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Article 1 DEFINITIONS

1

Article 2 LICENSES

26

2.1

Grant of Licenses to Roche

26

2.2

Grant of License to Sarepta

26

2.3

Sublicensing and Subcontracting Terms

27

2.4

No Other Rights and Retained Rights

28

2.5

In-Licenses

29

2.6

Exclusivity

30

2.7

Option

30

2.8

Rights of First Negotiation

33

Article 3 GOVERNANCE

35

3.1

Joint Steering Committee

35

3.2

Subcommittees

37

3.3

Joint Development Committee

38

3.4

Joint Commercialization Committee

39

3.5

Joint Manufacturing Committee

40

3.6

Additional Participants

41

3.7

Decision-Making

41

3.8

Resolution of Committee Disputes

42

3.9

Alliance Managers

43

Article 4 DEVELOPMENT

43

4.1

Overview

43

4.2

Development Diligence Obligations

44

4.3

Global Development Plans

44

4.4

Roche Territory Development Plan

46

4.5

Development Cost Sharing

47

4.6

Development Reports

47

4.7

Development Records

48

Article 5 REGULATORY AFFAIRS

48

5.1

Orphan Drug Designation

48

5.2

Regulatory Responsible Party

48

5.3

Collaboration With Respect to Regulatory Interactions

48

5.4

Regulatory Meetings

49

5.5

Cooperation

49

5.6

Assignment of Regulatory Submissions and Regulatory Approvals to Roche

50

5.7

Cost of Regulatory Activities

50

5.8

Right of Reference

50

5.9

Pharmacovigilance and Adverse Event Reporting

50

5.10

Recall, Withdrawal, or Field Alerts

51

Article 6 COMMERCIALIZATION

52

6.1

Commercialization Responsibilities for Licensed Product

52

6.2

Commercialization Reporting

52

6.3

Pricing

52

6.4

Branding and Marketing Plans

53

6.5

Roche Commercialization Diligence Obligations

53

6.6

Standards of Conduct; Compliance

54

6.7

Diversion

54

Article 7 MEDICAL AFFAIRS

54

7.1

Medical Affairs Plans

54

7.2

Medical Affairs Activities

55

7.3

Medical Affairs Cost Sharing

55

Article 8 MANUFACTURING AND SUPPLY

56

8.1

General.

56

8.2

Capacity Plan

56

8.3

Initial Forecasts

56

8.4

Demand Forecast Plans

57

8.6

Supply Agreements

57

8.8

Manufacturing Plan

58

8.9

Audit

59

8.10

Shortage and Supply Failure

59

8.11

Technology Transfer

60

Article 9 PAYMENTS

61

9.1

Upfront Payment

61

9.2

Equity Investment

61

9.3

Option Exercise Fees

61

9.4

Milestone Payments

61

9.5

Royalties

65

9.6

Accounting; Audit

67

9.7

No Refunds

67

9.8

Currency Conversion

68

9.9

Blocked Payments

68

9.10

Method of Payment

68

9.11

Taxes

68

9.12

Late Payments; Disputed Payments

68

Article 10 INTELLECTUAL PROPERTY

69

10.1

Patent Filing

69

10.2

Ownership

69

10.3

Disclosure; Inventorship

70

10.4

IP Committee

70

10.5

Prosecution of Sarepta Patent Rights

71

10.6

Prosecution of Joint Collaboration Patent Rights

72

10.7

Prosecution of Option Product Patent Rights

73

10.8

Prosecution of Roche Collaboration Patent Rights

74

10.9

Enforcement Against Third Party Infringement or Misappropriation

74

10.10

Defense of Third Party Patent Challenges

76

10.11

Third Party Infringement Claims

77

10.12

Patent Challenges of Third Party Patent Rights

78

10.13

Patent Term Extensions

78

10.14

Unified Patent Court

78

10.15

Common Interest

78

10.16

Marks

78

Article 11 REPRESENTATIONS, WARRANTIES, AND COVENANTS

81

11.1

Mutual Representations and Warranties

81

11.2

Additional Sarepta Warranties

82

11.3

Additional Roche Warranties

84

11.4

Additional Covenants

84

11.5

Additional Covenants of Sarepta

85

11.6

Additional Covenants of Roche

85

11.7

Time For Claims

85

11.8

Disclaimer

85

11.9

Limitation of Liability

85

Article 12 CONFIDENTIALITY

86

12.1

Duty of Confidence

86

12.2

Confidential Information

86

12.3

Exemptions

86

12.4

Authorized Disclosures

87

12.5

Tax Treatment

88

12.6

Publications

88

12.7

Publication and Listing of Clinical Trials

89

12.8

Publicity; Use of Names

89

12.9

Attorney-Client Privilege

91

Article 13 INDEMNIFICATION

91

13.1

Indemnification by Sarepta

91

13.2

Indemnification by Roche

92

13.3

Indemnification Procedure

92

13.4

Insurance

93

Article 14 TERM AND TERMINATION

93

14.1

Term

93

14.2

Termination for Breach

93

14.4

Termination by Roche for Convenience

94

14.5

Termination for Bankruptcy

94

14.6

Cessation of Development and Commercialization

95

14.7

Patent Challenges

95

14.8

Effects of Termination

95

14.9

Effects of Expiration

99

14.10

Survival; Accrued Rights

100

Article 15 EFFECTIVENESS

100

15.1

Effective Date

100

15.2

Filings

100

15.3

Outside Date

101

Article 16 DISPUTE RESOLUTION; GOVERNING LAW

101

16.1

Executive Officers; Disputes

101

16.2

Jurisdiction; Venue

101

16.3

Intellectual Property Disputes

101

16.4

Equitable Remedies

102

16.5

Governing Law; English Language

102

16.6

Waiver of Jury Trial

102

Article 17 MISCELLANEOUS

102

17.1

Assignment

102

17.2

Entire Agreement; Amendment

103

17.3

No Strict Construction; Interpretation

103

17.4

Severability

104

17.5

Notices

104

17.6

Further Assurances

105

17.7

Performance by Affiliates

105

17.8

Exit of the United Kingdom from EU

105

17.9

Agency

105

17.10

Binding Effect; No Third Party Beneficiaries or Obligors

105

17.11

Compliance with Export Regulations

105

17.12

No Waiver

105

17.13

Cumulative Remedies

105

17.14

Bankruptcy

106

17.15

Counterparts

106

“Abbreviated Application” means (a) any application submitted to the FDA under (i) subsection (k) of Section 351 of the PHSA (42 U.S.C. 262(k)) or (ii) Section 505(j) of the FD&C Act (21 U.S.C. 355(j)), or (iii) Section 505(b)(2) of the FD&C Act (21 U.S.C. 355), (b) any application submitted to the EMA under a provision of Articles 10, 10a, or 10b of Parliament and Council Directive 2001/83/EC as amended (including any application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), or (c) any analogous application to those applications set forth in clauses (a) or (b) submitted to any Regulatory Authority in the US, European Union, or in another country or jurisdiction in the world.

“Absent Countries” has the meaning set forth in Section 2.5.5(b)(A) (Absent Countries).

“Accounting Standard” means, with respect to a Party or any of its Affiliates or Sublicenses, either IFRS or GAAP, as used at the applicable time by such Party or such Affiliate or Sublicensee.

“Acquisition” has the meaning set forth in Section 2.6.2 (Acquisitions of Third Parties).

“Affiliate” means, with respect to a Person, any other Person, directly or indirectly through one or more intermediaries, controlled by, controlling, or under common control with such Person, whether now or in the future, with “control” meaning (a) direct or indirect beneficial ownership of more than 50% of the voting stock or other ownership interest of, or more than 50% interest in the income of, the applicable Person, or (b) the possession, directly or indirectly, of the power to direct the management or policies of the applicable Person, whether through the ownership of voting securities or other equity rights, by contract relating to voting rights or corporate governance, or otherwise.  Notwithstanding the foregoing, Chugai will not be deemed an Affiliate of Roche for any purpose under this Agreement unless and until Roche provides Sarepta with written notice of its desire to include Chugai as an Affiliate (it being understood that if Roche provides Sarepta with such notice, Chugai will be deemed an Affiliate of Roche for all purposes under this Agreement as of and after the date of such notice).

“Alliance Manager” has the meaning set forth in Section 3.9 (Alliance Managers).

“Allowable Overruns” means any and all Development Costs or Medical Affairs Costs, as applicable, incurred by or on behalf of Sarepta or its Affiliates with respect to any Licensed Product in any Calendar Quarter that are (a) above the then-current Joint Global Development Budget or Joint Global Medical Affairs Budget, as applicable, approved by the JSC by [**] or less or (b) otherwise attributable to Roche’s action or inaction that constitutes a breach of this Agreement.

“Antitrust Clearance Date” means the earliest date on which all applicable waiting periods and approvals required under Antitrust Laws in the U.S. with respect to the transactions contemplated under this Agreement and the Stock Purchase Agreement have expired or have been terminated (in the case of waiting periods) or been received (in the case of approvals), in each case, without the imposition of any conditions.

“Antitrust Filing” means filings by Sarepta and Roche with the United States Federal Trade Commission and the United States Department of Justice and any applicable Governmental Authority in the Territory, as required under any Antitrust Laws with respect to the transactions contemplated under this Agreement, together with all required documentary attachments thereto.

“Antitrust Laws” means any and all Applicable Laws designed to prohibit, restrict, or regulate actions for the purpose or effect of monopolization or restraint of trade.

“Applicable Law” means any applicable law (including common law), statute, rule, regulation, order, judgment, decree, directive, injunction, or ordinance of any Governmental Authority (including any Regulatory Authority), including those concerning environmental, health, regulatory, privacy, and safety matters.

“Approved Labeling” means, with respect to any Licensed Product and any jurisdiction: (a) the applicable Regulatory Authority-approved full prescribing information for such Licensed Product in such jurisdiction; and (b) the applicable Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Licensed Product in such jurisdiction.

“Asian Region” means all countries and territories of Asia other than (a) the Russian Federation, (b) the Middle Eastern Countries, and (c) Japan.

“Average Supply Price” has the meaning set forth in Section 8.7 (Supply Price).

“Biosimilar Competition” means, on a Licensed Product-by-Licensed Product and country-by-country basis, that, in a given Calendar Quarter, one or more Third Parties are Commercializing a Biosimilar Product with respect to such Licensed Product in such country.

“Biosimilar Product” means, with respect to any Licensed Product, a biologic product that is “biosimilar” (as such term is defined in 42 U.S.C. § 262(i)(2)), “similar biological medicinal product” (as such term is defined in EU CHMP/437/04 Rev 1), or its foreign equivalents, as applicable, to such Licensed Product.

“Breaching Party” has the meaning set forth in Section 14.2.1 (Notice and Cure).

“Business Day” means any day (other than a Saturday or Sunday) on which the banks in New York, New York and Basel, Switzerland are both open for business.

“Calendar Quarter” means each successive period of three calendar months ending on (and including) each of March 31, June 30, September 30, and December 31; except that (a) the first Calendar Quarter during the Term will begin on the Effective Date and end on the last day of the Calendar Quarter within which the Effective Date falls, and (b) the last Calendar Quarter during the Term will end upon the expiration of the Term.

“Calendar Year” means the period of 12 consecutive calendar months beginning on January 1 and ending on December 31; except that (a) the first Calendar Year during the Term will begin on the Effective Date and end on December 31 of the Calendar Year within which the Effective Date falls, and (b) the last Calendar Year during the Term will end upon expiration of the Term.

“Capacity Plan” has the meaning set forth in Section 8.2 (Capacity Plan).

“Change of Control” means, with respect to a Party, that: (a) any Third Party acquires directly or indirectly the beneficial ownership of any voting security of such Party, or if the percentage ownership of such Third Party in the voting securities of such Party is increased through stock redemption, cancellation, or other recapitalization, and immediately after such acquisition or increase such Third Party is, directly or indirectly, the beneficial owner of voting securities representing more than 50% of the total voting power of all of the then outstanding voting securities of such Party; (b) any merger, consolidation, recapitalization, or reorganization of such Party is consummated that would result in shareholders or equity holders of such Party immediately prior to such transaction owning 50% or less of the outstanding voting securities of the surviving entity (or its parent entity) immediately following such transaction; (c) the shareholders or equity holders of such Party approve any plan of complete liquidation of such Party, or an agreement for the sale or disposition by such Party of all or substantially all of such Party’s assets, in each case, through one or more related transactions, other than to an Affiliate or pursuant to one or more related transactions that would result in shareholders or equity holders of such Party immediately prior to such transaction owning more than 50% of the outstanding voting securities of the surviving entity (or its parent entity) immediately following such transaction; or (d) the sale or transfer to any Third Party, in one or more related transactions, of all or substantially all of such Party’s consolidated assets taken as a whole.

“Chugai” means Chugai Pharmaceutical Co., Ltd.

“Clinical Trial” means any clinical trial in humans.

“CMO” means a contract manufacturing organization.

“Collaboration In-License” means any Potential In-License [**].

“Collaboration Know-How” means any and all Know-How developed or invented by or on behalf of a Party’s or any of its Affiliates’ employees, agents, or independent contractors, or any other Persons contractually required to assign or license such Know-How to such Party or any Affiliate of such Party, either alone or jointly with the other Party’s or any of its Affiliates’ employees, agents, or independent contractors, or any other Persons contractually required to assign or license such Know-How to such other Party or any Affiliate of such other Party, in each case, in the performance of any activities related to the Exploitation of Licensed Products or Sarepta Diagnostic Products under this Agreement during the Term.

“Collaboration Patent Rights” means any and all Patent Rights that Cover any Collaboration Know-How.

“Commercial Supply Agreement” has the meaning set forth in Section 8.6.2 (Commercial Supply Agreement) and the corresponding quality agreements fulfilling the requirements set forth in Schedule 1.263.

“Commercialization” means with respect to any product, any and all activities directed to the marketing, promotion, distribution, pricing, reimbursement, import, export, offering for sale, and sale of such product and interacting with Regulatory Authorities following receipt of Regulatory Approval in the applicable country or region for such product regarding the foregoing, including seeking and maintaining any required Reimbursement Approval, but excluding any activities directed to Manufacturing, Development, or Medical Affairs. “Commercialize,” “Commercializing,” and “Commercialized” will be construed accordingly.

“Commercially Reasonable Efforts” means, with respect to the Exploitation of any Sarepta Product by a Party, those efforts and resources, including allocation of reasonably necessary personnel, equivalent to the efforts and resources that a biopharmaceutical company or a pharmaceutical company, in each case, that is of comparable size and resources to such Party would typically devote as part of an active and continuing program of Development, Manufacturing, and Commercialization of any pharmaceutical or biologic product of similar market potential, at a similar stage of its product life, taking into account the competitiveness of the marketplace and the proprietary position (including with respect to Patent Rights), product profile, market exclusivity, regulatory status and regulatory environment, cost of goods, price and reimbursement status, approved labeling, payors’ policies and regulations, and relative safety and efficacy of such product.

“Competing Acquisition Program” has the meaning set forth in Section 2.6.2 (Acquisitions of Third Parties).

“Competitive Infringement” means any infringement, unauthorized use, misappropriation or other violation or threatened infringement, unauthorized use, misappropriation, or other violation by any Third Party with respect to any Sarepta Patent Right, Sarepta Know-How, Roche Collaboration Patent Right, Roche Collaboration Know-How, Joint Collaboration Patent Right, or Joint Collaboration Know-How by reason of the making, using, offering to sell, selling or importing of any compound, product, method, or process that would be competitive with any Licensed Product in the Field.

“Competitive Product” has the meaning set forth in Section 2.6.1 (Exclusivity Obligation).

“Compulsory Sublicense” means a license or sublicense granted to any Third Party (a “Compulsory Sublicensee”) through the order, decree, or grant of a Governmental Authority having competent jurisdiction, authorizing such Third Party to Manufacture and Commercialize any Licensed Product in any country in the Roche Territory.

“Compulsory Sublicensee” has the meaning set forth in Section 1.35 (Compulsory Sublicensee).

“Confidential Disclosure Agreement” has the meaning set forth in Section 17.2 (Entire Agreement; Amendment).

“Confidential Information” means, subject to Section 12.3 (Exemptions), any and all (a) Know-How and any technical, scientific, pre-clinical, clinical, regulatory, trade, research, manufacturing, business, financial, marketing, product, supplier, intellectual property, and other non-public or proprietary data or information (including unpublished patent applications) that may be disclosed (whether in writing, orally, or by any other method) by one Party or any of its Affiliates or Sublicensees to the other Party or any of its Affiliates or Sublicensees pursuant to this Agreement (including information disclosed prior to the Effective Date pursuant to the Confidential Disclosure Agreement), regardless of whether such information is specifically marked or designated as confidential or proprietary and regardless of whether such information is in written, oral, electronic, or other form, and (b) the terms of this Agreement.

“Continuation Election Notice” has the meaning set forth in Section 14.8.3 (Sarepta Designees).

“Continued Countries List” has the meaning set forth in Section 14.8.3 (Sarepta Designees).

“Controlled” means the possession by a Party (whether by ownership, license, or otherwise other than pursuant to this Agreement) of, (a) with respect to any materials or other tangible Know-How, the legal authority or right to physical possession of such materials or tangible Know-How, with the right to provide such materials or tangible Know-How to the other Party on the terms set forth herein, (b) with respect to Patent Rights, Regulatory Approvals, Regulatory Submissions, intangible Know-How, or other intellectual property, the legal authority or right to grant a license, sublicense, access, or right to use (as applicable) to the other Party under such Patent Rights, Regulatory Approvals, Regulatory Submissions, intangible Know-How, or other intellectual property on the terms set forth herein, in each case ((a) and (b)), without breaching or otherwise violating the terms of any arrangement or agreement with a Third Party in existence as of the time such Party or its Affiliates would first be required hereunder to grant the other Party such access, right to use, license, or sublicense or incurring any additional payment obligations to a Third Party as a result of such access, right to use, license, or sublicense, other than payment obligations incurred under an Existing In-License or Collaboration In-License, and (c) with respect to any product, the legal authority or right to grant an exclusive license or sublicense under Patent Rights that Cover such product or Know-How that relates to such product.  Notwithstanding the foregoing, a Party and its Affiliates will not be deemed to “Control” any of the foregoing (a) – (c) that, prior to the consummation of a Change of Control of such Party, is owned or in-licensed by a Third Party that becomes an Affiliate of such acquired Party (or that merges or consolidates with such Party) after the Effective Date as a result of such Change of Control.  

“Country Designees List” has the meaning set forth in Section 14.8.3 (Sarepta Designees).

“Cover” means, with respect to any particular subject matter at issue and any relevant Patent Right or individual claim in such Patent Right, as applicable, that the Manufacture, use, sale, offer for sale, importation, or other Exploitation of such subject matter would fall within the scope of one or more claims in such Patent Right.

“CREATE Act” has the meaning set forth in Section 10.3 (Disclosure; Inventorship).

“Debarred/Excluded” has the meaning set forth in Section 11.1.11 (Mutual Representations and Warranties).

“Demand Forecast Plans” has the meaning set forth in Section 8.3.2 (Development Demand Forecast Plan).

“Development” means, with respect to any product, any and all internal and external research, development and regulatory activities regarding such product, including (a) research, process development, non-clinical testing, toxicology, non-clinical activities, IND-Enabling Studies, and Clinical Trials, and (b) preparation, submission, review, and development of data or information for the purpose of submission to a Regulatory Authority to obtain authorization to conduct Clinical Trials and to obtain, support, or maintain Regulatory Approval of such product, but excluding any activities directed to Manufacturing, Medical Affairs, or Commercialization.  Development will include research, development, and regulatory activities for additional presentations or indications for a product after receipt of Regulatory Approval of such product, including Clinical Trials initiated following receipt of Regulatory Approval or any Clinical Trial to be conducted after receipt of Regulatory Approval that was mandated by the applicable Regulatory Authority as a condition of such Regulatory Approval with respect to an approved indication (such as post-marketing approval studies and observational studies, if required by any Regulatory Authority in any country in the Territory to support or maintain Regulatory Approval for a product in such country).  “Develop,” “Developing,” and “Developed” will be construed accordingly.  

“Development Costs” means any and all costs and expenses actually incurred in connection with the performance of any Development activities for any Licensed Product, including [**].  In addition, Development Costs will include [**].  Development Costs will be recognized only in accordance with the applicable Accounting Standard.

“Development Supply Agreement” has the meaning set forth in Section 8.6.1 (Development Supply Agreement) and the corresponding quality agreements fulfilling the requirements set forth in Schedule 1.263.

“Disclosing Party” has the meaning set forth in Section 12.1.1 (Duty of Confidence).

“DMD” means Duchenne muscular dystrophy.

“DMD ROFN Exercise Notice” has the meaning set forth in Section 2.8.1 (DMD ROFN).

“DMD ROFN Negotiation Period” has the meaning set forth in Section 2.8.1 (DMD ROFN).

“DMD ROFN Notice” has the meaning set forth in Section 2.8.1 (DMD ROFN).

“DMD ROFN Rights” has the meaning set forth in Section 2.8.1 (DMD ROFN).

“Effective Date” has the meaning set forth in Section 15.1 (Effective Date).

“Eligible Global Development Costs” means the Development Costs, [**], actually incurred by or on behalf of Sarepta or its Affiliates with respect to any Licensed Product commencing as of the Execution Date and continuing thereafter during the Term to the extent in compliance with both the Joint Global Development Plan and the amount budgeted therefor in the Joint Global Development Budget, plus applicable Allowable Overruns or other amounts approved by the JSC.  In addition, Eligible Global Development Costs will include [**]. Eligible Global Development Costs will be recognized only in accordance with Sarepta’s then-applicable Accounting Standard.  For clarity, the Eligible Global Development Costs shall exclude all Internal Costs and External Costs, in each case, incurred by Sarepta prior to the Effective Date or to be incurred thereafter, in each case, in connection with any Clinical Trials included in the Joint Global Development Plan that are Initiated on or prior to the Execution Date.  

“Eligible Medical Affairs Costs” means the Medical Affairs Costs actually incurred by or on behalf of a Party or its Affiliates with respect to any Licensed Product to the extent in compliance with both the Joint Global Medical Affairs Plan and the amount budgeted therefor in the Joint Global Medical Affairs Budget, plus applicable Allowable Overruns or other amounts approved by the JSC.

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

“European Region” means (a) all members of the European Union or the European Economic Area (EEA) as of the Effective Date, and (b) the following countries: Switzerland, Andorra, San Marino, Monaco, and Vatican City.

“European Union” or “E.U.” means the economic, scientific, and political organization of member states of the European Union as it may be constituted from time to time; provided that, for the purposes of this Agreement, the term “European Union” will be deemed to include the United Kingdom regardless of whether it is a member of the European Union at the applicable time.

“[**] Development Costs” means the Development Costs incurred by or on behalf of Sarepta in the course of [**].  

“[**]” has the meaning set forth in [**].

“Exclusivity Period” has the meaning set forth in Section 2.6.1 (Exclusivity Obligation).

“Execution Date” has the meaning set forth in the Preamble.

“Executive Officer” means with regard to Sarepta, the chief executive officer, or his or her designee, and with regard to Roche, the head of Pharma Partnering, or his or her designee.  

“Existing In-Licenses” means any and all agreements entered into by either Party or an Affiliate of such Party with a Third Party prior to the Execution Date, including any amendments or restatements thereto entered into during the Term, pursuant to which such Party or its Affiliate Controls any Sarepta Technology or Roche Technology (as applicable).

“Exon-Skipping Product Clinical Milestone Event” has the meaning set forth in Section 9.4.2 (Clinical and Regulatory Milestones for Exon-Skipping Products that are Licensed Products).

“Exon-Skipping Product Clinical Milestone Payment” has the meaning set forth in Section 9.4.2 (Clinical and Regulatory Milestones for Exon-Skipping Products that are Licensed Products).

“Exon-Skipping Product Regulatory Milestone Event” has the meaning set forth in Section 9.4.2 (Clinical and Regulatory Milestones for Exon-Skipping Products that are Licensed Products).

“Exon-Skipping Product Regulatory Milestone Payment” has the meaning set forth in Section 9.4.2 (Clinical and Regulatory Milestones for Exon-Skipping Products that are Licensed Products).

“Exon-Skipping Products” means [**].

“Exploit” means to make, have made, use, import, export, offer to sell, sell, Develop, Manufacture, perform Medical Affairs activities, Commercialize, or otherwise exploit.  “Exploitation” will be construed accordingly.

“External Costs” means any and all expenses paid to Third Parties (or payable to Third Parties and accrued in accordance with the applicable Accounting Standard) by a Party (or any of its Affiliates) in consideration of the performance of activities under this Agreement, and excluding a Party’s Internal Costs.

“FD&C Act” means the United States Federal Food, Drug and Cosmetic Act, as amended from time-to-time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

“FDA” means the U.S. Food and Drug Administration or any successor agency thereto.

“Field” means all prophylactic, therapeutic, and diagnostic uses in all indications.

“Filing for Regulatory Approval” means the filing or submission of (a) an MAA with the FDA as defined in the FD&C Act and applicable regulations, or (b) an equivalent MAA with the equivalent agency in any other country or group of countries, the official approval of which application is required before any lawful commercial sale or marketing of Licensed Products in the applicable country is permitted.  

“First Commercial Sale” means, for each Licensed Product in a country, (a) with regards to the Milestone Payments due upon achievement of each of First Commercial Sale in Section 9.4.1 (Regulatory Milestones for Lead Product), Section 9.4.2 (Clinical and Regulatory Milestones for Exon-Skipping Products that are Licensed Products), Section 9.4.3 (Regulatory Milestones for Licensed Products other than Lead Product, a Gene-Editing Licensed Product, and Exon-Skipping Products), and Article 9.4.4 (Regulatory Milestones for Gene-Editing Licensed Products) the first sale of such Licensed Product in such country by a Party, or its Affiliates or Sublicensees after the receipt of Regulatory Approval and Reimbursement Approval in the Field for such Licensed Product from the relevant Regulatory Authority in such country, and (b) with regards to royalty payments due under Section 9.5 (Royalties) the sale in such country by a Party, or its Affiliates or Sublicensees in the Field for such Licensed Product in such country.  First Commercial Sale excludes any sale or other distribution for use in a Clinical Trial or other Development activity or for compassionate use sold or distributed at or below the applicable Seller’s costs.  

“Force Majeure” means any of the following events: embargoes, war or acts of war (including terrorism, insurrections, riots, or civil unrest), epidemics, fire, floods, earthquakes, or other acts of nature.

“FTE” means the equivalent of the work of one duly qualified employee of a Party full time for one year (consisting of a total of [**] hours per year) carrying out Development or Medical Affairs activities under this Agreement.  Overtime, and work on weekends, holidays and the like will not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution, and no individual may be charged at greater than one FTE, regardless of that individual’s hours worked during that year.  The portion of an FTE billable by a Party for one employee during a given accounting period will be determined by dividing the number of hours worked directly by such employee on the work to be conducted under this Agreement during such accounting period by the number of FTE hours applicable for such accounting period based on [**] working hours per Calendar Year.

“FTE Rate” means the rate of $[**] per FTE per Calendar Year for FTEs performing Medical Affairs or Development activities, which rate will be prorated on a daily basis as necessary, and which rate is subject to annual adjustment in each Calendar Year during the Term by the percentage increase in the CPI as of December 31 of each Calendar Year, over the level of the CPI as of December 31 of the prior Calendar Year, with the first such increase to be effective on January 1, 2021.  For the avoidance of doubt, such FTE Rate will be the fully-burdened rate and is intended to cover the cost of salaries, benefits, infrastructure costs, travel, general laboratory or office supplies, postage, insurance, training, and all other general expenses and overhead items.  Notwithstanding the foregoing, for any Calendar Year during the Term that is less than a full year, the above referenced rate will be proportionately reduced to reflect such portion of such full Calendar Year.

“GAAP” means the generally accepted accounting principles in the United States.

“Gene-Editing Licensed Product” means a Licensed Product that is a Gene-Editing Product.

“Gene-Editing Licensed Product Regulatory Milestone Events” has the meaning set forth in Section 9.4.4 (Clinical and Regulatory Milestones for Gene-Editing Licensed Products).

“Gene-Editing Licensed Product Regulatory Milestone Payments” has the meaning set forth in Section 9.4.4 (Clinical and Regulatory Milestones for Gene-Editing Licensed Products).

“Gene-Editing Option Product” has the meaning as set forth in Section 1.178.

“Gene-Editing Product” means a product that, alone or in combination with one or more other agents, modifies, repairs, or activates an endogenous dysfunctional dystrophin gene.

“Gene-Editing Sales Milestone Events” has the meaning set forth in Section 9.4.6 (Sales Milestones for Gene-Editing Licensed Products).

“Gene-Editing Sales Milestone Payments” has the meaning set forth in Section 9.4.6 (Sales Milestones for Gene-Editing Licensed Products).

“Gene Therapy Option Product” has the meaning as set forth in Section 1.178.

“Gene Therapy Product” means any product that delivers to cells as a therapeutic agent a transgene that encodes and directly expresses dystrophin or a derivative thereof (such as micro-dystrophin or mini-dystrophin).  The Lead Product is a Gene Therapy Product.

“Gene Therapy Product Regulatory Milestone Event” has the meaning set forth in Section 9.4.3 (Regulatory Milestones for Licensed Products other than Lead Product and Exon-Skipping Product).

“Gene Therapy Product Regulatory Milestone Payment” has the meaning set forth in Section 9.4.3 (Regulatory Milestones for Licensed Products other than Lead Product and Exon-Skipping Product).

“[**]” means [**].

“[**] Agreement” means that certain Clinical Research Collaboration and License Agreement, dated as of [**], by and between [**] and Sarepta Therapeutics [**].

“[**] Countries” means [**].

“[**] Product” has the meaning set forth in the [**] Agreement.

“Global Development Program” means the Joint Global Development Program and the Option Product Development Program.

“Global Trade Control Laws” means the U.S. Export Administration Regulations, the U.S. International Traffic in Arms Regulations, the economic sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Control, E.U.  Council Regulations on export controls, including Nos. 428/2009, 267/2012, other E.U.  Council sanctions regulations, as implemented in the E.U. member states, United Nations sanctions policies, and all relevant regulations made under any of the foregoing.

“Good Clinical Practices” or “GCP” means the then-current good clinical practice standards, practices, and procedures promulgated or endorsed by the applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time-to-time.

“Good Laboratory Practices” or “GLP” means the then-current good laboratory practice standards, practices, and procedures promulgated or endorsed by the applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time-to-time.

“Good Manufacturing Practices” or “GMP” means the then-current good manufacturing practice standards, practices, and procedures promulgated or endorsed by the applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time-to-time.

“Government Official” means any official, officer, employee, or representative of: (a) any federal, state, provincial, administrative division, county, or municipal government or any department or agency thereof; (b) any public international organization or any department or agency thereof; or (c) any company or other entity owned or controlled by any government or Governmental Authority.

“Governmental Authority” means any court, agency, department, authority, tribunal, or other instrumentality of any supra-national, national, state, provincial, county, city, or other political subdivision.  For clarity, Governmental Authorities include all Regulatory Authorities.

“IFRS” means the International Financial Reporting Standards, as consistently applied.

“IND” means an Investigational New Drug application required pursuant to 21 C.F.R.  Part 312 or any comparable filings outside of the U.S. (such as an application for a Clinical Trial Authorization in the E.U.).

“IND-Enabling Study” means a toxicology study, in species that satisfies applicable regulatory requirements, using applicable GLP that meets the standard necessary for submission as part of an IND with the applicable Regulatory Authority.

“Indemnified Party” has the meaning set forth in Section 13.3 (Indemnification Procedure).

“Indemnifying Party” has the meaning set forth in Section 13.3 (Indemnification Procedure).

“Initiation” means with respect to any Clinical Trial, first dosing of the first human subject in such Clinical Trial.

“Insufficient Supply Event” has the meaning set forth in Section 8.10.3(b) (Insufficient Quantities; To Meet Demand Under the Capacity Plan).

“Internal Costs” means, for any period of time, (a) the product obtained by multiplying (i) the actual total FTEs (or portion thereof) devoted to the performance of activity under this Agreement during such period, by (ii) the applicable FTE Rate for such period, plus (b) a Party’s reasonably allocated other internal costs with respect to such activity to the extent not included in the FTE Rate.

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

“IP Committee” has the meaning set forth in Section 10.4 (IP Committee).

“JCC” has the meaning set forth in Section 3.4.1 (Formation and Purpose of the JCC).

“JDC” has the meaning set forth in Section 3.3.1 (Formation and Purpose of the JDC).

“JMC” has the meaning set forth in Section 3.5.1 (Formation and Purpose of the JMC).

“Joint Collaboration Know-How” means any and all Collaboration Know-How developed or invented jointly by a Party’s or any of its Affiliates’ employees, agents, or independent contractors, or any Persons contractually required to assign or license such Collaboration Know-How to such Party or any Affiliate of such Party, on the one hand, and the other Party’s or any of its Affiliates’ employees, agents, or independent contractors, or any Persons contractually required to assign or license such Collaboration Know-How to such other Party or any Affiliate of such Party, on the other hand.

“Joint Collaboration Patent Rights” means any and all Collaboration Patent Rights that Cover any Joint Collaboration Know-How.

“Joint Collaboration Technology” means the Joint Collaboration Know-How and the Joint Collaboration Patent Rights.

“Joint Global Branding and Marketing Strategy” has the meaning set forth in Section 6.4 (Branding and Marketing Plans).

“Joint Global Development Budget” means the budget of all Internal Costs and External Costs to be incurred from and after Execution Date in the performance of activities under the Joint Global Development Plan for any Licensed Product.  

“Joint Global Development Plan” means the plan setting forth (a) all Clinical Trials for any Licensed Products and corresponding Sarepta Diagnostic Products, in each case, through the completion of Pivotal Clinical Trials and any other Development activities necessary to obtain and maintain Regulatory Approvals for such Licensed Products and corresponding Sarepta Diagnostic Products in the U.S. and the European Union, including process development activities and any post-Regulatory Approval studies, the data from which may be used in both the U.S. and the European Union to obtain or maintain Regulatory Approval, (b) the timelines for such activities, and (c) the Joint Global Development Budget, in each case ((a) through (c)), as the same may be amended from time-to-time in accordance with this Agreement. The initial Joint Global Development Plan is attached as Schedule 4.3.1 of this Agreement.  

“Joint Global Development Program” means the program of Development activities conducted under the Joint Global Development Plan.

“Joint Global Medical Affairs Budget” means the budget of External Costs to be incurred in the performance of activities under the Joint Medical Affairs Plan for any Licensed Product.

“Joint Global Medical Affairs Plan” has the meaning set forth in Section 7.1 (Medical Affairs Plan).

“Joint Medical Affairs Team” has the meaning set forth in Section 3.3.3(c).

“Joint Publication Strategy” has the meaning set forth in Section 12.6 (Publications).

“JSC” has the meaning set forth in Section 3.1.1 (Formation and Purpose of the JSC).

“Know-How” means proprietary Inventions, discoveries, trade secrets, materials, information, experience, data, formulas, procedures, technology, and results (whether or not patentable), including practices, knowledge, know-how, experience and test data (including physical, chemical, biological, toxicological, pharmacological, clinical and veterinary data), dosage regimens, assays, diagnostics, product specifications, manufacturing techniques and costs, analytical and quality control data and marketing, pricing and distribution costs, and sales practices, methods, data, and descriptions.

“Knowledge” means, with respect to a Party and any matter in question, the actual knowledge of such Party’s senior management as of the Execution Date, without any inquiry or investigation as to such matter.  For this purpose, “senior management” means any Person who is an “officer” of the applicable Party, as defined in Rule 16a-1(f) of the U.S. Securities Exchange Act of 1934 or the foreign equivalent thereof.  

“Latin American Region” means all of the following countries and territories: countries and territories of South America (excluding French Guiana), Mexico, Belize, Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panama, Cuba, Dominican Republic, Haiti, Guadeloupe, and Martinique.

“Lead Product” means SRP-9001, in any dosage strength, concentration, or formulation Controlled by Sarepta or any of its Affiliates.

“Lead Product Regulatory Milestone Event” has the meaning set forth in Section 9.4.1 (Lead Product Regulatory Milestones).

“Lead Product Regulatory Milestone Payment” has the meaning set forth in Section 9.4.1 (Lead Product Regulatory Milestones).

“Lead Product Royalties” has the meaning set forth in Section 9.5.1  (Royalty Payments For Lead Product).

“Lead Product Royalty Rates” has the meaning set forth in Section 9.5.1  (Royalty Payments For Lead Product).

“Lead Product Royalty Term” has the meaning set forth in Section 9.5.1  (Royalty Payments For Lead Product).

“Lead Product Sales Milestone Events” has the meaning set forth in Section 9.4.5 (Sales Milestones).

“Lead Product Sales Milestone Payments” has the meaning set forth in Section 9.4.5 (Sales Milestones).

“LGMD Diligence Package” means, with respect to each LGMD Product, a package of documents or information to be provided or made available to Roche containing the following: (a) the information set forth on Schedule 1.142; (b) a reasonably detailed summary of all Development activities undertaken by or on behalf of Sarepta or any of its Affiliates with respect to such LGMD Product; (c) all Regulatory Submissions related to such LGMD Product, if any, and a summary of all substantive correspondence to or from any Regulatory Authority related to such LGMD Product, if any; (d) a list of any Patent Rights Covering such LGMD Product and a description of the material Sarepta Know-How related to such LGMD Product; and (e) copies of all material agreements between Sarepta and any Third Party pursuant to which Sarepta is granted rights with respect to an LGMD Product.  

“LGMD Evaluation Period” has the meaning set forth in Section 2.8.3 (LGMD ROFN Evaluation Period).

“LGMD Initial Response” has the meaning set forth in Section 2.8.3 (LGMD ROFN Evaluation Period).

“LGMD Products” means any and all products Controlled by Sarepta or any of its Affiliates as of the Effective Date or at any time during the Term for the treatment, prevention, cure, amelioration, or therapy of Limb Girdle Muscular Dystrophy.  

“LGMD ROFN Exercise Notice” has the meaning set forth in Section 2.8.4 (LGMD ROFN Exercise).

“LGMD ROFN Negotiation Period” has the meaning set forth in Section 2.8.4 (LGMD ROFN Exercise).

“LGMD ROFN Notice” has the meaning set forth in Section 2.8.2 (LGMD ROFN).

“LGMD ROFN Rights” has the meaning set forth in Section 2.8.2 (LGMD ROFN).

“Licensed Products” means (a) as of the Effective Date, the Lead Product, and (b) thereafter during the Term, any and all Option Products for which Roche exercises the applicable Option in accordance with Section 2.7 (Exercise of Option).

“Losses” has the meaning set forth in Section 13.1 (Indemnification by Sarepta).

“MAA” or “Marketing Authorization Application” means any (a) Biologics License Application submitted under Section 351(a) of the PHSA, (b) New Drug Application as defined in the FD&C Act, or (c) substantially similar application or submission to those set forth in clause (a) or clause (b) filed with a Regulatory Authority in a country or group of countries to obtain Regulatory Approval to Commercialize a biopharmaceutical or diagnostic product in that country or in that group of countries, including, with respect to the E.U., a Marketing Authorization Application filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in the EU with respect to the mutual recognition or any other national approval, in each case ((a) through (c)), including any amendments thereto, and supplemental applications, but excluding Reimbursement Approval applications.

“Manufacture” means with respect to any product, any and all activities directed to manufacturing, processing, packaging, labeling, filling, finishing, assembly, quality assurance, quality control, testing, and release, shipping, supply, or storage of such product (or any components or process steps involving such product or any companion diagnostic), placebo, or comparator agent, as the case may be, including qualification, validation, and scale-up, pre-clinical, clinical, and commercial manufacture and analytic development, product characterization, and stability testing, but excluding any activities directed to Development, Medical Affairs, or Commercialization.  “Manufacturing” and “Manufactured” will be construed accordingly.

“Manufacturing Costs” means, with respect to a Licensed Product, the fully-burdened cost incurred by Sarepta or its Affiliates in Manufacturing such Licensed Product (including all activities related to CMC, formulation, quality control, packaging and labeling, scale-up, failed batches (as to the extent it can be reasonably expected on normal operating variations) and expired materials, and including all activities related to the supply of plasmids, raw materials, drug substance, and drug product) in accordance with this Agreement and consistent with the applicable Supply Agreement, including: (a) to the extent that such Licensed Product is Manufactured by one or more CMOs, (i) the actual External Costs paid by Sarepta or its Affiliates to such CMOs for the Manufacture thereof plus (ii) to the extent allocable to the Licensed Products, the actual Internal Costs incurred to engage with and oversee such Third Party; and (b) to the extent that such Licensed Product is Manufactured by Sarepta or its Affiliates: material costs, depreciation of capital expenditures, actual External Costs, and actual Internal Costs, in each case, directly attributable to the Manufacture of such Licensed Product, and in each case, to the extent such costs are fairly allocated to the Licensed Product.  Notwithstanding the foregoing, Manufacturing Costs exclude all costs and expenses related to or occasioned by (A) any and all unused Manufacturing capacity of Sarepta or any of its Affiliates or CMOs, in each case, that is not reserved for any Licensed Product, (B) any and all unused Manufacturing capacity of Sarepta or any of its Affiliates that is reserved for any Licensed Product to the extent Sarepta or any of its Affiliates can, using reasonable efforts, allocate such capacity to any product that is not a Licensed Product or to any Third Party, (C) the Manufacture of any products other than the Licensed Products at the same facilities in which any Licensed Product is Manufactured, and (D) any overhead costs that are not reasonably allocated to Manufacturing the Licensed Products. Manufacturing Costs will be recognized only in accordance with the applicable Accounting Standard.

“Manufacturing Plan” has the meaning set forth in Section 8.8 (Manufacturing Plan).  

“Manufacturing Transition Notice” has the meaning set forth in Section 8.11.1 (Request for Technology Transfer).

“Manufacturing Transition Period” has the meaning set forth in Section 8.11.2 (Manufacturing Transition Period).

“Manufacturing Transition Plan” has the meaning set forth in Section 8.11.2 (Manufacturing Transition Period).

“Mark” means any trademark, trade name, service mark, service name, product name, brand, domain name, trade dress, logo, slogan, or other indicia of origin or ownership, and any and all (a) registrations and applications for registrations, and, as applicable, other intellectual property rights associated with any of the foregoing, and (b) goodwill associated with each of the foregoing.  

“Material Communication” means material written, telephonic, or in person communications from or with any Regulatory Authority concerning any of the following: key product quality attributes (e.g., purity), safety findings affecting the platform (e.g., serious adverse events, emerging safety signals), clinical or non clinical findings affecting patient safety, lack of efficacy, receipt or denial of Regulatory Approval, the design of Clinical Trials, or the need for additional non clinical studies or IND-Enabling Studies (e.g., additional toxicology or carcinogenicity studies).

“Medical Affairs” means any and all activities conducted by or on behalf of a Party’s or any of its Affiliates’ medical affairs departments, including communications with key opinion leaders, medical education, symposia, advisory boards (to the extent related to medical affairs or clinical guidance), activities performed in connection with patient registries, and other medical programs and communications, including educational grants, research grants (including conducting investigator-initiated studies), and charitable donations to the extent related to medical affairs and not to activities that involve the promotion, marketing, sale, or other Commercialization of the Sarepta Products or any corresponding Sarepta Diagnostic Product and are not conducted by or on behalf of a Party’s or any of its Affiliates’ medical affairs departments.  Medical Affairs excludes any activities directed to Manufacturing, Development, or Commercialization.  

“Medical Affairs Costs” means any and all costs and expenses actually incurred in connection with the performance of any Medical Affairs activities for any Licensed Product, including External Costs actually incurred in connection with the performance of any Medical Affairs activities for any Licensed Product.  Medical Affairs Costs will be recognized only in accordance with the applicable Accounting Standard.

“Middle Eastern Countries” means all of the following countries and territories: Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Oman, the Palestinian territories, Qatar, Saudi Arabia, Syria, Turkey, United Arab Emirates, and Yemen.

“Milestone Events” has the meaning set forth in Section 9.4.7 (Notification of Milestone Events).

“Milestone Payments” has the meaning set forth in Section 9.4.7 (Notification of Milestone Events).

“Net Sales” means, with respect to a Licensed Product, for any period, the amounts stated in Roche’s and its Affiliates’ and Sublicensees’ “Sales” lines of their respective externally published audited (in the case of Roche) financial statements with respect to such Licensed Product for such period, which amount reflects the gross invoice price of such Licensed Product sold or otherwise disposed of (other than for use as clinical supplies or free samples) by Roche and its Affiliates and Sublicensees (other than Third Party Distributors and Compulsory Sublicensees) during such period (such sales, “Sales” and such Persons, each, a “Seller”) less the following gross-to-net deductions (to the extent applied consistently by the applicable Seller with respect to sales of their respective other products) not previously deducted from the amount invoiced:

[**];

[**];

[**]; and

[**].

“Non-Breaching Party” has the meaning set forth in Section 14.2.1 (Notice and Cure).

“OFAC” means the Office of Foreign Assets Control of the United States Department of the Treasury or any successor agency thereto.

“Option” has the meaning set forth in Section 2.7.1 (Grant of Option).

“Option Data Package” means, with respect to each Option Product, a package of documents or information to be provided or made available to Roche containing the following: (a) the information set forth on Schedule 1.170; (b) a reasonably detailed summary of all Development activities undertaken by or on behalf of Sarepta or any of its Affiliates or Sublicensees with respect to such Option Product; (c) all Regulatory Submissions related to such Option Product, if any, and a summary of all substantive correspondence to or from any Regulatory Authority related to such Option Product, if any; (d) a list of any and all Patent Rights Covering such Option Product, and a description of the material Sarepta Know-How related to such Option Product; (e) an updated disclosure letter containing all applicable disclosures related to the representations and warranties set forth in Section 11.1 (Mutual Representations and Warranties) and Section 11.2 (Additional Sarepta Warranties) with respect to such Option Product; and (f) copies of all material agreements between Sarepta and any Third Party pursuant to which Sarepta is granted rights with respect to an Option Product or any agreement with any CMO related to the Manufacture of an Option Product.  

“Option Exercise Fee” has the meaning set forth in Section 9.3 (Option Exercise Fee).

“Option Exercise Notice” has the meaning set forth in Section 2.7.3 (Exercise of Option).

“Option Exercise Period” means (a) for all the Exon-Skipping Products, the period commencing on [**] and ending [**] after Sarepta’s delivery to Roche of the Option Data Package, and (b) for each other Option Product that is not an Exon-Skipping Product, on an Option Product-by-Option Product basis, the period commencing on the Effective Date and ending on the date that is [**] after Sarepta’s delivery to Roche of an Option Data Package for such Option Product; provided, however, that Roche may terminate prior to its natural expiration any Option Exercise Period by delivering a notice to Sarepta indicating that it does not intend to exercise the Option for the Option Product to which such Option Exercise Period relates, as such period may be extended pursuant to Section 2.7.2(d) (Incomplete Option Data Package and Right to Ask Questions).

“Option Product Development Plan” means the plan setting forth (a) all Clinical Trials for all Option Products and any corresponding Sarepta Diagnostic Product through the completion of Pivotal Clinical Trials and any other Development activities necessary to obtain and maintain Regulatory Approvals for each Option Product and any corresponding Sarepta Diagnostic Product in the U.S. and the European Union, including process development activities, and (b) the timelines for such activities, in each case ((a) and (b)), as the same may be amended from time-to-time in accordance with this Agreement.  

“Option Product Development Program” means the program of Development activities conducted under the Option Product Development Plan.

“Option Product Know-How” means, with respect to any Option Product, any and all Know-How that is (a) Controlled by Sarepta or any of its Affiliates as of the Effective Date or at any time during the Term and (b) necessary or useful to Exploit such Option Product or any corresponding Sarepta Diagnostic Products in the Field.

“Option Product Patent Rights” means, with respect to any Option Product, any and all Patent Rights that are (a) Controlled by Sarepta or any of its Affiliates as of the Effective Date or at any time during the Term and (b) necessary or useful to Exploit such Option Product or any corresponding Sarepta Diagnostic Products in the Field in the Roche Territory.

“Option Products” means (a) any Gene Therapy Product, other than the Lead Product, [**] (“Gene Therapy Option Product”), (b) all Gene-Editing Products [**] (“Gene-Editing Option Products”) and (c) all Exon-Skipping Products.

“Orphan Drug Designation” means the granting of special status by a competent Regulatory Authority to a drug for treating a rare disease or condition that meets the applicable legal criteria such as those set forth in Regulation No 141/2000 of the European Parliament and of the Council as of December 16, 1999. Such a drug is protected by exclusive legal rights (“orphan drug exclusivity”) only after it receives Regulatory Approval by the Regulatory Authority for use in treating said rare disease or condition.

“Other Covered Party” means any political party or party official, or any candidate for political office, in each case, in any jurisdiction.

“Other Product Royalties” has the meaning set forth in Section 9.5.2 (Royalty Payments for Licensed Products other than Lead Product).

“Other Product Royalty Term” has the meaning set forth in Section 9.5.2 (Royalty Payments for Licensed Products Other than the Lead Product).

“Packaging and Labeling” means any and all primary, secondary, or tertiary packaging and labeling of a Licensed Product (in its commercial packaging presentation) for sale or use in a country, including the Approved Labeling and insertion of materials such as patient inserts, patient medication guides, and professional inserts and any other written, printed, or graphic materials accompanying such Licensed Product and any brand security or anti-counterfeiting measures included in the packaging elements for such Licensed Product considered to be part of the finished packaged Licensed Product, and all testing and release thereof.

“Party Vote” has the meaning set forth in Section 3.7 (Decision-Making).

“Patent Challenge” means any action that contests anywhere in the world the scope, validity, or enforceability of a Patent Right in any court, arbitration proceeding, tribunal, or administrative agency, including the U.S. Patent and Trademark Office, European Patent Office, a national court in any country or jurisdiction and the Unified Patent Court (as applicable if and when in force). For clarity, a Patent Challenge shall not include arguments made by a Party that distinguishes the inventions claimed in Patent Rights owned or Controlled by such Party from those claimed in another Patent Right.  As used in this definition the term “contest” includes (a) filing an action seeking a determination of invalidity or unenforceability of any such Patent Right; (b) filing, or joining in, a post-grant proceeding, including (i) a petition under 35 U.S.C. § 311 to institute inter partes review of any such Patent Right or (ii) a petition under 35 U.S.C. § 321 to institute post-grant review of any such Patent Right or any portion thereof; (c) filing, or joining in, any opposition, nullity, or similar proceedings challenging the validity of any such Patent Right in any country, (d) filing, or joining in, any derivation proceedings before an administrative agency, interferences, inventorship challenges or any other proceeding that challenges the inventorship or ownership of any such Patent Right, and (e) any foreign equivalent of clauses (a), (b), (c), or (d).

“Patent Rights” means any and all (a) patents, patent applications, and utility models in any country or jurisdiction, including provisional applications, priority applications, and international applications, (b) patent applications filed either from such patents or patent applications or from an application claiming priority from any of these, including divisionals, continuations, and continuations-in-part, (c) patents that have issued or in the future issue from the foregoing patent applications, (d) substitutions, renewals, registrations, confirmations, revalidations, reissues, and re-examinations of the foregoing patents or patent applications, and (e) extensions, restorations, supplemental protection certificates, and the like based on any of the foregoing patents or patent applications.

“Person” means any corporation, sole proprietorship, limited or general partnership, limited liability partnership, limited liability company, business trust, joint stock company, joint venture, trust, incorporated or unincorporated association, governmental or political body, subdivision, authority, bureau, or agency, or any other entity or body similar to any of the foregoing, or an individual.

“Pharmacovigilance Agreement” means an agreement regarding receipt, investigation, and reporting of product complaints, adverse events, product recalls, and any other information related to the safety of a Licensed Product in the Territory.

“PHSA” means the United States Public Health Service Act, as amended from time-to-time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

“Pivotal Clinical Trial” means any Clinical Trial of the active substance of a pharmaceutical or biologic product, the results of which, together with prior data and information concerning such product, are intended to be sufficient, without any additional Clinical Trial, to meet the evidentiary standard for demonstrating the safety, purity, and potency of such active substance of such product established by a Regulatory Authority in any particular jurisdiction and is intended to support the filing of a MAA by a Regulatory Authority in such jurisdiction.  

“Potential In-License” has the meaning set forth in Section 2.5.2 (Potential In-Licenses).

“Product Marks” means any and all Marks (whether registered or unregistered), other than any Sarepta Housemark or Roche Housemark, for use on, with, or to refer to any Licensed Product or used with patient support or other information or services or Product Materials associated with any Licensed Product in the Territory during the Term, together with any and all (a) registrations, applications for registrations, and other intellectual property rights associated with any of the foregoing, and (b) goodwill associated with each of the foregoing.  

“Product Materials” means any and all promotional materials, training materials, medical education materials, Packaging and Labeling, and all other literature or other information related to any Licensed Product.

“Professional Requirements” means (a) the codes and standards of the European Accreditation Council for Continuing Medical Education (EACCME) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), (b) the codes of the Prescription Medicines Code of Practice Authority (PMCPA) and the Association of the British Pharmaceutical Industry (ABPI), (c) FDA’s regulations, guidance, and enforcement letters concerning the advertising of prescription drug products, (d) the American Medical Association’s Guidelines on Gifts to Physicians from Industry, (e) the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support of Continuing Medical Education, (f) the Pharmaceutical Supply Chain Initiative (PSCI) and Pharmaceutical Industry Principles for Responsible Supply Chain Management, (g) the Code on Interactions with Healthcare Professionals promulgated by the Pharmaceutical Research and Manufacturers of America (PhRMA Code), (h) the Department of Health and Human Services Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers (OIG Compliance Guidance), and (i) all other accepted national and international pharmaceutical industry codes of practice in and for the relevant countries in the Territory, as any of the foregoing may be amended from time-to-time.

“Proof of Concept Trial” means a Clinical Trial (including any portion thereof) of an Option Product [**].

“Proof of Concept Trial Success” means, with respect to an Option Product, [**].  

“Prosecuting Party” has the meaning set forth in Section 10.6.1 (Filing of Joint Collaboration Patent Rights).

“Publication” has the meaning set forth in Section 12.6 (Publications).

“Publishing Notice” has the meaning set forth in Section 12.6(b).

“Publishing Party” has the meaning set forth in Section 12.6(b).

“[**]” means [**].

“Receiving Party” has the meaning set forth in Section 12.1.1 (Duty of Confidence).

“Region” means any of the Asian Region, the European Region, the Latin American Region, Japan, or the ROW Region.

“Regulatory Approval” means, with respect to a particular country or other regulatory jurisdiction, any approval of an MAA or other approval, product, or establishment license, registration, or authorization required by Applicable Law for the commercial sale of a pharmaceutical, diagnostic, or biologic product in such country or other regulatory jurisdiction, excluding, in each case, Reimbursement Approval.

“Regulatory Authority” means, in a particular country or jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or jurisdiction, including (a) in the U.S., the FDA and any other applicable Governmental Authority in the U.S. having jurisdiction over any pharmaceutical, diagnostic, or biologic product, (b) in the E.U., the EMA and any other applicable Governmental Authority in the E.U.  having jurisdiction over any pharmaceutical, diagnostic, or biologic product, and (c) in other countries, other analogous Governmental Authorities having jurisdiction over any pharmaceutical, diagnostic, or biologic product.

“Regulatory Exclusivity” means, with respect to any Licensed Product in any country or jurisdiction in the Roche Territory, the period of time during which: (a) a Party or its Affiliate or Sublicensee has been granted the exclusive legal right by a Regulatory Authority, other than through a Patent Right, including orphan drug exclusivity, pediatric exclusivity, rights conferred in the U.S. under the FD&C Act, rights in the EU under Directive 2001/83/EC, or rights similar thereto in other countries or regulatory jurisdictions in the Roche Territory, or is otherwise entitled to the exclusive legal right by operation of Applicable Law in such country to market and sell such Licensed Product, and such right precludes the receipt of Regulatory Approval of any Third Party product that is deemed to be the same or a similar drug, in each case, under applicable orphan drug regulations; or (b) the data and information submitted by a Party or its Affiliate or Sublicensee to the relevant Regulatory Authority in such country or jurisdiction for purposes of obtaining Regulatory Approval of such Licensed Product may not be disclosed, referenced, or relied upon in any way by any Third Party or such Regulatory Authority to support the Regulatory Approval or marketing of any product by any Third Party in such country or jurisdiction, or if such data and information is disclosed, referenced, or relied upon to support a Regulatory Approval granted to any Third Party in such country or jurisdiction, then the product may not be placed on the market for any indication.

“Regulatory Expert” has the meaning set forth in Section 3.8.2(a) (Regulatory Expert Matters).

“Regulatory Expert Matter” has the meaning set forth in Section 4.3.1 (Joint Global Development Plan).

“Regulatory Milestone Event” has the meaning set forth in Section 9.4.1 (Regulatory Milestones).

“Regulatory Milestone Payment” has the meaning set forth in Section 9.4.1 (Regulatory Milestones).

“Regulatory Responsible Party” means, for each Sarepta Product in the Sarepta Territory or Roche Territory and any corresponding Sarepta Diagnostic Product, the Party designated under Section 5.2 (Regulatory Responsible Party).

“Regulatory Submission” means any filing, application, or submission with any Regulatory Authority in support of the Development, Manufacture, Commercialization, or other Exploitation of a pharmaceutical, diagnostic, or biologic product (including to obtain, support, or maintain Regulatory Approval from that Regulatory Authority), and all written or electronic correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences, or discussions with the relevant Regulatory Authority.  Regulatory Submissions include all INDs, MAAs, and other applications for Regulatory Approval and their equivalents.

“Reimbursement Approval” means any approval, agreement, determination, or other decision by the applicable Governmental Authority in a given country that establishes prices charged to end-users for pharmaceutical, diagnostic, or biologic products at which such pharmaceutical, diagnostic, or biologic products will be reimbursed by the Regulatory Authorities or other applicable Governmental Authorities in such country or any other approvals related to pricing, reimbursement, or access to a pharmaceutical, diagnostic, or biologic product (including all activities related to tenders and contracts).

“Restricted Party” means any individual or entity on one or more of the Restricted Party Lists.

“Restricted Party List” means the list of sanctioned entities maintained by the United Nations; the Specially Designated Nationals and Blocked Persons List, the Foreign Sanctions Evaders List and the Sectoral Sanctions Identifications List, all administered by OFAC; the U.S. Denied Persons List, the U.S. Entity List, and the U.S. Unverified List, all administered by the U.S. Department of Commerce; and the entities subject to restrictive measures and the consolidated list of Persons, Groups, and Entities Subject to E.U.  Financial Sanctions, as implemented by the E.U.  Common Foreign & Security Policy.

“Right of Reference” has the meaning set forth in Section 5.6 (Assignment of Regulatory Submissions and Regulatory Approvals to Roche).

“Roche Background Know-How” means any and all Know-How (excluding the Roche Collaboration Know-How and Roche’s interest in Joint Collaboration Know-How) that is (a) Controlled by Roche or any of its Affiliates as of the Effective Date or during the Term and (b) (i) used by or on behalf of Roche or any of its Affiliates to Exploit one or more Licensed Products or corresponding Sarepta Diagnostic Products or (ii) otherwise disclosed to Sarepta or any of its Affiliates at any meeting of the JSC or any Subcommittee (as documented in the minutes of such JSC or Subcommittee meeting) or otherwise in writing, in each case, in the conduct of activities under this Agreement by or on behalf of Roche or any of its Affiliates.

“Roche Background Patent Rights” means any and all Patent Rights (excluding the Roche Collaboration Patent Rights and Roche’s interest in the Joint Collaboration Patent Rights) that are (a) Controlled by Roche or any of its Affiliates as of the Effective Date or during the Term and (b) (i) used by or on behalf of Roche or any of its Affiliates to Exploit one or more Licensed Products or corresponding Sarepta Diagnostic Products and that Cover any Roche Background Know-How or (ii) that, without a license thereunder, would be infringed by the Exploitation of one or more Licensed Products or corresponding Sarepta Diagnostic Products in accordance with this Agreement.

“Roche Background Technology” means the Roche Background Know-How and Roche Background Patent Rights.

“Roche Collaboration Know-How” means any and all Collaboration Know-How developed or invented solely by Roche’s or any of its Affiliates’ or Sublicensees’ employees, agents, or independent contractors, or any Persons contractually required to assign or license such Collaboration Know-How to Roche or any Affiliate or Sublicensee of Roche.

“Roche Collaboration Patent Rights” means any and all Collaboration Patent Rights that Cover any Roche Collaboration Know-How.

“Roche Collaboration Technology” means any and all Roche Collaboration Know-How, Roche Collaboration Patent Rights, and Roche’s interest in the Joint Collaboration Technology.

“Roche Housemarks” means (a) all corporate logos of Roche or any of its Affiliates, (b) the trademark “Roche”, (c) any other Mark (whether registered or unregistered) containing the word “Roche”, (d) any other corporate logo or other Mark used by Roche or any of its Affiliates to identify Roche or its Affiliates, (e) all registrations and applications for registrations of the foregoing, and (f) all goodwill associated with any and all of the foregoing in clauses (a) through (e).

“Roche Indemnitees” has the meaning set forth in Section 13.1 (Indemnification by Sarepta).

“Roche Major Country” means, with respect to all Licensed Products, [**].

“Roche Medical Affairs Plan” has the meaning set forth in Section 7.1 (Medical Affairs Plans).

“Roche Technology” means Roche Background Technology and Roche Collaboration Technology.

“Roche Territory” means worldwide, excluding the Sarepta Territory.

“Roche Territory Branding and Marketing Plan” has the meaning set forth in Section 6.4 (Branding and Marketing Plans).

“Roche Territory Development Plan” means the plan setting forth (a) all Development activities, other than activities included in the Joint Global Development Plan, that are necessary or desirable to obtain and maintain Regulatory Approvals or Reimbursement Approvals of each Licensed Product and any corresponding Sarepta Diagnostic Product in the Roche Territory (including in each Roche Major Country for the applicable Licensed Product), including all proposed post-Regulatory Approval studies and all other non-clinical and pre-clinical studies and Clinical Trials, in each case, the data from which will be used solely for the Roche Territory and regulatory plans, and (b) the timelines for such activities, in each case ((a) and (b)), as the same may be amended from time-to-time in accordance with this Agreement.

“Roche Territory Development Program” means the program of Development activities conducted under the Roche Territory Development Plan, which will exclude any Development activities conducted under the Joint Global Development Program.

“ROW Region” means all countries and territories within the Roche Territory that are not included in Japan, the Asian Region, the Latin American Region, or the European Region.

“Royalties” has the meaning set forth in Section 9.5.2 (Royalty Payments for Licensed Products Other than the Lead Product).

“Royalty-Bearing Patent Rights” means, with respect to a Licensed Product in a country in the Roche Territory, [**].  

“Royalty Report” has the meaning set forth in Section 9.5.4(a) (Royalty Report).

“Royalty Term” means, as applicable, the Lead Product Royalty Term or the Other Product Royalty Term.

“Sales” has the meaning set forth in Section 1.166 (Net Sales).

“Sales Milestone Event” has the meaning set forth in Section 9.4.2 (Sales Milestones).

“Sales Milestone Payment” has the meaning set forth in Section 9.4.2 (Sales Milestones).

“Sarepta Collaboration Know-How” means any and all Collaboration Know-How developed or invented solely by Sarepta’s or any of its Affiliates’ employees, agents, or independent contractors, or any Persons contractually required to assign or license such Collaboration Know-How to Sarepta or any Affiliate of Sarepta.  

“Sarepta Collaboration Patent Rights” means any and all Collaboration Patent Rights that Cover any Sarepta Collaboration Know-How.

“Sarepta Diagnostic Products” means (a) any and all in vitro diagnostic tests or products that (i) are Controlled by Sarepta or its Affiliates at any time during the Term that are being developed, or have been indicated by the applicable Regulatory Authority, for use with any Licensed Products, and (ii) provide information essential to the safe and effective use of one or more Licensed Products or are otherwise necessary for the Regulatory Approval of any Licensed Products, and (b) [**].

“Sarepta Housemarks” means (a) the corporate logo of Sarepta or any of its Affiliates, (b) the trademark for “Sarepta,” (c) any other Marks (whether registered or unregistered) containing the word “Sarepta,” (d) any other corporate logo or other Mark used by Sarepta or any of its Affiliates to identify Sarepta or its Affiliates, (e) all registrations, applications for registrations, and other intellectual property rights associated with any of the foregoing, and (f) all goodwill associated with any and all of the foregoing in clauses (a) through (e).  A list of all Sarepta Housemarks existing as of the Effective Date and Sarepta’s form of trademark use authorization is set forth on Schedule 1.243.

“Sarepta Inability to Supply” means Roche’s reasonable belief that Sarepta will be unable to deliver to Roche or its designee sufficient supply of Licensed Product to meet the quantities set forth in the then-current Demand Forecast Plan for the Licensed Product allocated for [**].  

“Sarepta Indemnitees” has the meaning set forth in Section 13.2 (Indemnification by Roche).

“Sarepta Know-How” means any and all Know-How (excluding Sarepta’s interest in Joint Collaboration Know-How) that is (a) Controlled by Sarepta or any of its Affiliates as of the Effective Date or at any time during the Term and (b) (i) necessary or useful to Exploit one or more Licensed Products or Sarepta Diagnostic Products in the Field or (ii) otherwise disclosed to Roche or any of its Affiliates at any meeting of the JSC or any Subcommittee (as documented in the minutes of such JSC or Subcommittee meeting) or otherwise in writing, in each case, in the conduct of activities under this Agreement by or on behalf of Sarepta or any of its Affiliates. Sarepta Know-How includes all Sarepta Collaboration Know-How.  

“Sarepta Manufacturing Know-How” means, on a Licensed Product-by-Licensed Product basis, the Sarepta Know-How that is related to the Manufacture of the applicable Licensed Product that is the subject of a Supply Failure.

“Sarepta Medical Affairs Plan” has the meaning set forth in Section 7.1.3 (Sarepta Medical Affairs Plan).

“Sarepta-Owned Marks” has the meaning set forth in Section 10.16.2 (Ownership of Trademarks).

“Sarepta Patent Rights” means any and all Patent Rights (excluding Sarepta’s interest in Joint Collaboration Patent Rights) that are (a) Controlled by Sarepta or any of its Affiliates as of the Effective Date or at any time during the Term and (b) necessary or useful (or, with respect to patent applications, would be necessary or useful if such patent applications were to issue as patents) to Exploit one or more Licensed Products or Sarepta Diagnostic Products in the Field in the Roche Territory.  Sarepta Patent Rights include all Sarepta Collaboration Patent Rights.  All Sarepta Patent Rights as of the Execution Date are set forth on Schedule 1.250(Sarepta Patent Rights).

“Sarepta Product” means any Licensed Product or Option Product.

“Sarepta Technology” means the Sarepta Know-How, the Sarepta Patent Rights, and Sarepta’s interest in the Joint Collaboration Technology.

“Sarepta Territory” means the U.S.

“Sarepta Territory Branding and Marketing Plan” has the meaning set forth in Section 6.4 (Branding and Marketing Plans).

“Seller” has the meaning set forth in Section 1.166 (Net Sales).

“Shortage” means the inability of Sarepta and its CMOs to, or either Party’s reasonable belief that Sarepta and its CMOs are reasonably likely to be unable to, Manufacture the quantities of conforming Licensed Product contemplated in the then-current Demand Forecast Plan that are in excess of the quantities set forth in the then-current Capacity Plan.

“SRP-9001” means a gene therapy product that delivers to cells as a therapeutic agent a transgene that encodes and directly expresses dystrophin or a derivative thereof (such as micro-dystrophin or mini-dystrophin) Controlled by Sarepta or any of its Affiliates having [**].  SRP-9001 includes the product known as SRP-9001 or rAAVrh74.MHCK7.micro-dystrophin.

“Stock Purchase Agreement” means that certain Stock Purchase Agreement dated as of the Execution Date between Roche Finance Ltd and Sarepta Therapeutics, Inc.

“Subcommittee” has the meaning set forth in Section 3.2.1 (Formation; Authority).

“Subcontracting Party” has the meaning set forth in Section 2.3.3 (Subcontracting).

“Sublicense” has the meaning set forth in Section 2.3 (Rights to Grant Sublicenses).

“Sublicensee” means any Third Party to which (a) Sarepta or any of its Affiliates grants a sublicense under any of the rights granted to Sarepta under this Agreement or (b) Roche or any of its Affiliates grants a sublicense under any of the rights granted to Roche under this Agreement.  

“Supply Agreements” means the Development Supply Agreement and the Commercial Supply Agreement and the corresponding quality agreements fulfilling the requirements set forth in Schedule 1.263.

“Supply Failure” means (a) the failure of Sarepta or the CMOs engaged by Sarepta to [**].   

“Supply Price” has the meaning set forth in Section 8.7 (Supply Price).

“Term” has the meaning set forth in Section 14.1 (Term).

“Terminated Product” has the meaning set forth in Section 14.1 (Effects of Termination).

“Terminated Region” means each Region in the Roche Territory with respect to which this Agreement has been terminated pursuant to Section 14.2 (Termination for Breach), Section 14.3 (Termination by Roche for Convenience), or Section 14.6 (Cessation of Development and Commercialization), and if this Agreement is terminated in its entirety, then all Regions in the Roche Territory will be Terminated Regions.