Government Official has the meaning set forth in Section 3.23(a).
Governmental Authority means (a) any government, (b) any governmental or regulatory entity, body, department, commission, subdivision, board, legislative body, administrative agency or instrumentality, (c) any court, tribunal, judicial body, quasi-judicial body, or an arbitrator or arbitration panel, or (d) any quasi-governmental or non-governmental self-regulatory agency, notified body, securities exchange, commission or authority, in each of the foregoing clauses (a) through (d), whether supranational, national, federal, state, county, municipal, provincial or designated by any of the foregoing, and whether local or foreign. The foregoing includes the FDA, HHS, or any successor agency thereto, applicable IRBs, and any other Regulatory Authority in any jurisdiction worldwide.
Grant Date has the meaning set forth in Section 3.16(l)(i).
Guaranteed Obligations has the meaning set forth in Section 12.16.
Guarantor has the meaning set forth in the preamble hereto.
Hazardous Material means (a) radioactive materials or wastes, petroleum (including crude oil or any fraction thereof and its byproducts and distillates), asbestos or asbestos-containing materials, urea formaldehyde foam insulation, per- or polyfluoroalkyl substances and polychlorinated biphenyls, or (b) any other materials, substances or wastes regulated pursuant to or which could give rise to liability under any applicable Environmental Law.
HCP means any Person (a) qualified to prescribe, administer, use or supply any medicinal or medical products or (b) perform any professional medical, laboratory, research, nursing, phlebotomy, behavioral health, or other clinical services; the foregoing to include any investigator, physician, pharmacist, registered nurse, licensed practical nurse, advanced practice nurse, nurse practitioner, certified registered nurse practitioner, physician assistant, therapist, mental health coach or other health care provider or practitioner, including any key opinion leaders.
Health Benefit Laws means Laws relating to the enrollment, participation, licensure, certification, accreditation, qualification or authority to transact business relating to the provision of, or payment for, or both the provision of and payment for, health benefits, health care or insurance coverage.
Health Compliance Laws means, collectively, all Laws that regulate medical devices and other medical products, including those related to Development, Manufacturing and Commercialization activities and interactions with health-care professionals (HCPs), including, as applicable, the following: (a) the FDCA, (b) Medicare (Title XVIII of the Social Security Act) and Medicaid (Title XIX of the Social Security Act), (c) the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), (d) the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), (e) the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), (f) the exclusion laws (42 U.S.C. 1320a-7), (f) the Ethics in Patient Referrals Act (42 U.S.C. § 1395nn), (g) the PPACA, (h) the federal Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), (i) GMP, (j) the FDA regulations set forth at 21 C.F.R. Part 11, (k) all Laws governing the collection, processing, retention, use, disclosure, access, transfer or destruction of information that identifies or could reasonably be used to identify an individual, (l) the Health Insurance