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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 |
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