control (including the terms controlled
by and under common control with) means the possession, directly or indirectly, or as trustee or executor, of the power to direct or cause the direction of the management and policies of a person, whether through the
ownership of voting securities, as trustee or executor, by Contract or credit arrangement or otherwise.
Convertible Debentures means the Companys 6.0% Convertible Debentures, due August 12, 2026.
COVID-19 means the SARS-CoV-2 or COVID-19 virus and any evolutions or mutations thereof.
COVID-19 Measure means any quarantine, shelter in place,
stay at home, workforce reduction, social distancing, shutdown, closure, sequester, safety or similar Law, judgment, guideline or recommendation promulgated by any Governmental Authority, including the Centers for Disease Control and
Prevention and the World Health Organization, in each case, in connection with or in response to COVID-19.
Device Regulatory Laws means Laws administered by the FDA relating to the regulation of the procurement,
design, research, development, testing, studying, manufacturing, quality, licensing, production, processing, handling, packaging, labeling, storage, advertising, use, promotion, marketing, importation, exportation, sale and distribution of medical
devices or components thereof, and any analogous applicable Laws of any applicable State or jurisdiction, but excluding Healthcare Laws.
Exclusively Licensed Intellectual Property means all Licensed Intellectual Property that is granted on an
exclusive basis to any member of the Company Group.
ERISA means the Employee Retirement Income Security
Act of 1974, as amended.
ERISA Affiliate means any corporation or trade or business under common
control with the Company as determined under Sections 414(b), (c), (m) or (o) of the Code.
FCPA means the Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations thereunder.
FDA means the United States Food and Drug Administration, or any successor agency thereto having the
administrative authority to regulate the marketing of human pharmaceutical products or biological therapeutic products, delivery systems and devices in the United States of America.
FDCA means the Federal Food, Drug, and Cosmetic Act, at 21 U.S.C. §§ 301 et.
seq. and its implementing regulations and guidance.
Foreign Investment Law means any Laws
that are designed to prohibit, restrict or regulate foreign investment.
Good Clinical Practices means
the FDAs standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials contained in 21 C.F.R. Parts 50, 54, 56 and 812.
Healthcare Laws means all foreign, federal, state, and local Laws relating to the regulation,
provision or administration of, or billing or payment for, healthcare products or services, whether criminal or civil, including: (a) federal Laws relating to the Medicare and Medicaid programs and any other federal healthcare programs;
(b) federal and state Laws relating to healthcare fraud and abuse, including the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the federal False Claims Act (31 U.S.C.
§§ 3729 et. seq.), the federal Stark Law (42 U.S.C. § 1395nn), the federal False Statements Statute (42 U.S.C. § 1320a-7b(a)), the
Exclusion Requirements of Laws (42 U.S.C. § 1320a-7), the Beneficiary Inducement Statute (42 U.S.C. § 1320a-7a(a)(5)), the Civil Monetary
Penalties Law (42 U.S.C. § 1320a-7a and § 1320a-7b) and the Federal Program Fraud Civil Remedies Act (31 U.S.C. § 3801
et. seq.); (c) the federal Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the regulations implemented thereunder and similar state Laws; (d) state
Laws relating to Medicaid or any other state healthcare or health insurance programs; (e) federal or state Laws relating to billing or claims for reimbursement submitted to any government or third-party payor; (f) any
A-53