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.
Sample 1Sample 2Sample 3
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

  • In the event the Territorial Commercial Lead shall so elect, the Territorial Commercial Lead shall determine the strategy and the other Party shall reasonably assist and co-operate in any such enforcement or defence.

  • 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.

  • The Territorial Commercial Lead may determine that the services of a Third Party are required or desirable to Commercialise an Antibody Product in any country in its Lead Territory.

  • 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.

  • For the avoidance of doubt, each budget prepared by a Territorial Commercial Lead will be provided to the Joint Commercialisation Committee for its information but not for its approval.

  • Publications or presentations to the extent relating to Marketing Clinical Studies shall be determined by the Territorial Commercial Lead that conducted such Marketing Clinical Studies, having considered the comments of the other Party.

  • 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.

  • 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.

  • If the Territorial Commercial Lead shall decide not to defend such an action, the other Party, to the extent it is named, may defend any such claim or action.

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

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;

  • developing country means a country which is for the time being regarded as such in conformity with the practice of the General Assembly of the United Nations;

  • 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 an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • 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.

  • 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, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

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

  • Commercial applicator means any person, unless exempted in I(4) hereunder, whether or not the person is a private applicator with respect to some uses, who:

  • 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).