Regulatory Audits definition

Regulatory Audits has the meaning set forth in Section 14.1(d)(i) of the Master Agreement.
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Examples of Regulatory Audits in a sentence

  • CryoLife shall have the same regulatory audit and QA assessment rights with respect to CPL and CPL Products as it has with respect to SMI and Products under Section 5.8 (Regulatory Audits and QA Assessments) of the Agreement.

  • State Regulatory Audits or Examinations as authorized by the Act.

  • If the audits under Sections 14.1 (Operational Audits) or Section 14.2 (Regulatory Audits) uncover a discrepancy between NTT DATA’ operations and NTT DATA’ Responsibilities under this Agreement, or any other failure of NTT DATA to comply with its obligations under this Agreement or Laws, then NTT DATA will, at its expense, and will cause each of its subcontractors, employees and agents to, promptly take action to alleviate the discrepancy or comply with such requirements or Laws.

  • REGULATORY MATTERS, PRODUCT SAFETY ISSUES, PRODUCT RECALLS 88 12.1. Regulatory Matters 88 12.2. Rights of Cross-Reference 88 12.3. Communications with Regulatory Authorities 89 12.4. Regulatory Audits 90 12.5. Ownership of Regulatory Documentation, Registrational Filings and Regulatory Approvals; Transfer of Registrational Filings and Regulatory Approvals 91 12.6. Medical and Customer Inquiries 91 12.7. Safety Agreement 91 12.8. Product Recalls 92 13.

  • ADCT’s obligations under this Section 6.5 (Regulatory Audits) are subject to the terms of ADCT’s agreements with its contractors, including contract manufacturing organizations.

  • State Regulatory Audits or Examinations as authorized by Code of Alabama, §8-6-3(i) (1975).

  • Upon completion of any Operational Audit, Regulatory Audits and/or Financial Audit (collectively, “Company Audits”), Company shall notify Service Provider of any deficiencies or material weaknesses found as a result of the Company Audit, and provide Service Provider with copies of portions of Company Audit reports reflecting or based upon information obtained from Service Provider.

  • Xxxxxxxxx agrees to use Commercially Reasonable Efforts to include in any contract or other written arrangement with its Third Party (sub)contractors, a clause permitting GSK to exercise its rights under this Section 3.8.1. 3.8.2 Regulatory Audits.

  • Notwithstanding the foregoing, each Party’s obligations related to Regulatory Audits in this Section 4.6(f) shall be limited to the extent performance of such obligations is prohibited by Applicable Law or to the extent necessary to allow such Party to timely comply with Applicable Law.

  • If the audits under Sections 14.1 (Operational Audits) or Section 14.2 (Regulatory Audits) uncover a discrepancy between Pxxxx Systems’ operations and Pxxxx Systems’ Responsibilities under this Agreement, or any other failure of Pxxxx Systems to comply with its obligations under this Agreement or Laws, then Pxxxx Systems will, at its expense, and will cause each of its subcontractors, employees and agents to, promptly take action to alleviate the discrepancy or comply with such requirements or Laws.

Related to Regulatory Audits

  • 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.

  • 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 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 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.

  • Statutory Auditors means a firm of chartered accountants appointed in terms of Section 224 of the Companies Act, 1956 and acting as the statutory auditors of the Concessionaire.

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • 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;

  • Statutory Auditor means the auditor of a Company appointed under the provisions of the Companies Act, 1956 or under the provisions of any other applicable governing law;

  • 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 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.

  • 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;

  • Regulatory entity means any board, commission, agency,

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

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

  • 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 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 Materials means materials developed or compiled in preparation for Regulatory Authority meetings, regulatory applications, submissions, dossiers, notifications, registrations, Regulatory Approvals and/or other filings made to or with, or other approvals granted by, a Regulatory Authority that are necessary or reasonably desirable for the Development, manufacture, market, sale, or Commercialization of a Licensed Product in a particular regulatory jurisdiction.

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

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • 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.

  • 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 assets means the unamortized net regulatory assets that are capitalized or deferred on the regulatory books of the electric utility, pursuant to an order or practice of the public utilities commission or pursuant to generally accepted accounting principles as a result of a prior commission rate-making decision, and that would otherwise have been charged to expense as incurred or would not have been capitalized or otherwise deferred for future regulatory consideration absent commission action. "Regulatory assets" includes, but is not limited to, all deferred demand-side management costs; all deferred percentage of income payment plan arrears; post-in-service capitalized charges and assets recognized in connection with statement of financial accounting standards no. 109 (receivables from customers for income taxes); future nuclear decommissioning costs and fuel disposal costs as those costs have been determined by the commission in the electric utility's most recent rate or accounting application proceeding addressing such costs; the undepreciated costs of safety and radiation control equipment on nuclear generating plants owned or leased by an electric utility; and fuel costs currently deferred pursuant to the terms of one or more settlement agreements approved by the commission.

  • 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.