Major Markets means [***].
Major European Country means any of France, Germany, Italy, Spain or the United Kingdom.
Major European Countries means France, Germany, Italy, Spain and the United Kingdom.
Major EU Country Major EU Country means France, Germany, Italy, Spain or the United Kingdom.
Major Market means any one of the following countries: United States, Japan, the United Kingdom, France, Germany, Italy or Spain.
Major Market Country means each of the United States, Japan, France, Germany, Italy, Spain and the United Kingdom.
Major Market Countries means the United States, Japan, England, Germany, France, Italy and Spain.
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.
European Community means the territory comprised by the Member States of the European Community as constituted from time to time;
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.
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.
EU means the European Union.
European Communities means the European Economic Community, the European Coal and Steel Community and the European Atomic Energy Community.
Treaty on European Union means the Treaty of Rome of March 25, 1957, as amended by the Single Xxxxxxxx Xxx 0000 and the Maastricht Treaty (which was signed at Maastricht on February 1, 1992 and came into force on November 1, 1993), as amended from time to time.
Major Country means the United States, Japan, France, Germany, Italy, Spain, and the United Kingdom.
Major Countries means Canada, France, Germany, Italy, Japan, Spain, United Kingdom and the United States.
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.
European Monetary System means the European Monetary System established by the Resolution of December 5, 1978 of the Council of the European Communities.
customs territory means the territory of the country of each Contracting Party in which the Customs laws of that country are in force;
Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;
Website of the European Central Bank means the website of the European Central Bank currently at http://www.ecb.europa.eu or any successor website officially designated by the European Central Bank.
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.
MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.
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 diet means meals served that are soft, low-fat, low-sodium or controlled calorie.
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.