European Core Territory definition

European Core Territory means [***].

Examples of European Core Territory in a sentence

  • 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 Major EU Country means France, Germany, Italy, Spain or 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.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • 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.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

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

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • 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.