Confidential Treatment Requested. Confidential portions of this document have been redacted and have been separately filed with the Commission. LICENSE, DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION AGREEMENT by and between Vertex Pharmaceuticals...

Exhibit 10.1

Execution Copy

Confidential Treatment Requested. Confidential portions of this document have been redacted

and have been separately filed with the Commission.

LICENSE, DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION AGREEMENT

by and between

Vertex Pharmaceuticals Incorporated

and

Xxxxxxx Pharmaceutica, N.V.

CONFIDENTIAL TREATMENT REQUESTED

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

TABLE OF CONTENTS


Article 1	Definitions
1.1	Intentionally Left Blank	1
1.2	“Additional Development Activities”	1
1.3	“Affiliate”	1
1.4	“API”	1
1.5	[]*	1
1.6	“Business Day”	1
1.7	“Calendar Quarter”	2
1.8	“Calendar Year”	2
1.9	“Change of Control”	2
1.10	“Clinical Trial”	2
1.11	“Code”	2
1.12	“Combination Product”	2
1.13	“Commercialization” or “Commercialize”	2
1.14	“Committees”	3
1.15	(Intentionally left blank)	3
1.16	“Compound”	3
1.17	“Control” or “Controlled by”	3
1.18	“Desired Label”	3
1.19	“Development” or “Develop”	3
1.20	“Development Program”	3
1.21	[]*	3
1.22	[]*	3
1.23	“Diligent Efforts”	3
1.24	“Effective Date”	3
1.25	“EMEA”	4
1.26	“European Union” or “EU”	4
1.27	“Excluded Claim”	4
1.28	“Excluded Territory”	4
1.29	“Exclusivity Period”	4
1.30	“Executive Officers”	4
1.31	“Existing Third Party Agreements”	4
1.32	“Far East”	4
1.33	“FDA”	4
1.34	“Field”	4
1.35	“First Commercial Sale”	4
1.36	“FTE”	4
1.37	“FTE Rate”	4
1.38	“GAAP”	5
1.39	“Generic Version”	5
1.40	“Global Development Costs”	5
1.41	“Global Development Plan” or “GDP”	5
1.42	“Good Clinical Practice” or “GCP”	6

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

1.43	“Good Laboratory Practice” or “GLP”	6
1.44	“Good Manufacturing Practice” or “GMP”	6
1.45	“HCV Infection”	6
1.46	“Improvement”	6
1.47	“IND”	6
1.48	“Indemnitee”	6
1.49	“Indemnitor”	6
1.50	“Information”	6
1.51	“Initiation”	7
1.52	“Invention”	7
1.53	“Investigator-Initiated Clinical Study”	7
1.54	“Xxxxxxx Know-How”	7
1.55	“Xxxxxxx Patent Rights”	7
1.56	“Joint Commercialization Committee” and “JCC”	7
1.57	“Joint Development Committee” and “JDC”	8
1.58	“Joint Information and Inventions”	8
1.59	“Joint Manufacturing Committee” and “JMC”	8
1.60	“Joint Patent Rights”	8
1.61	“Joint Philanthropic Committee” and “JPC”	8
1.62	“Joint Steering Committee” and “JSC”	8
1.63	“Key Country”	8
1.64	“Key Opinion Leaders” or “KOLs”	8
1.65	“MAA”	8
1.66	“Major Market Countries”	8
1.67	“Manufacturing” or “Manufacture”	8
1.68	“Manufacturing Cost”	9
1.69	(Intentionally left blank)	9
1.70	“Marketing Authorization”	9
1.71	“Material Adverse Effect”	9
1.72	“Medical Science Liaisons” or “MSL”	9
1.73	“Milestone Event”	9
1.74	“Milestone Payment”	9
1.75	“NDA”	9
1.76	[]*	9
1.77	“Net Sales”	9
1.78	“Non-Incurred Amount”	11
1.79	“Non-Publishing Party”	11
1.80	[]*	11
1.81	“North America”	11
1.82	[]*	11
1.83	“Packaging”	11
1.84	“Packaging Regulatory Approval”	11
1.85	“Party”	11
1.86	“Patent Costs”	11
1.87	“Permitted Sublicensee”	12
1.88	“Person”	12

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

1.89	“Phase I Clinical Trial”	12
1.90	“Phase II Clinical Trial”	12
1.91	“Phase III Clinical Trial”	12
1.92	“Phase IV Clinical Trial”	12
1.93	“Philanthropic Funds”	12
1.94	“Pivotal Clinical Trial”	12
1.95	“Primary Detail”	13
1.96	“Product”	13
1.97	“Product Candidate”	13
1.98	“Publishing Party”	13
1.99	“Regulatory Approval”	13
1.100	“Regulatory Authority”	13
1.101	“Related Party”	13
1.102	“Results”	13
1.103	“Sales Call”	13
1.104	“Sales Representative”	13
1.105	“Specifications”	14
1.106	“Supply Agreement”	14
1.107	“Tablet”	14
1.108	“Territory”	14
1.109	“Territory Product Materials”	14
1.110	“Third Party”	14
1.111	“Third Party Product”	14
1.112	“Trademark”	14
1.113	“U.S.” and United States” and “United States of America”	14
1.114	“Valid Patent Claim”	14
1.115	“Vertex Know-How”	14
1.116	“Vertex Patent Rights”	14
1.117	“VX-950”	15

Article 2	Collaboration Scope and Governance	15
2.1	Purposes of the Collaboration	15
2.2	Joint Steering Committee	15
2.3	Committee Governance	16
2.4	Alliance Managers	17

Article 3	Global Development of Product Candidate	17
3.1	Current Status	17
3.2	Development Program	17
3.3	Joint Development Committee	18
3.4	Global Development Plan	18
3.5	Additional Development Activities	19
3.6	Development Efforts; Manner of Performance; Reports	20
3.7	Regulatory Submissions and Regulatory Approvals	21

Article 4	Manufacture and Supply	23

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

iii

4.1.	General Background	23
4.2	Joint Manufacturing Committee	24
4.3	Manufacturing Director	24
4.4	Initial Forecast	24
4.5	Supply of Product	24
4.6	Packaging	26
4.7	Support for Establishment of Supply Capabilities	26

Article 5	Commercialization in the Territory	27
5.1	Xxxxxxx Commercialization Efforts.	27
5.2	Joint Commercialization Committee	27
5.3	Commercialization Plans	28
5.4	Scientific Meetings; []*	29
5.5	Advertising and Promotional Materials	29
5.6	Referral of Orders; Returns	30
5.7	Adverse Event and Product Complaint Reporting Procedures	30
5.8	Commercial Information	31
5.9	[]*	31
5.10	Recalls, Market Withdrawals or Corrective Actions	31
5.11	Medical Inquiries	32

Article 6	Philanthropic Program	32

Article 7	License Grants	33
7.1	Development License	33
7.2	Commercialization License	33
7.3	Know-How License	33
7.4	Licenses from Xxxxxxx	34
7.5	Manufacturing License	34
7.6	License of Trademarks	34
7.7	Right to Sublicense	34
7.8	Vertex Retained Rights	35
7.9	No Implied Licenses	35
7.10	[]*	35
7.11	[]*	35

Article 8	(Intentionally left blank)	36

Article 9	Financial Provisions	36
9.1	Upfront License Fee	36
9.2	Milestones	36
9.3	Development Cost Reimbursement	37
9.4	Royalties	38
9.5	Third Party Licenses	40
9.6	Reports; Payment of Royalty	40
9.7	Audits	41

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

9.8	Payments	41
9.9	Income Tax Withholding	42
9.10	Interest Penalty	42
9.11	[]*	42

Article 10	Intellectual Property Ownership, Protection and Related Matters	42
10.1	Filing, Prosecution and Maintenance of Vertex Patent Rights	42
10.2	Filing, Prosecution and Maintenance of Joint Patent Rights	43
10.3	Option to Prosecute and Maintain Patents	43
10.4	Interference, Opposition, Re-examination and Re-issue	44
10.5	Enforcement and Defense	44
10.6	Patent Term Restoration	46
10.7	Third Party Claims	46
10.8	Trademarks	47

Article 11	Confidentiality, Publication and Publicity	47
11.1	Nondisclosure Obligation	47
11.2	Employee, Consultant and Advisor Obligations	48
11.3	Publication	49
11.4	Publicity/Use of Names	50

Article 12	Representations and Warranties: Indemnification	50
12.1	Representations and Warranties of Vertex	50
12.2	Representations and Warranties of Xxxxxxx	52
12.3	Indemnification	53

Article 13	Term and Termination	54
13.1	Term and Expiration	54
13.2	Termination by Xxxxxxx Without Cause	54
13.3	Termination for Cause	55
13.4	Effect on License of Termination by Xxxxxxx for Cause	55
13.5	Effect of Termination by Vertex for Cause or by Xxxxxxx Without Cause	56
13.6	[]*	58
13.7	Survival	58
13.8	Non-exclusive Remedies	59

Article 14	Governing Law and Dispute Resolution	59
14.1	Governing Law	59
14.2	Referral to Executive Officers	59
14.3	Final Decision-Making Authority	59
14.4	Decision to Terminate or Suspend a Study Based on Safety Concerns	60
14.5	Dispute Resolution	60

Article 15	Miscellaneous	63
15.1	Force Majeure	63

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

15.2	Assignment	63
15.3	Severability	64
15.4	Notices	64
15.5	Entire Agreement; Amendments	65
15.6	Headings	65
15.7	Independent Contractors	65
15.8	Waiver	65
15.9	Cumulative Remedies	65
15.10	Waiver of Rule of Construction	65
15.11	Certain Conventions	66
15.12	Counterparts	66
15.13	Performance by Affiliates	66
15.14	Standstill	66
15.15	Export Controls	67

Schedules
Schedule 1.7	Xxxxxxx Universal Calendar
Schedule 1.19	[]*
Schedule 1.31	Existing Third Party Agreements
Schedule 1.32	Far East
Schedule 1.55	Xxxxxxx Patent Rights
Schedule 1.116	Vertex Patent Rights
Schedule 1.117	VX-950
[]*

Exhibits

Exhibit 4.5(a)	Supply Agreement Key Elements

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

License, Development, Manufacturing and Commercialization Agreement

This License, Development, Manufacturing and Commercialization Agreement (this “Agreement”) is effective as of June 30, 2006 (the “Effective Date”) and is entered into by and between Vertex Pharmaceuticals Incorporated, a Massachusetts corporation with corporate offices at 000 Xxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000-0000, Xxxxxx Xxxxxx of America (“Vertex”) and Xxxxxxx Pharmaceutica, N.V., a Belgium corporation with corporate offices at 30, Turnhoutsesteenweg, B-2340 Beerse, Belgium (“Xxxxxxx”).

Background

WHEREAS, Vertex is developing VX-950, a novel inhibitor of the NS3/4A hepatitis C viral protease, under a global development plan; and

WHEREAS, Vertex and Xxxxxxx would like Xxxxxxx to assist in the development of, and to commercialize, VX-950 in the Territory (as defined below).

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows.

Article 1 - Definitions

1.1 (Intentionally left blank)

1.2 “Additional Development Activities” shall have the meaning set forth in Section 3.5.

1.3 “Affiliate” shall mean, with respect to any Person, any other Person that directly or indirectly controls, is controlled by or is under direct or indirect common control with, such Person. For purposes of this Section 1.3, the term “control” means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by contract or otherwise. Control of any Person by another Person will be presumed if fifty percent (50%) or more of the securities or other ownership interests representing the equity, the voting stock or general partnership interest of the first Person are owned, controlled or held, directly or indirectly, by the other Person, or by an Affiliate of the other Person.

1.4 “API” means the active pharmaceutical ingredient that is intended to be used in the manufacture of a Product Candidate or a Product.

1.5 [*]**

1.6 “Business Day” means a day in which banking institutions in Boston, Massachusetts are open for business.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

1.7 “Calendar Quarter” shall mean a calendar quarter during any Calendar Year based on the Xxxxxxx Universal Calendar for that year, a copy of which, for 2006, is attached hereto as Schedule 1.7, and which shall be updated by Xxxxxxx for each Calendar Year during the term of this Agreement consistent with the Xxxxxxx Universal Calendar used for Xxxxxxx’x internal business purposes; provided, however, that the first Calendar Quarter under this Agreement shall extend from the Effective Date to the end of the then-current Calendar Quarter and the last Calendar Quarter under this Agreement shall extend from the first day of such Calendar Quarter until the effective date of the termination or expiration of the Agreement.

1.8 “Calendar Year” shall mean a calendar year during the term of this Agreement based on the Xxxxxxx Universal Calendar for that year, a copy of which, for 2006, is attached hereto as Schedule 1.7, and which shall be updated by Xxxxxxx for each Calendar Year during the term of this Agreement consistent with the Xxxxxxx Universal Calendar used for Xxxxxxx’x internal business purposes. For the first Calendar Year, the Calendar Year shall begin on the Effective Date and the last day shall be December 31, 2006. The last Calendar Year of the term of this Agreement shall begin on the first day of the Xxxxxxx Universal Calendar Year for the year during which termination or expiration of the Agreement will occur, and the last day of such Calendar Year shall be the effective date of such termination or expiration.

1.9 “Change of Control” means a transaction or series of related transactions that results in (a) the holders of outstanding voting securities of a Party immediately prior to such transaction ceasing to represent at least [] of the combined outstanding voting power of that Party, or if the surviving entity (or its parent) into which that Party may have merged or been combined, immediately after such transaction or series of transactions; (b) any Third Party (other than a trustee or other fiduciary holding securities under an employee benefit plan) becoming the beneficial owner of [] of the combined voting power of the outstanding securities of a Party, including as a single Third Party all Third Parties who act together as a “group” for purposes of acquiring shares of a Party, as referenced in Section 13(d) of the Securities Act of 1934; or (c) a sale or other disposition to a Third Party of all or substantially all of a Party’s assets or business.

1.10 “Clinical Trial” means a Phase I Clinical Trial, a Phase II Clinical Trial, a Phase III Clinical Trial or a Pivotal Clinical Trial.

1.11 “Code” shall have the meaning set forth in Section 13.4.2.

1.12 “Combination Product” means a single product that includes one or more therapeutically active ingredients other than a Product Candidate or a Product, in combination with a Product Candidate or Product. All references to Product in this Agreement shall be deemed to include a Combination Product unless otherwise specifically noted.

1.13 “Commercialization” or “Commercialize” means to take any action directed to marketing, promoting, distributing, importing or selling a Product, or obtaining pricing and reimbursement approvals for that Product. Commercialization shall also include post-approval Investigator-Initiated Clinical Studies and Phase IV Clinical Trials.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

1.14 “Committees” shall have the meaning set forth in Section 2.3.

1.15 Intentionally left blank.

1.16 “Compound” means VX-950, [*]**, and all of its or their prodrugs and metabolites, its or their stereoisomers and tautomers, and all of the esters, salts, hydrates, solvates, inclusion complexes and polymorphs of any of the foregoing.

1.17 “Control” or “Controlled by” means the ownership or other legal authority or right of a Party to grant a license or sublicense of intellectual property to another Party without breaching the terms of any agreement with a Third Party, infringing the intellectual property rights of a Third Party, or misappropriating the proprietary or trade secret information of a Third Party.

1.18 “Desired Label” shall have the meaning set forth in Section 1.41.

1.19 “Development” or “Develop” means any non-clinical and clinical drug development activities that are customarily undertaken after a compound has been designated as a development candidate [] including but not limited to []

1.20 “Development Program” means all activities associated with the Development of Product Candidates pursuant to the Global Development Plan and all Additional Development Activities.

1.21 [*]**

1.22 [*]**

1.23 “Diligent Efforts” means, with respect to each Party’s obligations related to Developing, Manufacturing and Commercializing Product Candidates and Products, the carrying out of those obligations [*]**

1.24 “Effective Date” shall have the meaning set forth in the preamble to this Agreement.

1.25 “EMEA” means the European Medicines Evaluation Agency or any successor EU agency that is responsible for approving the sale of pharmaceuticals in the EU.

1.26 “European Union” or “EU” means the countries of the European Union, as the European Union is constituted as of the Effective Date and as it may be expanded from time to time, [*]**

1.27 “Excluded Claim” shall have the meaning set forth in Section 14.5.7.

1.28 “Excluded Territory” means the Far East and North America.

1.29 “Exclusivity Period” means the [*]** beginning on the Effective Date.

1.30 “Executive Officers” means the Chief Executive Officer of Vertex and the World Wide Chairman, Pharmaceuticals Group of Xxxxxxx & Xxxxxxx.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

1.31 “Existing Third Party Agreements” means the agreements between Vertex and Third Parties listed on Schedule 1.31 hereto.

1.32 “Far East” means the countries listed on Schedule 1.32 hereto.

1.33 “FDA” means the United States Food and Drug Administration, or any successor U.S. governmental agency that is responsible for approving the sale of pharmaceuticals in the United States.

1.34 “Field” means all human and animal therapeutic and/or prophylactic uses of Product Candidates and Products.

1.35 “First Commercial Sale” means, with respect to any Product, the first arm’s-length sale of that Product to a Third Party in a country of the Territory for use or consumption by the general public in such country (rather than, e.g., in a Phase IV Clinical Trial) after Marketing Authorization for such Product has been obtained in such country. For the avoidance of doubt, a sale in a particular country prior to receipt of all marketing approvals necessary to commence regular commercial sales in that country, such as so-called “treatment IND sales,” “named patient sales” and “compassionate use sales,” shall not be construed as a First Commercial Sale in that country. Any such sale shall however constitute a part of Net Sales.

1.36 “FTE” means the equivalent in time of the work of one scientist or other professional conducting activities hereunder on a full time basis for a Calendar Year, [*]**

1.37 “FTE Rate” means, for 2006, [] per FTE; provided that effective January 1 of each Calendar Year, commencing with January 1, 2007, the FTE Rate applicable to each Party’s FTE’s will be the amount obtained by multiplying the FTE Rate applicable on December 31 of the immediately preceding Calendar Year by 1 + ((CPIx – CIPy) / CPIy), where CPIx is the Consumer Price Index for All Urban Consumers in the Boston Metropolitan Area published by the Bureau of Labor Statistics of the United States Department of Labor for December of the immediately preceding Calendar Year and CPIy is the Consumer Price Index for All Urban Consumers in the Boston Metropolitan Area published by the Bureau of Labor Statistics of the United States Department of Labor for the month immediately preceding the Effective Date, [] Any such increase shall be rounded to the nearest [*]**.

1.38 “GAAP” means accounting principles generally accepted in the United States, applied on a consistent basis.

1.39 “Generic Version” shall have the meaning set forth in Section 9.4.2.

1.40 “Global Development Costs” [*]**

[***]

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

[***]

1.41 “Global Development Plan” or “GDP” means the initial plan outlining the Parties’ intended program to Develop Product Candidates or Products in North America and the Territory, including a general description of all related activities therefor, all as reflected in the Global Development Plan, with associated budgets, discussed by the Parties immediately prior to the Effective Date and to which the Parties have agreed. The Parties have designed the Global Development Plan to support certain anticipated Product indications and label claims and related necessary label information (the “Desired Label”), and the Development activities listed in the Global Development Plan are considered critical to obtaining Regulatory Approval in both the United States and the EU for the Desired Label. Other Development activities that are critical to obtaining Regulatory Approval for the Desired Label in the United States or the EU, or that are required by a Regulatory Authority in either the United States or the EU for the Desired Label, may be added to the Global Development Plan from time to time by amendment as provided herein. Development activities that are not critical to obtaining Regulatory Approval in the United States or the EU for the Desired Label shall be considered Additional Development Activities, unless the Parties mutually agree to include such activities in the Global Development Plan. The Global Development Plan as amended from time to time in accordance with the terms of this Agreement shall constitute, as so amended, the Global Development Plan.

1.42 “Good Clinical Practice” or “GCP” means the current good clinical practice applicable to the clinical Development of the Product under applicable law including without limitation the ICH guidelines, or in the event such standards are less stringent than the current U.S. Good Clinical Practice, then “Good Clinical Practice” or “GCP” shall mean current U.S. Good Clinical Practice.

1.43 “Good Laboratory Practice” or “GLP” means the current good laboratory practice applicable to the Development of the Product under applicable law, including without limitation 21 C.F.R. Part 58, or in the event such standards are less stringent than the current U.S. Good Laboratory Practice, then “Good Laboratory Practice” or “GLP” shall mean current U.S. Good Laboratory Practice.

1.44 “Good Manufacturing Practice” or “GMP” means the current good manufacturing practice applicable to the Manufacturing of the Product under applicable law, including without limitation 21 C.F.R. parts 210 and 211 (as the same may be amended) and all applicable FDA rules, regulations, orders and guidances.

1.45 “HCV Infection” means human infection with the hepatitis C virus.

1.46 “Improvement” means any enhancement, whether or not patentable, in the formulation, use, preparation, presentation, means of delivery, or dosage of a Product Candidate or Product.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

1.47 “IND” shall mean an Investigational New Drug Application filed with FDA or a similar application filed with an applicable Regulatory Authority outside of the United States, such as a clinical trial application (CTA) or a clinical trial exemption (CTX).

1.48 “Indemnitee” shall have the meaning set forth in Section 12.3.3.

1.49 “Indemnitor” shall have the meaning set forth in Section 12.3.3.

1.50 “Information” means any and all information and data, including all scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, financial and commercial information or data, whether communicated in writing, electronically or orally or by any other method, which is provided by one Party to the other Party in connection with this Agreement.

1.51 “Initiation” means, with respect to a particular Clinical Trial, the administration of the [] dose of a Product Candidate to the [] patient in that Clinical Trial.

1.52 “Invention” means any process, method, use, composition of matter, article of manufacture, discovery or finding that is conceived or reduced to practice (whether or not patentable).

1.53 “Investigator-Initiated Clinical Study” means a human clinical trial or study of the Product that is sponsored and conducted by a Third Party who is a health-care professional, under an agreement with a Party pursuant to which that Party provides clinical supplies of the Product and/or funding for the clinical trial or study.

1.54 “Xxxxxxx Know-How” means all information, materials, discoveries, Improvements, processes, methods, protocols, formulas, data, Inventions and trade secrets, patentable or otherwise, that do not fall within Xxxxxxx Patent Rights, and (i) that are Controlled by Xxxxxxx or any of its Affiliates as of the Effective Date or (ii) are discovered, created or developed, and Controlled, by Xxxxxxx or its Affiliates in the course of Xxxxxxx’x performance of the Development Program, or of Manufacturing activities, under this Agreement or any supply agreement under which Xxxxxxx or any of its Affiliates supplies Compounds, Product Candidates or Products to Vertex, or during studies of a Compound, Product Candidate or Product undertaken after the end of the Development Program, or as part of the Commercialization of a Compound, Product Candidate or Product, and (iii) that are related to the Development, utilization, Manufacture or Commercialization of any Compound, Product Candidate or Product.

1.55 “Xxxxxxx Patent Rights” means all patents and patent applications that generically or specifically claim (a) (i) a Compound, a Product Candidate or a Product, (ii) a process for manufacturing a Compound, a Product Candidate or a Product, or an Intermediate used in such process; or (iii) a use of the Compound, a Product Candidate or a Product, and that are Controlled by Xxxxxxx or any of its Affiliates as of the Effective Date, or (b) Inventions Controlled by Xxxxxxx or any of its Affiliates that are conceived or reduced to practice in the course of Xxxxxxx’x performance of the Development Program, or of Manufacturing activities, under this Agreement or any supply agreement under which Xxxxxxx or any of its Affiliates supplies Product Candidates or Products to Vertex, or during studies of a Product

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Candidate or Product undertaken after the end of the Development Program, or as part of the Commercialization of a Product Candidate or Product, and that are related to the Development, utilization, Manufacture or Commercialization of the Compound or any Product Candidate or Product. Included within the definition of Xxxxxxx Patent Rights are all continuations, continuations-in-part, divisions, patents of addition, reissues, renewals or extensions, substitutions, re-examinations or restorations, registrations and revalidations thereof, and all supplementary protection certificates and the like. Schedule 1.55 lists all patent applications and patents encompassed within Xxxxxxx Patent Rights on the Effective Date.

1.56 “Joint Commercialization Committee” and “JCC” have the meaning set forth in Section 5.2.

1.57 “Joint Development Committee” and “JDC” have the meaning set forth in Section 3.1.

1.58 “Joint Know-How” means all information, Improvements and Inventions created, developed or invented jointly by employees of Xxxxxxx and Vertex or their Affiliates, or by others acting on behalf of Xxxxxxx and Vertex, in the course of activities undertaken under this Agreement.

1.59 “Joint Manufacturing Committee” and “JMC” have the meaning set forth in Section 4.2.

1.60 “Joint Patent Rights” means all national, regional and international patents and patent applications, certificates of invention and applications for certificates of invention, including divisions, continuations, continuations-in-part, additions, reissues, renewals, extensions, substitutions, re-examinations or restorations, registrations and revalidations, and supplementary protection certificates or the like or any of the foregoing and all foreign equivalents thereof, that, when granted, recite a claim directed to Joint Know-How.

1.61 “Joint Philanthropic Committee” and “JPC” shall have the meaning set forth in Article 6.

1.62 “Joint Steering Committee” and “JSC” have the meaning set forth in Section 2.2.

1.63 “Key Countries” means at the time of measurement the Major Market Countries, and to the extent not included as a Major Market Country, the [*]** in the Territory with respect to all pharmaceutical sales as reported by IMS, or by another independent Third Party source of market data selected by the Parties by mutual agreement.

1.64 “Key Opinion Leaders” or “KOLs” means scientific or health care professionals who are recognized experts in the relevant scientific or health care field, which in the context of this Agreement is the investigation and treatment of HCV Infection.

1.65 “MAA” means a Marketing Authorization Application, or similar application or submission for Marketing Authorization, that is filed to obtain marketing approval for a Product Candidate or Product in the EU.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

1.66 “Major Market Countries” means [*]**

1.67 “Manufacturing” or “Manufacture” means all of the activities relating to production of a Product Candidate or Product, including without limitation, purchasing raw materials and Intermediates, production of API, [], tableting, and all related quality control and quality assurance and all storage, shipping and handling. Manufacturing also includes Packaging and manufacturing technical transfer activities. “Intermediate” as used herein means [].

1.68 “Manufacturing Cost” means the cost of [*]**

1.69 Intentionally left blank.

1.70 “Marketing Authorization” means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in a particular country. For countries where governmental approval is required for pricing or reimbursement for the Product, “Marketing Authorization” shall not be deemed to occur until such pricing or reimbursement approval is obtained.

1.71 “Material Adverse Effect” means, with respect to any action by a Party or its Related Parties, [*]**

1.72 “Medical Science Liaisons” or “MSL” shall have the meaning set forth in Section 5.11.

1.73 “Milestone Event” shall have the meaning set forth in Section 9.2.1.

1.74 “Milestone Payment” shall have the meaning set forth in Section 9.2.1.

1.75 “NDA” means a New Drug Application or similar application or submission for Marketing Authorization that is filed with the FDA to obtain marketing approval for a Product Candidate or Product in the United States.

1.76 [*]**

1.77 “Net Sales” means the gross amount billed or invoiced by Xxxxxxx or its Related Parties on arms-length sales of Product Candidates and Products (for purposes of this definition, Product Candidates and Products are referred to collectively as “Products” or a “Product”) to a Third Party other than a Related Party, less Permitted Deductions. “Permitted Deductions” for any Product includes only the following, to the extent permitted by applicable law and specifically related to the gross amount billed or invoiced:

(i) customary transportation charges relating to the Product, including handling charges and insurance premiums relating thereto;

(ii) sales taxes, excise taxes and duties paid by and not refunded to the selling party and directly related to sale of the Product, and any other equivalent governmental charges imposed upon the importation, use or sale of the Product, but excluding income and similar taxes;

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

(iii) government-mandated rebates;

(iv) customary trade, quantity and prompt payment discounts allowed on the Product;

(v) allowances or credits to customers on account of retrospective price reductions affecting the Product; and

(vi) customary Product rebates and Product wholesaler charge-backs including those customarily granted to managed care entities

(vii) [***]

[***]

For the purposes of determining royalty rates and the royalties payable on Combination Products, Net Sales of a Product shall be calculated as follows: [***]

For purposes of clarity, no permitted deduction to Net Sales will be counted more than once or, with the exception of [***], adjusted more than [***] following the calculation of Net Sales for a given month.

Solely for the purposes of this Section 1.77, a Related Party of Xxxxxxx or of any of its Affiliates shall include a distributor acting as an actual or constructive sublicensee of rights granted hereunder with respect to sales of a Product in a particular country in the Territory, as evidenced by the fact that the distributor holds (A) sales and distribution rights for the Product in that country, coupled with (B) pricing authority or government pricing negotiation authority with respect to wholesalers or sub-distributors in that country.

If Xxxxxxx or any of its Related Parties makes any transfer of a Product to a Third Party as part of a multiproduct transaction, Net Sales of each unit of the Product transferred will be determined on a country-by-country basis, and will be equal to [***]

1.78 “Non-Incurred Amount” shall have the meaning set forth in Section 3.4.3.

1.79 “Non-Publishing Party” shall have the meaning set forth in Section 11.3.

1.80 [*]**

1.81 (a) “Noxxx Xxxxxxx” xxxxx xxx Xxxxxx Xxxxxx, Xxxxxx xnd Mexico, and the territories and possessions of each of them.

(b) “North America Product Materials” shall have the meaning set forth in Section 5.5(a).

1.82 [*]**

1.83 “Packaging” means importation, quality control, testing, primary and secondary packaging (including all labeling), qualified person release, storage and shipping and handling.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

1.84 “Packaging Regulatory Approval” means all requisite approvals of applicable Regulatory Authorities necessary for the Packaging of a Product.

1.85 “Party” means Xxxxxxx or Vertex, and “Parties” means Xxxxxxx and Vertex.

1.86 “Patent Costs” shall mean all reasonable costs and expenses incurred by Vertex in preparing, filing, prosecuting and/or maintaining Vertex Patent Rights, including, without limitation, out-of-pocket costs and reasonable time spent by Vertex’s professional personnel in patent preparation and prosecution, measured at the FTE Rate then in effect.

1.87 “Permitted Sublicensee” means a sublicensee of either Party under a sublicense permitted under Article 7 of this Agreement.

1.88 “Person” means any individual, corporation, partnership, limited liability company, association, joint-stock company, trust, unincorporated organization or government or political subdivision thereof.

1.89 “Phase I Clinical Trial” means a human clinical trial for a Product Candidate or Product, in any country, that would satisfy the requirements of 21 CFR §312.21(a).

1.90 “Phase II Clinical Trial” means a human clinical trial in any country that would satisfy the requirements of 21 CFR §312.21(b) and is intended to explore one or more doses, dose response, and duration of effect, and to generate initial evidence of clinical activity and safety, for a Product Candidate or Product in the target patient population

1.91 “Phase III Clinical Trial” means a human clinical trial in any country that would satisfy the requirements of 21 CFR §312.21(c) and is intended to confirm with statistical significance the efficacy and safety of the Product Candidate or Product, and is performed to obtain Regulatory Approval.

1.92 “Phase IV Clinical Trial” means a study or data collection effort for the Product that is initiated after receipt of Regulatory Approval for the Product and is not principally intended to support or maintain a Regulatory Approval, maintain a label or otherwise obtain a labeling change. Phase IV Clinical Trials shall include, without limitation, studies related to the Product that are sponsored by a Third Party but supported by a Party (either through financial support or through the provision of study drugs). Phase IV Clinical Trials may also include a human clinical trial of the Product that is required by the Regulatory Authority in a country to be conducted following Regulatory Approval of the Product in that country, as an explicit condition of that Regulatory Approval.

1.93 “Philanthropic Funds” shall have the meaning set forth in Article 6.

1.94 “Pivotal Clinical Trial” means a Phase III Clinical Trial or, under the following circumstances, a Phase II Clinical Trial. A Phase II Clinical Trial shall be considered a Pivotal Clinical Trial if and when (a) in the United States, the protocol for that Phase II Clinical Trial shall have been reviewed by the FDA under its current Special Protocol Assessment Guidelines (or equivalent guidelines issued in the future), and any comments from the FDA on that protocol are incorporated in the final protocol for that Phase II

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Clinical Trial or are resolved to the FDA’s satisfaction as evidenced by further written communications from the FDA; [*]**

1.95 “Primary Detail” means a Sales Call for the Product in which the Product receives the predominant portion of emphasis and time during the Sales Call (i.e., no other product or service receives more emphasis or time during the Sales Call, where such calculation of emphasis and time is conducted and measured in accordance with Xxxxxxx’x standard operating procedures for its own products to the target physician group for the Product.

1.96 “Product” means any pharmaceutical preparation in final commercial form containing the Product Candidate, for sale by prescription, over-the-counter or any other method. Product includes without limitation any Combination Product.

1.97 “Product Candidate” means a pharmaceutical composition containing a Compound as an active ingredient.

1.98 “Publishing Party” shall have the meaning set forth in Section 11.3.

1.99 “Regulatory Approval” means, with respect to any country or region, all authorizations by the appropriate governmental entity or entities necessary for commercial sale of a Product in that country or region (not including pricing or reimbursement approval). “Regulatory Approval” in the United States shall mean final approval of an NDA pursuant to 21 CFR §314 (or any successor regulation having the same purpose or effect), permitting marketing of a Product in interstate commerce in the United States. “Regulatory Approval” in the European Union shall mean final approval of a MAA pursuant to Council Directive 75/319/EEC, as amended, or Council Regulation 2309/93/EEC, as amended, or pursuant to any successor regulation having the same purpose or effect.

1.100 “Regulatory Authority” shall mean any applicable government regulatory authority involved in granting approvals for the manufacturing, marketing and sale of a Product.

1.101 “Related Party” shall mean each of a Party’s Affiliates and any Permitted Sublicensees, and “Related Parties” means all of a Party’s Affiliates and Permitted Licensees.

1.102 “Results” shall have the meaning set forth in Section 11.3.

1.103 “Sales Call” means face-to-face contact (or other contact which in the future is employed to substitute, in whole or in part, for face-to-face contact) of a Sales Representative with a health care professional with prescribing authority during which scientific and/or medical information is discussed about the use of a Product for the treatment of indications for which the Product has received Regulatory Approval.

1.104 “Sales Representative” means an individual who engages in or manages Sales Calls and other promotional efforts with respect to a Product and who is employed by a Party or its Related Parties. For purposes of clarity, an MSL is not a Sales Representative.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

1.105 “Specifications” means the manufacturing specifications for the Product to be filed with the FDA in the NDA.

1.106 “Supply Agreement” shall have the meaning set forth in Section 4.5.

1.107 “Tablet” means the form of the Product or Product Candidate that is ready for Packaging.

1.108 “Territory” means all of the countries in the world, and their territories and possessions, outside of the Excluded Territory.

1.109 “Territory Product Materials” shall have the meaning set forth in Section 5.5.

1.110 “Third Party” means an entity other than a Party or any of its Related Parties.

1.111 “Third Party Product” shall have the meaning set forth in Section 9.4.2.

1.112 “Trademark” shall mean the xxxx or marks used to promote and sell the Product.

1.113 “U.S.” and “United States” and “United States of America” shall mean the United States of America and its territories and possessions.

1.114 “Valid Patent Claim” means a claim of an issued and unexpired patent included within the Vertex Patent Rights or Joint Patent Rights that (a) claims (i) the Compound, a Product Candidate or a Product as a composition of matter, or (ii) the formulation, method of manufacture or use of the Compound, a Product Candidate or a Product; (b) has not been revoked or held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction (which decision is not appealable or has not been appealed within the time allowed for appeal); and (c) has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise.

1.115 “Vertex Know-How” means all information, materials, discoveries, Improvements, processes, methods, protocols, formulas, data, Inventions and trade secrets, patentable or otherwise, that do not fall within the Vertex Patent Rights, and (i) that are Controlled by Vertex or any of its Affiliates as of the Effective Date or (ii) are discovered, created or developed, and Controlled, by Vertex or its Affiliates in the course of Vertex’s performance of the Development Program or Additional Development Activities, or of Manufacturing activities, under this Agreement or the Supply Agreement, or during studies of a Compound, Product Candidate or Product undertaken after the end of the Development Program, or as part of the Commercialization of a Compound, Product Candidate or Product, and (iii) that are related to the Development, utilization, Manufacture or Commercialization of any Compound, Product Candidate or Product; provided, however, that the term “Vertex Know-How” shall not apply to Vertex’s general drug design technology whether in hardware or software form, tangible or intangible.

1.116 “Vertex Patent Rights” means all patents and patent applications that generically or specifically claim (a) (i) a Compound, a Product Candidate or a Product; (ii) a process for manufacturing a Compound, a Product Candidate or a Product, or an Intermediate used in

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

such process; or (iii) a use of the Compound, a Product Candidate or a Product, and that are Controlled by Vertex or any of its Affiliates as of the Effective Date, or (b) inventions Controlled by Vertex or any of its Affiliates that are conceived or reduced to practice in the course of either Vertex’s performance of the Development Program or Additional Development Activities, or of Manufacturing activities, under this Agreement or the Supply Agreement, or during studies of a Compound, Product Candidate or Product undertaken after the end of the Development Program, or as part of the Commercialization of a Compound, Product Candidate or Product and that are related to the Development, utilization, Manufacture or Commercialization of a Compound or any Product Candidate or Product. Included within the definition of Vertex Patent Rights are all continuations, continuations-in-part, divisions, patents of addition, reissues, renewals or extensions, substitutions, re-examinations or restorations, registrations and revalidations thereof, and all supplementary protection certificates and the like. Schedule 1.116 lists all patent applications and patents encompassed within Vertex Patent Rights as of the Effective Date.

1.117 “VX-950” means the chemical compound referred to by Vertex as VX-950 and having the chemical structure referenced on Schedule 1.117.

Article 2 - Collaboration Scope and Governance

2.1 Purposes of the Collaboration. The purpose of the collaboration between Vertex and Xxxxxxx established under this Agreement is to advance the Development and Commercialization of Product Candidates and Products as rapidly as reasonably practicable, for the treatment of Hepatitis C Infection in North America and the Territory.

2.2 Joint Steering Committee. Promptly after the Effective Date, the Parties will establish a Joint Steering Committee (the “Joint Steering Committee” or “JSC”), as more fully described in this Section 2.2, to review all Development, Manufacturing, Commercialization and philanthropic activities being conducted by the Parties under this Agreement. Each Party will keep the Joint Steering Committee, and other relevant committees referenced in Section 2.3 below, [*]** of its progress and activities under this Agreement. The Joint Steering Committee shall have no authority to amend this Agreement.

2.2.1 Membership. The Joint Steering Committee shall be comprised of [] The exact number of such representatives [] or such other number as the Parties may agree. Each Party shall provide the other with a list of its initial members of the Joint Steering Committee within []. Each Party will use all reasonable efforts to maintain the continuity of its representation, although each Party may nevertheless replace or substitute any or all of its representatives at any time. On an annual basis, the JSC shall meet [] with [] meetings being in person. Either Party may request that the JSC meet at any time upon [] notice to the other Party, for any purpose properly addressed by the JSC pursuant to this Agreement, and the Parties shall use best efforts to ensure that a meeting occurs within [*]** period or as soon thereafter as practicable.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

2.2.2 Responsibilities. The JSC shall oversee the collaborative relationship between Xxxxxxx and Vertex. To that end, the JSC shall also be responsible, without limitation, for the following:

2.2.2.1 oversight of the Development Program and Manufacturing activities undertaken with respect to any Product Candidate or Product hereunder;

2.2.2.2 reviewing matters referred to it by the other Committees (as defined below);

2.2.2.3 ensuring the exchange of relevant information and materials on a timely basis as required under this Agreement;

2.2.2.4 reviewing and approving substantive amendments and updates to the Global Development Plan, and to any Additional Development Activities, consistent with this Agreement; and

2.2.2.5 such other responsibilities as may be assigned to the Joint Steering Committee pursuant to this Agreement or as may be agreed upon by the Parties in writing from time to time.

2.3 Committee Governance. In addition to the JSC, the Parties will participate in the collaboration created by this Agreement through a number of other committees, including a Joint Development Committee (“JDC”), a Joint Manufacturing Committee (“JMC”), a Joint Commercialization Committee (“JCC”) and a Joint Philanthropic Committee (“JPC”) (each, including the JSC, a “Committee” and together, the “Committees”). Each Committee shall meet [] or as otherwise agreed by the Committee. Meetings will be held either in person or by teleconference or video conference, on such dates, and at such places and times, as provided herein or as the Parties shall agree. Meetings of each Committee that are held in person shall alternate between the offices of the Parties, or shall be conducted at such other place as the Parties may agree. Either Party may propose matters to the Committee Chair for inclusion on the Committee agenda for an upcoming meeting. Each Party shall initially have [] members on each Committee, or such other number as the Parties may agree with respect to any particular Committee. Each Party will provide the other with a list of its initial members of each Committee [] Each Party may thereafter replace any or all of its representatives at any time. A Committee meeting shall have a quorum if there are [] of each of Xxxxxxx and Vertex in attendance. The Chair of each Committee shall be responsible for scheduling each meeting, and for issuing appropriate minutes of each meeting of that Committee within [] of the date of such meeting. The minutes shall be considered as accepted by a Party if, [], none of that Party’s Committee members have objected to the draft of such minutes in writing or by email to the Chair. [] Where decisions are required of a Committee, the members of that Committee will attempt in good faith to reach consensus with respect to the matter at hand. If agreement cannot be reached after a good faith discussion among the members of [] Any decision required or permitted to be taken by any Committee may be taken without a meeting in person taking place, if (i) a consent in writing, setting forth the decision so taken, is signed by all designated members of that Committee; or (ii) by mutual

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

agreement of the Parties, the meeting is conducted by teleconference or videoconference; provided, however, that a Party that has requested a JSC meeting on [*]** may not object to the conduct of that meeting by teleconference or videoconference. Each Party may, in its reasonable discretion, invite non-member representatives of such Party to attend meetings of a Committee; provided, however that (i) the attendance by any such non-member representative shall be reasonably acceptable to both Parties and (ii) the requirements of Section 11.2 of this Agreement with respect to obligations of confidentiality and non-use shall have been satisfied with respect to any such non-member representative. Each Party will be responsible for its representatives’ expenses incurred in attending Committee meetings.

2.4 Alliance Managers. Promptly after the Effective Date, each Party may appoint an individual(s) to act as the alliance manager(s) for such Party (the “Alliance Managers”). Each Alliance Manager who is not otherwise a member shall thereafter be permitted to attend meetings of the Committees. The Alliance Managers, if appointed, shall be a significant point of contact for the Parties regarding the administration of this Agreement.

Article 3 - Global Development of Product Candidate

3.1 Current Status. Prior to the Effective Date, Vertex independently initiated Phase II Clinical Studies of VX-950 in North America and the EU, and has conducted or is conducting other clinical and non-clinical studies in support of the overall Development of VX-950. The Parties have agreed to continue the Development of Product Candidates under the Development Program and in accordance with the terms of this Agreement.

3.2 Development Program. Product Candidates will be Developed in the Territory and in North America pursuant to a Global Development Plan and in connection with any Additional Development Activities that may be undertaken by either Party. The Global Development Plan and any such Additional Development Activities together constitute the Development Program for a Product Candidate. The Global Development Plan identifies the type and timing of all planned Development activities to be undertaken in the Territory and in North America with the goal of securing Regulatory Approvals for the sale of Products in North America and the Territory with the Desired Label. The Global Development Plan also includes preliminary budgets covering all Development activities included in the Plan and allocates responsibilities for Development activities between the Parties.

3.3 Joint Development Committee. The Parties shall establish a JDC promptly after the Effective Date. The JDC shall be led by [*]**. Subject to oversight by the JSC, the JDC shall coordinate the Development of Product Candidates with the objective of obtaining Regulatory Approvals in North America and the Territory as soon as practicable, for each Product Candidate. The JDC may establish sub teams having representatives from both Parties for important functional areas, including but not limited to clinical trial teams, regulatory teams and the like. Each Party will keep the JDC reasonably informed of its Development activities and its progress in executing its responsibilities under the

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Development Program. The JDC’s responsibilities shall include, without limitation, the following:

3.3.1 consider and discuss strategies for the Development of Product Candidates; and

3.3.2 at least [*]**, review and discuss the Global Development Plan and related budgets and allocation of responsibilities between the Parties and, from time to time, present to the JSC for review and approval (i) proposed substantive amendments to the Global Development Plan in accordance with Section 3.4.3, and (ii) Additional Development Activities in accordance with Section 3.5.

3.4 Global Development Plan.

3.4.1 Global Development. The Development of Product Candidates in North America and the Territory shall be governed by the Global Development Plan, and the Parties agree that all Development activities relating to Product Candidates shall be conducted in accordance with the Global Development Plan, except for those activities that are specifically included within Additional Development Activities undertaken in accordance with Section 3.5. Each Party will contribute to the operational execution of the Global Development Plan, and will make best use of each Party’s established technological and process excellence for the optimal execution of the Global Development Plan. The JDC shall review the Global Development Plan not less frequently than [] and shall develop detailed and specific Global Development Plan updates, which shall include annual Development budgets and allocation of responsibilities between the Parties, for each Calendar Year under the Global Development Plan. The JDC shall submit all such updates to the JSC for review and approval such that JSC preliminary approval of the plan and budget for any Calendar Year would occur []. Updates with the JSC’s preliminary approval shall be submitted to each Party for its internal budgeting process with a target for final approval by the JSC [*]**, at which time any updates will be appended to the Global Development Plan.

3.4.2 Conduct of Activities under the Global Development Plan. Each Party will initially be responsible for conducting the Development activities assigned to it under the Global Development Plan. The allocation of responsibilities will be periodically reviewed by the JDC after the Effective Date, and may be supplemented or adjusted as determined by the JDC to be in the best interests of the collaboration, subject to review and approval by the JSC.

3.4.3 Amendments to the Global Development Plan. The JDC may develop and submit to the JSC from time to time proposed substantive amendments (which shall include necessary budget and allocation of responsibility updates) to the Global Development Plan as may be necessary or appropriate in its judgment to reflect changing circumstances. The JSC shall review any such proposed amendments presented by the JDC and may approve those proposed amendments and/or any other amendments proposed from time to time by members of the JDC and, upon approval of any such proposals by the JSC, the Global Development Plan shall be amended accordingly (provided that the JSC shall not be empowered to amend this Agreement). Amendments

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

to the Global Development Plan, associated budgets and allocation of responsibilities shall not be effective without the approval of the JSC. Except as provided below, disagreements that cannot be resolved within the JDC concerning any proposed amendment shall be submitted for resolution to the JSC. Disagreements that cannot be resolved by the JSC shall be submitted for resolution as Unresolved Matters under the provisions of Sections 14.2 and 14.3. Notwithstanding the foregoing, mutual agreement among the Parties’ representatives on the JSC shall be required for any proposed amendment to the Global Development Plan that would: (i) increase the aggregate amount of Global Development Costs [*]** In the event that during any Calendar Year any Development activity expressly provided for in the approved Global Development Plan budget to be completed during that year is not completed, and therefore the full expense budgeted for that activity for that year is not incurred (to the extent not incurred, a “Non-Incurred Amount”), then to the extent that the incomplete activity is scheduled for the next succeeding Calendar Year, the Non-Incurred Amount shall be included in the Global Development Plan budget for the succeeding Calendar Year.

3.5 Additional Development Activities.

If the JDC is unable to reach agreement on the inclusion in the Global Development Plan of (i) additional Development activities relating to the Development of a Product Candidate that are not critical to obtaining Regulatory Approval for the Desired Label, or (ii) that constitute an Out-of-Budget Proposal (“Additional Development Activities”), then the Party wishing to conduct those activities may do so at its own expense, but only after review and approval of the Additional Development Activities with the JSC and, failing approval by the JSC, subject to the provisions of Sections 14.2 and 14.3 hereof. If the results of any such activities are included by the other Party in a filing with a Regulatory Authority (other than a required submission for safety purposes) to support a label claim or a change in an approved label in that other Party’s territory, then the other Party using that data [*]**

3.5.1 [*]**

[*]**

3.6 Development Efforts; Manner of Performance; Reports

3.6.1 Standards for Conduct of Development Program. Each of Vertex and Xxxxxxx shall use Diligent Efforts to execute and to perform, or cause to be performed, the activities for which it is responsible under the Global Development Plan and to cooperate with and comply with all reasonable requests of the other Party in carrying out the Global Development Plan, in each case in good scientific manner and in compliance with applicable law, Good Clinical Practice and Good Laboratory Practice. Xxxxxxx shall use Diligent Efforts to seek Regulatory Approval to market the Product in the Territory including in each of the Key Countries. [*]**

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

3.6.2 Development Progress Reports. The minutes of the Committees will serve as Development Progress Reports.

3.6.3 Coordination of Certain Activities. The Parties will use reasonable efforts to coordinate their Development activities to effect the most efficient and reasonable contacts and [*]**

3.6.4 Drug Supply for Non-Clinical and Clinical Trials. During the Development Program prior to the First Commercial Sale, Vertex shall use Diligent Efforts to supply clinical trial material of the Product Candidate for use in clinical studies conducted in accordance with the Global Development Plan and, if applicable, for Additional Development Activities. [] With respect to supply for any Additional Development Activities prior to the First Commercial Sale, Vertex shall use Diligent Efforts to provide clinical trial material, subject to the primary commitment to supply clinical trial material for the Global Development Plan. Clinical trial material for Additional Development Activities conducted by Xxxxxxx shall be supplied to Xxxxxxx by Vertex [], and otherwise as further described in a Development Supply Agreement to be executed by the Parties in advance of Xxxxxxx’x need for such clinical trial material. In the event that Xxxxxxx conducts one or more clinical trials under the Global Development Plan, or as Additional Development Activities, Vertex shall supply the Product Candidate in bulk Tablet form, and Xxxxxxx will be responsible for Packaging and distribution, unless Vertex, after discussion at the JMC, elects in its sole discretion to take on that responsibility. Notwithstanding the foregoing, in the event Xxxxxxx is unable to perform Packaging due to regulatory requirements, Vertex will use commercially reasonable efforts to perform Packaging, consistent with Vertex’s current capabilities, upon Xxxxxxx request.

3.7 Regulatory Submissions and Regulatory Approvals

3.7.1 Regulatory Submissions. Vertex shall be solely and exclusively responsible for obtaining all Regulatory Approvals for Products in North America and shall own all regulatory submissions, including all applications for and dossiers relating to Regulatory Approval made by or at its direction under this Agreement. Xxxxxxx shall be solely and exclusively responsible for obtaining Regulatory Approvals for Products in the countries in the Territory, and shall own all regulatory submissions directed toward Regulatory Approval, including all applications for and dossiers relating to Regulatory Approval made by or at its direction under this Agreement. All activities conducted by each Party in their territory in connection with the preparation, filing and prosecution of applications for Regulatory Approval of a Product Candidate or Product, or with respect to pricing or reimbursement activities, shall be at each Party’s sole cost and expense. Each Party shall provide the other Party documentation to support the regulatory submissions of the other Party.

3.7.2 Discussions with Regulatory Authorities. Each Party will have the right to participate as an observer in all material meetings and other material contacts with Regulatory Authorities pertaining to the Development of a Product Candidate for Regulatory Approval in the territory of the other Party (excluding the Far East) to the

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

extent not prohibited by law. Each Party shall provide the other Party with reasonable advance notice of all such meetings and other contacts, and to the extent practicable will supply advance copies of all related documents and other relevant information sufficiently in advance of any such meetings or other contacts as may provide the receiving Party with a reasonable opportunity to comment on the substance of the documents or correspondence. Material submissions made by a Party to, or correspondence with, Regulatory Authorities in such Party’s territory [], will be provided to the other Party sufficiently in advance to enable translation, if any such submissions or correspondence are not available in English. Xxxxxxx and Vertex shall discuss any material documents or other material correspondence [] that either Party is planning to submit in connection with Regulatory Approvals, and each Party will consider the other Party’s comments in good faith.

3.7.3 Labeling. The Parties will use reasonable efforts to establish and maintain a core label for each Product. [*]** Each Party shall promptly provide to the other Party copies of all initially proposed labeling, Packaging and package inserts for a Product, in each case sufficiently in advance of submission to FDA and EMEA so that the other Party may review and have a reasonable opportunity to comment on the substance of such submissions. In addition, each Party shall promptly provide to the other Party copies of all initially proposed labeling, Packaging and package inserts for a Product that are materially different from the core label, in each case sufficiently in advance of submission to Regulatory Authorities, so that the other Party may review and have a reasonable opportunity to comment on the substance of such submissions. Thereafter, each Party will use reasonable efforts to provide the other Party with advance copies of any material changes to (i) the label, (ii) Packaging and (iii) package insert for review and comment. Vertex shall promptly provide to Xxxxxxx copies of any documents or correspondence pertaining to labeling received by Vertex or its Related Parties from the FDA. Xxxxxxx shall promptly provide to Vertex copies of any documents or correspondence pertaining to labeling received by Xxxxxxx or its Related Parties from EMEA or Regulatory Authorities in the Major Market Countries, and in addition, any such documents or correspondence, irrespective of the country to which the documents or correspondence relate, which address material issues concerning the label. Upon Vertex’s reasonable request, Xxxxxxx shall provide Vertex with any English translations of the documents and correspondence described in the preceding sentence that are produced for Xxxxxxx’x own use. Neither Party shall have the right to approve the proposed labeling for the Product in any country in the other Party’s territory. However, each Party shall have the right to object to the labeling to be initially submitted (or resubmitted following receipt of comments from, or negotiations with, Regulatory Authorities) for the Product in any country in the other Party’s territory or to any proposed variations or modifications to any labeling that has received Regulatory Approval, but in each case solely on the grounds that such labeling could in such Party’s’s reasonable judgment have a Material Adverse Effect; and provided, further, that such Party shall not be entitled to object to any variations or modifications to any labeling required by law or by any Regulatory Authority. Any objection or response to the other Party’s label or proposed label shall be made promptly so as to not delay the submission or approval of the label. Any such objection shall be submitted in writing to the JSC, with a full explanation of the concerns underlying the objection, and the matter shall be addressed by the JSC at a meeting called

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

for that purpose as soon as reasonably practicable. Failing agreement by the JSC, the objection shall be referred for resolution under Section 14.2 hereof.

3.7.4 Right to Cross-Reference. Each Party shall have the right to cross-reference and make any other use of the other Party’s NDAs/XXXx and INDs/CTAs for the Product that it would have if it were the owner [*]** including without limitation access to all data Controlled by the other Party and contained or referenced in such NDAs/XXXx and INDs/CTAs, in each case as may be reasonably necessary to enable such Party to Develop, Manufacture or Commercialize Products as permitted under this Agreement. In addition, each Party shall have the right to cross-reference the other Party’s drug master file (“DMF”) in connection with the performance of its obligations under this Agreement.

3.7.5 []. Subject to applicable law, Xxxxxxx shall provide Vertex at its request with all material information relating to Xxxxxxx’x [] in the EU and material information that serves as the basis for [*]** in the EU.

Article 4 -Manufacture and Supply

4.1 General Background. In general, the Parties intend that the provision of supply of raw materials, Intermediates, API and Product for both clinical and commercial purposes in the Territory will occur in accordance with the terms of this Agreement as follows:

(a) Clinical. Vertex will be responsible for providing Product Candidate supply under the Global Development Plan and, subject to availability, for Additional Development Activities pursuant to the provisions of Section 3.6.4.

(b) Commercial. The Parties intend that (i) Xxxxxxx will be responsible for the Manufacture of Product for Commercialization in the Territory including but not limited to Intermediates, API, and Product, and (ii) Vertex will be responsible for the Manufacture of Product for Commercialization outside the Territory, provided that Xxxxxxx will, as a secondary source for Vertex, also be responsible for the Manufacture of Product for Commercialization by Vertex outside the Territory as described in Section 4.5(d).

(c) Technical Transfer. Accordingly, the Parties will commence technical transfer activities [***] with the goal of enabling Xxxxxxx to supply Product for Commercialization in the Territory at Product launch and, as soon as practicable, to serve as a secondary source for Product for Commercialization outside the Territory as described in Section 4.5(d). In the event the Joint Manufacturing Committee determines that Xxxxxxx’x progress under the Technical Transfer Plan (as defined in Section 4.5(b)) [***] Vertex shall [***] to supply Product to Xxxxxxx in accordance with the terms of the Supply Agreement (as defined in Section 4.5(a)).

(d) [***]

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

4.2 Joint Manufacturing Committee. Promptly after the Effective Date, the Parties shall establish a Joint Manufacturing Committee (the “Joint Manufacturing Committee” or “JMC”) to oversee Manufacturing activities related to the Territory, subject to the terms of this Agreement and the oversight of the JSC. The JMC shall be responsible, without limitation, for the following:

4.2.1 consider and discuss the strategy for the Manufacture of the Product and Product Candidates in the Territory with the goal of synchronizing supply and demand; and

4.2.2 review and approve the Technical Transfer Plan described in Section 4.5(b), and monitor Xxxxxxx progress under such Technical Transfer Plan.

4.3 Manufacturing Director. Promptly following the Effective Date, each Party shall appoint one of its representatives to the JMC to direct all matters related to Manufacturing within its organization and to coordinate with the appointed representatives’ counterpart designated by the other Party.

4.4 Initial Forecast. [] As a necessary component of estimating supply chain capacity requirements, the Parties will deliver to each other [] forecast for Product [] which will also include []

4.5 Supply of Product.

(a) Supply Agreement. Within [***] of the Effective Date, Xxxxxxx and Vertex will negotiate [***], and separately enter into a supply agreement for the supply by Vertex, [***], of Xxxxxxx’x requirements of Product for distribution and sale in the Territory (the “Supply Agreement”). The Supply Agreement shall include the Supply Agreement Key Elements attached hereto as Exhibit 4.5(a) and such customary representations, warranties, covenants and conditions as are necessary or appropriate for transactions of this type, not inconsistent with the terms and conditions hereof; [***] Vertex will supply Product to Xxxxxxx [***] In the event Regulatory Authorities in the Territory require different specifications, [***]

(b) Technical Transfer to Xxxxxxx. Within [***] Xxxxxxx will propose to the JMC a plan for establishing manufacturing capabilities necessary for Xxxxxxx to manufacture the Product for the Territory and for use outside the Territory as a secondary source for Vertex (the “Technical Transfer Plan”). Following approval of the Technical Transfer Plan by the JMC, Xxxxxxx will commence and use Diligent Efforts to perform technical transfer activities and achieve its supply and secondary source obligations in accordance with such plan, the capacity expectations described in section 4.5(d) below and any applicable supply agreement. Xxxxxxx will provide Vertex with all documentation that is required and useful to effect regulatory filings necessary for regulatory approval of secondary source manufacturing facilities. Vertex will assist with such technical transfer by providing both technical documentation and FTE resources as may be reasonably requested to inform Xxxxxxx about the manufacturing process, subject to the understanding that Vertex will provide [***] at the initiation of the

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

technical transfer for each discrete aspect of the manufacturing process: [***] Following the initiation of the technical transfer, individuals having the expertise shared with Xxxxxxx at the initiation of the technical transfer (as provided above) will be available to participate in [***] project teleconferences with Xxxxxxx during the execution of the Technical Transfer Plan. If requested by Xxxxxxx and agreed by Vertex’s Third Party suppliers, Vertex will use reasonable efforts [***] Notwithstanding the foregoing, Xxxxxxx will retain sole responsibility for the implementation and progress of the Technical Transfer Plan and for meeting its needs for Product Supply (either through its own Manufacturing activities or through the supply agreement) at launch and thereafter.

(c) Sale of Intermediates. [***], and subject to the terms of the Supply Agreement, Vertex will use Diligent Efforts to supply Xxxxxxx with the raw materials, Intermediates required for its manufacture of the API to be converted into Product for Commercialization in the Territory and, as a secondary source to Vertex, for Product to be sold outside the Territory. [***]

(d) Notice of Establishment of Supply Capability; Secondary Source Capacity. Xxxxxxx shall notify Vertex promptly following its establishment of supply capability for Manufacture of Product for Commercialization in the Territory. [***] following delivery of such notice, the Parties will enter into a supply agreement for Xxxxxxx to be a secondary supplier, which supply agreement shall include usual and customary terms including, but not limited to, provisions for good faith forecasts, binding purchase orders for periodic orders by Vertex from Xxxxxxx, purchase price, and term, for supply of [***] provided the purchase price shall be [***]

In addition, Xxxxxxx agrees to use [***] to supply additional quantities of [***] if requested by Vertex, provided, however, [***]

(e) Third Party Agreements. Vertex will provide Xxxxxxx with copies of draft Third Party manufacturer agreements for the commercial supply of VX-950 and will consider in good xxxxx Xxxxxxx’x comments provided [*]**.

4.6 Packaging. Xxxxxxx will be responsible for Packaging of Products for commercial sale in the Territory.

4.7 Support for Establishment of Supply Capabilities. [] Vertex will invoice Xxxxxxx for costs incurred under Section 4.7 as they occur and Xxxxxxx will pay such invoice within [] Vertex may sell Product from its inventory following Regulatory Approval of the Product in Vertex’s territory and, [*]**

Article 5 - Commercialization in the Territory

5.1 Xxxxxxx Commercialization Efforts. Xxxxxxx shall warehouse and distribute the Product in the Territory and shall be responsible for recording sales and handling all aspects of Product order processing, invoicing, collection, inventory and receivables in the Territory. In this work and in all other aspects of Commercialization of the Product in the Territory, Xxxxxxx shall use Diligent Efforts, including without limitation by [*]** Except relating to the philanthropic and access programs and activities pursuant to Article 6, Xxxxxxx will use

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Diligent Efforts to maximize Net Sales of Products in the Territory through its commercial marketing, pricing and contracting strategies [*]** Xxxxxxx shall bear all of its own costs and expenses of Commercializing the Product in the Territory.

5.2 Joint Commercialization Committee. Promptly after the Effective Date, the Parties shall establish a Joint Commercialization Committee (the “Joint Commercialization Committee” or “JCC”). The JCC shall be led by co-chairs, one of which shall be selected by Vertex and one of which shall be selected by Xxxxxxx.

5.2.1 Responsibilities. The JCC shall be responsible for the following:

5.2.1.1 use reasonable efforts to establish a global brand for the Product including but not limited to, establishing overall strategic objectives for the Product;

5.2.1.2 review and discuss the Territory Commercialization Plan and the North American Commercialization Plan; and

5.2.1.3 discuss commercial activities that may benefit from joint involvement or coordination, including but not limited to [***] other matters of mutual interest.

5.3 Commercialization Plans. The JCC will review and discuss the Territory Commercialization Plan and the North American Commercialization Plan, each of which will be provided to the JCC by Xxxxxxx or Vertex, respectively, no later than [] prior to the projected commercial launch for the Product in the United States (with respect to the North American Commercialization Plan) or the European Union (with respect to the Territory Commercialization Plan). [] The responsible Party will also provide to the JCC, for review and discussion, any subsequent material amendments to the most recent Commercialization Plan that it provided to the JCC and in any event shall submit an updated plan on an annual basis. [] prior to the projected commercial launch for the Product in either the United States or the European Union, the JCC will consider plans for sharing certain global Commercialization activities (i.e., activities that benefit the Product in both the Vertex’ and Xxxxxxx’x territories, including without limitation such activities that relate to [] and the appropriate allocation of responsibilities and budget for such activities. Any such plan (including the allocation of responsibilities and budget) recommended by the JCC will be referred to the JSC for approval and if approved, will be reviewed and updated annually thereafter by the JSC upon referral from the JCC. The Territory Commercialization Plan will contain the annual Commercialization plans and budgets for [] with sufficient detail with respect to Commercialization, including but not limited to details [] to enable the JCC to conduct a meaningful review of such plans. Comparable information will be provided for the Territory as a whole and on a regional basis. Amendments and updates to the Territory Commercialization Plan and particularly the Commercialization plans for [*]** shall not be effective without review and discussion by the JCC.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Notwithstanding the foregoing, Xxxxxxx shall be solely responsible for all decisions regarding the prices charged for the Product in the Territory, as well as discounts, rebates and all other deductions from Net Sales allowed under Section 1.77.

5.4 Scientific Meetings; [] Commencing [], the Parties will discuss the scientific meetings inside and outside the Territory to which each Party intends to send a representative(s) during the balance of 2006 and for the following year, and will periodically review their respective plan in this regard with each other. The discussions will be for the purpose of coordinating efforts in connection with [] in connection with supporting the worldwide exchange of scientific information. []

5.5 Advertising and Promotional Materials.

(a) Xxxxxxx shall develop relevant educational, sales, promotion and advertising materials relating to the Product (“Territory Product Materials”), for use in the Territory, that shall be consistent with the Territory Commercialization Plan and compliant with applicable law and the provisions of applicable Regulatory Approvals. Copies of all Territory Product Materials used in the Territory will be archived by Xxxxxxx in accordance with applicable law. Upon Vertex’s request, Xxxxxxx shall provide copies of the material core Territory Product Materials for the Key Countries to Vertex for its review and comment prior to their first use. Moreover, upon request, Xxxxxxx shall provide copies of any other Territory Product Materials for other countries in the Territory to Vertex for its review and comment. Xxxxxxx will provide Vertex with any English translations, if available, of such Territory Product Materials that are produced for its own use. Xxxxxxx will consider in good faith any comments Vertex may have with respect to such Territory Product Materials. Upon Xxxxxxx’x request, Vertex shall provide Xxxxxxx with copies of the material core educational, sales, promotion and advertising materials relating to the Product in North America (“North American Product Material”), for review and comment prior to their use. Vertex will consider in good faith any comments Xxxxxxx may have with respect to such North American Product Material. Requests for North American Product Material and Territory Product Materials shall be made through a member of the JCC or his or her designee.

(b) Subject to any limitations imposed by applicable law, all Territory Product Materials and all documentary information and oral presentations, whether in hard-copy written, electronic or other media form regarding the education, marketing and promotion for the Product in countries of the Territory shall acknowledge the Parties’ license arrangement and shall display the Xxxxxxx or Xxxxxxx Affiliate and Vertex names and logos with equal prominence.

(c) In the event that Xxxxxxx uses, in a majority of the Major Market Countries in the Territory, the same Trademark for the Product used by Vertex in the United States, at Vertex’s option the Parties will coordinate the establishment, content, operation, and maintenance of any site or domain on the internet which incorporates the Trademark, and the related annual cost [***] The costs incurred by Vertex in the search for and selection of the Trademark will be shared in the same proportion.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

(d) Where not prohibited by law or regulation, and subject to any required Regulatory Approval, which Xxxxxxx shall use diligent efforts to obtain, Vertex’s name and logo will be carried on all Product packaging, package inserts, labels and containers, and on all printed, electronic and digital material related thereto (including educational materials and advertisements), with a prominence substantially equivalent to that of Xxxxxxx, or the Xxxxxxx Affiliate that is the most prominent name listed on any such material.

5.6 Referral of Orders; Returns. If Vertex receives any orders for the Product in the Territory, it shall refer such orders to Xxxxxxx. If Xxxxxxx receives any orders for the Product outside the Territory, it shall refer such orders to Vertex. Xxxxxxx shall be solely responsible for handling all returns of the Product sold in the Territory. If Product sold in the Territory is returned to Vertex, Vertex shall promptly ship such Product to a facility designated by Xxxxxxx. If Product sold in North America is returned to Xxxxxxx, Xxxxxxx shall promptly ship such Product to a facility designated by Vertex, at Vertex’s expense.

5.7 Adverse Event and Product Complaint Reporting Procedures. Each Party will (i) provide the other Party with all Product complaints, adverse event information, and safety data in its control necessary or desirable for the other Party to comply with all applicable law with respect to the Product and (ii) report and provide such information to the other Party in such a manner and time so as to enable the other Party to comply with all applicable law. Vertex shall maintain a global adverse event database for the Product and shall generate adverse event reports for Xxxxxxx’x use in the Territory. Xxxxxxx shall have access to all data in the global adverse event database. Xxxxxxx shall be responsible for submitting adverse events reports to the applicable Regulatory Authorities in the Territory. The Parties will enter into a Pharmacovigilance Agreement along with any other sublicensees of Vertex and Xxxxxxx (the “Pharmacovigilance Agreement”) within [], setting forth the product complaint procedures to which each Party will adhere; provided that in any event, the Pharmacovigilance Agreement will be in place prior to (a) the earlier of initiation by Xxxxxxx of any activities under the Global Development Plan, or any Additional Development Activities, or (b) the submission by Xxxxxxx of any applications for Regulatory Approval of the Product in the Territory. The costs and expenses of maintaining the global adverse event database shall be borne [] Notwithstanding the foregoing, [*]** the Parties will enter into a new Pharmacovigilance Agreement and Vertex and its sublicensees will have benefits and relevant obligations substantially similar to those which Xxxxxxx had in the initial Pharmacovigilance Agreement. The foregoing shall not be interpreted as requiring either Vertex or Xxxxxxx, respectively, to be responsible for the cost of maintenance of the global adverse event database, except as otherwise required by law, beyond the point at which Vertex or Xxxxxxx, respectively, terminates Development or Commercialization of Products under this Agreement.

[***] of this Agreement, the Parties shall meet to establish a safety oversight working group (the “Safety Oversight Working Group”) composed of members of both Parties, which during the [***] and as otherwise provided in the Pharmacovigilance Agreement, shall discuss processes and procedures for sharing information needed to support each Party’s respective regulatory responsibilities and to comply with applicable regulatory pharmacovigilance requirements. Any such procedures shall not be construed to restrict either Party’s ability to take action that it deems to be appropriate or required of it under

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

the applicable regulatory requirements, but when permitted by applicable laws and regulations, the Parties shall consult with each other before taking such action.

5.8 Commercial Information. In addition to royalty reports required pursuant to Section 9.6, Xxxxxxx will provide Vertex, on an annual basis as part of the Territory Commercialization Plan, with information relating to Sales Call metrics on a country-by-country basis in the [] on a country-by-country basis for the [].

5.9 [*]**

5.10 Recalls, Market Withdrawals or Corrective Actions.

5.10.1 In the Territory. If any Regulatory Authority issues or requests a recall or takes a similar action in connection with the Product in the Territory, or if either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in the Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, shall [*]** advise the other Party thereof by telephone or facsimile. Xxxxxxx, in consultation with Vertex, shall decide whether to conduct a recall in the Territory (except in the case of a government mandated recall, when Xxxxxxx may act without such advance notice but shall notify Vertex as soon as possible) and the manner in which any such recall shall be conducted. Vertex will make available to Xxxxxxx, upon request, all pertinent records within Vertex’s control that Xxxxxxx may reasonably request to assist Xxxxxxx in effecting any recall. Xxxxxxx shall bear the expense of any such recall in the Territory, subject to the terms of the Supply Agreement.

5.10.2 Outside the Territory. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with the Product in any country outside the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in any country outside the Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, shall [*]**, advise the other Party thereof by telephone or facsimile. Vertex and/or its Related Parties, in consultation with Xxxxxxx, shall decide whether to conduct a recall in any country outside the Territory and the manner in which any such recall shall be conducted. Xxxxxxx will make available to Vertex, upon request, all pertinent records within Xxxxxxx’x control that Vertex may reasonably request to assist Vertex in effecting any recall. Vertex and/or its Related Parties shall bear the expense of any such recall.

5.11 Medical Inquiries.

5.11.1 In the Territory. After the First Commercial Sale, Xxxxxxx shall handle all medical questions or inquiries from members of the medical profession in the Territory regarding the Product [] Vertex shall, and shall cause its medical affairs and/or sales department to, refer to Xxxxxxx all such questions and inquiries within [] of receipt. In no event will Vertex or its Sales Representatives or MSLs respond to any such medical question or inquiry. Notwithstanding the foregoing, [*]**

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

5.11.2 Outside the Territory. Vertex shall handle all medical questions or inquiries from members of the medical profession outside the Territory regarding the Product. Xxxxxxx shall, and shall cause its medical affairs and/or sales department to refer to Vertex all such questions and inquiries within [*]** of receipt. In no event will Xxxxxxx or its Sales Representatives or MSLs respond to any such medical question or inquiry.

Article 6 -Philanthropic Program.

Vertex and Xxxxxxx along with their respective Affiliates share the goal of promoting the diagnosis, prevention, treatment and cure of HCV Infection worldwide. In addition to Developing and Commercializing the Product in their respective territories, the Parties intend to engage in worldwide philanthropic activities directed toward this goal. Accordingly, the Parties agree that, [***], each Party will set aside an amount [***] to apply in furtherance of such philanthropic objectives (the “Philanthropic Funds”). Each Party shall make its contribution no later than [***]. The Philanthropic Funds will be provided by each Party in any one of a variety of approved forms at such Party’s election, such as [***] Also as part of this philanthropic program, the Parties shall consider in good faith activities and programs to increase the access to the Product, especially in countries identified by the World Health Organization as developing countries. In addition, as part of the Philanthropic program, Xxxxxxx may [***] The disposition of the Philanthropic Funds shall be determined by consensus of the members of a Joint Philanthropic Committee (“JPC”), with equal representation from each Party; provided, however, that the Philanthropic Funds shall be allocated in such a way as to maximally benefit the causes of the diagnosis, prevention, treatment and cure of HCV Infection. If the JPC is unable to reach consensus, either Party may refer the matter to the Executive Officers in accordance with Section 14.2. Each Party will afford equal recognition to the other Party in any public description by that Party of activities under this Article 6.

Article 7 -License Grants

7.1 Development License. Vertex and its Affiliates hereby grant to Xxxxxxx a co-exclusive (with Vertex) right and license under Vertex Patent Rights and Vertex’s rights under Joint Patent Rights, to Develop Product Candidates and Products in the Territory in the Field, provided however, that such license shall not include a license to Vertex Patent Rights resulting from inventions conceived or reduced to practice as a result of Additional Development Activities, if Xxxxxxx elected not to participate in those activities, unless and until Xxxxxxx has paid the amounts specified in Section 3.5 hereof with respect to those Additional Development Activities.

7.2 Commercialization License. Vertex and its Affiliates hereby grant to Xxxxxxx an exclusive right and license under Vertex Patent Rights and Vertex’s rights under Joint Patent Rights, to Commercialize Product Candidates and Products in the Territory in the Field, provided however, that such license shall not include a license to Vertex Patent Rights resulting from inventions conceived or reduced to practice as a result of Additional Development Activities, if Xxxxxxx elected not to participate in those activities, unless and

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

until Xxxxxxx has paid the amounts specified in Section 3.5 hereof with respect to those Additional Development Activities.

7.3 Know-How License. Vertex and its Affiliates hereby grant to Xxxxxxx an exclusive license in the Field in the Territory under all Vertex Know-How to the extent that it relates exclusively to Compounds, Product Candidates or Products, solely to discharge Xxxxxxx’x obligations and exercise its rights under this Agreement, provided however, that such license shall not include a license to Vertex Know-How resulting from inventions conceived or reduced to practice as a result of Additional Development Activities, if Xxxxxxx elected not to participate in those activities, unless and until Xxxxxxx has paid the amounts specified in Section 3.5 hereof with respect to those Additional Development Activities.

7.4 Licenses from Xxxxxxx. Xxxxxxx and its Affiliates hereby grant to Vertex a non-exclusive, royalty-free license in the Field under all Xxxxxxx Patent Rights, Xxxxxxx Know-How and Xxxxxxx’x rights under Joint Patent Rights, solely for the purpose of Developing or Manufacturing Product Candidates or Products worldwide, and an exclusive, royalty-free license in the Field under all Xxxxxxx Patent Rights, Xxxxxxx Know-How and Xxxxxxx’x rights under Joint Patent Rights, for Commercializing Product Candidates and/or Products outside the Territory, provided however, that such license shall not include a license to Xxxxxxx Patent Rights or Know-How resulting from inventions conceived or reduced to practice as a result of Additional Development Activities, if Vertex elected not to participate in those activities, unless and until Vertex has paid the amounts specified in Section 3.5 hereof with respect to those Additional Development Activities.

7.5 Manufacturing License. Vertex and its Affiliates hereby grant to Xxxxxxx an exclusive license in the Field in the Territory to Manufacture Product Candidates and Products for Commercial use in the Territory, and a co-exclusive (with Vertex) right and license to Manufacture Product Candidates and Products for purposes of exercising its rights under the Development License granted under Section 7.1 above, in each case under Vertex Patent Rights, Vertex Know-How and Vertex’s right under Joint Patent Rights. Any license provided to Xxxxxxx under the Supply Agreement shall be incremental to the license right granted in this section.

7.6 License of Trademarks. Prior to Commercialization of a Product, the Parties shall enter into a trademark licensing agreement under which Vertex and its Affiliates grant to Xxxxxxx a [*]** license during the term of the Agreement to use (i) logos chosen and owned by Vertex (the “Vertex Logo”) and (ii) the Trademarks Controlled by Vertex, on labeling, package inserts, monographs and packaging materials for the Product, Product Materials and samples, and other materials used in connection with the performance of this Agreement during its term. Xxxxxxx shall have no rights under this Agreement in or to the Vertex Logo, the Vertex Trademarks or the goodwill pertaining thereto except as specifically provided in the trademark licensing agreement. Xxxxxxx agrees that upon termination or expiration of this Agreement, it will discontinue all use of the Vertex Logo and the Vertex Trademarks, provided, however, Xxxxxxx shall have the right to sell off any inventory of Product containing Vertex Logo or Vertex Trademarks in accordance with the terms of this Agreement.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

7.7 Right to Sublicense. Each Party shall have the right to grant sublicenses under the rights and licenses granted to it under Sections 7.1, 7.2, 7.3, 7.4 and 7.5 of this Agreement, provided that any such sublicense obliges the sublicensee to comply with all relevant terms of this Agreement and that each Party remains liable to the other for all material acts and omissions of any such sublicensee.

Notwithstanding the foregoing, if Xxxxxxx wishes to grant a sublicense to a Third Party of its Development or Commercialization rights in [***] For the avoidance of doubt, Xxxxxxx shall not be required to seek the consent of Vertex in respect of sublicenses granted to its Affiliates.

7.8 Vertex Retained Rights. Notwithstanding the foregoing, Vertex shall retain rights under the Vertex Patent Rights and the Joint Patent Rights to the extent necessary or useful to discharge its obligations and exercise its rights under this Agreement, including but not limited to performing all activities (directly or with Related Parties) included in the Global Development Plan from time to time.

7.9 No Implied Licenses. Except as specifically set forth in this Agreement, neither Party shall acquire any license or other intellectual property interest, by implication or otherwise, in any Information disclosed to it under this Agreement or under any patents or patent applications owned or Controlled by the other Party or its Affiliates.

7.10 [*]**

7.11 [*]**

Article 8 -

(This Article is intentionally left blank).

Article 9 -Financial Provisions

9.1 Upfront License Fee. In consideration of the licenses granted pursuant to Article 7, Xxxxxxx shall pay to Vertex a one-time non-refundable, non-creditable payment of One Hundred Sixty Five Million Dollars (US $165,000,000) within [*]** the Effective Date.

9.2 Milestones

9.2.1 Milestone Payment. In further consideration of the licenses granted pursuant to Article 7, Xxxxxxx shall also pay each of the amounts set forth in the table below (each, a “Milestone Payment”) if and when the corresponding development milestone event (each, a “Milestone Event”) is achieved.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Milestone Event		Milestone Amount
		(USD)

[]*	[]*	[]*

[***]

9.2.2 Each Milestone Payment shall be payable only once upon the initial achievement of the associated Milestone Event. Vertex will invoice Xxxxxxx upon the occurrence of each of the Milestone Events [], and the invoiced amount shall be payable within [] of receipt of invoice. Xxxxxxx will notify Vertex in writing not later than [] after the occurrence (or deemed occurrence) of each of the Development Milestone Events [], and shall pay the appropriate Milestone Payment within [*]** of receipt of an invoice thereafter from Vertex.

9.3 Development Cost Reimbursement. Xxxxxxx will pay to Vertex fifty (50%) percent of the Global Development Costs. Not later than [] after the end of each calendar quarter, Vertex will submit to Xxxxxxx a summary of Global Development Costs for the Calendar Quarter just ended, including a brief description of the aggregate internal and external costs and an allocation of the Global Development Costs across various Development activities. With the summary, Vertex will include an invoice for fifty (50%) percent of the reported Global Development Costs, which invoice shall be due and payable by Xxxxxxx [] If Xxxxxxx has responsibility for Development activities under the Global Development Plan, Xxxxxxx will provide to Vertex, also on a quarterly basis and with a description as set forth above, a summary of the Xxxxxxx’x Global Development Costs under the Global Development Plan for the preceding quarter. Xxxxxxx may apply fifty (50%) percent of any such Global Development Costs appropriately incurred and disclosed hereunder against any unpaid amounts otherwise due to Vertex on account of Global Development Costs previously incurred by Vertex, and if the amount of any such offset exceeds the amount otherwise due and payable to Vertex, [] The books and records of each Party and any of that Party’s Related Parties relating to Global Development Costs to be charged to the other Party hereunder will be subject to inspection as provided below [] upon reasonable notice from the Party charged to the charging Party, for the purpose of verifying the accuracy of the summary of submitted Global Development Costs. Those records will be made available during normal business hours and will include all appropriate supporting information, such as a record of time expended on Development activities and invoices received covering all Third Party costs included in any summary of Global Development Costs submitted by the Party being audited. The inspection shall be conducted by an independent certified public accounting firm of nationally recognized standing, selected by (and at the expense of) the Party exercising its inspection right and reasonably acceptable to the Party being audited. The accounting firm conducting any such inspection shall only

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

disclose to the Party exercising its inspection right whether the summary of Global Development Costs being audited is accurate, and if not, by what aggregate amount the summary is inaccurate. The books and records of each Party pertaining to Global Development Costs shall be retained by such Party for a period of [*]** The summary information provided by either Party under the reporting provisions set forth above and any additional information disclosed by that Party upon audit shall be Information of the Party providing the information and subject to the confidentiality and non-use obligations of Section 11.1.

9.4 Royalties.

9.4.1 Royalties Payable By Xxxxxxx. In further consideration of the licenses granted pursuant to Article 7, Xxxxxxx shall pay to Vertex royalties on cumulative Net Sales of Products in the Territory as set out in this Section 9.4. The royalty rate payable shall be determined [*]**:

	[]*	[]*

Royalties on sales of Products, at the royalty rates determined as set forth above with reference to annual aggregate Net Sales in the Territory, shall be payable on a country-by-country basis until, [***] For purposes of determining aggregate Calendar Year Net Sales under this Section 9.4.1 for any Calendar Year, [***].

9.4.2 Unlicensed Competition. Notwithstanding Section 9.4.1, if a Third Party sells a pharmaceutical product in any country that is a “Generic Version” of a Product being sold in that country (the generic version, a “Third Party Product”), then [] For purposes of this subsection 9.4.2, a “Generic Version” of a product is [] This Section 9.4.2 shall not be applicable to any product being sold by a Third Party to which Xxxxxxx has granted a sublicense hereunder. The [] provided in this Section 9.4.2 shall not be applied to any Net Sales in respect of which a royalty report has already been provided pursuant to Section 9.7 prior to receipt by Vertex from Xxxxxxx of written notice that sales of a Generic Version of a Product covered by that royalty report []

9.5 Third Party Licenses. Xxxxxxx shall be responsible for [*]** of any royalties, or other amounts relating to intellectual property rights, payable on account of Products sold in the Territory, including without limitation, royalties due under any of the Existing Third Party Agreements. Neither Party shall enter into any agreement with a Third Party, without the other Party’s written consent, obligating the other Party to pay royalties or other amounts relating to the Third Party’s intellectual property rights in connection with the

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Development, Manufacture or Commercialization by that other Party of Product Candidate or Products in that other Party’s territory. If Vertex pays any such royalties or other payments otherwise the responsibility of Xxxxxxx, those payments will be deemed to have been made on behalf of Xxxxxxx and Xxxxxxx shall promptly reimburse Vertex for any such payments [*]** days of receipt of an invoice therefor from Vertex. The Parties shall establish such procedures as are reasonably necessary to permit them to reconcile Vertex’s actual payments pursuant to the foregoing with Xxxxxxx’x payments to Vertex or to any Third Party under this Section 9.5.

9.6 Reports; Payment of Royalty. During the term of this Agreement following the First Commercial Sale of a Product, Xxxxxxx shall furnish to Vertex [], at the end of each [], showing (i) the Net Sales of Products in each country in the Territory during the reporting period, and any permitted deductions from gross sales taken to arrive at the Net Sales calculation as set forth in Section 1.77 of this Agreement; (ii) the royalties payable under this Agreement on account of those Net Sales and the basis for calculating those royalties; (iii) the exchange rates and other methodology used in converting Net Sales into U.S. dollars, from the currencies in which sales were made in order to determine the appropriate royalty tier; and (iv) dispositions of Products other than pursuant to sale for cash. Net Sales in countries invoiced in currency other than U.S. Dollars shall be translated to U.S. Dollars using Xxxxxxx’x then-current standard exchange rate methodology, fairly applied, for the translation of foreign currency into U.S. dollars, as employed on a consistent basis throughout Xxxxxxx’x operations and disclosed to Vertex in advance. Should Xxxxxxx change its foreign currency translation methodology, the new methodology will be disclosed in writing to Vertex. [] Royalties shown to have accrued by each [] royalty report shall be due and payable to Vertex no later than the [*]**. Xxxxxxx shall keep complete and accurate records in sufficient detail to enable the royalties payable hereunder to be determined and the information provided hereunder to be verified by Vertex’s accounting firm pursuant to Section 9.7.

9.7 Audits. Upon the written request of Vertex, with [] prior written notice to Xxxxxxx, [], Xxxxxxx shall permit an independent certified public accounting firm of nationally recognized standing selected by Vertex and reasonably acceptable to Xxxxxxx, [], to have access during normal business hours to such of the records of Xxxxxxx and its Affiliates as may be reasonably necessary to verify the accuracy of the royalty reports hereunder for any []. Those records shall include, without limitation, gross sales of each Product or Product Candidate on a country-by-country basis, as well as all deductions taken from gross sales in that country to arrive at Net Sales in that country. The accounting firm shall disclose to Vertex only whether the royalty reports are correct or incorrect and the specific details concerning any discrepancies.

If such independent accountant’s review of Xxxxxxx’x royalty reports shows an underpayment, Xxxxxxx shall remit or cause its Related Parties to remit to Vertex within [***] after Xxxxxxx’x receipt of such report: (i) the amount of such underpayment plus interest as determined under Section 9.10 below, and (ii) if such underpayment exceeds [***] of the total amount owed for the period being audited, the reasonable and necessary fees and expenses of the independent accountant performing the audit. If such underpayment does not exceed [***], the fees and expenses of the independent accountant

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

performing any such audit shall be paid by Vertex. [***] Upon prior written notice to Xxxxxxx as provided above, Vertex shall have a further right, exercisable not more frequently than once [***], to audit Net Sales, deductions taken from gross sales, and royalties earned by Vertex in any country in which a prior audit has shown an understatement of royalties due of at least [***].

Xxxxxxx shall include in each sublicense granted by it pursuant to this Agreement a provision requiring the sublicensee to make reports to Xxxxxxx, to keep and maintain records of sales made pursuant to such sublicense and to grant access to such records by Vertex’s independent accountant to the same extent required of Xxxxxxx under this Agreement.

Upon the expiration of [***] the calculation of royalties payable with respect to such year shall be binding and conclusive upon the Parties, and Xxxxxxx and its Related Parties shall be released from any liability or accountability with respect to royalties for such Calendar Year.

Vertex shall treat all financial Information subject to review under this Section 9.7 or under any sublicense agreement in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with Xxxxxxx and/or its Related Parties obligating it to retain all such Information in confidence pursuant to such confidentiality agreement.

9.8 Payments. All payments to be made by Xxxxxxx to Vertex under this Agreement shall be made in U.S. dollars and shall be paid by bank wire transfer in immediately available funds to such bank account in the United States or elsewhere as may be designated in writing by Vertex from time to time.

9.9 Income Tax Withholding.

(a) Xxxxxxx will make all payments to Vertex under this Agreement without deduction or withholding for taxes except to the extent that any such deduction or withholding is required by law in effect at the time of payment, and Xxxxxxx has notified Vertex of any such deduction or withholding in the royalty report.

(b) Any tax required to be withheld on amounts payable under this Agreement will promptly be paid by Xxxxxxx on behalf of Vertex to the appropriate governmental authority, and Xxxxxxx will furnish Vertex with proof of payment of such tax. Any such tax required to be withheld will be an expense of and borne by Vertex.

(c) Xxxxxxx and Vertex will cooperate with respect to all documentation required by any taxing authority or reasonably requested by Xxxxxxx or Vertex to secure a reduction in the rate of applicable withholding taxes.

(d) If Xxxxxxx had a duty to withhold taxes in connection with any payment it made to Vertex under this Agreement but Xxxxxxx failed to withhold, and such taxes were assessed against and paid by Xxxxxxx, then Vertex will indemnify and hold harmless Xxxxxxx from and against such taxes (including interest but excluding penalties). If Xxxxxxx makes a

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

claim under this Section 9.9(d), it will comply with the obligations imposed by Section 9.9(b) as if Xxxxxxx had withheld taxes from a payment to Vertex.

9.10 Interest Penalty. In case of any delay in payment by Xxxxxxx to Vertex (including a delay in payment identified in connection with an audit under Section 9.7 above) [] interest at the [] assessed from the [] after the due date of the payment, shall be due from Xxxxxxx and payable [].

9.11 [*]**

Article 10 -Intellectual Property Ownership,
Protection and Related Matters

10.1 Filing, Prosecution and Maintenance of Vertex Patent Rights. Vertex shall have the exclusive right and the obligation (subject to Vertex’s election not to file, prosecute, or maintain pursuant to Section 10.3), to diligently file, prosecute and maintain (by timely paying all maintenance fees, renewal fees, and other such fees and costs required under applicable laws) the Vertex Patent Rights worldwide, and to conduct any interference, opposition and re-examination or other similar proceeding with respect thereto, in all such countries as is customary for Vertex to file, prosecute and maintain patent rights covering pharmaceutical products. [] If Xxxxxxx notifies Vertex that it wishes Vertex to file and prosecute patent applications covering Vertex Patent Rights in any country or countries in the Territory in which it is not customary for Vertex to do so, or to conduct any interference, opposition and re-examination or other similar proceedings with respect to the Vertex Patent Rights in the Territory, [] Vertex shall keep Xxxxxxx advised of the status of all actual and prospective patent filings in the Territory and upon the request of Xxxxxxx, provide advance copies of any papers related to the filing, prosecution and maintenance of such patent filings. Vertex shall promptly give reasonable advance notice to Xxxxxxx of the grant, lapse, revocation, surrender, invalidation or abandonment of any Vertex Patent Rights in the Territory for which Vertex is responsible for the filing, prosecution and maintenance. Vertex shall solicit Xxxxxxx’x advice and review of the nature and text of such patent applications and important prosecution matters related thereto in reasonably sufficient time prior to filing thereof, and Vertex shall consider Xxxxxxx’x comments related thereto.

10.2 Filing, Prosecution and Maintenance of Joint Patent Rights. In respect of any Joint Information and Inventions, the Parties shall agree, without prejudice to ownership, which Party shall have the right and/or obligation to prepare and file a priority patent application, and prosecute such application(s) and maintain any patents derived therefrom, with the Parties equally sharing the Patent Costs for the preparation, filing, prosecution and maintenance of such priority patent application. Should the agreed-upon Party elect not to prepare and/or file any such patent application, it shall (i) provide the other Party with written notice as soon as reasonably possible after making such election but in any event no later than [*]** before the other Party would be faced with a possible loss of rights, (ii)

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

give the other Party the right, at the other Party’s discretion and sole expense, to prepare and file the priority application(s), and (iii) offer reasonable assistance in connection with such preparation and filing [*]** The other Party, at its discretion and cost, may prosecute such application(s) and maintain any patents derived therefrom.

10.3 Option to Prosecute and Maintain Patents.

10.3.1 Vertex shall give notice to Xxxxxxx of any desire to cease prosecution and/or maintenance of Vertex Patent Rights or Joint Patent Rights on a country-by-country basis in the Territory and, in such case, shall permit Xxxxxxx, at its sole discretion, to continue prosecution or maintenance of such Vertex Patent Rights []. If Xxxxxxx elects to continue prosecution or maintenance or to file based on Vertex’s election not to file pursuant to this Section 10.3, Vertex shall execute such documents and perform such acts at [] expense as may be reasonably necessary to allow Xxxxxxx to initiate or continue such filing, prosecution or maintenance.

10.3.2 Xxxxxxx shall give notice to Vertex of any desire to cease prosecution and/or maintenance of Xxxxxxx Patent Rights or Joint Patent Rights in any country and, in such case, shall permit Vertex at its sole discretion, to continue prosecution or maintenance of such Xxxxxxx Patent Rights []. If Vertex elects to continue prosecution or maintenance or to file based on Xxxxxxx’x election not to file pursuant to this Section 10.3, Xxxxxxx shall execute such documents and perform such acts at [] expense as may be reasonably necessary to allow Vertex to initiate or continue such filing, prosecution or maintenance.

10.4 Interference, Opposition, Re-examination and Re-issue.

10.4.1 Vertex shall promptly, but in any case within [*]** of learning of such event, inform Xxxxxxx of any request for, or filing or declaration of, any interference, opposition, or re-examination by a Third Party relating to Vertex Patent Rights or Joint Patent Rights for which Vertex is responsible, in the Territory. Xxxxxxx and Vertex shall thereafter consult and cooperate fully to determine a course of action with respect to any such proceeding. Xxxxxxx shall have the right to review and approve any submission to be made in connection with such proceeding.

10.4.2 Vertex shall not initiate any re-examination, interference or re-issue proceeding relating to Vertex Patent Rights or Joint Patent Rights in the Territory without the prior written consent of Xxxxxxx, which consent shall not be unreasonably withheld.

10.4.3 In connection with any interference, opposition, re-issue, or re-examination proceeding relating to Vertex Patent Rights or Joint Patent Rights in the Territory, Xxxxxxx and Vertex will cooperate fully and will provide each other with any information or assistance that either may reasonably request. Vertex shall keep Xxxxxxx informed of developments in any such action or proceeding, including, to the extent permissible by law, consultation and approval of any settlement, the status of any settlement negotiations and the terms of any offer related thereto.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

10.4.4 The expense of any interference, re-examination or re-issue proceeding, and the expense of any opposition or similar two-party proceeding conducted under rules of the U.S. Patent and Trademark Office, or any comparable foreign authority shall, unless agreed otherwise, [*]**

10.5 Enforcement and Defense.

10.5.1 Each Party shall promptly give the other Party notice of (i) any infringement of Vertex Patent Rights, Xxxxxxx Patent Rights or Joint Patent Rights, or (ii) any misappropriation or misuse of Vertex Know-How or Xxxxxxx Know-How, that may come to the first Party’s attention. Xxxxxxx and Vertex shall thereafter consult and cooperate fully to determine a course of action, including but not limited to the commencement of legal action by either or both Xxxxxxx and Vertex, to terminate any infringement of Vertex Patent Rights, Xxxxxxx Patent Rights or Joint Patent Rights or any misappropriation or misuse of Vertex Know-How or Xxxxxxx Know-How, in the Territory. Vertex, upon notice to Xxxxxxx, shall have the first right to initiate and prosecute any such legal action in the name of Vertex and Xxxxxxx, or to control the defense of any declaratory judgment action, relating to Vertex Patent Rights, Joint Patent Rights or Vertex Know-How in the Territory. Xxxxxxx, upon notice to Vertex, shall have the first right to initiate and prosecute any such legal action in the name of Xxxxxxx and Vertex, or to control the defense of any declaratory judgment action, relating to Xxxxxxx Patent Rights or Xxxxxxx Know-How in the Territory. [] Each Party shall promptly inform the other Party if it elects not to exercise its first right as described above and the other Party shall thereafter have the right to either initiate and prosecute such action or to control the defense of such declaratory judgment action in its name of and, if necessary, the name of the first Party. Each Party shall have the right to be represented by counsel of its own choice []

10.5.2 For any action to terminate any infringement of Vertex Patent Rights, Xxxxxxx Patent Rights or Joint Patent Rights or any misappropriation or misuse of Vertex Know-How or Xxxxxxx Know-How, as permitted in accordance with Section 10.5.1, in the event that the Party initiating the action is unable to initiate or prosecute such action solely in its own name, the other Party will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for the first Party to initiate litigation to prosecute and maintain such action. In connection with any such action, Xxxxxxx and Vertex will cooperate fully and will provide each other with any information or assistance that either may reasonably request. Each Party shall keep the other informed of developments in any such action or proceeding, including, to the extent permissible by law, the consultation and approval of any settlement negotiations and the terms of any offer related thereto.

10.5.3 Any recovery obtained by either or both Xxxxxxx and Vertex in connection with or as a result of any action contemplated by this Section, whether by settlement or otherwise, shall be shared in order as follows:

[***]

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

[***]

10.5.4 Vertex shall inform Xxxxxxx of any certification regarding any Vertex Patent Rights it has received pursuant to either 21 U.S.C. §§355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) or its successor provisions or any similar provisions in a country in the Territory and shall provide Xxxxxxx with a copy of such certification [] Vertex’s and Xxxxxxx’x rights with respect to the initiation and prosecution of any legal action as a result of such certification or any recovery obtained as a result of such legal action shall be as defined in subsections 10.5.1 through 10.5.4; provided, however, that Vertex shall have the first right to initiate and prosecute any action and shall inform Xxxxxxx of such decision [], in the case of certification regarding any Vertex Patent Rights it has received pursuant to either 21 U.S.C. §§355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV), or within a similarly appropriate time in the case of certifications or the like in countries outside of the United States, of receipt of the certification, after which time Xxxxxxx shall have the right to initiate and prosecute such action.

10.6 Patent Term Restoration. Vertex shall be responsible for obtaining patent term restoration or supplemental protection certificates or their equivalents in any country in the Territory where applicable to Vertex Patent Rights and Joint Patent Rights. Xxxxxxx shall be responsible for obtaining patent term restoration or supplemental protection certificates or their equivalents in any country in the Territory where applicable to Xxxxxxx Patent Rights. The Parties hereto shall cooperate with each other in obtaining patent term restoration or supplemental protection certificates or their equivalents in any country in the Territory where applicable to Vertex Patent Rights, Xxxxxxx Patent Rights and Joint Patent Rights. In the event that elections with respect to obtaining such patent term restoration are to be made, Vertex shall have the right to make the election with respect to Vertex Patent Rights and Joint Patent Rights and Xxxxxxx shall have the right to make the election with respect to Xxxxxxx Patent Rights.

10.7 Third Party Claims.

10.7.1 Without prejudice to Section 12.3.2, if any action, suit or proceeding is brought against Xxxxxxx or Vertex or any Affiliate or sublicensee of either Party alleging the infringement of the intellectual property rights of a Third Party by reason of the discovery, development, manufacture, use, sale, importation or offer for sale of a Product Candidate or Product in the Territory, Xxxxxxx shall have the sole right but not the obligation to defend itself and Vertex in such action, suit or proceeding [*]** The Parties shall cooperate with each other in any defense of any such suit, action or proceeding. The Parties will give each other prompt written notice of the commencement of any such suit, action or proceeding, or receipt of any claim of infringement, and will furnish each other a copy of each communication relating to the alleged infringement. Without regard to which Party defends an Infringement Claim under this Section 10.7, all damages (including all reasonable costs and expenses associated with any defense of a claim hereunder) associated with any such infringement claim in the Territory shall be borne equally by the Parties.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

10.7.2 Neither Party shall compromise, litigate, settle or otherwise dispose of any such suit, action or proceeding without the other Party’s advice and prior consent, provided that the Party not having the right to defend the suit shall not unreasonably withhold its consent to any settlement which does not have a material adverse effect on its rights, obligations or benefits, either under this Agreement or otherwise. Notwithstanding the foregoing, if Xxxxxxx decides to seek a license, and Vertex elects not to seek such license, Xxxxxxx may seek to obtain such license for its benefit [*]** provided that the terms and conditions of such license do not include an admission of invalidity of any Vertex Patent Rights or Joint Patent Rights, or restrict Vertex’s ability to challenge or litigate the validity or applicability of any intellectual property to which the license relates.

10.7.3 The Party first having actual notice of any claim, action or proceeding referenced in Section 10.7.1 above shall promptly notify the other Party in writing, setting forth in reasonable detail, to its knowledge, the facts related to any such claim, action or proceeding. The Parties shall promptly discuss proposed responses to any such matters.

10.8 Trademarks. Xxxxxxx shall have the right but not the obligation to use Vertex’ Trademarks to market and promote the Product in its Territory, subject to the provisions of the license to be provided under Section 7.6 hereof. Xxxxxxx may, however, select all Trademarks which it employs in connection with Product in the Territory, and subject to the following sentence, shall own and control, and shall be responsible for registration and maintenance of all such Trademarks. In the event Xxxxxxx selects a Product Trademark for any country in the Territory that is the same as the Product Trademark selected by Vertex for use in the United States, Vertex will own the related Trademark and will provide Xxxxxxx with a license as provided in Section 7.6 of this Agreement to use that Trademark in the Territory. [*]** Nothing in this Agreement shall be construed as a grant of rights, by license or otherwise, to Vertex to use any Trademarks owned by Xxxxxxx for any purpose, except as might otherwise be permitted under applicable law or as provided in Article 13 hereof in the event of the termination of this Agreement by Vertex with cause or by Xxxxxxx without cause.

Article 11 -Confidentiality, Publication and Publicity

11.1 Nondisclosure Obligation. All Information disclosed by one Party to the other Party shall be maintained in confidence by the receiving Party and shall not be disclosed to a Third Party or used for any purpose except as set forth herein without the prior written consent of the disclosing Party, except to the extent that such Information:

11.1.1 is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by the receiving Party’s contemporaneous business records;

11.1.2 is in the public domain through no breach of this Agreement by the receiving Party;

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

11.1.3 is subsequently disclosed to the receiving Party by a Third Party who may lawfully make such disclosure and is not to the best of the receiving Party’s knowledge under an obligation of confidentiality to the disclosing Party;

11.1.4 is developed by the receiving Party independently of Information received from the disclosing Party, as documented by the receiving Party’s contemporaneous business records;

11.1.5 is disclosed to governmental or other regulatory agencies to comply with applicable law or regulations, provided the receiving Party provides to the disclosing Party prompt prior written notice of its obligation to make such disclosure and takes reasonable and lawful actions to avoid or minimize the degree of such disclosure; or

11.1.6 is deemed necessary by the receiving Party in the reasonable exercise of its judgment to be disclosed to Related Parties, agents or consultants, to the extent the receiving Party deems necessary or advisable, in connection with the Development, Manufacturing and/or Commercialization of a Product or Product Candidate (or for such entities to determine their interest in performing such activities) in accordance with this Agreement, on the condition that any such Third Parties agree to be bound by confidentiality and non-use obligations that are no less stringent than those confidentiality and non-use provisions contained in this Agreement.

A combination consisting of multiple components shall not be deemed to fall within the foregoing exclusions merely because one or more individual components of that disclosure are published or available to the general public or in the rightful possession of the receiving Party, unless the combination itself is published or available to the general public or otherwise falls within one of the foregoing exclusions.

If a Party is required by judicial or administrative process to disclose Information that is subject to the non-disclosure provisions of this Section 11.1, such Party shall promptly inform the other Party of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations. Information that is disclosed by judicial or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of this Section 11.1, and the receiving Party shall cooperate with any reasonable attempts of the disclosing Party to limit any such disclosure required by law, including without limitation by way of obtaining an order of confidentiality, to ensure the continued confidential treatment of such Information.

The confidential and non-use obligations of this Section 11.1 shall survive the termination or expiration of this Agreement.

11.2 Employee, Consultant and Advisor Obligations. Each Party agrees that it and its Affiliates shall provide or permit access to Information received from the other Party and such Party’s Affiliates and representatives only to the receiving Party’s employees, consultants, Permitted Sublicensees and subcontractors, and to the employees, consultants, Permitted Sublicensees and subcontractors of the receiving Party’s Affiliates, who in such Party’s reasonable judgment have a need to know such Information to assist the receiving Party with the activities contemplated by this Agreement and who are subject to

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

obligations of confidentiality and non-use with respect to such Information no less restrictive than the obligations of confidentiality and non-use of the receiving Party pursuant to Section 11.1; provided that each Party shall remain responsible for any failure by its Affiliates, and its and its Affiliates’ respective employees, consultants, permitted subcontractors and sublicensees, to treat such Information as required under Section 11.1 (as if such Affiliates, employees, consultants, permitted subcontractors and sublicensees were Parties directly bound to the requirements of Section 11.1).

11.3 Publication. Each of Xxxxxxx and Vertex reserves the right to publish or publicly present the results (the “Results”) of the Development Program, subject to the following terms and conditions. The Party proposing to publish or publicly present the Results (the “Publishing Party”) will submit a draft of any proposed manuscript, abstract or speech to the other Party (the “Non-Publishing Party”) for comments [] prior to submission for publication or oral presentation. The Non-Publishing Party shall notify the Publishing Party in writing [] of receipt of such draft whether such draft contains (i) information of the Non-Publishing Party which it considers to be confidential under the provisions of Section 11.1 hereof, (ii) information that if published would have an adverse effect on a patent application covering the subject matter of this Agreement, or (iii) information that the Non-Publishing Party reasonably believes would be likely to have a material adverse impact on the Development, Manufacture or Commercialization of a Product Candidate or Product. In any such notification, the Non-Publishing Party shall indicate with specificity its suggestions regarding the manner and degree to which the Publishing Party may disclose such information. In the case of item (i) above, no Party may publish Information of the other Party without its consent in violation of Section 11.1 of this Agreement. In the case of item (ii) above, the Non-Publishing Party may request a delay and the Publishing Party shall delay such publication or presentation, for a period [*]**, to permit the timely preparation and filing of a patent application or an application for a certificate of invention covering the information at issue. In the case of item (iii) above, if the Publishing Party shall disagree with the Non-Publishing Party’s assessment of the impact of the publication or presentation, then the issue shall be referred by the Publishing Party to the JSC for resolution, or if there is no JSC at the time of referral, then to the Parties’ respective Chief Executive Officers for discussion and resolution. The decision of the JSC or the Chief Executive Officers, if the referral is made to them, shall be final, provided that such decision shall always be subject to the confidentiality provisions of Section 11.1 hereof and shall be made with reasonable regard for the interests of the Non-Publishing Party and provided further that no decision shall be made to publish or present information if the publication or presentation would have a material adverse effect on the commercial prospects of any Product Candidate or Product. The Parties agree that authorship of any publication or presentation will be determined based on the customary standards then being applied in the relevant scientific journal or conference. The Parties will require any agents conducting the Development Program on their behalf to comply with publication and presentation restrictions comparable to those set forth herein. The forgoing provisions shall not be interpreted to prevent the publication by a Party of information required by law to be published by that Party.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

This Section 11.3 shall terminate with the termination of this Agreement, but the provisions of Section 11.1 hereof shall continue to govern the disclosure by one Party, whether by publication or otherwise, of Information of the other.

11.4 Publicity/Use of Names. Prior to the Effective Date, the Parties shall agree upon the timing and content of an initial press release relating to the execution of this Agreement and its terms. Except to the extent already disclosed in that initial press release, no disclosure of the existence of this Agreement or its terms may be made by either Party, and no Party shall use the name, trademark, trade name or logo of the other Party or its employees in any publicity, news release or promotional materials relating to this Agreement or its subject matter, without the prior express written permission of the other Party, except as permitted by this Agreement or as may be required by applicable laws, regulations, or judicial order. The Party desiring to make any such public announcement shall provide the other Party with a written copy of the proposed announcement sufficiently in advance of the public release to allow such other Party to comment upon such announcement, prior to its release.

In addition to the foregoing restrictions on public disclosure, if either Party concludes that a copy of this Agreement must be filed with a securities exchange or regulatory or governmental body to which that Party is subject, wherever situated, such Party shall provide the other Party with a copy of this Agreement showing any sections as to which the filing Party proposes to request confidential treatment, will provide the other Party with an opportunity and a reasonable time period to comment on any such proposal and to suggest additional portions of the Agreement for confidential treatment and will take such Party’s comments into consideration before filing the Agreement. If the filing Party disagrees with the other Party’s additional confidential treatment request, the Parties shall attempt in good faith to discuss the matter before the Agreement is filed.

Article 12 -Representations and Warranties; Indemnification

12.1 Representations and Warranties of Vertex. Vertex, for itself and its Affiliates, represents and warrants to Xxxxxxx that, as of the Effective Date:

12.1.1 Authorization. This Agreement has been duly executed and delivered by Vertex and constitutes the valid and binding obligation of Vertex, enforceable against Vertex in accordance with its terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles. The execution, delivery and performance of this Agreement have been duly authorized by all necessary action on the part of Vertex, its officers and directors.

12.1.2 Intellectual Property. The Vertex Patent Rights are existing and, to Vertex’s knowledge, the patents in Vertex Patent Rights are not invalid or unenforceable. Vertex has disclosed to Xxxxxxx all patent applications and issued patents comprising the Vertex Patent Rights, and all prosecution history relating thereto, which patent applications and issued patents are listed in Schedule 1.116. Except for [*]**, Vertex has full right and

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

interest in all Vertex Know-How and Vertex Patent Rights. Vertex has not granted any right, title or interest in or to any Vertex Know-How or Vertex Patent Rights that are inconsistent with the rights, licenses and interests granted under the terms of this Agreement.

12.1.3 Encumbrances. To Vertex’s knowledge,Vertex Patent Rights are free of any liens, charges and encumbrances.

12.1.4 Mitsubishi. Vertex has the right to sublicense to Xxxxxxx hereunder any rights to know-how or patents that it obtains from Mitsubishi Pharma Corporation under its existing agreement with Mitsubishi in connection with Products incorporating VX-950.

12.1.5 Government Funding. Vertex is not a party to any agreement with the U.S. Federal government or an agency thereof pursuant to which the U.S. federal government or such agency provided funding for the development of the Compound or Product.

12.1.6 No Third Party Patents. To Vertex’s knowledge, no Third Party right or patent would necessarily be infringed by the Development, Manufacture, use or Commercialization of VX-950 pursuant to this Agreement, and Vertex is not aware of any pending patent application that, if issued, would necessarily be infringed by the Development, Manufacture, use or Commercialization of VX-950 pursuant to this Agreement.

12.1.7 No Interference. The Vertex Patent Rights are not the subject of any interference proceeding known to Vertex, and Vertex is not aware of any pending or threatened action, suit, proceeding or claim by a Third Party challenging Vertex’s ownership rights in, or the validity or scope of, the Vertex Patent Rights.

12.1.8 [*]**

12.1.9 VX-950 Patents. Schedule 1.116 contains a complete list of all patents and patent applications Controlled by Vertex, as of the Effective Date, that [*]**

12.1.10 No Debarment. Neither Vertex nor any of its Affiliates has been debarred or is subject to debarment. During the term of the Development Program and any Supply Agreement adopted hereunder, Vertex and its Affiliates will use commercially reasonable efforts to avoid using in any capacity, in connection with the Development, Manufacture or Commercialization of the Product Candidate or Product, any Person who to Vertex’s knowledge has been debarred pursuant to Section 306 (or comparable law or regulation) of the United States Federal Food, Drug, and Cosmetic Act, or who to Vertex’s knowledge is the subject of a conviction described in such section. Vertex agrees to inform Xxxxxxx in writing immediately if it or any Person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 (or comparable law or regulation), or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of Vertex’s knowledge, is threatened, relating to the debarment or conviction of Vertex or any Person used in any capacity by Vertex or any of its Affiliates in connection with the Development, Manufacture or Commercialization of any Product.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

12.1.11 [*]**

12.2 Representations and Warranties of Xxxxxxx. Xxxxxxx, for itself and its Affiliates, represents and warrants to Vertex that, as of the Effective Date:

12.2.1 Authorization. This Agreement has been duly executed and delivered by Xxxxxxx and constitutes the valid and binding obligation of Xxxxxxx, enforceable against Xxxxxxx in accordance with its terms, except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to creditors’ rights generally and by general equitable principles. The execution, delivery and performance of this Agreement have been duly authorized by all necessary action on the part of Xxxxxxx, its officers and directors.

12.2.2 No Debarment. Neither Xxxxxxx nor any of its Affiliates has been debarred or is subject to debarment. During the term of the Development Program and any Supply Agreement adopted hereunder, Xxxxxxx and its Affiliates will use commercially reasonably efforts to avoid using in any capacity, in connection with the Development, Manufacture or Commercialization of the Product Candidate or Product, any Person who to Xxxxxxx’x knowledge has been debarred pursuant to Section 306 (or comparable law or regulation) of the United States Federal Food, Drug, and Cosmetic Act, or who to Xxxxxxx’x knowledge is the subject of a conviction described in such section. Xxxxxxx agrees to inform Vertex in writing immediately if it or any Person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 (or comparable law or regulation), or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of Xxxxxxx’x knowledge, is threatened, relating to the debarment or conviction of Xxxxxxx or any Person used in any capacity by Xxxxxxx or any of its Affiliates in connection with the Development, Manufacture or Commercialization of any Product.

12.2.3 [*]**

12.3 Indemnification.

12.3.1 Indemnification by Vertex. Except to the extent due to the negligence or willful misconduct of Xxxxxxx or its Affiliates, and subject to Section 12.3.5, Vertex shall indemnify, defend and hold Xxxxxxx and its Affiliates, and their respective directors, officers, employees and agents, harmless from and against any claims of damages (except to the extent arising from any claims of intellectual property infringement), bodily injury, death, or property damage made by a Third Party (a “Third Party Claim”) to the extent arising from: (i) the negligence or willful misconduct of Vertex under this Agreement or the Supply Agreement; (ii) the material breach by Vertex of any material warranty, representation or obligation of Vertex under this Agreement; or (iii) any product liability claims related to the Product and arising from Commercialization in North America and the Far East.

12.3.2 Indemnification by Xxxxxxx. Except to the extent due to the negligence or willful misconduct of Vertex or its Affiliates, and subject to Section 12.3.5, Xxxxxxx shall

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

indemnify, defend and hold Vertex and its Affiliates, and their respective directors, officers, employees and agents, harmless from and against any Third Party Claim resulting from (i) the negligence or willful misconduct of Xxxxxxx or its Affiliates under this Agreement, the Supply Agreement or any other supply agreement under which Xxxxxxx supplies Product Candidates or Products to Vertex; (ii) the material breach by Xxxxxxx of any material warranty, representation or obligation of Xxxxxxx under this Agreement; or (iii) any product liability claims related to the Product and arising from Commercialization in the Territory.

12.3.3 Claims for Indemnification. If a Party (the “Indemnitee”) intends to claim indemnification under this Section, it shall promptly notify the other Party (the “Indemnitor”) in writing of any Third Party Claim for which the Indemnitee intends to claim such indemnification. The failure of the Indemnitee to deliver written notice to the Indemnitor within a reasonable time after the commencement of any such action shall relieve the Indemnitor of any obligation to the Indemnitee under this Section with respect to any such action, to the extent that the failure prejudices the Indemnitor’s ability to defend a Third Party Claim. The Indemnitee shall permit the Indemnitor to control the litigation and/or settlement of such Third Party Claim, and cooperate fully with Indemnitor in all matters related thereto, provided that unless agreed by Indemnitee (i) counsel appointed by Indemnitor to defend Indemnitee shall not take any position which, if sustained, would cause Indemnitee not to be indemnified by Indemnitor and (ii) no settlement will involve any terms binding on Indemnitee except payment of money to be paid by Indemnitor.

12.3.4 Direct Damage Claims Only. Neither Party shall be liable to the other for indirect, consequential, special or punitive damages under this Agreement.

12.3.5 Claims Arising in Connection with Development. Except to the extent due to the negligence or willful misconduct of a Party,

(a) [*]**

(b) Xxxxxxx will indemnify Vertex from and against any Third Party Claims arising out of any Additional Development Activities conducted by or at the direction of Xxxxxxx or its Affiliates, and

(c) Vertex will indemnify Xxxxxxx from and against any Third Party Claims arising out of any Additional Development Activities conducted by or at the direction of Vertex.

Article 13 -Term and Termination

13.1 Term and Expiration. This Agreement shall be effective as of the Effective Date and unless terminated earlier pursuant to Sections 13.2, 13.3, 13.6 or 13.7, this Agreement shall continue in effect until expiration of all royalty obligations under Article 9.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

13.2 Termination by Xxxxxxx Without Cause. Notwithstanding anything contained herein to the contrary, Xxxxxxx shall have the right to terminate this Agreement at any time in its sole discretion by giving six months’ advance written notice to Vertex; provided, however, if a Product has received a Marketing Authorization in any Major Market Country, the notice required shall be [] unless such termination is for a reason other than a Valid Safety Issue, in which case termination may be with immediate effect. For the purposes of this Agreement, a “Valid Safety Issue” []

Following any delivery by Xxxxxxx of notice of termination pursuant to this Section 13.2, Xxxxxxx and Vertex will cooperate in good faith to agree and implement a transition plan, in order to give effect to Section 13.5. Until the earlier of (i) transfer of any central marketing authorization from Xxxxxxx to Vertex or its designee or the effective date of any such termination, Xxxxxxx will use all reasonable efforts to agree and implement a transition plan and will continue to use Diligent Efforts to Develop, Manufacture and Commercialize Product Candidates and Products in the Territory in accordance with the plans then in effect and approved by the JDC and/or JCC, and will otherwise conduct itself with the objective of avoiding a negative impact, either by its actions or inaction, on the value of a Product Candidate or Product.

13.3 Termination for Cause. This Agreement may be terminated at any time during the term of this Agreement:

13.3.1 upon written notice by either Party if the other Party is in breach of its material obligations hereunder and has not cured such breach after notice from the terminating Party requesting cure of the breach; provided, however, in the event of a good faith dispute with respect to the existence of a material breach, the cure period shall be tolled until such time as the dispute is resolved pursuant to Section 14.5; and provided that the terminating Party has given the defaulting Party the following opportunities to remedy any breach:

(i) the written notice of breach referenced above shall detail the specific obligation under this Agreement which is alleged to have been breached; the manner of such alleged breach; and the steps which must be taken in order to remedy such breach; and

(ii) the terminating Party has provided the defaulting Party with a reasonable amount of time (but no more than [***]) in which to complete any steps which might be taken to remedy the breach, as stated in the notification of breach;

13.3.2 by either Party upon the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors, by the other Party; provided, however, in the case of any involuntary bankruptcy proceeding such right to terminate shall only become effective if the Party consents to the involuntary bankruptcy or such proceeding is not dismissed within [*]** after the filing thereof.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

13.4 Effect on License of Termination by Xxxxxxx for Cause.

13.4.1 If Xxxxxxx terminates this Agreement under Section 13.3.1, then (i) Xxxxxxx’x licenses pursuant to Article 7 shall become perpetual, exclusive licenses subject to the financial provisions of Article 9; and (ii) Xxxxxxx shall have the right to offset against any monies owed to Vertex (pursuant to Article 9 of this Agreement) all of its direct costs, losses and expenses incurred as a result of Vertex’s breach, [] Notwithstanding the foregoing, no offsets may be taken by Xxxxxxx in any Calendar Year that would reduce the aggregate royalties payable to Vertex on account of Net Sales in that Calendar Year []

13.4.2 If Xxxxxxx terminates this Agreement pursuant to subsection 13.3.2, all licenses and rights to licenses granted under or pursuant to this Agreement by Vertex to Xxxxxxx are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code (the “Code”), licenses of rights to “intellectual property” as defined under Section 101(35A) of the Code. The Parties agree that Xxxxxxx, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Code, and that upon commencement of a bankruptcy proceeding by Vertex under the Code, or against Vertex if such proceeding is not dismissed within [*]** of its initial filing, Xxxxxxx shall be entitled to complete access to any such intellectual property and all embodiments of such intellectual property in the Territory.

13.5 Effect of Termination by Vertex For Cause or by Xxxxxxx Without Cause.

If Vertex terminates this Agreement under Section 13.3 or Xxxxxxx terminates this Agreement under Section 13.2:

13.5.1 The license granted to Xxxxxxx and its Affiliates under Article 7, and any sublicense granted by Xxxxxxx with respect to any [] under Section 7.7, shall terminate as of the effective date of termination, except to the extent necessary to enable Xxxxxxx to perform its obligations under this section 13.5, and Xxxxxxx shall, within [] after such termination, return or cause to be returned to Vertex at Vertex’s request all Vertex Information in tangible form, and all substances or compositions delivered or provided by Vertex, as well as any other material provided by Vertex in any medium, except that Xxxxxxx may retain one copy in its confidential files for records purposes.

13.5.2 The license granted to Vertex by Xxxxxxx under Section 7.4 hereof shall continue in effect notwithstanding termination of this Agreement and shall be extended in geographic scope to cover the right to Develop, Manufacture and Commercialize Product Candidates and Products in the Territory. During the period commencing with notice of termination and ending [*]** following the effective date of termination, Xxxxxxx will provide Vertex and its sublicensees, at Xxxxxxx’x expense and in accordance with procedures to be agreed by the Parties, with reasonable access to information and know-how necessary for Vertex to apply the licensed technology.

13.5.3 If Vertex terminates this Agreement pursuant to subsection 13.3.2, all licenses and rights to licenses granted under or pursuant to this Agreement by Xxxxxxx to Vertex are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code (the “Code”), licenses of rights to “intellectual property” as

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

defined under Section 101(35A) of the Code. The Parties agree that Vertex, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Code, and that upon commencement of a bankruptcy proceeding by Xxxxxxx under the Code, or against Xxxxxxx if such proceeding is not dismissed within [*]** of its initial filing, Vertex shall be entitled to complete access to any such intellectual property and all embodiments of such intellectual property in the Territory.

13.5.4 Upon termination by Xxxxxxx under Section 13.2, (a) all filings and approvals with Regulatory Authorities and Regulatory Approvals concerning Product Candidates or Products and Marketing Authorizations relating to any Product will be assigned or otherwise transferred to or at the direction of Vertex as soon as practicable and at Xxxxxxx’x expense, and any reports required to be made to any Regulatory Authority covering any periods prior to the effective date of termination of the Agreement will be prepared promptly and filed at Vertex’s direction with the appropriate Regulatory Authority or, at Vertex’s discretion, made available to or at the direction of Vertex for filing by Vertex. Xxxxxxx will also promptly deliver to or at the direction of Vertex (i) all governmental and regulatory correspondence and conversation logs relating to the Development, Manufacture or Commercialization of Product Candidates and Products in the Territory, (ii) copies of all data, reports, records and materials in Xxxxxxx’x possession or Control relating to the Development, Manufacture or Commercialization of Product Candidates and Products in the Territory, including all non-clinical and clinical data relating to Product Candidates and Products, and (iii) all records and materials in Xxxxxxx’x possession or Control containing Confidential Information of Vertex.

(b) Xxxxxxx will appoint Vertex as Xxxxxxx’x and/or its Affiliates’ agent for all Product-related matters involving Regulatory Authorities in the Territory.

(c) if Vertex so requests, Xxxxxxx and its Affiliates will assign to Vertex any agreements with Third Parties relating solely to the Development, Manufacture or Commercialization of the Product to which Xxxxxxx is a party to the extent permitted by the applicable law and the terms of such agreements, and Xxxxxxx will use best efforts not to enter into any agreement that restricts its ability to comply with this provision.

(d) Xxxxxxx will, upon request by Vertex, appoint Vertex or its designee as its exclusive distributor of the Product in the Territory, and grant Vertex or its designee the right to appoint sub-distributors.

(e) Xxxxxxx will, at its cost, return to Vertex or its designee all inventory of Intermediates and Product in its possession as of the date of termination and, at Vertex’s election, make payment to Vertex for any Intermediates and Product ordered by Xxxxxxx pursuant to the Supply Agreement but not yet paid for.

(f) Notwithstanding the provisions of Section 11.1, Vertex shall be able to disclose any such data and information as is necessary to exercise its rights with respect to a Compound, Product Candidate or Product.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

(g) Notwithstanding termination of this Agreement, this Section 13.5.4 shall remain in effect until the completion by Xxxxxxx of all actions which are required by it to enable a full transfer to Vertex of all filings for Regulatory Approvals and all Marketing Authorizations relating to any Product.

13.5.5 If Xxxxxxx or any of its Affiliates at the time of termination is performing any Manufacturing activities with respect to a Product Candidate or Product, then at Vertex’s request Xxxxxxx or its Affiliates, as applicable, shall continue to perform those Manufacturing activities with respect to a Product on the same terms in accordance with forecasts under the most recent and mutually agreed forecast for commercial supply, as applicable, until [] During that period Xxxxxxx shall use [] at Xxxxxxx cost to cooperate with Vertex in the transition of manufacturing capacity to other sources as early as practicable.

13.6 [*]**

This section 13.6 is not a termination provision under section 13.7 of this Agreement.

13.6.1 [*]**

13.6.2 [*]**

13.7 Survival.

Any expiration or termination of this Agreement shall be without prejudice to the rights of either Party against the other accrued or accruing under this Agreement prior to expiration or termination, including without limitation the obligation to pay royalties for Product(s) sold prior to such expiration or termination or make other payments under this Agreement. In addition to any other provisions which by their terms specifically survive expiration or termination of this Agreement, the following provisions shall indefinitely survive any expiration or termination of this Agreement: Section 7.4, provided that any and all licenses granted under Section 7.4 shall be non-exclusive, Sections 9.6, 9.7, 9.9, and 9.11, Article 11, Section 12.3, Article 13, sections 14.1, 14.2, 14.3, and 14.5, sections 15.1, 15.3, 15.4, 15.5, 15.6, 15.7, 15.8, 15.9, 15.10, 15.11, 15.12, 15.13, 15.14, and 15.15, and the definitions of terms from Article 1 that are part of the recitation of any of the sections listed in this section 13.7.

13.8 Non-exclusive Remedies. The remedies provided to either Party in this Article 13 shall not be deemed the exclusive remedies available to that Party, and in particular shall not limit any legal or equitable remedies otherwise available to that Party.

Article 14 -Governing Law and Dispute Resolution

14.1 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of The Commonwealth of Massachusetts without reference to any rules of conflict of laws. The United Nations Convention on the Sale of Goods shall not apply.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

14.2 Referral to Executive Officers. If for any reason the JSC cannot resolve any matter properly referred to it for resolution, either Party may refer the matter to the Executive Officers for resolution. If, after discussing the matter in good faith and attempting to find a mutually satisfactory resolution to the issue, the Executive Officers fail to come to consensus within [] after the date on which the matter is referred to the Executive Officers (unless a longer period is agreed to in writing by the Parties) the provisions of Section 14.3 shall apply and resolutions reached through such provisions shall be binding on the Parties; provided that []

14.3 Final Decision-Making Authority. If the Executive Officers fail to come to consensus on any matter properly referred to the Executive Officers within the period for resolution set forth in Section 14.2 (an “Unresolved Matter”) then the following provisions shall apply:

14.3.1 Subject to the provisions of subsections 14.3.2 through 14.3.3, Vertex shall have final decision-making authority over all Unresolved Matters;

14.3.2 Xxxxxxx shall have final decision-making authority with respect to the following:

14.3.2.1 [***]

14.3.2.2 [***]

14.3.2.3 [***]

14.3.2.4 [***]

14.3.3 Notwithstanding the foregoing provisions of this Section 14.3, neither Party shall have final decision-making authority pursuant to this Section 14.3 with respect to matters over which one or the other of the Parties is expressly allocated decision-making authority elsewhere in this Agreement.

14.4 Decision to Terminate or Suspend a Study Based on Safety Concerns. The Party sponsoring or controlling any clinical study of a Product Candidate may terminate or suspend such clinical study if (a) a Regulatory Authority or safety data review board for such clinical study has required such termination or suspension, or (b) if such Party believes in good faith that such termination or suspension is warranted because of safety or tolerability risks to the study subjects. In either case, such Party shall promptly notify the other Party of such termination or suspension, and shall use all reasonable efforts to notify and consult with the other Party prior to taking such action.

14.5 Dispute Resolution.

14.5.1 The Parties shall negotiate in good faith and use reasonable efforts to settle any dispute, controversy or claim arising from or related to this Agreement or the breach thereof. If the Parties are unable to resolve a dispute other than a dispute properly referred to the Executive Officers under Sections 14.2 and 14.3 above, despite using reasonable efforts to do so, either Party may, by written notice to the other, pursue any matter through binding arbitration in accordance with the Rules for Non-Administered

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Arbitration then pertaining of the International Institute for Conflict Prevention and Resolution (available at xxxx://xxx.xxxxxx.xxx/xxx-xxxxx.xxx?Xx0.0) or its successor (“CPR”), except where those rules conflict with these provisions, in which case these provisions control. This dispute resolution provision will be binding on any corporate parent, subsidiary, affiliate under common control, director or officer of the Parties hereto. All proceedings will be conducted in the English language.

14.5.2 The arbitration will be held in Boston, MA.

14.5.3 The panel shall consist of [] arbitrators chosen from the CPR Panels of Distinguished Neutrals (or, by agreement, from another provider of arbitrators) each of whom is either a lawyer [] In the event the aggregate damages sought by the claimant are stated to be less than [], and the aggregate damages sought by the counterclaimant are stated to be less than [] then a [*]** shall be chosen, having the same qualifications and experience specified above. Each arbitrator shall be impartial and independent of the Parties and shall abide by the Code of Ethics for Arbitrators in Commercial Disputes then pertaining (available at xxxx://xxx.xxx.xxx/XxxxxxXxxXxxxxxxxx).

14.5.4 The Parties agree to cooperate (1) to attempt to select the arbitrator(s) by agreement within [] of initiation of the arbitration, including jointly interviewing the final candidates, (2) to meet with the arbitrator(s) within [] of selection and (3) to agree at that meeting or before upon procedures for discovery and as to the conduct of the hearing which will result in the hearing being concluded within no more than [] after selection of the arbitrator(s) and in the award being rendered within [] of the conclusion of the hearings, or of any post-hearing briefing, which briefing will be completed by both sides within [*]** after the conclusion of the hearings.

14.5.5 In the event the Parties cannot agree upon selection of the arbitrator(s), the CPR will select arbitrator(s) as follows: CPR shall provide the Parties with a list of no less than [] proposed arbitrators ([] if a single arbitrator is to be selected) having the credentials referenced above. Within [] of receiving such list, the Parties shall rank at least [] of the proposed arbitrators on the initial CPR list, after exercising cause challenges. The Parties may then interview the [] candidates ([] if a [] arbitrator is to be selected) with the highest combined rankings for no more than [] each and, following the interviews, may exercise [] each. The panel will consist of the remaining [] candidates (or [], if [] is to be selected) with the highest combined rankings. In the event these procedures fail to result in selection of the required number of arbitrators, CPR shall select the appropriate number of arbitrators from among the members of the various CPR Panels of Distinguished Neutrals, allowing each side [*]** each.

14.5.6 In the event the Parties cannot agree upon procedures for discovery and hearing, then the arbitrator(s) shall set dates for a hearing, any post-hearing briefing, and the issuance of the award. The arbitrator(s) shall provide for discovery, giving recognition to the understanding of the Parties that they contemplate reasonable discovery, including

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

document demands and depositions. Multiple hearing days will be scheduled consecutively to the greatest extent possible.

14.5.7 The arbitrator(s) are expressly empowered to decide dispositive motions, including but not limited to pre-hearing motions to dismiss and summary judgment motions, and shall endeavor to decide such motions as would a U.S. District Judge of the District where the hearings are to be held.

14.5.8 The arbitrator(s) must render their award by application of the substantive law of the Commonwealth of Massachusetts and are not free to apply “amiable compositeur” or “natural justice and equity.” The arbitrator(s) shall render a written opinion setting forth findings of fact and conclusions of law with the reasons therefor stated. A transcript of the evidence adduced at the hearing shall be made and shall, upon request, be made available to either Party. The arbitrator(s) shall have power to exclude evidence on grounds of hearsay, prejudice beyond its probative value, redundance, or irrelevance and no award shall be overturned by reason of such ruling on evidence. To the extent possible, the arbitration hearings and award will be maintained confidential.

14.5.9 In the event the panel’s award exceeds [] in monetary damages or includes or consists of equitable relief, or rejects a claim in excess of that amount or for that relief, then the losing Party may obtain review of the arbitrators’ award or decision pursuant to the CPR Arbitration Appeal Procedure then pertaining by a single appellate arbitrator (the “Appeal Arbitrator”) selected from the CPR Panels of Distinguished Neutrals by agreement or, failing agreement within [] working days, pursuant to the selection procedures specified in Section 14.5.5. If CPR cannot provide such services, the Parties will together select another provider of arbitration services that can do so. No Appeal Arbitrator shall be selected unless he or she can commit to rendering a decision within [] following oral argument; any such review must be initiated within [] following the rendering of the award referenced in Section 14.5.8.

14.5.10 The Appeal Arbitrator will make the same review of the arbitration panel’s ruling and its bases that the U.S. Court of Appeals of the Circuit where the arbitration hearings are held would make of findings of fact and conclusions of law rendered by a district court after a bench trial and then reverse, modify, vacate or affirm the arbitration panel’s award or decision accordingly, or remand to the panel for further proceedings. The Appeal Arbitrator will consider only the arbitration panel’s findings of fact and conclusions of law, pertinent portions of the hearing transcript and evidentiary record as submitted by the Parties, opening and reply briefs of the Party pursuing the review, and the answering brief of the opposing Party, plus a total of no more than [] or oral argument evenly divided between the Parties. The Party seeking review must submit its opening brief and any reply brief within [] respectively, following the date of the

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

award under review, whereas the opposing Party must submit its responsive brief within [] of that date. Oral argument shall take place within [] after the date of the award under review, and the Appeal Arbitrator shall render a decision within [*]** following oral argument. That decision will be final and not subject to further review, except pursuant to the Federal Arbitration Act.

14.5.11 The Parties irrevocably consent to and submit their person to the jurisdiction of the U. S. District Court for the District in which the arbitration is held for the enforcement of these provisions and the entry of judgment on any award rendered hereunder (including after review by the Appeal Arbitrator where such an appeal is pursued). Should such court for any reason lack jurisdiction, any court with jurisdiction shall act in the same fashion.

14.5.12Each Party has the right before, or if the arbitrator(s) cannot hear the matter within an acceptable period, during the arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, preliminary injunction, repelevin, etc. to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration.

14.5.13 EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY.

14.5.14 EACH PARTY HERETO WAIVES ANY CLAIM TO PUNITIVE, EXEMPLARY OR MULTIPLIED DAMAGES FROM THE OTHER.

14.5.15 EACH PARTY HERETO WAIVES ANY CLAIM OF CONSEQUENTIAL DAMAGES FROM THE OTHER.

14.5.16 EACH PARTY HERETO WAIVES ANY CLAIM FOR ATTORNEYS’ FEES AND COSTS AND PREJUDGMENT INTEREST FROM THE OTHER, EXCEPT THAT THE COST OF THE ARBITRATORS AND ANY FEES AND EXPENSES PAYABLE TO CPR SHALL BE BORNE BY THE PARTY AGAINST WHOM THE MATTER AT ISSUE IS ULTIMATELY RESOLVED.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Article 15 -Miscellaneous

15.1 Force Majeure. Neither Party shall be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including, but not limited to, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, or other acts of God, or acts, omissions or delays in acting by any governmental authority or the other Party. The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practical, and shall promptly undertake all reasonable efforts necessary to cure such force majeure circumstances.

15.2 Assignment. Except as provided in this Section 15.2, this Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the consent of the other Party, which consent shall not be unreasonably withheld. Either Party may, without the other Party’s consent, assign this Agreement and its rights and obligations hereunder in whole or in part to an Affiliate, if that Party guarantees the full performance of its Affiliate’s obligations hereunder. Any permitted assignee shall assume all obligations of its assignor under this Agreement and shall be subject to all of the provisions of this Agreement. Any attempted assignment not in accordance with this Section shall be void. Notwithstanding the above, Vertex or Xxxxxxx may, without the other’s consent, assign this Agreement and all rights and obligations hereunder, in the event it experiences a Change of Control, to the Change of Control party, subject to the other provisions of this Agreement.

15.3 Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties shall in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.

15.4 Notices. All notices that are required or permitted hereunder shall be in writing and will be sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by internationally-recognized courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:

if to Vertex, to:

Vertex Pharmaceuticals Incorporated
000 Xxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attn: Office of Business Development
Facsimile No.: (000) 000-0000

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

and:		Attn: General Counsel Facsimile No.: (000) 000-0000

if to Xxxxxxx, to:		Xxxxxxx Xxxxxxxxxxxxx, X.X. 00, Xxxxxxxxxxxxxxxxxx X-0000 Xxxxxx, Xxxxxxx Attn: President Telephone: 00 00 00 0000 Facsimile No.: 32 14 60 2841
and:		Office of the General Counsel Xxxxxxx & Xxxxxxx Xxx Xxxxxxx & Xxxxxxx Xxxxx Xxx Xxxxxxxxx, XX 00000 Attn: General Counsel Telephone: 000-000-0000 Facsimile: 000-000-0000

or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given: (a) when delivered if personally delivered or sent by facsimile on a business day; (b) on the next business day after dispatch if sent by internationally-recognized overnight courier; and/or (c) on the fifth (5^th) business day following the date of mailing if sent by other internationally-recognized courier or by mail. Notices hereunder will not be deemed sufficient if provided only between or among each Party’s representatives on any committee established in accordance with this Agreement.

15.5 Entire Agreement; Amendments. This Agreement, together with the Exhibits and Schedules hereto, contains the entire understanding of the Parties with respect to the subject matter hereof and supercedes and cancels all previous express or implied agreements and understandings, negotiations, writings and commitments, either oral or written, in respect to the subject matter hereof. The Schedules to this Agreement are incorporated herein by reference and shall be deemed a part of this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both Parties.

15.6 Headings. The captions to the several articles, sections and subsections hereof are not a part of this Agreement, and shall not be interpreted as having any substantive meaning, but are merely for convenience to assist in locating and reading the several Articles and Sections hereof.

15.7 Independent Contractors. It is expressly agreed that Vertex and Xxxxxxx shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Vertex nor Xxxxxxx shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party. Neither Party shall have any responsibility for the hiring, firing or compensation of the other Party’s employees or for any employee benefits. No employee or representative of a Party shall have any authority to bind or obligate the other Party to

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

this Agreement for any sum or in any manner whatsoever, or to create or impose any contractual or other liability on the other Party without said Party’s written approval.

15.8 Waiver. The waiver by either Party hereto of any right hereunder, or the failure of the other Party to perform, or a breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise.

15.9 Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

15.10 Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.

15.11 Certain Conventions. Any reference in this Agreement to an Article, Section, subsection, paragraph, clause, Schedule or Exhibit shall be deemed to be a reference to an Article, Section, subsection, paragraph, clause, Schedule or Exhibit, of or to, as the case may be, this Agreement, unless otherwise indicated. Unless the context of this Agreement otherwise requires, (a) words of any gender include each other gender, (b) words such as “herein”, “hereof”, and “hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear, and (c) words using the singular shall include the plural, and vice versa.

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

15.13 Performance by Affiliates. To the extent that this Agreement imposes obligations on Affiliates of a Party, such Party agrees to cause its Affiliates to perform such obligations. Either Party may use one or more of its Affiliates to perform its obligations and duties hereunder, provided that the Parties shall remain liable hereunder for the prompt payment and performance of all their respective obligations hereunder. Each of Vertex and Xxxxxxx guarantees performance of this Agreement by any of its Affiliates. Any Affiliate of Vertex or Xxxxxxx to which rights are extended or which performs any of the obligations required of the respective Party hereunder shall be deemed to have accepted and be bound by the relevant terms and conditions of this Agreement including, without limitation, the jurisdiction and binding effect of the arbitration proceeding carried out pursuant to Section 14.5.

15.14 Standstill. Xxxxxxx agrees that during the period beginning on the Effective Date and ending on [] neither Xxxxxxx nor any of its Affiliates will, without the prior written consent of Vertex (i) acquire, or participate as part of a group which in the aggregate acquires, securities representing [] of the voting power of the outstanding voting securities of Vertex, or (ii) make, or in any way participate in, directly or indirectly, any

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

“solicitation” of “proxies” (as such terms are used in the rules of the United States Securities and Exchange Commission). The foregoing provisions of this Section 15.14 shall no longer apply (i) if Vertex announces publicly that (a) it is seeking, or considering seeking, purchasers for Vertex or (b) it is otherwise exploring, or considering exploring, strategic options in this regard; (ii) upon the commencement by a Third Party of a tender or exchange offer for shares of Vertex voting stock which, when added to shares then owned by the Third Party, would result in ownership by the Third Party of [] of the voting power of the outstanding voting securities of Vertex; (iii) if a Third Party acquires or seeks to acquire beneficial ownership of [] of the outstanding common stock of Vertex; (iv) if Vertex publicly announces a transaction, or an intention to effect any transaction which would result in (a) the sale by Vertex or one or more of its subsidiaries of assets representing [] of the consolidated earning power or assets of Vertex; (b) the common stockholders of Vertex (other than stockholders who are Affiliates of the acquiring entity) immediately prior to such transaction owning [] of the outstanding common stock of the acquiring entity or, in the case of a merger transaction, the surviving corporation (or, if the surviving corporation is a subsidiary of a parent company, the parent company); or (c) a Third Party acquiring beneficial ownership of [*]** or more of the outstanding common stock of Vertex.

15.15 Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States of America or other countries that may be applicable to Xxxxxxx or Vertex from time to time. Neither Party will export, directly or indirectly, any technical information acquired from the other Party under this Agreement, or any products using that technical information, to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining necessary and sufficient consents to do so from the appropriate agency or other governmental authority.

IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first set forth above.

XXXXXXX PHARMACEUTICA, N.V.				VERTEX PHARMACEUTICALS INCORPORATED

By:	/s/Xxxx Xxxxxxx			By:	/s/Xxxxxxx X. Xxxxx
Name: Xxxx Xxxxxxx				Name: Xxxxxxx X. Xxxxx
Title: Board Member				Title: Senior Vice President and General Counsel


Date: 30/6/06				Date: June 30, 2006

By:		/s/Didier de Chaffoy de Courcelles
Name: Didier de Chaffoy de Courcelles
Title: Senior Vice President, Research and
			Early Development Europe

Date: 30/6/06

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Schedule 1.7

Xxxxxxx 2006 Universal Calendar

	M	T	W	T	F	S	S

JAN	2	3	4	5	6	7	8
(4 Weeks)	9	10	11	12	13	14	15
	16	17	18	19	20	21	22
	23	24	25	26	27	28	29
	30	31

FEB			1	2	3	4	5
(4 Weeks)	6	7	8	9	10	11	12
	13	14	15	16	17	18	19
	20	21	22	23	24	25	26
	27	28

MAR			1	2	3	4	5
(5 Weeks)	6	7	8	9	10	11	12
	13	14	15	16	17	18	19
	20	21	22	23	24	25	26
	27	28	29	30	31

APR						1	2
(4 Weeks)	3	4	5	6	7	8	9
	10	11	12	13	14	15	16
	17	18	19	20	21	22	23
	24	25	26	27	28	29	30

MAY	1	2	3	4	5	6	7
(4 Weeks)	8	9	10	11	12	13	14
	15	16	17	18	19	20	21
	22	23	24	25	26	27	28
	29	30	31

JUN				1	2	3	4
(5 Weeks)	5	6	7	8	9	10	11
	12	13	14	15	16	17	18
	19	20	21	22	23	24	25
	26	27	28	29	30

JUL						1	2
(4 Weeks)	3	4	5	6	7	8	9
	10	11	12	13	14	15	16
	17	18	19	20	21	22	23
	24	25	26	27	28	29	30
	31

AUG		1	2	3	4	5	6
(4 Weeks)	7	8	9	10	11	12	13
	14	15	16	17	18	19	20
	21	22	23	24	25	26	27
	28	29	30	31

SEP					1	2	3
(5 Weeks)	4	5	6	7	8	9	10
	11	12	13	14	15	16	17
	18	19	20	21	22	23	24
	25	26	27	28	29	30

OCT							1
(4 Weeks)	2	3	4	5	6	7	8
	9	10	11	12	13	14	15
	16	17	18	19	20	21	22
	23	24	25	26	27	28	29
	30	31

NOV			1	2	3	4	5
(4 Weeks)	6	7	8	9	10	11	12
	13	14	15	16	17	18	19
	20	21	22	23	24	25	26
	27	28	29	30

DEC					1	2	3
(5 Weeks)	4	5	6	7	8	9	10
	11	12	13	14	15	16	17
	18	19	20	21	22	23	24
	25	26	27	28	29	30	31

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Schedule 1.19

[***]

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Schedule 1.31

Existing Third Party Agreements

[***]

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Schedule 1.32

Far East

[***]

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Schedule 1.55

Xxxxxxx Patent Rights

[***]

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Schedule 1.116

Vertex Patent Rights

[***]

Docket No.	Serial No.	Patent No.	Publication No.	Status	Filed
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
VPI/00-131 BR	0113666-6			PUBLISHED	08/31/2001
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
VPI/00-131 CN	01815055			PUBLISHED	08/31/2001
VPI/00-131 CO	03016961			PUBLISHED	08/31/2001
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
VPI/00-131 EA	200300318			PUBLISHED	08/31/2001
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
VPI/00-131 EP	01968040.4		1320540	PUBLISHED	08/31/2001
VPI/00-131 HK	03108422.8			PUBLISHED	01/20/2003
VPI/00-131 HR	20030139		02/2005	PUBLISHED	08/31/2001
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Docket No.	Serial No.	Patent No.	Publication No.	Status	Filed
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*		[]*	[]*	[]*
[]*	[]*	[]*		[]*	[]*

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

[*]**

Docket No.		Serial No.		Patent No.		Publication No.		Status		Filed
[]*		[]*						[]*		[]*

Docket No.		Serial No.		Patent No.		Publication No.		Status		Filed
[]*		[]*						[]*		[]*

Docket No.		Serial No.		Patent No.		Publication No.		Status		Filed
[]*		[]*						[]*		[]*

Docket No.		Serial No.		Patent No.		Publication No.		Status		Filed
[]*		[]*						[]*		[]*

Docket No.		Serial No.		Patent No.		Publication No.		Status		Filed
[]*		[]*						[]*		[]*

Docket No.	Serial No.	Patent No.	Publication No.	Status	Filed
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Docket No.		Serial No.		Patent No.		Publication No.		Status		Filed
[]*		[]*						[]*		[]*

Docket No.		Serial No.		Patent No.		Publication No.		Status		Filed
[]*		[]*						[]*		[]*

Docket No.	Serial No.	Patent No.	Publication No.	Status	Filed
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*

Docket No.		Serial No.		Patent No.		Publication No.		Status		Filed
[]*		[]*						[]*		[]*

Docket No.	Serial No.	Patent No.	Publication No.	Status	Filed
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
VPI/04-139 US	11/264,746		US 2006/0105978	PUBLISHED	10/31/2005
VPI/04-139 WO	PCT/US2005/039240		WO 2006/050250	PUBLISHED	10/31/2005

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Docket No.	Serial No.	Patent No.	Publication No.	Status	Filed
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
VPI/04-136 WO	PCT/US2005/035191		WO 2006/039488	PUBLISHED	09/30/2005

Docket No.	Serial No.	Patent No.	Publication No.	Status	Filed
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
VPI/04-114 US	11/147,524		US 2006/0089385	PUBLISHED	06/08/2005
VPI/04-114 WO	PCT/US2005/019929		WO 2005/123076	PUBLISHED	06/08/2005

Docket No.	Serial No.	Patent No.	Publication No.	Status	Filed
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

VPI/03-172 US		10/974,558				US 2005/0136400		PUBLISHED		10/27/2004
VPI/03-172 WO		PCT/US2004/035839				WO 2005/042570		PUBLISHED		10/27/2004

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Docket No.	Serial No.	Patent No.	Publication No.	Status	Filed
[]*	[]*			[]*	[]*
VPI/03-171 US	10/974,538		US 2006/0003942	PUBLISHED	10/27/2004
VPI/03-171 WO	PCT/US2004/035549		WO 2005/042020	PUBLISHED	10/27/2004

Docket No.	Serial No.	Patent No.	Publication No.	Status	Filed
XXX/00-000 XX	093127683		200518669	PUBLISHED	09/13/2004
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
[]*	[]*			[]*	[]*
VPI/03-149 US	10/939,958		US 2005/0120398	PUBLISHED	09/13/2004
VPI/03-149 WO	PCT/US2004/29961		WO 2005/025517	PUBLISHED	09/13/2004

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Schedule 1.117

VX-950

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

[***]

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Exhibit 4.5(a)

Supply Agreement Key Elements

The Parties agree to negotiate the terms of a supply agreement in good faith, subject to the terms of this Agreement, which will include the following:

1. Vertex will supply Product that meets the Specifications (unless otherwise agreed by Vertex) to Xxxxxxx [***] the Effective Date of the Agreement.

2. Xxxxxxx will forecast and place orders with Vertex for its Product requirements and its requirement of Intermediates for Commercialization in the Territory, commencing [***] of the first requested delivery of Tablets. Based on the current Development Program, the first forecast to be provided under the Supply Agreement will be due [***] Based on the forecast, Vertex will make commitments to Third Party Manufacturers for Territory supplies, in accordance with lead-time or contractual obligations with Third Party Manufacturers, that will be binding on Xxxxxxx.

3. Vertex will supply Xxxxxxx through its Third Party Manufacturers in accordance with the terms of the Third Party Manufacturer agreements.

4. Vertex will supply the Product to Xxxxxxx at [***]. All [***] directly related to supply of Product to the Territory will be borne by Xxxxxxx. Vertex will provide financial transparency for all [***] associated with supply of Product for the Territory.

5. Delivery will be FCA facility (see INCOTERMS 2000).

6. Xxxxxxx will be responsible for shipping and handling charges arising in connection with Product delivered to Xxxxxxx, and for defining the method of shipment and for undertaking, at its expense, any validation that may be required.

7 Rights with respect to non-conforming product, shortage of supply and late delivery will be consistent with comparable rights that Vertex has with the relevant Third Party Manufacturers. [***]

8. [***]

9. Representations, warranties, insurance and indemnification will be no more extensive than those which Vertex has in the relevant Third Party Agreements.

10. Vertex’s liability will be limited to its own negligence. [***] In the event product delivered to Xxxxxxx is non-conforming, Xxxxxxx’x remedy will be that Vertex will [***] to seek remedies available pursuant to the relevant Third Party Manufacturing Agreements and pass those remedies on to Xxxxxxx.

11. The agreement will include provisions that address continuity of supply concerns for Xxxxxxx.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

12. The Parties will execute a Quality Agreement.

Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Document Metadata

Table of Contents

Confidential Treatment Requested. Confidential portions of this document have been redacted and have been separately filed with the Commission. LICENSE, DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION AGREEMENT by and between Vertex Pharmaceuticals...

Document Metadata

Confidential Treatment Requested. Confidential portions of this document have been redacted and have been separately filed with the Commission. LICENSE, DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION AGREEMENT by and between Vertex Pharmaceuticals...

Article 1 - Definitions

1.1 (Intentionally left blank)

1.2 “Additional Development Activities” shall have the meaning set forth in Section 3.5.

1.4 “API” means the active pharmaceutical ingredient that is intended to be used in the manufacture of a Product Candidate or a Product.

1.5 [***]

1.6 “Business Day” means a day in which banking institutions in Boston, Massachusetts are open for business.

1.10 “Clinical Trial” means a Phase I Clinical Trial, a Phase II Clinical Trial, a Phase III Clinical Trial or a Pivotal Clinical Trial.

1.11 “Code” shall have the meaning set forth in Section 13.4.2.

1.14 “Committees” shall have the meaning set forth in Section 2.3.

1.15 Intentionally left blank.

1.16 “Compound” means VX-950, [***], and all of its or their prodrugs and metabolites, its or their stereoisomers and tautomers, and all of the esters, salts, hydrates, solvates, inclusion complexes and polymorphs of any of the foregoing.

1.18 “Desired Label” shall have the meaning set forth in Section 1.41.

1.19 “Development” or “Develop” means any non-clinical and clinical drug development activities that are customarily undertaken after a compound has been designated as a development candidate [***] including but not limited to [***]

1.20 “Development Program” means all activities associated with the Development of Product Candidates pursuant to the Global Development Plan and all Additional Development Activities.

1.21 [***]

1.22 [***]

1.23 “Diligent Efforts” means, with respect to each Party’s obligations related to Developing, Manufacturing and Commercializing Product Candidates and Products, the carrying out of those obligations [***]

1.24 “Effective Date” shall have the meaning set forth in the preamble to this Agreement.

1.25 “EMEA” means the European Medicines Evaluation Agency or any successor EU agency that is responsible for approving the sale of pharmaceuticals in the EU.

1.26 “European Union” or “EU” means the countries of the European Union, as the European Union is constituted as of the Effective Date and as it may be expanded from time to time, [***]

1.27 “Excluded Claim” shall have the meaning set forth in Section 14.5.7.

1.28 “Excluded Territory” means the Far East and North America.

1.29 “Exclusivity Period” means the [***] beginning on the Effective Date.

1.30 “Executive Officers” means the Chief Executive Officer of Vertex and the World Wide Chairman, Pharmaceuticals Group of Xxxxxxx & Xxxxxxx.

1.31 “Existing Third Party Agreements” means the agreements between Vertex and Third Parties listed on Schedule 1.31 hereto.

1.32 “Far East” means the countries listed on Schedule 1.32 hereto.

1.33 “FDA” means the United States Food and Drug Administration, or any successor U.S. governmental agency that is responsible for approving the sale of pharmaceuticals in the United States.

1.34 “Field” means all human and animal therapeutic and/or prophylactic uses of Product Candidates and Products.

1.36 “FTE” means the equivalent in time of the work of one scientist or other professional conducting activities hereunder on a full time basis for a Calendar Year, [***]

1.38 “GAAP” means accounting principles generally accepted in the United States, applied on a consistent basis.

1.39 “Generic Version” shall have the meaning set forth in Section 9.4.2.

1.40 “Global Development Costs” [***]

1.45 “HCV Infection” means human infection with the hepatitis C virus.

1.46 “Improvement” means any enhancement, whether or not patentable, in the formulation, use, preparation, presentation, means of delivery, or dosage of a Product Candidate or Product.

1.47 “IND” shall mean an Investigational New Drug Application filed with FDA or a similar application filed with an applicable Regulatory Authority outside of the United States, such as a clinical trial application (CTA) or a clinical trial exemption (CTX).

1.48 “Indemnitee” shall have the meaning set forth in Section 12.3.3.

1.49 “Indemnitor” shall have the meaning set forth in Section 12.3.3.

1.51 “Initiation” means, with respect to a particular Clinical Trial, the administration of the [***] dose of a Product Candidate to the [***] patient in that Clinical Trial.

1.52 “Invention” means any process, method, use, composition of matter, article of manufacture, discovery or finding that is conceived or reduced to practice (whether or not patentable).

1.56 “Joint Commercialization Committee” and “JCC” have the meaning set forth in Section 5.2.

1.57 “Joint Development Committee” and “JDC” have the meaning set forth in Section 3.1.

1.58 “Joint Know-How” means all information, Improvements and Inventions created, developed or invented jointly by employees of Xxxxxxx and Vertex or their Affiliates, or by others acting on behalf of Xxxxxxx and Vertex, in the course of activities undertaken under this Agreement.

1.59 “Joint Manufacturing Committee” and “JMC” have the meaning set forth in Section 4.2.

1.61 “Joint Philanthropic Committee” and “JPC” shall have the meaning set forth in Article 6.

1.62 “Joint Steering Committee” and “JSC” have the meaning set forth in Section 2.2.

1.64 “Key Opinion Leaders” or “KOLs” means scientific or health care professionals who are recognized experts in the relevant scientific or health care field, which in the context of this Agreement is the investigation and treatment of HCV Infection.

1.65 “MAA” means a Marketing Authorization Application, or similar application or submission for Marketing Authorization, that is filed to obtain marketing approval for a Product Candidate or Product in the EU.

1.66 “Major Market Countries” means [***]

1.68 “Manufacturing Cost” means the cost of [***]

1.69 Intentionally left blank.

1.71 “Material Adverse Effect” means, with respect to any action by a Party or its Related Parties, [***]

1.72 “Medical Science Liaisons” or “MSL” shall have the meaning set forth in Section 5.11.

1.73 “Milestone Event” shall have the meaning set forth in Section 9.2.1.

1.74 “Milestone Payment” shall have the meaning set forth in Section 9.2.1.

1.75 “NDA” means a New Drug Application or similar application or submission for Marketing Authorization that is filed with the FDA to obtain marketing approval for a Product Candidate or Product in the United States.

1.5 [*]**

1.16 “Compound” means VX-950, [*]**, and all of its or their prodrugs and metabolites, its or their stereoisomers and tautomers, and all of the esters, salts, hydrates, solvates, inclusion complexes and polymorphs of any of the foregoing.

1.19 “Development” or “Develop” means any non-clinical and clinical drug development activities that are customarily undertaken after a compound has been designated as a development candidate [] including but not limited to []

1.21 [*]**

1.22 [*]**

1.23 “Diligent Efforts” means, with respect to each Party’s obligations related to Developing, Manufacturing and Commercializing Product Candidates and Products, the carrying out of those obligations [*]**

1.26 “European Union” or “EU” means the countries of the European Union, as the European Union is constituted as of the Effective Date and as it may be expanded from time to time, [*]**

1.29 “Exclusivity Period” means the [*]** beginning on the Effective Date.

1.36 “FTE” means the equivalent in time of the work of one scientist or other professional conducting activities hereunder on a full time basis for a Calendar Year, [*]**

1.40 “Global Development Costs” [*]**

1.51 “Initiation” means, with respect to a particular Clinical Trial, the administration of the [] dose of a Product Candidate to the [] patient in that Clinical Trial.

1.66 “Major Market Countries” means [*]**

1.68 “Manufacturing Cost” means the cost of [*]**

1.71 “Material Adverse Effect” means, with respect to any action by a Party or its Related Parties, [*]**