EXHIBIT 10.51
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [**], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO SAREPTA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.
License, Collaboration, and Option Agreement
By and Between
Sarepta Therapeutics Three, LLC
and
F. Hoffmann-La Roche Ltd
Dated December 21, 2019
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Article 1 DEFINITIONS | 1 | ||
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Article 2 LICENSES | 26 | ||
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2.1 |
| Grant of Licenses to Roche | 26 |
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2.2 |
| Grant of License to Sarepta | 26 |
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2.3 |
| Sublicensing and Subcontracting Terms | 27 |
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2.4 |
| No Other Rights and Retained Rights | 28 |
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2.5 |
| In-Licenses | 29 |
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2.6 |
| Exclusivity | 30 |
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2.7 |
| Option | 30 |
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2.8 |
| Rights of First Negotiation | 33 |
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Article 3 GOVERNANCE | 35 | ||
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3.1 |
| Joint Steering Committee | 35 |
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3.2 |
| Subcommittees | 37 |
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3.3 |
| Joint Development Committee | 38 |
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3.4 |
| Joint Commercialization Committee | 39 |
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3.5 |
| Joint Manufacturing Committee | 40 |
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3.6 |
| Additional Participants | 41 |
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3.7 |
| Decision-Making | 41 |
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3.8 |
| Resolution of Committee Disputes | 42 |
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3.9 |
| Alliance Managers | 43 |
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Article 4 DEVELOPMENT | 43 | ||
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4.1 |
| Overview | 43 |
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4.2 |
| Development Diligence Obligations | 44 |
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4.3 |
| Global Development Plans | 44 |
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4.4 |
| Roche Territory Development Plan | 46 |
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4.5 |
| Development Cost Sharing | 47 |
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4.6 |
| Development Reports | 47 |
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4.7 |
| Development Records | 48 |
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TABLE OF CONTENTS (continued)
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Article 5 REGULATORY AFFAIRS | 48 | ||
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5.1 |
| Orphan Drug Designation | 48 |
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5.2 |
| Regulatory Responsible Party | 48 |
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5.3 |
| Collaboration With Respect to Regulatory Interactions | 48 |
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5.4 |
| Regulatory Meetings | 49 |
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5.5 |
| Cooperation | 49 |
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5.6 |
| Assignment of Regulatory Submissions and Regulatory Approvals to Roche | 50 |
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5.7 |
| Cost of Regulatory Activities | 50 |
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5.8 |
| Right of Reference | 50 |
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5.9 |
| Pharmacovigilance and Adverse Event Reporting | 50 |
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5.10 |
| Recall, Withdrawal, or Field Alerts | 51 |
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Article 6 COMMERCIALIZATION | 52 | ||
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6.1 |
| Commercialization Responsibilities for Licensed Product | 52 |
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6.2 |
| Commercialization Reporting | 52 |
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6.3 |
| Pricing | 52 |
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6.4 |
| Branding and Marketing Plans | 53 |
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6.5 |
| Roche Commercialization Diligence Obligations | 53 |
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6.6 |
| Standards of Conduct; Compliance | 54 |
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6.7 |
| Diversion | 54 |
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Article 7 MEDICAL AFFAIRS | 54 | ||
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7.1 |
| Medical Affairs Plans | 54 |
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7.2 |
| Medical Affairs Activities | 55 |
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7.3 |
| Medical Affairs Cost Sharing | 55 |
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Article 8 MANUFACTURING AND SUPPLY | 56 | ||
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8.1 |
| General. | 56 |
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8.2 |
| Capacity Plan | 56 |
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| Initial Forecasts | 56 | |
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| Demand Forecast Plans | 57 | |
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8.6 |
| Supply Agreements | 57 |
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8.8 |
| Manufacturing Plan | 58 |
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8.9 |
| Audit | 59 |
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8.10 |
| Shortage and Supply Failure | 59 |
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TABLE OF CONTENTS (continued)
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8.11 |
| Technology Transfer | 60 |
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Article 9 PAYMENTS | 61 | ||
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9.1 |
| Upfront Payment | 61 |
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9.2 |
| Equity Investment | 61 |
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9.3 |
| Option Exercise Fees | 61 |
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9.4 |
| Milestone Payments | 61 |
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9.5 |
| Royalties | 65 |
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9.6 |
| Accounting; Audit | 67 |
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9.7 |
| No Refunds | 67 |
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9.8 |
| Currency Conversion | 68 |
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9.9 |
| Blocked Payments | 68 |
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9.10 |
| Method of Payment | 68 |
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9.11 |
| Taxes | 68 |
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9.12 |
| Late Payments; Disputed Payments | 68 |
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Article 10 INTELLECTUAL PROPERTY | 69 | ||
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10.1 |
| Patent Filing | 69 |
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10.2 |
| Ownership | 69 |
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10.3 |
| Disclosure; Inventorship | 70 |
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10.4 |
| IP Committee | 70 |
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10.5 |
| Prosecution of Sarepta Patent Rights | 71 |
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10.6 |
| Prosecution of Joint Collaboration Patent Rights | 72 |
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10.7 |
| Prosecution of Option Product Patent Rights | 73 |
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10.8 |
| Prosecution of Roche Collaboration Patent Rights | 74 |
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10.9 |
| Enforcement Against Third Party Infringement or Misappropriation | 74 |
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10.10 |
| Defense of Third Party Patent Challenges | 76 |
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10.11 |
| Third Party Infringement Claims | 77 |
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10.12 |
| Patent Challenges of Third Party Patent Rights | 78 |
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10.13 |
| Patent Term Extensions | 78 |
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10.14 |
| Unified Patent Court | 78 |
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10.15 |
| Common Interest | 78 |
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10.16 |
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TABLE OF CONTENTS (continued)
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Article 11 REPRESENTATIONS, WARRANTIES, AND COVENANTS | 81 | ||
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11.1 |
| Mutual Representations and Warranties | 81 |
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11.2 |
| Additional Sarepta Warranties | 82 |
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11.3 |
| Additional Roche Warranties | 84 |
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11.4 |
| Additional Covenants | 84 |
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11.5 |
| Additional Covenants of Sarepta | 85 |
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11.6 |
| Additional Covenants of Roche | 85 |
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11.7 |
| Time For Claims | 85 |
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11.8 |
| Disclaimer | 85 |
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11.9 |
| Limitation of Liability | 85 |
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Article 12 CONFIDENTIALITY | 86 | ||
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12.1 |
| Duty of Confidence | 86 |
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12.2 |
| Confidential Information | 86 |
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12.3 |
| Exemptions | 86 |
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12.4 |
| Authorized Disclosures | 87 |
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12.5 |
| Tax Treatment | 88 |
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12.6 |
| Publications | 88 |
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12.7 |
| Publication and Listing of Clinical Trials | 89 |
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12.8 |
| Publicity; Use of Names | 89 |
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12.9 |
| Attorney-Client Privilege | 91 |
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Article 13 INDEMNIFICATION | 91 | ||
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13.1 |
| Indemnification by Sarepta | 91 |
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13.2 |
| Indemnification by Roche | 92 |
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13.3 |
| Indemnification Procedure | 92 |
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13.4 |
| Insurance | 93 |
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Article 14 TERM AND TERMINATION | 93 | ||
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14.1 |
| Term | 93 |
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14.2 |
| Termination for Breach | 93 |
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| Termination by Roche for Convenience | 94 | |
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| Termination for Bankruptcy | 94 | |
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| Cessation of Development and Commercialization | 95 | |
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14.7 |
| Patent Challenges | 95 |
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TABLE OF CONTENTS (continued)
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| Effects of Termination | 95 | |
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| Effects of Expiration | 99 | |
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| Survival; Accrued Rights | 100 | |
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Article 15 EFFECTIVENESS | 100 | ||
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15.1 |
| Effective Date | 100 |
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15.2 |
| Filings | 100 |
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15.3 |
| Outside Date | 101 |
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Article 16 DISPUTE RESOLUTION; GOVERNING LAW | 101 | ||
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16.1 |
| Executive Officers; Disputes | 101 |
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16.2 |
| Jurisdiction; Venue | 101 |
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16.3 |
| Intellectual Property Disputes | 101 |
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16.4 |
| Equitable Remedies | 102 |
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16.5 |
| Governing Law; English Language | 102 |
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16.6 |
| Waiver of Jury Trial | 102 |
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Article 17 MISCELLANEOUS | 102 | ||
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17.1 |
| Assignment | 102 |
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17.2 |
| Entire Agreement; Amendment | 103 |
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17.3 |
| No Strict Construction; Interpretation | 103 |
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17.4 |
| Severability | 104 |
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17.5 |
| Notices | 104 |
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17.6 |
| Further Assurances | 105 |
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17.7 |
| Performance by Affiliates | 105 |
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17.8 |
| Exit of the United Kingdom from EU | 105 |
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17.9 |
| Agency | 105 |
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17.10 |
| Binding Effect; No Third Party Beneficiaries or Obligors | 105 |
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17.11 |
| Compliance with Export Regulations | 105 |
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17.12 |
| No Waiver | 105 |
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17.13 |
| Cumulative Remedies | 105 |
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17.14 |
| Bankruptcy | 106 |
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17.15 |
| Counterparts | 106 |
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| LGMD Diligence Package | |
| Option Data Package Information | |
| Sarepta Housemarks | |
| Sarepta Patent Rights | |
Schedule 2.5.1 |
| Existing In-Licenses |
Schedule 4.3.1 |
| Joint Global Development Plan |
Schedule 11.6.2 |
| Compliance Policies |
Schedule 12.8.1(a) |
| Roche Initial Press Release |
Schedule 12.8.1(b) |
| Sarepta Initial Press Release |
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License, Collaboration, And Option Agreement
This License, Collaboration, and Option Agreement (this “Agreement”) is made and entered into as of December 21, 2019 (the “Execution Date”) between Sarepta Therapeutics Three LLC, a limited liability company organized and existing under the laws of the State of Delaware, United States of America, with its principal offices at 215 First Street, Cambridge, MA, 02142 (“Sarepta”) and F. Hoffmann-La Roche Ltd, a company organized and existing under the laws of Switzerland, with its principal office at Grenzacherstrasse 124, 4070 Basel, Switzerland (“Roche”).
Sarepta and Roche may be referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Sarepta is the owner of, or otherwise Controls, the Sarepta Technology, the Option Product Know-How, the Option Product Patent Rights, the Sarepta Products, and the Sarepta Diagnostic Products;
WHEREAS, Roche (itself and through its Affiliates) has expertise in the development of biopharmaceutical products and has regulatory, development, and commercial capabilities in the Roche Territory; and
WHEREAS, the Parties desire to collaborate to Develop, perform Medical Affairs for, and Commercialize the Licensed Products, and Sarepta wishes to grant Roche and Roche wishes to receive an exclusive license to Develop, perform Medical Affairs for, and Commercialize the Licensed Products in the Roche Territory and Sarepta wishes to grant Roche and Roche wishes to receive an exclusive option to acquire an exclusive license to Develop, perform Medical Affairs for, and Commercialize the Option Products in the Roche Territory, in each case, as set forth in, and subject to the terms of, this Agreement.
NOW THEREFORE, the Parties agree as follows:
1.1 | “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. |
1.3 | “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. |
1.10 | “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. |
1.13 | “Asian Region” means all countries and territories of Asia other than (a) the Russian Federation, (b) the Middle Eastern Countries, and (c) Japan. |
1.14 | “Average Supply Price” has the meaning set forth in Section 8.7 (Supply Price). |
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1.18 | “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. |
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1.28 | “Collaboration Patent Rights” means any and all Patent Rights that Cover any Collaboration Know-How. |
1.32 | “Competing Acquisition Program” has the meaning set forth in Section 2.6.2 (Acquisitions of Third Parties). |
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1.37 | “Confidential Disclosure Agreement” has the meaning set forth in Section 17.2 (Entire Agreement; Amendment). |
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1.45 | “Debarred/Excluded” has the meaning set forth in Section 11.1.11 (Mutual Representations and Warranties). |
1.46 | “Demand Forecast Plans” has the meaning set forth in Section 8.3.2 (Development Demand Forecast Plan). |
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1.62 | “[**] Development Costs” means the Development Costs incurred by or on behalf of Sarepta in the course of [**]. |
1.66 | “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. |
1.68 | “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). |
1.69 | “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). |
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1.70 | “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). |
1.71 | “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). |
1.80 | “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. |
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1.85 | “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). |
1.86 | “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). |
1.88 | “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. |
1.89 | “Gene-Editing Sales Milestone Events” has the meaning set forth in Section 9.4.6 (Sales Milestones for Gene-Editing Licensed Products). |
1.90 | “Gene-Editing Sales Milestone Payments” has the meaning set forth in Section 9.4.6 (Sales Milestones for Gene-Editing Licensed Products). |
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1.93 | “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). |
1.94 | “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). |
1.95 | “[**]” means [**]. |
1.96 | “[**] Agreement” means that certain Clinical Research Collaboration and License Agreement, dated as of [**], by and between [**] and Sarepta Therapeutics [**]. |
1.99 | “Global Development Program” means the Joint Global Development Program and the Option Product Development Program. |
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1.111 | “Initiation” means with respect to any Clinical Trial, first dosing of the first human subject in such Clinical Trial. |
1.112 | “Insufficient Supply Event” has the meaning set forth in Section 8.10.3(b) (Insufficient Quantities; To Meet Demand Under the Capacity Plan). |
1.114 | “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). |
1.120 | “Joint Collaboration Patent Rights” means any and all Collaboration Patent Rights that Cover any Joint Collaboration Know-How. |
1.121 | “Joint Collaboration Technology” means the Joint Collaboration Know-How and the Joint Collaboration Patent Rights. |
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1.122 | “Joint Global Branding and Marketing Strategy” has the meaning set forth in Section 6.4 (Branding and Marketing Plans). |
1.125 | “Joint Global Development Program” means the program of Development activities conducted under the Joint Global Development Plan. |
1.126 | “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. |
1.127 | “Joint Global Medical Affairs Plan” has the meaning set forth in Section 7.1 (Medical Affairs Plan). |
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1.134 | “Lead Product” means SRP-9001, in any dosage strength, concentration, or formulation Controlled by Sarepta or any of its Affiliates. |
1.135 | “Lead Product Regulatory Milestone Event” has the meaning set forth in Section 9.4.1 (Lead Product Regulatory Milestones). |
1.136 | “Lead Product Regulatory Milestone Payment” has the meaning set forth in Section 9.4.1 (Lead Product Regulatory Milestones). |
1.137 | “Lead Product Royalties” has the meaning set forth in Section 9.5.1 (Royalty Payments For Lead Product). |
1.138 | “Lead Product Royalty Rates” has the meaning set forth in Section 9.5.1 (Royalty Payments For Lead Product). |
1.139 | “Lead Product Royalty Term” has the meaning set forth in Section 9.5.1 (Royalty Payments For Lead Product). |
1.140 | “Lead Product Sales Milestone Events” has the meaning set forth in Section 9.4.5 (Sales Milestones). |
1.141 | “Lead Product Sales Milestone Payments” has the meaning set forth in Section 9.4.5 (Sales Milestones). |
1.143 | “LGMD Evaluation Period” has the meaning set forth in Section 2.8.3 (LGMD ROFN Evaluation Period). |
1.144 | “LGMD Initial Response” has the meaning set forth in Section 2.8.3 (LGMD ROFN Evaluation Period). |
1.147 | “LGMD ROFN Negotiation Period” has the meaning set forth in Section 2.8.4 (LGMD ROFN Exercise). |
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1.156 | “Manufacturing Transition Notice” has the meaning set forth in Section 8.11.1 (Request for Technology Transfer). |
1.157 | “Manufacturing Transition Period” has the meaning set forth in Section 8.11.2 (Manufacturing Transition Period). |
1.158 | “Manufacturing Transition Plan” has the meaning set forth in Section 8.11.2 (Manufacturing Transition Period). |
1.164 | “Milestone Events” has the meaning set forth in Section 9.4.7 (Notification of Milestone Events). |
1.165 | “Milestone Payments” has the meaning set forth in Section 9.4.7 (Notification of Milestone Events). |
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Sales for such Licensed Product will be reflective of bona fide, arms length transactions, as determined in accordance with the then-currently used applicable Accounting Standards. As such, the following will not be considered a Sale or count toward Net Sales: [**]. Also by way of example, the gross-to-net deductions of Sales in accordance with Accounting Standards as of the Effective Date are the following:
| (b) | [**]; |
| (c) | [**]; and |
| (d) | [**]. |
To the extent that any Seller receives consideration other than or in addition to cash upon the Sale of a Licensed Product, or in consideration of the performance of any services (including preliminary treatments or follow-up treatments) related to such Licensed Product, Net Sales will include the fair market value of such additional consideration.
1.168 | “OFAC” means the Office of Foreign Assets Control of the United States Department of the Treasury or any successor agency thereto. |
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1.175 | “Option Product Development Program” means the program of Development activities conducted under the Option Product Development Plan. |
1.180 | “Other Covered Party” means any political party or party official, or any candidate for political office, in each case, in any jurisdiction. |
1.181 | “Other Product Royalties” has the meaning set forth in Section 9.5.2 (Royalty Payments for Licensed Products other than Lead Product). |
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1.182 | “Other Product Royalty Term” has the meaning set forth in Section 9.5.2 (Royalty Payments for Licensed Products Other than the Lead Product). |
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1.195 | “Proof of Concept Trial” means a Clinical Trial (including any portion thereof) of an Option Product [**]. |
1.197 | “Prosecuting Party” has the meaning set forth in Section 10.6.1 (Filing of Joint Collaboration Patent Rights). |
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1.203 | “Region” means any of the Asian Region, the European Region, the Latin American Region, Japan, or the ROW Region. |
1.208 | “Regulatory Expert Matter” has the meaning set forth in Section 4.3.1 (Joint Global Development Plan). |
1.209 | “Regulatory Milestone Event” has the meaning set forth in Section 9.4.1 (Regulatory Milestones). |
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1.210 | “Regulatory Milestone Payment” has the meaning set forth in Section 9.4.1 (Regulatory Milestones). |
1.214 | “Restricted Party” means any individual or entity on one or more of the Restricted Party Lists. |
1.216 | “Right of Reference” has the meaning set forth in Section 5.6 (Assignment of Regulatory Submissions and Regulatory Approvals to Roche). |
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1.219 | “Roche Background Technology” means the Roche Background Know-How and Roche Background Patent Rights. |
1.221 | “Roche Collaboration Patent Rights” means any and all Collaboration Patent Rights that Cover any Roche Collaboration Know-How. |
1.222 | “Roche Collaboration Technology” means any and all Roche Collaboration Know-How, Roche Collaboration Patent Rights, and Roche’s interest in the Joint Collaboration Technology. |
1.229 | “Roche Territory Branding and Marketing Plan” has the meaning set forth in Section 6.4 (Branding and Marketing Plans). |
1.232 | “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. |
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1.233 | “Royalties” has the meaning set forth in Section 9.5.2 (Royalty Payments for Licensed Products Other than the Lead Product). |
1.234 | “Royalty-Bearing Patent Rights” means, with respect to a Licensed Product in a country in the Roche Territory, [**]. |
1.236 | “Royalty Term” means, as applicable, the Lead Product Royalty Term or the Other Product Royalty Term. |
1.241 | “Sarepta Collaboration Patent Rights” means any and all Collaboration Patent Rights that Cover any Sarepta Collaboration Know-How. |
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1.248 | “Sarepta Medical Affairs Plan” has the meaning set forth in Section 7.1.3 (Sarepta Medical Affairs Plan). |
1.252 | “Sarepta Technology” means the Sarepta Know-How, the Sarepta Patent Rights, and Sarepta’s interest in the Joint Collaboration Technology. |
1.254 | “Sarepta Territory Branding and Marketing Plan” has the meaning set forth in Section 6.4 (Branding and Marketing Plans). |
1.258 | “Stock Purchase Agreement” means that certain Stock Purchase Agreement dated as of the Execution Date between Roche Finance Ltd and Sarepta Therapeutics, Inc. |
1.259 | “Subcommittee” has the meaning set forth in Section 3.2.1 (Formation; Authority). |
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1.263 | “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. |
1.273 | “Third Party Patent Challenge” has the meaning set forth in Section 10.10 (Defense of Third Party Patent Challenges). |
1.278 | “United States” or “U.S.” means the United States of America (including all possessions and territories thereof, including Puerto Rico). |
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For clarity, the exclusivity obligations set forth in this Section 2.6.1 (Exclusivity Obligation) does not apply to any Licensed Products under this Agreement.
| (a) | Exon-Skipping Products Data Package. With regard to the Exon-Skipping Products, Sarepta will deliver to Roche an Option Data Package for all Exon-Skipping Products [**]. |
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| (c) | Gene Therapy Option Product Data Packages. With regards to Gene Therapy Option Products, on a Gene Therapy Option Product-by-Gene Therapy Option Product basis, [**], Sarepta will deliver to Roche an Option Data Package for such Gene Therapy Option Product. |
| 2.7.4 | Effect of Option Exercise. |
| (b) | For Gene-Editing Option Products. Upon Roche’s exercise of the Option for any Gene-Editing Option Product in accordance with Section 2.7.3 (Exercise of Option), from and after the date of receipt of the Option Exercise Fee for each such Gene-Editing Option Product, such Option Product will be a Licensed Product, and no longer a Gene-Editing Option Product, for all purposes of this Agreement. |
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| (d) | Sarepta Patent Rights and Patent Prosecution. Upon the exercise of the Option for an Option Product by Roche in accordance with Section 2.7.3 (Exercise of Option), the Option Product Patent Rights that are necessary or useful to Exploit such Licensed Product in the Roche Territory will become Sarepta Patent Rights, and the prosecution of such Patent Rights shall be governed by Section 10.5 (Prosecution of Sarepta Patent Rights) thereafter. |
| (e) | Sarepta Know-How. Upon the exercise of the Option for an Option Product by Roche in accordance with Section 2.7.3 (Exercise of Option), the Option Product Know-How that is necessary or useful to Exploit such Licensed Product will become Sarepta Know-How for all purposes under this Agreement. |
| (f) | Updates to the Development Plans. No later than 30 days following Sarepta’s receipt of the Option Exercise Notice for the Exon-Skipping Products or any Gene-Editing Option Product or Gene Therapy Option Product, Roche will provide to the JDC in accordance with Section 4.4 (Roche Territory Development Plan) an update to the Roche Territory Development Plan that includes such Option Products ([**]). In addition, following such exercise of the Option for such Option Products ([**]), in accordance with Section 4.3.1 (Joint Global Development Plan), the JDC will update the Joint Global Development Plan to include such Option Products ([**]) and until the JSC approves such an update, all activities relating to such Option Products ([**]) and any corresponding Sarepta Diagnostic Products under the Option Product Development Plan will be deemed to be included in the Joint Global Development Plan as activities relating to such Option Product and Sarepta Diagnostic Products. |
| (g) | Addition of [**] to the Development Plans. Reasonably in advance of, but at least [**] prior to, the [**], Sarepta will provide written notice to Roche of the planned commencement of such activities. No later than [**] following Roche’s receipt of such written notice from Sarepta, Roche will [**]. In addition, following such written notice from Sarepta to Roche, [**]. |
| 2.7.5 | Termination of Option. If (a) Roche does not deliver to Sarepta the Option Exercise Notice for the Exon-Skipping Products or any Gene-Editing Option Product or Gene Therapy Option Product, as applicable, prior to the expiration of the Option Exercise Period for such Exon-Skipping Products or such other Gene-Editing Option Product or Gene Therapy Option Product, (b) Roche exercises the Option for the Exon-Skipping Products or any other Gene-Editing Option Product or Gene Therapy Option Product but does not pay to Sarepta the applicable Option Exercise Fee in accordance with Section 9.3 (Option Exercise Fees), or (c) Roche notifies Sarepta in writing that it does not wish to exercise the Option for the Exon-Skipping Products or any Gene-Editing Option Product or Gene Therapy Option Product, then in each case ((a) – (c)), the Option with respect to the Exon-Skipping Products or such other Gene-Editing Option Product or any Gene Therapy Option Product, as applicable, will terminate and Roche will no longer have any rights under this Agreement with respect to such Exon-Skipping Products or such other Gene-Editing Option Product or Gene Therapy Option Product, as applicable. |
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Following receipt of the LGMD Diligence Package, Roche will have [**] to (a) notify Sarepta if such LGMD Diligence Package is missing any information that Roche reasonably needs in order to evaluate whether or not to exercise the DMD ROFN, which notice will describe the information that Roche believes is missing from such LGMD Diligence Package. If and to the extent in Sarepta’s possession and Control, Sarepta will provide Roche with the missing information identified in such notice no later than [**] after the date of Roche’s request therefor and in such case, the LGMD Evaluation Period will be extended to the extent necessary such that there are [**] from the date of receipt of such information remaining prior to the expiration of the LGMD Evaluation Period. In addition, until expiry of the applicable LGMD Evaluation Period Roche shall have the right to ask questions to Sarepta relating to the LGMD Diligence Package, and Sarepta shall use reasonable efforts to respond to all such reasonable questions of Roche.
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3.1 | Joint Steering Committee. |
| 3.1.2 | Membership. Each Party will designate up to [**] representatives with appropriate knowledge, expertise, and decision-making authority to serve as members of the JSC; provided that [**]. Each Party may replace its JSC representatives at any time upon written notice to the other Party. Sarepta will designate one of its JSC members as one of the co-chairpersons of the JSC and Roche will designate one of its members as the other co-chairperson of the JSC. For each Calendar Year, the Alliance Managers will alternate serving in the role of “lead Alliance Manager” with respect to the JSC. The lead Alliance Manager or his or her designee, in collaboration with the co-chairpersons, will be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting, and preparing and issuing minutes of each meeting within 30 days thereafter. Such minutes will be finalized upon endorsement by all JSC members. |
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| 3.1.4 | Meeting Agendas. The JSC meeting agenda for each meeting of the JSC will be finalized at least [**] Business Days in advance of such meeting, or such other shorter time period as the circumstances allow in the case of an ad-hoc meeting. |
| (a) | manage the overall strategic alignment between the Parties under this Agreement and maintain the relationship between the Parties; |
| (b) | [**]; |
| (c) | approve any material update to the Joint Global Development Plan or Joint Global Development Budget (as described in Section 4.3.1 (Joint Global Development Plans)); |
| (d) | review and discuss the initial Option Product Development Plan and any material update to the Option Product Development Plan (as described in Section 4.3.2 (Option Product Development Plans)); |
| (e) | approve the initial Roche Territory Development Plan and any material updates thereto (as described in Section 4.4 (Roche Territory Development Plan)); |
| (f) | approve any matters related to the Development of the Licensed Products or Medical Affairs activities with respect to the Licensed Products referred to the JSC by the JDC; |
| (g) | approve the initial Joint Global Medical Affairs Plan, the initial Joint Global Medical Affairs Budget, the initial Roche Medical Affairs Plan, and the initial Sarepta Medical Affairs Plan, and any material updates to any of the foregoing (in each case, as described in Section 7.1 (Medical Affairs Plans)); |
| (h) | approve the initial Development Demand Forecast Plan created by the JMC and any material updates to the Development Demand Forecast Plans (as described in Section 8.1 (Forecast)); |
| (i) | approve the initial Capacity Plan and any material updates thereto (as described in Section 8.2 (Capacity Plan)); |
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| (j) | approve the initial Manufacturing Plan and any material updates thereto (as described in Section 8.8 (Manufacturing Plan)); |
| (k) | approve, if applicable, the Manufacturing Transition Plan, as described in Section 8.11.2 (Manufacturing Transition Period); |
| (l) | approve the Joint Global Branding and Marketing Strategy and any material updates thereto (as described in Section 6.4 (Branding and Marketing Plans)); |
| (n) | approve any matters related to the Commercialization of the Licensed Products in the Roche Territory and the Sarepta Territory referred to the JSC by the JCC; |
| (o) | approve any matters related to the Manufacture of the Licensed Products referred to the JSC by the JMC; |
| (q) | approve the initial Joint Publication Strategy and updates thereto (as described in Section 12.6 (Publications)); |
3.2 | Subcommittees. |
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3.3 | Joint Development Committee. |
| 3.3.2 | Membership of the JDC. Each Party will designate up to [**] representatives with appropriate knowledge, expertise, and decision-making authority to serve as members of the JDC; provided that [**]. Each Party may replace its JDC representatives and co-chairpersons at any time upon written notice to the other Party. The Alliance Manager of each Party (or his or her designee) may attend meetings of the JDC as a non-voting participant. |
| (a) | oversee all Development activities and Medical Affairs activities for the Licensed Products under this Agreement in the Territory; |
| (b) | (i) review and discuss the initial Joint Global Development Plan, the initial Joint Global Development Budget (as described in Section 4.3.1 (Joint Global Development Plan)), (ii) prepare all updates to the Joint Global Development Plan (such as country and Clinical Trial site selection in the Roche Territory) and the Joint Global Development Budget (as described in Section 4.3.1 (Joint Global Development Plan)), and (iii) refer any material update to the Joint Global Development Plan or Joint Global Development Budget to the JSC to approve; |
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The first such review and discussion by the Joint Medical Affairs Team shall occur no later than [**] following the Effective Date with respect to any Lead Product and no later than [**] following exercise of the Option with respect to the Exon-Skipping Products or any other Option Product. Any subsequent review and approval, to the extent required, will occur annually thereafter at an appropriate time as agreed by the JDC, or more frequently as may be required during the Term.
| (d) | review and discuss the initial Option Product Development Plan (as described in Section 4.3.2 (Option Product Development Plan)); |
| (e) | review and discuss the initial Roche Territory Development Plan and all updates to the foregoing (as described in Section 4.4 (Roche Territory Development Plan)), and (ii) refer the initial Roche Territory Development Plan and all material updates thereto to the JSC to approve; |
| (f) | review and discuss the overall strategy regarding Regulatory Approval of each Licensed Product throughout the Sarepta Territory and Roche Territory, and oversee the implementation of, and discuss the progress regarding, the same; |
| (g) | review and discuss principal issues raised in each Material Communication with Regulatory Authorities with respect to the Licensed Products throughout the Sarepta Territory and Roche Territory; |
| (h) | share information related to, and review and discuss activities and progress under, the Joint Global Development Plan and the Roche Territory Development Plan, including through updates from each Party of the status of Development for the Licensed Products in each Party’s Territory, as described in Section 4.6 (Development Reports); |
| (i) | share information related to, and review and discuss activities and progress under, the Option Product Development Plan, including through updates from Sarepta of the status of Development for the Option Products, as described in Section 4.6 (Development Reports); |
| (j) | review and discuss [**] and refer such matter to the JSC to approve; |
| (l) | review and discuss the initial Joint Publication Strategy and updates thereto (as described in Section 12.6 (Publications)) and refer the initial Joint Publication Strategy and all updates thereto to the JSC to approve. |
3.4 | Joint Commercialization Committee. |
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| (a) | oversee all Commercialization activities for the Licensed Products in the Territory; |
| (b) | attempt to resolve any disputes or disagreements arising from matters within the jurisdiction of the IP Committee with respect to the Product Marks and associated usage instructions in the Roche Territory and escalate any such matters to the JSC for resolution if needed; |
| (d) | review and discuss the Roche Territory Branding and Marketing Plan and the Sarepta Territory Branding and Marketing Plan and all updates thereto; |
| (e) | oversee the implementation of, and discuss the progress regarding, Commercialization of the Licensed Products in the Territory; and |
| (f) | review and discuss updates provided by each Party regarding such Party’s Commercialization activities for the Licensed Products in each Party’s respective Territory, as described in Section 6.2 (Commercialization Reporting). |
3.5 | Joint Manufacturing Committee. |
| 3.5.2 | Membership of the JMC. Each Party will designate up to [**] representatives with appropriate knowledge, expertise, and decision-making authority to serve as members of the JMC; provided that [**]. Each Party may replace its JMC representatives and co-chairpersons at any time upon written notice to the other Party. The Alliance Manager of each Party (or his or her designee) may attend meetings of the JMC as a non-voting participant. |
| (a) | Oversee all aspects of the Manufacture of the Licensed Products under the Supply Agreements, including product specifications and quality; |
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| (b) | oversee interim supply arrangements for Licensed Products in the Roche Territory prior to the Parties’ execution of the Supply Agreements; |
| (c) | discuss planning, construction, qualification, and operating of manufacturing sites of the CMOs; |
| (d) | (i) prepare the initial Development Demand Forecast Plan and all updates thereto (as described in Section 8.1 (Initial Forecast)), and (ii) refer the initial Development Demand Forecast Plan and any material update to the Development Demand Forecast Plan to the JSC to approve; |
| (g) | prepare, if applicable, the Manufacturing Transition Plan, as described in Section 8.11.2 (Manufacturing Transition Period), and refer such Manufacturing Transition Plan to the JSC to approve; and |
3.6 | Additional Participants. At the request of a Party, other employees of such Party or any of its Affiliates involved in the Exploitation of the Sarepta Products may attend meetings of the JSC or any Subcommittee as non-voting participants. In addition, with the consent of each Party, consultants, representatives, or advisors involved in the same activities and under written obligations of confidentiality and non-use applicable to the Confidential Information of each Party that are at least as stringent as those set forth in Article 12 (Confidentiality) may attend meetings of the JSC or any Subcommittee as non-voting observers. |
| 3.7.1 | General Decision-Making Process. Each Party’s representatives on the JSC and each Subcommittee will, collectively, have one vote (the “Party Vote”) on all matters brought before such committee for a decision by consensus. The JSC and each Subcommittee will make decisions as to matters within its jurisdiction by unanimous Party Vote, which will be reflected in the minutes of the committee meeting. Except as otherwise expressly set forth in this Agreement, the words “determine” or “approve” by the JSC or any Subcommittee and similar phrases used in this Agreement will mean approval in accordance with this Section 3.7 (Decision-Making) and Section 3.8 (Resolution of Committee Disputes). For the avoidance of doubt, matters that are specified in Section 3.1.5 (Specific Responsibilities of the JSC), Section 3.3.3 (Specific Responsibilities of the JDC), Section 3.4.3 (Specific Responsibilities of the JCC), or Section 3.5.3 (Specific Responsibilities of the JMC) to be reviewed and discussed (as opposed to approved) do not require any agreement by the JSC or any Subcommittee and are not subject to the voting and decision making procedures set forth in this Section 3.7 (Decision-Making) or Section 3.8 (Resolution of Committee Disputes). |
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| (b) | Sarepta Final Decision Making Authority. Subject to Section 3.8.3 (Limitation on Decision-Making), Sarepta will have final decision making authority over [**]. |
| (c) | Roche Final Decision Making Authority. Subject to Section 3.8.3 (Limitation on Decision-Making), Roche will have final decision making authority over [**]. |
4.1 | Overview. As between the Parties and in accordance with this Agreement, (a) Sarepta will be the Party that performs all Development activities set forth in the Joint Global Development Plan for the Licensed Products and all Development activities for all Option Products worldwide, and (b) Roche will be the Party that performs all Development activities set forth in the Roche Territory Development Plan for the Licensed Products. Each Party will conduct all Development activities for which it is responsible under this Agreement in a good scientific manner, in accordance with GLP and GCP, as applicable, and in compliance with Professional Requirements and Applicable Law. |
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| 4.2.1 | Of Sarepta. Sarepta will use Commercially Reasonable Efforts to carry out the activities under the Joint Global Development Program in accordance with the Joint Global Development Plan. |
| 4.2.4 | Mitigation of Development Diligence Obligations. [**]. |
4.3 | Global Development Plans. |
| (b) | Initial Joint Global Development Plan and Updates. The initial Joint Global Development Plan, including the initial Joint Global Development Budget, is set forth on Schedule 4.3.1. On or before March 31st of each Calendar Year during the Term (and more frequently as may be necessary and determined by the JDC during the Term), the JDC will prepare an update to the Joint Global Development Plan to include the Development activities within the Joint Global Development Program to be conducted during the following Calendar Year, together with the updated Joint Global Development Budget associated with such update to the Joint Global Development Plan. In addition, from time to time during the Term, either Party may submit to the JDC any proposed update to the Joint Global Development Plan to include additional Development activities within the Joint Global Development Program (or otherwise update such Development activities or propose updates to the applicable Joint Global Development Budget), including [**], a “Regulatory Expert Matter”). |
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| (d) | Review and Approval of Updates to the Joint Global Development Plan. The JDC will review and discuss each update to the Joint Global Development Plan and will submit any such updates that are material (including any update that contemplates the initial Development activities to be performed thereunder for an Option Product that becomes a Licensed Product following Roche’s exercise of the Option for such product and any material update proposed by either Party) to the JSC for approval. Once reviewed and discussed by the JDC and approved by the JSC, each update to the Joint Global Development Plan (including any update to the Joint Global Development Budget) will become effective and supersede the previous Joint Global Development Plan or Joint Global Development Budget, as applicable, as of the date of such approval or at such other time as decided by the JSC. |
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| 4.5.2 | Option Product Development Costs. Sarepta will be solely responsible for all costs and expenses incurred in connection with the performance of the Option Product Development Program. |
| 4.5.3 | Roche Territory Development Program Costs. Roche will be solely responsible for all costs and expenses incurred in connection with the performance of the Roche Territory Development Program. |
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Article 5
REGULATORY AFFAIRS
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| (or summaries thereof), and (b) summaries of any material oral communications with (i) the FDA and the Regulatory Authorities in each Roche Major Country and (ii) upon Sarepta’s reasonable request, Regulatory Authorities in other countries in the Roche Territory, in each case ((a) and (b)), relating to Regulatory Submissions for a Licensed Product or a corresponding Sarepta Diagnostic Product in such jurisdiction or country, reasonably promptly after receipt or delivery by such Regulatory Responsible Party of such correspondence or communication, as the case may be (but in any event, with respect to correspondence or communications with the EMA no later than ten Business Days after receipt or delivery). |
| 5.3.2 | Regulatory Delays. The Regulatory Responsible Party will not be required to delay any submission, correspondence, or communication with any Regulatory Authorities in its jurisdiction in a manner that affects such Regulatory Responsible Party’s ability to comply with any Regulatory Authority requirement or deadline or Applicable Law in such jurisdiction. |
5.5 | Cooperation. The Parties will cooperate with each other to achieve the regulatory objectives contemplated herein in a timely, accurate, and responsive manner. The non-Regulatory Responsible Party shall use reasonable efforts to assist the Regulatory Responsible Party, including through meetings between the Parties to prepare documents to be filed, in order for such Regulatory Responsible Party to obtain and maintain each applicable Marketing Authorization Application for each Licensed Product and corresponding Sarepta Diagnostic Products in the Regulatory Responsible Party’s Territory, including in connection with the preparation, filing, and submission of all Regulatory Submissions by such Regulatory Responsible Party. |
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5.7 | Cost of Regulatory Activities. The Parties will share equally (50:50) all actual Internal Costs and actual External Costs relating to regulatory activities included within the Eligible Global Development Costs, and otherwise, the applicable Regulatory Responsible Party will be responsible for the costs and expenses incurred by each Party and its Affiliates in connection with the preparation or maintenance of Regulatory Submissions and Regulatory Approvals with respect to a Licensed Product and corresponding Sarepta Diagnostic Products in a given jurisdiction, including any filing fees. |
5.9 | Pharmacovigilance and Adverse Event Reporting. The Parties will cooperate with each other with regard to the reporting and handling of safety information involving the Licensed Products and Sarepta Diagnostic Products in accordance with Applicable Law, regulatory requirements, and regulations on pharmacovigilance and clinical safety. Prior to the commencement of any activities conducted by or on behalf of Roche or any of its Affiliates in furtherance of any Clinical Trial for any Licensed Product, the Parties will negotiate in good faith and enter into a Pharmacovigilance Agreement related to the Licensed Products and a quality agreement, or such other agreement as the Parties may agree, related to the Sarepta Diagnostic Products, which will define the pharmacovigilance responsibilities of the Parties and include safety data exchange procedures governing the exchange of information affecting the class and products (e.g., Serious Adverse Events, emerging safety issues) to enable each Party to comply with all of its legal and regulatory obligations related to such Licensed Products and Sarepta Diagnostic Products. Sarepta will own and maintain the global safety database for all Sarepta Products and Sarepta Diagnostic Products. |
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| 5.10.1 | Notification and Determination. If any Governmental Authority threatens in writing or initiates any action to remove a Licensed Product or Sarepta Diagnostic Product from the market (in whole or in part) in the Roche Territory, then the Party receiving notice thereof will notify the other Party of such communication immediately, but in no event later than two Business Days after receipt thereof. Notwithstanding the foregoing, in all cases the Regulatory Responsible Party for a Licensed Product in a given jurisdiction will determine whether to initiate any recall, withdrawal, or field alert of such Licensed Product or applicable Sarepta Diagnostic Product in such jurisdiction, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or field alert. Before the Regulatory Responsible Party for a Licensed Product in a certain jurisdiction in the Roche Territory initiates a recall, withdrawal, or field alert for such Licensed Product or Sarepta Diagnostic Product in such jurisdiction, the Parties will use reasonable efforts to promptly meet and discuss in good faith the reasons therefor, provided that such discussions will not delay any action that such Regulatory Responsible Party reasonably believes should be taken in relation to any actual or potential recall, withdrawal, or field alert. In the event of any such recall, withdrawal, or field alert in the Roche Territory, the Regulatory Responsible Party for the applicable Licensed Product and the applicable jurisdiction will determine the necessary actions to be taken and will implement such action. Without limiting the foregoing, either Party will have the right to propose that a recall, withdrawal, or field alert for a Licensed Product or Sarepta Diagnostic Product should be initiated by such Party, but the Regulatory Responsible Party for the applicable Licensed Product in the applicable jurisdiction in the Roche Territory will have the right to make the final decision as to whether or not to initiate the recall, withdrawal, or field alert. Notwithstanding any provision to the contrary set forth in this Agreement, if Sarepta notifies Roche of a Manufacturing issue related to a Licensed Product that Sarepta reasonably believes could give rise to a recall, withdrawal, or field alert, then Roche, if it is the Regulatory Responsible Party for the applicable Licensed Product in the applicable jurisdiction in the Roche Territory, will assess such notification from Sarepta and initiate such recall, withdrawal, or field alert as appropriate. In all cases, Sarepta will determine whether to initiate any recall, withdrawal, or field alert of any Option Product, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or field alert and will have sole control over and decision-making authority with respect thereto. |
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To the extent necessary to effectuate the cost-sharing principles set forth in this Section 5.10.2 (Cost Allocation), either Party may deliver an invoice to the Party responsible for the applicable recall, withdrawal, or field alert for such Party’s actual costs and expenses incurred in connection with such recall, withdrawal, or field alert, and the responsible Party will pay all undisputed invoiced amounts no later than 30 days after receipt of such invoice.
6.1 | Commercialization Responsibilities for Licensed Product. |
| 6.1.1 | Commercialization in the Sarepta Territory. Sarepta and its Affiliates will have sole control over and decision-making authority with respect to the Commercialization of the Licensed Products Sarepta in the Sarepta Territory, including, if applicable, seeking and maintaining any Reimbursement Approval for the Licensed Products in the Sarepta Territory, at its sole cost and expense. |
| 6.1.2 | Commercialization in the Roche Territory. Roche and its Affiliates will have sole control over and decision-making authority with respect to the Commercialization of the Licensed Products in the Roche Territory, including seeking and maintaining any Reimbursement Approval for the Licensed Products in the Roche Territory, at its sole cost and expense. |
| 6.1.3 | Coordination of Commercialization Activities. The Parties will coordinate global Commercialization activities, except pricing and reimbursement activities, with respect to Commercialization of Licensed Products in each Party’s Territory through the JCC, as further set forth in Section 3.3.3(a) (Joint Commercialization Committee). |
| 6.2.1 | Sarepta Obligations. No later than 45 days following the end of each Calendar Year, Sarepta will provide to the JCC a high-level summary of the material Commercialization activities, except pricing and reimbursement activities, conducted by Sarepta or its Affiliates or Sublicensees for each Licensed Product in the Sarepta Territory during such Calendar Year and the material Commercialization activities expected to be conducted by Sarepta or its Affiliates or Sublicensees in the Sarepta Territory during the upcoming Calendar Year. |
| 6.2.2 | Roche Obligations. No later than 45 days following the end of each Calendar Year, Roche will provide to the JCC a high-level summary of the material Commercialization activities, except pricing and reimbursement activities, conducted by Roche or its Affiliates or Sublicensees for such Licensed Product in the Roche Territory during such Calendar Year and the material Commercialization activities expected to be conducted by Roche or its Affiliates or Sublicensees in the Roche Territory during the upcoming Calendar Year. In addition, no later than 45 days prior to the end of each Calendar Year, Roche will provide to the JCC a report of the forecasted Net Sales anticipated to be generated by Roche or its Affiliates or Sublicensees in the Roche Territory during the upcoming Calendar Year. |
6.3 | Pricing. Notwithstanding any provision to the contrary set forth in this Agreement, all decisions for each Licensed Product related to any pricing matter, including list price, targeted net pricing, sales-weighted average discounts and rebates, pricing strategy (including the approach to pricing with different types of accounts and plans, including types of discounts and rebates), and modifications to any of the foregoing, will be solely made by (a) Sarepta for the Sarepta Territory and (b) Roche for the Roche Territory. |
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| 6.5.1 | Notice to JCC. If Roche determines not to (a) seek Reimbursement Approval for a Licensed Product in a country in the Roche Territory in which Roche or its Affiliates or Sublicensees has obtained Regulatory Approval or (b) Commercialize a Licensed Product in a country in the Roche Territory in which Roche or its Affiliates or Sublicensees has obtained Reimbursement Approval, in each case ((a) and (b)), then Roche will promptly inform Sarepta, through the JCC, of such decision and explain its rationale for such decision in reasonable detail at the next meeting of the JCC. |
| 6.5.3 | Mitigation of Commercialization Diligence Obligations. Notwithstanding any provision to the contrary set forth in this Agreement, any failure of Roche to comply with its obligations under this Section 6.5 (Roche Commercialization Diligence Obligations) with respect to a particular Licensed Product will be excused only to the extent that and for so long as such failure results from the failure of Sarepta or any of its Affiliates, Sublicensees, or subcontractors to supply such Licensed Product in accordance with its obligations under this Agreement or any of the Supply Agreements or to satisfy its obligations to Develop such Licensed Product in accordance with Section 4.2.1 (Of Sarepta). |
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| 6.7.1 | such Party will inform the other Party timely in advance of any marketing, promotion, or attendance at conferences and such activities must comply with Applicable Law and the Joint Global Medical Affairs Plan, Roche Medical Affairs Plan, and Sarepta Medical Affairs Plan; |
| 6.7.2 | such Party and its Affiliates will not engage, nor permit its Third Party Sublicensees and subcontractors to engage, in any advertising or promotional activities relating to any Licensed Product for use directed primarily to customers or other buyers or users of the Licensed Product located in any such country or jurisdiction; |
| 6.7.3 | such Party and its Affiliates will not solicit orders from any prospective purchaser located in any such country or jurisdiction; |
| 6.7.4 | such Party and its Affiliates will use reasonable efforts not to, and will take reasonable measures to cause its Third Party Sublicensees and subcontractors to not, deliver or tender (or cause to be delivered or tendered) any Licensed Product to Third Parties for use in such country or jurisdiction; and |
| 6.7.5 | if either Party or its Affiliates or Sublicensees receive any order for any Licensed Product from a prospective purchaser located in any such country or jurisdiction, then such Party will use reasonable efforts to refer that order to the other Party or its designee. |
Article 7
MEDICAL AFFAIRS
| 7.1.1 | Joint Global Medical Affairs Plan. The JDC, through the Joint Global Medical Affairs Team, will prepare a reasonably detailed, annual plan for Medical Affairs activities to be performed jointly by the Parties for the Licensed Products and any corresponding Sarepta Diagnostic Product, including a Joint Global Medical Affairs Budget (the “Joint Global Medical Affairs Plan”). |
| 7.1.2 | Roche Medical Affairs Plan. Roche will prepare a reasonably detailed, annual plan for Medical Affairs activities to be performed for the Licensed Products and any corresponding Sarepta Diagnostic Product by or on behalf of Roche or its Affiliates that are not included in the Joint Global Medical Affairs Plan (the “Roche Medical Affairs Plan”), in each case, no later than 120 days following the Effective Date. |
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| 7.1.4 | Addition of Option Products to Medical Affairs Plans. Following exercise of the Option for each of the Exon-Skipping Products or any other Option Product, the JDC will prepare an update to the Joint Global Medical Affairs Plan, Roche will prepare an update to the Roche Medical Affairs Plan, and Sarepta will prepare an update to the Sarepta Medical Affairs Plan, in each case, to include the Exon-Skipping Products or any other Option Product, as applicable, and any corresponding Sarepta Diagnostic Product. |
| 7.1.5 | Alignment of Medical Affairs Plans. The strategic objectives in the Roche Medical Affairs Plan and the Sarepta Medical Affairs Plan, respectively, will be consistent with the activities and strategic objectives set forth in the Joint Global Medical Affairs Plan, unless otherwise agreed by the Parties. In order to ensure consistency between the Joint Global Medical Affairs Plan and each of the Roche Medical Affairs Plan and the Sarepta Medical Affairs Plan, and coordination and alignment between the Parties with respect to the Medical Affairs to be conducted by each Party pursuant to the Joint Global Medical Affairs Plan, by Roche in the Roche Territory pursuant to the Roche Medical Affairs Plan, and by Sarepta in the Sarepta Territory pursuant to the Sarepta Medical Affairs Plan (including with respect to each Party’s communications with key opinion leaders in each Party’s Territory), the JDC will review and discuss each such plan and any update thereto and submit the initial Joint Global Medical Affairs Plan and any update that is material to the JSC to approve. |
7.3 | Medical Affairs Cost Sharing. |
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| incurred greater Eligible Medical Affairs Costs than the other Party during such Calendar Quarter will prepare and deliver to the other Party an invoice for a balancing payment between the Parties, which will be equal to the amount that is 50% of the difference between the Parties’ Eligible Medical Affairs Costs incurred during such Calendar Quarter. The other Party will pay the invoicing Party all undisputed invoiced amounts no later than 30 days after the date of each such invoice, and any disputed amounts within 30 days following resolution of the dispute. |
| 7.3.2 | Other Medical Affairs Costs. Other than as set forth in Section 7.3.1 (Eligible Medical Affairs Costs), each Party will be responsible for all costs and expenses related to the performance of Medical Affairs activities under this Agreement by or on behalf of such Party or any of its Affiliates or Sublicensees, including the costs of performing Medical Affairs activities under (a) the Roche Medical Affairs Plan (with respect to Roche) and (b) the Sarepta Medical Affairs Plan (with respect to Sarepta). |
Article 8
MANUFACTURING AND SUPPLY
8.3 | Initial Forecasts. |
| 8.3.1 | Commercial Demand Forecast Plan. Each Party will prepare an initial good faith five-year rolling forecast of its demand in the Sarepta Territory or the Roche Territory (as applicable) for each Licensed Product for Commercialization purposes (a) with respect to the Lead Product, within six months after the Effective Date, and (b) with respect to each other Licensed Product, within six months following Roche’s Exercise of Option pursuant to Section 2.7.3 (Exercise of Option) for such Licensed Product (each, a “Commercial Demand Forecast Plan”). |
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| 8.4.1 | Details. |
| (a) | [**] |
| (b) | [**]. |
| 8.4.2 | Updates. Each Demand Forecast Plan will be subsequently updated every Calendar Quarter for the upcoming five year period by the JMC and submitted for approval by the JSC. |
| 8.4.3 | Supply Agreements. The principles set forth in Section 8.4 (Demand Forecast Plans) shall be further detailed in the Supply Agreements established under Section 8.6 (Supply Agreement). |
8.5 | Purchase and Supply Obligation. |
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8.10 | Shortage and Supply Failure. |
| 8.10.1 | Mitigation. Each Party will promptly inform the other Party and the JMC if (a) the Demand Forecast Plans indicate that the Parties’ demand for Licensed Products will outstrip the Manufacturing capacity set forth in the Capacity Plan, (b) it becomes aware of any issues relating directly or indirectly to planning, construction, qualification, and operating of Sarepta or a CMOs’ manufacturing sites that could lead to a Shortage or Supply Failure, or (c) it otherwise believes that there is a reasonable risk of Shortage or Supply Failure of a Licensed Product for Development or Commercialization purposes in the Roche Territory in accordance with this Agreement. In such event, the JMC will meet to discuss potential remedies or mitigation strategies, including whether the Parties should invest in or otherwise procure such additional capacity and how such investments should be financed. |
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| 8.10.5 | Sarepta Inability to Supply. In the event of a Sarepta Inability to Supply, following discussion between the Parties, solely during the pendency of such Sarepta Inability to Supply, [**]. |
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9.2 | Equity Investment. Roche Finance Ltd will purchase shares of common stock of Sarepta Therapeutics, Inc. in accordance with the terms set forth in the Stock Purchase Agreement. |
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Lead Product Regulatory Milestone Event | Lead Product Regulatory Milestone Payment (in U.S. Dollars) | |
| Achievement of the Lead Product Regulatory Milestone Event in [**] | Achievement of the Lead Product Regulatory Milestone Event in [**] |
[**] | $[**] | $[**] |
[**] | $[**] | $[**] |
[**] | $[**] | $[**] |
[**] | $[**] | $[**] |
[**] | $[**] | $[**] |
[**] | $[**] | $[**] |
Exon-Skipping Product Clinical Milestone Payments and Exon-Skipping Product Regulatory Milestone Payments are due only for Exon-Skipping Product Clinical Milestone Events and Exon-Skipping Product Regulatory Milestone Events that occur after delivery of the Option Exercise Notice for the Exon-Skipping Products. Each Exon-Skipping Product Clinical Milestone Payment and each Exon-Skipping Product Regulatory Milestone Payment is payable only once with respect to each Exon-Skipping Product and each such milestone payment is due for achievement of the same Exon-Skipping Product Clinical Milestone Event or Exon-Skipping Product Regulatory Milestone Event for a maximum of [**] distinct Exon-Skipping Products. For clarity, the maximum aggregate amount of Exon-Skipping Product Clinical Milestone Payments and Exon-Skipping Product Regulatory Milestone Payments is $[**].
Table 9.4.2 – Exon-Skipping Product Clinical Milestones and Regulatory Milestones | |
Exon-Skipping Product Clinical Milestone Event | Exon-Skipping Product Clinical Milestone Payment (in U.S. Dollars) |
[**] | $[**] |
Exon-Skipping Product Regulatory Milestone Event in [**] | Exon-Skipping Product Regulatory Milestone Payment in [**] (in U.S. Dollars) |
[**] | $[**] |
[**] | $[**] |
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Table 9.4.3 – Gene Therapy Product Regulatory Milestones (other than for Lead Product) | ||
Gene Therapy Product Regulatory Milestone Event | Gene Therapy Product Regulatory Milestone Payment (in U.S. Dollars) | |
| Gene Therapy Product Regulatory Milestone Event in [**] | Gene Therapy Product Regulatory Milestone Event in [**] |
[**] | $[**] | $[**] |
[**] | $[**] | $[**] |
Gene-Editing Licensed Product Regulatory Milestone Payments and Gene-Editing Licensed Product Regulatory Milestone Payments are due only for Gene-Editing Licensed Product Regulatory Milestone Events and Gene-Editing Licensed Product Regulatory Milestone Events that occur after delivery of the Option Exercise Notice for the Gene-Editing Licensed Products. Each Gene-Editing Licensed Product Regulatory Milestone Payment and each Gene-Editing Licensed Product Regulatory Milestone Payment is payable only once for the [**] Gene-Editing Licensed Product (as applicable). If Roche or its Affiliates or Sublicensees files for Regulatory Approval for a Gene-Editing Licensed Product prior to Roche paying Sarepta any Gene-Editing Licensed Product Milestone Payment that is due upon Initiation of a Pivotal Clinical Trial for such Gene-Editing Licensed Product (e.g., because the Pivotal Clinical Trial was the same Clinical Trial as the Proof of Concept Trial for such Gene-Editing Licensed Product), then Roche will promptly pay to Sarepta such unpaid Gene-Editing Licensed Product Milestone Payment for Initiation of such Pivotal Clinical Trial. For clarity, the maximum aggregate amount of Gene-Editing Licensed Product Regulatory Milestone Payments and Gene-Editing Licensed Product Regulatory Milestone Payments is $[**].
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Table 9.4.4– Gene-Editing Licensed Product Clinical Milestones and Regulatory Milestones | ||
Gene-Editing Licensed Product Regulatory Milestone Event | Gene-Editing Licensed Product Regulatory Milestone Payment (in U.S. Dollars) | |
| Gene-Editing Licensed Product Regulatory Milestone Event in [**] | Gene-Editing Licensed Product Regulatory Milestone Event in [**] |
[**] | $[**] | $[**] |
[**] | $[**] | $[**] |
[**] | $[**] | $[**] |
[**] | $[**] | $[**] |
[**] | $[**] | $[**] |
[**] | $[**] | $[**] |
Table 9.4.5 – Lead Product Sales Milestones | |
One-time Lead Product Sales Milestone Event | Sales Milestone Payment (in U.S. Dollars) |
[**] | $[**] |
[**] | $[**] |
[**] | $[**] |
[**] | $[**] |
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Table 9.4.6 – Gene-Editing Licensed Products Sales Milestones | |
One-time Gene-Editing Licensed Products Sales Milestone Event | Sales Milestone Payment (in U.S. Dollars) |
[**] | $[**] |
[**] | $[**] |
[**] | $[**] |
[**] | $[**] |
Table 9.5.1 – Lead Product Royalty Rates | |
[**] | Lead Product Royalty Rate |
[**] | [**]% |
[**] | [**]% |
[**] | [**]% |
[**] | [**]% |
[**] | [**]% |
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| (b) | Biosimilar Competition Royalty Reduction for Licensed Products. Subject to Section 9.5.3(e) (Royalty Reductions Floor), on a Licensed Product-by-Licensed Product and country-by-country basis, in the event of Biosimilar Competition with respect to a Licensed Product in a given country in the Roche Territory, the applicable Royalties in such country for such Licensed Product shall be reduced as follows: |
| (A) | [**]. |
| (c) | Apportionment of Compulsory Sublicensee Consideration. The Parties will [**] all consideration from Compulsory Sublicensees received by Roche or its Affiliates or Sublicensees for a Licensed Product in a country in the Roche Territory from a Compulsory Sublicensee. |
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9.6 | Accounting; Audit. Each Party agrees to keep full, clear, and accurate records in accordance with the applicable Accounting Standard for such Party, for a period of at least three years after the relevant payment is owed pursuant to this Agreement, setting forth (as applicable) Eligible Global Development Costs, Eligible Medical Affairs Costs, Royalties, sales of the Licensed Products (including all calculations of Net Sales), and other amounts payable to the other Party hereunder, in each case, in sufficient detail to enable amounts owed or payable to the other Party hereunder to be determined. Each Party further agrees to permit its books and records to be examined by an independent accounting firm selected by the auditing Party and reasonably acceptable to the audited Party to verify the accuracy of any of the foregoing; provided that such independent accounting firm is subject to written obligations of confidentiality and non-use applicable to each Party’s Confidential Information that are at least as stringent as those set forth described in Article 12 (Confidentiality). Such audit will not be (a) performed more frequently than once per Calendar Year, (b) conducted for any Calendar Year more than three years after the end of such year, or (c) repeated for any Calendar Year or with respect to the same set of records (unless a discrepancy with respect to such records is discovered during a prior audit). Such examination is to be made at the expense of the auditing Party, except in the event that the results of the audit reveal an underpayment, or overcharge in the case of Manufacturing Costs charged, by the audited Party of [**]% or more during the period being audited, in which case reasonable audit fees for such examination will be paid by the audited Party. The underpaid Party will be entitled to recover any shortfall in payments as determined by such audit, plus interest thereon, calculated in accordance with Section 9.12 (Late Payments; Disputed Payments). If such examination of records reveals any overpayment by a Party, then the other Party will credit the amount overpaid against future amounts due to the other Party by the overpaying Party. |
9.7 | No Refunds. Except as expressly provided herein, all payments under this Agreement will be irrevocable, non-refundable, and non-creditable. |
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9.9 | Blocked Payments. If, in a given country, proceeds related to Net Sales are received in a local currency that cannot be removed from such country as a result of Applicable Law, then Roche will promptly notify Sarepta of the conditions preventing such transfer and such payments will be deposited in local currency in the relevant country to the credit of Sarepta in a recognized banking institution designated by Sarepta or, the Royalties for such Net Sales in such country shall continue to be accrued and shall continue to be reported, but not paid to Sarepta until the sales proceeds related to such Net Sales are permitted to be removed from such country under Applicable Law. At such time as Roche or its Affiliates or Sublicensees, as the case may be, is able to remove the sales proceeds related to such Net Sales from such country under Applicable Law, Roche will pay such accrued Royalties in accordance with Section 9.10 (Method of Payment) using the actual exchange rate that is used to remove such sales proceeds from such country (it being understood that such Royalties shall not be deemed to be a late payment or subject to any interest under Section 9.12 (Late Payments)). |
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Article 10
INTELLECTUAL PROPERTY
10.2 | Ownership. |
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| 10.3.1 | Invention Disclosure. Each Party will promptly disclose to the other Party through the IP Committee any Inventions within the Collaboration Know-How developed or invented during the Term by or on behalf of such Party, in each case, no later than 30 days after the applicable Party’s intellectual property department receives notice of such Invention and in any event as soon as practicable prior to an intended public disclosure of such Invention and prior to the filing of a patent application thereon. |
| 10.3.2 | Inventions by a Party. Inventorship for Inventions and discoveries (including Know-How) first invented or developed during the course of the performance of activities under this Agreement will be determined in accordance with United States Patent Laws for determining inventorship. |
| 10.3.3 | CREATE Act. Notwithstanding any provision to the contrary set forth in this Agreement, neither Party may invoke the Cooperative Research and Technology Enhancement Act, 35 U.S.C. § 102(c) (the “CREATE Act”) when exercising its rights under this Agreement without prior notice to the IP Committee and the prior written approval of the other Party. If a Party intends to invoke the CREATE Act, then it will notify the other Party through the IP Committee and if agreed by the Parties the other Party will cooperate and coordinate its activities with such Party with respect to any filings or other activities in support thereof. The Parties acknowledge and agree that this Agreement is a “joint research agreement” as defined in the CREATE Act. |
| 10.4.1 | Membership. Within [**] days following the Effective Date, the Parties will establish a committee (the “IP Committee”) comprised of at least [**] senior patent attorneys and one senior trademark attorney from each Party (provided that [**]) to (a) manage, review, and discuss the patent strategy for the preparation, filing, prosecution, and maintenance of (i) Collaboration Patent Rights, other than Joint Collaboration Patent Rights, (ii) Inventions within the Collaboration Know-How, other than Inventions within the Joint Collaboration Know-How, and (iii) any Patent Rights Controlled pursuant to a Collaboration In-License, (b) review, discuss, and, as provided in this Article 10 (Intellectual Property), comment on the preparation, filing, prosecution, and maintenance of Sarepta Patent Rights as provided under Section 10.5.2 (Status Updates), Joint Collaboration Patent Rights as provided under Section 10.6.3 (Status Updates), Option Product Patent Rights as provided under Section 10.7.2 (Status Updates), and Roche Collaboration Patent Rights as provided under Section 10.8.2 (Status Updates), (c) review, discuss, and, as provided in this Article 10 (Intellectual Property), comment on any Third Party Patent Challenges under Section 10.10 (Defense of Third Party Patent Challenges) or Third Party infringement claims or Patent Challenges as provided under Section 10.11 (Third Party Infringement Claims) or Section 10.12 (Patent Challenges of Third Party Patent Rights), as applicable, (d) review, discuss, and, as provided in this Article 10 (Intellectual Property), comment on the preparation, filing, prosecution, and maintenance of Sarepta-Owned Marks as provided under Section 10.16.3(b) (Status Updates) and review, discuss, and determine whether to approve the Product Marks and associated usage instructions in the Roche Territory under Section 10.16 (Marks), and (e) perform such other activities as may be delegated to the IP Committee from time to time during the Term by the JSC or otherwise by agreement of the Parties. |
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| 10.4.3 | Decision-Making. All decisions of the IP Committee will be made by consensus, with each Party’s representatives on the IP Committee having collectively one vote on all matters that are within the responsibility of the IP Committee. If the members of the IP Committee are unable to agree on any such matter after a period of [**] days, then, except as otherwise agreed by the Parties, the matter will be escalated to the JDC, JCC or JMC, as appropriate. |
| 10.5.1 | Sarepta First Right to Prosecute. Sarepta will have the first right, but not the obligation, to file, prosecute, and maintain the Sarepta Patent Rights using internal counsel and external counsel mutually agreed to by the Parties. Upon the reasonable request of Sarepta, Roche will at Sarepta’s own cost and expense cooperate with and assist Sarepta as needed in connection with the filing, prosecution, and maintenance of all Sarepta Patent Rights. |
| 10.5.3 | Assistance; Costs. Subject to Section 10.5.4 (Abandonment in Roche Territory), [**] will be responsible for [**] of the actual External Costs incurred by Sarepta with respect to the filing, prosecution, and maintenance of the Sarepta Patent Rights in the Roche Territory. Sarepta will invoice Roche quarterly for such External Costs incurred by Sarepta. Roche will pay Sarepta the undisputed invoiced amount within 30 days after the date of Sarepta’s invoice therefor, and any disputed amount within 30 days following the resolution of the dispute. |
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| 10.6.2 | Prosecuting Party’s First Right to Prosecute. The Prosecuting Party will have the first right, but not the obligation, to prosecute and maintain the Joint Collaboration Patent Rights using internal counsel and external counsel mutually agreed to by the Parties. On the reasonable request of the Prosecuting Party, the non-Prosecuting Party will at its own cost and expense cooperate with and assist the Prosecuting Party as needed in connection with the prosecution and maintenance of all Joint Collaboration Patent Rights. |
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10.7 | Prosecution of Option Product Patent Rights. |
| 10.7.1 | Sarepta’s Right to Prosecute. Sarepta will have the sole right, but not the obligation, to file, prosecute, and maintain the Option Product Patent Rights. |
| 10.7.3 | Costs. Sarepta will be responsible for the External Costs incurred by it with respect to the filing, prosecution, and maintenance of the Option Product Patent Rights in the Roche Territory. |
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| 10.8.1 | Filing of Roche Patent Rights. Except as provided in Section 10.8.4 (Abandonment), Roche will have the sole right to file, prosecute, and maintain the Roche Background Patent Rights and the Roche Collaboration Patent Rights, provided that Roche will file, prosecute, and maintain the Roche Collaboration Patent Rights using internal counsel and external counsel mutually agreed to by the Parties. |
| 10.8.3 | Assistance; Costs. Roche will be responsible for 100% of the External Costs incurred by it with respect to the filing, prosecution, and maintenance of the Roche Background Patent Rights and the Roche Collaboration Patent Rights. |
| 10.9.1 | Notice of Infringement or Misappropriation. Each Party will promptly notify the other of any apparent, threatened, or actual Competitive Infringement of which it becomes aware. |
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| substantive documents related to such Competitive Infringement suit prior to filing or submission of such documents. If Roche fails to initiate a suit or take other action to terminate any such Competitive Infringement within [**] after the notice provided under Section 10.9.1 (Notice of Infringement or Misappropriation) (or such shorter period of time as is required to comply with the provisions of Section 10.9.5 (Abbreviated Applications)), then Sarepta will have the second right, but not the obligation, to attempt to resolve such Competitive Infringement, as applicable, at its own expense, including the filing of an infringement or misappropriation suit, as applicable, to enforce the applicable Patent Rights or Know-How using counsel of its own choice. |
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| Infringement or Misappropriation) will provide the other Party with copies of all pleadings and other documents in advance of filing with the court and will consider reasonable input from the other Party during the course of the action. Neither Party may settle any action or proceeding brought under this Section 10.9 (Enforcement Against Third Party Infringement or Misappropriation) or knowingly take any other action in the course thereof (a) without Sarepta’s prior written consent with respect to the Sarepta Territory and (b) without Roche’s prior written consent with respect to the Roche Territory. The Parties will reasonably assist each other and cooperate with each other, at their own expense, in any such investigation, pre-litigation preparation, or litigation to ensure that there is an aligned global litigation and enforcement strategy. |
| 10.10.1 | Defense of Third Party Patent Challenges in the Roche Territory. Subject to the terms of Section 10.9.5 (Abbreviated Applications) and Section 10.10.2 (Cooperation; Procedures) and of any applicable license pursuant to which Sarepta Controls any Patent Right, and except as may be otherwise agreed by the Parties, Roche will have the first right, but not the obligation, to control the defense of any Third Party Patent Challenge relating to a Sarepta Patent Right or Collaboration Patent Right in the Roche Territory and to compromise, litigate, settle, or otherwise dispose of any such challenge, in each case at its own expense using counsel of its own choice; provided that Sarepta will be entitled to attend any substantive meetings, hearings, or other proceedings related to such Third Party Patent Challenge (together with its own counsel, at its own expense) and to review and comment on all substantive documents related to such Third Party Patent Challenge, and if Roche fails to initiate or continue the defense of such Third Party Patent Challenge of a Sarepta Patent Right or Collaboration Patent Right within [**] after the notice provided under Section 10.10 (Defense of Third Party Patent Challenges) (or such shorter period of time as is required to comply with the provisions of Section 10.9.5 (Abbreviated Applications)), or otherwise abandons or elects not to continue any such defense once initiated, then Sarepta will have the second right, but not the obligation, to control the defense of such Third Party Patent Challenge at its own expense using counsel of its own choice. |
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| 10.10.3 | Cooperation; Procedures. In any event, at the request and expense of the Party controlling the defense of any Third Party Patent Challenge under this Section 10.10 (Defense of Third Party Patent Challenges), the other Party will provide reasonable assistance and cooperation in any such action. In addition, the Party controlling the defense of any Third Party Patent Challenge under this Section 10.10 (Defense of Third Party Patent Challenges) will provide the other Party with copies of all pleadings and other documents to be filed with the court and will consider reasonable input from the other Party during the course of the action. Roche may not settle any action or proceeding brought or defended under this Section 10.10 (Defense of Third Party Patent Challenges) or knowingly take any other action in the course thereof without Sarepta’s prior consent. Sarepta may not settle any action or proceeding brought or defended under this Section 10.10 (Defense of Third Party Patent Challenges) or knowingly take any other action in the course thereof without Roche’s prior written consent with respect to the Roche Territory. The Parties will reasonably assist each other and cooperate with each other, at their own expense, in any such investigation, pre-litigation preparation, or litigation to ensure that there is an aligned global litigation strategy. |
| 10.11.1 | Infringement Claim; Patent Challenges of Third Party IP. If a Third Party asserts that a Patent Right controlled by it is, or will be, infringed by the Exploitation of a Licensed Product in the Roche Territory in accordance with this Agreement, then the Party first obtaining knowledge of such claim will promptly provide the other Party and the IP Committee with prompt written notice thereof and the related facts in reasonable detail. |
| 10.11.2 | Responsibility to Defend. During the Term of this Agreement, if a Third Party asserts that a Patent Right controlled by such Third Party is infringed, or will be infringed, by the Exploitation of a Licensed Product, then [**]. |
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| 10.12.1 | Notice of Third Party Patent Right. If either Party becomes aware of a Third Party Patent Right that might form the basis for a claim that the Exploitation of a Licensed Product anywhere in the world infringes, or will infringe, such Patent Right, then [**]. |
| 10.12.3 | Restrictions on Settlement. [**]. |
10.13 | Patent Term Extensions. Each Party will be solely responsible for making all decisions regarding patent term extensions in its respective Territory, including supplementary protection certificates and any other extensions that are now or become available in the future, in all cases, that are applicable to Sarepta Patent Rights or Collaboration Patent Rights licensed hereunder and that become available directly as a result of the Regulatory Approval of a Licensed Product; provided, however, that such Party will consult with the other Party with respect to such decisions and will consider the comments and concerns of the other Party in good faith. [**]. |
10.14 | Unified Patent Court. If the Unified Patent Court Agreement enters into force during the Term of this Agreement, then Roche will be solely responsible for making all decisions regarding Patent Rights, including decisions regarding the opting-out or opting-in of existing Patent Rights into the jurisdiction of the Unified Patent Court or the registration of Patent Rights with Unitary Effect; provided that Roche will consult with Sarepta with respect to such decisions and will consider the comments and concerns of Sarepta in good faith. |
10.15 | Common Interest. All information exchanged between the Parties regarding the prosecution, maintenance, enforcement, and defense of Patent Rights or a Patent Challenge with respect to a Third Party’s Patent Rights under this Article 10 (Intellectual Property) will be the Confidential Information of the disclosing Party. In addition, the Parties stipulate and agree that, with regard to such prosecution, maintenance, enforcement, and defense the interests of the Parties as collaborators and licensor and licensee are to obtain the strongest patent protection possible, and as such, are aligned and are legal in nature. The Parties stipulate and agree that they have not waived, and nothing in this Agreement constitutes a waiver of, any legal privilege concerning the Patent Rights under this Article 10 (Intellectual Property), including privilege under the common interest doctrine and similar or related doctrines. Notwithstanding any provision to the contrary set forth in this Agreement, to the extent a Party has a good faith belief that any information required to be disclosed by such Party to the other Party under this Article 10 (Intellectual Property) is protected by attorney-client privilege or any other applicable legal privilege or immunity, such Party will not be required to disclose such information and the Parties will in good faith cooperate to agree upon a procedure (including entering into a specific common interest agreement, disclosing such information on a “for counsel eyes only” basis or similar procedure) under which such information may be disclosed without waiving or breaching such privilege or immunity. |
| 10.16.1 | Product Mark. All Licensed Products will be sold in the Roche Territory solely under the Product Marks selected by the IP Committee with advice from the Parties’ intellectual property counsel and the Sarepta Housemarks and Roche Housemarks as provided in this Agreement. No such Mark will be used by Roche outside of the country as to which it has been approved for use by the IP Committee, unless otherwise agreed by the Parties in writing. |
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| 10.16.3 | Prosecution of Trademarks. |
| (a) | Sarepta’s First Right to Prosecute. Sarepta will have the first right, but not the obligation, to file, prosecute, and maintain all Sarepta-Owned Marks. Upon the reasonable request of Sarepta, Roche will [**] cooperate with and assist Sarepta in connection with the filing, prosecution, and maintenance of all Sarepta-Owned Marks in the Roche Territory. |
| (c) | Assistance; Costs. Subject to Section 10.16.3(d) (Abandonment in Roche Territory), [**] will be responsible for all actual External Costs incurred by or on behalf of Sarepta or its Affiliates in connection with the filing, prosecution, maintenance, and defense of the Product Marks in the Roche Territory. |
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| 10.16.6 | Enforcement of Product Marks in Roche Territory. Except as may be otherwise agreed by the Parties, Roche will have the first right, but not the obligation, to enforce any Product Mark in the Roche Territory against any infringement or threatened infringement by any Third Party with respect to any Product Mark by reason of the sale or marketing of any product that would be competitive with any Licensed Product in the Field in the Roche Territory, in each case, at its own cost and expense and using counsel reasonably acceptable to Sarepta. Sarepta will be entitled to attend any substantive meetings, hearings, or other proceedings related to such infringement or misappropriation suit (together with its own counsel, at its own expense) and to review and comment on all substantive documents related to such infringement suit prior to filing or submission of such documents. If Roche fails to initiate a suit or take other action to terminate any such infringement within [**] after receiving notice thereof from Sarepta, then Sarepta will have the second right, but not the obligation, to attempt to resolve such infringement, at its own expense, including the filing of an infringement suit, as applicable, to enforce the applicable Product marks using counsel of its own choice. In such case, Roche will be entitled to attend any substantive meetings, hearings, or other proceedings related to such infringement suit (together with its own counsel, at its own expense) and to review and comment on all substantive documents related to such infringement suit prior to filing or submission of such documents. Any amounts recovered in any such suit enforcing the Product Marks in the Roche Territory will be allocated between the Parties in the same manner as a suit regarding Competitive Infringement of the Sarepta Patent Rights would be allocated pursuant to Section 10.9.4 (Allocation of Recoveries). Each Party will provide the other Party with reasonable assistance and cooperating, at its own expense, in any such action (including entering into a common interest agreement if reasonably deemed necessary by any Party) and agrees to be joined as a party to the suit if necessary for the initiating Party to bring or continue a trademark infringement action hereunder. |
| 10.16.7 | Party Name on Product Promotional Material. Subject to Applicable Law, Roche will exercise commercially reasonable efforts to include a notice on all Product Materials in the Roche Territory indicating that the applicable Product Mark included in such Product Materials is a Mark of Sarepta. |
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Article 11
REPRESENTATIONS, WARRANTIES, AND COVENANTS
11.1 | Mutual Representations and Warranties. Each of Roche and Sarepta hereby represents and warrants to the other Party as of the Execution Date that: |
| 11.1.1 | It is a corporation or entity duly organized and validly existing under the laws of the state, municipality, provinces, administrative division, or other jurisdiction of its incorporation or formation. |
| 11.1.2 | It has full power and authority and the legal right to own and operate property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement. |
| 11.1.3 | The execution, delivery, and performance of this Agreement by it has been duly authorized by all requisite corporate action. |
| 11.1.4 | This Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, and binding obligation of such Party and is enforceable against it in accordance with its terms, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity. |
| 11.1.5 | It has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder. |
| 11.1.6 | It has obtained all necessary consents, approvals, and authorizations of all Regulatory Authorities and other Third Parties required to be obtained in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder, including, for the avoidance of doubt, to grant the licenses granted by it under this Agreement. |
| 11.1.7 | The execution and delivery of this Agreement and the performance of its obligations hereunder (a) do not conflict with or violate any requirement of Applicable Law or any provision of its articles of incorporation, bylaws, limited partnership agreement, or any similar instrument, as applicable, in any material way, and (b) do not conflict with, violate, or breach or constitute a default or require any consent under, any Applicable Law or any contractual obligation or court or administrative order by which it or any of its Affiliates are bound. |
| 11.1.8 | To its Knowledge, it has not, directly or indirectly, offered, promised, paid, authorized, or given to any Government Official or Other Covered Party for the purpose, pertaining to this Agreement, of: (a) influencing any act or decision of the Government Official or Other Covered Party; (b) inducing the Government Official or Other Covered Party to do or omit to do an act in violation of a lawful duty; (c) securing any improper advantage; or (d) inducing the Government Official or Other Covered Party to influence the act or decision of a government or government instrumentality, in order to obtain or retain business, or direct business to, any Person, in each case in any way related to this Agreement. |
| 11.1.9 | It is not aware of any Government Official or Other Covered Party having any financial interest in the subject matter of this Agreement or in any way personally benefiting, directly, or indirectly, from this Agreement. |
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| 11.2.2 | Sarepta has provided Roche with redacted and otherwise true copies of each Existing In-License entered into by Sarepta and listed on Schedule 2.5.1 (Existing In-Licenses). |
| 11.2.3 | Sarepta possesses, under the Existing In-Licenses or otherwise, all rights necessary to grant to Roche an exclusive license under Sarepta Technology with respect to Licensed Products pursuant to Section 2.1 (License Grants to Roche) and the right to grant sublicenses to one or more of its Affiliates or any Third Party sublicenses (which may be further granted through multiple tiers) as set forth in this Agreement, including Section 2.3.1 (Right to Grant Sublicenses). |
| 11.2.4 | The Sarepta Patent Rights set forth on Schedule 1.250 (Sarepta Patent Rights) have been duly filed and maintained in the Roche Territory and, to Sarepta’s Knowledge, are (a) being diligently prosecuted in the Roche Territory and (b) are valid and enforceable. |
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| 11.2.7 | There are no investigations, inquiries, actions, or other proceedings pending, or, to Sarepta’s Knowledge, threatened by any Person, disputing the Sarepta Technology. |
| 11.2.8 | To Sarepta’s Knowledge, no Third Party is infringing, misappropriating, or otherwise violating any Sarepta Technology. |
| 11.2.9 | There are no investigations, inquiries, actions, or other proceedings pending before or, to Sarepta’s Knowledge, threatened by any Regulatory Authority or other Governmental Authority in the Territory with respect to any Licensed Product in the Roche Territory arising from any violation of Applicable Law by Sarepta or any of its Affiliates or any Third Party acting on behalf of Sarepta or any of its Affiliates in the Exploitation of any Licensed Product, and Sarepta and its Affiliates have not received written notice threatening any such investigation, inquiry, action, or other proceeding, and to Sarepta’s Knowledge, there are no circumstances currently existing that, in Sarepta’s reasonable discretion, would reasonably be expected to lead to or result in an investigation, corrective action, or enforcement action by any other Regulatory Authority with respect to any Licensed Product. |
| 11.2.10 | There are no investigations, inquiries, actions or other proceedings pending, or, to Sarepta’s Knowledge, threatened in writing alleging that any Exploitation of any Licensed Product in the manner contemplated in this Agreement, infringes, misappropriates or otherwise violates, or would infringe, misappropriate or otherwise violate, any Patent Right or Know-How of any Third Party in the Roche Territory. |
| 11.2.11 | To Sarepta’s Knowledge, it, its Affiliates and its contractors and consultants, have complied in all material respects with all Applicable Law, including GLP, GCP, and the requirements of informed consent and institutional review boards (as those terms are defined by the FDA or other relevant Regulatory Authorities), and in accordance with its or their standard operating procedures for the conduct of Clinical Trials at the time such tests were conducted, in the Exploitation of the Licensed Products prior to the Execution Date. |
| 11.2.12 | All personal data collected, processed or disclosed by Sarepta or any of its Affiliates in connection with any Licensed Product have been, and are being, collected, processed, and disclosed in compliance, in all material respects, with all Applicable Laws that were in effect at the time such data was collected, processed or disclosed, or currently stored, including the Health Insurance Portability and Accountability Act of 1996 and the implementing regulations of the United States Department of Health and Human Services,; and neither Sarepta nor any of its Affiliates has received any: (a) written notice or complaint alleging non-compliance with any Applicable Law relating to the collection, processing, and disclosure of information or data; (b) written claim for compensation for loss or unauthorized collection, processing, or disclosure of data; or (c) written notification of an application for rectification, erasure or destruction of information or data that is still outstanding, in each case ((a) through (c)), in connection with any Licensed Product; Sarepta and its Affiliates have documented and stored all material data, documents, and reports resulting from the Exploitation of each Licensed Product in accordance with Sarepta’s practices and standards in place for its own activities at the time such data, documents, and reports were documented or stored. |
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11.4 | Additional Covenants. Each of Roche and Sarepta hereby covenant to the other: |
| 11.4.1 | Assignment of Inventions. Each Party will require all of its and its Affiliates’ employees to assign all Inventions that are developed or invented by such employees according to the ownership principles described in Section 10.1 (Ownership). |
| 11.4.2 | Compliance with Law. It will, and will cause its Affiliates and its and its Affiliates’ employees and contractors to, comply with all Applicable Laws (including anti-corruption and anti-slavery and anti-human trafficking laws, statutes, regulations, and codes) and, to the extent applicable, Professional Requirements, with respect to the performance of its obligations under this Agreement. |
| 11.4.3 | No Bribery. It will not, and will cause its Affiliates and its and its Affiliates’ employees and contractors not to, directly or indirectly, in the future offer, promise, pay, authorize, or give, money or anything of value, directly or indirectly, to any Government Official or Other Covered Party for the purpose, pertaining to this Agreement, of: (a) influencing any act or decision of the Government Official or Other Covered Party; (b) inducing the Government Official or Other Covered Party to do or omit to do an act in violation of a lawful duty; (c) securing any improper advantage; or (d) inducing the Government Official or Other Covered Party to influence the act or decision of a government or government instrumentality, in order to obtain or retain business, or direct business to, any Person, in each case, in any way related to this Agreement. |
| 11.4.5 | Debarred/Excluded Persons. Neither it nor any of its Affiliates will engage, in any capacity in connection with this Agreement or any ancillary agreements, any officer, employee, contractor, consultant, agent, representative, or other Person who has been Debarred/Excluded. Each Party will inform the other Party in writing promptly if it or any Person engaged by it or any of its Affiliates who is performing any obligations under this Agreement or any ancillary agreements is Debarred/Excluded, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending or, to each Party’s Knowledge, is threatened, pursuant to which a Party, any of its Affiliates or any such Person performing obligations hereunder or thereunder may become Debarred/Excluded, and such Party shall cease employing, contracting with, or retaining any such Person to perform any such services. |
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11.6 | Additional Covenants of Roche. |
| 11.6.1 | Diagnostic Tests. Roche will not Develop any in vitro diagnostic tests or products for use with any Licensed Product except as set forth in the Joint Global Development Plan or as otherwise agreed in writing by the Parties. |
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| 12.1.2 | the Receiving Party will treat all Confidential Information provided by the Disclosing Party with the same degree of care as the Receiving Party uses for its own similar information, but in no event less than a reasonable degree of care; |
| 12.1.3 | the Receiving Party may only use any Confidential Information of the Disclosing Party for the purposes of performing its obligations or exercising its rights under this Agreement; |
| 12.1.4 | a Receiving Party may only disclose Confidential Information of the Disclosing Party to: (a) such Receiving Party’s Affiliates and Sublicensees; and (b) employees, directors, officers, agents, contractors, consultants, attorneys, accountants, banks, investors, and advisors of the Receiving Party and its Affiliates and Sublicensees, in each case ((a) and (b)), to the extent reasonably necessary for the purposes of, and for those matters undertaken pursuant to, this Agreement; provided that such Persons are bound by legally enforceable obligations of confidentiality and non-use with respect to the Disclosing Party’s Confidential Information no less stringent than the confidentiality and non-use obligations set forth in this Agreement. Each Party will remain responsible for any failure by its Affiliates and Sublicensees, and its and its Affiliates’ and Sublicensees’ respective employees, directors, officers, agents, consultants, attorneys, accountants, banks, investors, advisors, and contractors, in each case, to treat such Confidential Information as required under this Section 12.1 (Duty of Confidence) (as if such Affiliates, Sublicensees, employees, directors, officers agents, consultants, advisors, attorneys, accountants, banks, investors, and contractors were Parties directly bound to the requirements of this Section 12.1 (Duty of Confidence)); and |
| 12.1.5 | each Party will promptly notify the other Party of any misuse or unauthorized disclosure of the other Party’s Confidential Information. |
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| 12.3.2 | is generally available to the public before its receipt from the Disclosing Party; |
| 12.3.3 | became generally available to the public or otherwise part of the public domain after its disclosure by the Disclosing Party and other than through any act or omission of the Receiving Party or any of its Affiliates or disclosees in breach of this Agreement; |
| 12.3.4 | is subsequently disclosed to the Receiving Party or any of its Affiliates without obligation of confidentiality by a Third Party who may rightfully do so and is not under a conflicting obligation of confidentiality to the Disclosing Party; or |
| 12.3.5 | is developed by the Receiving Party or any of its Affiliates independently and without use of or reference to any Confidential Information received from the Disclosing Party, as documented by the Receiving Party’s business records. |
No combination of features or disclosures will be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the Receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the Receiving Party.
| (a) | (i) the filing and prosecution of Sarepta Patent Rights, Joint Collaboration Patent Rights, or Roche Collaboration Patent Rights, in each case, as contemplated by this Agreement; or (ii) Regulatory Submissions and other filings with Governmental Authorities (including Regulatory Authorities), as necessary for the Exploitation of a Sarepta Product as contemplated by this Agreement; |
| (b) | disclosure of this Agreement, its terms, and the status and results of Exploitation of one or more Sarepta Products or Sarepta Diagnostic Products to actual or bona fide potential investors, acquirors, Sublicensees, lenders, and other financial or commercial partners (including in connection with any royalty financing transaction), and their respective attorneys, accountants, banks, investors, and advisors, solely for the purpose of evaluating or carrying out an actual or potential investment, acquisition, Sublicense, debt transaction, or collaboration; provided that, in each such case, on the condition that such Persons are bound by obligations of confidentiality and non-use at least as stringent as those set forth Article 12 (Confidentiality) or otherwise customary for such type and scope of disclosure any such disclosure is limited to the maximum extent practicable for the particular context in which it is being disclosed; |
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| (d) | disclosure pursuant to Section 12.7 (Publication and Listing of Clinical Trials) and Section 12.8 (Publicity; Use of Name). |
| 12.4.2 | Confidential Treatment. Notwithstanding any provision to the contrary set forth in this Agreement, if a Party is required or permitted to make a disclosure of the other Party’s Confidential Information pursuant to Section 12.4.1 (Permitted Circumstances), then it will, to the extent not prohibited by Applicable Law or judicial or administrative process, except where impracticable, give reasonable advance notice to the other Party of such proposed disclosure and use reasonable efforts to secure confidential treatment of such information and will only disclose that portion of Confidential Information that is legally required to be disclosed as advised by its legal counsel. In any event, each Party agrees to take all reasonable action to avoid disclosure of Confidential Information of the other Party hereunder. |
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| (a) | Both Parties acknowledge that it is their policy for the studies and results thereof to be registered and published in accordance with their internal guidelines. |
| (c) | Each Party will provide the other Party a copy of the Publication at the time of the submission or presentation thereof. |
| (d) | Each Party agrees to determine the authorship of all Publications in accordance with all applicable International Committee of Medical Journal Editors (ICMJE) guidelines, and, in addition, to acknowledge the contributions of the other Party and its employees, in each case, as scientifically appropriate. |
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| will be permitted to issue the initial press release regarding the execution of this Agreement and the Stock Purchase Agreement as set forth in Schedule 12.8.1(b). Following such initial press release, Sarepta may issue additional press releases and other public announcements related to the activities contemplated by this Agreement or the Stock Purchase Agreement that (a) have been approved by Roche, or (b) are required to be issued by Sarepta to comply with Applicable Law. In all circumstances, to the extent practicable, Sarepta shall provide Roche with a draft of such press release or announcement at least two days prior to its first intended publication for Roche’s review. During such two-day period, Roche may approve the draft press release or announcement and permit Sarepta to issue the press release or announcement or contact Sarepta to discuss modification to the draft press release or announcement. If Roche asks for modification of any press release following the initial press release, then Sarepta will consider implementing such modification in good faith. To ensure communication alignment between the Parties or Stock Purchase Agreement issuance of a permitted press release or announcement by Sarepta shall consist solely of the press release or other publicly announced language previously issued by either Party in accordance with this Agreement or shall follow the response guidelines that may be mutually developed by the Parties. |
| 12.8.2 | Other Releases. Other than such press release and the public disclosures permitted by this Section 12.8 (Publicity; Use of Names), and Section 12.4 (Authorized Disclosures), the Parties agree that the portions of any other news release or other public announcement relating to this Agreement, the Stock Purchase Agreement, or the performance hereunder or thereunder that would disclose information other than that already in the public domain will first be reviewed and approved by both Parties (with such approval not to be unreasonably withheld, conditioned, or delayed). However, the Parties agree that after (a) a disclosure pursuant to Section 12.8 (Publicity; Use of Names) or Section 12.4 (Authorized Disclosures) or (b) the issuance of a press release (including the initial press release) or other public announcement pursuant to this Section 12.8.1 (Press Release) that has been reviewed and approved by the other Party, the disclosing Party may make subsequent public disclosures reiterating such information without having to obtain the other Party’s prior consent and approval so long as the information in such press release or other public announcement remains true, correct, and the most current information with respect to the subject matters set forth therein. Similarly, after a Publication has been made available to the public in accordance with Section 12.6 (Publications), (i) each Party may post such Publication or a link to it on its corporate web site (or any website managed by such Party in connection with a Clinical Trial for a Licensed Product, as appropriate) without the prior written consent of the other Party and (ii) the disclosing Party may make subsequent public disclosures reiterating the information in such prior Publications without having to obtain the other Party’s prior consent and approval so long as the information in such Publication remains true, correct, and the most current information with respect to the subject matters set forth therein. |
| 12.8.3 | Disclosures. Notwithstanding any provision to the contrary set forth in this Agreement, each Party has the right to publicly disclose (in written, oral, or other form): (a) the achievement of any Regulatory Milestone Event or Sales Milestone Event under this Agreement (including the amount, payment, and timing of any such milestone event); (b) the commencement, completion, material data, or key results of any Clinical Trials for the Sarepta Products or Sarepta Diagnostic Product conducted by or on behalf of either Party; and (c) the achievement of Regulatory Approval for any Sarepta Product or Sarepta Diagnostic Product in its Territory; provided that, subject to Section 12.4.1(c) (Authorized Disclosures; Permitted Circumstances), Sarepta may disclose the achievement of Regulatory Approval for any Sarepta Product or Sarepta Diagnostic Product in the Roche Territory. |
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Article 14
TERM AND TERMINATION
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| 14.2.2 | Certain Breaches of Diligence in a Region. Notwithstanding any provision to the contrary set forth in this Agreement and on a Licensed Product-by-Licensed Product basis, |
| (b) | Roche’s breach of its Commercialization diligence obligation set forth in Section 6.5 (Roche Commercialization Diligence Obligation) with respect to a country in a Region but not all countries in the Region, will neither give Sarepta the right to terminate this Agreement pursuant to this Section 14.2.2 (Termination for Breach) with respect to such country in which Roche failed to use Commercially Reasonable Efforts nor give Sarepta the right to terminate this Agreement with respect to the applicable Region, provided that Roche uses Commercially Reasonable Efforts to Commercialize in the applicable Region when considered as a whole. |
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| sublicenses or other rights under such Roche Collaboration Patent Rights or Roche Collaboration Know-How necessary for Sarepta to Exploit the Terminated Products in the Terminated Regions (to the extent permitted under such Third Party agreement). If such a sublicense or other right is granted to Sarepta, then Sarepta will pay to Roche [**] of all payments due to the applicable Third Party under any such Third Party agreement in consideration of such sublicense or other rights. If Roche is unable to sublicense any such Roche Collaboration Patent Rights or Roche Collaboration Know-How to Sarepta without the consent of the Third Party, then Roche undertakes, on request from Sarepta, to use reasonable efforts to procure such consent with respect to the Terminated Products in the Terminated Regions on behalf of Sarepta to the extent that it is able to do so, and Sarepta will pay such fees and agree to be bound by the terms agreed between Roche and the Third Party licensor. |
| (a) | assign and transfer to Sarepta or its designee all of Roche’s rights, title, and interests in and to all (i) clinical trial agreements, manufacturing and supply agreements, distribution agreements, and other agreements to which Roche is a party that relates to the Terminated Product and (ii) data from any applicable Clinical Trials in Roche’s Control, in each case, solely to the extent assignable without consent of, or the provision of consideration (whether monetary or otherwise) to, any Third Party and not cancelled and solely to the extent the foregoing relates exclusively to the Terminated Products in the Terminated Regions and are necessary for the Exploitation of the Terminated Products in the Terminated Regions; |
| (b) | to the extent any agreement or data set forth in the foregoing clause (a) is not assignable to Sarepta or does not exclusively relate to the Terminated Products in the Terminated Regions, reasonably cooperate with Sarepta to arrange to continue to provide such services, at the costs of Sarepta, for a reasonable time but in no case longer than for 18 months after termination of this Agreement with respect to such Terminated Products in the Terminated Regions to facilitate the orderly transition of all Development, Commercialization, and other activities then being performed by or on behalf of Roche or its Affiliates or Sublicensees for the Terminated Products in the Terminated Regions to Sarepta or its designee; |
| (c) | assign and transfer (and if unable to assign and transfer, exclusively license) to Sarepta or its designee, as of the effective date of termination, all of Roche’s rights, title, and interests in and to the Product Marks and any domain names associated with the Product Marks (to the extent that Roche or its Affiliates has any), in each case, for the Terminated Products in the Terminated Regions, and promptly provide to Sarepta all login and password information necessary to maintain such domain names; |
| (d) | assign and transfer to Sarepta or its designee all of Roche’s rights, title, and interests in and to any necessary Product Materials for the Terminated Products in the Terminated Regions, training materials, medical education materials, packaging and labeling, related to the Terminated Products in the Terminated Regions, and copyrights and any registrations for the foregoing (and, with respect to copyrights, if unable to assign and transfer, exclusively license); and |
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Subject to Section 14.8.14 (Termination by Roche for Breach), Roche will be responsible for the costs and expenses associated with the assignments set forth in this Section 14.8.7 (Assignment and Disclosure).
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Article 16
DISPUTE RESOLUTION; GOVERNING LAW
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16.5 | Governing Law; English Language. This Agreement and all amendments, modifications, alterations, or supplements hereto, and the rights of the Parties, will be construed under and governed by the laws of the State of New York, United States, exclusive of its conflicts of laws principles. This Agreement has been prepared in the English language and the English language will control its interpretation. All consents, notices, reports, and other written documents to be delivered or provided by a Party under this Agreement will be in the English language, and in the event of any conflict between the provisions of any document and the English language translation thereof, the terms of the English language translation will control. |
16.6 | Waiver of Jury Trial. TO THE EXTENT NOT PROHIBITED BY APPLICABLE LAW THAT CANNOT BE WAIVED, THE PARTIES HEREBY WAIVE, AND COVENANT THAT THEY WILL NOT ASSERT (WHETHER AS PLAINTIFF, DEFENDANT, OR OTHERWISE), ANY RIGHT TO TRIAL BY JURY IN ANY ACTION ARISING IN WHOLE OR IN PART UNDER OR IN CONNECTION WITH THIS AGREEMENT, WHETHER NOW EXISTING OR HEREAFTER ARISING, AND WHETHER SOUNDING IN CONTRACT, TORT, OR OTHERWISE. THE PARTIES AGREE THAT ANY OF THEM MAY FILE A COPY OF THIS PARAGRAPH WITH ANY COURT AS WRITTEN EVIDENCE OF THE KNOWING, VOLUNTARY, AND BARGAINED-FOR AGREEMENT AMONG THE PARTIES IRREVOCABLY TO WAIVE ITS RIGHT TO TRIAL BY JURY IN ANY PROCEEDING WHATSOEVER BETWEEN THEM RELATING TO THIS AGREEMENT, WHICH WILL INSTEAD BE TRIED IN A COURT OF COMPETENT JURISDICTION BY A JUDGE SITTING WITHOUT A JURY. |
Article 17
MISCELLANEOUS
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If to Sarepta:
Sarepta Therapeutics Three, LLC
215 First Street
Cambridge, MA 02142
Attention: Matthew Gall
Email: [**]
With a copy (which will not constitute notice for purposes of this Agreement) to:
Ropes & Gray LLP
Prudential Tower, 800 Boylston Street
Boston, MA 02199-3600
Attention: David M. McIntosh
Email: [**]
If to Roche:
F. Hoffmann-La Roche Ltd
Grenzacherstrasse 124
4070 Basel
Switzerland
Attention: Legal Department
Facsimile: [**]
With a copy (which will not constitute notice for purposes of this Agreement) to:
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 will be deemed to have been given: (a) on the Business Day after dispatch if sent by internationally-recognized overnight courier; (b) on the fifth Business Day after dispatch if sent by registered or certified mail, postage prepaid, return receipt requested; and (c) when promptly confirmed by personal delivery, registered or certified mail or overnight courier if sent by facsimile.
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17.7 | Performance by Affiliates. Notwithstanding any provision to the contrary set forth herein, either Party will have the right to perform any or all of its obligations and exercise any or all of its rights under this Agreement through any Affiliate. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement and will cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. |
17.8 | Exit of the United Kingdom from EU. Exit of the United Kingdom from E.U. At either Party’s request, the Parties will discuss and agree upon such amendments to this Agreement as may be necessary to fairly and reasonably adjust the terms of this Agreement in light of the United Kingdom’s exit from the E.U. Any such amendment should preserve the basic economic and legal terms of this Agreement insofar as possible in light of the change in circumstances caused by the United Kingdom’s exit from the E.U. |
17.9 | Agency. Neither Party is, nor will be deemed to be an employee, agent, or representative of the other Party for any purpose. Each Party is an independent contractor, not an employee or Roche of the other Party. Neither Party will have the authority to speak for, represent, or obligate the other Party in any way without prior written authority from the other Party. |
17.10 | Binding Effect; No Third Party Beneficiaries or Obligors. As of the Execution Date, this Agreement will be binding upon and inure to the benefit of the Parties and their respective permitted successors and assigns. Except as set forth in Article 13 (Indemnification), no Person other than Sarepta, Roche, and their respective permitted successors and assigns hereunder will be deemed an intended beneficiary hereunder, nor have any right to enforce any obligation of any Party to this Agreement, nor will any Person other than Sarepta and Roche and their respective permitted successors and assigns have any obligations to any Party under this Agreement. |
17.11 | Compliance with Export Regulations. Neither Party will export any technology licensed to it by the other Party under this Agreement except in compliance with U.S. export laws and regulations. |
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17.15 | Counterparts. This Agreement may be executed in two or more counterparts, all of which taken together will be regarded as one and the same instrument. Each Party may execute this Agreement in Adobe™ Portable Document Format (PDF) sent by electronic mail. PDF signatures of authorized signatories of the Parties will be deemed to be original signatures, will be valid and binding upon the Parties, and, upon delivery, will constitute due execution of this Agreement. |
[Remainder of page intentionally left blank; Signature page follows.]
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IN WITNESS WHEREOF, the Parties have executed this Agreement through their duly authorized representatives to be effective as of the Execution Date.
Sarepta Therapeutics Three, LLC
By: |
| /s/ Peter Walsh |
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| Peter Walsh |
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Title: |
| Manager |
F. HOFFMANN-LA ROCHE LTD
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By: |
| /s/ James Sabky |
| By: |
| /s/ Stefan Arnold |
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Name: |
| James Sabky |
| Name: |
| Stefan Arnold |
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Title: |
| Global Head, Pharma Partnering |
| Title: |
| Head Legal Pharma |
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