Governmental Authority means any supranational, international, national,
commonwealth, provincial, territorial, county, municipal, district, federal, state or local body or entity exercising executive, legislative, judicial, regulatory, or administrative governmental functions, including any court (or any arbitrator or
other tribunal having competent jurisdiction), administrative agency or commission or other governmental authority, instrumentality, domestic or foreign, or any self-regulated organization or quasi-governmental authority.
Health Care Laws means (a) the FD&C Act and any other applicable Laws in the Territory governing or relating to
good laboratory practices, good clinical practices, recordkeeping, the development, approval, Manufacture, storage, use, sale or distribution of drugs, medical devices or Combination Products (or components or compounds thereof) and the purchase or
prescription of or reimbursement for drugs, medical devices or Combination Products by any Governmental Authority, private health plan or entity, or individual and (b) any Laws in the Territory pertaining to a government sponsored or funded
health care program, including the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment.
HSR Act means the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
IFRS means International Financial Reporting Standards as issued by the International Accounting Standards Board.
Intellectual Property Rights means all (a) Patent Rights, (b) Trademark Rights, (c) Copyrights, (d) Know-How, (e) domain names and social media identifiers (and accounts therefor), and (f) all other intellectual property rights and industrial rights arising in any jurisdiction of the world.
Inventory means the materials or components (including raw materials, intermediates, excipients, active ingredients, bulk
drug product and Product Labeling and packaging materials and components), work-in-process, packaging materials, goods in transit and finished goods inventory with
respect to the Products owned or held by Seller or its Affiliates.
Know-How
means any and all trade secrets, confidential data, technical information, technology, processes, techniques, inventions, assays, data, know-how and other proprietary information, including specifications,
formulations, methods, techniques, manufacturing processes, chemical or biological manufacturing control data, quality control and testing procedures, clinical data, and customer and supplier lists.
Later Purchased Inventory means the Purchased Inventory (as such term is defined in the Transition Agreement) sold by
Seller or any of its Affiliates and purchased by Buyer or any of its Affiliates pursuant to Section 2.9.2(b) of the Transition Agreement.
Law means any domestic or foreign, federal, state or local statute, law, treaty, ordinance, rule, administrative
interpretation, regulation, Order or other requirement having the force and effect of law of any Governmental Authority.
Liabilities means any obligations, debts, liabilities, Losses, claims, complaints or commitments of any kind, whether
accrued or unaccrued, matured or unmatured, known or unknown, asserted or unasserted, fixed or contingent, determined or determinable, and whether or not the same would be required to be reflected in financial statements or disclosed in the notes
thereto.
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