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4.8 Markings ........................................................................................................................ 51
4.9 Manufacturing ................................................................................................................ 52
4.10 Compliance .................................................................................................................... 57
ARTICLE 5 GRANT OF RIGHTS .............................................................................................. 58
5.1 Grants to AbbVie ........................................................................................................... 58
5.2 Grants to Richter ............................................................................................................ 58
5.3 Sublicenses ..................................................................................................................... 59
5.4 Distributorships .............................................................................................................. 60
5.5 Retention of Rights ........................................................................................................ 61
5.6 Confirmatory Patent License ......................................................................................... 61
5.7 Richter Activities in the Territory .................................................................................. 61
5.8 Exclusivity ..................................................................................................................... 61
5.9 In-License Agreements .................................................................................................. 65
5.10 Existing Collaboration Agreement ................................................................................ 67
ARTICLE 6 PAYMENTS AND RECORDS ............................................................................... 67
6.1 Upfront Payment ............................................................................................................ 67
6.2 Development and Regulatory Milestones ...................................................................... 67
6.3 Sales-Based Milestones ................................................................................................. 68
6.4 Royalties ........................................................................................................................ 69
6.5 Royalty Payments and Reports ...................................................................................... 72
6.6 Mode of Payment; Offsets ............................................................................................. 72
6.7 Accounting Procedures .................................................................................................. 72
6.8 Withholding Taxes ......................................................................................................... 72
6.9 Indirect Taxes................................................................................................................. 73
6.10 Interest on Late Payments .............................................................................................. 73
6.11 Financial Records........................................................................................................... 73
6.12 Audit .............................................................................................................................. 74
6.13 Audit Dispute ................................................................................................................. 74
6.14 Confidentiality ............................................................................................................... 74
6.15 Diagnostic or Veterinary Products ................................................................................. 75
6.16 No Other Compensation ................................................................................................ 75
6.17 No Limitation ................................................................................................................. 75
ARTICLE 7 INTELLECTUAL PROPERTY .............................................................................. 75
7.1 Ownership of Intellectual Property ................................................................................ 75
7.2 Maintenance and Prosecution of Patents ....................................................................... 76
7.3 Enforcement of Patents .................................................................................................. 79
7.4 Infringement Claims by Third Parties ............................................................................ 82
7.5 Invalidity or Unenforceability Defenses or Actions ...................................................... 83
7.6 Product Trademarks ....................................................................................................... 84
7.7 Inventor's Remuneration ............................................................................................... 85
7.8 Nonproprietary Name .................................................................................................... 85
7.9 Common Interest ............................................................................................................ 86
ARTICLE 8 PHARMACOVIGILANCE AND SAFETY ........................................................... 86
8.1 Pharmacovigilance ......................................................................................................... 86
8.2 Global Safety Database .................................................................................................. 86
8.3 Data Privacy and Security .............................................................................................. 87
ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE ................................................ 87
9.1 Product Information ....................................................................................................... 87
9.2 Confidentiality Obligations ............................................................................................ 87
9.3 Permitted Disclosures .................................................................................................... 88
9.4 Use of Name .................................................................................................................. 90
9.5 Public Announcements .................................................................................................. 90
9.6 Publications .................................................................................................................... 91
9.7 Return of Confidential Information ............................................................................... 91
9.8 Survival .......................................................................................................................... 92
ARTICLE 10 REPRESENTATIONS AND WARRANTIES ...................................................... 92
10.1 Mutual Representations and Warranties ........................................................................ 92
10.2 Additional Representations and Warranties of Richter ................................................. 93
10.3 Additional Representations and Warranties of AbbVie................................................. 98
10.4 DISCLAIMER OF WARRANTIES .............................................................................. 99
ARTICLE 11 INDEMNITY ......................................................................................................... 99
11.1 Indemnification of Richter ............................................................................................. 99
11.2 Indemnification of AbbVie .......................................................................................... 100
11.3 Certain Losses .............................................................................................................. 101
11.4 Notice of Claim ............................................................................................................ 101
11.5 Control of Defense ....................................................................................................... 101
11.6 Special, Indirect, and Other Losses.............................................................................. 103
11.7 Insurance ...................................................................................................................... 103
ARTICLE 12 TERM AND TERMINATION ............................................................................ 103
12.1 HSR and Other Governmental Filings ......................................................................... 103
12.2 Term ............................................................................................................................. 104
12.3 Termination for Material Breach ................................................................................. 104
12.4 Additional Termination Rights by AbbVie.................................................................. 106
12.5 Termination for Insolvency .......................................................................................... 106
12.6 Rights in Bankruptcy ................................................................................................... 106
12.7 Effect of Termination in its Entirety ............................................................................ 107
12.8 Termination of Terminated Territory; Discovery Program; or Licensed Product ....... 108
12.9 Reversion Royalty. ....................................................................................................... 109
12.10 Transition Agreement .................................................................................................. 110
12.11 Remedies ...................................................................................................................... 111
12.12 Accrued Rights; Surviving Obligations ....................................................................... 111
ARTICLE 13 MISCELLANEOUS ............................................................................................ 113
13.1 Force Majeure .............................................................................................................. 113
13.2 Change in Control ........................................................................................................ 113
13.3 Export Control ............................................................................................................. 114
13.4 Assignment .................................................................................................................. 114
13.5 Severability .................................................................................................................. 114
13.6 Governing Law, Jurisdiction and Service .................................................................... 115
13.7 Dispute Resolution ....................................................................................................... 115
13.8 Notices ......................................................................................................................... 116
13.9 Entire Agreement; Amendments.................................................................................. 117
13.10 English Language......................................................................................................... 117
13.11 Equitable Relief ........................................................................................................... 118
13.12 Waiver and Non-Exclusion of Remedies ..................................................................... 118
13.13 No Benefit to Third Parties .......................................................................................... 118
13.14 Further Assurance ........................................................................................................ 118
13.15 Relationship of the Parties ........................................................................................... 118
13.16 Performance by Affiliates ............................................................................................ 119
13.17 Counterparts; Facsimile Execution .............................................................................. 119
13.18 References .................................................................................................................... 119