Major EU Market Countries definition

Major EU Market Countries means [*].
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Major EU Market Countries means the following countries: [***].
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Major EU Market Countries means Germany, the United Kingdom, Spain, Italy and France.
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Examples of Major EU Market Countries in a sentence

  • On a Licensed Product-by-Licensed Product basis Juno shall have the right, exercisable upon written notice to Celgene at any time prior to, or within [***] for such Licensed Product, to elect to exercise a Commercialization Opt-In Right and provide [***] of the Commercialization Activities for such Licensed Product in the Major EU Market Countries.


More Definitions of Major EU Market Countries

Major EU Market Countries means [**].
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Major EU Market Countries means [*]. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to rule 24b-2 of the Securities Exchange Act of 1934, as amended. CONFIDENTIAL
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Major EU Market Countries means [*].[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities andExchange Commission pursuant to rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Sample 1

Related to Major EU 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 EU Country means one or more of the following countries within the European Union: France, Germany, Italy, Spain and the United Kingdom.

  • Major European Countries means 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 the [***].

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

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

  • 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.

  • 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.

  • Selected Countries the jurisdictions listed on Appendix C as such may be amended from time to time in accordance with Article II.

  • 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.

  • Designated country end product means a WTO GPA country end product, a Free Trade Agreement country end product, a least developed country end product, or a Caribbean Basin country end product.

  • 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.

  • EU GDPR means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC.

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

  • WTO GPA country end product means an article that—

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • customs territory means the territory of the country of each Contracting Party in which the Customs laws of that country are in force;

  • 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.

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

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

  • Host Country means, with respect to an Insured Person, the country or territory the Insured Person is visiting or in which the Insured Person is living, which is not the Insured Person’s Home Country.

  • Orange Book means the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, as may be amended from time to time.

  • Initial Indication means the treatment of Netherton Syndrome in humans in the Territory.