Annual Regulatory Report definition

Annual Regulatory Report has the meaning given in Section 2.4(a).
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Examples of Annual Regulatory Report in a sentence

  • Annexure A – Share Issue & Subscription Agreement – Mercari and Issuer Annexure B – Mercari Australian Market Licence Annexure C – Mercari AFSL Annexure D – Mercari Audited Accounts for FY 2017-2018 Annexure E – Annual Regulatory Report - Mercari Pty Limited, 2017-2018 TABLE OF CONTENTS 1.

  • It is understood that AVEO’s obligation to provide summaries under this Section 2.5 can be fulfilled by providing a copy of the Annual Regulatory Report conducted by or on behalf of AVEO, that AVEO (or others acting under its authority, including sublicensees) provides to Regulatory Authorities in the AVEO Territory (each an “Annual Regulatory Report”).

  • Accounting Date means the date at which a Service Provider’s General Purpose Financial Statements report its Statement of Financial Performance and Statement of Financial Position Annual Regulatory Report has the meaning specified in section 4.2 of these guidelines Asset Schedule means the schedule included in the Special Purpose (Regulatory) Financial Statements, described in section 2.7.8 of these guidelines.

  • Prior to 2015, the Annual Regulatory Report was based on the WA Network Holdings Pty Limited Consolidated Group (WANH) statutory accounts.

  • For the year ended 31 December 2015 and subsequent years, the statutory accounts that form the basis of the Annual Regulatory Report are the ATCO Gas Australia Limited Partnership Consolidated Group (AGALP) Annual Financial Report.

  • Annual Regulatory Report on 2021 Program Performance | 22 Automotive Materials Stewardship Inc.

  • Its main role is to advise on the implementation of HEFCW’s regulatory responsibilities under the HE (Wales) Act 2015 this includes the vital role of advising HEFCW on its HEFCW’s Annual Regulatory Report and development of, and monitoring of institutions' compliance with, Fee and Access Plans.

  • The Annual Regulatory Report must be submitted to the Commission within two months of the directors of a Service Provider signing audited annual General Purpose Financial Statements.

  • The Annual Regulatory Report must include;■ Statement of Compliance; and■ Regulatory Financial Statements comprising:- the Service Provider’s General Purpose Financial Statements;- Disaggregation Statements (including supporting schedules); and- Special Purpose (Regulatory) Financial Statements (including supporting schedules); and■ Auditor’s Report This report assists the Commission to determine compliance with the ring fencing minimum obligations specified in sections 4 of the Code.

  • A Service Provider must prepare an Annual Regulatory Report for submission to the Commission.

Related to Annual Regulatory Report

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

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • Drug Master File or “DMF” is described in 21 C.F.R. Part 314.420. A DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • StarCompliance Code of Ethics application means the web-based application used to electronically pre-clear personal securities transactions and file many of the reports required herein. The application can be accessed via the AB network at: https://alliance-ng.starcompliance.com/.

  • 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.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

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

  • 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.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

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

  • Planning Application means the application for [outline/full] planning permission dated [ ] bearing the Council’s reference number [ ];

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Progress Report Form means UN Women’s standard form for progress reports attached to this Agreement.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

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

  • 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.