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2.3 Discontinuation of the JGC............................................................................... 18 |
2.4 Interactions Between the JGC and Internal Teams ............................................. 18 |
2.5 Working Groups. ............................................................................................. 18 |
2.6 Expenses ......................................................................................................... 19 |
2.7 Monthly Updates ............................................................................................. 19 |
ARTICLE 3 DEVELOPMENT AND REGULATORY ............................................................... 20 |
3.1 Development Activities. .................................................................................... 20 |
3.2 AbbVie Option................................................................................................. 21 |
3.3 Post-Exercise Development Activities; Development Reporting ........................... 22 |
3.4 Supply of Technology for Development Purposes. .............................................. 23 |
3.5 Expenses and Invoicing .................................................................................... 23 |
3.6 Subcontracting ................................................................................................ 24 |
3.7 Regulatory Matters. ......................................................................................... 24 |
ARTICLE 4 COMMERCIALIZATION.................................................................................... 27 |
4.1 In General ....................................................................................................... 27 |
4.2 Commercialization Diligence ............................................................................ 27 |
4.3 Booking of Sales; Distribution........................................................................... 27 |
4.4 Product Trademarks ........................................................................................ 28 |
4.5 Commercial Supply of Licensed Antibodies or Licensed Products. ...................... 28 |
ARTICLE 5 GRANT OF RIGHTS ........................................................................................... 30 |
5.1 Grants to AbbVie. ............................................................................................ 30 |
5.2 Sublicenses ...................................................................................................... 30 |
5.3 Distributorships ............................................................................................... 30 |
5.4 Co-Promotion Rights ....................................................................................... 31 |
5.5 Retention of Rights........................................................................................... 31 |
5.6 Confirmatory Patent License ............................................................................ 31 |
5.7 Exclusivity with Respect to the Territory. .......................................................... 31 |
5.8 In-License Agreements. .................................................................................... 31 |
ARTICLE 6 PAYMENTS AND RECORDS .............................................................................. 32 |
6.1 Upfront Payment ............................................................................................. 32 |
6.2 License Option Exercise ................................................................................... 32 |
6.3 Development and Regulatory Milestones ........................................................... 32 |
6.4 First Commercial Sales Milestones .................................................................... 33 |
6.5 Sales-Based Milestones ..................................................................................... 34 |
6.6 Royalties. ........................................................................................................ 34 |
6.7 Royalty Payments and Reports ......................................................................... 36 |
6.8 Mode of Payment; Offsets................................................................................. 36 |
6.9 Withholding Taxes ........................................................................................... 36 |
6.10 Indirect Taxes.................................................................................................. 37 |
6.11 Interest on Late Payments ................................................................................ 37 |
6.12 Financial Records ............................................................................................ 37 |
6.13 Audit ............................................................................................................ 37 |
6.14 Audit Dispute .................................................................................................. 38 |
6.15 Confidentiality................................................................................................. 38 |
6.16 Diagnostic or Veterinary Products .................................................................... 38 |
6.17 No Other Compensation ................................................................................... 38 |
ARTICLE 7 INTELLECTUAL PROPERTY RIGHTS .............................................................. 38 |
7.1 Ownership of Intellectual Property.................................................................... 38 |
7.2 Maintenance and Prosecution of Patents. ........................................................... 40 |
7.3 Enforcement of Patents. ................................................................................... 42 |
7.4 Infringement Claims by Third Parties ............................................................... 44 |
7.5 Invalidity or Unenforceability Defenses or Actions. ............................................ 44 |
7.6 Product Trademarks ........................................................................................ 46 |
7.7 International Nonproprietary Name .................................................................. 46 |
7.8 Inventor's Remuneration.................................................................................. 46 |
7.9 Common Interest ............................................................................................. 46 |
7.10 Third Party Rights ........................................................................................... 46 |
ARTICLE 8 PHARMACOVIGILANCE AND SAFETY ............................................................ 46 |
8.1 Pharmacovigilance ........................................................................................... 46 |
8.2 Global Safety Database .................................................................................... 47 |
8.3 Data Privacy and Security. ............................................................................... 47 |
8.4 Security Breach Notification ............................................................................. 48 |
ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE .................................................. 48 |
9.1 Product Information ........................................................................................ 48 |
9.2 Confidentiality Obligations ............................................................................... 48 |
9.3 Permitted Disclosures....................................................................................... 49 |
9.4 Use of Name .................................................................................................... 50 |
9.5 Public Announcements ..................................................................................... 50 |
9.6 Publications..................................................................................................... 51 |
9.7 Return of Confidential Information................................................................... 51 |
9.8 Survival .......................................................................................................... 51 |
ARTICLE 10 REPRESENTATIONS AND WARRANTIES ....................................................... 51 |
10.1 Mutual Representations and Warranties ........................................................... 51 |
10.2 Additional Representations and Warranties of Licensor ..................................... 52 |
10.3 Covenants of Licensor ...................................................................................... 56 |
10.4 DISCLAIMER OF WARRANTIES .................................................................. 57 |
ARTICLE 11 INDEMNITY ..................................................................................................... 57 |
11.1 Indemnification of Licensor .............................................................................. 57 |
11.2 Indemnification of AbbVie................................................................................ 57 |
11.3 Notice of Claim ................................................................................................ 58 |
11.4 Control of Defense............................................................................................ 58 |
11.5 Special, Indirect, and Other Losses.................................................................... 59 |
11.6 Insurance ........................................................................................................ 59 |
ARTICLE 12 TERM AND TERMINATION ............................................................................. 60 |
12.1 Term. ............................................................................................................ 60 |
12.2 Termination for Material Breach. ..................................................................... 60 |
12.3 Additional Termination Rights by AbbVie. ........................................................ 61 |
12.4 Termination for Insolvency............................................................................... 61 |
12.5 AbbVie Cessation of Development and Commercialization ................................. 62 |
12.6 Rights in Bankruptcy. ...................................................................................... 62 |
12.7 Termination in Entirety.................................................................................... 62 |
12.8 Termination of Terminated Territory................................................................ 64 |
12.9 Transition Agreement. ..................................................................................... 65 |
12.10 Reverse Royalty ............................................................................................... 66 |
12.11 Remedies......................................................................................................... 67 |
12.12 Accrued Rights; Surviving Obligations. ............................................................. 67 |
ARTICLE 13 MISCELLANEOUS............................................................................................ 68 |
13.1 Force Majeure ................................................................................................. 68 |
13.2 Change in Control of Licensor. ......................................................................... 68 |
13.3 Export Control ................................................................................................ 68 |
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