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AMENDED AND RESTATED GLOBAL CO-DEVELOPMENT AND CO-COMMERCIALIZATION AGREEMENT
BRISTOL-MYERS SQUIBB COMPANY
and, solely for the purposes of Section 10.1 through Section 10.4,
ARTICLE 1 DEFINITIONS 2
ARTICLE 2 OVERVIEW 38
ARTICLE 3 DEVELOPMENT 39
3.1 Development Plans. 39
3.3 Exploratory Indications. 41
3.4 Joint Development Costs 42
3.5 Independent Development 44
3.6 Updates and Amendments to the Joint Development Plan 52
3.7 Information Sharing For Directly Competitive Assets. 53
3.8 Lead Development Party Activities under the Joint Development Plan Activities under Independent Plans 54
3.10 Records and Reports 55
3.11 Combinations with Third Party Products 57
3.12 Safety Issues. 60
3.14 Combination Products. 61
ARTICLE 4 REGULATORY MATTERS 62
4.1 Marketing Authorization IND 62
4.2 Regulatory Interactions and Cooperation 63
4.3 Global Safety Database.. 65
4.4 PV Agreement. . 65
4.5 Pricing and Reimbursement Matters 66
4.6 Regulatory Documentation for Proprietary Collaboration Assets 68
4.8 Regulatory Data Sharing 70
ARTICLE 5 COMMERCIALIZATION 71
5.2 Global Commercialization Strategy 71
5.3 Co-Commercialization Plan 71
5.4 Market Access Plan 73
5.5 Pricing Impact Matters 73
5.6 Parallel Imports Exports 73
5.8 Joint Commercialization Costs 73
5.9 BioNTech Commercialization Build-Up 74
5.10 Booking of Sales *** 75
5.11 Promotional Materials 76
5.13 Promotion of Licensed Product 78
5.14 Sales Representatives Sales Training 78
5.15 Unsolicited Requests for Medical Information 79
ARTICLE 6 DILIGENCE 79
ARTICLE 7 MANUFACTURING AND SUPPLY 80
7.1 Manufacture Generally 80
7.2 Joint Manufacturing Plan 80
7.3 Manufacturing Technology Transfers 81
7.4 Clinical Supply of Licensed Antibodies and Licensed Products 82
7.5 Commercial Supply of Licensed Products 84
7.6 Compliance for Licensed Antibodies and Licensed Products. 86
7.7 Audits of Manufacturing Facilities 87
7.8 Changes to Specifications and Manufacturing Process for Licensed Antibody or Licensed Product 88
7.9 Supply of Proprietary Asset for Proprietary Combination Therapy 88
7.10 Supply by Affiliates. 89
ARTICLE 8 GOVERNANCE 89
8.1 Joint Steering Committee. 89
8.2 Joint Development Committee 90
8.3 Joint Manufacturing Committee 92
8.4 Joint Commercialization Committee 94
8.5 Joint Finance Committee 96
8.6 Working Groups 97
8.7 General Provisions Applicable to Committees and Working Groups 99
8.8 Discontinuation Disbandment 106
8.9 Alliance Manager 106
ARTICLE 9 EXCLUSIVITY 106
9.1 Exclusivity Obligation 106
9.3 ROFN for Next Generation Antibodies 108
ARTICLE 10 FINANCIAL PROVISIONS 111
10.1 Upfront Payment 111
10.2 Maintenance Fees 111
10.3 Development and Regulatory Milestones Payments 111
10.4 Sales Milestones 114
10.5 Net Profit Loss in the Collaboration Territory 116
10.6 Joint Development Costs 116
10.7 FTE and Out-of-Pocket Costs 117
10.8 No Double Counting of Costs or Expenses or Revenues 117
10.9 Costs other than Allowable Costs 117
10.10 Other Invoiced Amounts 118
10.11 Mode of Payments 118
10.13 Interest on Late Payments 120
10.14 Financial Records 120
10.16 Confidentiality 121
10.17 Right to Offset 121
10.18 Internal BioNTech Payments 121
ARTICLE 11 INTELLECTUAL PROPERTY 122
11.1 Grants to BMS 122
11.2 Grants to BioNTech 123
11.3 Covenants Not to Sue 124
11.4 Sublicenses Rights by Licensee Further Grants of Licenses by Licensor 125
11.5 Subcontracting. 126
11.6 No Implied Licenses 127
11.7 Confirmatory Patent License Registration 127
11.8 Technology Transfer to Enable Collaboration 127
11.9 Ownership of Intellectual Property 128
11.10 Control of Intellectual Property 130
11.11 Filing, Prosecution and Maintenance of Patents 131
11.12 Enforcement 135
11.13 Invalidity or Unenforceability Defenses or Actions 138
11.14 Infringement Claims by Third Parties 139
11.15 In-License of Third Party Rights 140
11.16 Trademarks 142
11.17 Patent Challenge 145
ARTICLE 12 REPRESENTATIONS, WARRANTIES AND COVENANTS 146
12.1 Mutual Representations and Warranties. 146