Fraud
means an actual and intentional fraud committed by a Person with
the specific intent to deceive and mislead a party.
GAAP
means United States generally accepted accounting principles.
Government Contract
means any Contract with any United States Governmental Entity.
Governmental Entity
means any foreign or domestic court, arbitrational tribunal, administrative agency or commission or
other governmental or regulatory authority, agency or instrumentality, or any self-regulatory body or organization having authority or jurisdiction over the activities of any party or any Subsidiary of any party.
Hazardous Substance
means: (a) any substance that is regulated or which falls within the definition of a
hazardous substance, hazardous waste or hazardous material pursuant to any Environmental Law or (b) any petroleum product or by-product, asbestos-containing material, polychlorinated biphenyls, radioactive
materials or radon.
Healthcare Laws
means (a) the FDCA (including all applicable registration and listing
requirements set forth in Section 510 of the FDCA (21 U.S.C.A § 360) and 21 C.F.R. Part 807); (b) federal Medicare and Medicaid statutes (Title XVIII and Title XIX of the Social Security Act); (c) Patient Protection and
Affordable Care Act; (d) the Physician Payments Sunshine Act; (e) the federal AntiKickback Statute (42 U.S.C.A § 1320a7b(b)), Stark Law (42 U.S.C.A § 1395nn), False Claims Act (31 U.S.C.A § 3729 et seq.), Health Insurance
Portability and Accountability Act of 1996 (42 U.S.C.A § 1320d et seq.) (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act; (f) state or provincial device licensing, disclosure and reporting
requirements; (g) the Federal Trade Commission Act; and (h) any comparable federal, state, foreign, provincial or local laws for any of the foregoing, in each case as amended.
Healthcare Regulatory Authority
means any federal, national, state, local, foreign or multinational governmental health
regulatory agency or authority with jurisdiction over (a) the research, development, marketing, labeling, sale, distribution, use, handling and control, safety, efficacy, reliability, manufacturing, approval, licensing of any drug or medical
device, (b) healthcare programs under which such products are purchased or (c) the protection of personal health information. References in this Agreement to Healthcare Regulatory Authority shall be deemed to include the EMA and the FDA,
the Centers for Medicare & Medicaid Services, the U.S. Department of Justice, the U.S. 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.
Indemnified Party
means each Person who is now, or has been at any time prior to the date hereof, or who becomes prior to
the Effective Time a director, manager or officer of the Company or any of its Subsidiaries.
Intellectual Property
means (a) patents, patent applications, inventions and invention disclosures, and all related continuations, continuations-in-part, divisionals, reissues, re-examinations, substitutions and extensions thereof, (b) trademarks, service
marks, trade dress, logos, trade names, corporate names, Internet domain names, design rights and other source identifiers, together with the goodwill symbolized by any of the foregoing, (c) copyrightable works and copyrights, (d) trade
secrets, know-how, processes, ideas, formulae, models, schematics, technology, computer software programs, computer applications and methodologies, (e) other tangible or intangible proprietary or confidential information and materials,
(f) all rights in the foregoing and in other similar intangible assets, and (g) all applications and registrations for the foregoing.
Interim Period
means the period commencing on the date hereof and ending on the earlier of (a) June 9, 2018 and
(b) the date the Debt Financing is consummated.
A-56