FDC Act means the U.S. Federal Food, Drug, and Cosmetic Act (21 U.S.C.
§§ 301 et seq.), as amended.
GAAP means generally accepted accounting principles in the U.S., consistently
applied.
Governmental Authority means any government, court, regulatory or administrative agency, enforcement agency,
commission or authority, governmental instrumentality, body, board, department, standard setting organization, supervisory or disciplinary body, or other legislative, executive or judicial governmental entity (in each case including any
self-regulatory organization), whether federal, regional, state, provincial, local, domestic, foreign or multinational, including any multinational authority that have governmental or quasi-governmental powers, or any other industry self-regulatory
authority (including any securities exchange). For the EU, this shall include Notified Bodies, understood as the organizations that have been appointed by competent authorities of EU Member States to conduct conformity assessment procedures for the
CE marking of medical devices.
Hazardous Substances means any substance, material or waste (regardless of physical
form or concentration) defined, listed, restricted or otherwise regulated, or that forms the basis of liability, under Environmental Laws, and includes petroleum (or any fraction thereof), asbestos or asbestos-containing materials, toxic mold,
polychlorinated biphenyls, per- and polyfluoroalkyl substances (PFAS), 1,4-dioxane, medical wastes, infectious substances, and radioactive materials.
Health Care Laws means all Laws, if and to the extent applicable to the Company and its Subsidiaries, relating in any
way to: (a) the study, design, development, testing, manufacture, processing, labeling, supply, sale, advertising, labeling, packaging, marketing, promoting, commercializing, distribution, import, export, storage, service, record keeping,
traceability, training, reporting (including medical device reporting, adverse event and incident reporting, field alert reporting, and any other reporting required by applicable Laws), handling, provision, or payment for, health care services,
equipment, supplies, materials, Medical Devices, biologics, combination products, or precursors, ingredients, or components of Medical Devices, biologics, combination products, Products, goods, or services related to the Company or its Subsidiaries;
(b) required Health Care Permits; (c) quality, safety certification, and accreditation standards and requirements related to the study, design, development, testing, manufacture, processing, labeling, supply, sale, advertising, promoting,
labeling, packaging, marketing, commercializing, distribution, import, export, storage, service, handling, provision, or payment for health care services, equipment, supplies, materials, Medical Devices, biologics, precursors, ingredients, or
components of Medical Devices, biologics, combination products, Products, goods, or services related to the Company or its Subsidiaries; (d) the Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and its implementing regulations,
including those relating to the study, design, development, testing, manufacture, processing, labeling, supply, sale, advertising, labeling, packaging, marketing, promotion, commercializing, distribution, import, export, storage, service, handling,
provision, or payment for health care services, equipment, supplies,
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