Subject to the terms of this Agreement, in the event a first European Centralized Approval is not obtained in the European Core Territory for the First Indication by December 31, 2019“ European Marketing Approval”), KHK may terminate this Agreement solely with respect to the European Territory by providing Notice to UGNX within thirty (30) days following the expiration of such deadline.
Major European Countries means France, Germany, Italy, Spain and the United Kingdom.
Major European Country means the United Kingdom, France, Germany, Spain or Italy.
European Community means the territory comprised by the Member States of the European Community as constituted from time to time;
EU means the European Union.
U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.
European Commission means the European Commission or any successor entity that is responsible for granting Marketing Approvals authorizing the sale of pharmaceuticals in the European Union.
medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;
Major EU Country means one or more of the following countries within the European Union: France, Germany, Italy, Spain and the United Kingdom.
European Communities means the European Economic Community, the European Coal and Steel Community and the European Atomic Energy Community.
Territory means worldwide.
Relevant Territory means Hong Kong or such other territory as the Directors may from time to time decide if the issued ordinary share capital of the Company is listed on a stock exchange in such territory;
customs territory means the territory of the country of each Contracting Party in which the Customs laws of that country are in force;
the Territory means the sub-Saharan Continent, south of the 15N latitude.
Major Market Countries means the United States, Japan, England, Germany, France, Italy and Spain.
Union territory means the territory of—
Licensed Territory means worldwide.
OECD Country means a country which is a member of the Organization for Economic Cooperation and Development.
Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.
European Union means the member nations of the European Union established by the Treaty of European Union, signed at Maastricht on February 2, 1992, which amended the Treaty of Rome establishing the European Community.
Civil Aeronautical Product means any civil aircraft, aircraft engine, or propeller or subassembly, appliance, material, part, or component to be installed thereon.
Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.
CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.
Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.
Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.
Service Territory means the geographic area within which PG&E as a Utility Distribution Company is authorized and required to provide electric transmission and distribution service.
Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.