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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