Health Care Programs means the Medicare program, any state Medicaid
program, TRICARE, any heath care program of the Department of Veterans Affairs, the Maternal and Child Health Services Block Grant Program, any federally-funded state social services block grant program, the State Childrens Health Insurance
Program, or any similar U.S. or foreign programs.
Health Care Regulatory Laws means any applicable law relating to
healthcare, including, without limitation the following (as amended from time to time), (i) the Federal Food, Drug, and Cosmetic Act of 1938, as amended (21 U.S.C. § 301 et seq.), and (ii) the Public Health Service Act (42 U.S.C. §
201 et seq.), and all regulations promulgated thereunder (including, but not limited to, 21 C.F.R. Part 1271).
HIPAA
means the security and privacy standards adopted pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), as amended, and
implementing regulations.
HSR Act means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
IEC means an independent ethics committee.
Information Privacy and Security Laws means all applicable laws concerning the privacy, data protection, transfer, or
security of Personal Confidential Information, including, to the extent applicable, the Fair Credit Reporting Act, Federal Trade Commission Act, CAN SPAM Act, Telephone Consumer Protection Act, Telemarketing and Consumer Fraud and Abuse Prevention
Act, Childrens Online Privacy Protection Act, the Payment Card Industry Data Security Standards, the guidance of each Governmental Entity that pertains to such laws, the General Data Protection Regulation (EU), other state, and federal, data
security laws, data breach notification laws, and consumer protection laws.
Insider means any individual who is an
officer, director or employee of the Company or any of its Subsidiaries.
Insurance Policies means all material
insurance policies and material fidelity and surety bonds covering the assets, business, equipment, properties, operations, employees, officers and directors.
Intellectual Property Rights means any or all of the following and all worldwide common law and statutory rights in,
arising out of, or associated therewith: (i) Patents; (ii) inventions (whether patentable or not), invention disclosures, improvements, trade secrets, proprietary information, know how, technology, technical data and customer lists, and
all documentation relating to any of the foregoing; (iii) Copyrights; (iv) software and software programs; (v) domain names, uniform resource locators and other names and locators associated with the internet or mobile devices or
platforms; (vi) industrial designs and any registrations and applications therefor; (vii) Trademarks; (viii) all databases and data collections and all rights therein; (ix) all moral and economic rights of authors and inventors,
however denominated, (x) all rights to obtain renewals, continuations, divisions, or other extensions of legal protections pertaining thereto, and (xi) any similar or equivalent rights to any of the foregoing (as applicable).
IRB means an institutional review board.
knowledge means actual knowledge or awareness as to a specified fact or event (i) in the case of the Company, of
Jonathan Javitt or Brian Del Buono, and (ii) in the case of BRPA or Merger Sub, Richard Ackerman, Bennett Kim, or Lori Wittman.
Legal Requirements means any federal, state, local, municipal, foreign or other law, statute, constitution, principle of
common law, resolution, ordinance, code, edict, decree, rule, regulation, ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Entity, including but not
limited to, the Securities Act, Exchange Act, rules and regulations of the
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