1.20 Existing Confidentiality Agreement means that certain Confidentiality Agreement by and between Mirum and Shire Human Genetic Therapies, dated as of May 2, 2018, as amended August 8, 2018.
1.21 FDA means the U.S. Food and Drug Administration, and any successor thereto.
1.22 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).
1.23 Field means any therapeutic or prophylactic application in human (but not animal) health.
1.24 First Commercial Sale means, with respect to a Licensed Product in a particular country, the first commercial sale of such Licensed Product in such country after Regulatory Approval has been obtained in such country.
1.25 GAAP means U.S. generally accepted accounting principles consistently applied.
1.26 Generic Product means, with respect to a Licensed Product being sold by Mirum or its Affiliates or their sublicensees, as applicable, any product containing the same Compound as such Licensed Product (and the same Other Active Ingredient(s), as applicable, in the case of a Combination Product), which is marketed by an entity other than Mirum and its Affiliates or their sublicensees in the Field. A Licensed Product licensed or produced by Mirum, its Affiliates or their respective sublicensees (i.e., an authorized generic product) will not constitute a Generic Product.
1.27 Governmental Authority means any multi-national, federal, state, local, municipal, provincial or other government authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).
1.28 Indication means any disease or condition which could be listed under the header INDICATIONS AND USAGE or a subset of any disease or condition which could be listed under the header INDICATIONS AND USAGE of a Licensed Products label upon Regulatory Approval in the U.S., or equivalent thereof in or outside the U.S.
1.29 Information means all information, techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, know-how, skill, experience, data, specifications, results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms.
1.30 Initiation of a clinical trial (including a Phase 2 Clinical Trial and a Phase 3 Clinical Trial) means the first randomization of a subject enrolled in such clinical trial.