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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) ...
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.
12. Each Party shall have the right to be represented by counsel in all aspects of any ADR proceeding.
Confidential EXECUTION VERSION
DB1/ 92622394.30
CO-DEVELOPMENT AND OPTION AGREEMENT
between
ALECTOR, INC.
and
ABBVIE BIOTECHNOLOGY, LTD.
Dated as of October 16, 2017
TABLE OF CONTENTS
ARTICLE 1 DEFINITIONS .............................................................................................................. 1
ARTICLE 2 COLLABORATION MANAGEMENT ..................................................................... 32
2.1 Joint Steering Committee ............................................................................................ 32
2.2 Joint Development Committee ................................................................................... 33
2.3 Joint Commercialization Committee .......................................................................... 34
2.4 General Provisions Applicable to Joint Committees .................................................. 35
2.5 Discontinuation of Participation on a Committee ....................................................... 38
2.6 Interactions Between a Committee and Internal Teams ............................................. 38
2.7 Working Groups.......................................................................................................... 38
2.8 Information ................................................................................................................. 39
2.9 Expenses ..................................................................................................................... 39
ARTICLE 3 DEVELOPMENT AND REGULATORY ................................................................. 39
3.1 Pre Exercise Development Plan and Activities .......................................................... 39
3.2 Post Exercise Development Plan and Budget and Activities...................................... 41
3.3 Additional Licensor Development Activities ............................................................. 42
3.4 Development and Regulatory Diligence ..................................................................... 43
3.5 Pre-Clinical and Clinical Supply of Licensed Products; Subcontracting ................... 44
3.6 Supply of Technology for Development Purposes ..................................................... 46
3.7 Development Costs ..................................................................................................... 47
3.8 Regulatory Matters...................................................................................................... 52
3.9 Compliance ................................................................................................................. 55
3.10 Records ....................................................................................................................... 55
3.11 Human Samples .......................................................................................................... 56
ARTICLE 4 COMMERCIALIZATION ......................................................................................... 56
4.1 In General.................................................................................................................... 56
4.2 Commercialization Plan .............................................................................................. 56
4.3 Diligence ..................................................................................................................... 57
4.4 Compliance with Applicable Law .............................................................................. 58
4.5 Booking of Sales; Distribution ................................................................................... 58
4.6 Product Trademarks .................................................................................................... 58
4.7 Markings ..................................................................................................................... 58
4.8 Commercial Supply of Licensed Antibodies or Licensed Products ........................... 59
ARTICLE 5 GRANT OF RIGHTS ................................................................................................. 59
5.1 Option Grants to AbbVie ........................................................................................... 59
5.2 License Grants to AbbVie ........................................................................................... 59
5.3 Grants to Licensor ....................................................................................................... 60
5.4 Sublicenses .................................................................................................................. 60
5.5 Distributorships ........................................................................................................... 60
5.6 Co-Promotion Rights .................................................................................................. 60
5.7 Third Party Intellectual Property ................................................................................ 61
5.8 Retention of Rights ..................................................................................................... 62
5.9 Confirmatory Patent License ...................................................................................... 63
5.10 Exclusivity .................................................................................................................. 63
ARTICLE 6 PAYMENTS AND RECORDS .................................................................................. 64
6.1 Upfront Payment ......................................................................................................... 64
6.2 Development Milestones ............................................................................................ 64
6.3 Profit and Loss ............................................................................................................ 66
6.4 Calculation and Payment of US Net Profit, US Net Loss, or ROW Profit Share ...... 68
6.5 Royalties ..................................................................................................................... 70
6.6 Payments and Reports ................................................................................................. 74
6.7 Mode of Payment; Offsets .......................................................................................... 74
6.8 Accounting Procedures ............................................................................................... 75
6.9 Withholding Taxes ...................................................................................................... 75
6.10 Indirect Taxes.............................................................................................................. 76
6.11 Interest on Late Payments ........................................................................................... 76
6.12 Financial Records........................................................................................................ 76
6.13 Audit ........................................................................................................................... 77
6.14 Audit Dispute .............................................................................................................. 77
6.15 Confidentiality ............................................................................................................ 77
6.16 Diagnostic ................................................................................................................... 78
6.17 No Other Compensation ............................................................................................. 78
ARTICLE 7 INTELLECTUAL PROPERTY ................................................................................. 78
7.1 Ownership of Intellectual Property ............................................................................. 78
7.2 Maintenance and Prosecution of Patents .................................................................... 79
7.3 Enforcement of Patents ............................................................................................... 83
7.4 Infringement Claims by Third Parties ......................................................................... 84
7.5 Invalidity or Unenforceability Defenses or Actions ................................................... 85
7.7 Product Trademarks .................................................................................................... 86
7.7 Licensor's Costs .......................................................................................................... 87
7.8 Inventor's Remuneration ............................................................................................ 87
ARTICLE 8 PHARMACOVIGILANCE AND SAFETY .............................................................. 87
8.1 Pharmacovigilance ...................................................................................................... 87
8.2 Global Safety Database ............................................................................................... 88
ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE ................................................... 88
9.1 Product Information .................................................................................................... 88
9.2 Confidentiality Obligations ......................................................................................... 88
9.3 Permitted Disclosures ................................................................................................. 90
9.4 Use of Name ............................................................................................................... 91
9.5 Public Announcements ............................................................................................... 92
9.6 Publications ................................................................................................................. 92
9.7 Return of Confidential Information ............................................................................ 94
9.8 Prior Confidentiality ................................................................................................... 94
9.9 Survival ....................................................................................................................... 94
ARTICLE 10 REPRESENTATIONS AND WARRANTIES....................................................... 94
10.1 Mutual Representations and Warranties ..................................................................... 94