“Governmental Entity” means any Court, tribunal, arbitrator, Regulatory Authority, agency, commission, department, ministry, official or other instrumentality of the United States or other country, or any supra-national organization, or any foreign or domestic, state, county, city or other political subdivision.
“IND” means (a) an Investigational New Drug Application (as defined in the FDCA and the regulations promulgated thereunder) or any successor application or procedure required to initiate clinical testing of a therapeutic product in humans in the United States, (b) the equivalent of an Investigational New Drug Application that is required in any other country or region before beginning clinical testing of a therapeutic product in humans in such country or region (including any clinical trial authorization (“CTA”) required to initiate clinical testing of a therapeutic product in humans in the United Kingdom), and (c) all supplements and amendments to any of the foregoing.
“Inventory” means all amounts of the Acquired Compound in Seller’s possession and control, which amount is listed in Part 4 of Schedule A attached hereto.
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“Know-How” means, collectively, any knowledge, information, techniques, technology, trade secrets, inventions (whether patentable or not), discoveries, methods, know-how, data and results (including complementarity determining region sequence information and pharmacological and toxicological data and results), analytical and quality control data and results, regulatory filings and underlying data, regulatory documents and correspondence with regulatory agencies, and other information, compositions of matter, cells, cell lines, assays, animal models and other physical, biological, or chemical material.
“Knowledge” means, with respect to Seller, the actual knowledge (after reasonable inquiry of, and consultation with, the relevant persons within Seller and its Affiliates) of the individuals listed on Schedule B attached hereto.
“Law” means any federal, state, local or foreign law, statute, code or ordinance, or any rule or regulation promulgated by any Governmental Entity including all decisions of any Courts having the effect of law in each such jurisdiction.
“Liability” means any and all debts, liabilities and obligations, whether known or unknown, asserted or unasserted, determinable or otherwise, accrued or fixed, absolute or contingent, liquidated or unliquidated, incurred or consequential, or matured or unmatured, including, without limitation, those arising under any Law, Litigation, or Order.
“Litigation” means any suit, action, arbitration, cause of action, claim, complaint, criminal prosecution, investigation, inquiry, demand letter, judicial, arbitration or other administrative proceeding, whether at law or at equity, before or by any Court, Governmental Entity, arbitrator or other tribunal.
“MAA” means any application for Marketing Approval submitted to the EMA pursuant to the centralized approval procedure to obtain European Commission approval for the marketing of a Product in the European Union, or any successor application or procedure required to sell a Product in the European Union.
“Marketing Approval” means, with respect to a Product in a particular jurisdiction, all approvals or authorizations necessary for the commercialization of such Product in such jurisdiction, including, in each case, Pricing Approval.
“MHLW” means the Japanese Ministry of Health, Labour and Welfare or any successor entity or authority thereto.
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