Execution Copy
Collaboration And License Agreement
by and among
Wave Life Sciences USA, Inc.,
Wave Life Sciences UK Limited
and
Takeda Pharmaceutical Company Limited
February 19, 2018
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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1. |
| DEFINITIONS |
| 1 | ||
2. |
| COLLABORATION OVERVIEW |
| 27 | ||
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| 2.1. |
| Collaboration Overview |
| 27 |
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| 2.2. |
| [***]. |
| 27 |
3. |
| GRANT AND EXERCISE OF OPTIONS |
| 28 | ||
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| 3.1. |
| Grant of Options |
| 28 |
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| 3.2. |
| HTT Target |
| 28 |
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| 3.3. |
| Information Sharing |
| 28 |
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| 3.4. |
| Exercise of an Option |
| 29 |
4. |
| SELECTION OF CATEGORY 2 TARGETS |
| 33 | ||
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| 4.1. |
| Proposed Category 2 Targets |
| 32 |
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| 4.2. |
| Dispute Process |
| 32 |
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| 4.3. |
| Licensed Category 2 Target Replacement |
| 33 |
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| 4.4. |
| Total Targets |
| 33 |
5. |
| DEVELOPMENT |
| 34 | ||
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| 5.1. |
| Development of Category 1 Targets |
| 34 |
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| 5.2. |
| Research Activities for Licensed Category 2 Targets |
| 37 |
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| 5.3. |
| Development Activities for Licensed Category 2 Targets |
| 40 |
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| 5.4. |
| Development Lead Responsibilities |
| 42 |
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| 5.5. |
| Scientific Records |
| 43 |
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| 5.6. |
| Third Parties |
| 43 |
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| 5.7. |
| Technical Failure |
| 43 |
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| 5.8. |
| [***]. |
| 44 |
6. |
| REGULATORY MATTERS |
| 44 | ||
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| 6.1. |
| Regulatory Lead Responsibilities |
| 44 |
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| 6.2. |
| Assignment of Regulatory Materials |
| 44 |
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| 6.3. |
| Drug Master Files |
| 44 |
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| 6.4. |
| Communications with Regulatory Authorities |
| 45 |
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| 6.5. |
| Regulatory Meetings |
| 45 |
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| 6.6. |
| Submissions |
| 45 |
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| 6.7. |
| Right of Reference |
| 45 |
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| 6.8. |
| Pharmacovigilance for Collaboration Targets |
| 46 |
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| 6.9. |
| Costs of Regulatory Affairs |
| 46 |
7. |
| MANUFACTURING |
| 47 | ||
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| 7.1. |
| Manufacturing Lead Responsibilities |
| 47 |
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| 7.2. |
| Supply to Takeda |
| 47 |
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| 7.3. |
| Transition to Takeda |
| 47 |
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| 7.4. |
| Costs and Expenses of Manufacturing |
| 47 |
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| 7.5. |
| Second Source |
| 48 |
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| 7.6. |
| Shortages |
| 48 |
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| 7.7. |
| Manufacturing and Supply Agreements |
| 48 |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
i
| 7.8. |
| Supply Failure |
| 48 | |
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| 7.9. |
| Technology Transfer; Transition of Third Party Agreements to Takeda |
| 49 |
8. |
| COMMERCIALIZATION |
| 50 | ||
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| 8.1. |
| Commercialization of Licensed Category 1 Products |
| 50 |
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| 8.2. |
| Commercialization of Licensed Category 2 Products |
| 52 |
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| 8.3. |
| Commercialization Expenses |
| 52 |
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| 8.4. |
| Commercialization Diligence Obligations |
| 53 |
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| 8.5. |
| Advertising and Promotional Materials. |
| 53 |
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| 8.6. |
| Recalls, Market Withdrawals, or Corrective Actions |
| 54 |
9. |
| GOVERNANCE |
| 54 | ||
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| 9.1. |
| Alliance Manager |
| 54 |
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| 9.2. |
| Joint Steering Committee |
| 54 |
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| 9.3. |
| Licensed Category 1 Joint Team |
| 59 |
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| 9.4. |
| Category 2 Research Committee |
| 60 |
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| 9.5. |
| Subcommittee Meetings |
| 61 |
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| 9.6. |
| Decision‑Making |
| 62 |
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| 9.7. |
| Resolution of Committee Disputes |
| 62 |
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| 9.8. |
| Discontinuation of Participation on the JSC or any Subcommittee |
| 64 |
10. |
| LICENSES |
| 64 | ||
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| 10.1. |
| Category 1 Development Program |
| 64 |
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| 10.2. |
| Licensed Category 1 Targets |
| 65 |
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| 10.3. |
| Licensed Category 2 Targets |
| 66 |
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| 10.4. |
| Sublicensing Terms |
| 67 |
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| 10.5. |
| In‑Licenses |
| 68 |
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| 10.6. |
| Bankruptcy |
| 71 |
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| 10.7. |
| No Other Rights |
| 71 |
11. |
| PAYMENTS |
| 71 | ||
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| 11.1. |
| Upfront Payment |
| 71 |
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| 11.2. |
| Equity Investment |
| 72 |
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| 11.3. |
| Category 1 Targets |
| 72 |
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| 11.4. |
| Licensed Category 2 Targets |
| 75 |
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| 11.5. |
| Other Amounts Payable |
| 80 |
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| 11.6. |
| Payment Terms |
| 81 |
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| 11.7. |
| Mutual Convenience |
| 84 |
12. |
| CONFIDENTIALITY AND PUBLICATION |
| 84 | ||
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| 12.1. |
| Nondisclosure and Non‑Use Obligations |
| 84 |
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| 12.2. |
| Press Release |
| 87 |
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| 12.3. |
| Firewall Procedures |
| 88 |
13. |
| REPRESENTATIONS, WARRANTIES AND COVENANTS |
| 88 | ||
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| 13.1. |
| Mutual Representations and Warranties as of the Execution Date |
| 88 |
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| 13.2. |
| Representations and Warranties by Wave |
| 89 |
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| 13.3. |
| Additional Wave Representations and Warranties as of the Option Notice Date |
| 91 |
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| 13.4. |
| Warranty Disclaimer |
| 94 |
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| 13.5. |
| Certain Covenants |
| 94 |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
ii
| 13.6. |
| Exclusivity; Competing Programs |
| 96 | |
14. |
| INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE |
| 98 | ||
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| 14.1. |
| General Indemnification by Takeda |
| 98 |
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| 14.2. |
| General Indemnification by Wave |
| 98 |
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| 14.3. |
| Category 1 Third Party Losses |
| 99 |
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| 14.4. |
| Indemnification Procedure |
| 99 |
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| 14.5. |
| Limitation of Liability |
| 100 |
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| 14.6. |
| Insurance |
| 100 |
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| 14.7. |
| Disclaimer |
| 101 |
15. |
| INTELLECTUAL PROPERTY |
| 101 | ||
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| 15.1. |
| Inventorship |
| 101 |
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| 15.2. |
| Ownership |
| 101 |
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| 15.3. |
| Disclosure of Inventions |
| 102 |
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| 15.4. |
| Prosecution and Maintenance of Patents |
| 102 |
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| 15.5. |
| Third Party Infringement and Defense |
| 105 |
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| 15.6. |
| Patent Extensions |
| 108 |
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| 15.7. |
| Patent Listings |
| 108 |
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| 15.8. |
| Third Party Rights |
| 108 |
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| 15.9. |
| Common Interest |
| 108 |
16. |
| TERM AND TERMINATION |
| 109 | ||
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| 16.1. |
| Term |
| 109 |
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| 16.2. |
| Termination for Convenience |
| 109 |
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| 16.3. |
| Termination for Patent Challenge |
| 109 |
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| 16.4. |
| Termination for Cause. |
| 110 |
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| 16.5. |
| Termination for Insolvency |
| 111 |
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| 16.6. |
| Effects of Termination by Wave for Cause or Takeda for Convenience |
| 111 |
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| 16.7. |
| Effects of Termination by Takeda for Cause |
| 114 |
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| 16.8. |
| Alternative in Lieu of Termination |
| 115 |
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| 16.9. |
| Survival |
| 115 |
17. |
| MISCELLANEOUS |
| 116 | ||
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| 17.1. |
| Assignment |
| 116 |
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| 17.2. |
| Governing Law |
| 116 |
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| 17.3. |
| Dispute Resolution |
| 116 |
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| 17.4. |
| Entire Agreement; Amendments |
| 118 |
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| 17.5. |
| Severability |
| 118 |
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| 17.6. |
| Headings |
| 118 |
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| 17.7. |
| Waiver of Rule of Construction |
| 119 |
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| 17.8. |
| Interpretation |
| 119 |
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| 17.9. |
| No Implied Waivers; Rights Cumulative |
| 119 |
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| 17.10. |
| Notices |
| 119 |
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| 17.11. |
| Compliance with Export Regulations |
| 120 |
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| 17.12. |
| Force Majeure |
| 120 |
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| 17.13. |
| Independent Parties |
| 120 |
|
| 17.14. |
| Counterparts |
| 121 |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
iii
| 17.15. |
| Further Assurances |
| 121 | |
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| 17.16. |
| Performance by Affiliates |
| 121 |
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| 17.17. |
| Binding Effect; No Third Party Beneficiaries |
| 121 |
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| 17.18. |
| HSR Act |
| 121 |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
iv
SCHEDULE 1.28 – Candidate Category 1 Targets
SCHEDULE 1.95 – Other Eligible Development Expenses
SCHEDULE 1.156 – Lead Initial HTT Compounds
SCHEDULE 1.216– Form of Option Exercise Notice
SCHEDULE 1.242 – POM Criteria
SCHEDULE 1.283 – Takeda Patents
SCHEDULE 4.1 – Form of Proposed Category 2 Target Nomination Notice
SCHEDULE 5.1.2(a) – HTT Candidate Category 1 Development Plan
SCHEDULE 5.1.2(b) – C9orf72 Candidate Category 1 Development Plan
SCHEDULE 5.1.3 – Form of Licensed Category 1 Development Budget
SCHEDULE 7.7(a) – Clinical Supply Term Sheet
SCHEDULE 7.7(b) – Commercial Supply Term Sheet
SCHEDULE 8.1.2– Form of Licensed Category 1 Commercialization Budget
SCHEDULE 10.4.1 – Takeda Sublicensing Rights
SCHEDULE 11.3.4 – Licensed Category 1 Profit & Loss Share
SCHEDULE 12.2.1(a) – Wave Press Release
SCHEDULE 12.2.1(b) – Takeda Press Release
SCHEDULE 13.2.1 – Wave Patents and In‑Licenses
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
v
COLLABORATION AND LICENSE AGREEMENT
THIS COLLABORATION AND LICENSE AGREEMENT (this “Agreement”), entered into as of February 19, 2018 (the “Execution Date”), is entered into by and among Wave Life Sciences USA, Inc., a corporation organized and existing under the Laws of the State of Delaware (“Wave US”), Wave Life Sciences UK Limited, a private limited company incorporated under the laws of England and Wales (“Wave UK”, and together with Wave US, “Wave”), and Takeda Pharmaceutical Company Limited, a corporation organized and existing under the Laws of the Japan (“Takeda”). Wave and Takeda are referred to in this Agreement individually as a “Party” and collectively as the “Parties.”
RECITALS:
WHEREAS, Wave is a genetic medicine company focused on advancing Oligonucleotides that precisely target the underlying causes of rare diseases;
WHEREAS, Takeda possesses expertise in developing and commercializing therapeutics;
WHEREAS, Wave intends, through this Agreement, to enter into a collaboration with Takeda in which Takeda will be Wave’s partner in the field of CNS‑related therapeutics, on the terms and conditions set forth herein; and
WHEREAS, Wave and Takeda desire to collaborate to research, develop, and commercialize stereopure Oligonucleotide therapeutics directed toward various CNS indications, and Wave and Takeda would assume further development, manufacturing, and commercialization related to the Collaboration Compounds, the Collaboration Products, and Companion Diagnostics directed to a Collaboration Target, discovered in the collaboration as further described in this Agreement.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the Parties hereby agree as follows:
Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, will have the respective meanings set forth below:
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
1.12 | “Annual Research Fee” has the meaning set forth in Section 11.4.1.1 (Initial Licensed Category 2 Research Term). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
2
1.21 | “Business Day” means a calendar day other than a Saturday, Sunday, or a bank or other public holiday in Massachusetts or New York in the United States or in Tokyo in Japan. |
1.22 | “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30, and December 31 of each Calendar Year. |
1.23 | “Calendar Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31. |
1.24 | “Candidate Category 1 Compound” means, for each Candidate Category 1 Target, any Oligonucleotide directed to such Candidate Category 1 Target [***]. |
1.25 | “Candidate Category 1 Development Plan” has the meaning set forth in Section 5.1.2 (Candidate Category 1 Development Plan). |
1.31 | “Candidate Target Know‑How” has the meaning set forth in Section 13.3.2 (Existing Wave In‑License). |
1.33 | “Candidate Target Technology” has the meaning set forth in Section 13.3.2 (Existing Wave In‑Licenses). |
1.35 | “Category 1 Development Milestone Event” has the meaning set forth in Section 11.3.3 (Category 1 Targets Development Milestone Payments). |
1.36 | “Category 1 Development Milestone Payment” has the meaning set forth in Section 11.3.3 (Category 1 Targets Development Milestone Payments). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
3
1.37 | “Category 1 Development Plan” means any Candidate Category 1 Development Plan or Licensed Category 1 Development Plan. |
1.38 | “Category 1 Development Program” has the meaning set forth in Section 5.1.1 (Category 1 Development Overview). |
1.39 | “Category 1 Development Term” means the Candidate Category 1 Development Term and the Licensed Category 1 Development Term. |
1.40 | “Category 1 Development Report” has the meaning set forth in Section 5.1.6 (Category 1 Development Reports). |
1.43 | “Category 2 Development Milestone Event” has the meaning set forth in Section 11.4.2 (Licensed Category 2 Products Development Milestone Payments). |
1.44 | “Category 2 Development Milestone Payment” has the meaning set forth in Section 11.4.2 (Licensed Category 2 Products Development Milestone Payments). |
1.45 | “Category 2 Research Committee” has the meaning set forth in Section 9.4.1 (Purpose; Formation; Dissolution). |
1.47 | “Category 2 Sales Milestone Event” has the meaning set forth in Section 11.4.3 (Licensed Category 2 Targets Category 2 Sales Milestone Payments). |
1.48 | “Category 2 Sales Milestone Payment” has the meaning set forth in Section 11.4.3 (Licensed Category 2 Targets Sales Milestone Payments). |
1.49 | “Category 2 Target Specific Extension” has the meaning set forth in Section 5.2.2 (Licensed Category 2 Research Term). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
4
1.54 | “Clinical Supply Agreement” has the meaning set forth in Section 7.7 (Manufacturing and Supply Agreements). |
1.55 | “Clinical Supply Term Sheet” has the meaning set forth in Section 7.7 (Manufacturing and Supply Agreements). |
1.58 | “Collaboration Compound” means any Candidate Category 1 Compound, Licensed Category 1 Compound, or Licensed Category 2 Compound. |
1.59 | “Collaboration In‑License” has the meaning set forth in Section 10.5.4 (Collaboration In‑Licenses). |
1.61 | “Collaboration Target” means any Candidate Category 1 Target, Licensed Category 1 Target, or Licensed Category 2 Target. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
5
1.63 | “Commercial Supply Agreement” has the meaning set forth in Section 7.7 (Manufacturing and Supply Agreements). |
1.64 | “Commercial Supply Term Sheet” has the meaning set forth in Section 7.7 (Manufacturing and Supply Agreements). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
6
1.73 | “Consolidated Report” has the meaning set forth in Paragraph 2.2 of Schedule 11.3.4 (Licensed Category 1 Profit & Loss Share). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
7
1.84 | “Development Milestone Event” has the meaning set forth in Section 11.4.2 (Licensed Category 2 Products Development Milestone Payments). |
1.85 | “Development Milestone Payment” has the meaning set forth in Section 11.4.2 (Licensed Category 2 Products Development Milestone Payments). |
1.87 | “Disclosure Letter” has the meaning set forth in Section 13.3 (Additional Wave Representations and Warranties as of the Option Notice Date). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
8
1.89 | “Distribution Costs” means the [***]. Distribution expenses should be recognized in accordance with applicable Accounting Standards. |
in each case, to the extent such costs are included in the [***].
Eligible Commercialization Expenses specifically exclude (i) the cost of activities that [***], and (ii) any costs or expenses of a Party or its Affiliates to the extent [***].
If any cost or expense is specifically identifiable or reasonably allocable to more than one cost category set forth above in clause (a) through (f), then such cost or expense will only be counted as an Eligible Commercialization Expense with respect to one such category. [***].
For clarity, Eligible Commercialization Expenses will be recognized in accordance with applicable Accounting Standards.
1.96 | “EMA” means the European Medicines Agency and any successor Governmental Authority having substantially the same function. |
1.98 | “EU” means the European Union, as its membership may be constituted from time to time, and any successor thereto. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
9
the foregoing individuals may designate the Chief Financial Officer as his/her designee for financial related matters. In the event that the position of any of the Executive Officers identified in this Section 1.100 (Executive Officer) no longer exists due to a Change of Control, corporate reorganization, corporate restructuring, or the like that results in the elimination of the identified position, then the applicable Party will replace the applicable Executive Officer with another executive officer with responsibilities and seniority comparable to the eliminated Executive Officer. |
1.107 | “Ex‑U.S. Licensed Category 1 Commercialization Budget” has the meaning set forth in Section 8.1.2 (Licensed Category 1 Commercialization Plans). |
1.108 | “Ex‑U.S. Licensed Category 1 Commercialization Plan” has the meaning set forth in Section 8.1.2 (Licensed Category 1 Commercialization Plans). |
1.109 | “Ex-U.S. Territory Licensed Category 1 Profit & Loss Share” has the meaning set forth in Section 11.3.4 (Licensed Category 1 Profit & Loss Share for Commercialization Activities). |
1.110 | “Ex-U.S. P&L” has the meaning set forth in Schedule 11.3.4 (Licensed Category 1 Profit & Loss Share for Commercialization Activities). |
1.111 | “Ex-U.S. Territory” means the Territory other than the U.S. |
1.112 | “FDA” means the United States Food and Drug Administration or any successor agency thereto. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
10
1.115 | “Finance Officers” has the meaning set forth in Section 11.3.2.2 (Eligible Development Expenses Report). |
1.119 | “FTE Costs” means, for any period, the FTE Rate multiplied by the number of FTEs in such period. FTEs will be pro‑rated on a daily basis if necessary. |
1.121 | “GAAP” means generally accepted accounting principles as practiced in the United States, as consistently applied. |
1.125 | “GLP” means good laboratory practice as required by the FDA under 21 C.F.R. Part 58 and all applicable FDA rules, regulations, orders, and guidances, and the requirements with respect to good laboratory practices prescribed by the European Community, the OECD (Organization for Economic Cooperation and Development Council) and the ICH Guidelines, or as otherwise required by applicable Laws. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
11
1.127 | “Granting Party” means the Party that grants any licenses or other rights to the other Party under this Agreement. |
1.130 | “HSR Act” means the Hart‑Scott‑Rodino Antitrust Improvements Act of 1976, as amended, and the rules promulgated thereunder. |
1.143 | “Indication” means a disease or pathological condition for which clinical results for such disease or condition and a separate NDA application or a supplement (or other addition) to an existing |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
12
NDA application is required for the purpose of obtaining Regulatory Approval (other than Pricing Approval) in a country; [***]. |
1.145 | “Initiation” means, with respect to a Clinical Study of a product, the first dosing of the first human subject pursuant to the applicable protocol for such Clinical Study. |
1.146 | “In‑Licenses” means, collectively, the Existing Wave In‑Licenses, the Existing Takeda In‑Licenses, and the Collaboration In‑Licenses. |
1.148 | “Joint Collaboration Patents” has the meaning set forth in 15.4.3.1 (Takeda First Right). |
1.150 | “JSC” has the meaning set forth in Section 9.2.1 (Purpose; Formation; Dissolution). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
13
1.155 | “Lead Category 2 LP” has the meaning set forth in Section 5.3.2 (Licensed Category 2 Transition Plan). |
1.156 | “Lead Initial HTT Compounds” means those Category 1 Compounds directed to the HTT Target set forth in Schedule 1.156. |
1.158 | “Licensed Category 1 Commercialization Budget” has the meaning set forth in Section 8.1.2 (Licensed Category 1 Commercialization Plans). |
1.159 | “Licensed Category 1 Commercialization Plans” has the meaning set forth in Section 8.1.2 (Licensed Category 1 Commercialization Plans). |
1.161 | “Licensed Category 1 Development Budget” has the meaning set forth in Section 5.1.3 (Licensed Category 1 Development Plan). |
1.162 | “Licensed Category 1 Development Plan” has the meaning set forth in Section 5.1.3 (Licensed Category 1 Development Plan). |
1.164 | “Licensed Category 1 Global Commercialization Strategy” has the meaning set forth in Section 8.1.1 (Licensed Category 1 Global Commercialization Strategy). |
1.165 | “Licensed Category 1 Joint Team” has the meaning set forth in Section 9.3.1 (Formation; Composition; Dissolution). |
1.167 | “Licensed Category 1 Profit & Loss Share” has the meaning set forth in Section 11.3.4 (Licensed Category 1 Profit & Loss Share for Commercialization Activities). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
14
1.169 | “Licensed Category 1 Target” means any Candidate Category 1 Target for which Takeda has exercised an Option in accordance with Section 3.4.4 (Exercise of Options). |
1.170 | “Licensed Category 1 Transition Budget” has the meaning set forth in Section 5.1.7 (Licensed Category 1 Transition Plan). |
1.171 | “Licensed Category 1 Transition Plan” has the meaning set forth in Section 5.1.7 (Licensed Category 1 Transition Plan). |
1.172 | “Licensed Category 2 Commercialization Plan” has the meaning set forth in Section 8.2.1 (Licensed Category 2 Commercialization Plans). |
1.174 | “Licensed Category 2 Development Plan” has the meaning set forth in Section 5.3.3 (Licensed Category 2 Development Plan). |
1.175 | “Licensed Category 2 Development Program” has the meaning set forth in Section 5.3.1 (Licensed Category 2 Development Overview). |
1.176 | “Licensed Category 2 Development Term” means, on a Licensed Category 2 Target‑by‑Licensed Category 2 Target basis, the time period commencing on the [***]. |
1.179 | “Licensed Category 2 Research Budget” has the meaning set forth in Section 5.2.3 (Licensed Category 2 Research Plans). |
1.181 | “Licensed Category 2 Research Plan” has the meaning set forth in Section 5.2.3 (Licensed Category 2 Research Plans). |
1.182 | “Licensed Category 2 Research Program” has the meaning set forth in Section 5.2.1 (Licensed Category 2 Research Overview). |
1.183 | “Licensed Category 2 Research Report” has the meaning set forth in Section 5.2.6 (Licensed Category 2 Research Reports). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
15
1.185 | “Licensed Category 2 Target” means a Proposed Category 2 Target approved as a Licensed Category 2 Target in accordance with Section 4.1 (Proposed Category 2 Targets). |
1.187 | “Licensed Category 2 Transition Budget” has the meaning set forth in Section 5.3.2 (Licensed Category 2 Transition Plan). |
1.188 | “Licensed Category 2 Transition Plan” has the meaning set forth in Section 5.3.2 (Licensed Category 2 Transition Plan). |
1.193 | “Loss of Market Exclusivity” means an event where, with respect to any Licensed Category 2 Product in [***]. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
16
[***].
1.199 | “Material Communications” means written, telephonic, or in‑person communications from or with any Regulatory Authority concerning any of the following: [***]. |
1.200 | “Materials” means all tangible compositions of matter, devices, articles of manufacture, assays, biological, chemical, or physical materials, and other similar materials. |
1.201 | “Medical Affairs” means, with respect to a Licensed Product and Companion Diagnostics related to such Licensed Product, the performance of activities by or on behalf of a Party with respect to: continuing medical education therefor; development, publication, and dissemination of publications; exhibiting and presenting at seminars and conventions; conducting health economic studies; conducting health care professional and patient speakers programs; conducting appropriate activities involving opinion leaders; engaging medical science liaisons and conducting medical science liaison activities; conducting advisory board meetings or other consultant programs; and establishing clinical consumer and patient registries. |
1.203 | “Milestone Payments” has the meaning set forth in Section 11.4.3 (Licensed Category 2 Targets Category 2 Sales Milestone Payments). |
1.204 | “Named Candidate Category 1 Compounds” has the meaning set forth in Section 13.3 (Additional Wave Representations and Warranties as of the Option Notice Date). |
1.205 | “Named Candidate Category 1 Products” has the meaning set forth in Section 13.3 (Additional Wave Representations and Warranties as of the Option Notice Date). |
1.206 | “Named Companion Diagnostics” has the meaning set forth in Section 13.3 (Additional Wave Representations and Warranties as of the Option Notice Date). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
17
Notwithstanding the foregoing, in no event may the Party calculating Net Sales on gross amounts invoiced or received by or on behalf of such Party or any of its Related Parties for any Licensed Product or Companion Diagnostic related to any Licensed Category 1 Product take a deduction in a manner that is inconsistent with such Party’s Accounting Standard.
[***].
If a Licensed Product is sold as part of a Combination Product in a country in the Territory, then Net Sales for the Licensed Product included in such Combination Product in such country will be calculated as follows:
If the Licensed Product and the Other Components in such Combination Product are both sold separately in such country, then Net Sales for the Licensed Product will be calculated by [***].
If the Licensed Product is sold separately in such country, but the Other Components contained in the Combination Product are not sold separately in such country, then Net Sales for the Licensed Product will be calculated by [***];
If the Licensed Product is not sold separately in such country, but the Other Components contained in the Combination Product are sold separately in such country, then Net Sales for the Licensed Product will be calculated by multiplying [***]
If neither the Licensed Product nor the Other Components contained in the Combination Product are sold separately in such country, then Net Sales will be calculated by [***].
1.211 | “Non‑Granting Party” means the Party to whom licenses or rights are granted under this Agreement. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
18
1.219 | “Option Notice Date” has the meaning set forth in Section 13.3 (Additional Wave Representations and Warranties as of the Option Notice Date). |
1.223 | “Overhead Costs” means costs incurred by a Party or for its account that are attributable to a Party’s [***]. |
1.226 | “Patent Challenge” has the meaning set forth in Section 16.3 (Termination for Patent Challenge). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
19
1.235 | “Potential Candidate Category 1 In‑License” has the meaning set forth in Section 10.5.2(Candidate Category 1 In‑Licenses). |
1.236 | “Potential Candidate Category 1 In‑License Term Sheet” has the meaning set forth in Section 10.5.2 (Candidate Category 1 In‑Licenses). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
20
1.243 | “Proposed Category 2 Target” has the meaning set forth in Section 4.1 (Proposed Category 2 Targets). |
1.244 | “Proposed Category 2 Target Nomination Notice” has the meaning set forth in Section 4.1 (Proposed Category 2 Targets). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
21
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
22
1.264 | “SDEA” means one or more Safety Data Exchange Agreements entered into by the Parties relating to Collaboration Compounds or Collaboration Products. |
1.268 | “Subcommittee” means the Licensed Category 1 Joint Team, the Category 2 Research Committee, and any other subcommittee formed by the JSC in accordance with Section 9.6.2 (Decisions of the JSC). |
1.271 | “Supply Agreements” has the meaning set forth in Section 7.7 (Manufacturing and Supply Agreements). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
23
1.280 | “Takeda Indemnitees” has the meaning set forth in Section 14.2 (General Indemnification by Wave). |
1.281 | “Takeda In‑Licenses” means any Existing Takeda In‑License or any Collaboration In‑License to which Takeda is a party. |
1.286 | “Target” means any biological target that has or is anticipated to have a [***] to which a pharmaceutical compound binds in order to elicit a therapeutic or other pharmacodynamic response. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
24
1.294 | “Third Party Manufacturing Agreements” has the meaning set forth in Section 7.9.2 (Third Party Agreements). |
1.297 | “Transition Plan” means any Licensed Category 1 Transition Plan or Licensed Category 2 Transition Plan. |
1.300 | “United States” or “U.S.” means the United States and its territories, possessions and commonwealths. |
1.302 | “U.S. Licensed Category 1 Commercialization Budgets” has the meaning set forth in Section 8.1.2 (Licensed Category 1 Commercialization Plans). |
1.303 | “U.S. Licensed Category 1 Commercialization Plans” has the meaning set forth in Section 8.1.2 (Licensed Category 1 Commercialization Plans). |
1.304 | “U.S. Licensed Category 1 Profit & Loss Share” has the meaning set forth in Section 11.3.4 (Licensed Category 1 Profit & Loss Share for Commercialization Activities). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
25
1.317 | “Wave Indemnitees” has the meaning set forth in Section 14.1 (General Indemnification by Takeda). |
1.318 | “Wave In‑Licenses” means any Existing Wave In‑License, Candidate In‑Licenses, or any Collaboration In‑License to which Wave is a party. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
26
1.324 | “Wave Technology” means (a) Wave Know‑How, (b) Wave Patents, (c) Wave Improvements, (d) Wave Collaboration IP, and (e) Wave’s interest in the Joint Collaboration IP. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
27
| 3.3.1.2. | the Data Package for such Candidate Category 1 Target, which will be made available to Takeda through an electronic data room; |
| 3.3.1.3. | an initial Licensed Category 1 Development Plan for the Lead Category 1 CP directed to such Candidate Category 1 Target; |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
28
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
29
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
30
| Category 1 Targets) will terminate with respect to such Licensed Category 1 Target, (d) the licenses set forth in Section 10.3 (Licensed Category 2 Targets) will apply to such new Licensed Category 2 Target and to such new Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such new Licensed Category 2 Target, and (e) the further Development and Commercialization of Licensed Category 2 Compounds, Licensed Category 2 Products, and Companion Diagnostics directed to such Licensed Category 2 Target will thereafter be governed by Section 5.3 (Development Activities for Licensed Category 2 Targets) and Section 8 (Commercialization), respectively. Notwithstanding anything in this Agreement to the contrary, if Takeda elects to convert a Licensed Category 1 Target to a Licensed Category 2 Target in accordance with the previous sentence, then such conversion will be Takeda’s sole and exclusive remedy with respect to the applicable funding failure that gave rise to Takeda having the right to make such election. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
31
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
32
4.2. | Dispute Process. If a Party believes that a Proposed Category 2 Target identified in a Proposed Category 2 Target Nomination Notice is [***]. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
33
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
34
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
35
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
36
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
37
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
38
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
39
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
40
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
41
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
42
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
43
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
44
sufficient access to or rights to cross‑reference any such drug master files maintained by such Third Party, and (b) with respect to any agreement between Wave and any such Third Party that is entered into on or after the Effective Date, Wave will secure for Takeda such reasonably sufficient access to or rights to cross‑reference any such drug master files maintained by such Third Party. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
45
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
46
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
47
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
48
to Section 7.9 (Technology Transfer; Transition of Third Party Agreements to Takeda) from Wave to Takeda or to a Third Party contract manufacturer identified by Takeda, subject only to Wave’s prior consent (not to be unreasonably withheld) to any such second source that is a Third Party. [***]. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
49
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
50
| applicable Licensed Category 1 Product. Each Licensed Category 1 Commercialization Plan will include a high level budget in the format set forth on Schedule 8.1.2 for the activities set forth therein, taking into account the expected costs of the activities contemplated by the applicable Licensed Category 1 Commercialization Plan and the FTE Rate for non-scientific and non-technical personnel who will perform activities under such Licensed Category 1 Commercialization Plan, and will include the cost categories that are included in the Licensed Category 1 Profit & Loss Share (each, a “U.S. Licensed Category 1 Commercialization Budget” and “Ex-U.S. Licensed Category 1 Commercialization Budget,” respectively, and collectively the “Licensed Category 1 Commercialization Budgets”). [***], (i) Takeda, with input from Wave, will review and update each U.S. Licensed Category 1 Commercialization Plan (including the U.S. Licensed Category 1 Commercialization Budget set forth therein), and (ii) Takeda will update each Ex-U.S. Licensed Category 1 Commercialization Plan (including the Ex-U.S. Licensed Category 1 Commercialization Budget set forth therein). The JSC will review, discuss, and determine whether to approve each Licensed Category 1 Commercialization Budget and each material update thereto, and will review and discuss each Licensed Category 1 Commercialization Plan and each material update thereto. Neither of Takeda nor Wave US will be required to expend more than the amounts set forth in the applicable Licensed Category 1 Commercialization Budget then in effect for the applicable activities. |
| 8.1.4. | Commercialization Activities in the U.S. Except as set forth in Section 8.1.5 (Wave Commercialization Activities in the U.S.), Takeda will be solely responsible for all Commercialization and Medical Affairs activities in the U.S. for each Licensed Category 1 Product and Companion Diagnostics directed to each Licensed Category 1 Target, including handling all returns, recalls, order processing, invoicing and collection, booking of sales, inventory and receivables, and managed and government pricing programs, other than the Wave Commercialization Activities. Wave US will not accept orders for any Licensed Category 1 Product or Companion Diagnostic directed to a Licensed Category 1 Target or make sales for its own account or for Takeda’s account, and if Wave US receives any order for a Licensed Category 1 Product or Companion Diagnostic directed to a Licensed Category 1 Target in the U.S., then it will refer such orders to Takeda for acceptance or rejection. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
51
| 8.1.8. | Licensed Category 1 Product Commercialization Reporting. Commencing upon the First Commercial Sale of the Lead Category 1 LP, each Party will keep the Licensed Category 1 Joint Team informed regarding the progress and results of the Commercialization activities for Licensed Category 1 Products and Companion Diagnostics related to any such Licensed Category 1 Products for which such Party is responsible, including by providing an annual written report to the Licensed Category 1 Joint Team reviewing results versus goals set forth in the Licensed Category 1 Commercialization Plan. |
| 8.2.2. | Commercialization Activities for Licensed Category 2 Products. Takeda will be solely responsible for all Commercialization activities for each Licensed Category 2 Product and any Companion Diagnostic directed to any Licensed Category 2 Target, including Distribution Matters, warehousing, Pricing Matters, order processing, invoicing and collection, booking of sales, inventory and receivables, and managed, government pricing programs and Medical Affairs. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
52
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
53
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
54
| meeting. The Alliance Managers will work with the chairpersons to prepare and circulate agendas and to ensure the preparation and approval of minutes. The chairpersons have no additional powers or rights beyond those held by the other JSC representatives. |
| 9.2.3.3. | determine whether there has been a Technical Failure with respect to any Collaboration Target, as further described in Section 1.288 (Technical Failure) and Section 5.7 (Technical Failure); |
| 9.2.3.4. | provide each Party reasonably‑detailed updates regarding any activities undertaken by Third Parties, as described in Section 5.6 (Third Parties); |
| 9.2.3.5. | review and discuss any Material Communication with Regulatory Authorities, as described in Section 6.4 (Communications with Regulatory Authorities). |
| 9.2.3.6. | review and discuss filings or applications for Regulatory Approvals (other than INDs) of Collaboration Compounds, Collaboration Products, or Companion Diagnostics, and receipt or denial of Regulatory Approval for any such filings or applications for Collaboration Products or Companion Diagnostics, as described in Section 6.6 (Submissions); |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
55
| 9.2.3.11. | discuss in good faith strategies for abating any Competitive Infringement of any Collaboration Product within each Party’s respective Territory, as described in Section 15.5.1 (Notices); |
| 9.2.3.13. | establish, but not delegate decision making authority to, such additional Subcommittees as it deems necessary to achieve the objective and intent of this Agreement. |
| 9.2.4. | Additional Responsibilities with Respect to Category 1 Targets. In addition, the JSC will have the following responsibilities with respect to Category 1 Targets: |
| 9.2.4.1. | review and determine whether to approve any Candidate In‑Licenses in accordance with Section 10.5.2 (Candidate Category 1 In‑Licenses); |
| 9.2.4.2. | in good faith, equitably apportion Patent Costs between the Parties to reflect the fair value attributable to the Licensed Category 1 Compounds, Licensed Category 1 Product, or Companion Diagnostics directed to the applicable Licensed Category 1 Target, in each case, as compared to other products or applications, as described in Schedule 1.94; |
| 9.2.4.3. | review, discuss, and determine whether to approve any changes in the scope of the Wave Commercialization Activities, as described in Section 1.313 (Wave Commercialization Activities); |
| 9.2.4.6. | oversee the Development for each Category 1 Target in accordance with Section 5.1.1 (Category 1 Development Overview); |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
56
| 9.2.4.7. | review and discuss progress reports of Development activities for under each Licensed Category 1 Program, as described in Section 5.1.6 (Category 1 Development Reports); |
| 9.2.4.12. | review and discuss each Licensed Category 1 Global Commercialization Strategy, as described in Section 8.1.1 (Licensed Category 1 Target Global Commercialization Strategy); |
| 9.2.5. | Additional Responsibilities with Respect to Licensed Category 2 Targets. In addition, the JSC will in particular have the following responsibilities with respect to Licensed Category 2 Targets: |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
57
| 9.2.5.6. | review and discuss each Licensed Category 2 Development Plan and any updates thereto that are material, as described in Section 5.3.3 (Licensed Category 2 Development Plan); |
| 9.2.5.7. | review and discuss progress reports of Development activities for any Licensed Category 2 Development Programs, as described in Section 5.3.6 (Licensed Category 2 Development Reports); |
| 9.2.5.8. | review, discuss, and determine whether any Licensed Category 2 Product is being Developed [***]; and |
| 9.2.5.9. | facilitate the exchange of Licensed Category 2 Commercialization Plans, as described in Section 8.2.1 (Licensed Category 2 Commercialization Plans). |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
58
| Alliance Managers to provide the members of the JSC no later than [***] Business Day prior to the special meeting with an agenda for the meeting and materials reasonably adequate to enable an informed decision on the matters to be considered. The JSC may meet in person, by videoconference or by teleconference. Notwithstanding the foregoing, at least [***] will be in person unless the Parties agree in writing to waive such requirement. In‑person JSC meetings will be held at locations alternately selected by each Party. Each Party will bear the expense of its respective JSC members’ participation in JSC meetings. Meetings of the JSC will be effective only if at least [***] is present or participating in such meeting. The Alliance Managers will be responsible for preparing reasonably detailed written minutes of all JSC meetings that reflect material decisions made and action items identified at such meetings. The Alliance Managers will send draft meeting minutes to each member of the JSC for review and approval within [***] days after each JSC meeting. Such minutes will be deemed approved unless one or more members of the JSC objects to the accuracy of such minutes within [***] Business Days of receipt. |
| 9.3.2. | Responsibilities. In addition, the Licensed Category 1 Joint Team will have the following responsibilities with respect to Category 1 Targets: |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
59
| 9.3.2.2. | review and discuss progress reports of Development activities for under each Licensed Category 1 Program, as described in Section 5.1.6 (Category 1 Development Reports); |
| 9.3.2.4. | oversee the Commercialization of all Licensed Category 1 Products and Companion Diagnostics directed to each Category 1 Target within the Field in the U.S. as described in Section 8.1.3 (Oversight and Performance of Commercialization Activities); and |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
60
| 9.4.2.1. | review and discuss progress reports of Development activities under each Licensed Category 2 Research Program, as described in Section 5.2.6 (Licensed Category 2 Research Reports); |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
61
meeting. Such minutes will be deemed approved unless one or more members of the Subcommittee objects to the accuracy of such minutes within [***] Business Days of receipt. Minutes will be officially endorsed by the Subcommittee at the next Subcommittee meeting, and will be signed by the Alliance Managers. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
62
| 9.7.2.1. | Wave Decisions. Notwithstanding Section 9.7.2.3 (Development Lead Decisions) or Section 9.7.2.4 (Manufacturing Lead Decisions), Wave will have final decision making authority over: |
| 9.7.2.2. | Takeda Decisions. Notwithstanding Section 9.7.2.3 (Development Lead Decisions) or Section 9.7.2.4 (Manufacturing Lead Decisions), Takeda will have final decision making authority over: [***]. |
| 9.7.2.3. | Development Lead Decisions. The applicable Development Lead will have final decision making authority over matters related to the conduct of [***]. |
| 9.7.2.4. | Manufacturing Lead Decisions. The applicable Manufacturing Lead will not have final decision making authority over [***]. |
| 9.7.2.5. | Expedited Arbitration. Notwithstanding Section 9.7.2.3 (Development Lead Decisions) or Section 9.7.2.4 (Manufacturing Lead Decisions), [***] will be referred to Expedited Arbitration in accordance with Section 17.3.8 (Expedited Arbitration) if the Executive Officers are unable to reach unanimous agreement on any such matter. |
| 9.7.2.6. | No Change. Notwithstanding Section 9.7.2.3 (Development Lead Decisions) or Section 9.7.2.4 (Manufacturing Lead Decisions), no changes will be adopted with respect to the following matters if the Executive Officers are unable to reach unanimous agreement on any such matter: [***]. |
| 9.7.3.1. | Referral to Expedited Arbitration. The following Critical Matters will be referred to Expedited Arbitration in accordance with Section 17.3.8 (Expedited Arbitration): [***]. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
63
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
64
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
65
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
66
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
67
| 10.5.1. | Existing In‑Licenses. Responsibility for Collaboration In‑Licenses, Existing Wave In‑Licenses, and Existing Takeda In‑License (and Third Party Payments thereunder) will be as follows: |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
68
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
69
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
70
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
71
11.2. | Equity Investment. Takeda and Wave Singapore will enter into the Share Purchase Agreement as of the Execution Date. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
72
| Quarter, Takeda will prepare a reconciliation and send such report to the Finance Officers. Within twenty five (25) days after the last day of each Calendar Quarter, the Finance Officers will confer and agree in writing on whether a reconciliation payment is due either from Wave US to Takeda or from Takeda to Wave US to effect the sharing of expenses set forth in Section 11.3.2.1 (Expense Sharing), and if so, the amount of such reconciliation payment. Wave US or Takeda, as applicable, if required to pay such reconciliation payment, will submit the undisputed portion of any such payment to Takeda or Wave US, respectively, as applicable, within forty-five (45) days after receipt of the other Party’s invoice for such amount. In the event of any disagreement with respect to the calculation of such reconciliation payment, the Party owing payment will pay any undisputed portion of such reconciliation payment in accordance with the foregoing timetable and will pay the remaining, disputed portion within fifteen (15) days after the date on which Wave and Takeda, using good faith efforts, resolve the Dispute, which Dispute, at the request of either Party, will be resolved in accordance with Section 17.3.8 (Expedited Arbitration). In addition, each Party will consider in good faith other reasonable procedures proposed by the other Party for sharing financial information in order to permit each Party to close its books periodically in a timely manner. In addition to the above, within fifteen (15) days after the last day of the second month of every Calendar Quarter, so long as a Party incurs Eligible Development Expenses, each of Wave US and Takeda will submit to the Finance Officers a report setting forth, with respect to Licensed Category 1 Targets, the Eligible Development Expenses actually incurred by such Party in such just-completed two month period as well as an estimate of expected expenses to be incurred in the third month of the current Calendar Quarter. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
73
(1) [***] | [***] |
(2) [***] | [***] |
(3) [***] | [***] |
(4) [***] | [***] |
(5) [***] | [***] |
| 11.3.3.2. | HTT. For the avoidance of doubt, the Category 1 Development Milestone Payment corresponding to Category 1 Development Milestone [***]. |
| (a) | Subject to Section 11.3.3.1 (C9orf72) and Section 11.3.3.2 (HTT), but notwithstanding any other provision of this Agreement, [***]. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
74
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
75
Table 11.4.1.1 – Annual Research Fee | |
Date | Annual Research Fee |
[***] | [***] |
[***] | [***] |
[***] | [***] |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
76
| ||
(1) | [***] | [***] |
(2) | [***] | [***] |
(3) | [***] | [***] |
(4) | [***] | [***] |
(5) | [***] | [***] |
| 11.4.2.1. | Additional Category 2 Development Milestone Terms. Notwithstanding the foregoing, for the purpose of construing the Category 2 Development Milestone Payments specified in Table 11.4.2 above: |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
77
| (c) | Notwithstanding anything to the contrary set forth in this Agreement, if any of Category 2 Development Milestone Event [***]. |
Annual Net Sales in a Given Calendar Year for all Licensed Category 2 Products directed to a Particular Licensed Category 2 Target | |
[***] | [***] |
[***] | [***] |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
78
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
79
By way of example for the Category 2 Royalty, in the first Calendar Quarter of the Calendar Year, if the worldwide aggregate annual Net Sales of a Licensed Category 2 Product for which Category 2 Royalties are due under this Section 11.4.4 (Category 2 Royalties) were [***], then the following Category 2 Royalty payment for the Calendar Quarter would be payable under this Section 11.4.4 (Category 2 Royalties): [***].
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
80
| 11.6.1. | Manner of Payment. All payments to be made by a Party hereunder will be made in Dollars by wire transfer to such bank account as the other Party may designate. At any time at [***]. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
81
| the audit request is made. The Auditing Party agrees to hold in strict confidence all information received and all information learned in the course of any audit or inspection, except to the extent necessary to enforce its rights under this Agreement or to the extent required to comply with any law, regulation or judicial order. The Auditor will provide its audit report and basis for any determination to the Audited Party at the time such report is provided to the Auditing Party before it is considered final. In the event that the final result of the inspection reveals an undisputed underpayment or overpayment by either Party, the underpaid or overpaid amount will be settled promptly. The Auditing Party will pay for such inspections, as well as its expenses associated with enforcing its rights with respect to any payments hereunder. In addition, if an underpayment of more than [***] of the total payments due hereunder for the applicable year is discovered, then the fees and expenses charged by the Auditor will be paid by Audited Party. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
82
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
83
| 11.6.7. | Interest Due. Each paying Party will pay the other Party interest on any undisputed payments that are not paid on or before the date such payments are due under this Agreement at the [***]. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
84
| 12.1.2.1. | is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by the receiving Party’s business records; |
| 12.1.2.2. | is known to the public before its receipt from the disclosing Party, or thereafter becomes generally known to the public through no breach of this Agreement by the receiving Party; |
| 12.1.2.3. | is subsequently disclosed to the receiving Party by a Third Party who is not known by the receiving Party to be under an obligation of confidentiality to the disclosing Party; or |
| 12.1.2.4. | is developed by the receiving Party independently of Confidential Information received from the disclosing Party, as documented by the receiving Party’s business records. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
85
| the disclosure. Notwithstanding Section 12.1.2 (Exceptions to Confidentiality), Confidential Information that is permitted or required to be disclosed will remain otherwise subject to the confidentiality and non‑use provisions of this Section 12.1.3 (Permitted Disclosures). If either Party concludes that a copy of this Agreement must be filed with the United States Securities and Exchange Commission or similar regulatory agency in a country other than the United States, then such Party will, a reasonable time prior to any such filing, provide the other Party with a copy of such agreement showing any provisions hereof as to which the Party proposes to request confidential treatment, will provide the other Party with an opportunity to comment on any such proposed redactions and to suggest additional redactions, and will take such Party’s reasonable comments into consideration before filing such agreement and use Commercially Reasonable Efforts to have terms identified by such other Party afforded confidential treatment by the applicable regulatory agency. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
86
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
87
13.1. | Mutual Representations and Warranties as of the Execution Date. Each Party represents and warrants to the other Party, as of the Execution Date, that: |
| 13.1.1. | such Party is a corporation duly organized, validly existing, and in good standing under the Laws of its jurisdiction of incorporation or formation; |
| 13.1.2. | such Party has all requisite corporate power and corporate authority to enter into this Agreement and to carry out its obligations under this Agreement; |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
88
13.2. | Representations and Warranties by Wave. Wave represents and warrants to Takeda, as of the Execution Date that: |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
89
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
90
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
91
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
92
| any act, that may cause the Candidate Target Patents owned by Wave (or to Wave’s knowledge, any Candidate Target Patents that are exclusively licensed to Wave) to expire prematurely or be declared invalid or unenforceable. To Wave’s knowledge, Wave or its Affiliates have timely paid all application, registration, maintenance, and renewal fees in respect of the Candidate Target Patents owned by Wave and have filed with the Patent Offices all necessary documents and certificates for the purpose of maintaining such Candidate Target Patents. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
93
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
94
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
95
13.6.Exclusivity; Competing Programs.
| 13.6.1.1. | Wave Covenant. On a Collaboration Target‑by‑Collaboration Target basis, except as permitted under this Agreement: |
| (b) | during the Initial Licensed Category 2 Research Term, Wave will not, alone or with any Affiliates or Third Parties, without Takeda’s prior written approval, [***]. |
| 13.6.1.3. | Exception. The Parties hereby acknowledge and agree that (a) each Party’s obligations under this Section 13.6.1 (Exclusivity) will not apply to [***]. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
96
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
97
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
98
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
99
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
100
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
101
15.4.Prosecution and Maintenance of Patents.
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
102
| copies of proposed filings and documents received from outside counsel in the course of Prosecuting and Maintaining such Patents, or copies of documents filed with the relevant Patent Offices with respect to such Patents and such other documents related to the Prosecution and Maintenance of such Patents, and as applicable in sufficient time prior to filing such document or making any payment due thereunder to allow for review and comment by Wave. Takeda will consider in good faith timely comments from Wave thereon. Takeda will furnish Wave, via electronic mail or such other method as mutually agreed by the Parties, copies of documents filed with the relevant Patent Offices with respect to such Patents. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
103
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
104
| the Parties will meet to discuss any such decision by Takeda. Wave will have the right (but not the obligation) to Prosecute and Maintain worldwide such Patent (which right will include the right to file additional Patents claiming priority to such Patent) at Wave’s sole discretion and will have sole responsibility for all applicable Patent Costs with respect thereto. Wave will furnish Takeda, via electronic mail or such other method as mutually agreed by the Parties, copies of documents filed with the relevant Patent Offices with respect to such Patents. |
15.5.Third Party Infringement and Defense.
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
105
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
106
| 15.5.6.1. | Category 1 Targets. For any action related to a Licensed Category 1 Product, all recoveries will be [***] to Takeda; |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
107
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
108
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. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
109
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
110
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
111
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
112
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
113
| 16.7.1. | Termination of License Options. If this Agreement is terminated in its entirety, then all Options granted under this Agreement will terminate. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
114
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
115
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
116
| above‑named courts nor to make any motion or take any other action seeking or intending to cause the transfer or removal of any such action to any court other than one of the above‑named courts whether on the grounds of inconvenient forum or otherwise. Notwithstanding the foregoing, application may be made to any court of competent jurisdiction with respect to the enforcement of any judgment or award. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
117
17.6. | Headings. The captions to the Sections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the several Sections hereof. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
118
If to Wave, to: | Wave Life Sciences 733 Concord Avenue Cambridge, Massachusetts 02138 Attention: Chief Executive Officer |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
119
Goodwin Procter LLP 100 Northern Avenue Boston, Massachusetts 02210 Attention: Sarah A. Solomon, Esq. Facsimile No.: (415) 390-7962
| |
If to Takeda, to: | Takeda Pharmaceuticals U.S.A., Inc. One Takeda Parkway Deerfield, IL 60015 Attention: General Counsel Facsimile No.: (224) 554‑7831
|
With a copy to: | Ropes & Gray LLP Prudential Tower 800 Boylston Street Boston, MA 02199‑3600 Attention: David M. McIntosh Facsimile No.: (617) 235‑0507 |
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) when delivered if personally delivered on a Business Day (or if delivered or sent on a non‑Business Day, then on the next Business Day); (b) on the Business Day of receipt if sent by overnight courier or facsimile; or (c) on the Business Day of receipt if sent by mail.
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. |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
120
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
121
[THE REMAINDER OF THIS PAGE HAS BEEN LEFT INTENTIONALLY BLANK]
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
122
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Execution Date.
WAVE LIFE SCIENCES USA, INC.
BY: /s/ Keith Regnante
NAME: Keith Regnante
TITLE: CFO
| WAVE LIFE SCIENCES UK LIMITED
BY: /s/ Michael Panzara
NAME: Michael Panzara
TITLE: Franchise Lead, Neurology
|
TAKEDA PHARMACEUTICAL COMPANY LIMITED
BY: /s/ Fumihiko Sato
NAME: Fumihiko Sato
TITLE: Head of Portfolio Strategic Relations
|
|
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
CANDIDATE CATEGORY 1 TARGETS
Target 1: HTT (NCBI Entrez Gene ID: 3064)
| • | [***]. |
| • | [***]. |
Target 2: ATXN3 (NCBI Entrez Gene ID: 4287)
Target 3: C9orf72 (NCBI Entrez Gene ID: 203228)
For clarity, the Option for Target 1 may be exercised in accordance with Section 3.2 (HTT Target).
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
DATA PACKAGE
[***].
Notwithstanding the generality of the foregoing, the following items will be included in the Data Package for the relevant target:
| I. | mHTT |
| a. | Clinical |
[***]
| b. | Toxicology Reports |
[***]
| c. | Biomarker Assays |
[***]
| a. | Clinical |
[***]
| b. | Toxicology |
[***]
| c. | Assays |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Schedule 1.95
OTHER ELIGIBLE DEVELOPMENT EXPENSES
[***].
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
LEAD INITIAL HTT COMPOUNDS
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
FORM OF OPTION EXERCISE NOTICE
Takeda Pharmaceuticals U.S.A., Inc.
One Takeda Parkway
Deerfield, IL 60015
Attention: General Counsel
[________________, 20__]
Wave Life Sciences
733 Concord Avenue
Cambridge, Massachusetts 02138
Attention: Chief Executive Officer
Dear Sir or Madam:
In accordance with Section 1.216 (Option Exercise Notice) of that certain Collaboration and License Agreement dated [___________] by and among Wave Life Sciences USA, Inc., Wave Life Sciences UK Limited, and Takeda Pharmaceutical Company Limited (“Takeda”) (the “Collaboration Agreement”), Takeda is hereby providing written notice of its exercise of an Option with respect to the following Candidate Category 1 Target: [__________]. Capitalized terms used but not defined herein have the meanings assigned to them in the Collaboration Agreement.
Very truly yours, | ||
|
|
|
Takeda Pharmaceutical Company Limited | ||
|
|
|
By: |
|
|
|
| Name: |
|
| Title: |
cc: | Goodwin Procter LLP |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
SCHEDULE 1.242
POM CRITERIA
| ▪ | mHTT program |
[***]
| ▪ | C9orf72 program |
[***]
| ▪ | ATXN3 program |
[***]
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
FORM OF PROPOSED CATEGORY 2 TARGET NOMINATION NOTICE
Dear JSC:
In accordance with Section 4.1 (Proposed Category 2 Targets) of that certain Collaboration and License Agreement dated [___________] by and among Wave Life Sciences USA, Inc., Wave Life Sciences UK Limited, and Takeda Pharmaceutical Company Limited (the “Collaboration Agreement”), [_______] is hereby nominating the target described in Exhibit A attached hereto for consideration of such target as a possible Licensed Category 2 Target. Capitalized terms used but not defined herein have the meanings assigned to them in the Collaboration Agreement.
Very truly yours, | ||
|
|
|
[Takeda or Wave] | ||
|
|
|
By: |
|
|
|
| Name: |
|
| Title: |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Exhibit A
Proposed Category 2 Target: __________________________.
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
HTT CANDIDATE CATEGORY 1 DEVELOPMENT PLAN
[***]
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
C9orf72 CANDIDATE CATEGORY 1 DEVELOPMENT PLAN
[***]
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
FORM OF LICENSED CATEGORY 1 DEVELOPMENT BUDGET
Cost Type | Budget | Description | Who Prepares Initial Draft | Who Updates | Who Approves | Timing |
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
CLINICAL SUPPLY TERM SHEET
Summary | This Term Sheet summarizes the key terms for the Clinical Supply Agreement (the “Clinical Supply Agreement”).
The Clinical Supply Agreement covers Wave’s Manufacturing and supply of applicable Collaboration Compounds, Collaboration Products, and Companion Diagnostics directed to a Collaboration Product (“Supply Products”) to Takeda for Development purposes.
Any capitalized terms used herein that are not defined shall have the meanings assigned to them in the Agreement. |
1. General Supply Terms | |
Purchase and Supply | [***] |
Term | [***] |
Subcontracting | [***] |
2. Ordering and Forecasting | |
Forecasting Under Clinical Supply Agreement | [***] |
Statements of Work Under Clinical Supply Agreement | [***] |
Purchase Orders Under Clinical Supply Agreement | [***] |
Delivery Terms | [***] |
3. Second Source | |
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5. Quality; Non-Conforming Product | |
Manufacturing Quality & Documentation | [***] |
Compliance Audits | [***] |
6. Other Terms | |
Other Customary Provisions | [***] |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
COMMERCIAL SUPPLY TERM SHEET
Summary | This Term Sheet summarizes the key terms for the Commercial Supply Agreement (the “Commercial Supply Agreement”).
The Commercial Supply Agreement covers Wave’s Manufacturing and supply of applicable Collaboration Compounds, Collaboration Products, and Companion Diagnostics directed to a Collaboration Product (“Supply Products”) to Takeda for Commercialization purposes.
Any capitalized terms used herein that are not defined shall have the meanings assigned to them in the Agreement.
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1. General Supply Terms | |
Purchase and Supply | [***] |
Term | [***] |
Subcontracting | [***] |
2. Ordering and Forecasting | |
Forecasting Under Commercial Supply Agreement | [***] |
Purchase Orders Under Commercial Supply Agreement | [***] |
Delivery Terms | [***] |
3. Second Source | |
Second Sourcing
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4. Supply Shortfall | |
Shortages | [***] |
5. Quality; Non-Conforming Product | |
Manufacturing Quality & Documentation | [***] |
Compliance Audits | [***] |
6. Other Terms | |
Other Customary Provisions | [***] |
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
FORM OF LICENSED CATEGORY 1 COMMERCIALIZATION BUDGET
Cost Type | Budget | Description | Who Prepares Initial Draft | Who Updates | Who Approves | Timing |
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Takeda Sublicensing Rights
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
LICENSED CATEGORY 1 PROFIT & LOSS SHARE
This Schedule 11.3.4 to the Agreement covers financial planning, accounting policies and procedures to be followed in determining the U.S. Licensed Category 1 Profit & Loss Share and the Ex-U.S. Territory Licensed Category 1 Profit & Loss Share. The U.S. Licensed Category 1 Profit & Loss Share and the Ex-U.S. Territory Licensed Category 1 Profit & Loss Share are not legal entities and have been defined for identification purposes only.
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
WAVE PRESS RELEASE
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Wave to receive at least $230 million, including $110 million in upfront cash, $60 million in equity investment and at least $60 million in research support
Takeda to receive option to co-develop and co-commercialize investigational therapies in HD, ALS, FTD and SCA3 under a global 50:50 profit-split
Takeda to receive right to license additional preclinical CNS programs; Wave eligible to receive more than $1 billion in potential precommercial milestones
CAMBRIDGE, Mass., February 20, 2018 – Wave Life Sciences Ltd. (NASDAQ: WVE), a biotechnology company focused on delivering transformational therapies for patients with serious, genetically-defined diseases, today announced the formation of a global strategic collaboration with Takeda Pharmaceutical Company Limited to discover, develop and commercialize nucleic acid therapies for disorders of the central nervous system (CNS). Under the collaboration, Wave will provide Takeda the option to co-develop and co-commercialize programs in Huntington’s disease (HD), amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD) and spinocerebellar ataxia type 3 (SCA3). In addition, Takeda will have the right to license multiple preclinical programs targeting CNS disorders, including Alzheimer’s disease and Parkinson’s disease. Wave will continue to independently advance its activities in neuromuscular diseases, including its lead clinical program for the treatment of Duchene muscular dystrophy (DMD).
Under terms of the two-component agreement, Takeda will make an initial payment of $110 million to Wave and purchase $60 million of Wave’s ordinary shares at $54.70 per share. Takeda will also fund at least $60 million of Wave research over a four-year period to advance multiple preclinical targets selected by and licensed to Takeda.
“We are thrilled to be joining with Takeda in this ambitious alliance to bring meaningful therapies to patients suffering from devastating neurological diseases,” said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. “This partnership provides additional resources to advance our clinical programs through multiple data readouts while continuing to expand our pipeline in
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
neurology and other therapeutic areas. We look forward to working with Takeda and leveraging our expertise in oligonucleotides and clinical capabilities to grow our company and continue to make scientific and medical advances on behalf of patients.”
“At Takeda, we are focused on partnering with companies that share our research focus and commitment to deliver transformative medicines to patients,” Daniel Curran, MD, Head, Center for External Innovation at Takeda. “Wave’s expertise in optimizing oligonucleotides offers a complementary approach to programs that Takeda is currently pursuing for neurological disorders, maximizing our potential for success, and their pipeline and focus are closely aligned with our own.”
The first component of the agreement grants Takeda with the option to co-develop and co-commercialize the following nucleic acid investigational therapies upon Wave demonstrating proof of mechanism in initial clinical studies:
| • | WVE-120101 and WVE-120102, which selectively target the mutant allele of the huntingtin (HTT) gene and are currently in Phase 1b/2a clinical trials for the treatment of HD |
| • | WVE-3972-01, which targets the C9ORF72 gene and is expected to be evaluated in clinical studies for the treatment of ALS and FTD beginning in Q4 2018 |
| • | Program targeting the ATXN3 gene for the treatment of SCA3 |
Upon opt-in by Takeda on any individual program, Wave will receive an opt-in payment and will lead manufacturing and joint clinical co-development activities; Takeda will lead joint co-commercial activities in the United States and all commercial activities outside of the United States. Global costs and potential profits will be shared 50:50 and Wave will be eligible to receive development and commercial milestone payments.
The second component of the strategic collaboration provides Takeda with the right to license multiple preclinical programs for CNS indications, including Alzheimer’s disease and Parkinson’s disease. During a four-year term, the companies may collaborate on up to six preclinical targets at any one time. Takeda will fund at least $60 million of Wave’s preclinical activities and reimburse Wave for agreed-upon additional expenses. Assuming Takeda advances six programs that achieve regulatory approval and commercial milestones, Wave will be eligible to receive more than $2 billion in cash milestone payments, of which more than $1 billion would be in precommercial milestone payments. Wave is also eligible to receive tiered high single-digit to mid-teen royalty payments on global commercial sales of each licensed program.
The collaboration agreement will become effective upon satisfaction of customary closing conditions, including the requirements of the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Outside of the collaboration with Takeda, Wave continues to independently advance its activities in neuromuscular diseases, including its lead DMD program, an investigational therapy targeting exon 51 (WVE-210201) currently in a Phase 1 clinical trial. Wave’s next DMD program, targeting exon 53, is expected to initiate clinical development in Q1 2019. The company also continues to expand its preclinical research pipeline in other therapeutic areas, including metabolic liver diseases in collaboration with Pfizer and ophthalmology where Wave has wholly-owned discovery programs.
About WVE-120101 and WVE-120102
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
HD is an autosomal-dominant, progressive neurodegenerative disorder caused by an expanded cytosine-adenine-guanine (CAG) triplet repeat in the HTT gene that results in production of mutant HTT (mHTT) protein. Accumulation of mHTT protein causes progressive loss of neurons in the brain. Wild-type, or healthy, HTT (wtHTT) protein is critical for neuronal function, and research suggests that long-term suppression may have detrimental consequences. WVE-120101 and WVE-120102 are investigational stereopure antisense oligonucleotides designed to selectively target the mHTT mRNA transcript of SNP rs362307 (SNP1) and SNP rs362331 (SNP2), respectively. In vitro studies in patient-derived cell lines have shown that WVE-120101 and WVE-120102 selectively reduce levels of mHTT mRNA and protein, while leaving wtHTT mRNA and protein largely intact.
About WVE-3972-01
ALS and FTD can be caused by mutations in the C9ORF72 gene, which provides instructions for making protein found in various tissues, including nerve cells in the cerebral cortex and motor neurons. WVE-3972-01 is an investigational stereopure antisense oligonucleotide designed to preferentially target the pathogenic allele of the C9ORF72 gene. In vivo studies conducted in a transgenic animal model containing the mutated C9ORF72 gene demonstrated that WVE-3972-01 produced significant and sustained preferential knockdown of disease-associated biomarkers such as repeat-containing transcripts, RNA foci and dipeptide repeat proteins without altering total C9ORF72 protein levels.
About Wave Life Sciences
Wave Life Sciences is a biotechnology company focused on delivering transformational therapies for patients with serious, genetically-defined diseases. Our chemistry platform enables the creation of highly specific, well characterized oligonucleotides designed to deliver superior efficacy and safety across multiple therapeutic modalities. Our pipeline is initially focused on neurological disorders and extends across several other therapeutic areas. For more information, please visit www.wavelifesci.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the collaboration and license agreement between Wave and Takeda, including anticipated payments, as well as the future discovery, development, manufacture and commercialization of potential therapies for CNS disorders under the agreement; Wave’s and Takeda’s ability to successfully develop and commercialize potential therapies for CNS disorders; and Wave’s strategy and business plans. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to Wave’s ability to successfully advance multiple potential preclinical programs simultaneously on its platform; the delay of any current or planned clinical trials or the other development activities for Wave’s investigational therapies; Wave’s ability to successfully demonstrate the safety and efficacy of its investigational therapies; the preclinical and clinical results of Wave’s investigational therapies; actions
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
of regulatory authorities that may affect the initiation, timing and progress of clinical trials; and Wave’s ability to successfully commercialize any investigational therapies that receive regulatory approval. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Wave’s Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission (SEC) on March 16, 2017, and other filings that Wave may make with the SEC from time to time. Any forward-looking statements contained in this press release represent Wave’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Wave explicitly disclaims any obligation to update any forward-looking statements.
Investor Contact:
Jillian Connell
Investor@wavelifesci.com
Media Contact:
Jose Juves
617-949-4708
jjuves@wavelifesci.com
Patient Contact:
Wendy Erler
617-949-2898
werler@wavelifesci.com
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
SCHEDULE 12.2.1(b)
TAKEDA PRESS RELEASE
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Takeda Deepens Commitment to Develop Innovative Treatments for Neurological Diseases
Collaboration with Wave Life Sciences Ltd. to discover and develop best-in-class antisense oligonucleotides for potential treatment of genetically-defined neurological diseases
Osaka, Japan, February 20, 2018 – Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that it has entered into a research, development and commercial collaboration and multi-program option agreement with Wave Life Sciences Ltd. (Wave) to develop antisense oligonucleotides for genetically-defined neurological diseases. This partnership supports Takeda’s externalization strategy, which focuses on collaborations that complement its internal pipeline of programs, and represents the next generation of innovative therapies to treat diseases with no current treatment options.
“Takeda is deeply committed to pursuing innovative approaches in neuroscience research and development,” said Emiliangelo Ratti, Head, Neuroscience Therapeutic Area Unit at Takeda. “Our collaboration with Wave will further enable our focus to accelerate the development of transformational therapies for patients for whom there are currently no treatments available.”
The first component of the collaboration with Wave will focus on programs targeting Huntington’s disease (HD), amyotrophic lateral sclerosis (ALS) (commonly referred to as Lou Gehrig’s disease), frontotemporal dementia (FTD) and spinocerebellar ataxia type 3 (SCA3). Wave is developing oligonucleotide therapeutics to target diseases that have been historically difficult to treat with small molecules or biologics. Their molecules are designed to reduce the expression of disease-promoting proteins or to transform the production of dysfunctional mutant proteins into the production of functional proteins, with the potential of treating the targeted disease. The first component of this collaboration will investigate the following potential therapies with the option to co-develop and co-commercialize after demonstration of clinical proof of mechanism:
| • | WVE-120101 and WVE-120102, which selectively target mutant huntingtin and are currently in Phase 1b/2a clinical trials for the treatment of HD |
| • | WVE-3972-01, which targets C9ORF72 and is expected to be evaluated in clinical studies for the treatment of ALS and FTD beginning in Q4 2018 |
| • | Program targeting ATXN3 for the treatment of SCA3 |
The second component of the collaboration provides Takeda with the rights to exclusively license multiple preclinical programs targeting other neurological disorders including Alzheimer’s disease and Parkinson’s disease. At any one time during a four-year term, the companies may collaborate on up to six preclinical programs.
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
“At Takeda, we are focused on partnering with companies that share our research focus and commitment to deliver transformative medicines to patients,” said Daniel Curran, M.D., Head, Center for External Innovation at Takeda. “Wave’s expertise in optimizing oligonucleotides offers a complementary approach to programs that Takeda is currently pursuing for neurological disorders, maximizing our potential for success, and their pipeline and focus are closely aligned with our own.”
This collaboration with Wave is part of Takeda’s overall partnership strategy and deepened commitment in neuroscience, which also includes recently signed collaboration agreements with Mindstrong Health to explore the development of digital biomarkers for selected mental health conditions, and Denali Therapeutics, a company with an innovative platform technology for transporting antibodies into the brain, to develop and commercialize therapies for neurodegenerative diseases.
About Takeda Neuroscience
Neuroscience is a core therapeutic area for Takeda. Our aspiration is to provide innovative medicines for targeted patient populations suffering from neuropsychiatric disorders for whom there are no treatments available. We identify targets either genetically linked with specific neuropsychiatric disorders or with high association to the disease pathophysiology, design and operationalize clinical trials in novel ways in an effort to overcome historical challenges, and collaborate with patients, academic institutions, pharmaceutical and biotechnology partners, payors, regulators and prescribers to integrate their unique expertise and perspective. Takeda’s current portfolio consists of four approved medicines to treat adults with Major Depressive Disorder (MDD), Alzheimer’s-type dementia, insomnia and multiple sclerosis. In addition, there are many novel compounds in clinical development for targeted patient populations.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as Takeda’s presence in emerging markets, are currently fueling the growth of Takeda. Approximately 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda’s partners in health care in more than 70 countries. For more information, visit https://www.takeda.com/newsroom/.
Takeda’s Forward-Looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include all statements other than statements of historical fact, including plans, strategies and expectations for the future, statements regarding the expected timing of filings and approvals relating to the transaction, the expected timing of the completion of the transaction, the ability to complete the transaction or to satisfy the various closing conditions, future revenues and profitability from or growth or any assumptions underlying any of the foregoing. Statements made in the future tense, and words such as “anticipate,” “expect,” “project,” “continue,” “believe,” “plan,” “estimate,” “pro forma,” “intend,” “potential,” “target,” “forecast,” “guidance,” “outlook,” “seek,” “assume,” “will,” “may,” “should,” and similar expressions are intended to qualify as forward-looking statements. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors and security holders are cautioned not to place undue reliance on these forward-looking statements.
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to: required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the conditions to closing of the transaction may not be satisfied; competitive pressures and developments; applicable laws and regulations; the success or failure of product development programs; actions of regulatory authorities and the timing thereof; changes in exchange rates; and claims or concerns regarding the safety or efficacy of marketed products or product candidates in development.
The forward-looking statements contained in this press release speak only as of the date of this press release, and neither Wave nor Takeda undertake any obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If one or more of these statements is updated or corrected, investors and others should not conclude that additional updates or corrections will be made.
# # #
Takeda Contact:
Kelly Schlemm, +1-617-551-8865
kelly.schlemm@takeda.com
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
WAVE PATENTS AND IN‑LICENSES
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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.