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1.42 "CDA" means that certain Confidential Disclosure Agreement by and between AbbVie and Heptares dated February 4, 2019. |
1.43 "Centralized Approval Procedure" means the procedure through which a MAA filed with the EMA results in a single marketing authorization valid throughout the European Union. |
1.44 "Change in Control," with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Effective Date: |
1.44.1 any Person (as such term is defined below) acquires or becomes the "beneficial owner" (as defined below), directly or indirectly, of (a) shares of capital stock or other interests (including partnership interests) of such Party then outstanding and normally entitled (without regard to the occurrence of any conti... |
1.44.2 such Party enters into a merger, consolidation or similar transaction with another Person (whether or not such Party is the surviving entity) and as a result of such merger, consolidation or similar transaction (a) the members of the Board of Directors of such Party immediately prior to such transaction constitu... |
1.44.3 such Party sells or transfers to any Third Party, in one (1) or more related transactions, properties or assets representing all or substantially all of such Party's total assets to which this Agreement relates; or |
1.44.4 the holders of capital stock of such Party approve a plan or proposal for the liquidation or dissolution of such Party. |
1.45 "Clinical Program Data" means all Information with respect to any Licensed Compound or Licensed Product that is made, collected, or otherwise generated under or in connection with any Clinical Study, including any raw data, reports, and results with respect thereto. For clarity, "Clinical Program Data" includes an... |
1.46 "Clinical Study" means clinical tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain any Regulatory Approval for a Licensed Product for one (1) or more Indications, including tests or studies that are intended to expa... |
1.47 "Combination Product" means a Licensed Product that is comprised of or contains one (1) or more Licensed Compound(s) as an active ingredient together with one (1) or more other active ingredients, whether in the same or different formulations and is sold either (a) as a fixed-dose unit at a single price, or (b) so... |
1.48 "Commercialization" means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Licensed Compound or Licensed Product, including activities related to marketing, promoting, distributing, importing and exporting such Licensed Compound or Licensed Product, and interacting... |
1.49 "Commercially Reasonable Efforts" means, with respect to the performance of Development, Commercialization, or Manufacturing activities with respect to any Compound or Product (a) by AbbVie, the carrying out of such activities using efforts and resources comparable to the efforts and resources that AbbVie would ty... |
1.50 "Competing Product" means any molecule, compound or other therapeutic that is specifically directed to any Target to which any Compound is directed under this Agreement, and can be reasonably demonstrated to possess the same or similar Pharmacology as such Compound has with respect to such Target, or any salt, hyd... |
1.51 "Competitive Program" has the meaning set forth in Section 6.9.2. |
1.52 "Compound" means an Option Compound or Licensed Compound, as applicable. |
1.53 "Conduct" means, with respect to any Clinical Study, to (a) sponsor, support or perform, directly or indirectly through a Third Party, such Clinical Study; or (b) provide to a Third Party funding for, or clinical supplies (including placebos) for use in, such Clinical Study. |
1.54 "Confidential Information" means any Information or data provided orally, visually, in writing, electronically or in any 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, sublicensee or representative of such Party) in connection w... |
1.55 "Control" means, with respect to any item of Information, 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 Sections 6.1 or 6.3), to ... |
1.56 "Convicted Entity" has the meaning set forth in Section 10.2.27(iv). |
1.57 "Convicted Individual" has the meaning set forth in Section 10.2.27(iv). |
1.58 "Corporate Names" means the Trademarks and logos identified on Schedule 1.58 and such other names and logos as Heptares may designate in writing from time to time. |
1.59 "Data Security and Privacy Laws" means all Applicable Laws relating to the privacy, data protection, integrity, Processing and security of Personal Data, including but not limited to: (i) federal and state Applicable Laws, including the Health Insurance Portability and Accountability Act of 1996, as amended and al... |
1.60 "Debarred Entity" has the meaning set forth in Section 10.2.27(ii). |
1.61 "Debarred Individual" has the meaning set forth in Section 10.2.27(i). |
1.62 "Default Notice" has the meaning set forth in Section 12.2.1. |
1.63 "Designated Pharmacology" means, with respect to an Option Target, a Pharmacology that AbbVie designates for such Option Target in accordance with Section 3.8.1. |
1.64 "Development" means all activities related to research, discovery, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, pre-clinical studies ... |
1.65 "Dispute" has the meaning set forth in Section 13.7. |
1.66 "Distributor" has the meaning set forth in Section 6.5. |
1.67 "DOJ" means the United States Department of Justice, or any successor department or body thereto. |
1.68 "Dollars" or "$" means United States Dollars. |
1.69 "Drug Approval Application" means a New Drug Application as defined in the FFDCA, or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application (a "MAA") filed with the EMA pursuant to the Centralized Approval Procedure or with the a... |
1.70 "Effective Date" means the effective date of this Agreement as set forth in the preamble hereto. |
1.71 "EMA" means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function. |
1.72 "European Union" or "E.U." 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. |
1.73 "Excluded Entity" has the meaning set forth in Section 10.2.27(iii). |
1.74 "Excluded Individual" has the meaning set forth in Section 10.2.27(iii). |
1.75 "Exclusive License" has the meaning set forth in Section 6.2.1. |
1.76 "Existing Patents" has the meaning set forth in Section 10.2.1. |
1.77 "Exploit" or "Exploitation" means to make, have made, import, export, use, have used, sell, have sold, or offer for sale, including to Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold, or keep (whether for disposal or otherwise), formulate, optimize, transport, distr... |
1.78 "Failed Option Target" has the meaning set forth in Section 3.7.1. |
1.79 "FDA" means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function. |
1.80 "FDA's Disqualified/Restricted List" has the meaning set forth in Section 10.2.27(v). |
1.81 "FFDCA" 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). |
1.82 "Field" means all human and non-human diagnostic, prophylactic, and therapeutic uses. |
1.83 "First Commercial Sale" means, with respect to a Licensed Product and a country, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such country after all necessary Regulatory Approvals for such Licensed Product have been obtained in such country. Sales prior to re... |
1.84 "FPR2" means Formyl Peptide Receptor 2 (HGNC: 3827; Entrez Gene: 2358; UniProtKB: P25090). |
1.85 "FPR2 Program" means Heptares' Development program for therapeutic agents directed at FPR2 in the Designated Pharmacology, as described in the Research Plan, including all therapeutic agents directed at FPR2 that are identified or discovered by Heptares or its Affiliates as of the Effective Date and during the Ter... |
1.86 "FTC" means the United States Federal Trade Commission, or any successor agency thereto. |
1.87 "FTE" means a full time equivalent employee of Heptares working full time for Heptares or its Affiliate. |
1.88 "FTE Cost" means the FTE rate of Three Hundred and Thirty Thousand Dollars ($330,000) per FTE per Calendar Year (adjusted annually on the last day of each Calendar Year by the percentage RPI for the previous twelve (12) months, as published by the UK Office for National Statistics (pro-rated for the period beginni... |
1.89 "Generic Application" has the meaning set forth in Section 8.3.4. |
1.90 "Generic Competition" has the meaning set forth in Section 7.6.4(a). |
1.91 "Generic Product" means, with respect to a Licensed Product, any product that is approved in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Licensed Product as determined by the applicable Regulatory Authority, including any p... |
1.92 "Good Clinical Practices" or "GCP" means Good Clinical Practice as promulgated by the FDA under and in accordance with the FFDCA, Title 21, Parts 312 of the U.S. Code of Federal Regulations, and the guidelines and standards published by the FDA that relate thereto as may be amended from time-to-time, or any succes... |
1.93 "Good Laboratory Practices" or "GLP" means Good Laboratory Practices as promulgated by the FDA under and in accordance with the FFDCA, Title 21, Part 58 of the U.S. Code of Federal Regulations, and the guidelines and standards published by the FDA that relate thereto as may be amended from time-to-time, or any suc... |
1.94 "Good Manufacturing Practices" or "GMP" or "cGMP" means the applicable regulatory standards and requirements for current good manufacturing practices promulgated by the FDA under and in accordance with the FFDCA, Title 21, Parts 210 and 211 of the U.S. Code of Federal Regulations, and the guidelines and standards ... |
1.95 "Good Reason" has the meaning set forth in Section 12.4. |
1.96 "Governmental Authority" means any multinational, federal, national, state, provincial, local or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal exercising executive, judicial, legislative, police, reg... |
1.97 "GPR65" means G Protein-Coupled Receptor 65 (HGNC: 4517; Entrez Gene: 8477; UniProtKB: Q8IYL9). |
1.98 "GPR65 Program" means Heptares' Development program for therapeutic agents directed at GPR65 in the Designated Pharmacology, as described in the Research Plan, including all therapeutic agents directed at GPR65 that are identified or discovered by Heptares or its Affiliates as of the Effective Date and during the ... |
1.99 "GPR132" means G Protein-Coupled Receptor 132 (HGNC: 17482; Entrez Gene: 29933; UniProtKB: Q9UNW8). |
1.100 "GPR132 Program" means Heptares' Development program for therapeutic agents specifically directed at GPR132 in the Designated Pharmacology, as described in the Research Plan, including all therapeutic agents specifically directed at GPR132 that are identified or discovered by Heptares or its Affiliates as of the ... |
1.101 "Grantback Agreement" has the meaning set forth in Section 12.8.2. |
1.102 "Grantback Product" means any Licensed Compound or Licensed Product (i) for which AbbVie's license rights under Section 6.1 have terminated, (ii) that has been the subject of Development or Commercialization in the Territory prior to the date of such termination, and (iii) that, in the case of a Licensed Product,... |
1.103 "Heptares" has the meaning set forth in the preamble hereto. |
1.104 "Heptares Indemnitees" has the meaning set forth in Section 11.1. |
1.105 "Heptares Know-How" means all Information that is (a) subject to Section 6.9.1, Controlled by Heptares or any of its Affiliates (subject to Section 6.9.2, excluding Acquired Affiliates, unless such Acquired Affiliates perform any activities under this Agreement), as of the Effective Date or at any time during the... |
1.106 "Heptares Patents" means all of the Patents that are (a) subject to Section 6.9.1, Controlled by Heptares or any of its Affiliates (subject to Section 6.9.2, excluding Acquired Affiliates, unless such Acquired Affiliates perform any activities under this Agreement), as of the Effective Date or at any time during ... |
1.107 "Heptares Platform" means Heptares' proprietary platform covering stabilized G protein-coupled receptors and their creation and their use in drug discovery, identification, generation and optimization of therapeutic agents and Heptares' other proprietary structure-based drug design tools and technologies includin... |
1.108 "Heptares Platform Patents" has the meaning set forth in Section 8.2.1. |
1.109 "Heptares Product Patents" has the meaning set forth in Section 8.2.2(i). |
1.110 "HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. |
1.111 "HSR Clearance" means the earlier of (a) notification to the Parties from the FTC or DOJ of early termination of the applicable waiting period under the HSR Act with respect to the HSR Filings, or (b) expiration of the applicable waiting period under the HSR Act with respect to the HSR Filings; provided, however,... |
1.112 "HSR Filing" means the filings by Heptares and AbbVie with the FTC and the DOJ of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect to the matters set forth in this Agreement, together with all required documentary attachments thereto. |
1.113 "In-License Agreements" means any agreement between Heptares and a Third Party under which Heptares is granted rights under intellectual property rights that relate to the Heptares Platform and under which AbbVie is granted a sublicense or other right under this Agreement; provided, however that In-License Agreem... |
1.114 "In-Licensed Patents" has the meaning set forth in Section 10.2.6. |
1.115 "Incremental Manufacturing Cost Amount" has the meaning set forth in Section 3.9.1. |
1.116 "IND" means an application filed with a Regulatory Authority for authorization to commence Clinical Studies, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or r... |
1.117 "Indemnification Claim Notice" has the meaning set forth in Section 11.3. |
1.118 "Indemnified Party" has the meaning set forth in Section 11.3. |
1.119 "Indication" means, with respect to a Licensed Product, a diagnostic, prophylactic or therapeutic use for a disease or condition, which, (a) for a clinical trial for such Licensed Product, would be the use of such Licensed Product for which such clinical trial is intended to determine safety or effectiveness and ... |
1.120 "Indirect Taxes" has the meaning set forth in Section 7.12. |
1.121 "Information" means all knowledge of a technical, scientific, business and other nature, including know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs... |
1.122 "Intellectual Property Rights" has the meaning set forth in Section 12.6.1. |
1.123 "Invoiced Party" has the meaning set forth in Section 7.9. |
1.124 "Invoicing Party" has the meaning set forth in Section 7.9. |
1.125 "Joint Governance Committee" or "JGC" has the meaning set forth in Section 2.1. |
1.126 "Joint Intellectual Property Rights" means the Joint Know-How and the Joint Patents. |
1.127 "Joint Know-How" means any and all Information and inventions that are conceived, reduced to practice, discovered, developed or otherwise made jointly by or on behalf of Heptares or its Affiliates or sublicensees, on the one hand, and AbbVie or its Affiliates, on the other hand, under this Agreement, whether or n... |
1.128 "Joint Patents" means all of the Patents that claim inventions that are conceived, reduced to practice, discovered, developed or otherwise made jointly by or on behalf of Heptares or its Affiliates or sublicensees, on the one hand, and AbbVie or its Affiliates, on the other hand, under this Agreement, excluding a... |
1.129 "Know-How" means all Information that is not generally known. |
1.130 "Knowledge" means the good faith understanding of the facts and information after performing a diligent investigation with respect to such facts and information of the Chief Business Officer, Chief Scientific Officer, Chief Technology Officer, Vice President of Discovery, Vice President of Translational Sciences,... |
1.131 "Lead Optimization Activities" means the activities set forth in Stage 3, Appendix C of an applicable Research Plan, the (i) initiation of which shall be deemed to have occurred when Heptares has demonstrated to the JGC that at least one (1) of the activities in Stage 3, Appendix C of the applicable Research Plan... |
1.132 "License Option" has the meaning set forth in Section 4.1. |
1.133 "License Option Effective Date" means the date upon which AbbVie delivers to Heptares the License Option Exercise Notice for an Option Program; provided that, if AbbVie reasonably determines in good faith prior to the delivery of the License Option Exercise Notice that the transactions to be consummated upon the ... |
1.134 "License Option Exercise Notice" means AbbVie's written notice to Heptares exercising a License Option. |
1.135 "Licensed Compound" means, upon exercise of the License Option for an Option Program, (i) any Option Compounds from such Option Program, and (ii) any compound that is directed to an Option Target in the Designated Pharmacology and was Developed by or on behalf of AbbVie using Heptares Know-How, and in each case, ... |
1.136 "Licensed Product" means any product comprising a Licensed Compound, alone or in combination with one (1) or more other active ingredients, in any and all forms, in current and future formulations, dosage forms and strengths and delivery modes, including an improvement to any of the foregoing forms, formulations ... |
1.137 "Licensed Program" means any Option Program with respect to which AbbVie has exercised its License Option. |
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