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AbbVie Global Enterprises Ltd.
Dated as of May 6, 2022
TABLE OF CONTENTS
ARTICLE 1 DEFINITIONS........................................................................................................... 1
ARTICLE 2 INITIAL DEVELOPMENT .................................................................................... 26
2.1. Initial Development Plan and Budget ................................................................... 26
2.2. Diligence ............................................................................................................... 26
2.3. Performance of Initial Development and Regulatory Activities........................... 27
2.4. Information and Reports ....................................................................................... 29
2.5. Data Packages ....................................................................................................... 30
2.6. Expenses ............................................................................................................... 32
ARTICLE 3 LICENSE OPTION.................................................................................................. 32
3.1. License Option ...................................................................................................... 32
3.2. License Option Exercise ....................................................................................... 32
3.3. Licensed Therapeutic and Licensed Product Responsibility ................................ 33
3.4. Additional Cugene Obligations............................................................................. 34
3.5. Termination of License Option............................................................................. 36
ARTICLE 4 GRANT OF RIGHTS; EXCLUSIVITY.................................................................. 36
4.1. Grants to AbbVie .................................................................................................. 36
4.2. Grants to Cugene................................................................................................... 36
4.3. Sublicenses............................................................................................................ 36
4.4. No Implied Licenses ............................................................................................. 37
4.5. Confirmatory Patent License ................................................................................ 37
4.6. Exclusivity ............................................................................................................ 37
ARTICLE 5 DEVELOPMENT AND COMMERCIALIZATION BY ABBVIE........................ 38
5.1. In General.............................................................................................................. 38
5.2. Diligence ............................................................................................................... 38
5.3. Manufacturing Technology Transfer .................................................................... 38
5.4. Subcontracting; Distributors ................................................................................. 40
5.5. Records; Development and Commercialization Reports...................................... 41
5.6. Regulatory Activities ............................................................................................ 42
5.7. Adverse Event and Safety Information Agreement .............................................. 42
ARTICLE 6 COLLABORATION MANAGEMENT.................................................................. 42
6.1. Joint Governance Committee................................................................................ 42
6.2. General Provisions Applicable to the JGC ........................................................... 44
6.3. Working Groups.................................................................................................... 46
6.4. Alliance Managers. ............................................................................................... 46
ARTICLE 7 PAYMENTS AND RECORDS............................................................................... 47
7.1. Upfront Payment................................................................................................... 47
7.2. License Option Exercise Payment ........................................................................ 47
7.3. Development Milestone Events ............................................................................ 47
7.4. Sales Milestone Events ......................................................................................... 49
7.5. Royalties ............................................................................................................... 49
7.6. Estimated Sales Levels ......................................................................................... 52
7.7. Royalty Payments and Reports ............................................................................. 52
7.8. Mode of Payment.................................................................................................. 52
7.9. Taxes. .................................................................................................................... 52
7.10. Interest on Late Payments..................................................................................... 54
7.11. Financial Records.................................................................................................. 54
7.12. Audit ..................................................................................................................... 54
7.13. Right to Offset....................................................................................................... 55
7.14. Diagnostic and Veterinary Products ..................................................................... 55
7.15. No Other Compensation ....................................................................................... 55
7.16. No Limitation........................................................................................................ 55
7.17. Financial Obligations Under WuXi Agreements.................................................. 55
ARTICLE 8 INTELLECTUAL PROPERTY .............................................................................. 55
8.1. Ownership of Intellectual Property....................................................................... 55
8.2. Prosecution and Maintenance of Patents .............................................................. 57
8.3. Enforcement of Patents ......................................................................................... 62
8.4. Infringement Claims by Third Parties................................................................... 67
8.5. Invalidity or Unenforceability Defenses or Actions ............................................. 68
8.6. Third Party Licenses and Patents.......................................................................... 71
8.7. Product Trademarks .............................................................................................. 72
8.8. Inventor's Remuneration ...................................................................................... 73
ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE ................................................ 74
9.1. Confidentiality Obligations................................................................................... 74
9.2. Permitted Disclosures ........................................................................................... 75
9.3. Additional Permitted Disclosures and Use by AbbVie......................................... 76
9.4. Additional Permitted Disclosures and Use by Cugene ......................................... 76
9.5. Use of Name ......................................................................................................... 77
9.6. Public Announcements ......................................................................................... 77
9.7. Publications........................................................................................................... 78
9.8. Return of Confidential Information ...................................................................... 79
ARTICLE 10 REPRESENTATIONS AND WARRANTIES...................................................... 79
10.1. Mutual Representations and Warranties ............................................................... 79
10.2. Additional Representations, Warranties and Covenants of Cugene ..................... 79
10.3. Additional Covenants of Cugene .......................................................................... 85
10.4. Additional Representations, Warranties and Covenants of AbbVie..................... 87
10.5. DISCLAIMER OF WARRANTIES..................................................................... 88
10.6. Anti-Bribery and Anti-Corruption Compliance.................................................... 88
ARTICLE 11 INDEMNITY......................................................................................................... 88
11.1. Indemnification of Cugene ................................................................................... 88
11.2. Indemnification of AbbVie ................................................................................... 89
11.3. Indemnification Procedures .................................................................................. 89
11.4. Special, Indirect and Other Losses........................................................................ 92
11.5. Insurance ............................................................................................................... 92
ARTICLE 12 TERM AND TERMINATION .............................................................................. 93
12.1. Term and Expiration ............................................................................................. 93
12.2. Termination........................................................................................................... 93
12.3. Rights in Bankruptcy ............................................................................................ 95
12.4. Consequences of Termination............................................................................... 96
12.5. Transition Agreement. .......................................................................................... 99
12.6. Reverse Royalty .................................................................................................. 102
12.7. AbbVie Rights in Lieu of Termination............................................................... 102
12.8. Remedies............................................................................................................. 103
12.9. Accrued Rights; Surviving Obligations .............................................................. 103
ARTICLE 13 MISCELLANEOUS ............................................................................................ 104
13.1. Force Majeure ..................................................................................................... 104
13.2. Export Control .................................................................................................... 104