have breached or failed
to perform any of its representations, warranties, covenants or other agreements contained in this Agreement, which breach or failure to perform (A) would give rise to the failure of a condition set forth in Annex I to be satisfied and
(B) has not been or is incapable of being cured by Buyer or Parent by the earlier of 30 days after its receipt of written notice thereof from the Company and the Termination Date; 

  
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 (h) Buyer, if the Company shall have breached or failed to perform any of its
representations, warranties, covenants or other agreements contained in this Agreement, which breach or failure to perform (A) would give rise to the failure of a condition set forth in Annex I to be satisfied, and (B) has not been or is
incapable of being cured by the Company by the earlier of 30 days after its receipt of written notice thereof from Buyer and the Termination Date; 

(i) The Company, if the Offer (as it may be extended pursuant to Section 2.01) expires as a result of the non-satisfaction
of the Minimum Condition, without Buyer having accepted for payment any Company Shares tendered pursuant to the Offer; or 

(j) Buyer, if the conditions specified in clauses (ii) and (iii) of the first paragraph of Annex I hereto shall have
been satisfied and the Offer (as it may be extended pursuant to Section 2.01) expires as a result of the non-satisfaction of the Minimum Condition, without Buyer having accepted for payment any Company Shares tendered pursuant to the Offer.

 The party desiring to terminate this Agreement pursuant to this Section 8.01 (other than pursuant to Section 8.01(a)) shall
give two business days written notice of such termination to the other party hereto. Notwithstanding anything in this Agreement to the contrary, the right to terminate this Agreement under this Section 8.01 shall not be available to any party
whose failure to fulfill its obligations or to comply with its covenants and other agreements under this Agreement has been a significant factor in the cause of, or resulted in, the failure to satisfy any condition to the obligations of other
parties hereunder. 
 SECTION 8.02. Effect of Termination. In the event of the termination of this Agreement pursuant to
Section 8.01, this Agreement shall forthwith become void and, subject to Section 8.03 and the last sentence of Section 8.02, there shall be no liability under this Agreement on the part of Buyer, Parent or the Company or any of their
respective employees, officers or directors or Financing Sources and all rights and obligations of any party hereto shall cease; provided, however, that nothing herein shall relieve any party from liability for any breach of any of its
representations, warranties, covenants or agreements set forth in this Agreement prior to such termination; provided, further, however, that any claim against a party for monetary damages shall be subject to the limitations set
forth in Section 8.03(j) and Section 9.09(d). The provisions of Sections 7.02(b), 8.02 and 8.03, the last sentence of 7.08(c) and Article IX shall survive any termination hereof pursuant to Section 8.01. 

SECTION 8.03. Termination Fees and Expenses. 

(a) If this Agreement is terminated by Buyer pursuant to Section 8.01(d), then the Company shall pay to Buyer a sum of
US$12,500,000 (the “Company Termination Fee”) by wire transfer of same-day funds within two business days following the date of such termination of this Agreement. 

  
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 (b) If this Agreement is terminated by the Company pursuant to
Section 8.01(f), then the Company shall pay to Buyer the Company Termination Fee by wire transfer of same-day funds within two business days following the date of such termination of this Agreement. 

(c) If (i) after the date of this Agreement but prior to the date of termination of this Agreement, an Acquisition
Proposal shall have become publicly known and not withdrawn prior to the termination of this Agreement, (ii) thereafter, this Agreement is terminated (A) by Buyer or the Company pursuant to Section 8.01(b), or (B) by Buyer
pursuant to Section 8.01(h) and (iii) within 12 months after such termination, the Company enters into a definitive agreement providing for any transaction contemplated by any Acquisition Proposal (regardless of when made) (which
transaction is thereafter consummated) or consummates any Acquisition Proposal (regardless of when made), then, in any such case, the Company shall pay to Buyer the Company Termination Fee by wire transfer of same-day funds on the date such
transaction is consummated. Solely for purposes of this Section 8.03(c), the term “Acquisition Proposal” shall have the meaning assigned to such term in Section 1.01, except that all references to 25% therein shall be deemed to
be references to 50%; provided that notwithstanding anything to the contrary in this Section 8.03(c), the Company Termination Fee shall not be payable if the Nonclearance Termination Fee is payable by Buyer to the Company pursuant to the
terms of Section 8.03(h). 
 (d) If this Agreement is terminated by the Company or Buyer pursuant to
Section 8.01(e), then Buyer shall pay to the Company a sum of US$30,000,000 (a “Buyer Fee” and the “Buyer Termination Fee”) by wire transfer of same-day funds as promptly as reasonably practicable (and, in any
event, within two business days following the date of termination of this Agreement). 
 (e) If (i) this Agreement is
terminated by the Company pursuant to Section 8.01(g) due to a Knowing and Material Breach of this Agreement by Buyer or Parent, (ii) all Offer Conditions (other than the conditions specified in clauses (ii) or (iii) of the first
paragraph of Annex I) have been satisfied (or, with respect to certificates to be delivered at the Closing pursuant to Annex I, are capable of being satisfied upon the Closing), (iii) the conditions specified in clauses (ii) or
(iii) of the first paragraph of Annex I have been satisfied or would have been satisfied but for the Knowing and Material Breach of Section 7.01 of this Agreement by Buyer or Parent, and (iv) the financing provided for by the Debt
Financing Commitments (or any Alternative Financing) in an amount no less than US$430,000,000 has been funded, will be funded at the Closing if the Equity Financing is funded at the Closing, or would have been funded at the Closing but for the
Knowing and Material Breach of Section 5.05 or Section 7.08 of this Agreement by Buyer or Parent, then Buyer shall pay to the Company the Nonclearance Termination Fee by wire transfer of same-day funds as promptly as reasonably practicable
(and, in any event, within two business days following the date of termination of this Agreement). 
 (f) If this Agreement
is terminated by the Company pursuant to Section 8.01(g) due to a Knowing and Material Breach by Buyer or Parent in any circumstance 

  
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where the Nonclearance Termination Fee is not payable, then Buyer shall pay to the Company the Buyer Termination Fee by wire transfer of same-day funds as promptly as reasonably practicable (and,
in any event, within two business days following the date of termination of this Agreement). 
 (g) If this Agreement is
terminated by Buyer pursuant to Section 8.01(h) due to a Knowing and Material Breach of this Agreement by the Company, then the Company shall pay to Buyer the Company Termination Fee by wire transfer of same-day funds as promptly as reasonably
practicable (and, in any event, within two business days following the date of termination of this Agreement). 
 (h) If this
Agreement is terminated by the Company or Buyer pursuant to Section 8.01(b) or Section 8.01(c)(ii), or by Buyer pursuant to Section 8.01(c)(i), and at the time of such termination (i) the conditions specified in clauses
(ii) or (iii) of the first paragraph of Annex I hereto shall not have been satisfied, (ii) the conditions specified in clause (iv) of Annex I hereto (other than those set forth in clause (iv)(a)(i) and (iv)(a)(iii) and those
conditions which by their terms can only be satisfied at the Closing itself but as to which there is no state of facts or circumstances that would reasonably be expected to cause a failure of such conditions as of the Closing) have been satisfied,
(iii) there has been no failure of the Company to fulfill its obligations or to comply with its covenants and other agreements under Section 7.01 of this Agreement that has been a significant factor in the cause of, or resulted in, the
failure to satisfy any of the conditions set forth in sub-clause (i) of this clause (h), then Buyer shall pay a termination fee equal to US$50,000,000 (a “Buyer Fee” and the “Nonclearance Termination Fee”) on
or before the fifth business day following such termination by wire transfer of same day funds to an account designated in writing to Buyer by the Company at least two business days after such termination; provided that the Nonclearance
Termination Fee shall only be payable upon a termination of this Agreement pursuant to Section 8.01(c)(i) by Buyer or Section 8.01(c)(ii) by Buyer or the Company to the extent that (A) in the case of termination pursuant to
Section 8.01(c)(i), the legal prohibition is based on applicable Antitrust Laws and such prohibition shall have become final and nonappealable or (B) in the case of termination pursuant to Section 8.01(c)(ii), any Governmental
Authority shall have issued an order, decree or ruling enjoining or otherwise prohibiting the Offer pursuant to applicable Antitrust Laws, and such order, decree or ruling shall have become final and nonappealable. 

(i) No Company Termination Fee, Buyer Termination Fee, Nonclearance Termination Fee or monetary damages shall be payable by the
Company, Buyer or Parent, as applicable, other than as explicitly required by Section 8.03(a) through Section 8.03(h) above, and in no event shall (1) the Company be required to pay the Company Termination Fee on more than one
occasion; or (2) Buyer be required to pay a Buyer Fee on more than one occasion; or (3) Buyer be required to pay both the Buyer Termination Fee and the Nonclearance Termination Fee. 

(j) Subject to Section 9.09 but notwithstanding anything else to the contrary in this Agreement or otherwise, (i) the
Company’s receipt of the Buyer Termination 

  
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Fee or Nonclearance Termination Fee, as applicable, pursuant to Section 8.03(d), 8.03(e), 8.03(f) or 8.03(h) shall be the sole and exclusive remedy of the Company, its Subsidiaries, and
their respective shareholders, directors, officers, employees, advisors and representatives against Buyer, Parent and any of their respective former, current, or future shareholders, controlling persons, managers, members, directors, officers,
employees, assignees, subsidiaries, parents, affiliates, Financing Sources or agents or any former, current or future general or limited partners, stockholders, controlling persons, managers, members, directors, officers, employees, assignees,
subsidiaries, parents, affiliates or agents of any of the foregoing (together, the “Buyer Representatives”) for any loss suffered as a result of any breach of any representation, warranty, covenant or agreement in this Agreement or
the failure of the Offer to be consummated, and upon payment of the Buyer Termination Fee or the Nonclearance Termination Fee, as applicable, by Buyer, none of Buyer, Parent or any Buyer Representative shall have any further liability or obligation
relating to or arising out of this Agreement or the transactions contemplated by this Agreement, and (ii) Buyer’s receipt of the Company Termination Fee, as the case may be, pursuant to Section 8.03(a), Section 8.03(b),
Section 8.03(c) or Section 8.03(g) shall be the sole and exclusive remedy of Buyer and Parent against the Company, its Subsidiaries and any of their respective former, current, or future shareholders, controlling persons, managers,
members, directors, officers, employees, assignees, subsidiaries, parents, affiliates, or agents or any former, current or future general or limited partners, stockholders, controlling persons, managers, members, directors, officers, employees,
assignees, subsidiaries, parents, affiliates or agents of any of the foregoing (together, the “Company Representatives”) for any loss suffered as a result of any breach of any representation, warranty, covenant or agreement in this
Agreement or the failure of the Offer to be consummated, and upon payment of such amounts, none of the Company, its Subsidiaries or any Company Representatives shall have any further liability or obligation relating to or arising out of this
Agreement or the transactions contemplated by this Agreement. 
 SECTION 8.04. Amendment. This Agreement may not be amended except by
an instrument in writing signed by the parties hereto. 
 SECTION 8.05. Waiver. At any time prior to the Acceptance Time, either
party hereto may (a) extend the time for the performance of any obligation or other act of any other party hereto, (b) waive any inaccuracy in the representations and warranties of the other party contained herein or in any document
delivered by the other party pursuant hereto and (c) waive compliance with any agreement or condition contained herein. Any such extension or waiver shall be valid if set forth in an instrument in writing signed by the party or parties to be
bound thereby. The failure of either party to this Agreement to assert any of its rights under this Agreement or otherwise shall not constitute a waiver of such rights. No waiver by either party hereto of any right hereunder shall constitute a
waiver of such party’s rights under any other provision of this Agreement. 

  
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 ARTICLE IX 

GENERAL PROVISIONS 

SECTION 9.01. Nonsurvival of Representations and Warranties. The representations and warranties made in this Agreement or in any
instrument delivered pursuant to this Agreement shall not survive beyond the earlier of (a) termination of this Agreement or (b) the purchase of Company Shares by Buyer pursuant to the Offer. This Section 9.01 shall not limit any
covenant or agreement of the parties which by its terms contemplates performance after the Closing. The Nondisclosure Agreement shall survive any termination of this Agreement, and the provisions of such Nondisclosure Agreement shall apply to
information and material delivered by the Company or its Subsidiaries hereunder in accordance with the terms thereof. 
 SECTION 9.02. No
Additional Representations. 
 (a) Buyer and Parent each acknowledge that it and its representatives and agents have
received access to such books, records, facilities, equipment, contracts and other assets of the Company and its Subsidiaries which it and its representatives and agents have desired or requested to review, and that it and its representatives and
agents have had full opportunity to meet with management of the Company and its Subsidiaries and to discuss the business and assets of the Company and its Subsidiaries. 

(b) Buyer and Parent each acknowledge that, except for the representations and warranties of the Company contained in Article
IV or otherwise in this Agreement or in any certificate delivered hereunder, neither the Company nor any other Person on behalf of the Company makes any express or implied representation or warranty with respect to the Company or with respect to any
other information provided to Buyer and Parent in connection with the transactions contemplated hereby. Except as explicitly referenced by Sections 8.03(a) through 8.03(h) in respect of breaches of the representations and warranties contained in
Article IV or in any certificate delivered pursuant to this Agreement, neither the Company nor any other Person on behalf of the Company nor any other Person shall be held liable for any actual or alleged damage, liability or loss resulting from the
distribution to Buyer and Parent, or the use by Buyer and Parent of, any such information, including any information, documents, projections, forecasts, Evaluation Material or other material made available to Buyer and Parent in “data
rooms,” management presentations (formal and informational), or in any other form in connection with the transactions contemplated by this Agreement. 

SECTION 9.03. Counterparts. This Agreement may be executed in two or more counterparts (delivery of which may occur via facsimile or as
an attachment to an electronic message in “pdf” or similar format), each of which shall be binding as of the date first written above, and, when delivered, all of which shall constitute one and the same instrument. This Agreement and any
documents delivered pursuant hereto, and any amendments hereto or thereto, to the extent signed and delivered by means of a facsimile machine or as an attachment to an electronic mail message in “pdf” or similar format, shall be treated in
all manner and respects as an original agreement or instrument and shall be considered to have the same binding legal effect 

  
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as if it were the original signed version thereof delivered in person. At the request of any party hereto or to any such agreement or instrument, each other party hereto or thereto shall
re-execute original forms thereof and deliver them to all other parties. No party hereto or to any such agreement or instrument shall raise the use of a facsimile machine or electronic mail attachment in “pdf” or similar format to deliver
a signature or the fact that any signature or agreement or instrument was transmitted or communicated through the use of a facsimile machine or as an attachment to an electronic mail message as a defense to the formation of a contract and each such
party forever waives any such defense. A facsimile signature or electronically scanned copy of a signature shall constitute and shall be deemed to be sufficient evidence of a Party’s execution of this Agreement, without necessity of further
proof. Each such copy shall be deemed an original, and it shall not be necessary in making proof of this Agreement to produce or account for more than one such counterpart. 

SECTION 9.04. Costs and Expenses. Except as otherwise provided in Sections 8.02 and 8.03, whether or not the Offer is consummated, all
costs and expenses incurred in connection with this Agreement and the transactions contemplated by this Agreement shall be paid by the party incurring or required to incur such expenses. 

SECTION 9.05. Notices. All notices, requests, claims, demands and other communications hereunder shall be in writing and shall be given
(and shall be deemed to have been duly given upon receipt) by delivery in Person, by facsimile or by registered or certified mail (postage prepaid, return receipt requested) to the respective parties at the following addresses (or at such other
address for a party as shall be specified in a notice given in accordance with this Section 9.05): 
 if to Parent: 

Axcan Holdings Inc. 

100 Somerset Corporate Boulevard 

Bridgewater, New Jersey 08807 

Facsimile No: (908) 252-2026 

Attention: Dr. Frank Verwiel; President & CEO 

  
 59 

 with a facsimile copy to: 

Richard Tarte 

General Counsel 

Facsimile No: (450) 464-9979 

with a copy to: 

Ropes & Gray LLP 

Prudential Tower 

800 Boylston Street 

Boston, Massachusetts 02199 

Facsimile No: (617) 951-7050 

Attention: William Shields, Esq. and Patrick O’Brien, Esq. 

if to Buyer: 

Axcan Pharma Holding B.V. 

c/o Axcan Intermediate Holdings Inc. 

100 Somerset Corporate Boulevard 

Bridgewater, New Jersey 08807 

Facsimile No: (908) 252-2026 

Attention: Dr. Frank Verwiel; President & CEO 

with a facsimile copy 

Richard Tarte 

General Counsel 

Facsimile No: (450) 464-9979 

with a copy to: 

Ropes & Gray LLP 

Prudential Tower 

800 Boylston Street 

Boston, Massachusetts 02199 

Facsimile No: (617) 951-7050 

Attention: William Shields, Esq. and Patrick O’Brien, Esq. 

if to the Company: 

Eurand N.V. 

790 Township Line Road 

Suite 250 

Yardley, PA 19067 

Facsimile: +1 (215) 968-2941 

Attention: Manya Deehr and John Fraher 

  
 60 

 with a copy to: 

Morgan, Lewis & Bockius LLP 

1701 Market Street 

Philadelphia, Pennsylvania 19103 

Facsimile No: (215) 963-5001 

Attention: Timothy Maxwell, Esq. 

with a copy to: 

Warburg Pincus LLC 

450 Lexington Avenue 

New York, NY 10017 

Attention: Scott A. Arenare, Esq. 

with a copy to: 

Willkie Farr & Gallagher LLP 

787 Seventh Avenue 

New York, New York 10019 

Facsimile: (212) 728-8111 

Attention: Gregory B. Astrachan, Esq. 

SECTION 9.06. Severability. If any term or other provision of this Agreement is invalid, illegal or incapable of being enforced by any
applicable Law, or public policy, all other conditions and provisions of this Agreement shall nevertheless remain in full force and effect so long as the economic or legal substance of this Agreement and the Offer is not affected in any manner
materially adverse to any party. Upon such determination that any term or other provision is invalid, illegal or incapable of being enforced, the parties hereto shall negotiate in good faith to modify this Agreement so as to effect the original
intent of the parties as closely as possible in a mutually acceptable manner in order that the Offer, and the other transactions contemplated by this Agreement be consummated as originally contemplated to the fullest extent possible. 

SECTION 9.07. Entire Agreement; Assignment. This Agreement, together with the Nondisclosure Agreement, the Disclosure Schedule, and
Annex I hereto and the exhibits and schedules hereto, constitute the entire agreement among the parties with respect to the subject matter hereof and thereof and supersede all prior agreements and undertakings, both written and oral, among the
parties, or any of them, with respect to the subject matter hereof. This Agreement shall not be assigned (whether directly or indirectly, pursuant to an express 

  
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assignment, a merger, a change in equity ownership, by operation of law or otherwise), except that Buyer (and each permitted assign of Buyer) may assign all or any of its rights and obligations
hereunder to any affiliate of Buyer or Parent that is wholly owned, either directly or indirectly, by Borrower; provided that such assignment shall not impede or delay the consummation of the Offer or the other transactions contemplated by
this Agreement or otherwise adversely affect the rights of the holders of Company Shares under this Agreement; provided further, that no such assignment shall relieve Buyer of its obligations hereunder. Subject to the preceding
sentence, this Agreement shall be binding upon, inure to the benefit of, and be enforceable by, the parties hereto and their respective successors and permitted assigns. Any purported assignment not permitted under this Section 9.07 shall be
null and void. 
 SECTION 9.08. Parties in Interest. This Agreement shall be binding upon and inure solely to the benefit of each
party hereto, and nothing in this Agreement, express or implied, is intended to or shall confer upon any other Person (including holders of Company Shares and, except as set forth in clause (c) below, holders of Company Options) any right,
benefit or remedy of any nature whatsoever under or by reason of this Agreement, other than (a) with respect to the provisions of Section 7.04 which shall inure to the benefit of each of the Indemnified Parties (including their respective
heirs and representatives) who are intended to be third-party beneficiaries thereof, (b) with respect to the last sentence of Section 7.08(c) which shall inure to the benefit of each of the Representatives of the Company (including their
respective heirs and representatives) who are intended to be third-party beneficiaries thereof, (c) at the Closing, the rights of the holders of Company Options to receive the Per Share Amount in accordance with the terms and conditions of this
Agreement; and (d) solely with respect to the provisions of Sections 8.02, 8.03(j), 9.09, 9.11 and 9.12, the Financing Sources; provided, however, that the rights granted to the holders of Company Options pursuant to the foregoing
clause (c) of this Section 9.08 shall only be enforceable on behalf of such holders by the Company (or any successor in interest thereto) in its sole and absolute discretion. 

SECTION 9.09. Specific Performance. 

(a) The parties hereby acknowledge that irreparable damage would occur in the event any provision of this Agreement
(including failing to take such actions as are required of it hereunder to consummate the Offer or the transactions contemplated hereby) were not performed in accordance with the terms hereof. Accordingly, the parties acknowledge and agree that,
prior to the valid termination of this Agreement in accordance with Section 8.01 and in all cases subject to the specific requirements set forth in Section 9.09(b) (as it relates to obtaining a remedy contemplated by this
Section 9.09(a) with respect to the Company’s right to specific performance of the obligations of Buyer or Parent, as applicable, to (i) accept for payment Company Shares validly tendered and not withdrawn pursuant to the Offering,
(ii) pay for Company Shares validly tendered and not withdrawn pursuant to the Offering, and (iii) cause the Equity Financing to be funded) or Section 9.09(c) (as it relates to obtaining a remedy contemplated by this
Section 9.09(a) with respect to the Bridge Take Down), each party shall be entitled to an injunction or injunctions, specific performance and other equitable relief to prevent breaches of this Agreement and to enforce specifically the terms and
provisions hereof, this being in addition to any other remedy to which, subject to the terms and conditions of this Agreement, they are entitled at law or in equity. 

  
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 (b) Notwithstanding the foregoing, the right of the Company to obtain an
injunction, or other appropriate form of specific performance or equitable relief, in each case, solely with respect to causing Buyer or Parent, as applicable, to (i) accept for payment Company Shares validly tendered and not withdrawn pursuant
to the Offering, (ii) pay for Company Shares validly tendered and not withdrawn pursuant to the Offering, and (iii) cause the Equity Financing to be funded and the transactions contemplated hereby to be consummated at the Closing, shall be
subject to the requirements that (x) all Offer Conditions have been satisfied (or, with respect to certificates to be delivered at the Closing pursuant to Annex I, are capable of being satisfied upon the Closing), (y) the financing
provided for by the Debt Financing Commitments (or any Alternative Financing) in an amount no less than US$430,000,000 has been funded or will be funded at the Closing if the Equity Financing is funded at the Closing, and (z) the Company has
irrevocably confirmed that if specific performance is granted and the Equity Financing and Debt Financing are funded, then the Closing pursuant to Section 2.01(d) will occur. 

(c) The right of the Company to obtain an injunction, or other appropriate form of specific performance or equitable relief, in
each case, solely with respect to causing Buyer to effect a Bridge Take-Down shall be subject to the requirements set forth in Section 7.08(d). 

(d) Each of the parties agrees that it will not oppose the granting of an injunction, specific performance and other equitable
relief on the basis that the other parties have an adequate remedy at law or an award of specific performance is not an appropriate remedy for any reason at law or equity. For the avoidance of doubt, (1) under no circumstances will the Company
be entitled to, nor will Buyer, Parent or any Financing Source be liable under or in connection with this Agreement or the Offer for, aggregate monetary damages in excess of the aggregate amount of the Buyer Termination Fee (or, solely in the case
of Buyer and solely pursuant to and in accordance with the terms of Section 8.03(e) and Section 8.03(h), the Nonclearance Termination Fee), (2) under no circumstances will Buyer be entitled to, nor will the Company be liable under or
in connection with this Agreement or the Offer for, aggregate monetary damages in excess of the aggregate amount of the Company Termination Fee, and (3) while the Company may pursue both a grant of specific performance and the payment of either
the Buyer Termination Fee or Nonclearance Termination Fee under Section 8.03, under no circumstances shall the Company be permitted or entitled to receive both a grant of specific performance and any money damages, including all or any portion
of the Buyer Termination Fee or Nonclearance Termination Fee, and in no circumstances shall the Company be entitled to receive all or any portion of both the Buyer Termination Fee and the Nonclearance Termination Fee. Any party seeking an injunction
or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement shall not be required to provide any bond or other security in connection with any such order or injunction. To the extent
any party hereto brings an action, suit or proceeding to 

  
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enforce specifically the performance of the terms and provisions of this Agreement (other than an action to specifically enforce any provision that expressly survives termination of this
Agreement) when expressly available to such party pursuant to the terms of this Agreement, the Termination Date shall automatically be extended to (i) the twentieth (20th) business day following the resolution of such action, suit or
proceeding, or (ii) such other time period established by the court presiding over such action, suit or proceeding (it being understood that this Section 9.09 shall not be deemed to alter, amend, supplement or otherwise modify the terms of
any Financing Commitment (including the expiration or termination provisions thereof). 
 SECTION 9.10. Time is of the Essence. Time
is of the essence as to the performance of each party’s obligations under this Agreement. 
 SECTION 9.11. Governing Law. This
Agreement and the transactions contemplated hereby, and all disputes between the parties arising out of or relating to this Agreement or the facts and circumstances leading to its execution, whether in contract, tort or otherwise, shall be governed
by, and construed in accordance with, the laws of the State of New York, without giving effect to any choice of law or conflicts of laws provisions or rule of any jurisdiction that would cause the substantive laws of any other jurisdiction to apply.
All actions and proceedings arising out of or relating to this Agreement or the facts and circumstances leading to its execution, whether in contract, tort or otherwise, shall be heard and determined in any state or federal court sitting within the
County of New York. The parties hereto hereby (a) submit to the exclusive jurisdiction of any state or federal court sitting within the County of New York for the purpose of any Action arising out of or relating to this Agreement or
the facts and circumstances leading to its execution, whether in contract, tort or otherwise, brought by any party hereto (including any litigation against the Financing Sources arising out of this Agreement or the Financing Commitments) and
(b) irrevocably waive, and shall not to assert by way of motion, defense, or otherwise, in any such Action, any claim that it is not subject personally to the jurisdiction of the above-named courts, that its property is exempt or immune from
attachment or execution, that the Action is brought in an inconvenient forum, that the venue of the Action is improper, or that this Agreement may not be enforced in or by any of the above-named courts. 

SECTION 9.12. Waiver of Jury Trial. EACH OF THE PARTIES HERETO HEREBY WAIVES TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAWS ANY
RIGHT IT MAY HAVE TO A TRIAL BY JURY WITH RESPECT TO ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE FACTS AND CIRCUMSTANCES LEADING TO ITS EXECUTION, WHETHER IN CONTRACT, TORT OR OTHERWISE (INCLUDING ANY
LITIGATION AGAINST THE FINANCING SOURCES ARISING OUT OF THIS AGREEMENT OR THE FINANCING COMMITMENTS). Each of the parties hereto (a) certifies that no representative, agent or attorney of any other party has represented, expressly or otherwise,
that such other party would not, in the event of litigation, seek to enforce that foregoing waiver and (b) acknowledges that it and the other parties hereto have been induced to enter into this Agreement and the Offer, as applicable, by, among
other things, the mutual waivers and certifications in this Section 9.12. 

  
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 SECTION 9.13. Interpretation and Disclosure Schedule. Unless the context of this Agreement
clearly requires otherwise, (a) references to the plural include the singular, the singular the plural, the part the whole, (b) references to any gender include all genders, (c) “including” has the inclusive meaning
frequently identified with the phrase “but not limited to” and (d) references to “hereto,” “hereunder” or “herein” relate to this Agreement. The section and other headings
contained in this Agreement and the Disclosure Schedule are for reference purposes only and shall not control or affect the construction of this Agreement or the Disclosure Schedule or the interpretation hereof or thereof in any respect. Section,
subsection, Schedule and Annex references are to this Agreement unless otherwise specified. Each accounting term used herein that is not specifically defined herein shall have the meaning given to it under GAAP. The Disclosure Schedule shall be
arranged in paragraphs corresponding to numbered and lettered sections contained in Article IV, and the disclosures in any paragraph of the Disclosure Schedule shall qualify other sections in Article IV to the extent it is reasonably apparent from a
reading of the disclosure and the section of Article IV to which the disclosure relates that such disclosure is applicable to such other sections. 

SECTION 9.14. Negotiated Agreement. The parties hereto hereby acknowledge that the terms and language of this Agreement were the result
of negotiations among the parties hereto and, as a result, there shall be no presumption that any ambiguities in this Agreement shall be resolved against any particular party. Any controversy over construction of this Agreement shall be decided
without regard to events of authorship or negotiation. 
 {Signature Page to Follow} 

  
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 IN WITNESS WHEREOF, Parent, Buyer and the Company have caused this Agreement to
be executed as of the date first written above by their respective officers thereunto duly authorized. 
  

					
	AXCAN HOLDINGS INC.
		
	By	 	 /s/ Frank Verwiel

	Name:	 	Dr. Frank Verwiel
	Title:	 	President and Chief Executive Officer
	
	AXCAN PHARMA HOLDING B.V.
		
	By	 	 /s/ Frank Verwiel

		 	Name:	 	Dr. Frank Verwiel
		 	Title:	 	Authorized Person
	
	EURAND N.V.
		
	By	 	 /s/ Angelo C. Malahas

		 	Name:	 	Angelo C. Malahas
		 	Title:	 	Director

 ANNEX I 

CONDITIONS OF THE OFFER 

Notwithstanding any other provision of the Offer, but subject to compliance with any applicable rules and regulations of the SEC, including
Rule 14e-1(c) relating to Buyer’s obligation to accept or return tendered shares after the termination of the Offer, Buyer shall not be required to accept for purchase or pay for any Company Shares if (i) the Minimum Condition shall not
have been satisfied, (ii) the applicable waiting period under the HSR Act shall not have expired or been terminated, (iii) the consummation of the Offer is unlawful under any Antitrust Laws of Germany, or (iv) any of the following
events or circumstances occurs or exists and is continuing: 
 (a) there shall be (i) any Antitrust Laws applicable to
the Offer entered, promulgated or enforced by any Governmental Authority, (ii) any other Laws applicable to the Offer entered, promulgated or enforced by any Governmental Authority, (iii) any order of any kind issued by any Governmental
Authority enforcing applicable Antitrust Laws or (iv) any other order of any kind issues by any Governmental Authority; in each case, that prohibits or enjoins the consummation of the Offer or has the effect of making the Offer illegal; 

(b) (i) the Company shall have breached or failed to perform in any material respect its covenants or agreements under the
Agreement, (ii) except in the case of the representations and warranties contained in Sections 4.03(a), 4.03(b), 4.03(e) and 4.20, the representations and warranties of the Company contained in the Agreement that are qualified by reference to a
Material Adverse Effect shall not have been true and correct in all respects when made or at the expiration of the Offer as if made at and as of such time (other than representations and warranties which by their terms address matters only as of
another specified date, which shall be true and correct in all respects only as of such date), (iii) except in the case of the representations and warranties contained in Sections 4.03(a), 4.03(b), 4.03(e) and 4.20, the representations and
warranties of the Company contained in the Agreement that are not so qualified shall not have been true and correct when made or at the expiration of the Offer as if made at and as of such time (other than representations and warranties which by
their terms address matters only as of another specified date, which shall be true and correct only as of such date), except, in the case of clause (iii) only, for such failures to be true and correct as have not and would not, individually or
in the aggregate, resulted in a Material Adverse Effect, (iv) the representations and warranties of the Company contained in Sections 4.03(a), 4.03(b) and 4.20 shall not have been true and correct in all respects when made or at the expiration
of the Offer as if made at and as of such time (other than representations and warranties which by their terms address matters only as of another specified date, which shall be true and correct in all respects only as of such date), except for such
failure to be true and correct as have not and would not, individually or in the aggregate, reasonably be expected to give rise to damages, losses, costs and expenses in excess of US$5 million in the aggregate, and (v) the representations and
warranties of the Company contained in Section 4.03(e) shall not have been true and correct in all respects as of the date hereof, except for such failure 

  
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to be true and correct as have not and would not, individually or in the aggregate, reasonably be expected to give rise to damages, losses, costs and expenses in excess of US$5 million in the
aggregate; 
 (c) (i) the Board, or any committee thereof, shall have withdrawn or modified, in a manner adverse to Buyer
including by amending the Schedule 14D-9, the approval or recommendation of the Offer or the Agreement, or approved or recommended any Superior Proposal or any other acquisition of Company Shares other than the Offer or (ii) the Board, or any
committee thereof, shall have resolved to do any of the foregoing; 
 (d) since the date of this Agreement, there shall have
occurred a Material Adverse Effect. 
 (e) the Company shall not have obtained the Board Approvals and Stockholder Approvals
or the Board Approvals or Stockholder Approvals are no longer in full force and effect; or 
 (f) the Agreement shall have
been terminated in accordance with its terms. 
 The foregoing conditions are for the sole benefit of Buyer and Parent (except as provided
in the Agreement with respect to the Minimum Condition, which is also for the benefit of the Company) and may be asserted by Buyer or Parent regardless of the circumstances giving rise to any such condition or may be waived by Buyer and Parent in
whole or in part at any time and from time to time in its sole discretion prior to the expiration of the Offer. Buyer shall be entitled to receive immediately prior to the expiration of the Offer a certificate signed on behalf of the Company by a
senior executive officer of the Company to the effect that such officer has read Offer Conditions (b), (d) and (e) and that none of the events or conditions set forth in Offer Conditions (b), (d) and (e) have occurred or existed
and are continuing. The failure by Buyer or Parent at any time to exercise any of the foregoing rights shall not be deemed a waiver of any such right; the waiver of any such right with respect to particular facts and other circumstances shall not be
deemed a waiver with respect to any other facts and circumstances; and each such right shall be deemed an ongoing right that may be asserted at any time and from time to time. 

  
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