Applicable Regulatory Agency definition

Applicable Regulatory Agency means any supra-national, federal, national, regional, state, provincial or local regulatory agency, department, bureau, commission, council or other Governmental Authority regulating or otherwise exercising authority with respect to the Manufacturing, import and/or commercialization of the Products, including, as applicable, the FDA (as such term is hereinafter defined), Health Canada, the TGA (Australia) and the CFDA (China).
Sample 1Sample 2
Applicable Regulatory Agency means the FCC, the IUB, the MPUC or any other Governmental Authority that regulates any of the Grantors’ business.
Sample 1

Examples of Applicable Regulatory Agency in a sentence

  • FDA or Other Applicable Regulatory Agency Strategy and Communication(s) A Regulatory Communication Plan must be provided as an attachment called "Regulatory Communication Plan.pdf" and must not exceed 3 pages of a written description.

  • APPENDIX A – Applicable Regulatory RequirementsAPPENDIX B – Applicable Regulatory Agency Contacts for Waterfront Toronto Projects APPENDIX C – Recommended Procedures for Methane Management During ConstructionAcross the Designated Waterfront AreaAPPENDIX D – Methane Management Approach for Permanent Building Structures Across the Designated Waterfront AreaAPPENDIX E – Waterfront Toronto Environmental Management Plan Quarterly Update Documentation RequirementsLIST OF FIGURESFigure 1.

  • APPENDIX A – Applicable Regulatory RequirementsAPPENDIX B – Applicable Regulatory Agency Contacts for Waterfront Toronto Projects APPENDIX C – Recommended Procedures for Methane Management at the East BayfrontPrecinctLIST OF FIGURESFigure 1.

  • In the event that Supplier wishes to propose any material change to the Manufacturing process or the Specifications, it shall provide all relevant details related to such proposed change for review by Purchaser, but shall not implement any such change prior to Purchaser’s approval, which approval Purchaser shall not reasonably withhold or delay, and any necessary approval by the Applicable Regulatory Agency.

  • In the event: (a) Purchaser reasonably determines that any Product should be recalled due to its non-conformance with the terms of this Agreement; (b) any Applicable Regulatory Agency issues a request, directive or order that any Product be recalled; or (c) a court of competent jurisdiction orders such a recall (either (b) or (c) together, an “Order”), each Party shall take all appropriate corrective actions reasonably requested by the other Party or any Applicable Regulatory Agency.

  • Except as otherwise set forth herein with regard to Raw Materials, Supplier shall conduct all required quality control and other tests required to ensure that Products as Manufactured meet the mutually agreed upon Specifications and the cGMPs or other Manufacturing quality control regulations of the FDA or any other Applicable Regulatory Agency in the relevant jurisdiction.

  • Each of the Grantors agrees to take any and all necessary and appropriate commercially reasonable actions to preserve the Operating Licenses and to otherwise prevent any modification, revocation, suspension, cancellation, or refusal by any Applicable Regulatory Agency to renew any of the Operating Licenses held by it except to the extent such modification, revocation, suspension, cancellation or refusal could not reasonably be expected to have a Material Adverse Effect.

  • Each of the Grantors agrees, at such Grantor’s own cost and expense, to cooperate with any such purchaser and with the Collateral Agent in the preparation, execution and filing of any applications and other documents and providing any information that may be necessary or helpful in obtaining the consent of the Applicable Regulatory Agency to the assignment or transfer to such purchaser of the Collateral or any of the Operating Licenses.

  • Applicable Regulatory Agency means any governmental court, tribunal or any other authority in Mauritius, India or in any other jurisdiction having power and authority, under the laws of that jurisdiction to compel any Fund Agency to comply with its directions or order.

  • FDA or Other Applicable Regulatory Agency Strategy and Communication(s) A Regulatory Communication Plan must be provided as an attachment called “Regulatory Communication Plan.pdf" and must not exceed 3 pages of a written description.

Related to Applicable Regulatory Agency

  • 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.

  • 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.

  • Applicable Regulations As to any Mortgage Loan, all federal, state and local laws, statutes, rules and regulations applicable thereto.

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

  • 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;

  • Applicable Regional Entity means the Regional Entity for the region in which a Network Customer, Transmission Customer, New Service Customer, or Transmission Owner operates. Applicable Standards:

  • Public or private safety agency means a unit of state or local government, a special purpose district, or a private firm, which provides or has the authority to provide firefighting, police, ambulance, emergency medical services or hazardous materials response.

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

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

  • 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.

  • Public safety agency means a functional division of a public agency, county, or the state that provides fire fighting, law enforcement, ambulance, medical, or other emergency services.

  • Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of a Licensed Compound or a Licensed Product in the Territory.

  • Regulatory Rules means all corporate and securities laws, regulations, rules, policies, notices, instruments and other orders of any kind whatsoever which may, from time to time, apply to the implementation, operation or amendment of this Plan or the Options granted from time to time hereunder including, without limitation, those of the applicable Regulatory Authorities.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Governmental Agency(ies) means, individually or collectively, any federal, state, county or local governmental department, commission, board, regulatory authority or agency (including, without limitation, each applicable Regulatory Agency) with jurisdiction over the Company or a Subsidiary of the Company.

  • 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.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Regulatory entity means any board, commission, agency,

  • Market Abuse Regulation means Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse;

  • Regulatory Laws means all Applicable Laws governing (i) the import, export, testing, investigation, manufacture, marketing or sale of the Product, (ii) establishing recordkeeping or reporting obligations, (iii) any Field Action or (iv) similar regulatory matters.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • 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.

  • 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;