“Projections” means the model delivered by the Borrower as of June 14, 2022 (as adjusted for changes reasonably agreed with the Administrative Agent).
“Proposed Change” has the meaning set forth in Section 9.02(b).
“Public Health Laws” means any and all federal, state, local, foreign and international laws and any and all standards incorporated therein by reference, where compliance with such standards is required under such laws, relating to the procurement, development, manufacture, production, analysis, evaluation, distribution, dispensing, administration, importation, exportation, use, handling, quality, sale, pricing, reimbursement, or promotion of any food, drug, biological, gene therapy product, medical device, tissue- or cell-based product, or similar product (including any ingredient or component of such products) or of any other product or activity subject to regulation under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, the Controlled Substances Act, or similar federal, state, local, foreign and international law (including laws governing controlled substances, pharmacy, wholesale and other distribution activities, research animal welfare, poison prevention packaging, tamper resistant packaging and consumer product safety). Without limiting the generality of the foregoing, Public Health Laws shall include the federal Food, Drug and Cosmetic Act, 21. U.S.C. § 301 et seq., and implementing regulations, all legally binding ethical standards relating to human subject research and clinical trials, including without limitation the Federal Policy for the Protection of Human Subjects, 45 C.F.R. part 46, and all other related state, local and foreign laws.
“Public Health Regulatory Agency” means an authority or agency responsible for the implementation of a Public Health Law. The term Public Health Regulatory Agency includes, without limitation, the U.S. Food and Drug Administration, the European Commission, the European Medicines Agency and any national competent regulatory authority in the European Union.
“Qualified Equity Interests” means any Equity Interests that are not Disqualified Equity Interests.
“Recipient” (a) the Administrative Agent, (b) the Collateral Agent and (c) any Lender, as applicable.
“Refinanced Term Loans” has the meaning set forth in 9.02(c).
“Register” has the meaning set forth in Section 9.04(d).
“Registrations” means authorizations, approvals, licenses, permits, certificates, or exemptions issued by any Governmental Authority (including pre-market approval applications, pre market notifications, investigational drug or device exemptions, product recertifications, manufacturing approvals and authorizations, third party certification, pricing and reimbursement approvals, labeling approvals or their foreign equivalent) that are required under the applicable laws for the research, development, manufacture, distribution, marketing, storage, transportation, use and sale of the products of the Borrower and its Subsidiaries.
“Related Parties” means, with respect to any specified Person, such Person’s Affiliates and the respective principals, directors, officers, employees, representatives, agents and third party advisors of such Person and such Person’s Affiliates.
“Release” means any release, spill, emission, leaking, dumping, injection, pouring, deposit, disposal, discharge, dispersal, leaching or migration into or through the environment or within or upon any building, structure, facility or fixture.
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