Territorial Commercial Lead definition

Territorial Commercial Lead means, with respect to a particular country, the Party designated pursuant to Article 5.1 to lead Commercialisation of Antibody Products in such country.
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Territorial Commercial Lead means, with respect to a particular country, the Party designated pursuant to Article 5.1 to lead
Sample 1

Examples of Territorial Commercial Lead in a sentence

  • Each Territorial Commercial Lead shall have the right and responsibility for the filing of a Drug Approval Application in its own name, including the conformation of the data package provided by Amgen to the requirements of each jurisdiction within its Lead Territory and for seeking Regulatory Approvals for such Antibody Products in its Lead Territory.

  • The Territorial Commercial Lead shall keep such records and make such reports as are reasonably necessary to document such communications in compliance with all applicable regulatory requirements.

  • The Country Plan shall be developed to a standard and timing consistent with other products marketed by the Territorial Commercial Lead in that country.

  • The Territorial Commercial Lead shall be responsible for responding to all medical questions or inquiries relating to the Antibody Products sold in countries in its respective Lead Territory, except that the Co-Detailer, in the course of carrying out its activities under Article 5.11(c), may respond to any such question or inquiry which can be answered by reference to the Product Labelling and package insert in the applicable country.

  • In the event of any dispute between the Territorial Commercial Lead and the Co-Detailer on any matter relating to the Commercialisation of an Antibody Product in that country, the Territorial Commercial Lead shall, after taking due consideration of the views expressed by the other Party, determine the resolution of such matter.

  • To the extent permitted by law, as between the Parties, the Territorial Commercial Lead for a country shall have the exclusive right to file for, request and maintain any regulatory exclusivity rights for Antibody Products in such country (including regulatory exclusivity rights based upon an orphan drug designation of an Antibody Product) and to conduct and prosecute any proceedings or actions to enforce such regulatory exclusivity rights.

  • The Territorial Commercial Lead shall, in entering into such agreement, be entitled to grant such Third Party any licences or sublicences to [*] Technology or [*] Technology required by the Third Party solely to Commercialise an Antibody Product in such country.

  • The Territorial Commercial Lead shall have the right to conduct all activities for Marketing Clinical Studies in its Lead Territory.

  • The Territorial Commercial Lead shall designate a medical liaison to whom the Co-Detailer shall instruct its medical affairs group, as well as its sales forces engaged in the Detailing of Antibody Products, to direct medical questions or inquiries relating to the Antibody Products.

  • On an indication-by-indication basis, as reasonably required, each Territorial Commercial Lead shall have the right to monitor, review and direct all aspects of all regulatory matters to the extent the same concern the activities and studies for which it is responsible pursuant to Article 4.1 with respect to each such Antibody Product, including making all strategic and tactical decisions with respect thereto.

Related to Territorial Commercial Lead

  • Territory means worldwide.

  • Union territory means the territory of—

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

  • territorial sea (without more) means the territorial sea adjacent to the Isle of Man;

  • Licensed Territory means worldwide.

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

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

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

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

  • Patent Cooperation Treaty means the Patent Cooperation Treaty done at Washington on June 19, 1970;

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • 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.

  • Commercial domicile means the principal place from which the trade or business of the taxpayer is directed or managed.

  • Planning Application means the application for [outline/full] planning permission dated [ ] bearing the Council’s reference number [ ];

  • taxable territory means the territory to which the provisions of this Act apply;

  • Country means the Islamic Republic of Pakistan.

  • 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.

  • Territories means territories, including territorial waters;

  • Agricultural product means the products listed in Annex I to the Treaty, except fishery and aquaculture products listed in Annex I to Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013;

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

  • territorial waters means territorial waters provided for under section 3 of the Maritime Zones Act;

  • 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.

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

  • Commercial applicator means a person who, by contract or for hire, engages in the

  • Commercial sex act means any sex act on account of which anything of value is given to or received by any person.

  • land development application means the application for a land development permit on a form provided by [local jurisdiction] along with the supporting documentation required in Section [Y]-10(a).