Regulatory Agent definition

Regulatory Agent means that Party designated by an appropriate ---------------- authorization to the FDA or its regulatory equivalent to be the primary contact with and receiving party of all correspondence from the FDA in connection with any regulatory matter or filing.
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Regulatory Agent shall have the meaning set forth in Section 5.1.2.2.
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Regulatory Agent means Epic Pharma LLC and its respective successors and permitted assigns.
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Examples of Regulatory Agent in a sentence

  • In addition, to the extent that Citius receives any other communication or correspondence from any Regulatory Authority that may require a response or other action by Licensee, Citius will promptly provide Licensee and the Regulatory Agent with a copy of such communication or correspondence.

  • Citius shall remain responsible for preparation of annual reports to FDA and for any required updates to the CMC section of the Regulatory Approval and shall timely provide copies of these documents to Licensee and the Regulatory Agent for filing.

  • Until the Registrations are transferred to Buyer, Buyer, as the Regulatory Agent, shall have responsibility for all communications with FDA and corresponding foreign bodies relating to the Products, and Company shall, and shall cause each of the Sellers to, promptly provide Buyer with copies of all communications to or from the FDA with respect to each Product and/or the manufacture thereof.

  • Following such designation, the Regulatory Agent will be the sole point of contact with Regulatory Authorities with respect to all matters relating to the Regulatory Filings and Approvals.

  • Regulatory Agent: Gland will be the sole Regulatory Agent for the Products in North America for the term of the License.

  • This Power of Attorney is in addition to and does not revoke or replace any prior Power of Attorney issued to the Regulatory Agent which is on file with the R.O.C. authorities.

  • The Customer has appointed the Bank to act as the Regulatory Agent of the Customer under the Investment Regulations.

  • Upon receipt of Regulatory Approval of the Drug Approval Application for the first Collaboration Product hereunder, CTI shall submit an appropriate document to the regulatory agency designating ORTHO as the Regulatory Agent and thereafter ORTHO shall assume primary responsibility for dealings with the regulatory agency with respect thereto, including filing all supplements and other documents with such agency with respect to such existing Drug Approval Application.

  • 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.

Related to Regulatory Agent

  • 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.

  • Regulatory Body means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate or investigate the matters dealt with in this Agreement or any other affairs of the Provider or the Department, including, without limitation Ofsted, the European Commission and the European Court of Auditors;

  • 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.

  • 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.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Regulatory Authority means any federal, national, multinational, state, county, city, provincial, or local regulatory agency, department, bureau or other governmental entity with authority over the marketing, commercialization, manufacture or sale of a pharmaceutical product in the Territory, including the FDA in the United States and the EMA in the EU.

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

  • Regulatory Bodies means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate, investigate, or influence the matters dealt with in the Contract or any other affairs of the Authority and “Regulatory Body” shall be construed accordingly.

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

  • Regulatory Agreement means the regulatory agreement between HPD and the Owner establishing certain controls upon the operation of the Exemption Area during the term of the Exemption.

  • Regulatory entity means any board, commission, agency,

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

  • Bank Regulator means any Federal or state banking regulator, including but not limited to the OCC and the FRB, which regulates NBT, NBT Bank, Evans or Evans Bank, or any of their respective subsidiaries, as the case may be.

  • Regulatory Action means an administrative or regulatory enforcement action, proceeding, investigation or inspection, FDA Form 483 notice of inspectional observation, warning letter, untitled letter, other notice of violation letter, recall, seizure, Section 305 notice or other similar written communication, or consent decree, issued by the FDA.

  • Delivery Agent means, in relation to any Series of Covered Bonds that contemplates physical settlement, the financial institution appointed as delivery agent for the purposes of such Covered Bonds and named as such in the applicable Final Terms;

  • securities regulatory authority or “SRA” means a body created by statute in any Canadian or foreign jurisdiction to administer securities law, regulation and policy (e.g. securities commission), but does not include an exchange or other self regulatory entity;

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Regulatory Services Provider means the organization which provides regulatory services to BSEF pursuant to a Regulatory Services Agreement.

  • Regulator means, with respect to any person, any Government Authority charged with regulating, supervising or examining such person and its Affiliates.

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority, including all INDs and NDAs.

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

  • Canadian Securities Regulatory Authorities means the securities regulatory authorities in each of the provinces and territories of Canada;

  • Regulators means the SFC, the relevant Exchange, the relevant clearing house and any other regulators whether in Hong Kong or elsewhere

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Third Party Agent means any provider of services to the Client (other than the Custodian, a Subcustodian or Delegate under this Agreement) including any Investment Manager, adviser or sub-advisor, distributor, broker, dealer, transfer agent, administrator, accounting agent, audit firm, tax firm, or law firm.