definiens: shall mean : ( i ) the FDCA ; ( ii ) the PHSA ; ( iii ) federal Medicare and Medicaid statutes and relatedstate or local statutes ; ( iv ) state or provincial formulary and drug pricing statutes ; ( v ) any comparable foreign Laws forany of the foregoing applicable in jurisdictions in which material quantities of any of the Company Products are sold orintended by the Company to be sold ; ( vi ) federal, state or provincial criminal or civil Laws ( including the federal Anti - Kickback Statute ( 42 U.S.C. § 1320a-7(b ) ), Stark Law ( 42 U.S.C. § 1395nn ), False Claims Act ( 42 U.S.C. § 1320a-7b(a ) ), Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. § 1320d et seq . ), as amended by theHealth Information Technology for Economic and Clinical Health Act, and any comparable federal, state, provincial or 30 local Laws ) ; ( vii ) state or provincial licensing, disclosure and reporting requirements ; and ( viii ) the rules and regulationspromulgated pursuant to all such applicable Laws, each as amended from time to time . All pre - clinical and clinicalinvestigations in respect of a Company Product conducted or sponsored by each of the Company and the CompanySubsidiaries, and submitted or intended to be submitted to any Company Regulatory Agency as a basis for productapproval, are being and have been conducted in material compliance with all applicable Laws administered or issuedby the applicable Company Regulatory Agencies, including ( i ) FDA regulations for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314and 320 of the Code of Federal Regulations, ( ii ) any applicable federal, state and provincial Laws restricting thecollection, use and disclosure of individually identifiable health information and personal information