“Environmental Permits” means any permit, registration, license or other authorization required under any applicable Environmental Law.
“Equity Award” means, collectively, all RSU Awards, PSU Awards, Company Options and Company Restricted Stock Awards.
“Equity Award Consideration” means the RSU Consideration, the PSU Consideration, the Option Consideration and the Restricted Stock Consideration.
“ERISA Affiliate” means any entity that, together with another entity, would be treated as a single employer under Section 414(b), (c), (m) or (o) of the Code or Section 4001 of ERISA.
“Exchange Act” means the Securities Exchange Act of 1934 and the rules and regulations promulgated thereunder.
“Excluded Shares” means all Shares canceled pursuant to Section 2.01(a)(ii) and Dissenting Shares.
“FDA” means the United States Food and Drug Administration, or any successor agency thereto, having the administrative authority to regulate the marketing of human pharmaceutical products or biological therapeutic products, delivery systems and devices in the United States of America.
“FTC” means the Federal Trade Commission.
“GAAP” means generally accepted accounting principles as applied in the United States.
“Generative AI” means generative AI Technology or similar tools capable of automatically producing various types of content (such as source code, text, images, audio and synthetic data) based on user-supplied prompts.
“Global Trade Control Laws” means (a) all Laws imposing trade and economic sanctions on any person, including all sanctions Laws or embargos imposed or administered by the U.S. Department of the Treasury’s Office of Foreign Assets Control (“OFAC”), the U.S. Department of State, the United Nations Security Council, the European Union or any member state thereof, and His Majesty’s Treasury, (b) all anti-boycott Laws administered by the U.S. Department of State, the U.S. Department of Commerce or the U.S. Department of the Treasury and (c) all Laws relating to the import, export, deemed export, re-export, deemed re-export or transfer of information, data, goods, software and technology, including the Export Administration Regulations administered by the U.S. Department of Commerce’s Bureau of Industry and Security (“BIS”), the International Traffic in Arms Regulations administered by the U.S. Department of State, the export control Laws and regulations of the European Union or any member state thereof and the United Kingdom, and customs and import Laws administered by U.S. Customs and Border Protection.
“Good Clinical Practices” means the FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in 21 C.F.R. Parts 50, 54, 56 and 812, and equivalent foreign Laws to which the Company or any Company Subsidiary is subject.
“Governmental Entity” means any United States or foreign national, federal, state, county, municipal or local government, or other governmental or regulatory body, including any Notified Body, or political subdivision thereof, and any entity exercising executive, legislative, judicial, regulatory, taxing or administrative functions of or pertaining to government.
“Hazardous Substances” means any substance, material, chemical or waste that is defined as or included in the definition of “hazardous substance,” “hazardous waste,” “hazardous material,” “toxic substance,” “pollutant” or “contaminant” under any Environmental Law, including petroleum, asbestos, radioactive materials and polychlorinated biphenyls.
“Healthcare Law” means any Law to the extent applicable to the Company or any Company Subsidiary relating to the procurement, research, development, testing, manufacture, production, use, sale, marketing, promotion, advertising, processing, packaging, labeling, distribution, storage, importation, exportation, or safety surveillance and reporting of drugs, biologics, diagnostic tests, medical devices, combination products, chemical and biological materials any other healthcare or life sciences items or services, or any instruments or tools used in connection with any of the foregoing, or relating to the operation of clinical and research laboratories of any of the foregoing, including: (a) U.S. Federal Food, Drug and Cosmetic Act, the U.S. Public Health Service Act, and their respective implementing regulations, current Good Clinical Practices, Good Laboratory Practice Requirements, Good Manufacturing Practices and any foreign equivalents of the foregoing; (b) Clinical Laboratory Improvement Amendments of 1988 and its
