equivalent Governmental Entity to the Group Companies (including investigational device exemptions, device premarket approvals, devicepre-market clearances, establishment registrations and product listings, manufacturing, distribution or wholesaling approvals and authorizations, labeling approvals, or their foreign equivalents), that are required for the research, development, testing, manufacture, distribution, importation, exportation, licensing, marketing, processing, storage, transportation, use, promoting or sale of the Group Companies’ products or components thereof, including any authorizations, applications, approvals, clearances, licenses, permits, certificates or exemptions held by a third party contract manufacturer or development partner that are intended to be transferred to the Group Companies pursuant to a Contract between any third party and the Group Companies.
“Device Regulatory Laws” means the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq. and all other applicable Laws (domestic or foreign) relating to the procurement, design, research, development, testing, studying, manufacture, production, processing or handling, storage, distribution, importation, exportation, licensing, labeling or packaging, advertising, use, quality, sale, marketing or promotion of medical device products (including any component of the foregoing products) of the Group Companies, including any implementing regulations of each such Law promulgated under Title 21, Code of Federal Regulations, and analogous state laws and regulations, consumer product safety laws or analogous Laws of other Governmental Entities.
“Encumbrance” means any lease, pledge, option, easement, deed of trust, right of way, encroachment, conditional sales agreement, security interest, mortgage, adverse claim, encumbrance, covenant, condition, restriction of record, title defect, charge or restriction of any kind (except for restrictions on transfer under the Securities Act and other applicable securities laws), including any restriction on the use, voting, transfer, receipt of income or other exercise of any attributes of ownership, whether voluntarily incurred or arising by operation of Law, and includes any agreement to give any of the foregoing in the future.
“Environmental Claim” means any claim, action, Legal Proceeding, cause of action, investigation or written notice by any Person alleging potential Liability (including potential Liability for investigatory costs, cleanup costs, governmental response costs, natural resources damages, property damages, personal injuries, or penalties) arising out of, based on or resulting from (a) the actual or alleged presence, Release or threatened Release of any Hazardous Materials at any location, whether or not owned or operated by the Company, or (b) any actual or alleged violation of any Environmental Law.
“Environmental Laws” means all federal, state, local and foreign Legal Requirements (including common law) or Orders of any Governmental Entity relating to pollution or protection of human health and safety as it relates to exposure to any Hazardous Substance or the protection, investigation or restoration of the environment, including all those relating to the generation, handling, transportation, treatment, storage, disposal, distribution, labeling, discharge, Release, threatened Release, control, or cleanup of any Hazardous Materials.
“Environmental Permit” means any permit, license, authorization, registration, exemption, exception, certification or other governmental consent required by or from a Governmental Entity under Environmental Laws.
99