Regulatory Territory definition

Regulatory Territory means the United States, the European Union and its member states, Canada and its provinces, Japan, Australia, China, India, Brazil, and Mexico, and such additional countries and/or territories that the Parties agree to include as part of the Regulatory Territory in accordance with Section 3.5.
Sample 1

Examples of Regulatory Territory in a sentence

  • Since the Lookback Date, no member of the Seller Group has received any written communication or notice from any Governmental Entity threatening to withdraw, suspend or modify any Regulatory Approval or Regulatory Approval Application in the Relevant Regulatory Territory.

  • Nicholas Confessore, Cuomo’s Deep Reach Into Regulatory Territory Could Provoke Clash in Albany, N.Y. TIMES Feb.

  • Section ‎2.1.10(j)(iii) of the Disclosure Schedule lists each Regulatory Approval Application relating to a Product in the Relevant Regulatory Territory.

  • Congress Has Not "Explicitly" Acted to Reduce Tribes' Civil Regulatory Territory Under the Hemp Provisions of the 2018 Farm Bill to that of the Criminal Jurisdiction Statute.

  • Section ‎‎2.1.10(j)(ii) of the Disclosure Schedule lists each of the Regulatory Approvals relating to a Product in the Relevant Regulatory Territory.

  • The Exploitation of Products in the Relevant Regulatory Territory, as such Exploitation has been conducted by any member of the Seller Group since the Lookback Date, has been conducted in material compliance with all applicable Health Care Laws and Permits, including the Regulatory Approvals.

  • No member of the Seller Group is in material violation of the terms of any Regulatory Approval or Regulatory Approval Application for the Relevant Regulatory Territory.

  • All Clinical Trials, pre-clinical studies, and post-marketing studies and other post-marketing requirements, testing or investigations conducted by or on behalf of any of Sellers or other members of the Seller Group with regard to a Product in the Relevant Regulatory Territory or the Product are being, or have been, conducted in material compliance with applicable Health Care Laws and Permits, including applicable Regulatory Approvals.

  • All Regulatory Documentation required to be maintained with respect to a Product in the Relevant Regulatory Territory or the Product Business, by Sellers or other members of the Seller Group or filed or furnished to any Governmental Entity thereby or on any of their behalf, has been so maintained, filed or furnished and no material deficiencies have been asserted with regard thereto by a Governmental Entity since the Lookback Date.

Related to Regulatory Territory

  • Licensed Territory means worldwide.

  • Territory means worldwide.

  • 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.

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • 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.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • 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.

  • 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.

  • 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.

  • 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;

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Competing Product means […***…].

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • Traditional Territory means, subject to a Yukon First Nation Final Agreement, with respect to each Yukon First Nation and each Yukon Indian Person enrolled in that Yukon First Nation's Final Agreement, the geographic area within the Yukon identified as that Yukon First Nation's Traditional Territory on the map referred to in 2.9.0.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Licensed Field means all fields of use.

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Licensed Compounds means any EZH2 Compound(s) that is:

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

  • Regulatory Body means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate or investigate the matters dealt with in this Agreement or any other affairs of the Provider or the Department, including, without limitation Ofsted, the European Commission and the European Court of Auditors;

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Competing Products means any product or service in existence or under development that competes with any product or service of the Company Group about which the Participant obtained Confidential Information or for which the Participant provided advisory services or had sales, origination, marketing, production, distribution, research or development responsibilities in the last twenty-four (24) months of employment with the Company Group.