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.
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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.

  • 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.

  • 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.

  • 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.

Related to Territorial Regulator

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

  • national regulatory authority means the body or bodies charged by a Member State with any of the regulatory tasks assigned in this Directive and the Specific Directives;

  • 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.

  • 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;

  • Insurance Regulator means any Person charged with the administration, oversight or enforcement of any Insurance Regulation.

  • 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.

  • 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, Labor and Welfare, or a 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;

  • 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 Agency.