Regulatory Letters definition

Regulatory Letters means the MOU, the OCC Letter, the FRB Letter, the Financial Subsidiary Letter and the Financial Holding Company Letter.
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Examples of Regulatory Letters in a sentence

  • ASL shall provide Reliant with immediate notification of its receipt of any of the following related to the manufacture, production or testing storage of the Active Ingredient; a copy of any list of observations (Form FD483), Warning Letters, Information Letters, Regulatory Letters or the like issued by the FDA as well as provide Reliant an opportunity to review any written response prior to submission to the FDA.

  • Commissioner for Public Affairs of the Food and Drug Administration), Regulatory Letters, Publicity and Recalls, 31 Food Drug Cosm.

  • Commissioner for Public Affairs of the FDA), Regulatory Letters, Publicity and Recalls, 31 Food Drug Cosm.

  • Except with respect to the Regulatory Letters, neither the Borrower or any of its subsidiaries is a party to, or is bound by, any contract or agreement or instrument, or subject to any charter or other corporate restriction, which in the opinion of the Borrower materially and adversely affects its business, property, assets, operations or condition, financial or otherwise.

  • Neither Borrower nor First National has consented to or entered into any Regulatory Agreement, except for the Regulatory Letters.

  • Without limiting the generality of the foregoing, the Borrower and its subsidiaries have complied with, and are currently in compliance with, to the extent compliance is required as of the date hereof, all applicable requirements imposed upon the Borrower or its subsidiaries as a result of any formal or informal regulatory enforcement action or guidance, including, without limitation, the Regulatory Letters.

  • Except with respect to the Regulatory Letters, since December 31, 2008, there has not been any adverse change in the business, operations, properties or assets of the Borrower or its subsidiaries which is material to the Borrower and its subsidiaries taken as a whole or to the Borrower alone.

  • Changes in FDA Enforcement Activities Following Changes in Federal Administration: The Case of Regulatory Letters Released to Pharmaceutical Companies.

  • The Borrower shall, and shall cause First National to, at all times remain in compliance with all applicable requirements imposed upon the Borrower or its subsidiaries as a result of any formal or informal regulatory enforcement action or guidance, including, without limitation, to the extent compliance is required as of a particular date, the Regulatory Letters.

  • The clinical care guidelines that will be used for clinical audit may be, but are not limited to, the following: US Preventive Task Force, Guidelines and / or Regulatory Letters of the PR Department of Health, Joint Commission, CMS, NCQA, URAC and applicable professional associations.

Related to Regulatory Letters

  • 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.

  • 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.

  • 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.

  • Regulatory Law means the Xxxxxxx Act, as amended, the Xxxxxxx Act, as amended, the HSR Act, the Federal Trade Commission Act, as amended, and all other federal, state and foreign, if any, statutes, rules, regulations, orders, decrees, administrative and judicial doctrines and other laws that are designed or intended to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade or lessening of competition through merger or acquisition.

  • Regulatory Order means an Order issued by an Applicable Commission or FERC that affects or governs the rates, services, or other utility operations of the Business.

  • Third Party Applications means online, Web-based applications and offline software products that are provided by third parties and are identified as third-party applications, including but not limited to those listed on the AppExchange and the Reseller Application.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • 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 in a country, territory or possession.

  • 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;

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.

  • FCC Applications means those applications and requests for waivers required to be filed with the FCC to obtain the approvals and waivers of the FCC pursuant to the Communications Act and FCC Rules necessary to consummate the transactions contemplated by this Agreement.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • 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 Authorities means the Commissions and the Exchange;

  • 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.

  • 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 Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • 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.

  • Bank Regulator means any federal or state banking regulator, including but not limited to the FDIC, the NJDOBI, and the FRB, which regulates Somerset Bank or Regal Bank, or any of their respective holding companies or subsidiaries, as the case may be.

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

  • 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.

  • SAP Application(s) means all Packages (i.e. all Software and Third Party Software) licensed under the Agreement and/or SAP cloud services for which Customer has a valid subscription, excluding User Interfaces for ERP, SAP Technology Solutions and all database Packages.

  • Governmental Filings means all filings, including franchise and similar tax filings, and the payment of all fees, assessments, interests and penalties associated with such filings with all Governmental Authorities.