EU Major Market Countries definition

EU Major Market Countries means France, Germany, Italy, Spain, and the United Kingdom.
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EU Major Market Countries means [***].
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EU Major Market Countries shall have the meaning ascribed to it in the Mundipharma Collaboration Agreement.
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Examples of EU Major Market Countries in a sentence

  • If Novartis commercializes a Licensed Product for a Profile, after receipt of Regulatory Approval therefor, in any of the U.S., Japan or the EU Major Market Countries, Novartis will be deemed to satisfy all diligence obligations with respect to such Profile.

  • Novartis shall dedicate commercially reasonable efforts, during each [**] month period, necessary to commercialize a Licensed Product for a Profile, after receipt of Regulatory Approval therefor, in any of the U.S., Japan or the EU Major Market Countries.

  • The JSC shall meet [**] until Regulatory Approval for a Licensed Product has been obtained in the United States and at least [**] of the EU Major Market Countries, and shall meet [**] thereafter until Regulatory Approval for a Licensed Product has been obtained in all Major Market Countries, and at such other times as the Parties may agree.

Related to EU Major Market Countries

  • Major Market Countries means the United States, Japan, England, Germany, France, Italy and Spain.

  • Major Market Country means each of the United States, Japan, France, Germany, Italy, Spain and the United Kingdom.

  • Major Market means any one of the following countries: United States, Japan, the United Kingdom, France, Germany, Italy or Spain.

  • Major Markets means [***].

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

  • 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.

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

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

  • Licensed Territory means worldwide.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • 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.

  • Major Countries means Canada, France, Germany, Italy, Japan, Spain, United Kingdom and the United States.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • 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.

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

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

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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.

  • 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.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.