Territory Sponsor definition

Territory Sponsor means, with respect to a Territory-Specific Clinical Trial or a Global Clinical Trial for the Licensed Product to be conducted at sites in the Territory, the Party that holds the IND from the applicable Regulatory Authority in the Territory for such Clinical Trial in its name.
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Examples of Territory Sponsor in a sentence

  • If Partner (either itself or through its Affiliate) elects to serve as the Territory Sponsor or regulatory agent in the Territory for, and enroll and treat patients in, any such Global Clinical Trials for a New Development, then such Partner activities will be added to the Global Development Plan and submitted to the JSC for approval in accordance with Section 5.3 (Global Development Plan).

  • Subject to this Section 6.2.1(b) (Other Regulatory Approvals), for each Indication that is included in the Territory Development Plan or for which Partner is the Territory Sponsor under a Global Development Plan for a Licensed Product, Partner will be [***] and will be responsible for all regulatory activities leading up to and including obtaining, and thereafter maintaining, Regulatory Approvals and any Reimbursement Approvals in all countries and regions of the Territory, [***].

  • Efficient and wider public procurement and distribution of essential drugs can circumvent the challenges arising from the distribution chain, supplant suboptimal regulatory instruments suchas price control and allow for access to essential medicines at lower prices.

  • Except as otherwise set forth in the Ongoing Business Agreements, during the Restricted Period, Seller will not, directly or indirectly, in whole or in part, either alone, together or with others, do any of the following within the Restricted Territory: Sponsor or Conduct, or support, aid, help or otherwise assist any third party to Sponsor or Conduct, Professional Drag Racing, except to the extent required to fulfill its obligations to Buyer under the Ongoing Business Agreements.

  • Partner will be responsible for: (a) reporting to the applicable Regulatory Authorities in the Territory all quality complaints, adverse events, and safety data related to such Licensed Product for all Territory-Specific Clinical Trials, or Global Clinical Trials conducted in the Territory and for which Partner is Territory Sponsor; and (b) responding to safety issues and to all requests of Regulatory Authorities related to such Licensed Product in the Territory.

  • Table 2-5: Completed Mystery Shopping Calls by Sponsor Territory Sponsor 2.3.3 Craigslist Sample and MethodologyCadmus reviewed all Massachusetts14 ads for full-sized15 refrigerators or freezers posted on Craigslist over a one week period, from October 29th through November 5th.

  • During the Term of this Agreement and in the Territory, Sponsor shall be permitted to utilize Influencer's name, image, voice, endorsement, signature or biographical material (collectively, “Influencer’s Likeness”) in conjunction with the advertisement or marketing of the Event itself, in any and all media, including Sponsor digital platforms, without any review or approval.

Related to Territory Sponsor

  • EMEA means the European Medicines Agency.

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • Marketing Plan means a plan or system concerning a material aspect of conducting business. Indicia of a marketing plan include any of the following:

  • Union territory tax means the Union territory goods and services tax levied under the Union Territory Goods and Services Tax Act;

  • EMA means the European Medicines Agency or any successor agency thereto.

  • 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.

  • Territory means worldwide.

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • Drug Master File or “DMF” is described in 21 C.F.R. Part 314.420. A DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

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

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • 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).

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

  • WTO GPA country end product means an article that—

  • Wholesale drug distributor means anyone engaged in the

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • 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.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • 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.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.

  • local planning authority in relation to an area means⎯

  • Clinical peer means a physician or other health care professional who holds a non-restricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review.

  • Power production activities means any business operation that involves a project commissioned by the government of Iran whose purpose is to facilitate power generation and delivery, including, but not limited to, establishing power-generating plants or hydroelectric dams, selling or installing components for the project, providing service contracts related to the installation or maintenance of the project, as well as facilitating such activities, including by providing supplies or services in support of such activities.

  • Elan means Elan Corp and its Affiliates.