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7. The Neutral shall rule on each disputed issue within fourteen (14) days following completion of the hearing. Such ruling shall adopt in its entirety the proposed ruling and remedy of one (1) of the Parties on each disputed issue but may adopt one (1) Party's proposed rulings and remedies on some issues and the other...
8. The Neutral shall be paid a reasonable fee plus expenses. These fees and expenses, along with the reasonable legal fees and expenses of the prevailing Party (including all expert witness fees and expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, shall be paid as follows:
(a) If the Neutral rules in favor of one (1) Party on all disputed issues in the ADR, the losing Party shall pay one hundred percent (100%) of such fees and expenses.
(b) If the Neutral rules in favor of one (1) Party on some issues and the other Party on other issues, the Neutral shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the Parties. The Neutral shall allocate fees and expenses in a way that bears a reasonable r...
9. The rulings of the Neutral and the allocation of fees and expenses shall be binding, non-reviewable, and non-appealable, and may be entered as a final judgment in any court having jurisdiction.
10. Except as provided in paragraph 9 or as required by law, the existence of the Dispute, any settlement negotiations, the ADR proceeding, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed to be Confidential Information of both Parties. The Neutral shall hav...
11. All ADR proceedings shall be conducted in the English language, and the arbitration shall be seated in New York, New York, U.S.A.
12. Each Party shall have the right to be represented by counsel in all aspects of any ADR proceeding.
Confidential Execution Version
AMENDED AND RESTATED LICENSE AGREEMENT
between THE SCRIPPS RESEARCH INSTITUTE and ABBVIE GLOBAL ENTERPRISES LTD.
Dated as of September 29, 2023
TABLE OF CONTENTS
ARTICLE 1 DEFINITIONS ...................................................................................................... 1
ARTICLE 2 RESEARCH AND DEVELOPMENT PROGRAMS.............................................36
2.1 Target Program ..................................................................................................36
2.2 CD19 Program ...................................................................................................43
2.3 Platform Improvement Program .........................................................................44
2.4 Review of Plans .................................................................................................45
2.5 Research Program Manufacturing and Supply ....................................................45
2.6 Performance of Development Activities .............................................................46
2.7 AbbVie Materials ...............................................................................................47
2.8 Calibr Development Costs ..................................................................................47
2.9 Information and Reports .....................................................................................49
2.10 Data Packages ....................................................................................................50
2.11 Transition of Research Target Products. .............................................................52
ARTICLE 3 EXCLUSIVE LICENSE OPTIONS ......................................................................53
3.1 CD19 License Option .........................................................................................53
3.2 Platform Option .................................................................................................55
3.3 Calibr Cost-Sharing Option ................................................................................57
ARTICLE 4 GRANT OF RIGHTS; EXCLUSIVITY ................................................................59
4.1 Grants to AbbVie. ..............................................................................................59
4.2 Improvements to sCAR-T Platform ....................................................................60
4.3 Grants to Calibr; AbbVie Platform Improvements ..............................................60
4.4 Sublicenses ........................................................................................................61
4.5 Retention of Rights ............................................................................................61
4.6 Confirmatory Patent License ..............................................................................62
4.7 Exclusivity .........................................................................................................62
ARTICLE 5 DEVELOPMENT AND COMMERCIALIZATION BY ABBVIE........................67
5.1 In General ..........................................................................................................67
5.2 Diligence ...........................................................................................................67
5.3 Manufacturing Technology Transfer ..................................................................68
5.4 Subcontracting; Distributors ...............................................................................70
5.5 Development and Commercialization Reports ....................................................70
5.6 Regulatory Activities .........................................................................................70
ARTICLE 6 JOINT GOVERNANCE COMMITTEES .............................................................71
6.1 Target Discovery Joint Research Committee ......................................................71
6.2 CD19 Platform Proof-of-Principle Joint Development Committee .....................72
6.3 General Provisions Applicable to a Committee...................................................72
6.4 Decision-Making ...............................................................................................74
6.5 Working Groups. ...............................................................................................75
6.6 Alliance Managers .............................................................................................75
ARTICLE 7 PAYMENTS AND RECORDS .............................................................................75
7.1 Upfront Payments ..............................................................................................75
7.2 Platform Option Extension Fee ..........................................................................75
7.3 Platform Extension Payment ..............................................................................76
7.4 CD19 Autoimmune Option Fee ..........................................................................76
7.5 Non-Platform Option Milestones........................................................................76
7.6 Royalties ............................................................................................................78
7.7 Sublicensee Net Sales ........................................................................................82
7.8 Earnout Payments ..............................................................................................82
7.9 Estimated Sales Levels .......................................................................................83
7.10 Royalty Payments and Reports ...........................................................................83
7.11 Royalties on Calibr Sales ...................................................................................83
7.12 Mode of Payment ...............................................................................................84
7.13 Taxes .................................................................................................................85
7.14 Interest on Late Payments ..................................................................................86
7.15 Financial Records...............................................................................................86
7.16 Audit ..................................................................................................................86
7.17 Right to Offset ...................................................................................................87
7.18 Diagnostic or Veterinary Products ......................................................................87
7.19 Financial Obligations under In-License Agreements...........................................88
ARTICLE 8 INTELLECTUAL PROPERTY ............................................................................88
8.1 Ownership of Intellectual Property .....................................................................88
8.2 Control of Intellectual Property ..........................................................................89
8.3 Maintenance and Prosecution of Patents. ............................................................90
8.4 Enforcement of Patents ......................................................................................94
8.5 Biosimilar Applicants.........................................................................................96
8.6 Enforcement of a Party's Patents ........................................................................97
8.7 Invalidity or Unenforceability Defenses or Actions. ...........................................97
8.8 Infringement Claims by Third Parties .................................................................98
8.9 Third Party Rights ............................................................................................ 100
8.10 Product Trademarks ......................................................................................... 100
ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE ............................................. 101
9.1 Confidentiality Obligations .............................................................................. 101
9.2 Permitted Disclosures....................................................................................... 104
9.3 Additional Permitted Disclosures ..................................................................... 104
9.4 Use of Names. .................................................................................................. 105
9.5 Public Announcements ..................................................................................... 105
9.6 Publications ..................................................................................................... 105
9.7 Return of Confidential Information .................................................................. 107
ARTICLE 10 REPRESENTATIONS AND WARRANTIES .................................................. 107
10.1 Mutual Representations and Warranties ........................................................... 108
10.2 Additional Representations and Warranties of Calibr. ...................................... 108
10.3 Additional Covenants of Calibr. ....................................................................... 118
10.4 Data Privacy and Security ............................................................................... 120
10.5 Data Export ...................................................................................................... 121
10.6 Debarment ....................................................................................................... 121
10.7 DISCLAIMER OF WARRANTIES. ................................................................ 121
10.8 Anti-Bribery and Anti-Corruption Compliance................................................. 122