EXECUTION VERSION
1.66 “First-in-Human Clinical Trial” means the first-ever human clinical trial in any country conducted in accordance with good clinical practices (as defined under Applicable Law) that is intended to initially evaluate a Licensed Product with respect to safety, tolerability, pharmacological effects and determination of maximum tolerated dose or recommended dose of such Licensed Product for subsequent human clinical trials as the primary endpoint, or that would otherwise satisfy requirements of 21 CFR 312.21(a), or its foreign equivalent. Such trials may include but are not limited to dose range exploration, pharmacokinetics studies, mechanistic and pharmacodynamics studies, drug-drug-interaction and food effect studies, assessment of pharmacokinetics in renal or hepatic impairment patients, and initial evaluation of combinations of a Licensed Product with other drugs or drug candidates.
1.67 “IMS” has the meaning set forth inSection 7.6.3(a).
1.68 “Immune Effector Target” means a Target that is [***].
1.69 “In-Licensed Patents” has the meaning set forth inSection 11.2.3.
1.70 “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 thereof in other countries or regulatory jurisdictions, (e.g., a Clinical Trial Application (CTA) in the European Union) and (c) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.
1.71 “Indemnification Claim Notice” has the meaning set forth inSection 12.3.
1.72 “Indemnified Party” has the meaning set forth inSection 12.3.
1.73 “Indication” means each separate and distinct disease, disorder, illness, health condition, or interruption, cessation or disruption of a bodily function, system, tissue type or organ, for which Regulatory Approval is required.
1.74 “Indirect Taxes” has the meaning set forth inSection 7.10.
1.75 “Information” means all knowledge of a technical, scientific, business and other nature, includingknow-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, regulatory data, and other biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical,pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, reagents (e.g., plasmids, proteins, cell lines, assays and compounds) and biological methodology, in each case (whether or not confidential, proprietary, patented or patentable, of commercial advantage or not) in written, electronic or any other form now known or hereafter developed.
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[ ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.