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2.15 AbbVie Materials. ................................................................................................. 66 |
2.16 Program Activities and Efforts. ............................................................................ 67 |
2.17 Performance of Research Program and other Activities. ...................................... 67 |
2.18 Ophthalmology Research Program Costs. ............................................................ 69 |
2.19 Transferred Materials. ........................................................................................... 69 |
2.20 No Guarantee. ....................................................................................................... 69 |
2.21 Specific Performance. ........................................................................................... 70 |
ARTICLE 3 EXCLUSIVE OPTIONS.......................................................................................... 70 |
3.1 Option Grants. ....................................................................................................... 70 |
3.2 Delivery of Final Data Packages. .......................................................................... 70 |
3.3 Option Exercise. .................................................................................................... 71 |
3.4 Capsida Transition Obligations on Option Exercise. ............................................ 71 |
3.5 Allocation of Rights with Respect to Transferred Contracts. ............................... 73 |
3.6 HSR. ...................................................................................................................... 74 |
3.7 Non-Exercise of Options....................................................................................... 75 |
ARTICLE 4 DEVELOPMENT .................................................................................................... 77 |
4.1 Licensed Capsid Products and Licensed Ophthalmology Products. ..................... 77 |
4.2 ALS Product.......................................................................................................... 78 |
4.3 ALS Product Regulatory Activities. ..................................................................... 81 |
4.4 ALS Reversion Product. ....................................................................................... 82 |
4.5 Regulatory Support. .............................................................................................. 84 |
4.6 Shared Capsid Safety Information and Use. ......................................................... 84 |
4.7 Additional Disclosures to AbbVie. ....................................................................... 84 |
ARTICLE 5 MANUFACTURING............................................................................................... 84 |
5.1 Manufacturing Responsibilities Prior to Option Exercise. ................................... 84 |
5.2 Manufacturing After Option Exercise. ................................................................. 86 |
5.3 Manufacturing Technology Transfer and Continued Improvement. .................... 86 |
ARTICLE 6 COMMERCIALIZATION ...................................................................................... 90 |
6.1 General. ................................................................................................................. 90 |
6.2 Booking of Sales; Distribution. ............................................................................ 90 |
6.3 Commercialization of ALS Products. ................................................................... 90 |
6.4 Commercialization Reports. ................................................................................. 93 |
ARTICLE 7 MANAGEMENT OF THE COLLABORATION ................................................... 93 |
7.1 Joint Governance Committee. ............................................................................... 93 |
7.2 General Provisions Applicable to the JGCs. ......................................................... 95 |
7.3 Working Groups.................................................................................................... 98 |
7.4 Alliance Managers. ............................................................................................. 100 |
ARTICLE 8 GRANT OF RIGHTS; EXCLUSIVITY ................................................................ 100 |
8.1 Grants to AbbVie. ............................................................................................... 100 |
8.2 Grants to Capsida. ............................................................................................... 102 |
8.3 Sublicenses. ......................................................................................................... 103 |
8.4 In-License Agreements. ...................................................................................... 103 |
8.5 Section intentionally left blank. .......................................................................... 106 |
8.6 Retention of Rights. ............................................................................................ 106 |
8.7 Confirmatory Patent License. ............................................................................. 106 |
8.8 Exclusivity. ......................................................................................................... 106 |
ARTICLE 9 PAYMENTS AND RECORDS ............................................................................. 109 |
9.1 Upfront Payment and First Final Ophthalmology Data Package Payment......... 109 |
9.2 Equity Investment. .............................................................................................. 110 |
9.3 Option Exercise and Additional Capsid Program Payments. ............................. 110 |
9.4 α-syn and Tau Milestones. .................................................................................. 111 |
9.5 Final Selected Ophthalmology Target Milestones. ............................................. 114 |
9.6 AbbVie Royalties. ............................................................................................... 116 |
9.7 Third Party Payments. ......................................................................................... 118 |
9.8 Estimated Sales Levels. ...................................................................................... 119 |
9.9 Royalty Payments and Reports. .......................................................................... 119 |
9.10 Capsida ALS Reversion Product Milestones. ..................................................... 119 |
9.11 Capsida ALS Reversion Product Royalties. ....................................................... 120 |
9.12 Capsida ALS Reversion Product Third Party Payments..................................... 122 |
9.13 Profit Share for ALS Products in the Territory. .................................................. 123 |
9.14 Calculation and Payment of Co-Development Cost Share and Net Profit or Net Loss Share. ................................................................................................... 123 |
9.15 FTE Costs............................................................................................................ 124 |
9.16 Other Invoiced Amounts. .................................................................................... 124 |
9.17 Nonrefundability; Mode of Payment. ................................................................. 125 |
9.18 Taxes. .................................................................................................................. 125 |
9.19 Interest on Late Payments. .................................................................................. 126 |
9.20 Financial Records................................................................................................ 126 |
9.21 Audit. .................................................................................................................. 126 |
9.22 Right to Offset..................................................................................................... 127 |
9.23 Diagnostic or Veterinary Products. ..................................................................... 127 |
ARTICLE 10 INTELLECTUAL PROPERTY .......................................................................... 127 |
10.1 Ownership of Intellectual Property. .................................................................... 127 |
10.2 Maintenance and Prosecution of Patents. ........................................................... 130 |
10.3 Enforcement of Patents. ...................................................................................... 133 |
10.4 Invalidity or Unenforceability Defense or Actions. ............................................ 136 |
10.5 Infringement Claimed by Third Parties. ............................................................. 137 |
10.6 Third Party Licenses and Patents. ....................................................................... 138 |
10.7 Inventor's Remuneration. ................................................................................... 138 |
10.8 International Nonproprietary Name. ................................................................... 139 |
10.9 Common Interest. ................................................................................................ 139 |
10.10 Product Trademarks. ........................................................................................... 139 |
ARTICLE 11 CONFIDENTIALITY AND NON-DISCLOSURE ............................................ 140 |
11.1 Confidentiality Obligations. ................................................................................ 140 |
11.2 Permitted Disclosures. ........................................................................................ 142 |
11.3 Additional Permitted Disclosures. ...................................................................... 143 |
11.4 Use of Name. ...................................................................................................... 144 |
11.5 Public Announcements. ...................................................................................... 144 |
11.6 Publications. ........................................................................................................ 145 |
ARTICLE 12 REPRESENTATIONS AND WARRANTIES .................................................... 146 |
12.1 Mutual Representations and Warranties. ............................................................ 146 |
12.2 Representations, and Warranties of Capsida for the Neurology Program. ......... 147 |
12.3 Representations, and Warranties of Capsida for the Ophthalmology Program. .............................................................................................................. 151 |
12.4 Additional Representations and Warranties of Capsida as of the Option Bringdown Date. ................................................................................................. 156 |
12.5 Updated Disclosure Schedule and Bringdown. .................................................. 157 |
12.6 Mutual Covenants. .............................................................................................. 157 |
12.7 Additional Covenants of Capsida. ...................................................................... 158 |
12.8 Additional Representations and Warranties with respect to ALS Cargo and AbbVie Ophthalmology Cargo and AbbVie Obligations; Additional Acknowledgements. ............................................................................................ 160 |
12.9 Data Privacy and Security. .................................................................................. 161 |
12.10 DISCLAIMER OF WARRANTIES. .................................................................. 162 |
12.11 Anti-Bribery and Anti-Corruption Compliance. ................................................. 162 |
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