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13.4 Assignment ............................................................................................................... 118 |
13.5 Severability ............................................................................................................... 119 |
13.6 Governing Law, Jurisdiction and Service ................................................................. 119 |
13.7 Dispute Resolution .................................................................................................... 120 |
13.8 Notices ...................................................................................................................... 121 |
13.9 Entire Agreement; Amendments............................................................................... 122 |
13.10 English Language...................................................................................................... 122 |
13.11 Equitable Relief ........................................................................................................ 123 |
13.12 Waiver and Non-Exclusion of Remedies .................................................................. 123 |
13.13 No Benefit to Third Parties ....................................................................................... 123 |
13.14 Further Assurance ..................................................................................................... 123 |
13.15 Relationship of the Parties ........................................................................................ 123 |
13.16 Performance by Affiliates ......................................................................................... 124 |
13.17 Counterparts; Facsimile Execution ........................................................................... 124 |
13.18 References ................................................................................................................. 124 |
13.19 Construction .............................................................................................................. 124 |
SCHEDULES |
Schedule 1.69 Corporate Names |
Schedule 1.90 Existing In-License Agreements |
Schedule 1.127 AL003 and Backups |
Schedule 1.129 AL002 and Backups |
Schedule 1.150 Manufacturing Cost |
Schedule 1.188 PoC Trial Parameters |
Schedule 1.193 Pre Exercise Development Plan and Budget |
Schedule 3.1.3 PoC Trial Report Requirements |
Schedule 3.2.1 Initial Post Exercise Development Plan and Budget |
Schedule 3.3.2 Antibody Approved for Additional Licensor Development Activities |
Schedule 3.5.5 Pre-Approved Subcontractors |
Schedule 5.7.1 Example Calculations of Third Party Payment Responsibilities |
Schedule 6.4.4 FTE Rates |
Schedule 7.6.5 Existing In-License Agreement Obligations |
Schedule 10.2 Exceptions |
Schedule 10.2.1 Existing Patents |
Schedule 12.8.1(f) Enforcement and Defense of AbbVie Grantback Patents |
Schedule 13.7.3 ADR Procedures |
CO-DEVELOPMENT AND OPTION AGREEMENT |
This Co-Development and Option Agreement (this "Agreement") is made and entered into effective as of October 16, 2017 (the "Execution Date") by and between Alector, Inc. (f/k/a Alector LLC), a Delaware corporation ("Licensor"), and AbbVie Biotechnology, Ltd., a Bermuda limited company ("AbbVie"). Licensor and AbbVie ar... |
RECITALS |
WHEREAS, Licensor has developed certain Licensed Antibodies (as defined herein) and Controls (as defined herein) certain intellectual property and other rights with respect to such Licensed Antibodies in the Territory (as defined herein); and |
WHEREAS, Licensor wishes to grant an option to a license to AbbVie, and AbbVie wishes to take, such option to a license with respect to Licensed Antibodies under Licensor's intellectual property and other rights therein, for purposes of developing and commercializing Licensed Products (as defined herein) in the Territo... |
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows: |
ARTICLE 1. DEFINITIONS |
Unless otherwise specifically provided herein, the following terms shall have the following meanings: |
1.1 "AbbVie" has the meaning set forth in the preamble hereto. |
1.2 "AbbVie Background Know-How" means all Information that is (a) Controlled by AbbVie or any of its Affiliates on the Execution Date or at any time during the Term, (b) not generally known, (c) developed or invented outside the scope of this Agreement, and (d) either used by AbbVie or provided by AbbVie for use in th... |
1.3 "AbbVie Background Patents" means all Patents that are (a) Controlled by AbbVie or any of its Affiliates on the Execution Date or at any time during the Term, (b) developed or invented outside the scope of this Agreement, and (c) covering subject matter either used by AbbVie or provided by AbbVie for use in the Dev... |
1.4 "AbbVie Competing Product" has the meaning set forth in Section 5.10.2(a). |
1.5 "AbbVie Grantback Know-How" means, as used in connection with any grant back license provided in Section 12.8.1(c), AbbVie Program Know-How and Joint Program Know-How that (a) is Controlled by AbbVie as of the effective date of the applicable termination of this Agreement (either in its entirety or with respect to ... |
1.6 "AbbVie Grantback Patents" means, as used in connection with any grant back license provided in Section 12.8.1(c), AbbVie Program Patents and Joint Program Patents that (a) are Controlled by AbbVie as of the effective date of the applicable termination of this Agreement (either in its entirety or with respect to a ... |
1.7 "AbbVie Incorporated Background Know-How" has the meaning set forth in Section 12.8.1(d). |
1.8 "AbbVie Indemnitees" has the meaning set forth in Section 11.2. |
1.9 "AbbVie Independent New Technology" means New Technology which AbbVie or its Affiliates has either acquired from a Third Party or developed outside the Collaboration Program without use or reference to the Confidential Information of Licensor, and which the Parties agree in writing will be applied to a Licensed Pro... |
1.10 "AbbVie Opt In" has the meaning set forth in Section 3.3.4. |
1.11 "AbbVie Opt In Exercise Date" has the meaning set forth in Section 3.3.4. |
1.12 "AbbVie Opt In Product" means a Licensed Product for which AbbVie has exercised the AbbVie Opt In. |
1.13 "AbbVie Program Know-How" means all Information and inventions that are, as between the Parties, conceived, discovered, developed, or otherwise made solely by or on behalf of AbbVie, its Affiliates or their Sublicensees or subcontractors as a result of performance of this Agreement. AbbVie Program Know-How express... |
1.14 "AbbVie Program Patents" mean all Patents that claim inventions that, as between the Parties, are conceived, discovered, developed, or otherwise made solely by or on behalf of AbbVie, its Affiliates or their Sublicensees or subcontractors as a result of performance of this Agreement. AbbVie Program Patents express... |
1.15 "Accounting Standards" means, with respect to a Party, that such Party shall maintain records and books of accounts in accordance with United States Generally Accepted Accounting Principles, consistently applied. |
1.16 "Acquirer" has the meaning set forth in Section 13.2.1(a). |
1.17 "Acquisition" means, with respect to a Party, a merger, acquisition (whether of all of the stock or all or substantially all of the assets of a Person or any operating or business division of a Person) or similar transaction by or with the Party, other than a Change in Control of the Party. |
1.18 "Additional Development Costs" has the meaning set forth in Section 6.5.2(b)(i). |
1.19 "Additional Indication" means, with respect to the Licensed Antibodies and Licensed Products, each Indication other than the Alzheimer's Indication. |
1.20 "Additional Licensor Development Activities" has the meaning set forth in Section 3.3.1. |
1.21 "Additional Repayment Amount" has the meaning set forth in Section 3.7.1(e). |
1.22 "Adimab Agreement" has the meaning set forth in Schedule 1.90. |
1.23 "Adimab Applications" has the meaning set forth in Section 10.2.5. |
1.24 "Adjusted Royalty Rate" has the meaning set forth in Section 6.5.2(a). |
1.25 "ADR" has the meaning set forth in Section 13.7.1. |
1.26 "Adverse Ruling" has the meaning set forth in Section 12.2. |
1.27 "Affiliate" means, with respect to a subject Person, any other Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such subject Person. For purposes of this definition, "control" and, with correlative meanings, the terms "controlle... |
1.28 "Agreement" has the meaning set forth in the preamble hereto. |
1.29 "Alliance Manager" has the meaning set forth in Section 2.4.5. |
1.30 "Allowable Expenses" means, subject to the other provisions of this Agreement, the following expenses incurred by or on behalf of AbbVie (or, in the case of Licensor, in connection with clause (h) or (k) below or, if applicable, with respect to any costs or expenses incurred at AbbVie's request) that are specifica... |
(a) Sales and Marketing Costs; |
(b) Distribution Costs; |
(c) Manufacturing Costs for Licensed Products for sale or distribution in the United States (including manufacturing startup, for samples of Licensed Products distributed for use in the United States, inventory write-off, obsolescence and disposal); |
(d) Regulatory Expenses allocable to the Exploitation of a Licensed Product in the United States; |
(e) Phase IV Costs; |
(f) Medical Affairs Costs; |
(g) costs associated with patient assistance programs; |
(h) Patent Costs (to the extent not otherwise reimbursed through recoveries obtained in connection with any litigation as contemplated under Sections 7.3.5 and 7.4); |
(i) Trademark Costs (to the extent not otherwise reimbursed under Section 7.6); |
(j) product liability insurance with respect to the Licensed Products in the United States in the event the Parties obtain a joint policy; |
(k) payments made by AbbVie or Licensor to a Third Party in order to obtain a license or right in the United States under a Patent or intellectual property right owned or controlled by such Third Party; |
(l) costs associated with recall or withdrawal of a Licensed Product in the United States, to the extent treated as Allowable Expenses pursuant to Section 3.8.2(e); |
(m) Losses specifically identifiable or reasonably allocable to the Commercialization of a Licensed Product in the United States, or the Manufacture of a Licensed Product in support of such Commercialization, to the extent treated as Allowable Expenses pursuant to Section 11.3; and |
(n) any other costs and expense of AbbVie or its Affiliates, specifically identifiable or reasonably allocable to the Commercialization of a Licensed Product in the United States. |
For clarity, it is understood that Allowable Expenses shall (x) include only Out-of-Pocket Costs and FTE Costs (except in the case of Manufacturing Costs), and other than overhead costs expressly included within Manufacturing Costs, the internal costs of a Party and its Affiliates shall be reimbursed only as reflected ... |
1.31 "Alzheimer's Indication" means an Indication involving Alzheimer's disease. For purposes of this Agreement, "Alzheimer's disease" means any of the conditions categorized in the World Health Organization's International Classification of Diseases 10 coding system under the G30 code (including G30.0, G30.1, G30.8 an... |
1.32 "Amount" has the meaning set forth in Section 6.9. |
1.33 "Antibody(ies)" means an immunoglobulin (Ig) molecule, or other composition comprising an amino acid based structure, in each case that binds or incorporates one or more moieties capable of binding CD33 or Trem2, including any such composition containing a scaffold based on an Ig molecule or a fragment, alternativ... |
1.34 "Antitrust Approvals" has the meaning set forth in Section 12.1.2. |
1.35 "Applicable Law" means federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, regulatory guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be ... |
1.36 "Audit Arbitrator" has the meaning set forth in Section 6.14. |
1.37 "Bankruptcy Code" has the meaning set forth in Section 12.7.1. |
1.38 "Base Royalty Rate" has the meaning set forth in Section 6.5.1. |
1.39 "Biosimilar Application" has the meaning set forth in Section 7.3.3. |
1.40 "Biosimilar Competition" has the meaning set forth in Section 6.5.4(a). |
1.41 "Biosimilar Product" means, on a country-by-country basis, a biologic product determined by the FDA or other Regulatory Authority outside of the United States to be biosimilar or interchangeable with a Licensed Product under Applicable Law. A Licensed Product licensed, marketed, sold, manufactured, or produced by ... |
1.42 "BLA" has the meaning set forth in the definition of "Drug Approval Application." |
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