CONFIDENTIAL
1.148 “FDA” means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function.
1.149 “FDCA” 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).
1.150 “Field” means all human diagnostic, prophylactic and therapeutic uses.
1.151 “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 Regulatory Approvals for such Licensed Product have been obtained in such country. Sales prior to receipt of all Regulatory Approvals for such Licensed Product, such as so-called “treatment IND sales,” “named patient sales,” and “compassionate use sales,” shall not be construed as a First Commercial Sale.
1.152 “FTE” means the equivalent of the work of [***] employee full time for [***] Calendar Year (consisting of at least a total of [***] hours per Calendar Year) of work performing activities for a Collaboration CAR-T Product or Licensed Product. No additional payment shall be made with respect to any person who works more than [***] hours per Calendar Year and any person who devotes less than [***] hours per Calendar Year (or such other number as may be agreed by the JGC, as applicable) shall be treated as an FTE on a pro rata basis based upon the actual number of hours worked divided by [***].
1.153 “FTE Costs” means, with respect to a Party for any period, the applicable FTE Rate multiplied by the applicable number of FTEs of such Party performing the relevant activities during such period in accordance with the applicable Research Plan.
1.154 “FTE Rate” means the applicable FTE rate set forth on attached Schedule 1.154.
1.155 “Gatekeeper” has the meaning set forth in Section 3.2.3.
1.156 “Good Laboratory Practice” or “GLP” means the FDA’s standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58, and any equivalent standards promulgated by the EMA.
1.157 “Good Manufacturing Practice” or “GMP” means the current good manufacturing practices applicable from time to time to the Manufacturing of a Collaboration CAR-T Product or Licensed Product or any intermediate thereof pursuant to Applicable Law.
1.158 “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 FDCA or any successor application or procedure filed with the FDA (b) any equivalent of a United States IND in other countries or regulatory jurisdictions (i.e., clinical trial application (CTA)), and (c) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.
1.159 “Indemnification Claim Notice” has the meaning set forth in Section 10.3.
1.160 “Indemnified Party” has the meaning set forth in Section 10.3.
1.161 “Indirect Taxes” has the meaning set forth in Section 6.11.
1.162 “Information” means all knowledge of a technical, scientific, business and other nature, including 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, 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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