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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 |
10.2 Additional Representations and Warranties of Licensor ............................................ 95 |
10.3 Additional Covenants of Licensor ............................................................................ 101 |
10.4 DISCLAIMER OF WARRANTIES ......................................................................... 101 |
ARTICLE 11 INDEMNITY ........................................................................................................ 101 |
11.1 Indemnification of Licensor ...................................................................................... 101 |
11.2 Indemnification of AbbVie ....................................................................................... 102 |
11.3 Certain Losses ........................................................................................................... 102 |
11.4 Notice of Claim ......................................................................................................... 103 |
11.5 Control of Defense .................................................................................................... 103 |
11.6 Special, Indirect, and Other Losses........................................................................... 105 |
11.7 Insurance ................................................................................................................... 105 |
ARTICLE 12 TERM AND TERMINATION ............................................................................. 106 |
12.1 Term .......................................................................................................................... 106 |
12.2 Termination for Material Breach .............................................................................. 107 |
12.3 Material Breach Related to Diligence in Major Markets .......................................... 108 |
12.4 Invocation of Termination for Material Breach ........................................................ 108 |
12.5 For Convenience ....................................................................................................... 108 |
12.6 Termination for Insolvency ....................................................................................... 108 |
12.7 Rights in Bankruptcy ................................................................................................ 108 |
12.8 Effects of Termination and Option Expiration ......................................................... 109 |
12.9 Transition .................................................................................................................. 112 |
12.10 Reverse Royalty ........................................................................................................ 115 |
12.11 Remedies ................................................................................................................... 115 |
12.12 Accrued Rights; Surviving Obligations .................................................................... 115 |
ARTICLE 13 MISCELLANEOUS ............................................................................................. 116 |
13.1 Force Majeure ........................................................................................................... 116 |
13.2 Change in Control of Licensor .................................................................................. 116 |
13.3 Export Control .......................................................................................................... 118 |
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