1.39 First Commercial Sale means the first invoice for commercial quantities of any Product sold to a Third Party by a member of the BI Group and/or sublicensees in any country after receipt of Marketing Authorization Approval for such Product in such country. Sales for test marketing, sampling and promotional uses, clinical trial purposes or compassionate or similar uses shall not be considered to constitute a First Commercial Sale.
1.40 Force Majeure Event shall have the meaning assigned thereto in Section 15.6.
1.41 FTE means a full-time equivalent person-year based upon a total of **** working hours per year, undertaken in connection with the conduct of Research in accordance with the Research Collaboration.
1.42 Generic Competition shall have the meaning assigned thereto in Section 9.6.5(a).
1.43 Generic Product means, with respect to a particular Product and a particular country, any pharmaceutical product (other than such Product) that contains the same active ingredient(s) as such Product, has substantially the same formulation, mode of administration and duration of release as such Product, and is approved for the same indications as such Product in such country.
1.44 Good Laboratory Practices or GLP means, with respect to the United States, the then-current requirements for non-clinical (animal or laboratory) studies that will be submitted to a Government Authority to support a marketing application, specified in 21 C.F.R. Part 58, as may be amended, and, with respect to any other country or jurisdiction, the equivalent regulations in such other country or jurisdiction.
1.45 Good Manufacturing Practices or GMP means, with respect to the United States, the minimum then-current good manufacturing practices for methods, facilities, and controls to be used for the manufacture, processing, packing, or holding of a drug to assure that it meets the requirements of the Federal Food, Drug, and Cosmetic Act for safety and has the identity and strength and meets the quality and purity characteristics, specified in 21 C.F.R. Parts 210 and 211, as may be amended, and, with respect to any other country or jurisdiction, the equivalent regulations in such other country or jurisdiction.
1.46 Governmental Authority means any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of (i) any government of any country, (ii) a federal, state, province, county, city or other political subdivision thereof or (iii) any supranational body, including, but not limited to, the FDA and EMEA.
1.47 Handelsgesetzbuch or HGB shall have the meaning assigned thereto in Section 1.72.
1.48 Indemnified Party shall have the meaning assigned thereto in Section 12.3.1.
****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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