including any Law or Order relating to: (i) the exposure to, or Releases or threatened Releases of, Hazardous Substances; (ii) the generation, manufacture, processing, distribution,
use, treatment, containment, disposal, storage, transport or handling of Hazardous Substances; or (iii) recordkeeping, notification, disclosure and reporting requirements respecting Hazardous Substances.
Environmental Permits
means all Governmental Authorizations relating to or required by Environmental Laws.
ERISA
means the Employee Retirement Income Security Act of 1974, as amended.
ERISA Affiliate
of any entity means each entity that is treated as a single employer with such entity for purposes of
Section 4001(b)(1) of ERISA or Section 414(b), (c), (m) or (o) of the Code.
FDA
means United States Food and Drug
Administration.
FDCA
means United States Food, Drug and Cosmetic Act of 1938, as amended.
GAAP
means generally accepted accounting principles in the United States.
Governmental Authority
means any (i) nation or government, any federal, state, city, town, municipality, county, local
or other political subdivision thereof or thereto and any department, commission, board, bureau, instrumentality, agency, merger control authority, (ii) any federal, state, local or foreign court, tribunal or arbitrator, (iii) any national
securities exchange, or (iv) other governmental entity or quasi-governmental entity created or empowered under a statute (or rule, regulation or ordinance promulgated thereunder) or at the direction of any governmental authority, including
those set forth in clauses (i), (ii) or (iii) of this definition, and that is empowered thereunder or thereby to exercise executive, legislative, judicial, taxing, regulatory or administrative powers or functions of or pertaining to government.
Governmental Authorization
means any license, approvals, clearances, permits, certificates, waivers, amendments,
consents, exemptions, variances, expirations and terminations of any waiting period requirements (including pursuant to Competition Laws), other actions by, and notices, filings, registrations, qualifications, declarations and designations with, and
other authorizations and approvals issued by or obtained from a Governmental Authority, including a Healthcare Regulatory Authority.
Hazardous Substance
means any material, substance, chemical, or waste (or combination thereof) that (i) is listed,
defined, designated, regulated or classified as hazardous, toxic, radioactive, dangerous, a pollutant, a contaminant, petroleum, oil, or words of similar meaning or effect under any Law or Order relating to pollution, waste, the environment, or the
protection of human health and safety; or (ii) can form the basis of any liability under any Law or Order relating to pollution, waste, the environment, or the protection of human health and safety.
Healthcare Regulatory Authority
means any, state, local, federal, national, foreign or multinational governmental health
regulatory agency or authority with jurisdiction over (i) the development, testing, marketing, labeling, sale, use, handling and control, safety, efficacy, reliability, manufacturing, approval, pricing, import, export or licensing of any drug,
device or
over-the-counter
pharmaceutical product, (ii) federal, state, or other government healthcare programs under which such products are purchased or
(iii) the protection of personal health information. For clarity, references in this Agreement to Healthcare Regulatory Authority shall be deemed to include the EMA and the FDA, the Centers for Medicare and Medicaid Services, the United States
Department of Justice, the United States Department of Health and Human Services, Office of Civil Rights, and the Federal Trade Commission and their equivalent foreign entities.
HSR Act
means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations
promulgated thereunder.
Intellectual Property Rights
means any and all intellectual property rights or similar
proprietary rights throughout the world, including all (i) patents, trademarks, service marks, trade names, domain names, copyrights, designs and trade secrets, (ii) applications for and registrations of patents, trademarks, service marks,
trade dress, trade names, domain names, social media addresses, copyrights and designs, (iii) processes, formulae, methods, schematics, technology,
know-how,
data, computer software programs and
applications, and (iv) trade secrets and other tangible or intangible proprietary or confidential information and materials.
Intervening Event
means any material event, occurrence or development that (i) is unknown to the Company Board as of
the date of this Agreement, or if known to the Company Board as of the date of this
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