Territorial Regulator definition

Territorial Regulator means, with respect to any jurisdiction within the Territory, the agency or organization performing functions and having authority comparable to the functions and authority of the FDA with respect to the authorization of the testing and marketing of medical devices or biological products.
Sample 1Sample 2Sample 3

Examples of Territorial Regulator in a sentence

  • Any proposed design changes or modifications to the Product incorporating any Improvements into the Product may be implemented by the Licensee or Fresenius AG, unless such proposed design changes or modifications may require any new approval of a Territorial Regulator in order for the Product to be marketed as modified, in which case the prior written consent of Licensor shall be required, which may be withheld in Licensor's sole and absolute discretion.

  • Licensor, Licensee and Fresenius AG shall also disclose and make available to each other all information in their possession relating to recalls or other corrective actions either ordered by the FDA or a Territorial Regulator or initiated by Licensor, Licensee or Fresenius AG and which involve the safety or integrity of the Product, as well as all such material information which they may obtain concerning the development by any Third Party of any product that is or could be competitive with the Product.

  • For the avoidance of doubt, Licensor shall have the sole and absolute discretion to decide whether to permit any change or Improvement that may require any new approval of a Territorial Regulator in order for such modified Product or the Product produced by such modified process, as the case may be, to be marketed and may condition its approval on obtaining a license or other access to such change or Improvement upon any termination of this Agreement.

  • Notwithstanding the foregoing, the Steering Committee shall in any event be obligated to approve budgets for, and reimbursement of, all Research and Development and Clinical Trials Costs of a party to the extent that any of such costs are incurred in connection with any portion of the Clinical Trials Program that is required by the FDA or a Territorial Regulator.

  • Notwithstanding the foregoing, neither party shall be required to disclose to the other party any change or Improvement unless such change or Improvement may require any new approval of a Territorial Regulator in order for such modified Product or the Product produced by such modified process, as the case may be, to be marketed.

Related to Territorial Regulator

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • State regulator means an agency of the state which is empowered to engage in the regulation of construction, alteration, remodeling, building, repair, and other activities subject to the codes adopted pursuant to this chapter.

  • 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.

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

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • foreign regulatory authority means a securities commission, exchange or other securities market regulatory authority in a designated foreign jurisdiction;

  • Relevant Electric Retail Regulatory Authority means an entity that has jurisdiction over and establishes prices and policies for competition for providers of retail electric service to end- customers, such as the city council for a municipal utility, the governing board of a cooperative utility, the state public utility commission or any other such entity.

  • local planning authority in relation to an area means⎯

  • Drug addiction means a disease characterized by a

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

  • Insurance Regulator means, with respect to any jurisdiction, the Governmental Authority charged with the supervision of insurance companies in such jurisdiction.

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • Sanctioning Authority means [The FA][the [ ] County Football Association Limited].

  • Planning Authority means the responsible entity that coordinates and integrates transmission facility and service plans, resource plans, and protection systems.

  • Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

  • Licensed clinical social worker means an individual who meets the licensed clinical social worker requirements established in KRS 335.100.

  • Territory means worldwide.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • MHLW means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

  • Council Regulation means Council Regulation (EC) No. 2100/94 of 27th July 1994 on Community plant variety rights;

  • Territories means territories, including territorial waters;

  • relevant planning authority means the district planning authority for the area in which the land to which the relevant provision of this Order applies is situated;

  • Governmental Regulations means all statutes, ordinances, rules and regulations of the Authorities applicable to Seller or the use or operation of the Real Property or the Improvements or any portion thereof.

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

  • Applicable Insurance Regulatory Authority means, when used with respect to any Insurance Subsidiary, the insurance department or similar administrative authority or agency located in (x) the state or other jurisdiction in which such Insurance Subsidiary is domiciled or (y) to the extent asserting regulatory jurisdiction over such Insurance Subsidiary, the insurance department, authority or agency in each state or other jurisdiction in which such Insurance Subsidiary is licensed, and shall include any Federal insurance regulatory department, authority or agency that may be created in the future and that asserts regulatory jurisdiction over such Insurance Subsidiary.