European Core Territory definition

European Core Territory means [***].
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Examples of European Core Territory in a sentence

  • 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.

  • In accordance with Section 4.9.3, the Parties agree that pre-filled syringe Licensed Products (the “Pre-filled Syringe”) will be Developed for obtaining Marketing Approval in the U.S. and the European Core Territory.

  • KHK shall be responsible for performing (i) CMC activities including manufacturing, stability, tech transfer and lab study, and (ii) clinical and regulatory activities necessary to obtain the regulatory approval for the Pre-filled Syringe in the European Core Territory, in accordance with the attached Exhibit A.

Related to European Core Territory

  • Major European Countries means France, Germany, Italy, Spain and the United Kingdom.

  • Major European Country means any of France, Germany, Italy, Spain or the United Kingdom.

  • 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 authority within the European Union that has the legal authority to grant Regulatory Approvals in the European Union based on input received from the EMA or other competent Regulatory Authorities.

  • 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 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 that is a member of the grouping of countries that are full members of the Organization of 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 human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • 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.