Document:

cara_Ex10_1

		

			Exhibit 10.1

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			Execution Version

		

		
			Non-Exclusive License Agreement
		

		
			 
		

		
			 
		

		
			between
		

		
			 
		

		
			 
		

		
			ENTERIS BIOPHARMA, INC.
		

		
			 
		

		
			 
		

		
			and
		

		
			 
		

		
			 
		

		
			CARA THERAPEUTICS, INC.
		

		
			 
		

		
			 
		

		
			Dated as of August 20, 2019
		

		
			 
		

		
			 
		

		
			

		 

		

			 

		

		

		
			Table of Contents
		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						Page

				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 1 DEFINITIONS

					
5
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 2 LICENSE GRANT

					
14
				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						2.1

					
					
						Grant of License to Cara

					
14
				
	
					
						2.2

					
					
						Right to Sublicense

					
14
				
	
					
						2.3

					
					
						Rights in Bankruptcy

					
15
				
	
					
						2.4

					
					
						Disclosure of Technology

					
15
				
	
					
						2.5

					
					
						Retained Rights

					
15
				
	
					
						2.6

					
					
						Use of Licensed Technology

					
15
				
	
					
						2.7

					
					
						Negative Covenant

					
15
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 3 DEVELOPMENT, REGULATORY AND COMMERCIALIZATION

					
16
				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						3.1

					
					
						Manufacture by Enteris

					
16
				
	
					
						3.2

					
					
						Technology Transfer by Enteris

					
16
				
	
					
						3.3

					
					
						Cara’s Rights and Obligations

					
17
				
	
					
						3.4

					
					
						Regulatory Responsibility

					
18
				
	
					
						3.5

					
					
						Recalls

					
18
				
	
					
						3.6

					
					
						Safety Information. 

					
18
				
	
					
						3.7

					
					
						Reference Rights

					
19
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 4 CONFIDENTIALITY, PUBLICITY, PUBLICATIONS

					
19
				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						4.1

					
					
						Confidentiality

					
19
				
	
					
						4.2

					
					
						Authorized Disclosure

					
20
				
	
					
						4.3

					
					
						Employees and Consultants

					
21
				
	
					
						4.4

					
					
						Publicity

					
21
				
	
					
						4.5

					
					
						Public Filings

					
21
				
	
					
						4.6

					
					
						Publications and Presentations

					
22
				
	
					
						4.7

					
					
						Permitted Publications

					
22
				
	
					
						4.8

					
					
						Use of Proprietary Materials

					
22
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 5 INTELLECTUAL PROPERTY RIGHTS

					
23
				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						5.1

					
					
						Enteris Rights

					
23
				
	
					
						5.2

					
					
						Cara Rights

					
23
				
	
					
						5.3

					
					
						Notice; Inventorship

					
23
				
	
					
						5.4

					
					
						Third Party Infringement

					
24
				
	
					
						5.5

					
					
						Defense of Claims

					
25
				
	
					
						5.6

					
					
						Patent Term Extension

					
26
				
	
					
						5.7

					
					
						Patent Marking

					
26
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 6 CONSIDERATION

					
26
				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						6.1

					
					
						Upfront Fee

					
26
				
	
					
						6.2

					
					
						Milestone Payments

					
26
				
	
					
						6.3

					
					
						[***]

					
27
				
	
					
						6.4

					
					
						Notice and Payment of Milestones

					
27
				

		
			
		

		
			

		 

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

				
	
					
						6.5

					
					
						Payment of Royalties; Accounting and Records

					
27
				
	
					
						6.6

					
					
						Payment Dates and Reports

					
29
				
	
					
						6.7

					
					
						Records; Audit Rights

					
29
				
	
					
						6.8

					
					
						Overdue Payments

					
30
				
	
					
						6.9

					
					
						Payments; Withholding Tax

					
30
				
	
					
						6.10

					
					
						Foreign Currency Exchange

					
30
				
	
					
						6.11

					
					
						Cara Obligations

					
30
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 7 REPRESENTATIONS AND WARRANTIES; COVENANTS; LIABILITY

					
30
				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						7.1

					
					
						Mutual

					
30
				
	
					
						7.2

					
					
						By Cara. 

					
31
				
	
					
						7.3

					
					
						By Enteris

					
31
				
	
					
						7.4

					
					
						Warranty Disclaimer

					
33
				
	
					
						7.5

					
					
						Indemnification; Insurance

					
33
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 8 TERM AND TERMINATION

					
35
				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						8.1

					
					
						Term

					
35
				
	
					
						8.2

					
					
						Expiration of Term

					
35
				
	
					
						8.3

					
					
						Termination for Material Breach

					
35
				
	
					
						8.4

					
					
						Termination for Challenge

					
35
				
	
					
						8.5

					
					
						Without Cause Termination. 

					
36
				
	
					
						8.6

					
					
						Consequences of Termination

					
36
				
	
					
						8.7

					
					
						Survival

					
37
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 9 ASSIGNMENT; SUCCESSORS AND ASSIGNS

					
37
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 10 GOVERNING LAW

					
38
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 11 DISPUTE RESOLUTION; ARBITRATION

					
38
				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						11.1

					
					
						Dispute Resolution. 

					
38
				
	
					
						11.2

					
					
						Arbitration of Unresolved Disputes. 

					
38
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 12 MISCELLANEOUS

					
40
				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						12.1

					
					
						Amendment and Modification. 

					
40
				
	
					
						12.2

					
					
						Headings. 

					
40
				
	
					
						12.3

					
					
						Counterparts. 

					
40
				
	
					
						12.4

					
					
						Waiver. 

					
40
				
	
					
						12.5

					
					
						No Third Party Beneficiaries. 

					
40
				
	
					
						12.6

					
					
						Independent Relationship. 

					
40
				
	
					
						12.7

					
					
						Interpretation. 

					
41
				
	
					
						12.8

					
					
						Entire Agreement; Severability. 

					
41
				
	
					
						12.9

					
					
						Delay Due to Force Majeure. 

					
42
				
	
					
						12.10

					
					
						Further Assurances. 

					
42
				
	
					
						12.11

					
					
						Expenses. 

					
42
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 13 NOTICE

					
42
				

		
			 
		

		
			
		

		
			

		 

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			Exhibits and Schedules
		

		
			 
		

			
					
						 

					
					
						 

				
	
					
						Exhibit A

					
					
						Wire Instructions

				
	
					
						Exhibit B

					
					
						Form Stock Purchase Agreement

				
	
					
						Exhibit C

					
					
						Project Plan

				

		
			 
		

		
			 
		

		
			

		 

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			NON-EXCLUSIVE LICENSE AGREEMENT
		

		
			This NON-EXCLUSIVE LICENSE AGREEMENT (“Agreement”) is made August 20, 2019 (the “Effective Date”) by and between CARA THERAPEUTICS, INC., incorporated and registered in the State of Delaware and having offices at 4 Stamford Plaza, 107 Elm Street, 9th Floor, Stamford, CT 06902, USA (hereinafter referred to as “Cara”), and ENTERIS BIOPHARMA, INC., incorporated and registered in the State of Delaware and having offices at 83 Fulton St., Boonton, NJ 07005, USA (hereinafter referred to as “Enteris”).  Each of Enteris and Cara is sometimes referred to individually herein as a “Party” and collectively as the “Parties.”
		

		
			RECITALS
		

		
			A.        Enteris owns or otherwise controls certain proprietary technology and patent rights (defined below as Licensed Technology) claiming or covering formulations for oral delivery of peptide active pharmaceutical ingredients with functional excipients to enhance permeability and/or solubility, including in any oral solid dosage forms, and the development and manufacture of drug products using such formulations;
		

		
			B.         Cara wishes to obtain a non-exclusive license under the Licensed Technology on the terms and conditions of this Agreement; and
		

		
			C.         Enteris is willing to grant to Cara the requested license rights and Cara is willing to accept such rights pursuant to the terms and conditions of this Agreement.
		

		
			NOW THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, it is hereby agreed by and between the Parties as follows:
		

		
			ARTICLE 1
		

		
			DEFINITIONS
		

		
			In this Agreement the following words and phrases shall have the following meanings unless the context requires otherwise:
		

		
			“AAA” shall have the meaning set forth in Article 11.
		

		
			“Affiliate” means, with respect to a particular Party, any person, company, partnership or other entity, whether or not incorporated or in existence at the Effective Date, that directly or indirectly controls, is controlled by or is under common control with such Party to this Agreement.  The term “control” for the purposes of this definition (with correlative meanings for the terms “controlled by” and “under common control with”) means that the applicable person, company, partnership, or other entity  owns fifty percent (50%) or more (including ownership by trusts with substantially the same beneficial interests) of the voting and equity rights of the applicable Party, or otherwise has the legal power to direct or cause the direction of the general management and policies of such Party.
		

		
			“Agreement” shall have the meaning set forth in the Recitals.
		

		
			
		

		
			

		 

		

			-  5  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			  “Applicable Laws” means any national, international, federal, state or local laws, treaties, statutes, ordinances, rules and regulations, including any rules, regulations, guidance, guidelines or requirements of any national, international, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, national securities exchanges or securities listing organizations, that are in effect from time to time during the Term and apply to a particular activity or obligation hereunder.
		

		
			“Assist” means knowingly providing, directly or indirectly, a Third Party with (a) any analysis of the Licensed Patent Rights or any portion thereof; (b) prior art or analysis of any prior art to any of the Licensed Patent Rights; (c) any documents in a Party’s possession, custody, or control relating to the Licensed Patent Rights, in whole or in part, or to any prior art to any of the Licensed Patent Rights; or (d) financial or technical support, in each case in connection with a Challenge by such Third Party of the Licensed Patent Rights or any portion thereof.
		

		
			“Bankruptcy Code” means, as applicable, the U.S. Bankruptcy Code, as amended from time to time, and the rules and regulations and guidelines promulgated thereunder, or the bankruptcy laws of any other Governmental Authority, as amended from time to time, and the rules and regulations and guidelines promulgated thereunder, or any applicable bankruptcy laws of any other country or competent Governmental Authority, as amended from time to time, and the rules and regulations and guidelines promulgated thereunder.
		

		
			“Business Day” means any day, other than a Saturday or Sunday, on which banking institutions in New York, New York are open for business.
		

		
			“Calendar Quarter” means the period beginning on the Effective Date and ending on the last day of the calendar quarter in which the Effective Date falls, and thereafter each successive period of three (3) consecutive calendar months beginning on January 1, April 1, July 1, or October 1 and ending, respectively on March 31, June 30, September 30 and December 31; provided, that, the final Calendar Quarter shall end on the last day of the Term.
		

		
			“Calendar Year” means the period beginning on the Effective Date and ending on December 31 of the calendar year in which the Effective Date falls, and thereafter each successive period of twelve (12) months commencing on January 1 and ending on December 31; provided, that, the final Calendar Year shall end on the last day of the Term.
		

		
			“Cara Indemnitees” shall have the meaning set forth in Section 7.5(b).
		

		
			“Cara Indemnity Claims” shall have the meaning set forth in Section 7.5(b).
		

		
			“Challenge” means to contest, or knowingly to Assist a Third Party in its contest, of the validity or enforceability of the Licensed Patent Rights, in whole or in part, in any court, arbitration proceeding or other legal, judicial, or administrative tribunal, including the United States Patent and Trademark Office and the United States International Trade Commission.  For the avoidance of doubt, for the purposes of this definition, the term “contest” means: (a) filing an action under 28 U.S.C. §§ 2201-2202 seeking a declaration of invalidity or unenforceability of any Licensed Patent Rights; (b) citation to the United States Patent and Trademark Office pursuant to 35 U.S.C.
		

		
			
		

		
			

		 

		

			-  6  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			§ 301 of prior art patents or printed publications or statements of the patent owner concerning the scope of any of the Licensed Patent Rights; (c) filing a request under 35 U.S.C. § 302 for re-examination of any of the Licensed Patent Rights; (d) filing, or joining in, a petition under 35 U.S.C. § 311 to institute inter partes review of any Licensed Patent Rights or any portion thereof; (e) filing, or joining in, a petition under 35 U.S.C. § 321 to institute post-grant review of the Licensed Patent Rights or any portion thereof; (f) provoking or becoming a party to an interference with an application for any of the Licensed Patent Rights pursuant to 35 U.S.C. § 135; or (g) filing or commencing any re-examination, opposition, cancellation, nullity or similar proceedings against any of the Licensed Patent Rights in any country.
		

		
			“Change of Scope” shall have the meaning set forth in Section 3.2(c).
		

		
			“CMO” means the third party manufacturer that Cara selects for commercial Manufacturing.
		

		
			“Commercialization” or “Commercialize” means any and all activities directed to the offering for sale and sale of a Product, from the initial launch, including (a) activities directed to marketing, promoting, detailing, distributing, Manufacturing, importing, selling and offering to sell that Product in the Territory (including pre-approval marketing activities); (b) conducting Phase IV clinical trials with respect to that Product; (c) interacting with Regulatory Authorities regarding any of the foregoing; and (d) seeking pricing approvals and reimbursement approvals (as applicable) for that Product in the Territory. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization and “Commercialized” has a corresponding meaning.
		

		
			“Commercially Reasonable Efforts” means, with respect to the applicable task or activity under this Agreement, the application of efforts and resources that are generally consistent with those that a comparable company in the pharmaceutical industry generally would devote to accomplish such task or activity relating to products that are at a similar stage of development and have similar commercial potential as Product, taking into account all applicable competition, market, scientific, technical, intellectual property, regulatory, and commercial factors (including potential and actual economic return for the product), all based on then-prevailing conditions.
		

		
			“Completion of Analytical Procedures Transfer” means the date of the full and complete transfer of the analytical procedures by Enteris to the CMO designated by Cara as specified in and in accordance with Section 3.2(a), as summarized in Section I (Transfer of Analytical Procedures) of the Project Plan.
		

		
			“Completion of Manufacturing Process Transfer” means the date of the full and complete transfer of the Manufacturing process by Enteris to the CMO designated by Cara as specified in and in accordance with Section 3.2(a), as summarized in Section II (Transfer of Manufacturing Process) of the Project Plan.
		

		
			“Confidential Information” means, for a particular Party, any and all confidential and proprietary information, including any Know-how, disclosed by such Party to the other in writing, orally or in any other form in connection with this Agreement, which may include samples,
		

		
			
		

		
			

		 

		

			-  7  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			documents, drawings, specifications data, graphics, technical know-how, letters, electronically transmitted documents, e-mails, etc.  Confidential Information of a Party includes the Proprietary Materials of such Party.  In the case of Enteris, Confidential Information includes Licensed Know-how and Improvements. In the case of Cara, Confidential Information includes any information disclosed by Cara relating to any Drug and Product(s) produced with the support of the Licensed Technology.  With respect to each Party, Confidential Information includes this Agreement and the terms of this Agreement.
		

		
			“Control” or “Controlled” means, with respect to Know-how or Patent Rights, that the applicable Party, either directly or through any of its Affiliates, owns or has a license (or sublicense) to or under, and has the right to grant to the other Party access to and a license or sublicense under, such Know-how or Patent Rights as provided herein without the payment of additional consideration to, or violating the terms of any agreement or arrangement with any Third Party, and without violating any Applicable Laws.  For clarity, no Party (or Affiliate of a Party, as applicable) shall be deemed to Control any Know-how or Patent Rights by virtue of the license grants to that Party from or by the other Party as set forth in this Agreement.
		

		
			“Debarred Entity” shall have the meaning set forth in Section 7.1(e).
		

		
			“Development” or “Develop” means, with respect to a Product, all non clinical and clinical drug development activities that are undertaken after the Effective Date, including (a) the preparation and filing of Regulatory Filings and all regulatory affairs related to the foregoing, (b) obtaining, maintaining or expanding Regulatory Approvals of a Product, or (c) developing the ability to manufacture clinical and commercial quantities of a Product.  This includes: (i) preclinical testing, toxicology, and clinical trials; (ii) preparation, submission, review, and development of data or information for the purpose of submission to a Regulatory Authority to obtain, maintain or expand Regulatory Approvals of a Product; and (iii) Manufacturing Process Development associated with the supply of a Product for preclinical testing and clinical trials, and related quality assurance and technical support activities. When used as a verb, “Developing” means to engage in Development and “Developed” has a corresponding meaning. For clarity, “Development” shall not include any Commercialization activities.
		

		
			“Dispute” shall have the meaning set forth in Section 11.1.
		

		
			“Drug” means CR845 (difelikefalin), and any salt forms, esters, prodrugs, biologically active metabolites or biologically active structural analogs, solvates, hydrates and crystalline forms thereof.
		

		
			“Effective Date” shall have the meaning set forth in the Recitals.
		

		
			“EMA” means the European Medicines Agency or any successor agency or authority thereto.
		

		
			“End of Phase 2 Meeting” means the end of Phase 2 meeting with the FDA, as described in 21 C.F.R. § 312.47(b), intended to determine the safety of proceeding to Phase 3, to evaluate
		

		
			
		

		
			

		 

		

			-  8  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			the Phase 3 plan and protocols, and to identify any additional information necessary to support a marketing application for the uses under investigation.
		

		
			“Enteris DMF” means that certain [***] and the information contained therein.
		

		
			“Enteris Indemnitees” shall have the meaning set forth in Section 7.5(a).
		

		
			“Enteris Indemnity Claims” shall have the meaning set forth in Section 7.5(a).
		

		
			“FDA” means the United States Food and Drug Administration, or any successor entity thereto having substantially the same functions.
		

		
			“FDCA” means the United States Federal Food, Drug, and Cosmetic Act, enacted in 1938 as Public Law 75-717, as such may have been amended, and which is contained in Title 21 of the U.S. Code, Section 301 et seq., as amended, and the regulations promulgated thereunder from time to time.
		

		
			“Field” means all fields and uses, including all prophylactic, therapeutic and diagnostic uses for all human diseases, conditions and indications.
		

		
			“Force Majeure” means any occurrence beyond the reasonable control of a Party that (a) prevents or substantially interferes with the performance by such Party of any of its obligations hereunder and (b) occurs by reason of any act of God, flood, fire, explosion, earthquake, casualty or accident, or war, revolution, civil commotion, act of terrorism, blockage or embargo, or any injunction, law, order, proclamation, regulation, ordinance, demand or requirement of any government or of any subdivision, authority or representative of any such government.
		

		
			“Generic Competition” means and shall be deemed to exist in a particular country in the Territory with respect to a particular Product in a given Calendar Quarter if in such country during such Calendar Quarter one or more Generic Products (other than a Generic Product sold by Cara or its Affiliates or by a Sub-licensee under a license granted by Cara or its Affiliates) in the aggregate account (on a units sold basis) for more than [***] of the sum of (a) the aggregate unit sales of such Product sold by Cara or its Affiliates or Sub-licensees in such country, and (b) the aggregate unit sales of such Generic Products in such country, each in such Calendar Quarter, based on data provided by IQVIA (formerly, Quintiles IMS Holding, Inc.), or if such data is not available, such other reliable data source as reasonably agreed upon by Cara and Enteris. If no data is commercially available, then the Parties shall reasonably agree upon a commercially reasonable methodology for estimating the percentage unit-based market share of Generic Products in such country during the applicable time period.
		

		
			“Generic Product” means, with respect to a particular Product and a particular country, any pharmaceutical product (other than the Product) that contains the same active ingredient(s) in the same or substantially the same formulation and in a comparable quality and quantity as such Product, and is approved under an Abbreviated New Drug Application (ANDA) or any foreign equivalent thereof.
		

		
			
		

		
			

		 

		

			-  9  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			“Governmental Authority” means any multi-national, national, federal, state, local, municipal, provincial or other governmental, regulatory, administrative, judicial, public or statutory instrumentality, court or governmental tribunal, agency, commission, authority, body or entity, or any political subdivision thereof, having legal jurisdiction over the matter or party in question.
		

		
			“Improvement” means any Invention that constitutes a specific enhancement or improvement to or modification of the proprietary Licensed Technology (including Peptelligence® Formulation Technology), whether or not patentable.
		

		
			  “IND” means (a) an Investigational New Drug Application as defined in the FDCA or any successor application or procedure required to initiate clinical testing of the Product in humans in the United States; (b) a counterpart of an Investigational New Drug Application that is required in any other country or region in the Territory before beginning clinical testing of the Product in humans in such country or region; and (c) all supplements and amendments to any of the foregoing.
		

		
			“Indemnified Party” shall have the meaning set forth in Section 7.5(c).
		

		
			“Indemnifying Party” shall have the meaning set forth in Section 7.5(c).
		

		
			“Infringement” shall have the meaning set forth in Section 5.4(a)
		

		
			“Infringement Notice” shall have the meaning set forth in Section 5.4(a).
		

		
			“Invention” means any new or useful process, machine, method of manufacture, or composition of matter, whether or not patentable, or any idea, invention, discovery, improvement, enhancement, modification or derivative work, whether or not patentable or copyrightable, including in respect of, relating to or comprising a Product, that is conceived and/or first reduced to practice (actually or constructively), whether or not patentable, by or on behalf of Cara (including by an Affiliate, Sub-licensee or other Third Party) in connection with the Development, Manufacture and/or Commercialization of Products.
		

		
			“Know-how” means any and all proprietary technical and other information, whether or not patentable, including ideas, concepts, know-how, inventions, discoveries, data, formulae, processes, trade secrets, specifications, procedures for experiments and tests and other protocols, results of experimentation and testing, manufacturing and purification techniques and protocols.
		

		
			“Licensed Know-how” means any and all Know-how comprising, relating to or using the Peptelligence® Formulation Technology (including any formulations developed by Enteris using the Peptelligence® Formulation Technology, and any manufacturing processes of Enteris of drugs using such formulations), that is Controlled by Enteris, prior to or during the Term, including any Improvements, that is necessary or useful for the Development, Manufacture, use or sale of the Product.  To the extent that Cara exercises its right to a Royalty Buyout, “Licensed Know-how” shall exclude Improvements to such Know-how that are made by Enteris after the date on which Enteris receives a payment from Cara in connection with such Royalty Buyout.
		

		
			
		

		
			

		 

		

			-  10  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			“Licensed Patent Rights” means any and all Patent Rights that claim or cover any Licensed Know-how, including the Peptelligence® Formulation Technology (including any formulations developed by Enteris using the Peptelligence® Formulation Technology, and any manufacturing processes of Enteris for drugs using such formulations), that are Controlled by Enteris prior to or during the Term, and including any Improvements, that is necessary or useful for the Development, Manufacture, use or sale of the Product; provided, however, to the extent that Cara exercises its right to a Royalty Buyout, “Licensed Patent Rights” shall exclude Improvements claimed or covered in any such Patent Rights that are made by Enteris after the date on which Enteris receives a payment from Cara in connection with such Royalty Buyout.
		

		
			“Licensed Technology” means the Licensed Know-how and the Licensed Patent Rights.
		

		
			“Losses” shall have the meaning set forth in Section 7.5(a).
		

		
			“MAA” means any application for Regulatory Approval submitted to the EMA pursuant to the centralized approval procedure to obtain European Commission approval for the marketing of the Product in the European Union, or any successor application or procedure required to sell the Product in the European Union.
		

		
			“Manufacture” means, with respect to the Product, any activities related to the formulation, production, manufacture, processing, filling, finishing, packaging, labeling, release, shipping, holding, conduct of Manufacturing Process Development, stability testing, quality assurance, release testing and quality control of such Product or any intermediate thereof for Development or Commercialization, and regulatory activities related to any of the foregoing. When used as a verb, “Manufacturing” means to engage in Manufacture.
		

		
			“Manufacturing Process Development” means the development, qualification, validation and scale-up of the process used to manufacture the Product and analytic development and product characterization with respect thereto.
		

		
			“Manufacturing Services Agreement” means that certain Phase 2 Clinical Manufacturing Services Agreement dated July 1, 2015, by and between Enteris BioPharma, Inc., and Cara Therapeutics, Inc., as amended from time to time.
		

		
			“NDA” means a New Drug Application, as defined in the FDCA and regulations promulgated thereunder, or any successor application or procedure required to sell the Product in the United States.
		

		
			“Net Sales” means the gross amount billed or invoiced by Cara or any of its Affiliates or Sub-licensees (each, a “Seller”) to Third Parties (excluding sales of Products among Cara, its Affiliates and Sub-licensees for resale to Third Parties), throughout the Territory for sales or other dispositions or transfers for value of Products,  less [***].  In addition, Net Sales are subject to the following:
		

		
			[***]
		

		
			
		

		
			

		 

		

			-  11  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			In the case of pharmacy incentive programs, hospital performance incentive program chargebacks, disease management programs, similar programs or discounts on products, all discounts shall be allocated among products on the basis on which such discounts were actually granted or, if such basis cannot be determined, in proportion to the respective list prices of such products.
		

		
			For purposes of this Agreement, “sale” shall mean any commercial transfer or other commercial distribution or disposition, but shall not include transfers or other distributions or dispositions of Products at no charge (or at cost) for academic research, preclinical, clinical, or regulatory purposes (including the use of Products in clinical trials) or in connection with patient assistance programs or other charitable purposes or to physicians or hospitals for promotional purposes (including free samples to a level and in an amount which is customary in the industry and/or which is reasonably proportional to the market for such Product).
		

		
			Net Sales (including the deductions) shall be determined from the books and records of Cara, its Affiliates and its Sub-licensees, in all cases maintained in accordance with the relevant accounting standards, consistently applied. Such amounts shall be calculated using the same accounting principles used by Cara (or the applicable Affiliate or Sub-licensee) for other Cara (or its Affiliate or Sub-licensee) products for financial reporting purposes.
		

		
			“One Year Royalty Buyout” shall have the meaning in Section 6.5(c)(i).
		

		
			“Patent Rights” means issued patents and pending patent applications (which, for purposes of this Agreement, include certificates of invention, applications for certificates of invention and priority rights) in any country or region, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, all letters patent granted thereon, and all reissues, re-examinations and extensions thereof, and all foreign counterparts of any of the foregoing, and all the rights and interests in and to any of the foregoing.
		

		
			“Peptelligence® Formulation Technology” means Enteris’ proprietary technology relating to the methods and processes used by Enteris concerning the formulation, development, testing, manufacturing and/or packaging of active pharmaceutical ingredients, including: (i) the development of formulations for oral delivery of peptide active pharmaceutical ingredients in an enteric coated capsule or tablet containing a proprietary dry blend formulation of functional excipients to enhance permeability and/or solubility, including in any oral solid dosage forms, and/or (ii) the manufacture of drugs using such formulations.  Such proprietary technology is generally described in Exhibit C of this Agreement.
		

		
			“Product” means any drug product containing Drug in a formulation using or covered by the Licensed Technology.
		

		
			“Project Plan” means that certain project plan attached hereto as Exhibit C of this Agreement and incorporated herein, as such plan may be amended or modified by the Parties in writing from time to time.
		

		
			
		

		
			

		 

		

			-  12  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			“Proprietary Materials” means any tangible chemical, biological or physical materials that are furnished by or on behalf of one Party to the other Party in connection with this Agreement, whether or not specifically designated as proprietary by the transferring Party.  Proprietary Materials of Enteris shall include the Enteris DMF and all contents contained therein.
		

		
			“Recipient Party” shall have the meaning set forth in Section 4.8.
		

		
			“Recipients” shall have the meaning set forth in Section 4.1.
		

		
			“Regulatory Approval” means (a) in the United States, approval by the FDA of an NDA or similar application for marketing approval, and satisfaction of all related applicable FDA registration and notification requirements, if any, or (b) in any other country in the Territory, approval by Regulatory Authorities (including pricing and reimbursement approvals) having jurisdiction over such country of a single application or set of applications comparable to an NDA and satisfaction of all related applicable regulatory and notification requirements required for the marketing and sale of pharmaceuticals in such country.
		

		
			“Regulatory Authority” means any national, international, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity with authority over the distribution, importation, exportation, manufacture, production, use, storage, transport, clinical testing, pricing, sale or reimbursement of the Product in the Territory, including the FDA and the EMA.
		

		
			“Regulatory Filing” means, collectively: (a) any IND, NDA, MAA, establishment license application, drug master file, application for designation as an “Orphan Product(s)” under the Orphan Drug Act, for “Fast Track” status under Section 506 of the FDCA (21 U.S.C. § 356), for “Breakthrough Therapy” status under Section 506 of the FDCA (21 U.S.C. §356), or for a Special Protocol Assessment under Section 505(b)(4)(B) and (C) of the FDCA (21 U.S.C. § 355(b)(4)(B)) and all other similar filings (including counterparts of any of the foregoing in any country or region in the Territory); (b) all supplements and amendments to any of the foregoing; and (c) all data and other information contained in, and correspondence relating to, any of the foregoing.
		

		
			“Royalty Buyout” or “Royalty Buyouts” shall have the meaning set forth in Section 6.5(c)(ii).
		

		
			“Royalty Term” shall have the meaning set forth in Section 6.5(a).
		

		
			“Securities Act” shall have the meaning set forth in Section 6.5(c)(iii).
		

		
			“Significant Development Event”  means any of the following material Development events, a summary of which shall be included in any summary report: (a) any material interaction and/or written correspondence between Cara and any Regulatory Authority with respect to the Manufacture of a Product; (b) any material event with respect to any clinical trial involving the Manufacture of a Product; and (c) any material result obtained in the conduct of any clinical trial involving the Manufacture of a Product during the period covered by the Development report.
		

		
			
		

		
			

		 

		

			-  13  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			“Stock Purchase Agreement” means that certain common stock purchase agreement, in the form set forth in Exhibit B of this Agreement, that is entered into by the Parties concurrently with entry into this Agreement; for clarity, the Stock Purchase Agreement is not incorporated into or made part of this Agreement.
		

		
			“Sub-licensee” means any Third Party to which Cara grants (directly or indirectly) a sublicense in accordance with Section 2.2.
		

		
			“Sublicense Agreement” means any agreement by and between Cara and a Sub-licensee, and any agreement between any of Cara’s Sub-licensees and a further Sub-licensee, and all additional downstream sublicense agreements thereafter, that are entered into in accordance with Section 2.2.
		

		
			“Successful Completion” means the delivery of the meeting minutes from the FDA for the End of Phase 2 Meeting allowing for the continuation into Phase 3 clinical trials on Product.
		

		
			“Term” shall have the meaning set forth in Section 8.1.
		

		
			“Territory” means the United States (“U.S.”) and the rest of world excluding Japan and South Korea.
		

		
			“Third Party” means any Party other than Cara and Enteris and their respective Affiliates.
		

		
			“Transferring Party” shall have the meaning set forth in Section 4.8.
		

		
			“Two Year Royalty Buyout” shall have the meaning in Section 6.5(c)(ii).
		

		
			“VWAP” shall have the meaning set forth in Section 6.1.
		

		
			ARTICLE 2
		

		
			LICENSE GRANT
		

		
			2.1       Grant of License to Cara. Subject to the terms of this Agreement, Enteris hereby grants to Cara a non-exclusive, royalty-bearing license, including the right to grant sublicenses through multiple tiers as provided in Section 2.2, under the Licensed Technology, to Develop, Manufacture, and Commercialize Products in the Territory for use in the Field.
		

		
			2.2       Right to Sublicense. Cara shall have the right to grant sublicenses through multiple tiers under the license granted to it under Section 2.1 to any of Cara’s Affiliates and to any Third Parties (including the rights of Sub-licensees to grant further sublicenses) for the Development and Commercialization of Products in the Territory in the Field, including for Manufacture of Product by a CMO; provided that (i) Cara shall not be relieved of any of its obligations under this Agreement; (ii) Cara shall secure all appropriate covenants, obligations and rights from any such Sub-licensee, including licenses, assignment of intellectual property rights and confidentiality obligations, to ensure that such Sub-licensee is subject to, and complies with,
		

		
			
		

		
			

		 

		

			-  14  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			all of Cara’s applicable covenants and obligations under this Agreement; (iii) Cara shall be responsible for the performance of its obligations under this Agreement and shall use Commercially Reasonable Efforts to enforce the obligations of each Sub-licensee under the relevant Sublicense Agreement, including the performance of activities required, the making of all payments due and the making of any reports under this Agreement with respect to sales of Product by such Sub-licensee, and such Sub-licensee’s compliance with provisions of Sections 2.1, 2.6, 5.1, 5.4, 5.5, 5.7 and Article 4 of this Agreement; (iv) Cara shall require such Sub-licensee to retain such books and records, and Cara agrees that Cara will audit the books and records of any Sub-licensee, at Enteris’ request and expense, in accordance with the provisions of Section 6.7; (v) Cara shall provide Enteris with a copy of any such Sublicense Agreement executed by Cara pursuant to this Section 2.2 within [***] after execution; provided, that, the financial terms and any other confidential terms of any such Sublicense Agreement may be redacted to the extent not relevant to the determination or enforcement of Enteris’ rights under this Agreement; and (vi) Cara shall provide written notice to Enteris of such Sub-licensee within [***] after execution, but not in order to seek approval.  All obligations of Cara under this Section 2.2  shall apply mutatis mutandis to all Sub-licensees of Cara that further sublicense their rights and obligations under this Agreement to further Sub-licensees, and Cara shall require each of its Sub-licensees to include appropriate provisions in such further sublicense.
		

		
			2.3       Rights in Bankruptcy. All licenses and rights to licenses granted under or pursuant to this Agreement by Enteris to Cara are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code.
		

		
			2.4       Disclosure of Technology. Enteris shall provide periodic written notice and disclosure to Cara of any and all Licensed Technology that is necessary or useful for the Manufacture, use or sale of the Product that is or comes under the Control of Enteris on or after the Effective Date and during the Term of the Agreement, except in the event that Cara exercises its Royalty Buyout, Enteris shall only provide notice to Cara under this Section 2.4 of any Licensed Technology that comes under the Control of Enteris after the Effective Date and on or prior to the date on which Enteris receives a payment from Cara in connection with the Royalty Buyout.
		

		
			2.5       Retained Rights. Subject to the other terms of this Agreement, Enteris hereby retains the right to use and/or practice the Licensed Technology to develop, manufacture, or commercialize or have developed, manufactured, or commercialized any product (other than the Product) and for any and all uses either inside or outside of the Field and to otherwise exploit the Licensed Technology for any and all uses outside of the license grant.
		

		
			2.6       Use of Licensed Technology. Cara hereby agrees that (a) it shall not use or practice the Licensed Technology for any purpose other than exercising its rights and performing its obligations under this Agreement; and (b) except for the rights expressly set forth in this Agreement, Cara is not granted any rights, title or interest in or to such Licensed Technology.
		

		
			2.7       Negative Covenant. In order to preserve the economic value of the business deal in this Agreement for each Party, Enteris covenants that during the Term, it and its Affiliates shall not grant any third party generic manufacturer of pharmaceutical or drug products any license
		

		
			
		

		
			

		 

		

			-  15  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			or other rights (such as a covenant not to sue) under the Licensed Technology to Develop, Manufacture, or Commercialize any drug products containing the Drug in the Territory for use in the Field; provided that, the foregoing covenant shall automatically terminate, and this Section 2.7 shall thereafter be of no force and effect, if none of Cara or its Affiliates or Sub-licensees have launched a commercial Product by [***].
		

		
			ARTICLE 3
		

		
			DEVELOPMENT, REGULATORY AND COMMERCIALIZATION
		

		
			3.1       Manufacture by Enteris.  Enteris shall continue to perform its obligations under the Manufacturing Services Agreement in accordance with the terms thereof, including manufacture and supply requirements for Drug products for ongoing and (if applicable) future Phase 1 and Phase 2 clinical trials, until termination of such agreement.  For clarity, the first sentence of Section 2.5 and the first sentence of Section 4.1(b) of the Manufacturing Services Agreement are hereby terminated.
		

		
			3.2       Technology Transfer by Enteris.
		

		
			(a)        Enteris acknowledges that the transfer of all Licensed Technology existing as the Effective Date is critical to Cara’s ability to exercise its rights and receive its benefits under this Agreement. Enteris hereby covenants that it shall complete the transfer of all such Licensed Technology, subject, however, to the cooperation, resources and efforts of Cara's CMO to fully and effectively receive such technology transfer, commencing on a date as reasonably specified by Cara, and Enteris shall use diligent, good faith efforts to complete such technology transfer, including achieving the Completion of Analytical Procedures Transfer and Completion of Manufacturing Processes Transfer, as soon as reasonably practicable thereafter.  Cara shall cause its CMO to use diligent, good faith efforts to accept the technology transfer, and the Parties shall (and Cara shall cause its CMO to) work collaboratively and in good faith to conduct the full, accurate, and complete technology transfer under the Project Plan through the Completion of Analytical Procedures Transfer and Completion of Manufacturing Process Transfer.
		

		
			(b)       The Parties agree that the fee for the work as set forth under Section I of the Project Plan as of the Effective Date (Completion of Analytical Procedures Transfer) is [***]. Prior to commencement of the transfer of the manufacturing process, fees for all work contemplated under Section II of the Project Plan (Transfer of Manufacturing Process) shall be proposed by Enteris and agreed to by Cara, and such fees shall be commercially reasonable and typical for similar technology transfer work. In the event that Cara reasonably determines that additional technology transfer work by Enteris – beyond the tasks generally set forth in the then-current Project Plan – are needed to enable the CMO successfully to complete manufacture of amounts of Product as specified in and in accordance with the criteria in Section II (Transfer of Manufacturing Process) of the Project Plan to achieve Completion of Manufacturing Process Transfer, then the Parties shall discuss and agree reasonably and in good faith on such additional work required to be conducted by the Parties (and, if applicable, any CMO selected by Cara) to satisfy all the
		

		
			
		

		
			

		 

		

			-  16  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			acceptance criteria in the Project Plan, and a timeline and budget for such work (with the Enteris fees for such additional Enteris work to be commercially reasonable and typical for similar technology transfer work), in each case in accordance with Section 3.2(c). Notwithstanding the foregoing, any additional work performed by Enteris in furtherance of the analytical procedures transfer under Section I of the initial Project Plan, but not set forth in Section I of the Project Plan as of the Effective Date, shall not be included in the [***] fee, and the fee for such additional work shall be commercially reasonable and typical for similar technology transfer work. All payments due under this Section 3.2 shall be paid upon Completion of the Analytical Procedures Transfer or Completion of the Manufacturing Process Transfer, as applicable.
		

		
			(c)       Cara shall request additional services to the Project Plan in writing, detailing the proposed changes to the services (“Change of Scope”). Within [***] of Enteris’ receipt of such proposed Change of Scope, Enteris shall provide Cara with a cost and time estimate for performing the additional services as proposed, and the fees for such work, which costs and fees shall be commercially reasonable and typical for similar work.  The Parties shall jointly review and discuss the proposed Change of Scope, costs, fees and time estimate reasonably and in good faith.  Such additional services shall become part of the Project Plan upon execution by both Parties of the Change of Scope.   Any disagreements with respect to the Change of Scope shall be subject to Section 11.1.
		

		
			(d)       For purposes of this Section 3.2, Cara shall ensure that any CMO of Cara is subject to confidentiality provisions comparable in scope to Article 4 with respect to the transfer by Enteris to Cara and its CMO of information and Know-how under Section 3.2. Enteris does not represent or warrant that the use of, or results from, the analytical procedures or manufacturing processes will satisfy the requirements of any Regulatory Authority at the time of submissions of any Regulatory Filings to any such Regulatory Authority.
		

		
			3.3       Cara’s Rights and Obligations.
		

		
			(a)        Except as provided in Section 3.1, Cara shall have the sole right and responsibility, at its sole cost and expense, and in its sole discretion, for the Development, Manufacture and Commercialization of Products for use in the Field and in the Territory.
		

		
			(b)       Cara shall have the sole right and responsibility, at its sole cost and expense, and in its sole discretion, during the Term to Develop, seek Regulatory Approval, and (if Regulatory Approval is achieved) Commercialize Products in the Field in the Territory and shall, in its sole discretion, commit such resources (including employees, consultants, contractors, facilities, funding, equipment and materials) as it determines are necessary or appropriate to conduct such Development and Commercialization activities.
		

		
			(c)        Cara shall provide Enteris with written reports describing in reasonable summary its Development activities and Commercialization activities with respect to the Products in the Territory and the results of such activities on an annual basis, with the first report being due [***] after the Effective Date, which reports shall include a reasonable
		

		
			
		

		
			

		 

		

			-  17  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			summary of: (a) all Development and Commercialization activities conducted with respect to the Product (including the status of any clinical trials) and any launch plans (including expected date of first commercial sales of Product); (b) the Regulatory Filings with respect to such Products that Cara or any of its Affiliates have filed, sought or obtained in the prior [***] period or reasonably expect to make, seek or attempt to obtain in the following [***] period in the Territory, and (c) any Significant Development Events applicable to the Product. The reports shall also include a summary of all material questions asked by any Regulatory Authority to Cara regarding the Licensed Technology and of Cara’s responses thereto.  For purposes of clarity, the obligation to provide summary reports hereunder does not affect or supersede any such reporting or disclosure obligations of Cara as set forth in the Manufacturing Services Agreement.
		

		
			3.4       Regulatory Responsibility. Cara (and including its Affiliates and Sub-licensees) shall have the sole right and responsibility, at its and their sole discretion for (a) preparing, filing and maintaining all Regulatory Filings for Products in its own name in the Territory; provided that Enteris shall prepare, file and solely and exclusively own the Enteris DMF and all contents therein, and Cara shall have no ownership interest whatsoever in the Enteris DMF or the contents therein, and (b) reporting to Regulatory Authorities all adverse events and serious adverse events occurring in any clinical trials conducted by Cara related to any Products, to the extent required by Applicable Laws.  Enteris agrees to provide Cara with all information contained in the Enteris DMF, and in any analogous regulatory filing or documents in any other jurisdiction, to facilitate Cara’s Regulatory Filings in jurisdictions where the Enteris DMF is not recognized, subject to Section 4.8, it being understood that such information is deemed Proprietary Materials of Enteris.
		

		
			3.5       Recalls. If any Regulatory Authority issues or requests a recall or takes similar action in connection with any Product in the Territory, or if Cara (or and its Affiliate or Sub-Licensee) reasonably believes that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or other corrective action regarding the Product, Cara shall promptly advise Enteris thereof by telephone or facsimile.  Following such notification, Cara (or and its Affiliate or Sub-Licensee) shall decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it shall be required) or to take other corrective action in any country and the manner in which any such recall, market withdrawal or corrective action shall be conducted; provided, that, Cara shall keep Enteris regularly informed regarding any such recall, market withdrawal or corrective action.  All expenses incurred by Cara in connection with any such recall, market withdrawal or corrective action (including, without limitation, expenses for notification, destruction and return of the affected Product and any refund to customers of amounts paid for such Product) shall be the sole responsibility of Cara.
		

		
			3.6       Safety Information.  Each Party shall disclose to other Party any and all information of which that Party (or its Affiliate) becomes aware relating to any safety issues for formulations using or based on the Licensed Technology, which reasonably may impact the safety of Product, such disclosure to be made promptly after the Party becomes aware thereof.
		

		
			
		

		
			

		 

		

			-  18  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			3.7       Reference Rights. Cara (and its Affiliates and Sub-Licensees) shall have (i) the right of reference to the Enteris DMF and the information therein, and (ii) the right to reference the information contained in the Enteris DMF in all of Cara’s (and its Affiliates and Sub-Licensees) Regulatory Filings in jurisdictions where the Enteris DMF is not recognized, in each case solely for the purpose of exercising, using and practicing the licenses and other rights granted to Cara pursuant to this Agreement, provided that Cara shall bear any expenses (including expenses of Enteris) in respect of exercising any such right of reference.
		

		
			ARTICLE 4
		

		
			CONFIDENTIALITY, PUBLICITY, PUBLICATIONS
		

		
			4.1       Confidentiality. Each Party agrees that, during the Term and for a period of [***] thereafter, it and its Affiliates shall keep confidential and shall not publish or otherwise disclose to any Third Party and shall not use for any purpose other than to exercise its rights or perform its obligations under this Agreement or the Project Plan any Confidential Information furnished to it or its Affiliate by the other Party or its Affiliate pursuant to this Agreement or the Project Plan, except to the extent expressly authorized by this Agreement or the Project Plan, or as otherwise agreed to in writing by the Parties. Each Party shall further require its Affiliates, and its and their respective directors, officers, employees, agents, consultants, sublicensees, contractors, partners, acquirors, assignees, and distributors (collectively, “Recipients”) who receive the other Party’s Confidential Information to agree, in writing, to be bound by duties and obligations of confidentiality and non-use no less stringent than those contained in this Section 4.1.  The foregoing confidentiality and non-use provisions will apply over any preceding obligations of confidentiality between Enteris and Cara, including those set forth in the Manufacturing Services Agreement. The foregoing confidentiality and non-use obligations do not apply to any particular portion of the disclosing Party’s Confidential Information that the receiving Party can demonstrate by competent written proof:
		

		
			(a)       was already known to or otherwise in the possession of, the receiving Party, other than under an obligation of confidentiality, prior to the time of disclosure by the disclosing Party or its Affiliate, as evidenced by contemporaneous writing;
		

		
			(b)       was part of the public domain at the time of its disclosure to the receiving Party or any of its Recipients;
		

		
			(c)        became part of the public domain after its disclosure and other than through any act or omission of the receiving Party or any of its Recipients in breach of this Agreement;
		

		
			(d)       was disclosed to the receiving Party on a non-confidential basis by a Third Party who, to the receiving Party’s knowledge after due inquiry, had a legal right to make such disclosure; or
		

		
			(e)        was independently discovered or developed by the receiving Party or its Affiliate without aid, application, reference to or use of the disclosing Party’s Confidential
		

		
			
		

		
			

		 

		

			-  19  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			Information, as evidenced by a contemporaneous writing dated prior to the time of disclosure by the disclosing Party or its Affiliate.
		

		
			4.2       Authorized Disclosure. Notwithstanding the obligations set forth in Section 4.1, a Party or its Affiliate may disclose the other Party’s Confidential Information and the terms of this Agreement to the extent:
		

		
			(a)        such disclosure is reasonably necessary (i) for the filing or prosecuting of Patent Rights as contemplated by this Agreement; (ii) to comply with the requirements of Regulatory Authorities with respect to obtaining and maintaining Regulatory Approval of a Product or submission of information to tax or other Governmental Authorities; (iii) for prosecuting or defending litigation as contemplated by this Agreement; or (iv) complying with Applicable Law;
		

		
			(b)       such disclosure is reasonably necessary to its officers, directors, employees, agents, consultants, contractors, licensees, sublicensees, attorneys, accountants, sources of debt or equity financing, insurers or licensors who need to know such information in order for such Party to perform its obligations or exercise its rights under this Agreement, and to potential acquirers, merger partners, strategic partners, or sources of debt or equity financing, and their professional advisors, for use in diligence and related activities in the proposed transaction(s); provided that in each case, the disclosees are bound by written obligations of confidentiality and non-use, or by equivalent professional ethical obligations, no less stringent than those of this Agreement with a reasonable duration based on customary terms;
		

		
			(c)        such disclosure is reasonably necessary to any bona fide potential or actual investor, acquiror, merger partner or other financial or commercial partner for the sole purpose of evaluating an actual or potential investment, acquisition or other business relationship; provided that, in each case, the disclosees are bound by written obligations of confidentiality and non-use no less stringent than to those of this Agreement with a reasonable duration based on customary terms, and further provided that in the case of any such disclosure of Confidential Information to any actual or potential competitor of either Party, all competitively sensitive information (including, for the avoidance of doubt, all financial information) herein shall be redacted until, subject to Applicable Laws, the execution of a definitive agreement with such actual or potential competitor to implement a transaction with the receiving Party is imminent; or
		

		
			(d)       such disclosure is reasonably necessary to comply with Applicable Laws, including regulations promulgated by applicable security exchanges, court order, administrative subpoena or other order.
		

		
			(e)        Notwithstanding the foregoing, if a Party or its Affiliate is required to make a disclosure of the other Party’s Confidential Information pursuant to Section 4.2(a)(iii)-(iv) or 4.2(d), then such Party shall (i) promptly notify the other Party of such required disclosure, (ii) give the other Party an opportunity to seek confidential treatment and, upon the other Party’s request, such Party and its Affiliates shall use reasonable efforts to obtain,
		

		
			
		

		
			

		 

		

			-  20  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			or to assist the other Party in obtaining, a protective order preventing or limiting the required disclosure and (iii) if the other Party is unsuccessful in its efforts pursuant to subsection (ii), disclose only that portion of the Confidential Information that such Party is legally required to disclose.
		

		
			4.3       Employees and Consultants. Enteris and Cara each hereby represents that all of its employees and consultants, and all of the employees and consultants of its Affiliates, who have access to Confidential Information of the other Party are or will, prior to having such access, be bound by written obligations to maintain such Confidential Information in confidence. Each Party agrees to use, and to cause its Affiliates to use, Commercially Reasonable Efforts to enforce such obligations and to prohibit its employees and consultants from using such information except as expressly permitted hereunder. Recipient party will be liable to the other for any disclosure or misuse by its employees of Confidential Information of the disclosing Party.
		

		
			4.4       Publicity.  The Parties shall, upon the execution of this Agreement, issue a joint press release with respect to this Agreement in a form mutually agreeable by both Parties, and each Party may make subsequent public disclosure of the contents of such press release without further approval of the other Party.  After release of such press release, if either Party or its Affiliate desires to make a public announcement concerning the existence or terms of this Agreement, or any clinical or regulatory announcements, early notification of such public announcement by the proposing Party shall be given in writing to the other Party at least [***] before the proposed disclosure date and a draft of such public announcement shall be sent to the commenting Party for its review and comment at least [***] before the proposed disclosure date, but subject to Section 4.5.  Under no circumstances shall any competitively sensitive information contained in this Agreement (including all financial information, including total value of this Agreement) be disclosed, except as otherwise provided in Section 4.5.
		

		
			4.5       Public Filings. The Parties acknowledge that either or both Parties may be obligated to file under Applicable Laws a copy of this Agreement with the U.S. Securities and Exchange Commission or other Governmental Authorities. Each Party shall be entitled to make such a required filing, provided that it requests confidential treatment of the commercial terms and sensitive technical terms hereof and thereof to the extent such confidential treatment is reasonably available to such Party.  In the event of any such filing, each Party will provide the other Party with a copy of this Agreement marked to show provisions for which such Party intends to seek confidential treatment and shall reasonably consider and incorporate the other Party’s reasonable comments thereon to the extent consistent with the legal requirements, with respect to the filing Party, governing disclosure of material agreements and material information that must be publicly filed.  Further, each Party acknowledges that the other Party, or its successor, may be required by Applicable Laws to make public disclosure of events or results of activities under this Agreement, and that such disclosures may be made, if required by such Applicable Laws, prior to the expiration of the notice periods in Section 4.4., provided that a Party (or successor) shall not, in any such public disclosure, disclose any of the other Party’s Confidential Information, unless such Party is required by Applicable Law to make such a public disclosure of such particular information.  In such event, such Party shall submit the proposed disclosure in writing to the other Party as far in advance as reasonably practicable so as to provide a reasonable opportunity to comment thereon, and such Party required to make the disclosure shall consider all comments from such other Party
		

		
			
		

		
			

		 

		

			-  21  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			in good faith, and shall in any event only disclose such information of the other Party as is required by Applicable Law to be disclosed publicly in such manner.
		

		
			 
		

		
			4.6       Publications and Presentations.  Except for disclosures permitted pursuant to Section 4.4 or Section 4.5, if a Party wishes to make a publication relating to activities conducted under this Agreement or the results of such activities hereunder, and such publication would disclose Confidential Information of the other Party,  (a) it shall deliver to the other Party a copy of any such proposed written publication or an outline of a proposed oral disclosure at least [***] prior to submission for publication or presentation, (b) the reviewing Party shall have the right to require a delay of up to [***] in publication or presentation in order to enable patent applications to be filed protecting such reviewing Party’s rights in potentially patentable inventions that are owned by such Party and that would be publicly disclosed by the publication of the information in such publication, and (c) such reviewing Party shall have the right to prohibit disclosure of any of its Confidential Information in any such proposed publication or presentation.  In any such publication or presentation by a Party, the other Party’s contribution shall be duly recognized, in accordance with customary industry standards.  For clarity, Cara is free to make publications about its (and its Affiliates’ and Sub-licensees’) activities under this Agreement, and results of such activities, without review by Enteris, provided that such publications do not disclose Confidential Information of Enteris.  Further, Enteris covenants that it and its Affiliates shall not publish (or permit publication of) any non-public information relating to Cara’s (and its Affiliate’s and Sub-licensee’s) activities under this Agreement, or the results of such activities, without the prior written consent of Cara, such consent not to be unreasonably withheld.
		

		
			4.7       Permitted Publications. Notwithstanding Sections 4.4 through  4.6, either Party may include in a public disclosure or in a scientific or medical publication or representation, without prior delivery to or approval by the other Party, any information which has previously been included in a public disclosure or scientific or medical publication that has been approved or otherwise made pursuant to Section 4.4 or 4.5 or reviewed pursuant to Section 4.6 or published or publicly disclosed by the other Party. A Party relying on this Section 4.7 shall bear the burden of establishing that information has previously been included in a public disclosure or scientific or medical publication that has been approved pursuant to Section 4.4 or 4.5 or reviewed pursuant to Section 4.6 or published or publicly disclosed by the other Party.  For clarity, Cara (and its Affiliates and Sub-licensees) retain the full rights to publish clinical and other data and results relating to Drug or Product without consent of or comment by Enteris, provided that such publications do not disclose Enteris Confidential Information.   Cara and Enteris each may further disclose or publish that Cara and Enteris are parties to this Agreement and the general scope of the rights granted hereunder, but excluding any financial terms or the total value of the Agreement.
		

		
			4.8       Use of Proprietary Materials. From time to time during the Term, one Party (the “Transferring Party”) may supply the other Party (the “Recipient Party”) with Proprietary Materials of the Transferring Party for use in the Manufacture or Development of a Product.  In connection therewith, each Recipient Party hereby agrees that: (a) it shall not use such Proprietary Materials for any purpose other than exercising its rights or performing its obligations hereunder; (b) it shall use such Proprietary Materials only in compliance with all Applicable Laws; (c) it shall not transfer any such Proprietary Materials to any Third Party without the prior written consent of the Transferring Party, except for (i) the transfer of Products for use in clinical trials or
		

		
			
		

		
			

		 

		

			-  22  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			(ii) in a transaction expressly permitted hereby (such as transfer by Cara to its CMO); (d) the Recipient Party shall not acquire any right of ownership or title in or to such Proprietary Materials as a result of such supply by the Transferring Party; and (e) upon the expiration or termination of this Agreement, the Recipient Party shall, if and as instructed by the Transferring Party, either destroy or return any such Proprietary Materials that are not the subject of the grant of a continuing license under this Agreement.
		

		
			ARTICLE 5
		

		
			INTELLECTUAL PROPERTY RIGHTS
		

		
			5.1       Enteris Rights. Enteris shall own all rights, title, and interest on a worldwide basis in and to the Licensed Patent Rights and Licensed Know-how, including any Improvements (including any Patent Rights claiming or covering such Improvements) regardless of inventorship, used to formulate, develop or otherwise exploit the Drug or Product, and Enteris retains all rights to prosecute and maintain the Licensed Patent Rights at its sole discretion and sole expense.  Cara shall cooperate with and assist Enteris in all reasonable respects, at Enteris’ expense, in connection with Enteris’ preparation, filing, prosecution (including review and comments regarding responses to office actions and/or official actions from worldwide patent offices) and maintenance of such Licensed Patent Rights, including by obtaining assignments to reflect chain of title consistent with the terms of this Agreement, gaining United States patent term extensions, supplementary protection certificates and any other extensions that are now or become available in the future wherever applicable to such Licensed Patent Rights.
		

		
			5.2       Cara Rights. Cara shall own all rights, title, and interest on a worldwide basis in and to any Inventions, other than Improvements, including any Patent Rights claiming or covering any such Invention, and Cara shall retain all rights to prosecute and maintain such Patent Rights in its sole discretion and sole expense.  Further, and notwithstanding the foregoing, Cara shall own the overall formulation of the Product, provided that Enteris shall retain ownership of all Licensed Technology that claims or is incorporated in such formulation.  Notwithstanding the foregoing, Cara acknowledges that a license shall be required with respect to any formulation to the extent that the formulation uses or practices issued patents or Confidential Information of Enteris in the Licensed Technology (excluding any Confidential Information that is subject to any of the exceptions in subsections 4.1(a)-(e)).
		

		
			5.3       Notice; Inventorship.  Cara hereby agrees to promptly notify Enteris of the conception or reduction to practice of any Improvements made by or on behalf of  Cara and to promptly execute any documents that may be necessary to perfect Enteris’ ownership and rights in and to any such Improvements. In case of a dispute between the Parties over whether any particular Invention is an Improvement, such dispute shall be resolved according to U.S. patent law pursuant to Article 11, with an arbitration (if conducted) by patent counsel mutually selected by the Parties who (and whose firm) is not at the time of the Dispute, and was not at any time during the [***] prior to such Dispute, performing services for either of the Parties.  Expenses of the patent counsel shall be shared equally by the Parties.  With respect to any Inventions that are Improvements, Cara, its Affiliates and Sub-licensees, and their respective employees,
		

		
			
		

		
			

		 

		

			-  23  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			subcontractors and contractors, and agents, shall assign, and do hereby irrevocably and perpetually assign, to Enteris, all worldwide rights, title and interest in and to all such Improvements (including all Patent Rights or other intellectual property rights relating thereto).
		

		
			5.4       Third Party Infringement.
		

		
			(a)        Notice. If either Party becomes aware of any suspected infringement or misappropriation of any Licensed Technology that cover the Development, Manufacture or Commercialization of the Product anywhere in the Territory (each, an “Infringement”), that Party shall promptly notify the other Party within [***] and provide it with all details of such Infringement of which it is aware, excluding privileged information (each, an “Infringement Notice”).
		

		
			(b)       Enteris Right to Enforce. Enteris shall have the first right, but not the obligation, to address such Infringement in the Territory that involves such Licensed Technology by taking reasonable steps, which may include the institution of legal proceedings or other action, and to compromise or settle such Infringement (each, an “Infringement Response”); provided, that: (A) Enteris shall keep Cara fully informed about such Infringement Response and Cara shall provide, at Enteris’ expense all reasonable cooperation to Enteris in connection with such Infringement Response; (B) Enteris shall not take any position with respect to, or compromise or settle, any such Infringement in any way that is reasonably likely to directly and adversely affect the scope, validity or enforceability of any such Licensed Technology, without the prior consent of Cara, which consent shall not be unreasonably withheld, conditioned or delayed; and (C) if Enteris does not intend to prosecute or defend an Infringement, or ceases to diligently pursue an Infringement Response with respect to such an Infringement, it shall inform Cara in such a manner that such Infringement Response will not be prejudiced and Section 5.4(c) shall apply.  [***]
		

		
			(c)        Cara’s Right to Enforce.  If (A) Enteris informs Cara in writing that it does not intend to prosecute any Infringement Response with respect to any such Infringement, (B) within [***] after the receipt of notice of any such Infringement, Enteris has not commenced to take any Infringement Response with respect thereto, or (C) if Enteris does not diligently pursue any such Infringement Response, then, unless Enteris provides Cara with a commercially reasonable justification for its delay of such Infringement Response, and provided that such delay will not adversely affect the scope, validity or enforceability of the Licensed Technology subject to the Infringement and will not materially affect Cara’s Commercialization of Product, Cara shall have the right, at its own expense, upon written notice to Enteris to take appropriate action to address such Infringement, including by initiating an Infringement Response or taking over prosecution of any legal proceedings initiated by Enteris. In that event, Cara shall keep Enteris fully informed about such Infringement Response and shall consult with Enteris before taking any major steps during the conduct of that Infringement Response. Enteris shall provide reasonable cooperation to Cara in connection with that Infringement Response. Cara shall not take any position with respect to, or compromise or settle, such Infringement in any way that is reasonably likely
		

		
			
		

		
			

		 

		

			-  24  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			to directly and adversely affect the scope, validity or enforceability of such Licensed Technology. [***]
		

		
			(d)       Right to Representation. Each Party shall have the right to participate and be represented by counsel that it selects, in any Infringement Response instituted under Section 5.4(b) or 5.4(c) by the other Party. If a Party with the right to initiate an Infringement Response under Section 5.4 to eliminate an Infringement lacks standing to do so and the other Party has standing to initiate such action, then the Party with the right to initiate an action under Section 5.4 may name the other Party as plaintiff in such action or may require the Party with standing to initiate such Infringement Response at the expense of the other Party.
		

		
			(e)        Cooperation. In any Infringement Response instituted under this Section 5.4, the Parties shall cooperate with and assist each other in all reasonable respects. Upon the reasonable request of the Party instituting that Infringement Response, the other Party shall join such Infringement Response and shall be represented using counsel of its own choice, at the requesting Party’s expense.
		

		
			(f)        Allocation of Recoveries. Any settlements, damages or monetary awards (“Recovery”) recovered by either Party pursuant to any Infringement Response shall, after reimbursing the Parties for their reasonable out-of-pocket expenses in making such recovery (which amounts shall be allocated pro rata if insufficient to cover the totality of such expenses), [***].
		

		
			5.5       Defense of Claims. If any action, suit or proceeding is brought against either Party or any Affiliate of either Party alleging the infringement of the Know-how or Patent Rights of a Third Party by reason of the Development, Manufacture or Commercialization of any Product, such Party shall notify the other Party within [***] of the earlier of (a) receipt of service of process in such action, suit or proceeding, or (b) the date such Party becomes aware that such action, suit or proceeding has been instituted, and the Parties shall meet as soon as possible to discuss the overall strategy for defense of such matter.  Except as otherwise agreed in writing by the Parties, the Party alleged to have infringed, or whose Affiliate or Sub-licensee is alleged to have infringed, shall have the obligation to defend such action, suit or proceeding at its sole expense, and in its sole discretion; the other Party shall have the right to separate counsel at its own expense in any such action, suit or proceeding, provided that its intellectual property rights are actually at issue in the action or proceeding, and that it shall not interfere or compromise the defending Party’s defense of such action.  In any such action or proceeding, the Parties shall cooperate with each other in all reasonable respects in the defense of any such action, suit or proceeding.  All such expenses with respect to any such action, suit or proceeding in the Territory shall be borne solely by the Party defending such action, suit or proceeding.  Each Party shall promptly furnish the other Party with a copy of each communication relating to the alleged infringement that is received by such Party including all material documents filed in any related litigations as to such infringement that are reasonably needed by the other Party, but excluding confidential or privileged communications or documents.
		

		
			
		

		
			

		 

		

			-  25  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			5.6       Patent Term Extension. The Parties shall cooperate with each other in obtaining patent term extensions or supplemental protection certificates or their equivalents in any country in the Territory where applicable to Licensed Patent Rights. Such cooperation shall include diligently and timely conferring and coordinating with respect to such matters to ensure compliance with applicable filing deadlines, and agreeing on procedures to be followed by the Parties to ensure such compliance. In the event that elections with respect to obtaining such patent term extension are to be made, Enteris shall have the right to make the election with respect to Licensed Patent Rights.
		

		
			5.7       Patent Marking. Cara agrees to mark, and to cause its Affiliates and Sub-licensees to mark, Products sold in the U.S. with all applicable U.S. patent numbers in issued Patent Rights that claim the Product (or its manufacture), and to mark Products shipped to or sold in other countries, in each case to comply with the patent laws and practices of the countries of manufacture, use and sale.  Such marking may be on the packaging for the Products, if permitted by Applicable Laws.
		

		
			ARTICLE 6
		

		
			CONSIDERATION
		

		
			6.1       Upfront Fee. In consideration of the grant by Enteris to Cara of the license in Section 2.1, Cara shall pay Enteris or Enteris’ designees (as contemplated by the Stock Purchase Agreement) a non-refundable, non-creditable upfront fee in an aggregate amount equal to eight million dollars ($8,000,000), fifty percent (50%) of which shall be payable by transfer of immediately available funds, within five (5) days of execution of this Agreement, in accordance with the wire transfer instructions set forth in Exhibit A, attached hereto and incorporated herein, and the invoice provided in writing by Enteris to Cara prior to the Effective Date, and the other fifty percent (50%) of which shall be paid in Cara stock issued by Cara to Enteris, or its designee, pursuant to the terms of the Stock Purchase Agreement.
		

		
			6.2       Milestone Payments. Cara shall make the following non-refundable, non-creditable one-time payments to Enteris within [***] after the first achievement of each of the following milestone events with respect to Cara’s first Product (or Products, cumulatively, in the case of sales milestones) (whether such milestone is achieved by Cara or its Affiliate or Sub-licensee) utilizing the Licensed Technology, regardless of indication:
		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						Milestone Event

					
					
						Payment

				
	
					
						 

					
					
						 

					
					
						($ U.S. Dollars)

				
	
					
						Milestone #1

					
					
						[***]

					
					
						$[***]

				
	
					
						Milestone #2

					
					
						[***]*

					
					
						$[***]

				

		
			 
		

		
			
		

		

		 

		

			-  26  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

	
					
						

					
						 

					
					
						 

					
					
						 

				
	
					
						Milestone #3

					
					
						[***]

					
					
						$[***]

				
	
					
						Milestone #4

					
					
						[***]

					
					
						$[***]

				
	
					
						Milestone #5

					
					
						[***]

					
					
						$[***]

				
	
					
						Milestone #6

					
					
						[***]

					
					
						$[***]

				
	
					
						Milestone #7

					
					
						[***]

					
					
						$[***]

				

		
			 
		

		
			*[***]
		

		
			6.3       [***]
		

		
			6.4       Notice and Payment of Milestones. Cara shall provide Enteris with prompt written notice, in any event within [***] thereafter, upon Cara’s knowledge of the occurrence of each milestone event set forth in Section 6.2.  If Enteris believes any such milestone event has occurred and has not received a written notice of same from Cara, it shall so notify Cara and shall provide to Cara documentation or other information that support its belief.  Any dispute under this Section 6.4 that relates to whether or not a milestone event has occurred shall be resolved by discussion and, if needed, arbitration in accordance with Article 11.  If Cara determines that there is a reasonable likelihood of a particular milestone event being achieved on or about a particular date, Cara shall use reasonable efforts to provide advance notice thereof to Enteris, which notice shall be provided solely for Enteris’ planning purposes and shall not be construed as a representation, warranty or covenant by Cara that such milestone event will occur when anticipated, or at all.  Each milestone payment under Section 6.2 shall only be payable once, and, for clarity, the total amount of milestones payable under Section 6.2 shall not exceed $[***].
		

		
			6.5       Payment of Royalties; Accounting and Records.
		

		
			(a)        Payment of Royalties. Cara shall pay Enteris a tiered royalty on the applicable amount of Net Sales of Products in each Calendar Year (or partial Calendar Year) at the following rates:
		

		
			
		

		

		 

		

			-  27  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

	
					
						

					
						 

					
						 

					
						 

					
						 

					
						 

					
					
						 

				
	
					
						Aggregate Amount of Net Sales in

					
					
						Royalty Rate (%)

				
	
					
						a Calendar Year for All Products

					
					
						 

				
	
					
						in All Indications

					
					
						 

				
	
					
						Amount of annual Net Sales [***]

					
					
						[***]%

				
	
					
						Amount of annual Net Sales [***]

					
					
						[***]%

				

		
			 
		

		
			[***]
		

		
			(b)       Royalty Reductions. For sales of Product in countries where there is no valid claim in an issued patent in the Licensed Patent Rights that covers the Product, royalties for such Product in such country will be paid on Net Sales of such Product in such country at [***] of the royalty rate otherwise applicable to such Net Sales in the above schedule.
		

		
			(c)        Royalty Buyout.
		

		
			(i)         On or before the first (1st) anniversary of the Effective Date, Cara shall have the right, but not the obligation, to terminate its obligation to pay any royalties by paying to Enteris or Enteris’ designees (as contemplated by the Stock Purchase Agreement) the sum of [***] payable in cash (the “One Year Royalty Buyout”).
		

		
			(ii)       After the first (1st) anniversary of the Effective Date but on or before the second (2nd) anniversary of the Effective Date, Cara shall have the right, but not the obligation, to terminate its obligation to pay any royalties by paying to Enteris or Enteris’ designees (as contemplated by the Stock Purchase Agreement) the sum of [***] payable in cash (the “Two Year Royalty Buyout”, collectively with the One Year Royalty Buyout, the “Royalty Buyouts”, and each a “Royalty Buyout”).
		

		
			(iii)      If either (x) Cara is a “well-known seasoned issuer,” as such term is defined in Rule 405 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), as of the date of the exercise of the Royalty Buyout, or (y) (i) the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission has issued to Cara a no-action letter regarding the commencement of the holding period under Rule 144(d) promulgated under the Securities Act for such shares of Cara stock as are otherwise issuable at the election of Cara as partial payment of the Royalty Buyout as permitted under this Section 6.5(c)(iii), and such no-action letter permits tacking of such holding period back to the date of this Agreement, and (ii) sufficient time has passed since the date of this Agreement (and all other requirements under Rule 144 are met) to permit the holders of the stock to be issued by Cara in relation to the Royalty Buyout to sell all such shares on the date of Cara’s exercise of such option in compliance with Rule 144 under the Securities Act without any restrictions, then Cara shall have the option, but not the
		

		
			
		

		
			

		 

		

			-  28  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			obligation, to pay fifty percent (50%) of the Royalty Buyout amount by issuing Cara stock to Enteris or its designee pursuant to the Stock Purchase Agreement.
		

		
			(iv)       In order to exercise a Royalty Buyout, Cara shall notify Enteris and, if the option to partially pay in Cara stock as permitted by Section 6.5(c)(iii) above is exercised by Cara, EBP Holdco LLC and any designees of Enteris and EBP Holdco LLC,  in writing that it is paying the Royalty Buyout and shall pay such Royalty Buyout within [***] of such notice. For avoidance of doubt, upon Enteris’ receipt of the Royalty Buyout under this Section 6.5(c), no royalties shall thereafter be due to Enteris under this Agreement and the Royalty Term (and the provisions of this Section 6.5) shall end immediately.  For the avoidance of doubt, the expiration of the Royalty Term, including due to payment of a Royalty Buyout, shall not affect Cara’s obligation to pay Enteris milestones pursuant to Section 6.2 of this Agreement, including milestone events based on [***]. In the event that Cara provides Enteris with a notice that it is exercising the Royalty Buyout but no payment is received by Enteris within the [***] period (other than solely due to an issue with Enteris or its bank), then the Royalty Buyout is deemed to not have been exercised. Such failure to pay the Royalty Buyout amount within that [***] period is not subject to cure.
		

		
			6.6       Payment Dates and Reports. Cara shall make all royalty payments due hereunder within [***] after the end of each Calendar Quarter in which the sale of such Product shall occur.  Cara shall provide, within [***] after each Calendar Quarter in which a sale of such Product shall occur, a report showing: (a) the Net Sales of each Product by type of Product and country in the Territory; (b) an itemization of the deductions permitted to determine Net Sales; (c) a calculation of the amount of royalty due to Enteris, if applicable; and (d) [***]. Payment of all milestone events due hereunder, including the milestones on [***], shall be made in accordance with Section 6.2.  The Parties agree that, notwithstanding anything to the contrary in the Manufacturing Services Agreement, Cara has and shall have no further obligation under Section 4.1(b) of the Services Agreement to pay any additional License Access Fees (as defined in the Manufacturing Services Agreement), and any such obligation going forward is hereby terminated.
		

		
			6.7       Records; Audit Rights.  Cara and its Affiliates and Sub-licensees shall keep and maintain, for [***] from the date of (x) each payment of royalties under this Agreement and (y) each milestone owed, complete and accurate records of gross sales and Net Sales by Cara and its Affiliates and Sub-licensees, in sufficient detail to allow royalties and milestones on Net Sales to be determined accurately.  All such records required to be maintained under this Section 6.7 shall include the information contained in the reports required under Section 6.6.  Enteris shall have the right for a period of [***] after receiving any such payments to appoint at its expense an independent certified public accountant reasonably acceptable to Cara to audit such records of Cara, or its Affiliates, to verify that the amount of any such payment was correctly determined.  Cara and its Affiliates shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] written notice from Enteris.  Such audit right shall not be exercised by Enteris more than once in any Calendar Year or more than once with respect to sales of a particular Product in a particular period or with respect to an individual milestone.  All records
		

		
			
		

		
			

		 

		

			-  29  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			made available for audit shall be deemed to be Confidential Information of Cara.  The results of each audit, if any, shall be binding on both Parties absent manifest error.  In the event there was an underpayment by Cara under this Agreement, Cara shall promptly (but in any event no later than [***] after Cara’s receipt of the report so concluding) make payment to Enteris of any shortfall together with interest as provided in Section 6.8 from the date such payment was due to the date paid in full.  Enteris shall bear the full cost of such audit unless such audit discloses a variance to the detriment of Enteris of five percent 5% or more from the amount of the original payment calculation in which case Cara shall bear all reasonable cost of the performance of such audit.
		

		
			6.8       Overdue Payments. All payments not made by Cara to Enteris when due under this Agreement shall bear interest at a rate equal at [***] (as quoted in The Wall Street Journal or its successor on the day after the payment is due) calculated from the due date to the date paid in full. Any such overdue payment shall, when made, be accompanied by, and credited first to, all interest so accrued.
		

		
			6.9       Payments;  Withholding Tax.
		

		
			(a)        Payments in Dollars. All payments made by Cara under this Section shall be made by wire transfer from a banking institution in United States Dollars in accordance with instructions given in writing from time to time by the other Party.
		

		
			(b)       Withholding Taxes. If Applicable Laws require withholding of income or other taxes imposed upon any payments made by Cara to Enteris under this Agreement, Cara shall (i) make such withholding payments as may be required, (ii) subtract such withholding payments from such payments, (iii) submit appropriate proof of payment of the withholding taxes to Enteris within a reasonable period of time, and (iv) promptly provide Enteris with all official receipts with respect thereto.  Cara shall render Enteris reasonable assistance in order to allow Enteris to obtain the benefit of any present or future treaty against double taxation which may apply to such payments.
		

		
			6.10     Foreign Currency Exchange. If, in any Calendar Quarter, Net Sales are made in any currency other than United States Dollars, such Net Sales shall be converted into United States Dollars by applying the exchange rate conversion consistently used by Cara in its audited consolidated accounts making use of a publicly available foreign exchange rate source.
		

		
			6.11     Cara Obligations. Cara shall be solely responsible for all amounts it owes to any Third Party in connection with the Development, Manufacture, or Commercialization of Products in the Field in the Territory.
		

		
			ARTICLE 7
		

		
			REPRESENTATIONS AND WARRANTIES; COVENANTS; LIABILITY
		

		
			7.1       Mutual. Enteris and Cara each represents and warrants to the other Party, as of the Effective Date, as follows:
		

		
			
		

		
			

		 

		

			-  30  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			(a)        It is a corporation or company duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver and perform this Agreement.
		

		
			(b)       The execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action and will not violate (a) such Party’s certificate of incorporation or bylaws, (b) any agreement, instrument or contractual obligation to which such Party is bound in any material respect, (c) any requirement of any Applicable Laws, or (d) any order, writ, judgment, injunction, decree, determination or award of any court or governmental agency presently in effect applicable to such Party.
		

		
			(c)        This Agreement is a legal, valid and binding obligation of such Party, enforceable against it in accordance with its terms and conditions, subject to all bankruptcy and other debtor laws and protections and to equitable principles.
		

		
			(d)       It is not under any obligation, contractual or otherwise, to any other person or entity that conflicts with or is inconsistent in any respect with the terms of this Agreement or that would impede the diligent and complete fulfillment of its obligations hereunder.
		

		
			(e)        Such Party has never been, and is not currently, a Debarred Entity. Each of the Parties further warrants and represents that no Debarred Entity has performed or rendered, any services or assistance on its behalf relating to activities contemplated or rights granted pursuant to this Agreement.  Each Party certifies and covenants that it shall not use, in any capacity, a Debarred Entity in the performance of this Agreement.   “Debarred Entity” for purposed of this Section 7.1(e) means a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or an employee, partner, shareholder, member, subsidiary or affiliate of a Debarred Entity.
		

		
			7.2       By Cara. Cara represents, warrants, and covenants to Enteris that:
		

		
			(a)        All of its activities and the activities of its Affiliates and its Sub-licensees, related to its use and practice of the Licensed Technology and all Development, Manufacture and Commercialization of the Products pursuant to this Agreement, shall to its knowledge comply in all material respects with all Applicable Laws.
		

		
			(b)       Cara, its Affiliates, and to its knowledge its Sub-licensees, shall not encumber, with liens, mortgages, or security interests, the Licensed Technology, except as otherwise expressly permitted in this Agreement.
		

		
			7.3       By Enteris.
		

		
			(a)        Enteris owns or has license rights to all the Licensed Technology existing as of the Effective Date.  Enteris is entitled to grant the licenses specified in this Agreement. The Licensed Patent Rights existing as of the Effective Date constitute all of the Patent
		

		
			
		

		
			

		 

		

			-  31  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			Rights owned by or licensed to Enteris or its Affiliate as of the Effective Date that are necessary or reasonably useful to Develop, Manufacture, sell and otherwise Commercialize the Product.  The Licensed Know-how existing as of the Effective Date constitute all of the Licensed Know-how owned by or licensed to Enteris or its Affiliate as of the Effective Date that are necessary or reasonably useful to Develop, Manufacture, sell and otherwise Commercialize the Product.
		

		
			(b)       To Enteris’ knowledge, there is no actual or threatened infringement of the Licensed Technology in the Field by any Third Party;
		

		
			(c)        To Enteris’ knowledge, the Licensed Patent Rights existing as of the Effective Date are subsisting and are not invalid or unenforceable, in whole or in part.  As of the Effective Date, there are no claims, judgments, or settlements against, or amounts with respect thereto owed by, Enteris or any of its Affiliates relating to the Licensed Patent Rights that would have a material adverse effect on the license rights granted to Cara under this Agreement or on Cara’s ability to use or practice such license rights;
		

		
			(d)       As of the Effective Date, no claim or litigation has been brought against Enteris or, to Enteris’ knowledge, against any Third Party or, to Enteris’ knowledge, threatened, alleging that (A) the Licensed Patent Rights are invalid or unenforceable; or (B) the Licensed Patent Rights or the licensing or exploiting of such Licensed Patent Rights violates, infringes, or other conflicts or interferes with any intellectual property or proprietary right of any Third Party, nor is there any reasonable basis for any such claim; or (C) the Licensed Know-how has been misappropriated; or (D) the Licensed Know-how or the licensing or exploiting of such Licensed Know-how violates, misappropriates, or otherwise conflicts or interferes with any intellectual property or proprietary right of any Third Party;
		

		
			(e)        The practice or use of the Licensed Technology (including  in the Manufacture or Commercialization of Products) does not, and to the knowledge of Enteris shall not, result in any payment obligation by Cara (of any royalty, milestone payment or other license fee), other than the payments due to Enteris under this Agreement, to any Third Party;
		

		
			(f)        Neither Enteris, nor any of its Affiliates, has granted any mortgage, pledge, claim, security interest, encumbrance, lien, or other charge of any kind (collectively, “liens” and each a “lien”) on any of the Licensed Technology anywhere in the Territory, and the Licensed Patents and Licensed Know-how are free and clear of all liens in the Territory; except with respect to (i) any such liens on the Licensed Technology that are junior in priority to the rights of a licensee in ordinary course of business, or (ii) liens on revenue received under this Agreement.
		

		
			(g)        Within [***] of the Effective Date of this Agreement, Enteris shall have provided to Cara all material documentation, data, and information under its control requested by Cara relating to the Licensed Know-how and the use thereof in formulations, including all material safety information.  All information and data provided by or on
		

		
			
		

		
			

		 

		

			-  32  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			behalf of Enteris to Cara as set forth in this Section 7.3(g) in contemplation of this Agreement or the transactions contemplated hereby is, to Enteris’ knowledge, true, accurate and complete in all material respects, and Enteris shall not knowingly fail to disclose any material information or data in Enteris’ (or its Affiliate’s) control that could be reasonably expected to cause the Enteris information or data that has been disclosed to Cara to be misleading in any material respect.
		

		
			7.4       Warranty Disclaimer. EXCEPT FOR THE EXPRESS WARRANTIES PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY, EXPRESS OR IMPLIED, WITH RESPECT TO ANY KNOW-HOW, PATENT RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT, AND EACH PARTY HEREBY DISCLAIMS ALL SUCH OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT.
		

		
			7.5       Indemnification; Insurance.
		

		
			(a)        Cara shall indemnify, defend and hold harmless Enteris and its Affiliates, and their respective directors, officers, employees and agents, and their respective successors, heirs and assigns (collectively, the “Enteris Indemnitees”), against all liabilities, damages, losses and expenses (including reasonable attorneys’ fees and expenses of litigation) (collectively, “Losses”) incurred by or imposed upon the Enteris Indemnitees, or any of them, as a direct result of claims, suits, actions, demands or proceedings (“Claims”) brought by a Third Party against Enteris Indemnitees, including, personal injury and product liability claims (collectively, “Enteris Indemnity Claims”), to the extent arising out of (i) the Development, Manufacture and/or Commercialization of any Product by Cara or any of its Affiliates, Sub-licensees and/or agents in the Territory, including warranty claims or Product recalls; (ii) any breach of this Agreement by Cara or any of its Affiliates, Sub-licensees or agents; (iii) any tort claims for the death, personal injury, or illness of any person or claims relating to any damage to any property related in any way to the rights granted under this Agreement or activities conducted by or on behalf of Cara, its Affiliates or Sub-licensees and their respective directors, officers, employees and agents, in connection with this Agreement; except, in each case, to the extent such Claim or Loss is caused by a breach by Enteris of its representations, warranties, covenants or obligations in this Agreement, or the gross negligence or willful misconduct of any Enteris Indemnitee; or (iv) the gross negligence or willful misconduct of any Cara Indemnitee, or agent of Cara; but excluding any Enteris Indemnity Claim or Losses to the extent that Enteris has an obligation to indemnify Cara Indemnitees pursuant to Section 7.5(b), as to which Claim or Losses each Party shall indemnify the other to the extent of their respective liability for such Losses.
		

		
			(b)       Enteris shall indemnify, defend and hold harmless Cara, its Affiliates and Sub-licensees, and their respective directors, officers, employees and agents, and their respective successors, heirs and assigns (collectively, the “Cara Indemnitees”), against all Losses incurred by or imposed upon the Cara Indemnitees, or any of them, as a direct result of claims, suits, actions, demands or proceedings brought by a Third Party against
		

		
			
		

		
			

		 

		

			-  33  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			Cara Indemnitees, including personal injury and product liability claims (collectively, “Cara Indemnity Claims”) to the extent arising out of (i) any breach of this Agreement by Enteris or any of its Affiliates or agents, except, in each case, to the extent such Claim is caused by a breach by Cara of its representations, warranties, covenants or obligations in this Agreement, or the gross negligence or willful misconduct of any Cara Indemnitee; or (ii) the gross negligence or willful misconduct of any Enteris Indemnitee; or (iii) infringement or violation of Third Party intellectual property rights to the extent due to the use or practice of the Licensed Technology; but excluding any Cara Indemnity Claim or Losses to the extent that Cara has an obligation to indemnify any Enteris Indemnitees pursuant to Section  7.5(a) as to which Claims or Losses each Party shall indemnify the other to the extent of their respective liability for such Losses.
		

		
			(c)        Upon receipt of notice of any Loss, or of any claim, suits, action, demand or proceeding, that may give rise to a right of indemnity from the other Party hereto, the Party seeking indemnification (the “Indemnified Party”), either on behalf of itself or, as applicable, for a member of its group entitled to such indemnity (an “Indemnified Member”), shall give prompt written notice to the other Party (the “Indemnifying Party”) of the Loss (or related claim, action, or allegation) for which indemnification is sought (a “Claim”).  Provided that the Indemnifying Party is not contesting its obligation to indemnify as to the noticed Claim under this Article 7, the Indemnified Party (and the Indemnified Member, as applicable) shall permit the Indemnifying Party to control any the defense of such Claim and any litigation relating to such Claim and all related Losses and the disposition of such Claim and Losses.  The Indemnifying Party shall (i) act reasonably and in good faith with respect to all matters relating to the settlement or disposition of such Claim and all related Losses as the settlement or disposition relates to such Indemnified Party and (ii) not settle or otherwise resolve such Claim and related Losses in a way that would adversely impact the Indemnified Party (or the Indemnified Member, as applicable) without the prior written consent of such Indemnified Party (which consent shall not be unreasonably withheld, conditioned or delayed).  Each Indemnified Party (and all applicable Indemnified Members) shall cooperate with the Indemnifying Party in its defense of any such Claim and related Losses in all reasonable respects and shall have the right to be present in person or through counsel at all legal proceedings with respect to such Claim and Loss.  If the Indemnifying Party does not assume and conduct the defense of the Claim and Loss as provided above, (a) the Indemnified Party may defend against, consent to the entry of any reasonable judgment, or enter into any reasonable settlement with respect to such Loss in any manner the Indemnified Party may deem reasonably appropriate (and the Indemnified Party need not consult with, or obtain any consent from, the Indemnifying Party in connection therewith), and (b) the Indemnifying Party shall remain responsible to indemnify the Indemnified Party as provided in this Article 7.
		

		
			(d)       Limited Liability. EXCEPT FOR LIABILITY ARISING FROM A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS HEREUNDER, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES FOR ANY SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING LOST PROFITS OR LOST REVENUES, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH
		

		
			
		

		
			

		 

		

			-  34  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION  7.5(d) IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION  7.5(a) OR 7.5(b).
		

		
			(e)        Cara shall procure and maintain insurance, including product liability insurance, or shall self-insure, in each case in a manner adequate to cover its obligations under this Agreement and consistent with normal business practices of prudent companies similarly situated at all times during the Term and for a period of [***] thereafter. Such insurance shall provide that the policy is primary and not in excess or contributory with regard to other insurance Enteris may have. Cara shall provide Enteris with written evidence of such insurance or self-insurance upon request.   Cara shall provide Enteris with written notice at least [***] prior to the cancellation, non-renewal or material change in such insurance.
		

		
			7.6       The terms of this Article 7 shall survive termination of this Agreement for whatever reason.
		

		
			ARTICLE 8
		

		
			TERM AND TERMINATION
		

		
			8.1       Term.  This Agreement shall commence on the Effective Date, and shall continue in full force and effect until the earlier of (i) the expiration of the Agreement upon the expiration or termination of all payment obligations under this Agreement with respect to the last Product in all countries in the Territory, or (ii) the termination of this Agreement by either Party pursuant to Sections 8.3 through 8.5, inclusive (the “Term”).
		

		
			8.2       Expiration of Term. Upon expiry of the Term pursuant to clause (i) of Section 8.1, all rights and licenses granted to Cara under this Agreement in respect of Products shall become fully paid-up and irrevocable with respect to all countries in the Territory.
		

		
			8.3       Termination for Material Breach. A Party may terminate this Agreement by notice in writing to the other Party if such other Party materially breaches its obligations under the Agreement, and does not cure such breach, in accordance with the following:  In the case of such material breach, the non-breaching Party may provide the breaching Party with a written notice specifying in reasonable detail the nature of the material breach, and stating its intention to terminate this Agreement if such breach is not cured.  If the material breach is not cured within sixty (60) days (or thirty (30) days with respect to a material breach of a payment obligation) after the receipt of such notice, the non-breaching Party shall be entitled, without prejudice to any of its other rights under this Agreement, and in addition to any other remedies available to it by law or in equity, to terminate this Agreement by providing written notice to the other Party, such notice to be provided no later than [***] after the end of the cure period (and subject to Article 11).
		

		
			8.4       Termination for Challenge Enteris shall have the right to terminate this Agreement upon written notice to Cara, if all the following criteria are met:  (a) Cara or any of its
		

		
			
		

		
			

		 

		

			-  35  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			Affiliates formally Challenges the validity of any Licensed Patent Rights or Assists a Third Party in initiating a Challenge of any Licensed Patent Rights, and (b) Enteris provides Cara written notice that it intends to terminate this Agreement as a result of such Challenge by Cara (or its Affiliate), or of such Assist by Cara of a Third Party Challenge. Such termination by Enteris shall become effective thirty (30) days after notice of termination to Cara (but subject to Article 11), unless Cara has withdrawn such Challenge of such Licensed Patent Rights or ceased providing such Assist to the Third Party (as applicable). The notice provided by Enteris must provide the details of Enteris’ belief that Cara has initiated, or has Assisted in the initiation of, such a Challenge. If a Sub-licensee of Cara, or a Sub-licensee of Cara’s Sub-licensee, initiates a Challenge of any Licensed Patent Rights, then Cara shall, upon written notice from Enteris, terminate such sublicense or direct Cara’s Sub-licensee to do so, unless such Sub-licensee has ceased such Challenge within thirty (30) days of such written notice.
		

		
			8.5       Without Cause Termination. Cara may terminate this Agreement for any reason or no reason: (a) prior to receipt of first Regulatory Approval for a Product in the United States for any indication upon thirty (30) days prior written notice to Enteris or (b) on or after receipt of first Regulatory Approval for a Product in the United States for any indication upon sixty (60) days prior written notice to Enteris.
		

		
			8.6       Consequences of Termination. Upon early termination of this Agreement pursuant to clause (ii) of Section  8.1 for any reason (but not upon expiration of the Term pursuant to clause (i) of Section  8.1), in addition to any remedies available to a Party at law or in equity, the following provisions shall apply, as applicable:
		

		
			(a)        all licenses and rights granted by Enteris to Cara pursuant to this Agreement, including the licenses and rights granted to Cara under Section 2.1 shall terminate as of the effective date of termination;
		

		
			(b)       Cara shall not use or practice any issued Licensed Patent Rights or, to the extent consisting of Enteris Confidential Information, any Licensed Know-how that, in each case, are incorporated into any Product for any purpose;
		

		
			(c)        Cara shall cease all Commercialization and Development activities with respect to the Products (except as otherwise provided in this Section) and shall diligently wind down, according to good clinical practice, any clinical trials of such Product(s) that are ongoing at the time of notice of such termination or expiration, to the extent any such activities would use or practice issued claims in the Licensed Patent Rights, or Enteris Confidential Information or Licensed Know-how that is not subject to the exceptions in subclauses (a) – (e) of Section 4.1;
		

		
			(d)       all reference rights granted by Enteris to Cara under this Agreement shall cease, including Cara’s right to reference the Enteris DMF, the contents therein, and any set of documents referencing the Enteris DMF, in any Regulatory Filings, and (1) such Regulatory Filings referencing the Enteris DMF or the contents therein shall immediately be withdrawn with appropriate notification to the Regulatory Authority, and (2) all copies (in any form, including electronic) of documents referencing the Enteris DMF which have
		

		
			
		

		
			

		 

		

			-  36  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			been provided to Third Parties shall be sequestered until the applicable retention period of the Regulatory Authority expires and shall thereafter be promptly destroyed; and
		

		
			(e)        each Party shall cease use of, and promptly return, all Confidential Information of the other Party that are not subject to a continuing license hereunder; provided, that, each Party may retain one (1) copy of the Confidential Information of the other Party in its archives solely for the purpose of establishing the contents thereof and ensuring compliance with its obligations hereunder.
		

		
			(f)        Except in the event Enteris terminates this Agreement pursuant to this Article 8, Cara and its Affiliates and Sub-licensees shall be entitled, during the [***] period following such termination, to continue to sell any commercial inventory of such terminated Product(s) so long as Cara pays to Enteris the amounts applicable to said subsequent sales in accordance with the terms and conditions set forth in this Agreement. Any drug substance, clinical supplies and finished forms of such terminated Product(s) remaining following such [***] period shall be destroyed.
		

		
			8.7       Survival Termination or expiration of this Agreement for any reason shall be without prejudice to: (a) any obligations of the Parties that arose or accrued prior to the effective date of such termination; (b) the survival of rights specifically stated in this Agreement to survive; (c) the rights and obligations of the Parties provided in Article 1,  Article 4,  Article 5,  Article 10,  Article 11,  Article 13, Sections 3.5,  3.63.6,  6.5,  6.7,  6.8,  6.9,  6.10,  6.11,  7.5,  8.2,  8.6,  8.7, 12.1-12.8 (including all other Sections referenced in any such Section), all of which shall survive such termination except as provided in this Article 8; and (d) any other rights or remedies provided at law or equity which either Party may otherwise have.
		

		
			ARTICLE 9
		

		
			ASSIGNMENT; SUCCESSORS AND ASSIGNS
		

		
			9.1       Neither Party shall be entitled to assign, transfer, charge or in any way make over the benefit and/or the burden of this Agreement without the prior written consent of the other, which consent shall not be unreasonably withheld, conditioned or delayed, except that (a) each Party shall be entitled without the prior written consent of the other Party to assign this Agreement and the rights, obligations and interests thereunder to (i) an Affiliate, provided that the assigning Party shall remain liable and responsible to the non-assigning Party for the performance and observance of all such duties and obligations by such Affiliate, or (ii) its successor in interest in connection with a sale, merger, or acquisition of all or substantially all of the assets of its business to which this Agreement relates and (b) Enteris shall be entitled without the prior written consent of Cara to (i) pledge, grant a security interest, lien or charge in, or other encumbrance upon, any of its rights or interests in this Agreement (and may assign this Agreement or the rights hereunder, in whole or in part in connection with any of the foregoing), including without limitation pursuant to the terms of any secured indebtedness (and any amendment, restatement, replacement or refinancing thereof) and any related documents, and (ii) assign all or a portion of its rights and interests to receive any payments pursuant to Article 6 to its current or former shareholders, provided, however, in such event, Cara shall, in accordance with Article 6, continue to make such payments directly to Enteris (who shall receive such payments on behalf of, and as agent for, such 
		

		
			
		

		
			

		 

		

			-  37  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			current or former shareholders, to the extent of the payment rights and interests so assigned).  Any attempted assignment in violation of this Article 9 shall be null and void.
		

		
			9.2       The terms and conditions of this Agreement shall be binding on and inure to the benefits of permitted successors and assigns of each Party.
		

		
			ARTICLE 10
		

		
			GOVERNING LAW
		

		
			10.1     This Agreement shall be construed, governed and interpreted in accordance with the laws of the State of New York without regard to the application of its principles of conflict of law.
		

		
			ARTICLE 11
		

		
			DISPUTE RESOLUTION; ARBITRATION
		

		
			11.1     Dispute Resolution.   If a dispute or issues arises between the Parties regarding any matter under this Agreement, including interpretation of a provision of the Agreement or performance or breach of an obligation hereunder, (a “Dispute”) then on notice from either Party detailing such Dispute, the senior executive officers of each Party shall promptly meet and discuss and seek to resolve, reasonably and in good faith, such Dispute, for a period of up to [***] from the date of receipt of such notice.  Any resolution by the Parties of such a Dispute shall be set forth in writing acknowledged by the Parties. Neither Party shall initiate any court or other legal proceeding to resolve or enforce its rights as to, any Dispute except as provide in this Article 11.
		

		
			11.2     Arbitration of Unresolved Disputes.  For any Dispute that is not resolved by the Parties pursuant to Section 11.1 above, such Dispute shall be resolved, at the election of either Party, by binding arbitration before a panel of three (3) neutral, fully independent arbitrators in accordance with the rules of the American Arbitration Association (“AAA”) in effect at the time the proceeding is initiated, by such Party providing written notice of the arbitration, such notice setting forth in detail the Dispute to be resolved.  In any such arbitration, the following procedures shall apply:
		

		
			(a)        The panel will be comprised of one arbitrator chosen by Cara, one by Enteris and the third, who shall act as the chairman of the panel, by the two co-arbitrators.   If either Party fails or both Parties fail to choose an arbitrator or arbitrators within [***] after receiving notice of commencement of arbitration or if the two arbitrators fail to choose a third arbitrator within [***] after their appointment, then either or both Parties shall immediately request that the AAA select the remaining number of arbitrators to be selected, which arbitrator(s) shall have the requisite scientific background, experience and expertise.  All such arbitrators must have no current or prior relationship with or to either Party and all its respective Affiliates, be neutral and unbiased as to the subject matter of the Dispute, and have significant experience in the creation and interpretation of license agreements similar to this Agreement.  The place of arbitration shall be New York, New York. The language of the arbitration shall be English.
		

		
			
		

		
			

		 

		

			-  38  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			(b)       Either Party may apply to the arbitrators for interim injunctive relief until the arbitration decision is rendered or the Dispute is otherwise resolved. Either Party also may, without waiving any right or remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party pending resolution of the Dispute pursuant to this Section 11.2. The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damages.
		

		
			(c)        The award of the arbitrators shall be final and binding on the parties (except for those remedies expressly set forth in this Agreement). Judgment on the award rendered by the arbitrators may be entered in any court having jurisdiction thereof. Notwithstanding anything in this Section 11.2 to the contrary, each Party shall have the right to institute judicial proceedings against the other Party or anyone acting by, through or under such other Party, in order to enforce the instituting Party’s rights hereunder through specific performance, injunction or similar equitable relief.
		

		
			(d)       Each Party shall bear its own costs and expenses and attorneys’ fees in connection with any such arbitration; provided, that, the arbitrators shall be authorized to determine whether a Party is the prevailing Party, and if so, to award to the prevailing Party reimbursement for its reasonable attorneys’ fees, costs and expenses (including, for example, expert witness fees and expenses, photocopy charges and travel expenses).
		

		
			(e)        Unless otherwise agreed by the parties, Disputes relating to patents and non-disclosure, non-use and maintenance of Confidential Information shall not be subject to arbitration, and shall be submitted to a court of competent jurisdiction.
		

		
			(f)        The arbitration shall be confidential. Except to the extent necessary to confirm an award or decision or as may be required by Applicable Laws, neither Party nor any arbitrator may disclose the existence or results of any arbitration without the prior written consent of both parties. In no event shall any arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the Dispute would be barred by the applicable New York statute of limitations.
		

		
			(g)        In the event of a Dispute involving the alleged breach of this Agreement (including whether a Party has satisfied its diligence obligations hereunder), (i) the running of the time periods as to which a Party must cure a breach of this Agreement shall be tolled during the period the breach that is the subject matter of the Dispute is being arbitrated, and (ii) if the arbitrators render a decision that a breach of this Agreement has occurred, the arbitrators shall have no authority to modify the right of the non-breaching Party to terminate this Agreement in accordance with Section 8.3. Any disputed performance or suspended performance, pending the resolution of a Dispute that the arbitrators determine to be required to be performed by a Party, shall be completed within a reasonable time period following the final decision of the arbitrators.
		

		
			(h)       Any monetary payment to be made by a Party pursuant to a decision of the arbitrators shall be made in U.S. dollars, free of any tax or other deduction.
		

		
			
		

		
			

		 

		

			-  39  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			ARTICLE 12
		

		
			MISCELLANEOUS
		

		
			12.1     Amendment and Modification. This Agreement may only be amended, modified, or supplemented by an agreement in writing signed by each Party hereto.
		

		
			12.2     Headings. Section and subsection headings are inserted for convenience of reference only and do not form a part of this Agreement.
		

		
			12.3     Counterparts.  This Agreement may be executed simultaneously in two or more counterparts, each of which shall be deemed an original and both of which, together, shall constitute a single agreement. Each Party may execute this Agreement by facsimile transmission or in AdobeTM Portable Document Format (“PDF”) sent by electronic mail. In addition, facsimile or PDF signatures of authorized signatories of any Party will be deemed to be original signatures and will be valid and binding, and delivery of a facsimile or PDF signature by any Party will constitute due execution and delivery of this Agreement.  This Agreement may be amended, modified, superseded or canceled, and any of the terms of this Agreement may be waived, only by a written instrument executed by each Party or, in the case of waiver, by the Party or parties waiving compliance. The delay or failure of either Party at any time or times to require performance or to exercise any right arising out of any provisions shall in no manner affect the rights at a later time to enforce the same.
		

		
			12.4     Waiver. Any waiver by a Party of a particular provision or right shall be in writing, shall be as to a particular matter and, if applicable, for a particular period of time and shall be signed by such Party.  No single or partial exercise of any right, power or privilege will preclude any other or further exercise of such right, power or privilege or the exercise of any other right, power or privilege. No waiver by either Party of any condition or of the breach of any term contained in this Agreement, whether by conduct, or otherwise, in any one or more instances, shall be deemed to be, or considered as, a further or continuing waiver of any such condition or of the breach of such term or any other term of this Agreement. Except as otherwise expressly set forth in this Agreement, all rights and remedies available to a Party, whether under this Agreement or afforded by Applicable Law or otherwise, will be cumulative and not in the alternative to any other rights or remedies that may be available to such Party.
		

		
			12.5     No Third Party Beneficiaries. Except as set forth in Sections 7.5(a) and 7.5(b) and in Article 9, no Third Party (including employees of either Party) shall have or acquire any rights by reason of this Agreement.
		

		
			12.6     Independent Relationship. The Parties understand and agree that the relationship between the Parties to this Agreement is purely contractual and is limited to the activities, rights and obligations as set forth in this Agreement.   Nothing in this Agreement shall be construed (a) to create or imply a general partnership between the parties, (b) to make either Party the agent of the other for any purpose, (c) to alter, amend, supersede or vitiate any other arrangements between the Parties with respect to any subject matter not covered hereunder, (d) to give either Party the right to bind the other, (e) to create any duties or obligations between the
		

		
			
		

		
			

		 

		

			-  40  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			parties except as expressly set forth herein, or (f) to grant any direct or implied licenses or any other rights other than as expressly set forth herein.
		

		
			12.7     Interpretation. The Parties acknowledge and agree that: (a) each Party and its counsel reviewed and negotiated the terms and provisions of this Agreement and have contributed to its revision; and (b) the rules of construction to the effect that any ambiguities are resolved against the drafting Party shall not be employed in the interpretation of this Agreement. In addition, unless a context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders, the word “or” is used in the inclusive sense (and/or) and the word “including” is used without limitation and means “including without limitation”. Unless otherwise specified, references in this Agreement to any Section shall include all Sections, subsections and paragraphs in such Section, references to any Section shall include all subsections and paragraphs in such Section, and references in this Agreement to any subsection shall include all paragraphs in such subsection. The words “herein,” “hereof” and “hereunder” and other words of similar import refer to this Agreement as a whole and not to any particular Section or other subdivision. All references to days in this Agreement shall mean calendar days, unless otherwise specified. Unless the context requires otherwise, (i) any definition of or reference to any agreement, instrument or other document herein will be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein), (ii) any reference to any Applicable Laws herein will be construed as referring to such Applicable Laws as from time to time enacted, repealed or amended, (iii) any reference herein to any person will be construed to include the person’s successors and permitted assigns, (iv) any reference herein to the words “mutually agree” or “mutual written agreement” will not impose any obligation on either Party to agree to any terms relating thereto or to engage in discussions relating to such terms except as such Party may determine in such Party’s sole discretion, (v) all references herein to Sections or Exhibits will be construed to refer to Sections and Exhibits to this Agreement, (vi) except as otherwise expressly provided herein all references to “$” or “dollars” refer to the lawful money of the U.S., and (vii) the words “copy” and “copies” and words of similar import when used in this Agreement include, to the extent available, electronic copies, files or databases containing the information, files, items, documents or materials to which such words apply. This Agreement has been prepared in the English language and the English language shall control its interpretation. In addition, all notices required or permitted to be given hereunder, and all written, electronic, oral or other communications between the parties regarding this Agreement shall be in the English language.
		

		
			12.8     Entire Agreement; Severability.  This Agreement and the Stock Purchase Agreement set forth the entire agreements between the Parties with respect to the subject matter of this Agreement and of such Stock Purchase Agreement and supersede all other agreements and understandings between the Parties with respect to such subject matter.  There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties with respect to the subject matter of this Agreement other than as are set forth in this Agreement and any other documents delivered pursuant hereto or thereto.  If any provision of this Agreement is or becomes invalid or is ruled invalid by any court of competent jurisdiction or is deemed unenforceable, it is the intention of the parties that the remainder of the Agreement shall not be affected.
		

		
			
		

		
			

		 

		

			-  41  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			12.9     Delay Due to Force Majeure. A Party shall not be liable for failure of or delay in performing any of its obligations set forth in this Agreement, and shall not be deemed in breach of such obligations, if such failure or delay is due to a Force Majeure. In the event of such Force Majeure, the Party affected shall use Commercially Reasonable Efforts to cure or overcome the same and resume performance of its obligations hereunder.  Notice of a Party’s failure or delay in performance due to Force Majeure must be given to the other Party within thirty (30) days after the affected Party becomes aware of its occurrence. All delivery dates under this Agreement that have been affected by Force Majeure shall be tolled for the duration of such Force Majeure. If a Force Majeure persists for more than ninety (90) days, then the Parties will discuss in good faith the reasonable modification of the Parties’ respective obligations under this Agreement in order to mitigate the delays caused by such Force Majeure and the impacts of such delays.
		

		
			12.10   Further Assurances.  Each of Enteris and Cara, upon the reasonable request of the other Party, whether before or after the Effective Date, will do, execute, acknowledge, and deliver or cause to be done, executed, acknowledged or delivered all such further reasonable acts, deeds, documents, assignments, transfers, conveyances, powers of attorney, instruments and assurances as may be reasonably necessary to effect complete consummation of the transactions contemplated by this Agreement, and to do all such other reasonable acts, as may be necessary or reasonably needed in order to carry out the purposes and intent of this Agreement. The Parties agree to execute and deliver such other reasonable documents, certificates, agreements and other writings and to take such other reasonable actions as may be reasonably necessary in order to consummate or implement expeditiously the transactions contemplated by this Agreement.
		

		
			12.11   Expenses. Each of the Parties will bear its own direct and indirect expenses incurred in connection with the negotiation and preparation of this Agreement and, except as set forth in this Agreement, the performance of the obligations contemplated hereby and thereby.
		

		
			ARTICLE 13
		

		
			NOTICE
		

		
			13.1     Any notice or other documents to be given under this Agreement shall be in writing and shall be deemed to have been duly given if sent by registered post, courier, facsimile or other electronic media to a Party or delivered in person to a Party at the address or facsimile number set out below for such Party or such other address as the Party may from time to time designate by written notice to the other(s):
		

		
			Address of Enteris:
		

		
			 
		

		
			Enteris Biopharma, Inc., 83 Fulton St., Boonton, NJ 07005, USA
		

		
			Facsimile: [***]
		

		
			E-mail: [***]
		

		
			For the attention of the President & CFO
		

		
			 
		

		
			
		

		
			

		 

		

			-  42  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			Address of Cara:
		

		
			 
		

		
			Cara Therapeutics, Inc.
		

		
			4 Stamford Plaza
		

		
			107 Elm Street, 9th Floor
		

		
			Stamford, CT 06902
		

		
			 
		

		
			Facsimile: [***]
		

		
			E-mail:  [***]
		

		
			For the attention of:  Chief Executive Officer
		

		
			With a copy to:
		

		
			Cara Therapeutics, Inc.
		

		
			4 Stamford Plaza
		

		
			107 Elm Street, 9th Floor
		

		
			Stamford, CT 06902
		

		
			 
		

		
			Facsimile: [***]
		

		
			E-mail:  [***]
		

		
			For the attention of:  General Counsel
		

		
			13.2     Any such notice or other document shall be deemed to have been received by the addressee seven (7) working days following the date of dispatch of the notice or other document by post or, where the notice or other document is sent by hand or is given by facsimile or other electronic media or transmission, simultaneously with the transmission or delivery.
		

		
			
		

		
			

		 

		

			-  43  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			IN WITNESS WHEREOF, the hands of the duly authorized representatives of the Parties have caused this License Agreement to be executed effective as of the Effective Date.
		

		
			 
		

		
			Signed for and on behalf of
		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						/s/ Brian Zietsman

				
	
					
						ENTERIS BIOPHARMA, INC.

					
					
						 

					
					
						 

				
	
					
						 

					
					
						NAME

					
					
						Brian Zietsman

				
	
					
						 

					
					
						TITLE

					
					
						President & CFO

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						Signed for and on behalf of

					
					
						 

					
					
						 

				
	
					
						CARA THERAPEUTICS, INC.

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						/s/ Derek Chalmers

				
	
					
						 

					
					
						NAME

					
					
						Derek Chalmers

				
	
					
						 

					
					
						TITLE

					
					
						CEO

				

		
			
		

		
			

		 

		

			-  44  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			EXHIBIT A
		

		
			Wire Instructions
		

		
			
		

		
			

		 

		

			-  45  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			EXHIBIT B
		

		
			Form Stock Purchase Agreement
		

		
			
		

		
			

		 

		

			-  46  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

		

		

			 

		

		

		
			EXHIBIT C
		

		
			Project Plan
		

		
			Transfer of Analytical Procedures and Manufacturing Process
		

		 

		

			-  47  -

		

		

			 

		

		

			CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.bpmc_Ex10.1

		

			Exhibit 10.1

		

		

			 

		

		
			[***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
		

		
			 
		

		
			 
		

		
			LICENSE AGREEMENT
		

		
			 
		

		
			by and between
		

		
			 
		

		
			Blueprint Medicines Corporation
		

		
			 
		

		
			and
		

		
			 
		

		
			Clementia Pharmaceuticals, Inc.
		

		
			 
		

		
			Dated as of October 15, 2019
		

		
			 
		

		
			 
		

		
			

		 

		

			 

		

		

		
			TABLE OF CONTENTS
		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						Page

				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 1 DEFINITIONS

					
1
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 2 LICENSE GRANTS AND EXCLUSIVITY

					
16
				
	
					
						2.1

					
					
						License Grants to Clementia.  

					
16
				
	
					
						2.2

					
					
						License Grant to Blueprint

					
17
				
	
					
						2.3

					
					
						Sublicensing and Subcontracting. 

					
17
				
	
					
						2.4

					
					
						Reservation of Rights

					
18
				
	
					
						2.5

					
					
						Bankruptcy Code § 365(n) Election

					
18
				
	
					
						2.6

					
					
						Third Party Agreements

					
18
				
	
					
						2.7

					
					
						Exclusivity. 

					
19
				
	
					
						2.8

					
					
						Program Liaison

					
19
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 3 TECHNOLOGY TRANSFER OF LICENSED KNOW-HOW

					
19
				
	
					
						3.1

					
					
						Documents and Filings Technology Transfer. 

					
19
				
	
					
						3.2

					
					
						Manufacturing Technology Transfer. 

					
21
				
	
					
						3.3

					
					
						Assistance by Blueprint

					
22
				
	
					
						3.4

					
					
						Follow-up Period

					
22
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 4 RESEARCH, DEVELOPMENT, REGULATORY, MANUFACTURING AND COMMERCIALIZATION

					
22
				
	
					
						4.1

					
					
						General

					
22
				
	
					
						4.2

					
					
						Diligence. 

					
22
				
	
					
						4.3

					
					
						Manner of Performance; Records

					
23
				
	
					
						4.4

					
					
						Notice of Metabolites; Reports

					
23
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 5 FINANCIAL TERMS

					
24
				
	
					
						5.1

					
					
						Upfront Payment

					
24
				
	
					
						5.2

					
					
						Development Milestone Payments. 

					
24
				
	
					
						5.3

					
					
						Sales Milestone Payments. 

					
25
				
	
					
						5.4

					
					
						Royalties. 

					
25
				
	
					
						5.5

					
					
						Royalty Payments and Reports

					
26
				
	
					
						5.6

					
					
						Payment Reductions. 

					
26
				
	
					
						5.7

					
					
						Financial Audits. 

					
28
				
	
					
						5.8

					
					
						Taxes. 

					
29
				
	
					
						5.9

					
					
						Currency of Payments; Payments

					
30
				
	
					
						5.10

					
					
						Interest on Overdue Payments

					
30
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 6 INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS

					
30
				
	
					
						6.1

					
					
						Ownership of Inventions. 

					
30
				
	
					
						6.2

					
					
						Prosecution and Maintenance of Licensed Patents. 

					
31
				
	
					
						6.3

					
					
						Patent Extensions and Orange Book Listings

					
33
				
	
					
						6.4

					
					
						Marking

					
33
				
	
					
						6.5

					
					
						Third Party Infringement. 

					
33
				
	
					
						6.6

					
					
						Claimed Infringement

					
34
				

		
			 
		

		
			
		

		

		 

		

			i

		

		

			 

		

	
					
						

					
						 

					
					
						 

					
					
						 

				
	
					
						ARTICLE 7 CONFIDENTIALITY AND PUBLICITY

					
35
				
	
					
						7.1

					
					
						Confidential Information. 

					
35
				
	
					
						7.2

					
					
						Publicity. 

					
36
				
	
					
						7.3

					
					
						Tax Treatment

					
38
				
	
					
						7.4

					
					
						Attorney-Client Privilege

					
38
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 8 REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS

					
38
				
	
					
						8.1

					
					
						Mutual Representations and Warranties

					
38
				
	
					
						8.2

					
					
						Additional Representations and Warranties of Blueprint

					
39
				
	
					
						8.3

					
					
						No Debarment

					
40
				
	
					
						8.4

					
					
						Additional Covenants. 

					
40
				
	
					
						8.5

					
					
						No Other Representations or Warranties. 

					
41
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 9 INDEMNIFICATION; DAMAGES

					
42
				
	
					
						9.1

					
					
						Indemnification by Blueprint

					
42
				
	
					
						9.2

					
					
						Indemnification by Clementia

					
42
				
	
					
						9.3

					
					
						Claims for Indemnification. 

					
42
				
	
					
						9.4

					
					
						Insurance

					
43
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 10 LIMITATION OF LIABILITY

					
43
				
	
					
						10.1

					
					
						No Consequential or Punitive Damages

					
43
				
	
					
						10.2

					
					
						Exclusion from Liability Limitation

					
44
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 11 TERM AND TERMINATION

					
44
				
	
					
						11.1

					
					
						Term

					
44
				
	
					
						11.2

					
					
						Termination by Clementia for Convenience

					
44
				
	
					
						11.3

					
					
						Termination for Material Breach

					
44
				
	
					
						11.4

					
					
						Termination by Blueprint for Validity Challenge

					
44
				
	
					
						11.5

					
					
						Termination for Insolvency

					
45
				
	
					
						11.6

					
					
						Effects of Termination

					
45
				
	
					
						11.7

					
					
						Termination by Clementia Due to Material Breach

					
49
				
	
					
						11.8

					
					
						Alternative in Lieu of Termination by Clementia Due to Material Breach. 

					
49
				
	
					
						11.9

					
					
						Continuation of Sublicenses

					
50
				
	
					
						11.10

					
					
						Survival

					
50
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 12 DISPUTE RESOLUTION

					
50
				
	
					
						12.1

					
					
						Disputes

					
50
				
	
					
						12.2

					
					
						Dispute Escalation

					
50
				
	
					
						12.3

					
					
						Governing Law

					
51
				
	
					
						12.4

					
					
						Jurisdiction

					
51
				
	
					
						12.5

					
					
						Injunctive Relief

					
51
				
	
					
						12.6

					
					
						Patent, Trademark and Copyright Disputes

					
51
				
	
					
						 

					
					
						 

				
	
					
						ARTICLE 13 MISCELLANEOUS

					
51
				
	
					
						13.1

					
					
						Assignment

					
51
				
	
					
						13.2

					
					
						Non-Solicitation

					
52
				
	
					
						13.3

					
					
						Notices

					
52
				
	
					
						13.4

					
					
						Severability

					
53
				
	
					
						13.5

					
					
						Integration

					
53
				
	
					
						13.6

					
					
						Waivers and Amendments

					
53
				
	
					
						13.7

					
					
						Independent Contractors; No Agency

					
53
				

		
			
		

		
			

		 

		

			ii

		

		

			 

		

		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

				
	
					
						13.8

					
					
						Force Majeure

					
54
				
	
					
						13.9

					
					
						No Third Party Beneficiary Rights

					
54
				
	
					
						13.10

					
					
						Non-Exclusive Remedy

					
54
				
	
					
						13.11

					
					
						Interpretation

					
54
				
	
					
						13.12

					
					
						Performance by Affiliates; Guarantee

					
54
				
	
					
						13.13

					
					
						Further Assurances

					
55
				
	
					
						13.14

					
					
						Ambiguities; No Presumption

					
55
				
	
					
						13.15

					
					
						Execution in Counterparts; Facsimile Signatures

					
55
				

		
			 
		

		
			 
		

			
					
						Exhibit A-1

					
					
						Blueprint Compounds

				
	
					
						Exhibit A-2

					
					
						Metabolites

				
	
					
						Exhibit B

					
					
						Development Plan

				
	
					
						Exhibit C-1

					
					
						Blueprint Product-Specific Patents

				
	
					
						Exhibit C-2

					
					
						Blueprint Platform Patents

				
	
					
						Exhibit D

					
					
						Transition Plan

				
	
					
						Exhibit E

					
					
						Press Release

				
	
					
						Exhibit F

					
					
						Third Party Agreements

				
	
					
						Exhibit 1.57

					
					
						[***]

				
	
					
						Exhibit 3.2.2

					
					
						Bill of Sale

				
	
					
						 

					
					
						 

				
	
					
						Schedule 1.18

					
					
						Blueprint CMOs

				
	
					
						Schedule 1.23

					
					
						Certain Blueprint Platform Know-How

				
	
					
						Schedule 1.26

					
					
						Certain Blueprint Product-Specific Know-How

				
	
					
						Schedule 2.1.1

					
					
						Blueprint Permitted Activities

				
	
					
						Schedule 3.2.2(a)

					
					
						Existing Manufacturing Inventory

				
	
					
						Schedule 3.2.2(b)

					
					
						In Process Manufacturing Inventory

				
	
					
						Schedule 7.2.2(b)(ii)

					
					
						Exceptions to Restrictions on Publications – By Blueprint

				
	
					
						Schedule 7.2.2(b)(iii)

					
					
						Exceptions to Restrictions on Publications – Jointly by the Parties

				
	
					
						Schedule 8.2

					
					
						Exceptions to Blueprint’s Representations and Warranties

				
	
					
						 

					
					
						 

				

		
			 
		

		
			 
		

		
			

		 

		

			iii

		

		

			 

		

		

		
			LICENSE AGREEMENT
		

		
			This License Agreement (this “Agreement”) is effective as of October 15, 2019 (the “Effective Date”), by and between Blueprint Medicines Corporation, a Delaware corporation with offices at 45 Sidney Street, Cambridge, MA, 02139 U.S.A. (“Blueprint”), and Clementia Pharmaceuticals, Inc., 1000 de la Gauchetière Street West, Suite 1200, Montreal, QC, H3B 4W5, Canada (“Clementia”).  Blueprint and Clementia are each sometimes referred to herein as a “Party” or collectively as the “Parties.” Capitalized terms used but not defined in this paragraph and the Recitals below will have the meanings ascribed to such terms in Article 1 or elsewhere in this Agreement.
		

		
			RECITALS
		

		
			WHEREAS, Blueprint Controls Licensed Technology related to the proprietary compound known as “BLU-782” and identified on Exhibit A-1 (“BLU-782”) and other Blueprint Compounds and has the exclusive right to grant licenses under such Licensed Technology;
		

		
			WHEREAS,  Clementia desires to obtain, and Blueprint desires to grant, an exclusive license under the Blueprint Product-Specific Technology and a non-exclusive license to the Blueprint Platform Technology to Exploit Blueprint Compounds and Licensed Products on the terms and conditions set forth herein; and
		

		
			WHEREAS, the Parties desire that the activities performed under this Agreement will accelerate the development and availability of treatment options for patients suffering from FOP and other diseases.
		

		
			NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the amount and sufficiency of which are hereby acknowledged, Blueprint and Clementia hereby agree as follows:
		

		
			ARTICLE 1
		

		
			DEFINITIONS
		

		
			As used in this Agreement, the following terms will have the meanings set forth below:
		

		
			1.1        “Acceptance” means (a) with respect to an NDA, in the United States, the receipt of written notice from the FDA in accordance with 21 C.F.R. § 314.101(a)(2) (or its successor regulation) that such NDA is officially “filed”; or (b) with respect to an MAA, the receipt of written validation of the filing of such MAA from the EMA or acceptance or validation by the MHRA (as applicable).
		

		
			1.2        “Accounting Standards” means, with respect to a Person, the generally accepted accounting principles as practiced in the United States (“GAAP”), or the international standards that are promulgated by the IFRS® Foundation or its successor organization, in each case as consistently applied by such Person.
		

		
			1.3        “Acquiring Party” has the meaning set forth in Section 2.7.2.
		

		
			1.4        “Action” means any claim, action, cause of action or suit (whether in contract or tort or otherwise), litigation (whether at law or in equity, whether civil or criminal), assessment, arbitration, investigation, hearing, charge, complaint, demand, notice or proceeding of, to, from, by or before any Governmental Authority.
		

		
			
		

		
			

		 

		

			1

		

		

			 

		

		

		
			1.5        “Adverse Event” has the meaning set forth in 21 C.F.R. § 312.32(a) and generally means any untoward medical occurrence associated with the use of a product in human subjects, whether or not considered related to such product.
		

		
			1.6        “Affiliate” means, with respect to a specified Person, any other Person which (directly or indirectly) is controlled by, controls or is under common control with such Person.  For the purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to a Person means (a) in the case of a corporation, direct or indirect ownership of voting securities entitled to cast more than fifty percent (50%) of the votes in the election of directors, (b) in the case of a non-corporate Person, direct or indirect ownership of more than fifty percent (50%) of the equity interests with the power to direct the management and policies of such entity or (c) the power to direct the management or policies of a Person, whether through ownership of voting securities or by contract relating to voting rights or corporate governance, resolution, regulation or otherwise.
		

		
			1.7        “Agreement” has the meaning set forth in the introductory paragraph of this Agreement.
		

		
			1.8        “Alexion” means Alexion Pharma Holding and its Affiliates.
		

		
			1.9        “Alternative Breach Recovery” has the meaning set forth in Section 11.8(a).
		

		
			1.10      “Anti-Corruption Laws” means the U.S. Foreign Corrupt Practices Act of 1977 (the “FCPA”) and similar Laws in any jurisdiction as applicable to either Party.
		

		
			1.11      “Bankruptcy Code” has the meaning set forth in Section 2.5.
		

		
			1.12      “BLA” means a biologics license application submitted to the FDA pursuant to the Public Health Service Act, 42 U.S.C. § 262.
		

		
			“Blocking Third Party Patent Payments” means [***].
		

		
			1.13      paid to a Third Party who Controls Blocking Third Party Patent(s) in order to obtain a license or otherwise acquire the relevant rights to such Blocking Third Party Patent(s).
		

		
			“Blocking Third Party Patent(s)” means, with respect to a Licensed Product in any country in the Territory, any Patent(s) owned or in-licensed by a Third Party that are [***].
		

		
			1.14      such Licensed Product in such country.
		

		
			1.15      “BLU-782” has the meaning set forth in the Recitals.
		

		
			1.16      “Blueprint” has the meaning set forth in the introductory paragraph of this Agreement.
		

		
			1.17      “Blueprint Change of Control Program” has the meaning set forth in Section 2.7.2.
		

		
			1.18      “Blueprint CMO” means, as of the Effective Date, any CMO that manufactures and supplies BLU-782 to Blueprint or its designee and identified on Schedule 1.18.
		

		
			1.19      “Blueprint Compounds” means (a) BLU-782 and the other compounds identified in Exhibit A-1; (b) [***] ; (c) [***]; (d) [***] (“Metabolites”) that are identified in Exhibit A-2; (e) [***]; and (f) [***].
		

		
			
		

		
			

		 

		

			2

		

		

			 

		

		

		
			1.20      “Blueprint Development Know-How” means any Know-How that is [***].
		

		
			1.21      “Blueprint Future Technology” means [***].
		

		
			1.22      “Blueprint Indemnified Parties” has the meaning set forth in Section 9.2.
		

		
			1.23      “Blueprint Platform Know-How” means (a) any and all Know-How Controlled by Blueprint as of the Effective Date [***], (b) Blueprint Development Know-How, and (c) Blueprint’s interest in any and all Joint Know-How, in each case (clauses (a), (b) and (c)) that is not Blueprint Product-Specific Know-How.
		

		
			1.24      “Blueprint Platform Patents” means (a) any and all Patents identified on Exhibit C-2, (b) [***]; and (c) Blueprint’s interest in any and all Joint Patents that are not Blueprint Product-Specific Patents (such Joint Patents, “Joint Platform Patents”).
		

		
			1.25      “Blueprint Platform Technology” means, collectively, the Blueprint Platform Know-How and Blueprint Platform Patents.
		

		
			1.26      “Blueprint Product-Specific Know-How” means (a) any and all Know-How [***], (b) Blueprint Development Know-How, and (c) Blueprint’s interest in any and all Joint Know-How, in each case (clauses (a), (b) and (c)) that is solely applicable to the Exploitation of Blueprint Compounds or Licensed Products in the Field in the Territory.
		

		
			1.27      “Blueprint Product-Specific Patents” means (a) any and all Patents identified on Exhibit C-1, (b) [***], and (c) Blueprint’s interest in any and all Joint Patents that solely Cover Joint Know-How that is Blueprint Product-Specific Know-How (such Patents, “Joint Product-Specific Patents”).
		

		
			1.28      “Blueprint Product-Specific Technology” means, collectively, the Blueprint Product-Specific Know-How and Blueprint Product-Specific Patents.
		

		
			1.29      “Breaching Party” has the meaning set forth in Section 11.3.
		

		
			1.30      “Business Day” means any day other than a Saturday or a Sunday or other bank or public holiday in Boston, Massachusetts or Montreal, Quebec.
		

		
			1.31      “Calendar Quarter” means each of the three (3) month periods ending on March 31, June 30, September 30, and December 31 of any Calendar Year.
		

		
			1.32      “Calendar Year” means each twelve (12) month period commencing on January 1 and ending on December 31.
		

		
			1.33      “Change of Control” means with respect to a Party (or its Affiliate), any of the following events:  (a) any Third Party (or group of Third Parties acting in concert) acquires in a transaction or series of transactions (including by way of a tender or exchange offer or issuance by such Party (or its Affiliate)), directly or indirectly, beneficial ownership or a right to acquire beneficial ownership of shares of such Party (or its Affiliate) representing fifty percent (50%) or more of the then outstanding voting shares (where voting refers to being entitled to vote for the election of directors) of such Party (or its Affiliate); (b) such Party (or its Affiliate) consolidates with or merges into another corporation or entity which is a Third Party, or any corporation or entity which is a Third Party consolidates with or merges into such Party (or its Affiliate), in either event, pursuant to a transaction or series of transactions in which more than fifty percent (50%) of the voting shares of the acquiring or resulting entity outstanding immediately after such
		

		
			
		

		
			

		 

		

			3

		

		

			 

		

		

		
			consolidation or merger is not held by the holders (or Affiliates of the holders) of the outstanding voting shares of such Party (or its Affiliate) immediately preceding such consolidation or merger; or (c) such Party (or its Affiliate) sells, transfers, exclusively licenses or otherwise disposes of all or substantially all of the assets to which this Agreement relates to a Third Party.
		

		
			1.34      “Clementia” has the meaning set forth in the introductory paragraph of this Agreement.
		

		
			1.35      “Clementia Development Know-How” means all Know-How conceived, discovered, developed, invented or created solely by or on behalf of Clementia or any of its Affiliates or Sublicensees, or jointly with a Third Party, (a) [***] and (b) [***].
		

		
			1.36      “Clementia Development Patents” means all Patents that Cover any of the Clementia Development Know-How.
		

		
			1.37      “Clementia Development Technology” means, collectively, the Clementia Development Know-How and Clementia Development Patents.
		

		
			1.38      “Clementia Indemnified Parties” has the meaning set forth in Section 9.1.
		

		
			1.39      “Clementia Technology” means any and all Know-How and Patents [***].
		

		
			1.40      “Clinical Study” means a study in which human subjects or patients are dosed with a drug, whether approved or investigational, including any Phase I Clinical Study, Phase II Clinical Study, Phase III Clinical Study or any Pivotal Study.
		

		
			1.41      “Clinical Trial Application” or “CTA” has the meaning set forth in Section 1.89.
		

		
			1.42      “CMC Data” means any data included in the Chemistry, Manufacturing and Controls (“CMC”) portion of a Regulatory Filing or in any supporting development reports thereto, in each case, with respect to any Licensed Product in any country in the world.
		

		
			1.43      “CMO” means a contract manufacturing organization.
		

		
			1.44      “Code” means the Internal Revenue Code of 1986, as amended from time to time (or any corresponding provisions of succeeding law).
		

		
			1.45      “Combination Product” means:  (a) a single pharmaceutical formulation [***] or (b) a combination therapy comprised of [***].
		

		
			1.46      “Commercialization Report” has the meaning set forth in Section 4.4.2.
		

		
			1.47      “Commercialize” or “Commercializing” means (a) to market, promote, distribute, offer for sale, sell, have sold, import or export for commercial purposes or otherwise commercialize a pharmaceutical or biologic product, (b) to conduct activities, other than Research, Development and Manufacturing, in preparation for the foregoing activities, including obtaining Pricing and Reimbursement Approval, or (c) to conduct post-Regulatory Approval studies (including Clinical Studies).  When used as a noun, “Commercialization” means any activities involved in Commercializing.  “Commercialization” excludes Development and Manufacturing.
		

		
			1.48      “Commercially Reasonable Efforts” means, with respect to any Blueprint Compound or Licensed Product, that level of efforts, personnel and resources substantially similar to those commonly
		

		
			
		

		
			

		 

		

			4

		

		

			 

		

		

		
			dedicated by [***] to the Research, Development, Manufacture or Commercialization, as the case may be, of a product [***] (a “Comparable Product”) to any Blueprint Compound or Licensed Product, in each case, taking into account [***].  Without limiting the foregoing, Commercially Reasonable Efforts requires that Clementia or any of its Affiliates or Sublicensees:  [***].
		

		
			1.49      “Comparable Product” has the meaning set forth in Section 1.48.
		

		
			1.50      “Competitive Infringement” has the meaning set forth in Section 6.5.2(a).
		

		
			1.51      “Compulsory License” means, with respect to a Licensed Product, in a country, a license or rights granted to a Third Party by a Governmental Authority within such country to sell or offer for sale such Licensed Product in such country under any Patents Controlled by Blueprint or its Affiliates, without direct or indirect authorization from Blueprint or its Affiliates including, for example, a right granted pursuant to requests under 30 August 2003 WTO decision.
		

		
			1.52      “Confidential Information” means (a) all Know-How and any technical, scientific, trade, research, manufacturing, business, financial, marketing, product, supplier, intellectual property, and other non-public or proprietary data or information (including unpublished patent applications) of any kind whether in written, oral, graphical, electronic, machine-readable or other form, whether or not marked as confidential or proprietary that are disclosed, delivered or made available to the Receiving Party by or on behalf of the Disclosing Party, (b) “Proprietary Information” (as defined in the Prior CDA) that was disclosed by a Party or any of its Affiliates to the other Party or any of its Affiliates or Representatives under the Prior CDA, and (c) the terms and conditions of this Agreement; provided, however, that information of a Disclosing Party will not be Confidential Information of such Disclosing Party to the extent that the Receiving Party can demonstrate through competent evidence that such information:
		

		
			(i)          is known by the Receiving Party or any of its Affiliates without an obligation of confidentiality at the time of its receipt from the Disclosing Party, and not through a prior disclosure by or on behalf of the Disclosing Party;
		

		
			(ii)         was or is generally available to the public before the Receiving Party received such information from the Disclosing Party;
		

		
			(iii)       became generally available to the public or otherwise part of the public domain after its disclosure by the Disclosing Party and other than through any act or omission of the Receiving Party or any of its Affiliates or disclosees in breach of this Agreement;
		

		
			(iv)        is subsequently disclosed to the Receiving Party or any of its Affiliates without obligation of confidentiality by a Third Party who may rightfully do so and is not under a conflicting obligation of confidentiality to the Disclosing Party; or
		

		
			(v)         is developed by the Receiving Party or any of its Affiliates independently and without use of, reference to or reliance upon any Confidential Information received from the Disclosing Party.
		

		
			No combination of features or disclosures will be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the Receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the Receiving Party.
		

		
			
		

		
			

		 

		

			5

		

		

			 

		

		

		
			All Regulatory Filings and Know-How Controlled during the Term by a Party will be deemed to be the Confidential Information of such Party, and such Party will be deemed to be the Disclosing Party and the other Party will be deemed to be the Receiving Party with respect thereto.
		

		
			1.53      “Continuing Applications” has the meaning set forth in Section 6.2.3.
		

		
			1.54      “Control” or “Controlled” means, with respect to any Know-How, Patent, Regulatory Filing, Regulatory Approval, or other property (including intellectual property) right, the legal authority or right (whether by ownership, license (other than a license granted pursuant to this Agreement) or otherwise) of a Party or its Affiliate, to grant the right to access or use, or to grant a license or a sublicense to or under such Know-How, Patent, Regulatory Filing, Regulatory Approval or other property (including intellectual property) right as provided for herein (in whole or in part), without breaching the terms of any agreement or other arrangement between such Party (or any of its Affiliates) and a Third Party, in each case, existing at the time such Party would be required hereunder to grant the other Party such access, use, license or sublicense.
		

		
			1.55      “Cover,” “Covering” or “Covered” means:  (a) with respect to a Patent, that, in the absence of a license granted to a Person under an issued Valid Claim included in such Patent, the practice by such Person of the subject matter at issue would infringe such Valid Claim, or (b) with respect to an application for Patents, that, in the absence of a license granted to a Person under a pending Valid Claim included in such application, the practice by such Person of the subject matter at issue would infringe such Valid Claim if such Patent application were to issue as a Patent.
		

		
			1.56      “Declined Patent” has the meaning set forth in Section 6.2.4.
		

		
			1.57      “Delay or Suspension” means a failure or delay in performance of Clementia’s Research, Development, Manufacture and Commercialization obligations due to [***], in each case, that (x) [***] and (y) [***].  Notwithstanding the foregoing, a failure or delay in performance of Clementia’s Research, Development, Manufacture and Commercialization obligations resulting from [***] shall not be deemed a “Delay or Suspension.”
		

		
			1.58      “Develop” or “Developing” means to conduct nonclinical and clinical drug development activities, whether before or after Regulatory Approval, including with respect to drug metabolism and pharmacokinetics, translational research, toxicology, pharmacology, test method development, conduct of in vitro and animal studies, stability testing, process and packaging development and improvement, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, conduct of Clinical Studies, regulatory affairs, the preparation and submission of Regulatory Filings, Clinical Study regulatory activities, and any other activities directed towards obtaining Regulatory Approval of any Licensed Product.  When used as a noun, “Development” means any activities involved in Developing.  “Development” excludes Research, Commercialization and Manufacturing.
		

		
			1.59      “Development Milestone Event” has the meaning set forth in Section 5.2.1.
		

		
			1.60      “Development Milestone Payment” has the meaning set forth in Section 5.2.1.
		

		
			1.61      “Development Plan” means the written Development plan intended to support Development and Regulatory Approval of Licensed Products in the Field in the Territory, as may be updated and amended periodically in accordance with Section 4.4.  The initial Development Plan is attached hereto as Exhibit B.
		

		
			
		

		
			

		 

		

			6

		

		

			 

		

		

		
			1.62      “Development Report” has the meaning set forth in Section 4.4.
		

		
			1.63      “Disclosing Party” means the Party disclosing or delivering Confidential Information or on whose behalf such Confidential Information is disclosed or delivered.
		

		
			1.64      “Disputes” has the meaning set forth in Section 12.1.
		

		
			1.65      “DMF” means any drug master file with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.
		

		
			1.66      “Documents and Filings” has the meaning set forth in Section 3.1.2.
		

		
			1.67      “Dollars” or “$” means United States dollars.
		

		
			1.68      “Effective Date” has the meaning set forth in the introductory paragraph of this Agreement.
		

		
			1.69      “EMA” means the European Medicines Agency, or any successor Regulatory Authority thereto in the European Union having substantially the same function.
		

		
			1.70      “Employing Party” has the meaning set forth in Section 13.2.
		

		
			1.71      “Exclusive Reversion License” has the meaning set forth in Section 11.6.4(a)(i).
		

		
			1.72      “Executive Officers” means (a) with respect to Blueprint, the Chief Executive Officer of Blueprint, and (b) with respect to Clementia, the Chief Executive Officer of Guarantor.  If the position of any of the Executive Officers identified in this Section 1.72 no longer exists due to a corporate reorganization, corporate restructuring or the like that results in the elimination of the identified position, the applicable title of the Executive Officer set forth herein will be replaced with the title of another executive officer with responsibilities and seniority comparable to the eliminated Executive Officer, and the relevant Party will promptly provide notice of such replacement title to the other Party.
		

		
			1.73      “Exemplified Compounds” means, excluding the Blueprint Compounds, the compounds (a) [***]; (b) [***]; (c) [***]; or (d) [***].
		

		
			1.74      “Existing Manufacturing Inventory” has the meaning set forth in Section 3.2.2(a).
		

		
			1.75      “Exploit” or “Exploiting” means to Research, Develop, Manufacture or Commercialize or have others do the same.  When used as a noun, “Exploitation” means any activities involved in Exploiting.
		

		
			1.76      “FDA” means the United States Food and Drug Administration or any successor agency thereto.
		

		
			1.77      “Field” means all uses in humans and animals.
		

		
			1.78      “First Commercial Sale” means, with respect to any Licensed Product in any country or jurisdiction, the first sale of such Licensed Product by Clementia or any of its Affiliates or Sublicensees to a Third Party for distribution, use or consumption in such country or jurisdiction after the applicable Regulatory Authority of such country or jurisdiction has granted Regulatory Approval of such Licensed Product in such country or jurisdiction.
		

		
			
		

		
			

		 

		

			7

		

		

			 

		

		

		
			1.79      “FOP” means fibrodysplasia ossificans progressiva.
		

		
			1.80      “Force Majeure Event” has the meaning set forth in Section 13.8.
		

		
			1.81      “FTE” means the equivalent of a full-time person’s work time over a twelve (12) month period (including normal vacation, sick days and holidays) devoted to, and directly related to, conducting activities under this Agreement, in accordance with this Agreement, based on [***].  In the event that an individual devotes less than such full time to conducting activities under this Agreement in accordance with this Agreement during such twelve (12) month period, then for purposes of this Agreement, such individual will only count as a portion of an FTE which will be determined by dividing the number of full days during the applicable twelve (12) month period devoted to, and directly related to, conducting activities under this Agreement in accordance with this Agreement by the total number of working days during such twelve (12) month period.  No individual may be charged at greater than [***] in a given Calendar Year.
		

		
			1.82      “FTE Rate” means [***] per one (1) full FTE per full twelve (12) month Calendar Year; provided, that, starting January 1, 2020, such rate will adjust on January 1 of each Calendar Year by an amount equal to the change, if any, in the Consumer Price Index for All Urban Consumers (CPI-U) for the U.S. City Average, 1982-84 = 100, calculated by the Bureau of Labor Statistics during the immediately preceding Calendar Year.  Notwithstanding the foregoing, for any Calendar Year during the Term that is less than a full year, the above referenced rate will be proportionately reduced to reflect such portion of such full Calendar Year.
		

		
			1.83      “Fully Burdened Costs” means, with respect to any Blueprint Compound or Licensed Product (or component thereof), in each case, supplied by or on behalf of Blueprint or its Affiliates hereunder:  (a) the actual costs of such Manufacturing incurred by Blueprint or its Affiliates, including [***],  plus (b) any [***].
		

		
			1.84      “Generic Launch Quarter” means, with respect to a Generic Product in a country in the Territory, the Calendar Quarter in which the First Commercial Sale of the applicable Generic Product in such country occurred following receipt of all necessary Regulatory Approvals from the applicable Regulatory Authorities in such country to market and sell such Generic Product as a pharmaceutical product for one or more Indication included in the approved labeling for such Licensed Product in such country.
		

		
			1.85      “Generic Product” means, with respect to a Licensed Product that has received Regulatory Approval in a country in the Territory and is being marketed and sold by Clementia or any of its Affiliates or Sublicensees in such country, any pharmaceutical product that:  (a) is sold in such country by a Third Party that is not a Sublicensee of Clementia or its Affiliates and did not purchase or acquire such product in a chain of distribution that included Clementia or any of its Affiliates or Sublicensees; and (b) has received Regulatory Approval in such country, for at least one of the same Indications as such Licensed Product, as a “generic medicinal product,” “biosimilar,” “bioequivalent,” “similar biological medicinal product” or similar designation of interchangeability by the applicable Regulatory Authority in such country, pursuant to an expedited or abbreviated approval process in accordance with the then-current rules and regulations in such country, where (i) such Licensed Product is the “reference medicinal product,” “reference listed product” or similar designation in such country, and (ii) such approval referred to or relied on (A) the approved MAA for such Licensed Product held by Blueprint or its Affiliate, Clementia or its Affiliate or Sublicensee in such country or (B) Regulatory Data contained or incorporated by reference in such approved MAA for such Licensed Product.
		

		
			1.86      “Governmental Authority” means any multinational, federal, national, state, provincial, local or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal, official or officer, exercising executive,
		

		
			
		

		
			

		 

		

			8

		

		

			 

		

		

		
			judicial, legislative, police, regulatory, administrative or taxing authority or functions of any nature pertaining to government, including a Regulatory Authority.
		

		
			1.87      “Guarantor” means Ipsen Pharma SAS, a French corporation with principal offices located at 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France.
		

		
			1.88      “ICH” means the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
		

		
			1.89      “IND” means an application submitted to a Regulatory Authority for authorization to commence Clinical Studies, including (a) an Investigational New Drug Application as defined in 21 C.F.R. Part 312 or any successor application or procedure submitted to the FDA, (b) any equivalent of a United States IND in other countries, or regulatory jurisdictions, including a Clinical Trial Application (“CTA”) and (c) all supplements, amendments, variations, extensions and renewals thereof that may be submitted with respect to the foregoing.
		

		
			1.90      “Indemnified Party” means a Person entitled to indemnification under Article 9.
		

		
			1.91      “Indemnifying Party” means a Party from whom indemnification is sought under Article 9.
		

		
			1.92      “Indication” means a [***].  For clarity, [***].
		

		
			1.93      “Infringement Claim” has the meaning set forth in Section 6.6.
		

		
			1.94      “Initiation” or “Initiates” means with respect to a Clinical Study of a product, the administration of the first dose of such product to the first patient or subject in such Clinical Study.
		

		
			1.95      “In Process Manufacturing Inventory” has the meaning set forth in Section 3.2.2(b).
		

		
			1.96      “Insolvent Party” has the meaning set forth in Section 2.5.
		

		
			1.97      “Joint Know-How” means any Know-How conceived, discovered, developed, invented or created jointly by one or more employees of Clementia, its Affiliate, a Sublicensee or a Third Party acting under authority of one of the foregoing, on the one hand, and one or more employees of Blueprint or its Affiliate or a Third Party acting under authority of Blueprint or its Affiliate, on the other hand, in the course of performing activities under or in connection with this Agreement, including the Development Plan or Transition Plan.
		

		
			1.98      “Joint Patents” means all Joint Platform Patents and Joint Product-Specific Patents.  Notwithstanding anything to the contrary in this Agreement, Joint Patents shall not be deemed to include any Patents listed on Exhibit C-1 or Exhibit C-2 of this Agreement.
		

		
			1.99      “Joint Platform Patents” has the meaning set forth in Section 1.24.
		

		
			1.100    “Joint Product-Specific Patents” has the meaning set forth in Section 1.27.
		

		
			1.101    “Joint Technology” means, collectively, the Joint Know-How and the Joint Patents.
		

		
			1.102    “Know-How” means any data, results, creative expressions and information of any type whatsoever, in any tangible or intangible form, including know-how, trade secrets, practices, techniques, methods, processes, discoveries and claims, including synthesis, preparation, recovery and purification
		

		
			
		

		
			

		 

		

			9

		

		

			 

		

		

		
			processes and techniques, control methods and assays, inventions, works of authorship, developments, specifications, formulations, formulae, materials (including biological or chemical) or compositions of matter of any type or kind, software, source code, object code, user interfaces, application programming interfaces, databases, database schema, algorithms, graphics or images, marketing reports, clinical and non-clinical study reports, regulatory submission documents and summaries, expertise, stability, technology, test data including pharmacological, biological, chemical, biochemical, toxicological, and clinical test data, analytical and quality control data, stability data, studies and procedures; in each case, whether or not patentable or copyrightable, but which are not in the public domain.
		

		
			1.103    “Law” or “Laws” means all laws, statutes, rules, codes, regulations, orders, decrees, judgments or ordinances of any Governmental Authority, or any license, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law.
		

		
			1.104    “Licensed Know-How” means Blueprint Platform Know-How and Blueprint Product-Specific Know-How.
		

		
			1.105    “Licensed Patents” means Blueprint Platform Patents and Blueprint Product-Specific Patents.
		

		
			1.106    “Licensed Product” means any pharmaceutical product comprised of a Blueprint Compound, [***], including a Combination Product.
		

		
			1.107    “Licensed Technology” means, collectively, the Licensed Patents and the Licensed Know-How.
		

		
			1.108    “Loss of Market Exclusivity” means a condition where, with respect to a particular Licensed Product in a particular country in the Territory, one or more Generic Products are being marketed or sold in such country by a Third Party.
		

		
			1.109    “Losses” means damages, losses, liabilities, costs (including costs of investigation, defense), fines, penalties, taxes, expenses, or amounts paid in settlement (in each case, including reasonable attorneys’ and experts’ fees and expenses), in each case resulting from an Action by a Third Party.
		

		
			1.110    “Major European Market” means any of the following countries:  [***].
		

		
			1.111    “Major Market” means any of the following:  [***].
		

		
			1.112    “Manufacture” or “Manufacturing” means to engage in activities related to production, manufacture, synthesis, processing, filling, finishing, packaging, labeling, shipping and holding of product or any intermediate thereof, including process development, process qualification and validation, scale-up, commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control.  When used as a noun, “Manufacturing” means any of the foregoing activities.  “Manufacturing” refers to both nonclinical and clinical Manufacturing for Research and Development, and Manufacturing for Commercialization.
		

		
			1.113    “Manufacturing Documents” has the meaning set forth in Section 3.2.2(c).
		

		
			1.114    “Marketing Authorization” means the grant of all necessary permits, registrations, authorizations, licenses and approvals (or waivers) required for the Manufacture and Commercialization of a Licensed Product for use in the Field and in the Territory, including any Regulatory Approval for sale or marketing, and, where required, Pricing and Reimbursement Approvals.
		

		
			
		

		
			

		 

		

			10

		

		

			 

		

		

		
			1.115    “Marketing Authorization Application” or “MAA” means an application to the appropriate Regulatory Authority for approval to market for commercial sale a Licensed Product in a country, including (a) an NDA, (b) a BLA, or (c) an equivalent application for regulatory approval required before commercial sale and use of a Licensed Product submitted to a Regulatory Authority in a country other than the U.S.
		

		
			1.116    “Metabolites” has the meaning set forth in Section 1.19.
		

		
			1.117    “MHRA” means the Medicines and Healthcare products Regulatory Agency in the United Kingdom an any successor agency thereto.
		

		
			1.118    “MO” means multiple osteochondroma.
		

		
			1.119    “NDA” means a new drug application submitted to the FDA pursuant to Section 505(b) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(b).
		

		
			1.120    “Net Sales” means, with respect to a Licensed Product, the gross amount invoiced by Clementia, its Affiliates or its Sublicensees on sales or other dispositions for value of Licensed Products to a Third Party, less the following deductions, in each case, related specifically to the Licensed Products and actually incurred, paid or accrued by Clementia, its Affiliates or Sublicensees or specifically allocated in Clementia’s, its Affiliates’ or Sublicensees’ financial statements, as applicable, and calculated in accordance with the applicable Accounting Standards as consistently applied:
		

		
			(a)         discounts (including trade, cash, price and quantity discounts) [***] granted to any Third Party (including to Governmental Authorities, purchasers, reimbursers, customers, distributors, wholesalers, and group purchasing and managed care organizations or entities (and other similar entities and institutions));
		

		
			(b)         tariffs, duties, excises, taxes (including import, export, excise, consumption, sales, value added, or use taxes, other than income taxes) or other governmental charges or fees imposed upon and paid directly with respect to the production, sale, delivery or use of the Licensed Product (excluding taxes based on the income or profits of the selling party);
		

		
			(c)         amounts repaid or credited by reason of rejections, defects, recalls or returns or because of chargebacks, refunds, rebates or retroactive price reductions;
		

		
			(d)         amounts written off as uncollectible, if and when actually written off or allowed, after commercially reasonable debt collection efforts have been exhausted (not to exceed [***] of Net Sales in the aggregate in any period); provided that any such amounts will be added back to Net Sales if and when collected;
		

		
			(e)         price concessions mandated by or negotiated with commercial or governmental payers; and
		

		
			(f)         freight, insurance and other transportation charges incurred and separately invoiced in shipping a Licensed Product to Third Parties.
		

		
			For the avoidance of doubt, if a single item falls into more than one of the categories set forth in clauses (a)-(f) above, then such item may not be deducted more than once.
		

		
			
		

		
			

		 

		

			11

		

		

			 

		

		

		
			In the case of any sale or other disposition of Licensed Products for consideration other than cash (whether such non-cash consideration is payment in kind, exchange or other form), Net Sales shall include an amount calculated based on the on average price charged for the applicable Licensed Product(s) in the applicable country during the preceding royalty period.
		

		
			Notwithstanding anything to the contrary in the foregoing:
		

		
			(A)        Net Sales will not include [***].
		

		
			(B)        Net Sales will include [***].
		

		
			In the event that a Licensed Product is sold as a Combination Product, for the purposes of determining royalty payments on the Combination Product, Net Sales will mean the gross amount collected for the Combination Product less the deductions set forth in clauses (a)-(f) above, multiplied by a proration factor that is determined as follows:
		

		
			(i)          If the Blueprint Compound and the Other Components of the Combination Product were sold separately during the same or immediately preceding Calendar Quarter in the same dosages contained in the Combination Product, the proration factor will be determined by the formula [A / (A+B)], where A is the average gross sales price of Licensed Product containing only the Blueprint Compound as its active pharmaceutical ingredient in the same dosage during such period when sold separately from the Other Component(s), and B is the average gross sales price of the Other Component(s) in the same dosage(s) during such period when sold separately from the Licensed Product components (as applicable);
		

		
			(ii)         If a Licensed Product containing only the Blueprint Compound as its active pharmaceutical ingredient was sold separately during the same or immediately preceding Calendar Quarter in the same dosage contained in the Combination Product, but the Other Component(s) of the Combination Product were not sold separately in the same dosage(s) contained in the Combination Product during the same or immediately preceding calendar quarter, the proration factor will be determined by the formula [A/C], where A is the average gross sales price of Licensed Product containing only the Blueprint Compound as its active pharmaceutical ingredient in the same dosage during such period when sold separately from the Other Component(s), and C is the average gross sales price of Combination Product during such period;
		

		
			(iii)       If a Licensed Product containing only the Blueprint Compound as its active pharmaceutical ingredient was not sold separately during the same or immediately preceding Calendar Quarter, but the Other Component(s) of the Combination Product were sold separately in the same dosage(s) contained in the Combination Product during the same or immediately preceding Calendar Quarter, the proration factor will be determined by the formula [1-B/C], where B is the average gross sales price of the Other Components in the same dosage(s) during such period when sold separately from the Licensed Product component, and C is the average gross sales price of Combination Product during such period; or
		

		
			(iv)        If all active pharmaceutical ingredient(s) of the Combination Product were not sold or provided separately during the same or immediately preceding Calendar Quarter, the proration factor will be determined by the Parties in good faith negotiations based on the relative value contributed by each component.
		

		
			Clementia will not, and will cause its Affiliates and Sublicensees not to, use any Licensed Product as a loss leader or otherwise unfairly or inappropriately discount the gross invoiced sales price of a Licensed
		

		
			
		

		
			

		 

		

			12

		

		

			 

		

		

		
			Product in a manner that is intended to benefit, or provide an incentive to enhance sales of, any other pharmaceutical product sold by Clementia or any of its Affiliates or Sublicensees.
		

		
			1.121    “New Metabolite” has the meaning set forth in Section 4.4.1.
		

		
			1.122    “Non-Breaching Party” has the meaning set forth in Section 11.3.
		

		
			1.123    “Non-Competitive Infringement” has the meaning set forth in Section 6.5.2(c).
		

		
			1.124    “Non-Exclusive Reversion License” has the meaning set forth in Section 11.6.4(a)(ii).
		

		
			1.125    “Other Components” has the meaning set forth in Section 1.45.
		

		
			1.126    “Party” or “Parties” has the meaning set forth in the introductory paragraph of this Agreement.
		

		
			1.127    “Patent” means (a) a U.S. or foreign patent or a patent application, (b) any additions, priority applications, divisions, continuations, and continuations-in-part of any of the foregoing and (c) all patents issuing on any of the foregoing patent applications, together with all invention certificates, substitutions, reissues, reexaminations, registrations, supplementary protection certificates, confirmations, renewals and extensions of any of clauses (a), (b) or (c), and U.S. or foreign counterparts of any of the foregoing.
		

		
			1.128    “Patent Challenge” has the meaning set forth in Section 11.4.
		

		
			1.129    “Payee” has the meaning set forth in Section 5.8.2.
		

		
			1.130    “Payor” has the meaning set forth in Section 5.8.2.
		

		
			1.131    “Person” means any natural person, corporation, general partnership, limited partnership, joint venture, proprietorship or other business organization or a Governmental Authority.
		

		
			1.132    “Phase I Clinical Study” means a human clinical trial of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a) (as amended or any replacement thereof), or a similar clinical trial prescribed by the Regulatory Authority in a country other than the United States.
		

		
			1.133    “Phase I NHV Study” has the meaning set forth in Section 3.1.4.
		

		
			1.134    “Phase II Clinical Study” means a human clinical trial of a product, the principal purpose of which is a determination of safety and efficacy in the target patient population, as described in 21 C.F.R. 312.21(b) (as amended or any replacement thereof), or a similar clinical trial prescribed by the Regulatory Authority in a country other than the United States.
		

		
			1.135    “Phase III Clinical Study” means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.
		

		
			1.136    “Pivotal Study” means:  (a) a Phase III Clinical Study; or (b) [***].
		

		
			
		

		
			

		 

		

			13

		

		

			 

		

		

		
			1.137    “Pricing and Reimbursement Approval” means, with respect to a Licensed Product, the governmental or relevant health insurance organization’s approval, determination or decision establishing the price or level of reimbursement for such Licensed Product, in a given jurisdiction and the written agreement of such price by the Marketing Authorization holder in the Territory enabling the sale and payment of such Licensed Product in such jurisdiction in the Territory.
		

		
			1.138    “Prior CDA” means that certain Confidentiality Agreement, by and between Blueprint and Ipsen Bioscience, Inc., dated as of [***].
		

		
			1.139    “Product-Specific Reversion Technology” has the meaning set forth in Section 11.6.4(a)(i).
		

		
			1.140    “Program Liaison” has the meaning set forth in Section 2.8.
		

		
			1.141    “Prosecution and Maintenance” means, with regard to a particular Patent, the preparation, filing, prosecution, and maintenance (including payment of any patent annuity or maintenance fees) of such Patent, as well as re-examinations, reissues, appeals, post grant reviews, and inter partes reviews or their equivalents with respect to such Patent, together with the initiation or defense of interferences, oppositions and other similar proceedings with respect to the particular Patent.
		

		
			1.142    “QP” means a qualified person as defined under Directive 2001/83/EC of the European Parliament and of the Council.
		

		
			1.143    “Receiving Party” means the Party to whom Confidential Information is disclosed or delivered, including to such Party’s Representatives.
		

		
			1.144    “Recruiting Party” has the meaning set forth in Section 13.2.
		

		
			1.145    “Regulatory Approval” means the approval, license, registration or authorization of the applicable Regulatory Authority necessary for the marketing and sale of a Licensed Product in the Field in a country or jurisdiction, but excluding separate Pricing and Reimbursement Approval that may be required.  Regulatory Approvals include approvals by Regulatory Authorities of MAAs, or NDAs.
		

		
			1.146    “Regulatory Authority” means any multinational, federal, national, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the clinical development, manufacture, marketing or sale of a Licensed Product in a country or region, including the FDA in the United States, the EMA in Europe and the MHRA in the UK.
		

		
			1.147    “Regulatory Data” means any and all Research data, pharmacology data, CMC Data, Safety Data, nonclinical data, clinical data and all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with Regulatory Filings and Regulatory Approvals for the Licensed Products (including any applicable DMFs or similar documentation).
		

		
			1.148    “Regulatory Exclusivity Period” means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by applicable Law or by a Regulatory Authority in such country that confers exclusive marketing rights with respect to such Licensed Product in such country or prevents another Person from using or otherwise relying on any data supporting Regulatory Approval of such Licensed Product without the prior written consent of the holder of the MAA, such as new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, non-patent related pediatric exclusivity, reference product exclusivity or any other applicable marketing or data exclusivity.
		

		
			
		

		
			

		 

		

			14

		

		

			 

		

		

		
			1.149    “Regulatory Filing” means any documentation comprising or relating to or supporting any submission or application with any Regulatory Authority with respect to a Licensed Product or its use or potential use in humans, including any documents submitted to any Regulatory Authority and all supporting data, including INDs, NDAs, MAAs, and all correspondence with any Regulatory Authority with respect to any Licensed Product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).
		

		
			1.150    “Representatives” means a Party’s Affiliates and such Party’s or its Affiliate’s employees, directors, officers, permitted subcontractors, permitted sublicensees and agents, and advisors (including attorneys, accountants, consultants, bankers and financial advisors).
		

		
			1.151    “Research” to conduct activities related to the synthesis, discovery, identification, screening, optimization, design, profiling and characterization of compounds.  When used as a noun, “Research” means any activities involved in conducting Research.  “Research” excludes (a) Development, (b) Commercialization and (c) Manufacturing.
		

		
			1.152    “Reversion Licenses” has the meaning set forth in Section 11.6.4(a)(ii).
		

		
			1.153    “Reversion Patents” has the meaning set forth in Section 11.6.4(d)(ii)
		

		
			1.154    “Reversion Products” has the meaning set forth in Section 11.6.4(a)(i).
		

		
			1.155    “Reversion Royalty” has the meaning set forth in Section 11.6.4(n)(i).
		

		
			1.156    “Reversion Technology” means any Clementia Technology, and Clementia’s interest in any jointly owned technology, including Joint Technology, that is necessary for Blueprint to Exploit (including, continued Development in accordance with the then current Development Plan) any Reversion Product, as such Reversion Product exists as of the date of the notice of termination that results in termination, including, without limitation, [***].
		

		
			1.157    “Reversion Transition Period” has the meaning set forth in Section 11.6.4(g).
		

		
			1.158    “Reverted Licensed Patents” shall have the meaning set forth in Section 11.6.4(d)(i).
		

		
			1.159    “Royalty Payment” has the meaning set forth in Section 5.5.2.
		

		
			1.160    “Royalty Reduction Trigger” has the meaning set forth in Section 5.6.3.
		

		
			1.161    “Royalty Term” has the meaning set forth in Section 5.4.2.
		

		
			1.162    “Safety Data” means any Adverse Event information and similar data related to the actual or anticipated use of a Blueprint Compound or Licensed Product in humans, including data from Clinical Studies, all results from nonclinical safety studies and data from post-Regulatory Approval use, including toxicology and carcinogenicity data (if any), required by one (1) or more Regulatory Authorities to be collected or to be reported to such Regulatory Authorities under applicable Laws, but excluding any information related to the efficacy of the Licensed Product.
		

		
			1.163    “Sales Milestone Event” has the meaning set forth in Section 5.3.1.
		

		
			1.164    “Sales Milestone Payment” has the meaning set forth in Section 5.3.1.
		

		
			1.165    “Severed Clause” has the meaning set forth in Section 13.4.
		

		
			
		

		
			

		 

		

			15

		

		

			 

		

		

		
			1.166    “Sublicense” means a grant of rights from Clementia to an Affiliate or permitted Third Party under any of the rights licensed to Clementia by Blueprint under Section 2.1 with respect to the Exploitation of any Licensed Product, including, for the avoidance of doubt, Third Party distributors.
		

		
			1.167    “Sublicensee” means any Affiliate or permitted Third Party granted a Sublicense.
		

		
			1.168    “Term” has the meaning set forth in Section 11.1.
		

		
			1.169    “Territory” means worldwide.
		

		
			1.170    “Third Party” means any Person other than a Party or any of its Affiliates.
		

		
			1.171    “Third Party Agreements” means any [***] agreement between Blueprint (or any of its Affiliates) and any Third Party (a) related to the Research, Development, Manufacture or Commercialization of any Blueprint Compound or Licensed Product, or (b) [***].
		

		
			1.172    “Third Party Claim” has the meaning set forth in Section 9.3.1.
		

		
			1.173    “Trademark” means any trademark, trade name, service mark, service name, brand, domain name, trade dress, logo, slogan or other indicia of origin or ownership, including the goodwill and activities associated with each of the foregoing.
		

		
			1.174    “Transition Coordinator” has the meaning set forth in Section 3.1.1(a).
		

		
			1.175    “Transition Period” has the meaning set forth in Section 3.3.
		

		
			1.176    “Transition Plan” means the plan attached hereto as Exhibit D.
		

		
			1.177    “United States,” “U.S.” or “US” means the United States of America and its territories and possessions.
		

		
			1.178    “Valid Claim” means, with respect to a particular country, a claim [***] of (a) an issued and unexpired patent (or a supplementary protection certificate thereof) that has not (i) irretrievably lapsed or been abandoned, permanently revoked, dedicated to the public or disclaimed or (ii) been held invalid, unenforceable or not patentable by a court, governmental agency, national or regional patent office or other appropriate body that has competent jurisdiction, which holding, finding or decision is final and unappealable or unappealed within the time allowed for appeal or (b) a pending patent application, which claim has not been abandoned or finally disallowed without the possibility of appeal; provided, that, if a pending patent application has been pending for longer than [***] from the date of filing [***], then such corresponding claim in such pending patent application will not be deemed to be a Valid Claim; provided that, if a claim ceases to be a Valid Claim by reason of the foregoing subclause (b), then such claim will again be deemed a Valid Claim in the event such claim subsequently issues prior to the end of the Royalty Term in such country.
		

		
			ARTICLE 2
		

		
			LICENSE GRANTS AND EXCLUSIVITY
		

		
			2.1        License Grants to Clementia.
		

		
			2.1.1     Exclusive License to Blueprint Product-Specific Technology.  Subject to the terms and conditions of this Agreement (including Section 2.1.4), Blueprint hereby grants to Clementia an
		

		
			
		

		
			

		 

		

			16

		

		

			 

		

		

		
			exclusive (even with respect to Blueprint and its Affiliates), royalty-bearing, with the right to sublicense and subcontract (subject to Section 2.3), non-transferable (except as provided in Section 13.1) license under the Blueprint Product-Specific Technology to Exploit Blueprint Compounds or Licensed Products in the Field in the Territory during the Term; provided, however, that Blueprint hereby retains, on behalf of itself (and its Affiliates, licensees, and sublicensees) the rights under the Blueprint Product-Specific Technology to perform either itself, or have performed by Third Parties, [***].
		

		
			2.1.2     [***] License to Blueprint Future Technology.  Subject to the terms and conditions of this Agreement (including Section 2.1.4), Blueprint hereby grants to Clementia a [***] (subject to Section 2.3), [***] (except as provided in Section 13.1) license under the Blueprint Future Technology to Exploit Blueprint Compounds or Licensed Products in the Field in the Territory during the Term.
		

		
			2.1.3     Non-Exclusive License to Blueprint Platform Technology.  Subject to the terms and conditions of this Agreement (including Section 2.1.4), Blueprint hereby grants to Clementia a non-exclusive, with the right to sublicense and subcontract (subject to Section 2.3), non-transferable (except as provided in Section 13.1) license under the Blueprint Platform Technology to Exploit Blueprint Compounds or Licensed Products in the Field in the Territory during the Term.  For clarity, this license under this Section 2.1.3 will not grant or create (by implication, estoppel or otherwise) any license or right under the Blueprint Platform Technology to Exploit any compound or product that is not a Blueprint Compound or Licensed Product.
		

		
			2.1.4     Limitations of Licenses.  Each of the foregoing licenses to Clementia under Sections 2.1.1,  2.1.2 and 2.1.3 is subject to the limitations in this Section 2.1.4.  Under the licenses granted under Sections 2.1.1,  2.1.2, and 2.1.3,  Clementia may only make modifications to the Blueprint Compounds to the extent necessary to generate other compounds that are Blueprint Compounds (as set forth in Section 1.19).
		

		
			2.2        License Grant to Blueprint.  Clementia hereby grants to Blueprint a non-exclusive, royalty-free, fully paid-up, transferrable, sublicensable (through multiple tiers) license under the Clementia Technology to perform, either itself or through its Affiliates or subcontractors, its obligations under this Agreement, including under the Transition Plan.
		

		
			2.3        Sublicensing and Subcontracting.
		

		
			2.3.1     Clementia Right to Sublicense.  Clementia will have the right to grant Sublicenses of any and all rights granted to Clementia by Blueprint pursuant to Section 2.1 to its Affiliates and to Third Parties, in each case, with or without the right to grant further Sublicenses; provided that, prior to [***],  Clementia will not be permitted to grant to Third Parties any Sublicenses [***] without Blueprint’s prior written consent (such consent not to be unreasonably withheld, conditioned or delayed).  After [***],  Clementia will not be permitted to grant to Third Parties any Sublicenses [***] without Blueprint’s prior written consent (such consent not to be unreasonably withheld, conditioned or delayed).
		

		
			2.3.2     Clementia Right to Subcontract.  Clementia, its Affiliates and its Sublicensees will be permitted to engage and utilize Third Party service providers to provide services to Clementia, its Affiliates and Sublicensees, as applicable, with respect to the Exploitation of the Licensed Products hereunder.
		

		
			2.3.3     Performance by Clementia Affiliates and Sublicensees.  Each Sublicense and subcontract under this Article 2 will be in writing.  Clementia will promptly provide Blueprint with a copy of each fully executed Sublicense granted to a Third Party hereunder, which may be redacted solely to
		

		
			
		

		
			

		 

		

			17

		

		

			 

		

		

		
			remove information that is not necessary to monitor Clementia’s compliance with this Agreement, including information involving products other than the Licensed Product.  Any such Sublicense or subcontract entered into by Clementia or its Affiliate will (a) be subject and subordinate to, and consistent with, the terms and conditions of this Agreement; and (b) require the applicable Sublicensee or subcontractor to comply with all applicable terms of this Agreement (except for the payment obligations, for which Clementia will remain responsible), including (i) a requirement that such Sublicensee or subcontractor submit applicable sales or other reports to Clementia (or its Affiliate) to the extent necessary or relevant to the reports required to be made or records required to be maintained under this Agreement; (ii) audit requirements consistent with that set forth in Sections 4.3 and 5.7, as applicable; (iii) a requirement that such Sublicensee or subcontractor comply with confidentiality and non-use provisions of Confidential Information no less stringent than those contained in Article 7 with respect to Blueprint’s Confidential Information; and (iv) a requirement that such Sublicensee or subcontractor support or enable Clementia’s obligations upon and after termination consistent with Section 11.6.  No Sublicense or subcontract will diminish, reduce or eliminate any obligation of Clementia under this Agreement, and Clementia will remain responsible for its obligations under this Agreement and will be responsible for the performance of the relevant Sublicensee or subcontractor as if such Sublicensee or subcontractor, as applicable, were “Clementia” hereunder.
		

		
			2.4        Reservation of Rights.  No rights, other than those expressly set forth in this Agreement, are granted to either Party under this Agreement, and no additional rights will be deemed granted to either Party by implication, estoppel or otherwise, with respect to any intellectual property rights.  All rights not expressly granted by either Party or its Affiliates to the other under this Agreement are reserved.
		

		
			2.5        Bankruptcy Code § 365(n) Election.  All rights and licenses now or hereafter granted under or pursuant to this Agreement, are rights to “intellectual property” (as defined in Section 101(35A) of Title 11 of the United States Code (such Title 11, the “Bankruptcy Code”)).  Each Party, as licensee of such rights under this Agreement, will retain and may fully exercise all of its rights and elections under the United States Bankruptcy Code.  In the event of the commencement of a bankruptcy proceeding by or against a Party under the Bankruptcy Code (the “Insolvent Party”), the other Party will be entitled to a complete duplicate of (or complete access to, as appropriate) any intellectual property licensed to it under this Agreement and all embodiments of such intellectual property (including all information related to such intellectual property and rights of reference with respect to Regulatory Filings and Regulatory Approvals), and same, if not already in its possession, will be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon its written request therefore, unless the Insolvent Party continues to perform all of its obligations under this Agreement, or (b) if not delivered or granted under (a) above, upon rejection of this Agreement by or on behalf of the Insolvent Party upon written request therefore by the other Party.  The Insolvent Party (in any capacity, including debtor-in-possession) and its successors and assigns (including any trustee) agrees not to interfere with the exercise by other Party or its Affiliates of its rights and licenses to such intellectual property and such embodiments of intellectual property in accordance with this Agreement, and agrees to assist the other Party and its Affiliates in obtaining such intellectual property and such embodiments of intellectual property in the possession or control of Third Parties as reasonably necessary or desirable for the other Party to exercise such rights and licenses in accordance with this Agreement.  The Parties hereto acknowledge and agree that all payments by Clementia to Blueprint under this Agreement, other than royalty payments pursuant to Section 5.4, do not constitute royalties within the meaning of Bankruptcy Code § 365(n) or relate to licenses of intellectual property under this Agreement.  The foregoing provisions are without prejudice to any rights the Parties may have arising under the Bankruptcy Code or other applicable Laws.
		

		
			2.6        Third Party Agreements.  With respect to the Third Party Agreements set forth on Exhibit F, subject to any confidentiality obligations under such Third Party Agreements or to such Third Party, Blueprint will [***] assist Clementia in [***].  For the avoidance of doubt, Blueprint’s efforts will
		

		
			
		

		
			

		 

		

			18

		

		

			 

		

		

		
			not include the expenditure of funds or payments to such Third Party or, except to the extent agreed to by such Third Party, the assignment by Blueprint to Clementia of such Third Party Agreements.
		

		
			2.7        Exclusivity.
		

		
			2.7.1     Except for activities performed by or on behalf of Blueprint or its Affiliates pursuant to the Transition Plan, Blueprint will not, directly or with or through any of its Affiliates or a  Third Party, (a) Exploit any compound that is Covered by the Licensed Patents for the treatment [***] of FOP or MO during the Term, nor (b) with respect to any small molecule compound that is not Covered by the Licensed Patents, (i) Research, Develop or Manufacture such a compound for the treatment, [***] of FOP or MO for a period of five (5) years from the Effective Date, or (ii) Commercialize such a compound for the treatment, [***] of FOP or MO for a period of seven (7) years from the Effective Date, in each case, other than as specifically permitted under this Agreement.
		

		
			2.7.2     Notwithstanding Section 2.7.1, if a Change of Control of Blueprint occurs, and a Third Party becomes or has become an Affiliate of Blueprint as a result of such Change of Control (or any of such Third Party’s Affiliates or any successors or assigns of such Third Party or such Third Party’s Affiliates, other than Blueprint and its Affiliates as of such Change of Control, collectively with such Third Party, an “Acquiring Party”) already has a program (whether pre-clinical, clinical or commercial stage) that existed prior to such Change of Control, that would otherwise violate any of Section 2.7.1 (a “Blueprint Change of Control Program”), then (a) Section 2.7.1 will not apply with respect to such Blueprint Change of Control Program, and (b) such Acquiring Party will be permitted to continue such Blueprint Change of Control Program after such Change of Control and such initiation, pursuit and continuation will not constitute a violation of Section 2.7.1; provided that (i) none of the Licensed Technology, Clementia Technology, or Clementia Development Technology hereunder will be used in such Blueprint Change of Control Program, (ii) the Development activities required under this Agreement will be conducted separately from any Research or Development activities directed to such Blueprint Change of Control Program, including the maintenance of separate lab notebooks and records and separate personnel working on each of the activities under this Agreement and the activities covered under such Blueprint Change of Control Program and (iii) Blueprint will not, and it will cause its Representatives not to, disclose any of Clementia’s Confidential Information, Licensed Technology, Clementia Technology, or Clementia Development Technology to, such Acquiring Party or Representative of such Acquiring Party, as applicable.  [***]
		

		
			2.8        Program Liaison.  Each Party shall appoint a person(s) (each, a “Program Liaison”) who shall be the primary point of contact between the Parties, to facilitate communications and the sharing of information related to the Blueprint Compounds and Licensed Products and shall have such other responsibilities as the Parties may agree in writing after the Effective Date, it being understood that any communications between the Program Liaisons, including written communications, shall not constitute a notice or report under Section 13.3.  Each Party may replace its Program Liaison at any time by written notice to the other Party.
		

		
			ARTICLE 3
		

		
			TECHNOLOGY TRANSFER OF LICENSED KNOW-HOW
		

		
			3.1        Documents and Filings Technology Transfer.
		

		
			3.1.1     Transition Coordinator.
		

		
			(a)         Each Party shall appoint one transition coordinator in accordance with the Transition Plan (each, a “Transition Coordinator”) who shall serve as the principal contact for Clementia
		

		
			
		

		
			

		 

		

			19

		

		

			 

		

		

		
			and Blueprint for matters relating to the implementation of the Transition Plan solely during the Transition Period.  Each Party may replace its Transition Coordinator at any time upon written notice to the other Party.  The initial Transition Coordinators designated by the Parties are set forth on Schedule 1 to the Transition Plan.  Other personnel from a Party may assist such Party’s Transition Coordinator with the foregoing, including by attending and participating in any meetings (whether by phone or in person) with respect thereto.
		

		
			(b)         The Transition Coordinators shall be responsible solely during the Transition Period for (i) coordinating Transition Plan activities between the Parties, (ii) reviewing the progress being made under the Transition Plan, (iii) modifying the Transition Plan as necessary or desired (provided that any such modification shall be in writing and mutually agreed to by the Transition Coordinators), and (iv) implementing the Transition Plan.
		

		
			3.1.2     Documents and Filings.  Within [***] after the Effective Date and to the extent necessary during the [***] following the Effective Date, as may be reasonably requested by Clementia,  Blueprint will transfer electronic copies and assign ownership to Clementia or its Affiliates of all Regulatory Data, Regulatory Filings, Regulatory Approvals and other documents to or from Regulatory Authorities and other Third Parties, relating to the Blueprint Compounds and Licensed Products in the Territory (collectively, “Documents and Filings”), as identified on Schedule 2 to the Transition Plan.  During the Transition Period,  (i) [***] or (ii) [***], Blueprint will provide such documents to Clementia reasonably promptly after becoming aware of such documents or Clementia’s request, as applicable.  [***]  In addition, at Clementia’s request, to the extent permitted by the applicable Regulatory Authorities, Blueprint will appoint Clementia as Blueprint’s agent (or cause its Representative to appoint Clementia as its agent) for all matters solely related to Licensed Product-related matters in the Territory involving such Regulatory Authorities until all Regulatory Data, Regulatory Approvals and Regulatory Filings in the Territory have been assigned to Clementia or its designee, with it being understood and agreed that Clementia shall promptly take any and all actions as may be required by the relevant Regulatory Authority to permit or finalize the aforementioned assignments to Clementia or its designee.
		

		
			3.1.3     Right of Reference.  Blueprint hereby grants to Clementia and its Affiliates and Sublicensees a “Right of reference or use,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous law recognized outside of the U.S.) to all DMFs Controlled by Blueprint that pertain to the Blueprint Compounds.  To the extent Blueprint does not Control such DMFs, Blueprint will reasonably assist Clementia and its Affiliates and Sublicensees in obtaining a Right of reference or use from the Third Party holder of such DMFs.
		

		
			3.1.4     Ongoing Clinical Study.  With respect to Blueprint’s Phase 1 Clinical Study for BLU-782 in normal healthy volunteers (the “Phase I NHV Study”), Blueprint will, and will cause such Persons conducting such Phase I NHV Study on its behalf to, complete activities necessary for database lock for the Phase I NHV Study.
		

		
			3.1.5     Phase II Clinical Study Meetings.  Blueprint will accommodate Clementia’s reasonable requests to participate in communications with FDA regarding the first Phase II Clinical Study of Licensed Product, including attending meetings and reviewing minutes of any meetings, material telephone conferences or material discussions with FDA, in each case solely with respect to Licensed Product and to the extent permitted by FDA.
		

		
			3.1.6     Blueprint Trademarks and Copyrights.  Blueprint will promptly transfer and assign to Clementia, at no cost, all of Blueprint and its Affiliates’ rights, title, and interests in and to any Trademarks and copyrights Controlled by Blueprint and exclusively used in connection with the Licensed
		

		
			
		

		
			

		 

		

			20

		

		

			 

		

		

		
			Products (but not any Blueprint house marks or any Trademark containing the words “Blueprint,” “Blueprint Medicines” or “Blueprint Medicines Corporation”).
		

		
			3.1.7     Patent Information.  Upon request by Clementia, Blueprint will provide (a) any and all material correspondence with the relevant patent office(s) pertaining to the Prosecution and Maintenance of the Licensed Patents prior to the Effective Date,  (b) a Patent docket report detailing the status of all Licensed Patents with upcoming deadlines for the [***] period following the Effective Date, and (c)  [***] the following: (1)  [***], (2)  [***] and (3)  [***] in connection with the Prosecution and Maintenance of the Licensed Patents prior to the Effective Date.
		

		
			3.1.8     Data Room Transfer.  Within [***] of the Effective Date, Blueprint shall provide Clementia with complete, unabridged and unrestricted (including with ability to print and download) electronic copies of all documents and materials that had been placed in the data room established prior to the Effective Date for Clementia’s and its Affiliates’ diligence of the Blueprint Compounds and Licensed Products.
		

		
			3.2        Manufacturing Technology Transfer.
		

		
			3.2.1     Technology Transfer.  Within [***] after the Effective Date, [***] Blueprint will transfer to Clementia or its designated CMO an electronic copy of Manufacturing technology related to the Manufacture of BLU-782, as identified on Schedule 3 to the Transition Plan.  At Clementia’s request, Blueprint will [***].  For the avoidance of doubt, Blueprint’s efforts will not include the expenditure of funds or payments to such Blueprint CMO or the assignment by Blueprint to Clementia of any of Blueprint’s master service agreements or similar agreements with any such Blueprint CMO.
		

		
			3.2.2     Manufacturing Inventory.
		

		
			(a)         Existing Manufacturing Inventory.  [***] after the Effective Date, the Parties will enter into a  bill of sale in the form set forth in Exhibit 3.2.2, and Blueprint will sell to Clementia, and Clementia will purchase, the quantities of BLU-782 and the Licensed Product containing BLU-782 (in bulk form or finished dosage product form) or works-in-progress of each of the foregoing Controlled by Blueprint, identified on and upon the terms and conditions set forth in Schedule 3.2.2(a) (“Existing Manufacturing Inventory”), at an amount equal to (i) the aggregate Fully Burdened Costs for such Manufacturing Inventory set forth in Schedule 3.2.2(a), multiplied by (ii) [***].  Title to and risk of loss of such Existing Manufacturing Inventory will pass to Clementia at the time of sale, and such Existing Manufacturing Inventory shall be sold “as is” to Clementia.
		

		
			(b)         In Process Manufacturing Inventory.  [***],  for the quantities of BLU-782 and the Licensed Product containing BLU-782 (in bulk form or finished dosage product form) and all raw materials or works-in-progress of each of the foregoing Controlled by Blueprint,  identified on Schedule 3.2.2(b) (“In Process Manufacturing Inventory”), the Parties will enter into a bill of sale in the form set forth in Exhibit 3.2.2, and Blueprint will sell to Clementia, and Clementia will purchase, the In Process Manufacturing Inventory upon the terms and conditions set forth in Schedule 3.2.2(b), at an amount equal to (i) the aggregate Fully Burdened Costs for such In Process Manufacturing Inventory set forth in Schedule 3.2.2(b), multiplied by (ii) [***].  Title to and risk of loss of such In Process Manufacturing Inventory will pass to Clementia at the time of sale, and such In Process Manufacturing Inventory shall be sold “as is” to Clementia.
		

		
			(c)         Manufacturing Documents.  Within [***] after the Effective Date (with respect to such Existing Manufacturing Inventory) and within [***] after such sale (with respect to such In Process Manufacturing Inventory), Blueprint will also transfer (or cause to be transferred) to Clementia
		

		
			
		

		
			

		 

		

			21

		

		

			 

		

		

		
			copies of Blueprint’s Manufacturing records relating to such supply, including copies of the applicable batch records, in-process and release test results, and certificates of analysis and, to the extent applicable, release with respect thereto (the “Manufacturing Documents”); provided, however, that in no event shall Blueprint be required to transfer any of its CMO’s confidential or proprietary information.
		

		
			3.3        Assistance by Blueprint.  Blueprint will provide reasonable assistance to Clementia in accordance with the Transition Plan for up [***] hours at no cost to Clementia (other than external costs and expenses incurred by Blueprint in connection therewith, for which Blueprint will invoice Clementia); provided that, [***].  For any assistance by Blueprint to Clementia in excess of [***] hours, Blueprint will invoice Clementia for FTEs at the FTE Rate for any FTE hours and external costs and expenses incurred by Blueprint in connection with providing such assistance for a period not to exceed [***] to facilitate (a) the transition of the Licensed Technology and Documents and Filings to Clementia and (b) the transfer of the Manufacturing Documents to Clementia (such period, the “Transition Period”).  Clementia will pay such invoices within [***] of receipt of each invoice from Blueprint in accordance with Section 5.9.  For the avoidance of doubt, Blueprint shall not be required to provide assistance to Clementia pursuant to this Section 3.3 beyond such [***] period, subject to Section 3.4.
		

		
			3.4        Follow-up Period.  If no later than [***], either Party discovers or learns of any material, non-duplicative documents or materials that should have been included in the Documents and Filings or any Know-How that should have been included in the Licensed Technology, such Party shall provide written notice to the other Party, and Blueprint shall [***] provide Clementia with such Documents and Filings or such Licensed Know-How in accordance with the manner specified on Schedule 2 to the Transition Plan.
		

		
			ARTICLE 4
		

		
			RESEARCH, DEVELOPMENT, REGULATORY, MANUFACTURING AND COMMERCIALIZATION
		

		
			4.1        General.  Without limiting Clementia’s obligations pursuant to Section 4.2, as between the Parties, Clementia will have sole authority and responsibility, at its sole expense, to Develop, Manufacture (subject to Blueprint’s obligations pursuant to Section 3.2) and Commercialize Licensed Products in the Field in the Territory.  Without limiting the generality of the foregoing, subject to Clementia’s obligations pursuant to Section 4.2, as between the Parties, Clementia will be solely responsible and have sole authority for preparing, and submitting all required Regulatory Filings in connection with obtaining and maintaining Regulatory Approvals with respect to Blueprint Compounds and Licensed Products in the Field, including all INDs and NDAs, at Clementia’s sole expense.  All such submissions and Regulatory Filings relating to Blueprint Compounds and Licensed Products will be submitted in the name of, and owned by, Clementia.
		

		
			4.2        Diligence.
		

		
			4.2.1     Research and Development Diligence.  During the period commencing with the Effective Date and ending with the date of FDA approval of the first NDA for a Licensed Product, Clementia (directly, or through its Affiliates, Sublicensees and permitted subcontractors) will use Commercially Reasonable Efforts to Research, Develop and obtain Regulatory Approval of [***] Licensed Product for use in humans in the Field in [***] for the treatment [***] of FOP in patients.  Without limiting the foregoing sentence, Clementia will (a) use Commercially Reasonable Efforts to implement the initial Development Plan attached hereto as Exhibit B and (b) Initiate a Phase II Clinical Study or Pivotal Study of a Licensed Product for the treatment [***] of FOP in patients by no later than [***] 2020.
		

		
			4.2.2     Commercialization Diligence.  Clementia (directly, or through its Affiliates, Sublicensees and permitted subcontractors) will be responsible for and use Commercially Reasonable
		

		
			
		

		
			

		 

		

			22

		

		

			 

		

		

		
			Efforts to Commercialize [***] Licensed Product(s) during the Term following Regulatory Approval for such Licensed Product(s) for use in humans in the Field in [***]
		

		
			4.2.3     Notification of Inability to Exploit; Resumption of Performance.  Notwithstanding the foregoing, Clementia shall not be in breach of this Section 4.2 in the event and to the extent its failure to perform its obligations under this Section 4.2 arises from or is a result of a Delay or Suspension.  Clementia will promptly notify Blueprint in writing (and in any event, within [***]) upon it obtaining knowledge of the occurrence of a Delay or Suspension.  Such notice shall state the nature of the event or condition, and its anticipated duration (to the extent such anticipated duration can reasonably be estimated).    Clementia will promptly respond to Blueprint’s reasonable questions or requests for additional information relating to such cause for Delay or Suspension and resumption of Development or Commercialization obligations.  Clementia will use Commercially Reasonable Efforts to resolve the cause for such Delay or Suspension and resume performance of its obligations pursuant to Sections 4.2.1 and/or 4.2.2, as applicable.
		

		
			4.3        Manner of Performance; Records.  Clementia will (a) perform, and will cause its Affiliates and Sublicensees to perform, all Research, Development, Manufacturing and Commercialization activities and obligations under this Agreement in good scientific manner and in compliance with all applicable Laws (including with respect to each such activity that will or would reasonably be expected to be submitted to a Regulatory Authority in support of a Regulatory Filing or NDA, then-current Good Laboratory Practices, Good Clinical Practices and Good Manufacturing Practices) and (b) maintain, or cause to be maintained, complete and accurate records of all such activities conducted by or on behalf of Clementia, its Affiliates and Sublicensees, including all results, data, inventions and developments, at a level of detail appropriate for patent and regulatory purposes.  In the event Blueprint has a reasonable basis to believe Clementia is not in compliance with applicable Law, Blueprint may appoint an independent third party reasonably acceptable to Clementia to review any such records of Clementia and its Affiliates and Sublicensees, as applicable, in the location(s) where such records are maintained by Clementia and its Affiliates and Sublicensees, upon reasonable prior written notice, during regular business hours and under obligations of confidentiality reasonably satisfactory to Clementia, for the sole purpose of verifying Clementia’s and its Affiliates’ and Sublicensees’ compliance with applicable Law.
		

		
			4.4        Notice of Metabolites; Reports.
		

		
			4.4.1     Notice of Metabolites.  At any time during the Term, Clementia shall provide Blueprint with written notice of any Metabolite(s) not identified in Exhibit A-2,  which notice shall include the chemical structure of such metabolite (such metabolite, a “New Metabolite”).  Effective upon receipt by Blueprint of such written notice, (a) such New Metabolite shall become a Blueprint Compound and (b) Blueprint hereby grants to Clementia the licenses specified under Sections 2.1.1,  2.1.2, and 2.1.3 with respect to such New Metabolite as a Blueprint Compound; provided that in each case (clauses (a) and (b)) if Blueprint does not, as of the date of such written notice, Control the (i) Blueprint Product-Specific Technology, (ii) Blueprint Future Technology, or (iii) Blueprint Platform Technology, in each case (clauses (i), (ii) and (iii)), respectively, that Covers (with respect to Licensed Patents) or relates to (with respect to Licensed Know-How) the New Metabolite, then (A) such New Metabolite shall not become a Blueprint Compound and (B) Blueprint will not grant to Clementia any license under Section 2.1 with respect to such New Metabolite.  Clementia covenants that it will not Develop or Commercialize any Metabolite unless and until such Metabolite becomes a Blueprint Compound; provided, however, that nothing in this Section 4.4.1 will be interpreted to prevent Clementia from continuing to Develop and Commercialize then-existing Blueprint Compounds as contemplated by this Agreement.
		

		
			4.4.2     Development and Commercialization Reports.  During the period commencing with the Effective Date [***],  Clementia will provide to Blueprint a written report (in English) at least [***]
		

		
			
		

		
			

		 

		

			23

		

		

			 

		

		

		
			describing in reasonable detail Clementia’s and its Affiliates’ and Sublicensees’ activities and progress, including through its Affiliates and Sublicensees, related to the Research, Development, Manufacturing and Commercialization of the Licensed Products in the Territory including with respect to Development, on a Licensed Product-by-Licensed Product and Indication-by-Indication basis and country-by-country basis:  (a) [***], (b) [***], (c) [***], (d) [***], (e) [***], (f) [***], and (g) [***] (each such report, a “Development Report”).  Concurrently with such Development Report, Clementia will provide any updates and amendments to the Development Plan.  Beginning after the [***],  Clementia will provide such report [***], including a brief overview of (i) any of the foregoing activities ((a) through (g)) related to (A) [***], and (B) [***] and (ii) [***] (each such report, a “Commercialization Report”).  Clementia will promptly respond to Blueprint’s reasonable questions or requests for additional information relating to reported activities and progress in such Development Reports or Commercialization Reports, as applicable.  For avoidance of doubt, each Development Report and Commercialization Report shall be Clementia’s Confidential Information.
		

		
			ARTICLE 5
		

		
			FINANCIAL TERMS
		

		
			5.1        Upfront Payment.  Clementia will pay Blueprint an irrevocable, non-refundable, non-creditable payment in the amount of Twenty Five Million Dollars ($25,000,000) within [***] after the Effective Date.
		

		
			5.2        Development Milestone Payments.
		

		
			5.2.1     Development Milestones and Development Payments.  In partial consideration of the licenses and rights granted to Clementia hereunder, Clementia will make each of the irrevocable, non-refundable, non‐creditable, one-time milestone payments set forth below in Table 5.2.1 (each, a “Development Milestone Payment”) to Blueprint within [***] after the first achievement by Clementia or any of its Affiliates or Sublicensees of the corresponding milestone event set forth below in such table with respect to a Licensed Product (each, a “Development Milestone Event”).
		

		
			 
		

			
					
						Table 5.2.1 – Development Milestones

				
	
					
						 

					
					
						Development Milestone Event

					
					
						Development Milestone 
Payments

				
	
					
						1

					
					
						[***]

					
					
						$20,000,000
(Twenty Million Dollars)

				
	
					
						2

					
					
						[***]

					
					
						[***]

				
	
					
						3

					
					
						[***]

					
					
						[***]

				
	
					
						4

					
					
						[***]

					
					
						[***]

				
	
					
						5

					
					
						[***]

					
					
						[***]

				
	
					
						6

					
					
						[***]

					
					
						[***]

				
	
					
						7

					
					
						[***]

					
					
						[***]

				
	
					
						8

					
					
						[***]

					
					
						[***]

				
	
					
						9

					
					
						[***]

					
					
						[***]

				
	
					
						10

					
					
						[***]

					
					
						[***]

				

		
			 
		

		
			
		

		
			

		 

		

			24

		

		

			 

		

		

		
			5.2.2     [***]
		

		
			(a)         [***].
		

		
			(b)         [***].
		

		
			5.2.3     One-Time Payments.  For clarity, each Development Milestone Payment in Table 5.2.1 will be due and payable one time only with respect to the first achievement of each Development Milestone Event by the first Licensed Product to achieve such Development Milestone Event (regardless of the number of Licensed Products to achieve such Development Milestone Event), such that the maximum total amount payable under this Section will not exceed [***].
		

		
			5.2.4     Milestone Event Notice.  Within [***] after Clementia becomes aware that a Development Milestone Event was achieved, Clementia will notify Blueprint thereof in writing, including identifying the event and the date of its achievement.
		

		
			5.3        Sales Milestone Payments.
		

		
			5.3.1     Sales Milestones and Sales Milestone Payments.  Clementia will pay to Blueprint the following irrevocable, non-refundable, non-creditable one-time sales milestone payments (each, a “Sales Milestone Payment”) within [***] following the end of the first Calendar Year during the Royalty Term in which the aggregate Net Sales of Licensed Products by Clementia, its Affiliates and Sublicensees in the Territory achieves the sales threshold (set forth in the table below) corresponding to such Sales Milestone Payment (each a “Sales Milestone Event”):
		

		
			 
		

			
					
						Table 5.3.1 – Sales Milestones

				
	
					
						 

					
					
						Sales Milestone Event

					
					
						Sales Milestone Payments

				
	
					
						1

					
					
						[***]

					
					
						[***]

				
	
					
						2

					
					
						[***]

					
					
						[***]

				
	
					
						3

					
					
						[***]

					
					
						[***]

				
	
					
						4

					
					
						[***]

					
					
						[***]

				

		
			 
		

		
			Each Sales Milestone Payment will be payable only one-time and only upon the first achievement of the applicable Sales Milestone Event for aggregate Net Sales of Licensed Products in the Territory, and no amounts would be due for subsequent or repeated achievements.  For clarity, more than one (1) Sales Milestone Event may occur in a single Calendar Year.  For example, [***].  The maximum total amount payable under this Section will not exceed [***].
		

		
			5.3.2     Milestone Event Notice.  Within [***] after Clementia becomes aware that a Sales Milestone Event was achieved, Clementia will notify Blueprint thereof in writing, including identifying the event and the date of its achievement.
		

		
			5.4        Royalties.
		

		
			5.4.1     Royalty Rate.  Subject to the applicable adjustments in accordance with Section 5.6, during the applicable Royalty Term, Clementia will pay to Blueprint royalties based on the
		

		
			
		

		
			

		 

		

			25

		

		

			 

		

		

		
			aggregated Net Sales of all Licensed Products (whether by Clementia, its Affiliates or Sublicensees) in the Territory at the rates set forth in the table below.
		

		
			 
		

			
					
						Table 5.4.1 – Royalty Rates for Net Sales of Licensed Products

				
	
					
						Worldwide Aggregate Annual Net Sales of Licensed Products

					
					
						Royalty Rate (as a 
percentage of Net Sales)

				
	
					
						[***]

					
					
						[***]

				
	
					
						[***]

					
					
						[***]

				
	
					
						[***]

					
					
						[***]

				
	
					
						[***]

					
					
						[***]

				

		
			 
		

		
			5.4.2     Royalty Term.  Royalties will be due under this Section 5.4.2 on a country-by-country and Licensed Product-by-Licensed Product basis during the period commencing on the First Commercial Sale of such Licensed Product in such country and ending upon the latest of (a) the expiration of the last Valid Claim within the Licensed Patents Covering such Licensed Product in such country, (b) upon the expiration of the Regulatory Exclusivity Period for such Licensed Product in such country or (c) the [***] anniversary of the First Commercial Sale of such Licensed Product in such country (such period for such Licensed Product in such country, the “Royalty Term”).
		

		
			5.5        Royalty Payments and Reports.
		

		
			5.5.1     [***] Flash Reports.  Beginning after the first sale of a Licensed Product,  (i) as part of the reports described in Section 4.4.2,  Clementia will provide a forecast of estimated quarterly and annual Net Sales and (ii) [***],  Clementia will provide Blueprint with a flash report providing a good-faith estimate of the amount of Net Sales and the royalties payable to Blueprint on such Net Sales on a Licensed Product-by-Licensed Product and country-by-country basis in the Territory during such [***] (including such amounts expressed in local currency and as converted to Dollars).  Notwithstanding the foregoing, Clementia will provide final reports for each Calendar Quarter as set forth in Section 5.5.2, and it is understood that for purposes of calculating the royalty owed under Section 5.4.1 or Section 5.6, as applicable, final reported Net Sales (as reported pursuant to Section 5.5.2) may vary from the flash report for the [***].
		

		
			5.5.2     Quarterly Royalty Payments and Final Reports.  Within [***] after the end of each of the Calendar Quarters ended March 31, June 30 and September 30 of each Calendar Year and within [***] after the end of the Calendar Quarter ended December 31 of each Calendar Year, Clementia  (i) will pay to Blueprint any amounts due pursuant to Section 5.4.1 (“Royalty Payments”), and (ii) will provide to Blueprint concurrently with such payment a statement (in English) setting forth (a) the amount of Net Sales on a Licensed Product-by-Licensed Product and country-by-country basis in the Territory during such Calendar Quarter (including such amounts expressed in local currency and as converted to Dollars); (b) the type and amount of permitted deductions from gross sales to determine Net Sales and the total amount of such deductions; (c) the applicable royalty rates for each Licensed Product in each country in the Territory after applying any permitted deductions in accordance with Section 5.6; and (d) a calculation of the royalties due to Blueprint for such Calendar Quarter.
		

		
			5.6        Payment Reductions.
		

		
			
		

		
			

		 

		

			26

		

		

			 

		

		

		
			5.6.1     Blocking Third Party Patent(s).  Subject to Section 5.6.5,  Clementia will be entitled to deduct from Royalty Payments under Section 5.4 otherwise payable to Blueprint on Net Sales of a Licensed Product in a specific country or countries, [***] of any Blocking Third Party Patent Payments actually paid by Clementia or any of its Affiliates or Sublicensees under a license to Blocking Third Party Payments applicable to such Licensed Product in such country or countries, up to a maximum reduction under this Section 5.6.1 of [***] of the royalties otherwise owed to Blueprint hereunder for the applicable Calendar Quarter for such Licensed Product in such country.
		

		
			5.6.2     No Exclusivity.  Subject to Section 5.6.5 if at any time during the Royalty Term a Licensed Product is sold in a country in the Territory by Clementia or an Affiliate or Sublicensee and such Licensed Product, at the time of such sale:
		

		
			(a)         is not Covered by a Valid Claim within the Licensed Patents Covering such Licensed Product in such country, but is within any applicable Regulatory Exclusivity Period, then, the applicable royalty in effect with respect to such sale of such Licensed Product in such country as specified in Section 5.4.1 will be reduced by [***]; or
		

		
			(b)         is not Covered by a Valid Claim within the Licensed Patents Covering such Licensed Product in such country and is not within any applicable Regulatory Exclusivity Period, then, the applicable royalty in effect with respect to such sale of such Licensed Product in such country as specified in Section 5.4.1 will be reduced by [***].
		

		
			5.6.3     Generic Competition.  Subject to Section 5.6.5, on a Licensed Product-by-Licensed Product and country-by-country basis, if during any Calendar Quarter, there is Loss of Market Exclusivity for such Licensed Product in such country and the aggregate Net Sales of such Licensed Product in such country during any [***] following the Generic Launch Quarter are at least [***] lower than the aggregate Net Sales of such Licensed Product in such country during the [***] immediately prior to the Generic Launch Quarter, then the royalty rate applicable to Net Sales of such Licensed Product in such country in such Calendar Quarter will be reduced by [***] of the applicable royalty rate that would otherwise be owed on such Net Sales of such Licensed Product in such country under Section 5.4.1;  provided, that if the aggregate Net Sales of such Licensed Product in that country during any [***] following the Generic Launch Quarter are at least [***] lower than the aggregate Net Sales of such Licensed Product in such country during [***] immediately prior to the Generic Launch Quarter, then the royalty rate applicable to Net Sales of such Licensed Product in such country in such Calendar Quarter will be reduced by [***] of the applicable royalty rate that would otherwise be owed on such Net Sales of such Licensed Product in such country under Section 5.4.1 (each, a “Royalty Reduction Trigger”); provided, however, if the aggregate Net Sales of such Licensed Product in a country during any [***] subsequently become equal to or exceed the aggregate Net Sales of such Licensed Product in such country during the last [***] immediately prior to the Generic Launch Quarter, then the applicable royalty rate reduction will cease with respect to such Licensed Product in such country, unless and until a Royalty Reduction Trigger occurs again with respect to such Licensed Product in such country.  In the event a royalty rate reduction under this Section 5.6.3 is applied with respect to a Licensed Product in a country during a Calendar Quarter following a Generic Launch Quarter, any royalty reduction previously applied under Section 5.6.2 shall no longer apply with respect to such Licensed Product in such country as of such Calendar Quarter.    Clementia will promptly notify Blueprint of the occurrence of Loss of Market Exclusivity, which notice will specify the applicable Generic Products, Indication, and country in the Territory.
		

		
			5.6.4     Compulsory License.  If a Compulsory License is granted to a Third Party with respect to any Licensed Product in any country in the Territory with a royalty rate lower than the applicable royalty rate set forth in this Section 5.6.4, and such Third Party actually sells such Licensed Product in such
		

		
			
		

		
			

		 

		

			27

		

		

			 

		

		

		
			country under such Compulsory License, then the royalty rate to be paid by Clementia on Net Sales in that country under this Section 5.6.4 will be reduced to the rate paid by the compulsory licensee.
		

		
			5.6.5     Maximum Aggregate Reduction.  The maximum aggregate of all reductions under Sections 5.6.1 through Section 5.6.3 will reduce the amount of royalties owed to Blueprint hereunder in any given Calendar Quarter by no more than [***] from the amounts otherwise due to Blueprint hereunder in such Calendar Quarter in the absence of any such reductions.    Clementia may carry forward to subsequent Calendar Quarters any amounts that it was not able to credit under this Section 5.6.5 on account of such maximum aggregate royalty reduction, subject to the maximum aggregate royalty reduction for all subsequent Calendar Quarters.
		

		
			5.7        Financial Audits.
		

		
			5.7.1     Record Keeping.  Clementia and its Affiliates and Sublicensees will keep, and will require each of its Sublicensees to keep, complete and accurate records in accordance with the applicable Accounting Standards of the activities and payments underlying (a) the Development Milestone Payments, (b) the Sales Milestone Payments, (c) Net Sales, including the Net Sales and proration factor applied for Combination Products and the deductions from gross revenue to determine Net Sales, (d) Royalty Payments, including reductions taken in accordance with Section 5.6, if any, and (e) any other payments under this Agreement.  Blueprint will have the right not more than [***] during the Term and [***] thereafter, at its sole expense, to have an independent, certified public accountant, selected by Blueprint and reasonably acceptable to Clementia, review any such records of Clementia and its Affiliates and Sublicensees, as applicable, in the location(s) where such records are maintained by Clementia and its Affiliates and Sublicensees, as applicable, upon reasonable prior written notice, during regular business hours and under obligations of confidentiality, for the sole purpose of verifying the basis and accuracy of payments made under this Agreement, within the prior [***] period.  The records for any Calendar Year may be audited no more than once absent fraud or intentional misconduct that directly inhibited Blueprint’s ability to conduct a complete and accurate audit.
		

		
			5.7.2     Audit Report.  The report prepared by the independent certified public accounting firm pursuant to Section 5.7.1, a copy of which report (which will be in English) will be sent or otherwise provided to each Party by such independent public accountant at the same time, will contain the conclusions of such accounting firm regarding the audit and will specify that the amounts paid pursuant thereto were correct or, if incorrect, the amount of any underpayment or overpayment, and the specific details regarding any discrepancies.  No other information will be provided to Blueprint without the prior consent of Clementia unless disclosure is required by Law, regulation or judicial order, and if so determined by Blueprint, it will, if permitted, give Clementia prior notice thereof reasonably sufficient for Clementia to seek a protective order against or limiting such disclosure.  If such report shows any underpayment, then Clementia will remit to Blueprint, within [***] after receipt of such report, (a) the amount of such underpayment and (b) if such underpayment exceeds [***] of the total amount owed for the period then being audited, the reasonable out-of-pocket costs incurred by Blueprint in conducting such audit.  If such report shows any overpayment, then any overpayments will, at Clementia’s election, be refunded by Blueprint to Clementia within [***] of receipt of the audit report or deducted from future payments owed to Blueprint.  The Parties mutually agree that all information of Clementia, its Affiliates and Sublicensees that is subject to review under this Section is Confidential Information of Clementia and that Blueprint will retain and cause the accountant to retain all such information in confidence in accordance with Article 7.
		

		
			5.7.3     Audit Period.  Upon the expiration of [***] following the end of any Calendar Year, the audit rights set forth in this Section 5.7 will no longer apply to such Calendar Year and the calculation of amounts payable with respect to such Calendar Year will be binding and conclusive absent a showing of fraud or intentional misconduct in the calculation of such amounts.
		

		
			
		

		
			

		 

		

			28

		

		

			 

		

		

		
			5.8        Taxes.
		

		
			5.8.1     VAT.  It is understood and agreed between the Parties that any payments made under this Agreement are exclusive of any value added or similar tax (“VAT”), which will be added thereon as applicable.
		

		
			5.8.2     Withholding Taxes.  Subject to Section 5.8.5, if a Party is required to make a payment under this Agreement (the “Payor”) to the other Party (the “Payee”) and such payment is subject to a deduction of tax or withholding tax, then (a) if such withholding or deduction obligation arises as a result of any failure on the part of Payor to comply with applicable tax laws or filing or record retention requirements, that has the effect of modifying the tax treatment of either of the Parties, then the sum payable by Payor (in respect of which such deduction or withholding is required to be made) will be increased to the extent necessary to ensure that Payee receives a sum equal to the sum which it would have received had no such action or failure to act occurred and (b) otherwise, the sum payable by Payor (in respect of which such deduction or withholding is required to be made) will be made to Payee after deduction of the amount required to be so deducted or withheld, which deducted or withheld amount will be remitted in accordance with applicable Law. In addition, in the event of any changes in applicable Law that result (or may result) in any withholding taxes, the Parties shall reasonably cooperate to minimize the amount of any taxes withheld.
		

		
			5.8.3     Tax Cooperation.  To the extent the Payor is required by applicable Law to deduct and withhold taxes on any payments to the Payee, the Payor will pay the amounts of such taxes to the proper Governmental Authority in a timely manner and promptly transmit to the Payee an official tax certificate or other evidence of such withholding sufficient to enable the Payee to claim such payments of taxes.  If Payor fails to perform its obligations as set forth in the foregoing sentence, Payor shall reimburse the Payee for any and all interest, penalties, costs and expenses incurred by the Payee arising from such failure.  Payee will timely provide to the Payor any tax forms or reports that may be reasonably necessary in order for Payor not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. Each Party will provide the other with timely and reasonable assistance to enable the recovery, as permitted by applicable Law, of withholding taxes, VAT, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party effectively bearing such withholding tax or VAT.  If the sum payable by Payor (in respect of which a deduction or withholding was required to be made) has been increased to the extent necessary to ensure that Payee would receive a sum equal to the sum which it would have received had no such deduction or withholding been required by applicable Law, and if Payee subsequently obtains a tax credit or deduction on account of any such withholding tax, VAT or similar payment obligation paid by Payor (or any fraction thereof), Payee shall promptly refund in cash to Payor an amount equal to such withholding taxes, VAT, or similar payment obligations remitted by Payor to the proper Governmental Authority, to the extent of such tax credit or deduction obtained by Payee; provided that such refund shall only become due and payable if, as and when Payee (i) receives such tax credit as a cash refund from the applicable taxing authority or (ii) is able to apply such tax credit to, or deduct such tax deduction from, a current amount owed by Payee to such taxing authority.
		

		
			5.8.4     Tax Forms.  The Parties agree to cooperate and produce on a timely basis any tax forms or reports reasonably requested by the other Party in connection with any payment made under this Agreement, including any documents reasonably necessary to determine whether the Payee may, or actually did, obtain a foreign tax credit or refund of any withholding tax due on a payment made under this Agreement.
		

		
			5.8.5     Assignment.  If either Party assigns its rights and obligations hereunder to an Affiliate or Third Party in compliance with Section 13.1 and if such Affiliate or Third Party will be required by applicable Law to withhold any taxes from or in respect of any amount payable under this Agreement
		

		
			
		

		
			

		 

		

			29

		

		

			 

		

		

		
			as a result of such assignment, then any such amount payable under this Agreement will be increased to take into account the additional taxes withheld as may be necessary so that, after making all required withholdings, Payee receives an amount equal to the sum it would have received had no such assignment been made.  The foregoing sentence will not apply to any assignment to an Affiliate or Third Party in compliance with Section 13.1 where such Affiliate or Third Party is a tax resident of the United States, United Kingdom (or any successor country thereto that encompasses England) or France under applicable Law (provided that the Parties shall reasonably cooperate to minimize any taxes withheld).  If either Party assigns its rights and obligations hereunder to an Affiliate or Third Party in compliance with Section 13.1 and the other Party will be required by applicable Law to withhold any taxes from or in respect of any amount payable under this Agreement to such Affiliate or Third Party as a result of such assignment, then the sum payable by Payor (in respect of which such deduction or withholding is required to be made) will be made to Payee after deduction of the amount required to be so deducted or withheld, which deducted or withheld amount will be remitted in accordance with applicable Law.
		

		
			5.9        Currency of Payments; Payments.  All amounts payable and calculations under this Agreement will be in Dollars.  With respect to Royalty Payments for Net Sales invoiced in any currency other than Dollars and, if applicable, any Royalty Payment reductions in any currency other than Dollars, such amounts shall be converted into Dollars calculated using (i) the exchange rate corresponding to the average of the daily reference rate published by the European Central Bank for the Dollar against the Euro, multiplied by (ii) the average over the applicable Calendar Quarter of the daily fixing cross rate published by the European Central Bank for the Euro against the currency of the country in which the applicable Net Sales were made or the Royalty Payment reduction applies, in each case, as consistently used by Clementia and its Affiliates for purposes of their group consolidated accounts.  All payments due to Blueprint under this Agreement will be paid in Dollars by bank wire transfer of immediately available funds to the following bank account of Blueprint (which account Blueprint may update from time to time by written notice to Clementia):
		

		
			[***]
		

		
			 
		

		
			For Further Credit to:
		

		
			[***]
		

		
			 
		

		
			5.10      Interest on Overdue Payments.  Interest will be payable on any payments that are not paid on or before [***] after the date such payments are due under this Agreement at a rate per annum equal to the lesser of SOFR USD plus [***] or the highest rate allowed by applicable Law, as applicable and commencing on the date such payments are due and ending when paid.  In the event that no rate is available for SOFR USD, the Parties shall agree in good faith to substitute a reasonable alternative rate for purposes of this Section 5.10.
		

		
			ARTICLE 6
		

		
			INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS
		

		
			6.1        Ownership of Inventions.
		

		
			6.1.1     Ownership.  Inventorship for patentable Know-How conceived or reduced to practice during the course of the performance of activities pursuant to this Agreement will be determined on a worldwide basis in accordance with United States Patent Laws and, except as expressly set forth herein, ownership of any such patentable Know-How will be determined by inventorship under applicable Law.
		

		
			
		

		
			

		 

		

			30

		

		

			 

		

		

		
			(a)         Pre-existing Patents and Know-How.  Subject only to the rights expressly granted to the other Party under this Agreement, each Party will and does own all rights, title, and interest in and to any Patents and Know-How that are Controlled by such Party prior to the Effective Date or that such Party creates or obtains outside the scope of this Agreement.
		

		
			(b)         Clementia Development Technology.  Subject only to the rights expressly granted to Blueprint under this Agreement, Clementia will and does own all rights, title, and interest in and to all Clementia Development Technology.
		

		
			(c)         Blueprint Development Know-How and Blueprint Future Technology.  Subject only to the rights expressly granted to Clementia under this Agreement, Blueprint will and does own all rights, title, and interest in and to any Blueprint Development Know-How and Blueprint Future Technology.
		

		
			(d)         Joint Technology.  Subject only to the rights expressly granted to the Parties under this Agreement, the Parties will and do jointly own the Joint Technology, with each Party having an equal, undivided interest therein.  Each Party will promptly disclose to the other Party in writing and will cause its Affiliates, and its and their licensees and sublicensees to so disclose, the making of any Joint Technology.  Subject to the licenses granted hereunder and the other terms and conditions of this Agreement, including Section 2.1, each Party may exercise its ownership rights in and to such Joint Technology, including the right to license and sublicense or otherwise to exploit, transfer or encumber its ownership interest, throughout the world, without an accounting or obligation (including paying royalties) to, or consent required from, the other Party.  At the reasonable written request of a Party, the other Party will in writing grant such consents and confirm that no such accounting is required to effect the foregoing regarding such Joint Technology.
		

		
			6.2        Prosecution and Maintenance of Licensed Patents.
		

		
			6.2.1     Clementia Development Patents.  Clementia will have the sole right to control the Prosecution and Maintenance of all Clementia Development Patents, at its sole expense.
		

		
			6.2.2     Blueprint Future Technology.  Blueprint will have the sole right to control the Prosecution and Maintenance of all Patents within the Blueprint Future Technology, at its sole expense.
		

		
			6.2.3     Licensed Patents and Joint Patents in the Territory.  During the Term, Clementia will be responsible (subject to Section 6.2.4), at its sole cost and expense, to Prosecute and Maintain the (a) Licensed Patents (except Joint Patents) in the name of Blueprint in all countries in the Territory and (b) Joint Patents in the name of Blueprint and Clementia in all countries in the Territory, in each case (clauses (a) and (b)) using qualified outside patent counsel and foreign patent associates selected by Clementia; provided that Clementia identifies such counsel and foreign patent associates for Blueprint in advance and Blueprint consents to such counsel and foreign patent associates (such consent not to be unreasonably withheld, conditioned or delayed).  Clementia will keep Blueprint informed of all steps with regard to and the status of such Prosecution and Maintenance of such Licensed Patents, including by providing Blueprint with (i) copies of all correspondence and material communications Clementia or its designee sends to or receives from any patent office or agency in the Territory relating to the Licensed Patents, (ii) a draft copy of all applications sufficiently in advance (and no less than [***] in advance) of filing to permit reasonable review and comment by Blueprint, and (iii) a copy of applications as filed, together with notice of its filing date and serial number.  During the Term, upon Blueprint’s request and not more than [***],  Clementia’s and Blueprint’s patent counsel (and other personnel, as necessary) will meet, in-person or telephonically at a mutually agreeable time and location, to discuss the status and strategy regarding the Prosecution and Maintenance of the Licensed Patents (including Joint Patents).  Before
		

		
			
		

		
			

		 

		

			31

		

		

			 

		

		

		
			Clementia submits any material filing, including a new patent application, or response to patent authorities with respect to the Licensed Patents, Clementia will provide Blueprint with the opportunity to review and comment on such filing or response (and no less than [***] in advance, to the extent reasonably practicable) and will consider in good faith Blueprint’s requests and suggestions regarding the Prosecution and Maintenance of the Licensed Patents under this Section 6.2.3.  Upon Blueprint’s request, Clementia will file continuing or divisional Patent applications with respect to the Licensed Patents [***] (“Continuing Applications”).  [***].
		

		
			6.2.4     Step-In Right.  If Clementia elects not to Prosecute and Maintain or not to continue to Prosecute and Maintain a given Patent within the Licensed Patents (such patent, a  “Declined Patent”) in the Territory pursuant to Sections 6.2.3, then Clementia will give Blueprint written notice thereof within a reasonable period (but not less than [***]) prior to allowing such Declined Patent to lapse or become abandoned or unenforceable.
		

		
			(a)         If Blueprint agrees that such Declined Patent should be allowed to lapse or become abandoned or unenforceable, Blueprint will provide written notice to Clementia of such agreement.  [***].
		

		
			(b)         If Blueprint desires to maintain the Prosecution and Maintenance of such Declined Patent, Blueprint will provide written notice to Clementia, and will have the following rights with respect to such Declined Patent:
		

		
			(i)          If such Declined Patent is a Blueprint Product-Specific Patent in a country, Blueprint will have the right to require Clementia to continue to Prosecute and Maintain such Declined Patent in such country, and Clementia and Blueprint will equally share the costs and expenses directly related to such Prosecution and Maintenance of such Declined Patent.  As of the date of Clementia’s notice to Blueprint in accordance with this Section 6.2.4 with respect to a Declined Patent under this Section 6.2.4(b)(i), any exclusive license Clementia may have in such Declined Patent in such country will convert to a non-exclusive license.  Before Clementia submits any material filing, including a new patent application, or response to patent authorities with respect to such Declined Patent under this Section 6.2.4(b)(i),  Clementia will provide Blueprint with the opportunity to review and comment on such filing or response (and no less than [***] in advance, to the extent reasonably practicable) and will consider in good faith Blueprint’s requests and suggestions regarding the Prosecution and Maintenance of such Declined Patent.
		

		
			(ii)         If such Declined Patent is a Blueprint Platform Patent in a country, Blueprint will have the right, but not the obligation to assume responsibility or designate such responsibility to a Third Party for continuing the Prosecution and Maintenance of such Declined Patent in such country, at Blueprint’s sole expense, through patent counsel or agents of Blueprint’s choice.  Reasonably promptly after receipt of Blueprint’s notice under this Section 6.2.4 with respect to a Declined Patent under this Section 6.2.4(b)(ii),  Clementia will transfer responsibility for the Prosecution and Maintenance of the applicable Declined Patent to Blueprint and Clementia will take all actions and execute all documents reasonably necessary for Blueprint to assume such Prosecution and Maintenance, at no cost to Blueprint.  As of the date of Clementia’s notice to Blueprint in accordance with this Section 6.2.4, the term “Licensed Patents” will automatically exclude such Declined Patent.  For the avoidance of doubt, Section 6.1.1(d) shall apply with respect to any such Declined Patent under this Section 6.2.4(b)(ii) that is a Joint Patent.
		

		
			6.2.5     Cooperation.  With respect to all Prosecution and Maintenance of the Licensed Patents and Continuing Applications, each Party will:  (a) execute any instruments to document their respective ownership consistent with this Agreement as reasonably requested by the other Party; (b) make its employees, agents and consultants reasonably available to the other Party (or to the other Party’s
		

		
			
		

		
			

		 

		

			32

		

		

			 

		

		

		
			authorized attorneys, agents or representatives), to the extent reasonably necessary to enable the appropriate Party hereunder to undertake its Prosecution and Maintenance responsibilities; (c) cooperate, if necessary, with the other Party in gaining Patent term extensions; and (d) act in good faith to coordinate its efforts under this Agreement with the other Party to minimize or avoid interference with such Prosecution and Maintenance by the other Party.
		

		
			6.3        Patent Extensions and Orange Book Listings.  If elections with respect to obtaining patent term extensions or supplemental protection certificates or their equivalents in any country arising from the Exploitation of a Licensed Product, Clementia will have the sole and exclusive right in good faith to make any such elections with respect to a Blueprint Product-Specific Patent.  With respect to Regulatory Exclusivity Periods, such as those periods listed in the FDA’s Orange Book (including any available pediatric extensions) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or orphan exclusivity periods, and all equivalents in any country, Clementia will have the sole and exclusive right in good faith to seek and maintain all such Regulatory Exclusivity Periods available for the Licensed Products.
		

		
			6.4        Marking.  To the extent required by applicable Law, Clementia will, and will cause its Affiliates and all Sublicensees to, mark all Licensed Products made, used or sold, or their containers, with the number of each issued Licensed Patent that applies to such Licensed Product.
		

		
			6.5        Third Party Infringement.
		

		
			6.5.1     Notice.  Each Party will promptly notify the other in writing of any (a) apparent, threatened or actual infringement by a Third Party of any Licensed Patent in the Territory, or (b) unauthorized use or misappropriation of any Licensed Know-How in the Territory by a Third Party of which it becomes aware, and, in each case, will provide the other Party with all evidence in such Party’s possession or control supporting such infringement or unauthorized use or misappropriation (each, an “Infringement”).
		

		
			6.5.2     Enforcement of Patents in the Territory.
		

		
			(a)         Clementia will have the first right, but not the obligation, using qualified outside counsel of its choosing, provided that Clementia identifies such counsel for Blueprint in advance and Blueprint consents to such counsel (such consent not to be unreasonably withheld, conditioned or delayed), and at Clementia’s sole expense, to institute any Action alleging Infringement of any Licensed Patent on account of a Third Party’s manufacture, use, offer to sell or sale of any compound or product that competes with a Licensed Product for the treatment, [***] of FOP (each such Infringement, a “Competitive Infringement”).  Prior to commencing any such Action, Clementia will consult with Blueprint and will consider Blueprint requests and recommendations regarding such proposed Action.  Clementia will give Blueprint timely notice of any proposed settlement of any such Action and Clementia will not settle, stipulate to any facts, or make any admission with respect to such Competitive Infringement without Blueprint’s prior written consent (such consent not to be unreasonably withheld, conditioned or delayed) if such settlement, stipulation, or admission would:  (i) adversely affect the validity, enforceability, or scope, or admit non-Infringement, of any of the Licensed Patents; (ii) give rise to liability of Blueprint or its Affiliates; (iii) grant to a Third Party a license or covenant not to sue under, or with respect to, any Licensed Technology or Blueprint Future Technology; or (iv) otherwise impair Blueprint’s or any of its Affiliates’ rights in any Licensed Technology or Blueprint’s or any of its Affiliates’ rights under this Agreement.
		

		
			(b)         If Clementia  (i) does not initiate any Action against such Competitive Infringement in a country in the Territory, including by commencement of a lawsuit against the accused Person if necessary or obtain settlement thereof (in accordance with this Agreement), within [***] after
		

		
			
		

		
			

		 

		

			33

		

		

			 

		

		

		
			discovering or receiving notice of such Competitive Infringement of such Licensed Patent or Joint Patent or (ii) if such Action is initiated within such period, ceases to pursue or withdraws from such Action, then in each case (clauses (i) and (ii)) Blueprint will be entitled (but will not be obligated), after taking into reasonable consideration Clementia’s reason for not initiating such Action, including any identified risks to the Licensed Patents and the Licensed Products, to take all actions reasonably necessary to abate such violation in such country, including commencement of a lawsuit against such accused Third Party if necessary.  If Clementia does not prosecute such an Action against such Third Party in such country, then any sales of Generic Products by such Third Party will not be counted to determine whether the market share of Generic Products in such country has been achieved for purposes of determining the amount of any royalty reduction under Section 5.6.3.
		

		
			(c)         Subject to Section 6.5.2(a), Blueprint will have the first right, but not the obligation, using counsel of its choosing at Blueprint’s sole expense, to institute any Action alleging Infringement other than a Competitive Infringement (“Non-Competitive Infringement”) of the Licensed Patents, (including Joint Patents and Continuing Applications) or Blueprint Future Technology in the Field and in the Territory.  Blueprint will notify Clementia in writing prior to initiating such Action for Non-Competitive Infringement.  If such Action for Non-Competitive Infringement requires the assertion of one or more Licensed Patents that are Blueprint Product-Specific Patents, Blueprint will obtain Clementia’s prior written consent before instituting such Action (such consent not to be unreasonably withheld, conditioned or delayed).  If such Action for Non-Competitive Infringement requires [***], the Parties shall discuss in good faith the advisability of such Action for Non-Competitive Infringement and Blueprint shall [***] in view of any identified risks to the Licensed Patents and the Licensed Products.  For the avoidance of doubt, if such Action for Non-Competitive Infringement requires the assertion only of Patents Covering Blueprint Future Technology, Blueprint may initiate such Action without consulting with or accounting for Clementia.
		

		
			6.5.3     Cooperation.  In any Action alleging Infringement brought under Section 6.5.2, each Party will, and will cause its Affiliates to, reasonably cooperate with each other, in good faith, relative to the other Party’s efforts to protect the Patents or Know-How at issue and will join such suit as a party, if requested by the other Party or if required by applicable Law to bring or maintain such Action, and at the cost of the other Party.  Furthermore, the Party initiating any Action alleging Infringement pursuant to Sections 6.5.2 will consider in good faith all reasonable and timely comments from the other Party on any proposed arguments asserted or to be asserted in litigation related to the enforcement or defense of any such Patents or Know-How.
		

		
			6.5.4     Allocation of Recoveries.  If a Party brings any Action alleging Competitive Infringement under Section 6.5.2 (except with respect to Blueprint Future Technology) and recovers any damages or other sums in such action, such damages or other sums recovered will first be applied to all out-of-pocket costs and expenses incurred by the Parties in connection therewith (including attorneys’ fees).  If such recovery is insufficient to cover all such costs and expenses of both Parties, the controlling Party’s costs will be paid in full first before any of the other Party’s costs.  If after such reimbursement any funds will remain from such damages or other sums recovered, such funds will be retained by the Party that controlled the action or proceeding under Section 6.5.2; provided, however, that (a) if Clementia is the Party that controlled such action or proceeding, [***] and (b) if Blueprint is the Party that controlled such action or proceeding, [***].
		

		
			6.6        Claimed Infringement.  Each Party will promptly notify the other Party if a Third Party brings any Action alleging patent infringement by Clementia or any of its Affiliates or Sublicensees or by Blueprint or its Affiliates, in each case with respect to the Exploitation of any Licensed Product under this Agreement (any such Action, an “Infringement Claim”).  In the case of any Infringement Claim, Clementia will have the right, but not the obligation, to control the defense and response to any such
		

		
			
		

		
			

		 

		

			34

		

		

			 

		

		

		
			Infringement Claim in the Territory against Clementia, its Affiliates or Sublicensees.  Upon the request of Clementia with respect to any Infringement Claim, Blueprint will reasonably cooperate with Clementia, at its sole cost and expense, in the reasonable defense of such Infringement Claim.  Blueprint will have the right to consult with Clementia concerning any Infringement Claim and to participate in and be represented by independent counsel in any associated litigation.  If the Infringement Claim is brought against both Parties (or their Affiliates), then each Party will have the right to defend against the Infringement Claim.  The Party defending an Infringement Claim under this Section 6.6 will (a) consult with the other Party as to the strategy for the prosecution of such defense, (b) consider in good faith any comments from the other Party with respect thereto and (c) keep the other Party reasonably informed of any material steps taken and provide copies of all material documents filed, in connection with such defense.  The Party controlling the defense against an Infringement Claim will have the right to settle such Infringement Claim on terms deemed reasonably appropriate by such Party, provided, that, unless any such settlement includes a full and unconditional release from all liability of the other Party and does not adversely affect the rights of the other Party, any such settlement will be subject to the other Party’s prior written consent.
		

		
			ARTICLE 7
		

		
			CONFIDENTIALITY AND PUBLICITY
		

		
			7.1        Confidential Information.
		

		
			7.1.1     Confidentiality Obligation.  During the Term and for a period of [***] after any termination or expiration of this Agreement, the Receiving Party agrees to, and will cause its Affiliates and its and their respective Representatives to, (a) keep in confidence and not to disclose to any Third Party or (b) use for any purpose other than performing its obligations or exercising its rights under this Agreement, any Confidential Information of the Disclosing Party.  The Receiving Party will treat all Confidential Information provided by the Disclosing Party with the same degree of care as the Receiving Party uses for its own similar information, but in no event less than a reasonable degree of care.  The Receiving Party will promptly notify the Disclosing Party of any misuse or unauthorized disclosure of the Receiving Party’s Confidential Information, and the Receiving Party will be responsible for any breach of this Article 7 by any Third Party or any of its Representatives to whom the Disclosing Party’s Confidential Information is disclosed by or on behalf of the Receiving Party, and agrees, at its sole expense, to take all reasonable measures (including to court proceedings) to restrain such Third Parties and its Representatives from any prohibited or unauthorized use or disclosure of the Disclosing Party’s Confidential Information.
		

		
			7.1.2     Permitted Disclosures.  Notwithstanding Section 7.1.1, each Party may use or disclose Confidential Information of the other Party to the extent reasonably necessary in the following situations:
		

		
			(a)         to the Receiving Party’s Affiliates and Representatives on a need-to-know basis to the extent reasonably necessary for purposes of performing its obligations or exercising its rights under this Agreement this Agreement; provided, however, that all such Persons are subject to obligations of confidentiality and non-use at least as stringent as those set forth in this Article 7  or otherwise customary for such type and scope of disclosure (which, for the avoidance of doubt, may include professional ethical obligations) and any such disclosure is limited to the maximum extent practicable for the particular context in which it is being disclosed;
		

		
			(b)         with respect to the terms of this Agreement only, to any bona fide actual or prospective (i) investors, underwriters, lenders or other financing sources or (ii) acquirers, collaborators, licensors, licensees or Sublicensees, or strategic or commercial partners (including in connection with any royalty factoring transaction) and their respective Representatives, who reasonably require such Confidential Information in connection with the evaluation of or due diligence for any actual or potential
		

		
			
		

		
			

		 

		

			35

		

		

			 

		

		

		
			investment, debt or other financing transaction, acquisition, license or sublicense, or partnership or collaboration; provided that, in each such case, such Persons are bound by obligations of confidentiality and non-use at least as stringent as those set forth in this Article 7 or otherwise customary for such type and scope of disclosure (which, for the avoidance of doubt, may include professional ethical obligations) and any such disclosure is limited to the maximum extent practicable for the particular context in which it is being disclosed;
		

		
			(c)         to the extent such use or disclosure is consistent with this Agreement and is reasonably necessary for Prosecution and Maintenance of the Licensed Patents, in each case, as contemplated by this Agreement; or (ii) regulatory filings and other filings with Governmental Authorities (including Regulatory Authorities), as necessary for the Exploitation of Licensed Product;
		

		
			(d)         to the extent required to comply with applicable Law (including the rules and regulations of the U.S. Securities and Exchange Commission or equivalent foreign regulatory agency) or judicial or administrative process (including any such disclosures as are required by a Regulatory Authority in connection with seeking Regulatory Approval for any Licensed Product in the Territory); provided that, for the avoidance of doubt, information regarding the achievement of any milestone event and/or the payment of royalties under this Agreement (including the nature, probability, amount, payment and timing of any such milestone event or royalty) shall be disclosable by a Party pursuant to this Section 7.1.2(d).  If reasonably practicable, such Party shall provide written notice to the other Party together with a copy of such disclosure prior to such disclosure (which, in the case of Blueprint, such notice may be via e-mail to [***] and, in the case of Clementia, such notice may be via e-mail to [***] for purposes of this Section 7.1.2(d)), and in any event shall provide such notice as soon as is reasonably practicable after such disclosure; or
		

		
			(e)         any disclosure that is permitted pursuant to Section 7.2.
		

		
			7.1.3     Confidential Treatment.  Notwithstanding anything to the contrary set forth in this Agreement, if a Party is required or permitted to make a disclosure of the other Party’s Confidential Information pursuant to Section 7.1.2, then it will, to the extent not prohibited by applicable Law or judicial or administrative process, except where impracticable, provide prompt notice to the non-disclosing Party of such disclosure (together with a copy of the proposed text of such disclosure), will consider in good faith any timely comments provided by the non-disclosing Party (provided that the disclosing Party may or may not accept such comments in its sole discretion) and will take (or causes to be taken) all reasonable and lawful actions to seek to avoid and minimize the extent of such disclosure.
		

		
			7.2        Publicity.
		

		
			7.2.1     Press Releases.  Promptly following the Effective Date, the Parties will issue a mutually agreed upon joint press release in the form attached hereto as Exhibit E.  However, the Parties agree that after (a) a disclosure pursuant to Section 7.2 or Section 7.1.2 or (b) the issuance of a press release (including any initial press release) or other public announcement pursuant to this Section 7.2.1 that has been reviewed and approved by the other Party, the Disclosing Party may make subsequent public disclosures reiterating such information without having to obtain the other Party’s prior consent and approval so long as the information in such press release or other public announcement remains true, correct, and the most current information with respect to the subject matters set forth therein.  Similarly, after a publication has been made available to the public, each Party may post such publication or a link to it on its corporate web site (or any website managed by such Party in connection with a Clinical Study for a Licensed Product, as appropriate) without the prior written consent of the other Party, so long as the information in such publication remains true, correct, and the most current information with respect to the subject matters set forth therein.
		

		
			
		

		
			

		 

		

			36

		

		

			 

		

		

		
			7.2.2     Further Publicity; Publications.
		

		
			(a)         Publicity.  Except as set forth in Section 7.2.1, neither Party will issue any press release or public announcement relating to this Agreement without the prior written approval of the other Party (such approval not to be unreasonably withheld, conditioned or delayed), except that a Party may (i) once a press release or other public statement is approved in writing by both Parties, make subsequent public disclosure of the information contained in such press release or other written statement without the further approval of the other Party (so long as such information remains true and correct), and (ii) issue a press release or public announcement as required by applicable Law, including by the rules or regulations of the U.S. Securities and Exchange Commission or equivalent foreign regulatory agency or of any stock exchange or listing entity, provided that the Party issuing such press release gives reasonable prior notice to the other Party of and the opportunity to comment on the press release or public announcement, and otherwise complies with this Article  7.
		

		
			(b)         Publications.
		

		
			(i)          By Clementia.  Clementia may publish or present the results of Research and Development of a Licensed Product, subject to the prior review and approval by Blueprint for protection of Blueprint’s Confidential Information as provided in this Section 7.2.2(b).  Clementia will provide to Blueprint the opportunity to review any proposed abstracts, manuscripts or summaries of presentations that cover the results of Research and Development of a Licensed Product (each, a “Publication”).  Blueprint will designate a person or persons who will be responsible for reviewing such Publications.  Such designated person will respond in writing promptly and in no event later than [***] after receipt of the proposed material (or [***] in the case of an abstract) with either approval of the proposed material, or a request to remove Blueprint’s Confidential Information from such Publication, and upon such request Clementia shall so remove Blueprint’s Confidential Information; provided that, Clementia shall not be required to remove Blueprint’s Confidential Information to the extent disclosure is permitted pursuant to this Article 7.  In the event of concern, Clementia agrees not to submit or present such proposed Publication until Blueprint is given a reasonable period of time (not to exceed [***]) to seek patent protection for any material in such proposed Publication or presentation that it believes is patentable or to resolve any other issues.  Clementia will comply with standard academic practice regarding authorship of scientific publications and recognition of contribution of other parties in any publication.
		

		
			(ii)         By Blueprint.  Blueprint may publish or present, without Clementia’s prior approval, the academic, scientific or medical abstracts, articles, papers, presentations or other type of public disclosures described on Schedule 7.2.2(b)(ii); provided that, Blueprint shall provide a copy of any such disclosure to Clementia; and provided further that Clementia provides any comments with respect to such disclosure in writing promptly and in no event later than [***] after receipt of the proposed material (or [***] in the case of an abstract), then Blueprint will consider in good faith any such timely comments provided by Clementia.
		

		
			(iii)       Jointly by the Parties.  The Parties will jointly present the presentations described on Schedule 7.2.2(b)(iii).  The Parties will cooperate in preparing the content and materials for, and in presenting, such presentation.
		

		
			7.2.3     Use of Names.  Following the issuance of the press release attached hereto as Exhibit E,  each Party will have the right to use the other Party’s name and logo in presentations, its website, collateral materials, investor and analyst presentations and corporate overviews to describe the collaboration relationship, as well as in taglines of press releases issued pursuant to this Section 7.2.3; provided that neither Party will use the other Party’s corporate name in such manner that the distinctiveness, reputation, and validity of any Trademarks and corporate or trade names of such other Party will not be
		

		
			
		

		
			

		 

		

			37

		

		

			 

		

		

		
			impaired, and consistent with best practices used by such other Party for its other collaborators.  Except as permitted under this Section 7.2.3 or with the prior express written permission of the other Party, neither Party will use the name, trademark, trade name, or logo of the other Party or its Affiliates or their respective employees in any publicity, promotion, news release, or disclosure relating to this Agreement or its subject matter except as may be required by applicable Law.  Each Party will use the other Party’s corporate name in all publicity relating to this Agreement, including the initial press release and all subsequent press releases.
		

		
			7.3        Tax Treatment.  Nothing in Section 7.1 will limit either Party in any way from disclosing to any Third Party such Party’s U.S. or foreign income tax treatment and the U.S. or foreign income tax structure of the transactions relating to such Party that are based on or derived from this Agreement, or materials of any kind (including opinions or other tax analyses) relating to such tax treatment or tax structure to the extent that nondisclosure of such matters is reasonably necessary in order to comply with applicable securities laws.
		

		
			7.4        Attorney-Client Privilege.  Neither Party is waiving, nor will be deemed to have waived or diminished, any of its attorney work product protections, attorney-client privileges or similar protections and privileges or the like as a result of disclosing information pursuant to this Agreement, or any of its Confidential Information (including Confidential Information related to pending or threatened litigation) to the Receiving Party, regardless of whether the Disclosing Party has asserted, such privileges and protections.  The Parties:  (a) share a common legal and commercial interest in such disclosure that is subject to such privileges and protections; (b) are or may become joint defendants in proceedings to which the information covered by such protections and privileges relates; (c) intend that such privileges and protections remain intact should either Party become subject to any actual or threatened proceeding to which the Disclosing Party’s Confidential Information covered by such protections and privileges relates; and (d) intend that after the Effective Date both the Receiving Party and the Disclosing Party will have the right to assert such protections and privileges.  Notwithstanding the foregoing, nothing in this Section 7.4 will apply with respect to a Dispute between the Parties (including their respective Affiliates).
		

		
			ARTICLE 8
		

		
			REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS
		

		
			8.1        Mutual Representations and Warranties.  Each Party represents and warrants to the other Party that, as of the Effective Date:
		

		
			8.1.1     Organization.  It is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement.
		

		
			8.1.2     Authority.  It has full right, power and authority to enter into this Agreement and to perform its respective obligations under this Agreement, it has the right to grant to the other the licenses and sublicenses granted pursuant to this Agreement, and this Agreement and the performance by such Party of this Agreement do not violate such Party’s charter documents, bylaws or other organizational documents.
		

		
			8.1.3     Consents.  Except for any Marketing Authorizations, Regulatory Filings, manufacturing approvals or similar approvals necessary for the Research, Development, Manufacture or Commercialization of Licensed Products, all necessary consents, approvals and authorizations of all Governmental Authorities and other Persons required to be obtained by it in connection with the execution, delivery and performance of this Agreement have been obtained.
		

		
			
		

		
			

		 

		

			38

		

		

			 

		

		

		
			8.1.4     No Conflict.  It is not under any obligation, contractual or otherwise, to any Person that would adversely affect the diligent and complete fulfillment of obligations under this Agreement and the execution and delivery of this Agreement by such Party, and the performance of such Party’s obligations under this Agreement (as contemplated as of the Effective Date) and the licenses and sublicenses to be granted by such Party pursuant to this Agreement (a) do not conflict with or violate any requirement of Laws applicable to such Party, (b) do not conflict with or violate any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to such Party, and (c) do not conflict with, violate, breach or constitute a default under any contractual obligations of such Party or any of its Affiliates.
		

		
			8.1.5     Enforceability.  This Agreement is a legal and valid obligation binding upon it and is enforceable against it in accordance with its terms, subject to the general principles of equity and subject to bankruptcy, insolvency, moratorium, judicial principles affecting the availability of specific performance and other similar Laws affecting the enforcement of creditors’ rights generally.
		

		
			8.2        Additional Representations and Warranties of Blueprint.  Blueprint represents and warrants to Clementia that, as of the Effective Date, except as set forth on Schedule 8.2:
		

		
			8.2.1     Licensed Technology.  Blueprint solely Controls the Licensed Technology existing as of the Effective Date, free and clear of any claims, liens, charges or encumbrances.
		

		
			8.2.2     Licensed Patents.  None of the issued Licensed Patents existing as of the Effective Date has been adjudged, in a final and non-appealable decision, invalid, unenforceable or unpatentable by any Governmental Authority of competent jurisdiction, and, to the knowledge of Blueprint, all such issued Licensed Patents existing as of the Effective Date are valid and enforceable.
		

		
			8.2.3     Third Party Challenges.  There are no claims, judgments, or settlements against, or amounts with respect thereto, made against Blueprint or any of its Affiliates relating to the Licensed Technology.  No claim or litigation has been brought or, to Blueprint’s knowledge, threatened by any Person (a) alleging that the Licensed Patents are invalid or unenforceable, (b) asserting the misuse, or non-infringement of any of the Licensed Patents, (c) regarding inventorship of or challenging Blueprint’s Control of the Licensed Patents or (d) alleging misappropriation of the Know-How used in the Development or Manufacture of Licensed Products by or on behalf of Blueprint prior to the Effective Date.
		

		
			8.2.4     Non-Infringement by Third Parties.  To Blueprint’s knowledge, no Third Party has infringed, misappropriated or otherwise violated any Licensed Technology.
		

		
			8.2.5     Blueprint Product-Specific Patents.  Exhibit C-1 is, to Blueprint’s knowledge, a complete and accurate list of all Blueprint Product-Specific Patents as of the Effective Date, including, where relevant and reasonably available, all application numbers and filing dates, patent numbers, issue dates and jurisdictions.
		

		
			8.2.6     Scientific and Technical Information.  Blueprint has disclosed to Clementia  (i) [***], (ii) [***] and (iii) [***].  [***].
		

		
			8.2.7     Regulatory.  All INDs, other regulatory approval applications, and foreign equivalents relating to the Blueprint Compounds are in the name of Blueprint or its Affiliates.
		

		
			8.2.8     Governmental Authorities; Compliance with Laws.  Neither Blueprint or its Affiliates has received written notice from any Governmental Authority terminating or refusing to renew any material governmental licenses, permits, registrations, concessions, franchises and authorizations
		

		
			
		

		
			

		 

		

			39

		

		

			 

		

		

		
			relating to the Blueprint Compound or Licensed Products; Blueprint and its Affiliates have complied in all material respects with all applicable Laws in connection with the preparation and submission to all Governmental Authorities and Regulatory Authorities of any IND, or foreign equivalents thereto relating to the Blueprint Compounds; and Blueprint and its Affiliates have not received any notice, and to Blueprint’s knowledge, there are no facts, which have, or reasonably should have, led Blueprint or its Affiliates to believe that any such IND, or foreign equivalent is not, or will not be, in good standing with the relevant Governmental Authority or Regulatory Authority or is or will be withdrawn.
		

		
			8.2.9     Third Party Agreements.  Blueprint has disclosed to Clementia [***].  In addition, Blueprint has disclosed to Clementia [***].  All agreements described under this Section 8.2.9 are set forth in Exhibit F.
		

		
			8.2.10   Non-Infringement of Third Party Rights.  To Blueprint’s knowledge, neither the Development, Manufacture and Commercialization of Licensed Products in the Field as conducted on or prior to the Effective Date, nor the Development, Manufacture and Commercialization of Licensed Products (as currently constituted) in the Field as described in the Development Plan as of the Effective Date does or would infringe, interfere with or result in the misappropriation of any intellectual property rights of any Third Party existing as of the Effective Date.
		

		
			8.2.11   Alexion Termination.  Alexion has no right, title or interest in Blueprint Compounds, Licensed Products and Blueprint Technology.  Blueprint does not and will not have any obligations to Alexion with respect to Blueprint Compounds, Licensed Products and Blueprint Technology that conflicts or will conflict with, interferes or will interfere with or diminishes or will diminish the rights granted to Clementia under this Agreement.
		

		
			8.3        No Debarment.  Each Party represents and warrants that, to its knowledge, neither it nor any of its or its Affiliates’ employees or agents performing under this Agreement, or in the case of Blueprint, no employee or agent engaged by Blueprint or its Affiliates in the development of any of the Blueprint Compound or Licensed Product prior to the Effective Date, has ever been, or is currently:  (a) debarred under 21 U.S.C. § 335a or its equivalents in the Territory; (b) excluded, debarred, suspended, or otherwise ineligible to participate in federal health care programs or in federal procurement or non-procurement programs; (c) listed in the FDA’s Clinical Investigators – Disqualification Proceedings Database, including for restrictions; or (d) convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a) or its equivalents in the Territory, but has not yet been excluded, debarred, suspended, or otherwise declared ineligible.  Each Party further covenants that if, during the Term of this Agreement, it becomes aware that it or any of its or its Affiliates’ employees or agents performing under this Agreement is the subject of any investigation or proceeding that could lead to that Party becoming a debarred entity or individual, an excluded entity or individual or a convicted entity or individual, such Party will immediately notify the other Party.  This provision will survive termination or expiration of this Agreement.
		

		
			8.4        Additional Covenants.
		

		
			8.4.1     Clementia represents and warrants to Blueprint that, as of the Effective Date:
		

		
			(a)         Neither Clementia nor any of its Affiliates (or any of their respective Sublicensees, employees and contractors) will, in connection with the exercise of Clementia’s rights or performance of its obligations under this Agreement, directly or indirectly through Third Parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to a public official or entity or other Person for purpose of obtaining or retaining business for or with, or directing business to, any Person, including Clementia and its Affiliates, nor will Clementia or any of its Affiliates directly or indirectly promise, offer or provide any
		

		
			
		

		
			

		 

		

			40

		

		

			 

		

		

		
			corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a public official or entity or any other Person in connection with the exercise of Clementia’s rights or performance of Clementia’s obligations under this Agreement; and
		

		
			(b)         Neither Clementia nor any of its Affiliates (or any of their respective Sublicensees, employees and contractors), in connection with the exercise of Clementia’s rights or performance of Clementia’s obligations under this Agreement, will knowingly cause Blueprint to be in violation of Anti-Corruption Laws or Export Control Laws.
		

		
			8.4.2     Additional Covenants of Blueprint.
		

		
			(a)         Blueprint will not, and shall cause its Affiliates not to (i) license, sell, assign or otherwise transfer to any Person (other than Clementia or its Affiliates or Sublicensees pursuant to the terms of this Agreement) any Licensed Technology (or agree to do any of the foregoing) or (ii) incur or permit to exist, with respect to any Licensed Technology, any lien, encumbrance, charge, security interest, mortgage, liability, assignment, grant of license, in each case (clauses (i) and (ii)) in a manner that is or would be inconsistent with the licenses and other rights granted to Clementia or its Affiliates under this Agreement.
		

		
			(b)         Blueprint will not, and shall cause its Affiliates not to, take any action that diminishes the rights under the Licensed Technology granted to Clementia or Clementia’s Affiliates under this Agreement.
		

		
			8.4.3     Blueprint will, and shall cause its Affiliates to, (a) not enter into any agreement or arrangement that adversely affects (i) the rights granted to Clementia,  Clementia’s Affiliates or Sublicensees or (ii) Blueprint’s ability to fully perform its obligations hereunder; (b) not amend or otherwise modify any Third Party Agreements in any manner that (i) materially and adversely affects the rights granted to Clementia or Clementia’s Affiliates or Sublicensees or (ii) Clementia’s ability to fully perform its obligations hereunder; (c) promptly furnish Clementia with true and complete copies of all amendments, modifications, consents and waivers to Third Party Agreements to the extent related to either Party’s performance of its obligations or exercise of its rights hereunder (subject to any confidentiality obligations to such Third Party); (d) remain, and cause its Affiliates to remain, in compliance in all material respects with Third Party Agreements and (e) furnish Clementia with copies of all notices received by Blueprint or its Affiliates relating to any alleged breach or default by Blueprint or its Affiliates under any Third Party Agreements specifically related to a Licensed Product within [***] after receipt thereof.
		

		
			8.5        No Other Representations or Warranties.
		

		
			8.5.1     EXCEPT AS EXPRESSLY STATED IN THIS ARTICLE 8, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, IS MADE OR GIVEN BY OR ON BEHALF OF A PARTY.  EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.
		

		
			8.5.2     THE MATERIALS AND INFORMATION PROVIDED BY BLUEPRINT (OR ITS AFFILIATES) TO CLEMENTIA ARE PROVIDED TO CLEMENTIA “AS IS” WITHOUT ANY REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
		

		
			
		

		
			

		 

		

			41

		

		

			 

		

		

		
			NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS.  REGARDING THE MATERIALS AND THE INFORMATION PROVIDED BY BLUEPRINT (OR ITS AFFILIATES) TO CLEMENTIA, BLUEPRINT (AND ITS AFFILIATES) WILL NOT BE LIABLE FOR ANY USE OF SUCH MATERIALS AND INFORMATION BY CLEMENTIA OR ANY OTHER RECIPIENTS, OR FOR ANY LIABILITIES, LOSSES, COSTS, DAMAGES, FEES, EXPENSES OR OTHER AMOUNTS THAT MAY BE SUFFERED BY CLEMENTIA OR ANY OTHER RECIPIENTS FROM OR IN CONNECTION WITH THIS AGREEMENT OR FROM THE USE, HANDLING OR STORAGE OF SUCH MATERIALS, OR THE USE OF, OR RELIANCE PLACED ON SUCH INFORMATION, OR ANY OTHER ACT OR OMISSION, OF CLEMENTIA OR ANY OTHER RECIPIENTS REGARDING SUCH MATERIALS OR INFORMATION.
		

		
			ARTICLE 9
		

		
			INDEMNIFICATION; DAMAGES
		

		
			9.1        Indemnification by Blueprint.  Blueprint will defend, indemnify and hold harmless Clementia, its Affiliates and their respective directors, officers, employees and agents (collectively, the “Clementia Indemnified Parties”), from, against and in respect of any and all Losses incurred or suffered by any Clementia Indemnified Party to the extent resulting from:  (a) any breach of any obligation, representation, warranty or covenant made by Blueprint in this Agreement; (b) the negligence or intentional misconduct of, or violation of Law by, Blueprint or any of its Affiliates, licensees or sublicensees, or any of their respective directors, officers, employees and agents, in performing Blueprint’s obligations or exercising Blueprint’s rights under this Agreement or (c) the Exploitation of any Reversion Product under a Reversion License by or on behalf of Blueprint, its Affiliates or sublicensees, including product liability claims relating to a Reversion Product or any actions (or omissions) in the performance of regulatory activities; in each case (clauses (a) through (c)), except to the extent Losses arise from, are based on, or result from any activity or occurrence for which Clementia is obligated to indemnify the Blueprint Indemnified Parties under Section 9.2.
		

		
			9.2        Indemnification by Clementia.  Clementia will defend, indemnify and hold harmless Blueprint, its Affiliates and their respective directors, officers, employees and agents (collectively, the “Blueprint Indemnified Parties”), from, against and in respect of any and all Losses incurred or suffered by any Blueprint Indemnified Party to the extent resulting from:  (a) any breach of any obligation, representation, warranty or covenant made by Clementia in this Agreement, (b) the negligence or intentional misconduct of, or violation of Law by, Clementia, any of its Affiliates or Sublicensees, or any of their respective directors, officers, employees and agents, in performing Clementia’s obligations or exercising Clementia’s rights under this Agreement, or (c) the Exploitation of any Blueprint Compound or Licensed Product by or on behalf of Clementia, its Affiliates or Sublicensees, including product liability claims relating to a Licensed Product or any actions (or omissions) in the performance of regulatory activities, in each case (clauses (a) through (c)), except to the extent such Losses arise from, are based on, or result from any activity or occurrence for which Blueprint is obligated to indemnify the Clementia Indemnified Parties under Section 9.1.
		

		
			9.3        Claims for Indemnification.
		

		
			9.3.1     Notice.  An Indemnified Party entitled to indemnification under Sections 9.1 or 9.2 will give prompt written notification to the Indemnifying Party from whom indemnification is sought of the commencement of any Action by a Third Party for which indemnification may be sought (a “Third Party Claim”) or, if earlier, upon the assertion of such Third Party Claim by a Third Party; provided, however, that failure by an Indemnified Party to give notice of a Third Party Claim as provided in this Section 9.3.1 will not relieve the Indemnifying Party of its indemnification obligation under this
		

		
			
		

		
			

		 

		

			42

		

		

			 

		

		

		
			Agreement, except and only to the extent that such Indemnifying Party is actually prejudiced as a result of such failure to give notice.
		

		
			9.3.2     Defense.  Within [***] after delivery of a notice of any Third Party Claim in accordance with Section 9.3.1, the Indemnifying Party may, upon written notice thereof to the Indemnified Party, assume control of the defense of such Third Party Claim with counsel reasonably satisfactory to the Indemnified Party.  If the Indemnifying Party does not assume control of such defense, the Indemnified Party may control such defense.  The Party not controlling such defense may participate therein at its sole expense.
		

		
			9.3.3     Cooperation.  The Party controlling the defense of any Third Party Claim will keep the other Party advised of the status of such Third Party Claim and the defense thereof and will reasonably consider recommendations made by the other Party with respect thereto.  The other Party will reasonably cooperate with the Party controlling such defense and its Affiliates and agents in defense of the Third Party Claim, with all out-of-pocket costs of such cooperation to be borne by the Party controlling such defense.
		

		
			9.3.4     Settlement.  The Indemnified Party will not agree to any settlement of such Third Party Claim or admit liability with respect to such Third Party Claim without the prior written consent of the Indemnifying Party, which consent will not be unreasonably withheld, conditioned or delayed.  The Indemnifying Party will not, without the prior written consent of the Indemnified Party, which will not be unreasonably withheld, conditioned or delayed, agree to any settlement of such Third Party Claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto or that imposes any liability or obligation on the Indemnified Party.
		

		
			9.4        Insurance.  Clementia, at its sole expense, will maintain liability insurance with respect to its activities under this Agreement in an amount consistent with industry standards.  Clementia will provide a certificate of insurance (or evidence of self-insurance) evidencing such coverage to the other Party upon request.  Without limiting the foregoing, during the Term and for [***] thereafter, each Party will maintain on an ongoing basis comprehensive general liability insurance in the minimum amount of [***].  All of such insurance coverage may be satisfied through one (1) or more policies, including an umbrella policy.  Not later than [***] following receipt of written request from a Party, the other Party will provide to the requesting Party a certificate of insurance evidencing such coverage in accordance with this Agreement.  Each Party will provide certificates or letters evidencing such insurance coverage without interruption as reasonably requested during the period of time for which such coverage must be maintained.  Either Party’s failure to maintain adequate insurance will not relieve that Party of its obligations set forth in this Agreement.
		

		
			ARTICLE 10
		

		
			LIMITATION OF LIABILITY
		

		
			10.1      No Consequential or Punitive Damages.  EXCEPT AS SET FORTH IN SECTION 10.2, NEITHER PARTY NOR ANY OF ITS AFFILIATES WILL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE OR MULTIPLE DAMAGES OR FOR ANY LOST PROFITS ARISING OUT OF THIS AGREEMENT, IN EACH CASE HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES.
		

		
			
		

		
			

		 

		

			43

		

		

			 

		

		

		
			10.2      Exclusion from Liability Limitation.  THE LIMITATIONS AND DISCLAIMER SET FORTH IN SECTION 10.1 WILL NOT APPLY TO A CLAIM (A) FOR GROSS NEGLIGENCE OR WILLFUL MISCONDUCT; (B) FOR A BREACH OF [***]; (C) FOR A BREACH OF [***]; (D) LIABILITY FOR MISAPPROPRIATION OR INFRINGEMENT OF INTELLECTUAL PROPERTY OWNED OR CONTROLLED BY A PARTY, OR (E) FOR INDEMNIFIABLE LOSSES PURSUANT TO SECTION 9.1, OR SECTION 9.2.
		

		
			ARTICLE 11
		

		
			TERM AND TERMINATION
		

		
			11.1      Term.  This Agreement will be effective as of the Effective Date and, unless earlier terminated in accordance with this Article 11, will expire on a country-by-country basis and Licensed Product-by-Licensed Product basis at the end of the applicable Royalty Term (such period, the “Term”).  Following the end of the Term for any such Licensed Product and in such country by expiration (but not termination), the license granted to Clementia under Section 2.1.1, will become exclusive, perpetual, irrevocable, fully paid-up and royalty-free, and the licenses granted to Clementia under Sections 2.1.2 and 2.1.3, will become non-exclusive, perpetual, irrevocable, fully paid-up and royalty-free.
		

		
			11.2      Termination by Clementia for Convenience.  After the second (2nd) anniversary of the Effective Date, Clementia may terminate this Agreement at any time upon at least twelve (12) months’ prior written notice to Blueprint.  For the avoidance of doubt, Clementia may deliver such notice at any time after the first (1st) anniversary of the Effective Date.
		

		
			11.3      Termination for Material Breach.  Upon (a) any material breach of this Agreement by Blueprint or (b) any material breach of this Agreement by Clementia (the Party so allegedly breaching being the “Breaching Party”), the other Party (the “Non-Breaching Party”) will have the right, but not the obligation, to terminate this Agreement by providing [***] written notice to the Breaching Party in the case of a material breach of a payment obligation, and [***] written notice to the Breaching Party in the case of any other material breach.  If the Breaching Party in good faith disputes that it has materially breached this Agreement, the dispute will be resolved in accordance with Article 12, and this Agreement may not be terminated during the pendency of such dispute resolution procedure unless and until such dispute resolution process has been completed.  The termination will become effective at the end of the notice period unless the Breaching Party cures such breach during such notice period; provided, however, that the Non-Breaching Party may, by notice to the Breaching Party, designate a later date for such termination in order to facilitate an orderly transition of activities relating to Licensed Products.  If, as a result of the application of such dispute resolution procedures, the Breaching Party is determined to be in material breach of this Agreement, then the Non-Breaching Party may terminate this Agreement immediately upon written notice to the Breaching Party as provided in this Section 11.3.
		

		
			11.4      Termination by Blueprint for Validity Challenge.  If during the Term, Clementia or any of its Affiliates or Sublicensees challenges (other than in response to any formal legal proceeding initiated against Clementia, its Affiliates or Sublicensees by Blueprint or its Affiliates, licensees or sublicensees) the validity or enforceability or actively assists any Person in challenging the validity or enforceability of any Licensed Patent before any court, administrative agency, or regulatory body including any patent opposition, re-examination or invalidation proceeding (a “Patent Challenge”), then, to the extent permitted by Law, Blueprint will have the right, in its sole discretion, to terminate this Agreement upon [***] prior written notice to Clementia; provided that Blueprint will not have the right to terminate this Agreement if Clementia withdraws or causes to be withdrawn such Patent Challenge within [***] after Clementia’s receipt of notice from Blueprint under this Section 11.4.  For the avoidance of doubt, a Patent Challenge does not include Clementia or its Affiliates or Sublicensees (a) responding to compulsory discovery,
		

		
			
		

		
			

		 

		

			44

		

		

			 

		

		

		
			subpoenas or other requests for information in a judicial or arbitration proceeding or (b) complying with any applicable Law or a court order.
		

		
			11.5      Termination for Insolvency.  If, at any time during the Term (a) a case is commenced by or against either Party under the Bankruptcy Code and, in the event of an involuntary case under the Bankruptcy Code, such case is not dismissed within [***] after the commencement thereof, (b) either Party files for or is subject to the institution of bankruptcy, liquidation or receivership proceedings (other than a case under the Bankruptcy Code), (c) either Party assigns all or a substantial portion of its assets for the benefit of creditors, (d) a receiver or custodian is appointed for either Party’s business, or (e) a substantial portion of either Party’s business is subject to attachment or similar process; then, in any such case ((a), (b), (c), (d) or (e)), the other Party may terminate this Agreement upon written notice to the extent permitted under applicable Law.
		

		
			11.6      Effects of Termination.
		

		
			11.6.1   Effects of Termination Generally.  Upon termination of this Agreement in its entirety pursuant to Section 11.2 through 11.5, the Parties’ rights and obligations under this Agreement will terminate, and neither Party will have any further rights or obligations under this Agreement from and after the effective date of termination, except as set forth in this Article 11.
		

		
			11.6.2   Accrued Obligations.  Expiration or termination of this Agreement for any reason will not release either Party from any obligation or liability which, on the effective date of such expiration or termination, has already accrued to the other Party or which is attributable to a period prior to such expiration or termination.
		

		
			11.6.3   Termination of Rights and Licenses.  Any rights and licenses with respect to the Licensed Products granted to Clementia under Section 2.1 will immediately terminate, and all such rights will revert back to Blueprint.
		

		
			11.6.4   Reversion.  Upon termination of this Agreement in its entirety by Clementia under [***] or by Blueprint under [***], the following additional provisions will apply:
		

		
			(a)         Reversion Licenses.
		

		
			(i)          Subject to the terms and conditions of this Agreement (including Section 11.6.4(n)(ii)), effective upon the date of termination, Clementia hereby grants (without any further action required on the part of Blueprint) to Blueprint and its Affiliates, a worldwide, irrevocable, perpetual, sublicensable through multiple tiers, exclusive, license under any [***] (collectively, the “Reversion Products”, and, such license, the “Exclusive Reversion License”).
		

		
			(ii)         Subject to the terms and conditions of this Agreement (including Section 11.6.4(n)(ii)), effective upon the date of termination, Clementia hereby grants (without any further action required on the part of Blueprint) to Blueprint and its Affiliates, a worldwide, irrevocable, perpetual, sublicensable [***] (such license, the “Non-Exclusive Reversion License” and together with the Exclusive Reversion License, the “Reversion Licenses”).
		

		
			(b)         Regulatory Approvals and Regulatory Filings.  Clementia as promptly as practicable, to the extent permitted by applicable Law, will (i) assign to Blueprint or Blueprint’s designee possession and ownership of all Regulatory Approvals, Regulatory Filings, and Pricing and Reimbursement Approvals relating exclusively to the Exploitation of the Reversion Products in the Territory (to the extent any of the foregoing is owned by Clementia or held in Clementia’s name) and (ii) transfer and assign to
		

		
			
		

		
			

		 

		

			45

		

		

			 

		

		

		
			Blueprint or Blueprint’s designee copies of all material correspondence and conversation logs with Regulatory Authorities in Clementia’s possession or Control related exclusively to the Reversion Products in the Territory and all data, reports, records, and materials, and other sales and marketing related information in Clementia’s possession or Control to the extent that such data, reports, records, materials, or other information relate exclusively to the Exploitation of the Reversion Products in the Territory, including all Regulatory Data, and nonclinical and clinical data relating to the Reversion Products and customer lists and customer contact information and all Adverse Event data and Safety Data related to the Reversion Products, in each case, in the Territory and in Clementia’s possession or Control.  In addition, at Blueprint’s request, Clementia will appoint Blueprint or its designee as Clementia’s agent (or cause its Representative to appoint Blueprint or its designee as its agent) for all Reversion Product‐related matters in the Territory involving Regulatory Authorities until all Regulatory Approvals, Regulatory Filings, and Pricing and Reimbursement Approval in the Territory have been assigned to Blueprint or its designee, with it being understood and agreed that Blueprint shall promptly take any and all actions as may be required by the relevant Regulatory Authority to permit or finalize the aforementioned assignments to Blueprint or its designee.
		

		
			(c)         Clementia Trademarks and Copyrights.  Clementia will promptly transfer and assign to Blueprint, at no cost, all of Clementia and its Affiliates’ rights, title, and interests in and to any Trademarks and copyrights (and any registrations therefor) Controlled by Clementia and exclusively used in connection with the Reversion Products (but not any Clementia house marks or any Trademark containing the word “Clementia”).
		

		
			(d)         Reversion Patent Prosecution and Maintenance.
		

		
			(i)          Clementia’s right under Section 6.2.3 to Prosecute and Maintain the Licensed Patents (excluding Joint Patents) shall revert to Blueprint (“Reverted Licensed Patents”).  For the avoidance of doubt, Blueprint may Prosecute and Maintain such Reverted Licensed Patents without consulting with or accounting for Clementia.
		

		
			(ii)         Prosecution and Maintenance of Patents Covering Product-Specific Reversion Technology (“Reversion Patents”) shall revert to Blueprint, including Joint Product-Specific Patents.  Blueprint will keep Clementia informed of all steps with regard to and the status of such Prosecution and Maintenance of such Reversion Patents, including by providing Clementia with (x) copies of all correspondence and material communications Blueprint or its designee sends to or receives from any patent office or agency in the Territory relating to the Reversion Patents, (y) a draft copy of all applications sufficiently in advance (and no less than [***] in advance, to the extent reasonably practicable) of filing to permit reasonable review and comment by Clementia and (z) a copy of applications as filed, together with notice of its filing date and serial number.
		

		
			(iii)       For the avoidance of doubt, Blueprint’s Prosecution and Maintenance of the Reverted Licensed Patents and Reversion Patents under this Section 11.6.4(d) shall be at Blueprint’s cost and expense.
		

		
			(e)         Patent Information.  Upon request by Blueprint, Clementia will provide any and all (i) documents, files and other materials that Blueprint provided to Clementia under Section 3.1.7 in their current form, including as augmented or supplemented pursuant to Clementia’s Prosecution and Maintenance activities under Section 6.2.3 of the Reverted Licensed Patents, (ii)  material correspondence with the relevant patent office(s) pertaining to Clementia’s Prosecution and Maintenance under Section 6.2.3 of the Reverted Licensed Patents and Reversion Patents to the extent not previously provided to Blueprint during the course of the Agreement,  (iii) a Patent docket report detailing the status of all Reverted Licensed Patents and Reversion Patents with upcoming deadlines for the [***] period following the
		

		
			
		

		
			

		 

		

			46

		

		

			 

		

		

		
			effective date of termination, and (iv)  in a manner to maintain privilege in accordance with Section 7.4,  the following: (1)  [***], (2)  [***] and (3)  [***]. For the avoidance of doubt, Blueprint shall be responsible for reasonable costs and expenses related to actions with respect to Reverted Licensed Patents and Reversion Patents under this Section 11.6.4(e).
		

		
			(f)         Appointment as Distributor.  If the effective date of termination is after the First Commercial Sale of a Reversion Product, then at Blueprint’s request, to the extent permitted by applicable Laws, Clementia or its Affiliates or Sublicensees will use its Commercially Reasonable Efforts to appoint Blueprint or its designee as its exclusive distributor of such Reversion Product in the Territory and grant Blueprint or its designee the right to appoint subdistributors, until such time as all Regulatory Approvals in the Territory have been transferred to Blueprint or its designee.
		

		
			(g)         Transition Assistance.  Clementia will, and will cause its Affiliates and Sublicensees, to provide reasonable assistance of up to [***] FTE hours at no cost to Blueprint (other than external costs and expenses incurred by Clementia in connection therewith, for which Clementia will invoice Blueprint).  Thereafter, Clementia will invoice Blueprint for FTEs at the FTE Rate for any FTE hours and external costs and expenses incurred by Clementia in connection with providing such assistance, for the purpose of enabling Blueprint or its designee to commence or continue Researching, Developing, Manufacturing or Commercializing Licensed Products in the Territory pursuant to this Section 11.6.4, for a period of no longer than [***] after the effective date of such termination (the “Reversion Transition Period”).  To the extent Clementia is then performing or having performed such activities, including assigning, transferring or amending as appropriate, upon request of Blueprint, any agreements or arrangements with Third Parties to Research, Develop, Manufacture and Commercialize the Licensed Products in the Territory (including distributors and CMOs) shall be assigned to Blueprint (or its designee) or terminated.  At Blueprint’s request, Clementia shall assign to Blueprint (or its designee) any Sublicenses that Clementia entered into with Third Parties.  To the extent that any such contract between Clementia and a Third Party is not assignable to Blueprint or its designee, then Clementia will reasonably cooperate with Blueprint to arrange to continue to and provide such services from such entity.
		

		
			(h)         Ongoing Clinical Studies.  If at the time of such termination, any Clinical Studies for the Licensed Products are being conducted by or on behalf of Clementia, then, at Blueprint’s election, subject to patient safety and well-being on a Clinical Study-by-Clinical Study basis:  (i) Clementia will, and will cause its Affiliates and Sublicensees to, [***], and (ii) Clementia will, and will cause its Affiliates and Sublicensees to, [***].  Clementia will accommodate Blueprint’s reasonable requests to participate in communications with FDA regarding any such Clinical Studies for the Licensed Products, including attending meetings and reviewing minutes of any meetings, material telephone conferences or material discussions with FDA, in each case, solely with respect to applicable Licensed Product and to the extent permitted by FDA.
		

		
			(i)          Inventory.  At Blueprint’s election, Clementia will (i) transfer to Blueprint or its designee all inventory of the Blueprint Compounds and Licensed Products (including all final Blueprint Compounds, Licensed Products and raw materials and work-in-progress as supplied by Blueprint) and all works in progress of the foregoing then in possession or control of Clementia, its Affiliates or Sublicensees; provided that Blueprint will pay Clementia a price equal to the actual price paid by Clementia for Licensed Products or (ii) (A) have the right to continue to Commercialize all inventory of the Licensed Products then in possession or control of Clementia during the Reversion Transition Period and make the corresponding payments, including any milestone payments or royalties to Blueprint under this Agreement as though this Agreement had not been terminated and (B) after the Reversion Transition Period, transfer to Blueprint or its designee any remaining inventory of the Licensed Products to Blueprint or its designee at a price equal to Clementia’s costs for such Licensed Products.
		

		
			
		

		
			

		 

		

			47

		

		

			 

		

		

		
			(j)         Supply of Reversion Products and Palovarotene.  At Blueprint’s request, Clementia will supply to Blueprint (or have supplied) such quantities of the Reversion Products (in bulk drug substance, bulk drug product, or finished dosage product form, as requested by Blueprint) as Blueprint reasonably indicates in written forecasts and orders therefor from time to time at Clementia’s Manufacturing costs for such supplies, [***], to Manufacture or have Manufactured such Reversion Products until the earlier of (i)  [***] and (ii) [***]; provided, that Blueprint shall use Commercially Reasonable Efforts (defined for purposes of this Section 11.6.4(j) to apply to Reversion Products in the same manner as defined hereunder with respect to Blueprint Compounds and Licensed Products) to obtain an alternative supply of Reversion Products as promptly as practicable.  [***].
		

		
			(k)         Return of Confidential Information.  Except in the case of Blueprint for any Confidential Information that is the subject of its Reversion Licenses, each Party will promptly return to the other Party (or as directed by such other Party destroy and certify to such other Party in writing as to such destruction) all of such other Party’s Confidential Information provided by or on behalf of such other Party hereunder that is in the possession or control of such Party (or any of its Affiliates, Sublicensees or subcontractors), except that such Party will have the right to retain one (1) copy of intangible Confidential Information of such other Party for legal purposes.
		

		
			(l)          Cooperation.  Each Party will cause its Affiliates and Sublicensees to comply with the obligations in this Section 11.6; provided that the good faith failure by Clementia to provide immaterial information, reports records, correspondence or other materials to Blueprint shall not be a breach of Clementia’s obligations under this Section 11.6.  Within a reasonable period of time following notice of termination from Clementia to Blueprint, if requested by Blueprint, the Parties will meet to mutually agree upon a transition plan to effect an orderly and timely transition to Blueprint of all Development, Manufacture and Commercialization activities and responsibilities with respect to Reversion Products consistent with this Section 11.6.
		

		
			(m)       Termination of Rights and Obligations.  Except as set forth in this Section 11.6 and Sections 11.8 and 11.8(a), as of the effective date of such termination all rights and obligations of the Parties under this Agreement will terminate.
		

		
			(n)         Consideration for Reversion Product License.
		

		
			(i)          Upon termination by Clementia under [***] as partial consideration for the licenses granted under Section 11.6.4(a), Blueprint will pay to Clementia a royalty (“Reversion Royalty”), as set forth below Table 11.6.4(n)(i), based on the aggregated net sales (whether by Blueprint, its Affiliates or Sublicensees), calculated on the same basis as Net Sales and using the same terms, mechanics, adjustments and procedures applied to payments by Clementia to Blueprint under Article 5, mutatis mutandis, with respect to such Reversion Products in the Territory.  [***].  For the avoidance of doubt, if aggregate Net Sales of Reversion Products meet or exceed the applicable Net Sales Reversion Threshold in a given Calendar Year, Blueprint will pay Clementia the applicable Reversion Royalty (A) [***] and (B) [***];  provided, however, that Blueprint will have no obligation to pay an applicable Reversion Royalty if aggregate payments of Reversion Royalties for Reversion Products equal the amount set forth in Table 11.6.4(n)(i) (the “Reversion Royalty Cap”).
		

		
			 
		

			
					
						

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Table 11.6.4(n)(i) – Consideration for Reversion Product License

				
	
					
						 

					
					
						[***]

					
					
						[***]

					
					
						[***]

				
	
					
						[***]

					
					
						[***]

					
					
						[***]

					
					
						[***]

				
	
					
						[***]

					
					
						[***]

					
					
						[***]

					
					
						[***]

				

		
			 
		

		
			
		

		
			

		 

		

			48

		

		

			 

		

		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Table 11.6.4(n)(i) – Consideration for Reversion Product License

				
	
					
						 

					
					
						[***]

					
					
						[***]

					
					
						[***]

				
	
					
						[***]

					
					
						[***]

					
					
						[***]

					
					
						[***]

				

		
			 
		

		
			(ii)         Notwithstanding anything to the contrary in this Section 11.6.4,  Clementia will have the right to terminate the licenses granted to Blueprint in Section 11.6.4(a) with respect to Reversion Products in full upon [***] prior written notice to Blueprint in the event of any material breach by Blueprint of its payment obligations under this Section 11.6.4(n).  Notwithstanding the foregoing, any such termination under this Section 11.6.4(n) will not be effective if such breach has been cured within [***] after written notice thereof is given by Clementia to Blueprint specifying the nature of the alleged breach.
		

		
			(o)         As partial consideration for the Reversion Licenses, Blueprint would fully and forever release and discharge Clementia and its Affiliates, from any and all claims, demands, liabilities, obligations, responsibilities, suits, actions and causes of action, known or unknown, past, present or future, or otherwise, arising out of or relating to this Agreement or a breach of Clementia’s rights and obligations under this Agreement; provided, however, that the foregoing release does not discharge any rights or obligations set forth in Sections 11.6.4(b) through 11.6.4(l),  11.6.4(n),  11.6.4(p) and 11.8 or for payment of any royalties, milestones, or any amounts owed under this Agreement.
		

		
			(p)         Future Assurances.  Clementia will execute all documents and take, or cause to be taken, all such further actions as may be reasonably requested by Blueprint in order to give effect to the foregoing clauses.
		

		
			11.6.5   Other Remedies.  Except as provided in Section 11.6.4(n) or Section 11.8, termination or expiration of this Agreement for any reason will not constitute a waiver or release of, or otherwise be deemed to prejudice or adversely affect, any rights, remedies or claims, whether for damages or otherwise, that a Party may have hereunder or that may arise out of or in connection with such termination or expiration.
		

		
			11.7      Termination by Clementia Due to Material Breach.  Notwithstanding anything to the contrary set forth in this Agreement, upon the termination of this Agreement by Clementia pursuant to Section 11.3, all of the provisions of Section 11.6.4 will apply, except that to the extent Clementia is obligated to perform under any of the provisions of Sections 11.6.4(b),  11.6.4(c),  11.6.4(g) and 11.6.4(h), Blueprint will reimburse Clementia for all reasonable and documented committed and non-cancellable costs incurred by Clementia in connection with such performance, including after the effective date of termination, including both its reasonable external costs plus its reasonable internal costs calculated on a reasonable FTE basis.
		

		
			11.8      Alternative in Lieu of Termination by Clementia Due to Material Breach.
		

		
			(a)         Notwithstanding anything to the contrary set forth in this Agreement, if Clementia notifies Blueprint in writing of a material breach by Blueprint such that Clementia would have a right of termination of this Agreement in its entirety by Clementia pursuant to Section 11.3, in lieu of such termination right pursuant to Section 11.3, in the event such material breach remains uncured after [***] such that Clementia would be entitled to terminate this Agreement pursuant to Section 11.3,  Clementia may elect, beginning on the date Clementia would be entitled to terminate this Agreement for such uncured material breach, to have this Agreement continue in full force and effect without such termination; provided that Clementia notifies Blueprint within [***] of its election.  Upon Blueprint’s receipt of such election notice from Clementia, (a) [***], (b) all other rights and obligations of each Party
		

		
			
		

		
			

		 

		

			49

		

		

			 

		

		

		
			hereunder with respect to all Licensed Products throughout the Territory shall continue in full force and effect, and (c) Clementia shall fully and forever release and discharge Blueprint and its Affiliates, from any and all claims, demands, liabilities, obligations, responsibilities, suits, actions and causes of action, known or unknown, past, present or future, or otherwise, arising out of or relating to such uncured material breach.
		

		
			(b)         For the avoidance of doubt, (i)  [***], or (ii) [***].
		

		
			11.9      Continuation of Sublicenses.  In the event that the licenses granted to Clementia under this Agreement are terminated by Blueprint, any granted Sublicenses by Clementia (or by its Affiliates or Sublicensees) will remain in full force and effect; provided that the Sublicensee is not then in breach of its Sublicense and the Sublicensee as licensee agrees to be bound to Blueprint as a licensor under the terms and conditions of the Sublicense.  Blueprint will enter into appropriate agreements or amendments to the Sublicense to substitute itself for Clementia as the licensor under such Sublicense.
		

		
			11.10    Survival.  Any termination of this Agreement shall be without prejudice to the rights of either Party against the other accrued or accruing under this Agreement upon or prior to termination, including without limitation (a) obligations to pay any royalties, license fees, milestone payments or other payments that accrue under this Agreement upon or prior to termination and (b) the obligation to share any costs incurred prior to such termination in accordance with this Agreement, in accordance with the provisions of Article 5.  In addition, the following Articles and Sections, as well as, to the extent applicable, any other Sections or defined terms referred to in such Sections or Articles or necessary to give them effect, will survive any expiration or termination of this Agreement in its entirety:  Section 2.4 (Reservation of Rights), Section 6.1 (Ownership of IP), Section 6.2 (Prosecution and Maintenance of Licensed Patents) (but, solely with respect to, and to the extent, any Patent is a Joint Patent or Reversion Technology), Section 6.5 (Third Party Infringement) (but, solely with respect to, and to the extent, any Patent is a Joint Patent or Reversion Technology), Section 7.1 (Confidentiality), Section 7.3 (Tax Treatment), Section 7.4 (Attorney-Client Privilege), Section 8.5 (No Other Representations or Warranties), Article 9 (Indemnification), Article 10 (Limitation of Liability), Section 11.1 (Term) (but solely with respect to expiration and not termination), Section 11.6 (Effects of Termination), Section 11.7 (Termination by Clementia Due to Material Breach), Section 11.9 (Survival of Sublicenses), Section 11.10 (Survival), Article 12 (Dispute Resolution), Article 13 (Miscellaneous).  Furthermore, any other provisions required to interpret the Parties’ rights and obligations under this Agreement, including applicable definitions in Article 1 (Definitions), will survive to the extent required.  Except as otherwise expressly provided in this Agreement, all rights and obligations of the Parties under this Agreement, including any licenses granted under this Agreement, will terminate upon expiration or termination of this Agreement in its entirety for any reason.
		

		
			ARTICLE 12
		

		
			DISPUTE RESOLUTION
		

		
			12.1      Disputes.  Disputes of any nature arising under, relating to, or in connection with this Agreement (“Disputes”) will be resolved pursuant to this Article 12.
		

		
			12.2      Dispute Escalation.  In the event of a Dispute between the Parties, the Parties will first attempt to resolve such dispute by negotiation and consultation between themselves.  In the event that such dispute is not resolved on an informal basis within twenty (20) days from receipt of the written notice of a Dispute, any Party may, by written notice to the other have such dispute referred to the Executive Officers (or their designee, which designee is required to have decision-making authority on behalf of such Party), who will attempt to resolve such Dispute in good faith by negotiation and consultation for a thirty (30) day period following receipt of such written notice.  If the matter is not resolved within such thirty (30) day
		

		
			
		

		
			

		 

		

			50

		

		

			 

		

		

		
			period, either Party will thereafter have the right to pursue any and all other remedies available at law or in equity, subject to this Article 12.
		

		
			12.3      Governing Law.  This Agreement will be governed by and interpreted under the laws of the State of New York, other than any principle of conflict or choice of laws that would cause the application of the laws of any other jurisdiction; provided, however, that all questions concerning inventorship, scope, validity, enforceability or infringement of any Patents will be determined in accordance with the laws of the country, region or other jurisdiction in which the particular patent has been filed or granted, as the case may be.  The Parties agree to exclude the application to this Agreement of the United Nations Conventions on Contracts for the International Sale of Goods.
		

		
			12.4      Jurisdiction.  For the purposes of this Article 12, the Parties, except as provided in Section 12.6, agree to accept the jurisdiction of any United States District Court located in the State of New York.
		

		
			12.5      Injunctive Relief.  Nothing in this Article 12 will preclude either Party from seeking equitable relief or interim or provisional relief from a court of competent jurisdiction, including a temporary restraining order, preliminary injunction or other interim equitable relief.  For the avoidance of doubt, nothing in this Section 12.5 will otherwise limit a breaching Party’s opportunity to cure a material breach as permitted in accordance with Section 11.3.
		

		
			12.6      Patent, Trademark and Copyright Disputes.  Notwithstanding Section 12.3 and Section 12.4, any dispute, controversy or claim relating solely to the inventorship, scope, validity, enforceability or infringement of any Patents, Trademarks or copyrights within the Licensed Technology, Blueprint Future Technology or Joint Technology or otherwise Covering the manufacture, use, importation, offer for sale or sale of any Blueprint Compounds or Licensed Products will be submitted to a court of competent jurisdiction in the country in which such Patents, or Trademarks or copyrights were granted or arose.
		

		
			ARTICLE 13
		

		
			MISCELLANEOUS
		

		
			13.1      Assignment.  This Agreement and the rights and obligations of each Party under this Agreement cannot be assigned or otherwise transferred by either Party without the prior written consent of the other Party; provided, however, that (i) either Party may assign or transfer this Agreement, without such consent (but with written notice to the other Party promptly following such assignment or transfer), to an Affiliate of such Party, (ii) Blueprint may assign or transfer this Agreement, without such consent (but with written notice to Clementia promptly following such assignment or transfer) to a successor in interest to all or substantially all of the business or assets of Blueprint to which this Agreement relates, whether by merger, consolidation, reorganization, acquisition, sale of stock, sale of assets, royalty factoring or similar transaction or series of transactions, or (iii) beginning on the [***] of the Effective Date, Clementia may assign or transfer this Agreement without such consent (but with written notice to Blueprint promptly following such assignment or transfer) to a successor in interest to all or substantially all of the business or assets of Clementia to which this Agreement relates (including FOP and MO), whether by merger, consolidation, reorganization, acquisition, sale of stock, sale of assets, royalty factoring or similar transaction or series of transactions.  For the avoidance of doubt, at no time during the Term shall  a Change of Control with respect to Ipsen S.A. or Guarantor be deemed an assignment or transfer requiring the consent of Blueprint pursuant to this Section 13.1.  Any permitted assignment of the rights and obligations of a Party under this Agreement will be binding on, and inure to the benefit of and be enforceable by and against, the successors and permitted assigns of the assigning Party.  Any permitted assignee or transferee will assume all obligations of its assignor or transferor under this Agreement.  Any assignment or attempted
		

		
			
		

		
			

		 

		

			51

		

		

			 

		

		

		
			assignment by either Party in violation of the terms of this Section 13.1 will be null, void and of no legal effect.
		

		
			13.2      Non-Solicitation.  During the first [***] after the Effective Date, each Party (each, a “Recruiting Party”) agrees that neither it nor any of its Affiliates will recruit, solicit, or induce any full-time employee of the other Party (the “Employing Party”) or any of its Affiliates who has been in contact with the Recruiting Party in connection with this Agreement (whether prior to, on or after the Effective Date) to terminate his or her employment with the Employing Party or any of its Affiliates and become employed by or consult for the Recruiting Party or any of its Affiliates, and whether or not such employment or consulting is pursuant to a written agreement or such employment is at-will.  For purposes of the foregoing, “recruit,” “solicit,” or “induce” will not be deemed to mean (a) circumstances where an employee of an Employing Party or any of its Affiliates (i) initiates contact with the Recruiting Party or any of its Affiliates with regard to possible employment; or (ii) responds to general solicitations of employment not specifically targeted at employees of the Employing Party or any of its Affiliates, including responses to general advertisements or postings, and (b) discussions, interviews, negotiations, offers, or acceptances of employment or similar activities that arise as a result of circumstances described in the foregoing clause (a); provided that the obligations under this Section 13.2 shall terminate upon a Change of Control of the Employing Party.
		

		
			13.3      Notices.  Any notice or report required or permitted to be given or made under this Agreement by one Party to the other will be in writing in English and, unless a right or obligation is triggered by receipt of a notice or report, will be deemed to have been delivered (a) upon personal delivery and (b) on the second (2nd) Business Day (at the place of delivery) next following deposit with a reputable, internationally recognized overnight courier that maintains records of delivery (with a courtesy copy sent by e-mail to the addresses specified below, which will not constitute notice).  This Section 13.3 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement.
		

		
			 
		

			
					
						 

					
					
						 

				
	
					
						If to Clementia:

					
					
						Clementia Pharmaceuticals Inc.

				
	
					
						 

					
					
						1000 de la Gauchetière Street West, Suite 1200

				
	
					
						 

					
					
						Montreal, QC H3B 4W5, Canada

				
	
					
						 

					
					
						Attn: Chief Executive Officer

				
	
					
						 

					
					
						Email: [***]

				
	
					
						 

					
					
						 

				
	
					
						With a copy to:

					
					
						Ipsen Pharma SAS

				
	
					
						 

					
					
						65 quai Georges Gorse

				
	
					
						 

					
					
						92100 Boulogne-Billancourt, France

				
	
					
						 

					
					
						Attn: General Counsel

				
	
					
						 

					
					
						Email: [***]

				
	
					
						 

					
					
						 

				
	
					
						 

					
					
						 

				
	
					
						With a copy to (which copy will not constitute notice):

				
	
					
						 

					
					
						 

				
	
					
						 

					
					
						Faber Daeufer & Itrato PC

				
	
					
						 

					
					
						125 Park Avenue, 25th floor

				
	
					
						 

					
					
						New York, NY 10017

				
	
					
						 

					
					
						Attn: [***]

				
	
					
						 

					
					
						Email: [***]

				
	
					
						 

					
					
						 

				
	
					
						If to Blueprint:

					
					
						Blueprint Medicines Corporation 

				
	
					
						 

					
					
						45 Sidney Street

				
	
					
						 

					
					
						Cambridge, Massachusetts 02139 USA

				

		
			 
		

		
			
		

		
			

		 

		

			52

		

		

			 

		

		

		
			 
		

			
					
						 

					
					
						 

				
	
					
						 

					
					
						Attention: Chief Executive Officer 

				
	
					
						 

					
					
						Email: [***]

				
	
					
						With copies to (which copies will not constitute notice):

				
	
					
						 

					
					
						Goodwin Procter LLP 

				
	
					
						 

					
					
						100 Northern Avenue  

				
	
					
						 

					
					
						Boston, Massachusetts 02210 USA

				
	
					
						 

					
					
						Attention: [***]

				
	
					
						 

					
					
						Email: [***]

				
	
					
						 

					
					
						 

				
	
					
						 

					
					
						Blueprint Medicines Corporation

				
	
					
						 

					
					
						45 Sidney Street

				
	
					
						 

					
					
						Cambridge, Massachusetts 02139 USA

				
	
					
						 

					
					
						Attention: Chief Legal Officer

				
	
					
						 

					
					
						Email: [***]

				

		
			 
		

		
			13.4      Severability.  If, under applicable Law, any provision of this Agreement is invalid or unenforceable, (such invalid or unenforceable provision, a “Severed Clause”), it is mutually agreed that (a) this Agreement will endure except for the Severed Clause, (b) this Agreement will be construed and enforced as if such Severed Clause had never comprised a part hereof, (c) the remaining provisions of this Agreement will remain in full force and effect and will not be affected by the Severed Clause or by its severance herefrom, and (d) in lieu of such illegal, invalid, or unenforceable provision, there will be added automatically as a part of this Agreement a legal, valid, and enforceable provision as similar in terms to such illegal, invalid, or unenforceable provision as may be possible and reasonably acceptable to the Parties.
		

		
			13.5      Integration.  This Agreement, together with all schedules and exhibits attached hereto, constitutes the entire agreement between the Parties with respect to the subject matter of this Agreement and supersedes all previous arrangements between the Parties with respect to the subject matter hereof, whether written or oral, including the Prior CDA.  In the event of a conflict between any schedules or attachments to this Agreement, on the one hand, and this Agreement, on the other hand, the terms of this Agreement will govern.  Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement.
		

		
			13.6      Waivers and Amendments.  The failure or delay of any Party to assert a right under this Agreement or to insist upon compliance with any term or condition of this Agreement will not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other Party.  No waiver will be effective unless it has been given in writing and signed by the Party giving such waiver, and no provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives of each Party.
		

		
			13.7      Independent Contractors; No Agency.  Neither Party will have any responsibility for the hiring, firing or compensation of the other Party’s or such other Party’s Affiliates’ employees or for any employee benefits with respect thereto.  No employee or representative of a Party or its Affiliates will have any authority to bind or obligate the other Party for any sum or in any manner whatsoever, or to create or impose any contractual or other liability on such other Party, without such other Party’s written approval.  For all purposes, and notwithstanding any other provision of this Agreement to the contrary, each Party’s legal relationship under this Agreement to the other Party will be that of independent contractor, and the relationship between the two Parties will not constitute a partnership, joint venture, or agency, including for all tax purposes.
		

		
			
		

		
			

		 

		

			53

		

		

			 

		

		

		
			13.8      Force Majeure.  Neither Party will be responsible to the other for, or be deemed to have defaulted under or breached this Agreement for, any failure or delay in performing any of its obligations under this Agreement or for other nonperformance under this Agreement (excluding, in each case, the obligation to make payments when due) if such delay or nonperformance is caused by or results from events beyond the reasonable control of the non-performing Party, including strike, fire, flood, earthquake, hurricanes, accident, war, acts of war (whether war be declared or not), insurrections, riots, civil commotion, strikes, lockouts, or other labor disturbances (whether involving the workforce of the non-performing Party or of any other Person), act of terrorism, act of God or acts, omissions or delays in acting of the government of any region or of any local government, or by cause unavoidable or beyond the reasonable control of such Party (except to the extent such delay results from the breach by the non-performing Party or any of its Affiliates of any term or condition of this Agreement) (a “Force Majeure Event”).  In such event, the Party affected will promptly (and, in any event, subject to Section 4.2.3, within thirty (30) days) notify the other Party in writing of such Force Majeure Event, stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect.  The suspension of performance will be of no greater scope and no longer duration than is necessary and the non-performing Party and will use Commercially Reasonable Efforts to resume performance of its obligations.
		

		
			13.9      No Third Party Beneficiary Rights.  This Agreement is not intended to and will not be construed to give any Third Party any interest or rights (including any third party beneficiary rights) with respect to or in connection with any agreement or provision contained herein or contemplated hereby, other than, to the extent provided in Article 9, the Indemnified Parties.
		

		
			13.10    Non-Exclusive Remedy.  Except as expressly provided herein, the rights and remedies provided herein are cumulative and each Party retains all remedies at law or in equity, including the Parties’ ability to receive legal damages or equitable relief, with respect to any breach of this Agreement.  Neither Party will be required to terminate this Agreement due to a breach of this Agreement by the other Party.
		

		
			13.11    Interpretation.  The captions and headings to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement.  Unless specified to the contrary, references to Articles, Sections or Exhibits mean the particular Articles, Sections or Exhibits to this Agreement and references to this Agreement include all Exhibits hereto.  Unless context otherwise clearly requires, whenever used in this Agreement:  (a) the words “include” or “including” will be construed as incorporating, also, “but not limited to” or “without limitation;” (b) the word “day” or “year” means a calendar day or year unless otherwise specified; (c) the word “notice” means notice in writing (whether or not specifically stated) and will include notices, consents, approvals and other written communications contemplated under this Agreement; (d) the words “hereof,” “herein,” “hereby” and derivative or similar words refer to this Agreement (including any Exhibits); (e) the word “or” will be construed as the inclusive meaning identified with the phrase “and/or;” (f) provisions that require that a Party or the Parties hereunder “agree,” “consent” or “approve” or the like will require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter or otherwise and that consents not be unreasonably withheld, delayed or conditioned; (g) words of any gender include the other gender; and (h) words using the singular or plural number also include the plural or singular number, respectively.  Ambiguities and uncertainties in this Agreement, if any, will not be interpreted against either Party, irrespective of which Party may be deemed to have caused the ambiguity or uncertainty to exist.  This Agreement has been prepared in the English language, and the English language will control its interpretation.  In addition, all notices required or permitted to be given hereunder, and all written, electronic, oral or other communications between the Parties regarding this Agreement will be in the English language.
		

		
			13.12    Performance by Affiliates; Guarantee.
		

		
			
		

		
			

		 

		

			54

		

		

			 

		

		

		
			13.12.1 Performance by Affiliates.  Each of Blueprint and Clementia acknowledge that their obligations under this Agreement may be performed by their respective Affiliates.  Notwithstanding any delegation of obligations under this Agreement by a Party to an Affiliate, each Party will remain primarily liable and responsible for the performance of all of its obligations under this Agreement and for causing its Affiliates to act in a manner consistent with this Agreement.  Wherever in this Agreement the Parties delegate responsibility to Affiliates or local operating entities, the Parties agree that such entities will not make decisions inconsistent with this Agreement, amend the terms of this Agreement or act contrary to its terms in any way.
		

		
			13.12.2 Guarantee.  Guarantor has agreed to guarantee certain obligations and undertakings of Clementia under or in connection with this Agreement pursuant to the letter agreement, dated as of the Effective Date, between Blueprint and Guarantor.
		

		
			13.13    Further Assurances.  Each Party will duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.
		

		
			13.14    Ambiguities; No Presumption.  Each of the Parties acknowledges and agrees that this Agreement has been diligently reviewed by and negotiated by and between them, that in such negotiations each of them has been represented by competent counsel and that the final agreement contained herein, including the language whereby it has been expressed, represents the joint efforts of the Parties hereto and their counsel.  Accordingly, in interpreting this Agreement or any provision hereof, no presumption will apply against any Party as being responsible for the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement will not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.
		

		
			13.15    Execution in Counterparts; Facsimile Signatures.  This Agreement may be executed in counterparts, each of which counterparts, when so executed and delivered, will be deemed to be an original, and all of which counterparts, taken together, will constitute one and the same instrument even if both Parties have not executed the same counterpart.  Signatures provided by facsimile transmission or in AdobeTM Portable Document Format (PDF) sent by electronic mail will be deemed to be original signatures.
		

		
			[Remainder of this page intentionally blank.]
		

		
			 
		

		
			 
		

		
			

		 

		

			55

		

		

			 

		

		

		
			IN WITNESS WHEREOF, each Party has caused this Agreement to be duly executed by its authorized representative on the Effective Date.
		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						BLUEPRINT MEDICINES CORPORATION

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						By:

					
					
						/s/ Jeffrey W. Albers

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						Name:

					
					
						Jeffrey W. Albers

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						Title:

					
					
						President and Chief Executive Officer

				
	
					
						 

					
					
						 

				
	
					
						 

					
					
						CLEMENTIA PHARMACEUTICALS, INC.

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						By:

					
					
						/s/ Clarissa DESJARDINS

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						Name:

					
					
						Clarissa DESJARDINS

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						Title:

					
					
						Chief Executive Officer

				

		
			 
		

		
			 
		

		
			 
		

		
			

		 

		

			[Signature Page to License Agreement]

		

		

			 

		

		

		
			EXHIBIT A-1
		

		
			 
		

		
			BLUEPRINT COMPOUNDS
		

		
			 
		

		
			[***]
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			EXHIBIT A-2
		

		
			 
		

		
			METABOLITES
		

		
			 
		

		
			[***]
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			EXHIBIT B
		

		
			 
		

		
			DEVELOPMENT PLAN
		

		
			 
		

		
			[***]
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			EXHIBIT C-1
		

		
			 
		

		
			BLUEPRINT PRODUCT-SPECIFIC PATENTS
		

		
			 
		

		
			[***]
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			EXHIBIT C-2
		

		
			 
		

		
			BLUEPRINT PLATFORM PATENTS
		

		
			 
		

			
					
						Country

					
					
						Application Number

					
					
						Filing Date

					
					
						Patent 
Number

					
					
						Issue Date

				
	
					
						[***]

					
					
						[***]

					
					
						[***]

					
					
						[***]

					
					
						[***]

				

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			EXHIBIT D
		

		
			 
		

		
			TRANSITION PLAN
		

		
			 
		

		
			[***]
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			EXHIBIT E
		

		
			 
		

		
			PRESS RELEASE
		

		
			 
		

		
			(omitted intentionally)
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			EXHIBIT F
		

		
			 
		

		
			THIRD PARTY AGREEMENTS
		

		
			 
		

		
			[***]
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			EXHIBIT 1.57
		

		
			 
		

		
			[***]
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			EXHIBIT 3.2.2
		

		
			 
		

		
			BILL OF SALE
		

		
			 
		

		
			[***]
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			Schedule 1.18
		

		
			 
		

		
			BLUEPRINT CMOS
		

		
			 
		

		
			[***]
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			Schedule 1.23
		

		
			 
		

		
			CERTAIN BLUEPRINT PLATFORM KNOW-HOW
		

		
			 
		

		
			[***]
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			Schedule 1.26
		

		
			 
		

		
			CERTAIN BLUEPRINT PRODUCT-SPECIFIC KNOW-HOW
		

		
			 
		

		
			[***]
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			Schedule 2.1.1
		

		
			 
		

		
			BLUEPRINT PERMITTED ACTIVITIES
		

		
			 
		

		
			Blueprint is permitted to use, or have used by Third Parties, the Blueprint Compounds as follows:
		

		
			 
		

		
			[***]
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			Schedule 3.2.2(a)
		

		
			 
		

		
			EXISTING MANUFACTURING INVENTORY
		

		
			 
		

		
			[***]
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			Schedule 3.2.2(b)
		

		
			 
		

		
			IN PROCESS MANUFACTURING INVENTORY
		

		
			[***]
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			Schedule 7.2.2(b)(ii)
		

		
			BLUEPRINT’S PERMITTED PUBLICATIONS
		

		
			 
		

		
			Blueprint plans to publish manuscripts related to the topics set forth below; provided that nothing in this Schedule 7.2.2(b)(ii) shall prevent Blueprint from submitting such manuscripts to a different journal or on a different timing, subject to Blueprint’s compliance with Section 7.2.2(b)(ii) of the Agreement.
		

		
			 
		

			
					
						Planned Topic

					
					
						Planned
Journal

					
					
						Planned Submission
Timing

				
	
					
						[***]

					
					
						[***]

					
					
						[***]

				
	
					
						[***]

					
					
						[***]

					
					
						[***]

				
	
					
						[***]

					
					
						[***]

					
					
						[***]

				

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			Schedule 7.2.2(b)(iii)
		

		
			JOINT PRESENTATIONS
		

		
			1.    IFOPA Drug Development Forum
		

		
			a.    Abstract Title: An update on BLU-782, a selective ALK2 inhibitor in development for Fibrodysplasia Ossificans Progressiva (FOP)
		

		
			b.    Dates: November 13-14, 2019
		

		
			2.    IFOPA Drug Development Forum – Family Poster Session
		

		
			a.    Poster Title: An update on BLU-782, a selective ALK2 inhibitor in development for Fibrodysplasia Ossificans Progressiva (FOP)
		

		
			b.    Date: November 15, 2019
		

		
			3.    IFOPA Family Conference
		

		
			a.    Oral Presentation: an update on BLU-782
		

		
			b.    Dates: November 15-17, 2019
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			Schedule 8.2
		

		
			 
		

		
			EXCEPTIONS TO BLUEPRINT’S REPRESENTATIONS AND WARRANTIES
		

		
			 
		

		
			[***]

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00301-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00301-of-00352.parquet"}]]