1.92 “Executive Officer” has the meaning set forth in Section 15.1.1 (Executive Officer Negotiations).
1.93 “Existing Upstream License” means any agreement in effect as of the Effective Date pursuant to which Cellectis or any of its Affiliates in-licenses any Licensed Technology from a Third Party that is listed on Schedule 1.93 (Existing Upstream Licenses).
1.94 “Exploit” means to make, have made, import, use, sell, or offer for sale, including to Develop, have Developed, register, Manufacture, have Manufactured, Commercialize, have Commercialized, hold or keep (whether for disposal or otherwise), have used, export, transport, or otherwise exploit or have exploited. “Exploitation” means the act of Exploiting.
1.95 “FDA” means the United States Food and Drug Administration and any successor agency thereto.
1.96 “FD&C Act” means United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., together with any rules, regulations, and requirements promulgated thereunder.
1.97 “Field” means all human therapeutic, prophylactic, palliative, and analgesic uses and all animal uses to reasonably support such human uses, excluding: (a) therapeutic, prophylactic, palliative, and analgesic uses for animals; and (b) diagnostic uses.
1.98 “Final DC Data Package” has the meaning set forth in Section 2.5.4 (Final DC Data Package).
1.99 “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 Regulatory Approval for such Licensed Product has been obtained in such country, excluding, for clarity, sales prior to receipt of Regulatory Approval for such Licensed Product, such as so-called “treatment IND sales,” “named patient sales,” and “compassionate use sales.”
1.100 “Force Majeure” means any act of God, pandemic, flood, fire, explosion, earthquake, strike, lockout, labor dispute (except for any strike, lockout, or labor dispute involving a Party’s or its Affiliates’ own employees), casualty, or accident, or war, revolution, civil commotion, act of terrorism, blockage or embargo, or any injunction, law, order, proclamation, regulation, ordinance, demand, or requirement of any Governmental Authority.
1.101 “FTE” means the equivalent of the work of one (1) full-time employee for one (1) Calendar Year (consisting of at least a total of [***] hours per Calendar Year) of work directly related to the performance of Research Activities in accordance with this Agreement (including the applicable Research Plan) or other activities under this Agreement.
1.102 “FTE Costs” means, with respect to any period during the Research Term, the FTE Rate multiplied by the number of FTEs performing Research Activities during such period in accordance with this Agreement (including the applicable Research Plan).
1.103 “FTE Rate” means [***] per FTE, prorated on a daily basis.
1.104 “Future Upstream License” has the meaning set forth in Section 3.6.3(a).
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