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Whereas, AbbVie will have exclusive rights and will be solely responsible for the clinical development and commercialization of Licensed Products worldwide, in accordance with the terms and conditions set forth in this Agreement. |
Now Therefore, in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, the Parties agree as follows. |
ARTICLE 1 DEFINITIONS |
As used in this Agreement, the terms with initial letters capitalized, whether used in the singular or plural form, shall have the meanings set forth in this Article 1 or, if not listed below, the meaning designated in places throughout this Agreement. |
1.1 "AbbVie" has the meaning set forth in the preamble hereto. |
1.2 "AbbVie Claims" has the meaning set forth in Section 11.1. |
1.3 "AbbVie Compound" means any molecule directed to a DUB that (a) originates from AbbVie's Compound Library, or (b) is acquired, discovered or invented by AbbVie independently of the Collaboration, in each case, ((a) or (b)), that was screened as part of the Research Plan, and including in each case, ((a) or (b)), an... |
1.4 "AbbVie's Compound Library" means the collection of molecules that is Controlled by AbbVie as of the Effective Date, including any molecules not synthesized as of the Effective Date but documented in Patents or laboratory notebooks of AbbVie, together with any molecules added to such collection after the Effective ... |
1.5 "AbbVie Derived Compound" means any (a) analog or derivative of an AbbVie Compound directed to a DUB that is identified by or on behalf of either Party under the Collaboration either (i) using any Mission Know-How or (ii) for which the identification of such analog or derivative, but for the licenses granted to Abb... |
1.6 "AbbVie Indemnitees" has the meaning set forth in Section 11.1. |
1.7 "AbbVie IP" means any Patent or Know-How that is (a) Controlled by AbbVie or its Affiliates on or after the Effective Date other than Mission IP, (b) developed by AbbVie or any of its Affiliates on or after the Effective Date and during the Term as a result of performance under this Agreement, (c) solely with respe... |
1.8 "AbbVie Patents" has the meaning set forth in Section 7.4(b). |
1.9 "AC Licensed Product" has the meaning set forth in Section 6.2(c)(vi). |
1.10 "Accounting Standards" means, with respect to a Party, that such Party shall maintain records and books of accounts in accordance with (a) United States Generally Accepted Accounting Principles or (b) to the extent applicable, International Financial Reporting Standards as issued by the International Accounting St... |
1.11 "Active Development" means with respect to a given Licensed Compound, that at any given time AbbVie or a Sublicensee of AbbVie, shall be using Commercially Reasonable Efforts to Develop a such Licensed Compound. |
1.12 "Acquirer" means, with respect to a Change of Control Transaction involving a Party, the Third Party referenced in the definition of "Change of Control Transaction" and such Third Party's Affiliates, (other than the applicable Party and the applicable Party's Affiliates determined as of immediately prior to the cl... |
1.13 "Adverse Ruling" has the meaning set forth in Section 9.4(a)(i). |
1.14 "Affiliate" means, with respect to a Party, any Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, "control" and, with correlative meanings, the terms "controlled by" and "under common cont... |
1.15 "Agreed Assays" means the assays set forth on Schedule 1.15, as such Schedule may be amended by the JGC pursuant to Sections 2.1(c), 2.1(f) and/or 3.4. |
1.16 "Agreement" has the meaning set forth in the preamble hereto. |
1.17 "Alliance Manager" has the meaning set forth in Section 2.3. |
1.18 "Applicable Law" means any federal, state, provincial, local, national and supra-national law, statute, ordinance, rule, regulation, standard, judgment, order, writ, injunction, decree, arbitration award, or license or permit of any Governmental Authority, including any rule, regulation, guideline (excluding Paten... |
1.19 "Approved Labeling" means, with respect to a Licensed Product (a) the Regulatory Authority-approved full prescribing information for such Licensed Product, and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used... |
1.20 "Approved Subcontractor" has the meaning set forth in Section 3.8. |
1.21 "Audit Arbitrator" has the meaning set forth in Section 6.11. |
1.22 "Bankruptcy Code" has the meaning set forth in Section 9.7(a). |
1.23 "Binds" means, with respect to determining whether a molecule "binds" to a DUB, that such molecule has an IC50 of less than or equal to 10 μM with respect to such DUB as determined in the relevant Agreed Assay or, solely in the event that there is no Agreed Assay, a suitable biochemical assay, including those set ... |
1.24 "Breaching Party" has the meaning set forth in Section 9.4(a)(i). |
1.25 "Business Day" means (a) a day other than a Saturday, Sunday, or (b) any day on which banking institutions in New York, New York, Chicago, Illinois or London, England are not open for business. |
1.26 "Calendar Quarter" means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30 and December 31, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of March 31, June 30, Se... |
1.27 "Calendar Year" means the one (1) year period beginning on January 1 and ending on December 31 except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January ... |
1.28 "Centralized Approval Procedure" means the procedure through which a Marketing Authorization Application filed with the EMA results in a single marketing authorization valid throughout the EU (other than the UK). |
1.29 "Change of Control Transaction" means, with respect to a Party: (a) the acquisition by a Third Party of fifty percent (50%) or more of either (i) the then outstanding shares of common stock of such Party or (ii) the combined voting power of the then outstanding voting securities of such Party entitled to vote gene... |
1.30 "Claim" has the meaning set forth in Section 11.3. |
1.31 "Clinical Study" means any clinical study in humans that is designed to generate data in support or maintenance of a Drug Approval Application, including any Phase 1 Clinical Study, Phase 2 Clinical Study, or Phase 3 Clinical Study. |
1.32 "CLOOC" has the meaning set forth in Section 2.2(a). |
1.33 "Collaboration" means any or all activities performed by or on behalf of either Party or its Affiliates as contemplated in this Agreement, including the activities set forth in the Research Plan. |
1.34 "Collaboration Compound" means any Mission Compound, Mission Derived Compound or AbbVie Derived Compound. |
1.35 "Combination Product" means a Licensed Product that is comprised of or contains one (1) or more Licensed Compounds as an active ingredient together with one (1) or more other active ingredients, whether in the same or different formulations, and is sold either as a fixed dose or as separate doses as one (1) produc... |
1.36 "Commercialize" or "Commercialization" means the marketing, promotion, sale (and offer for sale or contract to sell), distribution, importation or other commercial exploitation (including pricing and reimbursement activities) for a Licensed Compound or Licensed Product in the Territory. Commercialization shall inc... |
1.37 "Commercialization Wind-Down Period" has the meaning set forth in Section 9.12(b). |
1.38 "Commercially Reasonable Efforts" means, with respect to the performance of Development, Commercialization, or Manufacturing activities with respect to the Licensed Compound or a Licensed Product by a Party, the carrying out of such activities using efforts and resources comparable to the efforts and resources tha... |
1.39 "Compound" means an AbbVie Compound or a Collaboration Compound. |
1.40 "Confidential Information" means any Information or data provided orally, visually, in writing or other form by or on behalf of one (1) Party (or an Affiliate or representative of such Party) to the other Party (or to an Affiliate or representative of such Party) in connection with this Agreement, whether prior to... |
1.41 "Control" means, with respect to any item of Information, Regulatory Materials, material, Patent, or other property right, the possession of the right, whether directly or indirectly, and whether by ownership, license, covenant not to sue or otherwise (other than by operation of the license and other grants in Sec... |
1.42 "Debarred/Excluded" has the meaning set forth in Section 10.3. |
1.43 "Default Notice" has the meaning set forth in Section 9.4(a)(i). |
1.44 "Development" means all activities related to research (including the identification of molecules and screening of molecules for activity against targets), pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-u... |
1.45 "Directed to" means, with respect to determining whether a Patent is "Directed to" a molecule, that such Patent specifically claims the composition of matter, use or manufacture of the molecule. For clarity, a genus claim with a Markush structure that covers the molecule shall not be considered as Directed to the ... |
1.46 "Dispute" has the meaning set forth in Section 12.1. |
1.47 "Distributor" has the meaning in Section 4.3. |
1.48 "Dollar" or "$" means the lawful currency of the U.S. |
1.49 "Drug Approval Application" means an application for Regulatory Approval in a country or region of the Territory, and includes a New Drug Application as defined in the FD&C Act, or any corresponding foreign application in the Territory, including, with respect to the EU, a Marketing Authorization Application filed... |
1.50 "DSS Excluded DUB" means any Excluded DUB (other than any Initially Selected DUBs which are not selected by AbbVie as a Selected DUB) for which there is an Agreed Assay set forth on Schedule 1.15 that is included in the DUB Selectivity Screen. |
1.51 "DUB" means a deubiquitylating enzyme or deubiquitinating enzyme. |
1.52 "DUB Failure" has the meaning set forth in Section 9.3(a). |
1.53 "DUB Failure Notice" has the meaning set forth in Section 9.3(a). |
1.54 "DUB Hit" means, on an Exclusively Licensed DUB-by-Exclusively Licensed DUB basis, any Collaboration Compound or AbbVie Compound, or any racemate, enantiomer, salt or hydrate thereof, that, following a DUB Selectivity Screen of such molecule: (a) Binds to such Exclusively Licensed DUB; and (b) satisfies the follow... |
1.55 "DUB Selection Guidelines" means the threshold criteria for (a) the in vitro genetic CRISPR screening experiments, and/or (b) in vitro pharmacologic screening in the α-Syn and/or tau clearance experiments, in each case as set forth in the Research Plan attached hereto. |
1.56 "DUB Selectivity Screen" means, with respect to a molecule, a screen conducted on such molecule using the Agreed Assays to determine the IC50 of such molecule with respect to the DUBs that are the subject of the Agreed Assays. |
1.57 "Effective Date" has the meaning set forth in the preamble. |
1.58 "EMA" means the European Medicines Agency and any successor agency thereto. |
1.59 "Enforcement and Enforce" has the meaning set forth in Section 7.6(b). |
1.60 "Enforcing Party" has the meaning set forth in Section 7.6(b). |
1.61 "EU" means the economic, scientific, and political organization of member states known as the European Union, as its membership may be altered from time to time, and any successor thereto. For clarity, the United Kingdom shall be considered part of the EU in all situations for all purposes for the entire Term. |
1.62 "Exclusively Licensed DUB" has the meaning set forth in Section 3.3(b). |
1.63 "Exclusively Licensed DUB Fee" has the meaning set forth in Section 3.3(b). |
1.64 "Excluded DUB" means any DUB that is not a Pre-Selected DUB (including each Initially Excluded DUB) and any Pre-Selected DUB that becomes an Excluded DUB pursuant to Sections 3.2 and 3.3 or any Terminated DUB that becomes an Excluded DUB pursuant to Section 9.8(a)(i), 9.8(b)(ii) or 12.1(d). |
1.65 "Excluded Mission Compounds" has the meaning set forth on Schedule 1.65. |
1.66 "Executive Officer" means, in the case of AbbVie its Chief Scientific Officer or his or her designee, and in the case of Mission, Mission's Chief Executive Officer. |
1.67 "Existing Patents" has the meaning set forth in Section 10.2(a). |
1.68 "Exploit" or "Exploitation" means to make, have made, import, use, sell, or offer for sale, including to Develop, Commercialize, register, modify, enhance, improve, manufacture, have manufactured, hold or keep (in connection with such other activities), formulate, optimize, have used, export, transport, distribute... |
1.69 "FDA" means the United States Food and Drug Administration and any successor agency thereto. |
1.70 "FD&C Act" or "Act" means the United States Federal Food, Drug and Cosmetic Act 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto). |
1.71 "Field" means all human and non-human diagnostic, prophylactic, and therapeutic uses. |
1.72 "First Commercial Sale" means, with respect to a Licensed Product and country, the first sale to a Third Party of such Licensed Product in such country after Regulatory Approval (including any pricing and reimbursement approvals) has been obtained in such country. Sales prior to receipt of Regulatory Approval for ... |
1.73 "GCP" means the then-current good clinical practice standards, practices, and procedures promulgated or endorsed by the applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time-to-time. |
1.74 "Generic Product" means, with respect to a Licensed Product, any product that (a) is sold by a Third Party under a Drug Approval Application granted by a Regulatory Authority to a Third Party; (b) contains the Licensed Compound as an active ingredient; and (c) is approved in reliance, in whole or in part, on the p... |
1.75 "GLP" means the then-current good laboratory practice standards, practices, and procedures promulgated or endorsed by the applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time-to-time. |
1.76 "Governmental Authority" means any multi-national, federal, state, local, municipal or other government authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, court, tribunal or other entity). |
1.77 "IC50" means, with respect to a given molecule and a given DUB, the concentration of such molecule needed to inhibit such DUB by half. For the purposes of the formulas in the applicable definitions herein, IC50 values are expressed in units of Molar (e.g., for a 1 nM IC50 (10-9 M) the log10 IC50 is negative nine (... |
1.78 "IND" means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the applicable Regulatory Authority in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct cli... |
1.79 "Indemnified Party" has the meaning set forth in Section 11.3. |
1.80 "Indemnifying Party" has the meaning set forth in Section 11.3. |
1.81 "Indication" means a separate and distinct disease, disorder or medical condition that a Licensed Product is intended to treat, prevent, cure, or ameliorate, as set forth in the indications section of the Approved Labeling for such Licensed Product. |
1.82 "Indirect Taxes" has the meaning set forth in Section 6.6(c). |
1.83 "Information" means all technical, scientific, and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs,... |
1.84 "Infringement" has the meaning set forth in Section 7.6(a). |
1.85 "Infringement Action" has the meaning set forth in Section 7.6(b). |
1.86 "Initially Excluded DUBs" means the initially excluded DUBs set forth on Schedule 1.86 attached hereto. |
1.87 "Initially Excluded Mission Compounds" means the molecules set forth on Schedule 1.87. |
1.88 "Initially Selected DUBs" has the meaning set forth in Section 3.2(a). |
1.89 "Initially Selected DUB Exchange" has the meaning set forth in Section 12.1(d)(iv)(1). |
1.90 "Initiation" or "Initiate" means, with respect to a Clinical Study and a Licensed Product, the first dosing of the applicable Licensed Product in a human subject in the applicable Clinical Study. |
1.91 "Intellectual Property" has the meaning set forth in Section 9.7(a). |
1.92 "Joint Governance Committee" or "JGC" has the meaning set forth in Section 2.1(a). |
1.93 "Joint Program IP" means, collectively, Joint Program Know-How and Joint Program Patents. |
1.94 "Joint Program Know-How" means any and all Know-How that is developed or invented after the Effective Date (a) jointly by a Party's or its Affiliate's employees or Third Party contractors, or Persons contractually required to assign or license such Know-How to such Party or its Affiliate, on the one hand, and by t... |
1.95 "Joint Program Patent" means any and all Patents that cover any Joint Program Know-How. |
1.96 "Know-How" means Information that is not generally known to the public and is necessary or useful for the conduct of the Research Plan or the Exploitation of Licensed Compounds or Licensed Products. |
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