Authorized Regulatory Agent definition

Authorized Regulatory Agent means a local entity (a) authorized by TPTX or any of its Affiliates, where TPTX, its Affiliate or its third party contractor research organization is the license holder of imported drug product, to exclusively (even as to TPTX and its Affiliates but in accordance with terms and conditions hereunder) manage the work associated with obtaining any Regulatory Approval or product registration in the Territory; and (b) which possesses and maintains valid licenses or permits in the Territory if such licenses or permits are required for such local entity to engage in the relevant activities in the Territory.
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Authorized Regulatory Agent means a local entity (a) authorized by Xxxxxxxx or any of its Affiliates, where Xxxxxxxx, its Affiliate or its third party contractor research organization is the license holder of imported drug product, to exclusively (even as to Xxxxxxxx and its Affiliates but in accordance with terms and conditions hereunder) manage the work associated with obtaining any Regulatory Approval or product registration in the Territory; and (b) which possesses and maintains valid licenses or permits in the Territory if such licenses or permits are required for such local entity to engage in the relevant activities in the Territory.
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Authorized Regulatory Agent means (a) a local entity authorized by Hutchmed or any of its Affiliates, if Hutchmed or its Affiliate is the CTA holder or license holder of imported Drug Product or (b) Hutchmed or its Affiliate, if Hutchmed or its Affiliate is not the CTA holder or license holder of imported Drug Product, in either case ((a) or (b)), where such entity, Hutchmed, or Hutchmed Affiliate, as applicable, manages the work associated with obtaining and maintaining any Regulatory Approval or product registration in the Territory and which possesses and maintains valid licenses or permits in the Territory if such licenses or permits are required for such local entity to engage in the relevant activities in the Territory.
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Examples of Authorized Regulatory Agent in a sentence

  • Other than to the extent Hutchmed serves as an Authorized Regulatory Agent as provided in this Agreement, neither Party is, nor will be deemed to be a partner, employee, agent or representative of the other Party for any purpose.

  • Unless prohibited by Applicable Law, Hutchmed, itself or with or through any other Hutchmed Entity, shall be the CTA owner or Authorized Regulatory Agent of each Local Trial, as determined by Hutchmed in its sole discretion.

  • Unless prohibited by Applicable Law, Hutchmed, itself or with or through any other Hutchmed Entity, shall be the Authorized Regulatory Agent of each Joint Global Trial in the Territory.


More Definitions of Authorized Regulatory Agent

Authorized Regulatory Agent means a local entity (a) authorized by Karuna or any of its Affiliates, where Karuna, its Affiliate or its Third Party contractor research organization is the license holder of imported drug product, to exclusively (even as to Karuna and its Affiliates, but in accordance with terms and conditions hereunder) manage the work associated with obtaining any Regulatory Approval or product registration in the Licensed Territory, and (b) which possesses and maintains valid licenses or permits in the Licensed Territory if such licenses or permits are required for such local entity to engage in the relevant activities in the Licensed Territory.
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Related to Authorized Regulatory Agent

  • Authorized Recipient means (1) the Shareholder of Record, or (2) any other Officially Designated person to whom redemption proceeds may be sent.

  • Authorized Reseller a reseller, distributor or other partner authorized by Celonis to sell Celonis products or services.

  • Regulatory Agency means any federal or state agency charged with the supervision or regulation of depository institutions or holding companies of depository institutions, or engaged in the insurance of depository institution deposits, or any court, administrative agency or commission or other authority, body or agency having supervisory or regulatory authority with respect to the Company, the Bank or any of their Subsidiaries.

  • Regulatory Agencies The Office of the Comptroller of the Currency; the Board of Governors of the Federal Reserve System; the Federal Deposit Insurance Corporation; the Federal Housing Finance Agency; the Securities and Exchange Commission; and the Department of Housing and Urban Development.

  • Duly authorized representative shall include any person or persons acting within the limits of his or her authority.

  • Authorized User means one named employee, contractor or agent of Customer (each identified by a unique email address) for whom Customer has purchased a subscription to the Subscription Services and who is authorized by Customer to access and use the Services under the rights granted to Customer pursuant to this Agreement.

  • Applicable Insurance Regulatory Authority means the insurance department or similar insurance regulatory or administrative authority or agency of the jurisdiction in which the Company is domiciled.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.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.

  • Non-Controlling Authorized Representative means, at any time with respect to any Shared Collateral, any Authorized Representative that is not the Applicable Authorized Representative at such time with respect to such Shared Collateral.

  • Specifically Authorized Representative (SAR), as used in this clause, means any person the Contracting Officer has so designated by written notice (a copy of which shall be provided to the Contractor) which shall refer to this subparagraph and shall be issued to the designated representative before the SAR exercises such authority.

  • Authorized Driver means any of the following:

  • Authorized Representative means any representative appointed, from time to time, by the Client, the Purchaser or the Contractor.

  • Authorized City Representative means the Mayor, City Manager or Director of Finance of the City, or such other Person at the time designated to act on behalf of the City as evidenced by written certificate furnished to the Trustee containing the specimen signature of such Person and signed on behalf of the City by its Mayor. Such certificate may designate an alternate or alternates, each of whom shall be entitled to perform all duties of the Authorized City Representative.

  • Applicable Authorized Representative means, with respect to any Shared Collateral, (i) until the earlier of (x) the Discharge of Credit Agreement Obligations and (y) the Non-Controlling Authorized Representative Enforcement Date, the Administrative Agent and (ii) from and after the earlier of (x) the Discharge of Credit Agreement Obligations and (y) the Non-Controlling Authorized Representative Enforcement Date, the Major Non-Controlling Authorized Representative.

  • UCC Filing Authorization Letter means a letter duly executed by each Loan Party authorizing the Collateral Agent to file appropriate financing statements on Form UCC-1 without the signature of such Loan Party in such office or offices as may be necessary or, in the opinion of the Collateral Agent, desirable to perfect the security interests purported to be created by each Security Agreement and each Mortgage.

  • Authorized entity means a nonprofit organization or a governmental agency that has a primary mission to provide specialized services relating to training, education, or adaptive reading or information access needs of blind or other persons with disabilities;

  • Regulatory Authority means any applicable supranational, national, regional, state or local regulatory agency, department, bureau, commission, counsel, or other government entity involved in granting of Regulatory Approval for a Licensed Product in a regulatory jurisdiction within the Territory, including the FDA and the EMEA.

  • Authorized Use The Student Data shared pursuant to the Service Agreement, including persistent unique identifiers, shall be used for no purpose other than the Services outlined in Exhibit "A" or stated in the Service Agreement, or authorized under the statutes referred to herein by this DPA. Provider may use or disclose data to: 1190353v1

  • Issuing authority means the authorized representative of the department of the City who issued the solicitation.