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.
Regulatory Agent shall have the meaning set forth in Section 5.1.2.2.
Regulatory Agent means Epic Pharma LLC and its respective successors and permitted assigns.

Examples of Regulatory Agent in a sentence

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

  • 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.

  • Upon receipt of regulatory approval of each subsequent separate Drug Approval Application with respect to a Collaboration Product the process described above shall be repeated and CTI shall appoint ORTHO as Regulatory Agent upon approval thereof.

  • 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.

  • CTI shall have the right of cross-reference with respect to all Drug Approval Applications for which ORTHO is Regulatory Agent.

  • 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.

  • In connection with all Drug Approval Applications with respect to which ORTHO is Regulatory Agent, ORTHO agrees to provide CTI with a copy (which may be wholly or partly in electronic form) of all filings to regulatory agencies that it makes hereunder.

  • 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 Authorized Regulatory Agent of each Joint Global Trial in the Territory.

  • 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.

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 the insurance department or similar insurance regulatory or administrative authority or agency of the jurisdiction in which the Company is domiciled.

  • 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 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.

  • 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.

  • 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 CDBO, the FRB, the OCC and the FDIC, which regulates or has the statutory authority to regulate Hanmi Bank, Southwestern National Bank, and their respective holding companies and subsidiaries, as the case may be, and the Department of Justice or the Federal Trade Commission, or any other relevant federal or state regulator, as it relates to anticompetitive matters.

  • Regulatory Action means an administrative, regulatory, or judicial 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, injunction or consent decree, issued by the FDA or a federal or state court.

  • 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;

  • 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;

  • 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, notifications, authorizations, orders, exemptions, registrations, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies, including all Product Authorizations.

  • 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 commissions and similar regulatory authorities of each of the provinces or 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;