regulatory document definition

regulatory document means a regulation, rule, code of conduct or other document that has legislative effect with respect to financial service providers or any specified class of fin- ancial service providers.
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regulatory document is a document (or set of documents) that provides rules, guidelines and characteristics for PH services.
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regulatory document means a regulation, 40
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Examples of regulatory document in a sentence

  • Regulatory Document Renewals and Updates — Annual Site Maintenance Throughout the study, Omnicare CR will collect updated essential documents.

  • Should Lilly elect to sublicense, or to co-market or co-promote Licensed Product with a Third Person in the Territory, Lilly shall have the right to provide appropriate access to such Clinical Trial data or information, Clinical Trial databases, all data generated in support of any Marketing Application, Regulatory Approval other regulatory commitment, or Regulatory Document to such Third Person, subject to payment of the compensation amounts as agreed for any such access and use by such Third Person.

  • In the event that the term of any procedure described below conflicts with the term of any Regulatory Document or any applicable law or regulation, the term of such Regulatory Document, law or regulation supersede such procedure.

  • Should Lilly elect to sublicense, or to co-market or co-promote Product with a Third Person in the Territory, pursuant to Lilly’s rights under this Section 11.3, Lilly shall have the right to provide appropriate access to such Clinical Trial data or information, Clinical Trial databases, all data generated in support of any Application for Marketing Authorization, Regulatory Approval other regulatory commitment, or Regulatory Document to such Third Person.

  • The Company has previously delivered or made available to Buyer a true, correct and complete copy of each such Regulatory Document filed with the SEC after January 1, 1993, and prior to the date hereof (including a Form ADV of each of the Company and Optima as in effect on the date hereof) and will deliver to Buyer promptly after the filing thereof a true, correct and complete copy of each Regulatory Document filed by the Company with the SEC after the date hereof and prior to the Closing Date.

  • Purchaser acknowledges and agrees that after transfer, as holder of the Regulatory Documents, it will have sole responsibility for all regulatory reporting and Regulatory Document maintenance obligations, including, among other things, for adverse event reporting.

  • With respect to any transfer of Regulatory Documents, if Amgen reasonably determines that such transfer of ownership is not permitted under Law, then Amgen will provide Celldex the right of reference and right of access to such Regulatory Document until such time as the transfer of such Regulatory Document is permitted by Law, and Amgen (through its Affiliate, Immunex) will endeavor to promptly transfer such Regulatory Document at such time.

  • InterMune agrees and acknowledges that as holder of the Regulatory Documents it will have sole responsibility for, among other things, adverse event reporting and all other regulatory reporting and Regulatory Document maintenance obligations.

  • UK Regulatory Document Additional information about the offer, including a copy of the Rule 2.5 announcement issued in the United Kingdom, is contained in a Current Report on Form 8-K filed with the Securities and Exchange Commission today.

  • If a Regulatory Authority requires EyePoint to execute any document or attend any meeting, as for example as the applicant/owner of an EyePoint Territory Regulatory Document, then EyePoint will promptly provide Betta with the necessary support at the expense of Betta.


More Definitions of regulatory document

regulatory document document that provides rules, guidelines, or characteristics of an activity or its results, including but not limited to documents, regulations, technical specifications, codes and standards, as well as any medium with information recorded on or in it.
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regulatory document means either (i) a copy of written documentation from the applicable regulatory authority to the effect that Home Savings may not distribute the Litigation Proceeds, or any portion thereof, to Ahmanson, or (ii), prior to the expiration of any applicable prior notice or application period following Home Savings' submission to the applicable regulatory authority of a notice or application for approval of a distribution of the Litigation Proceeds to Ahmanson, an officer's certificate from the chief financial officer of Home Savings certifying that Home Savings has submitted such a notice or application and that Home Savings has not received any written documentation from such regulatory authority to the effect that Home Savings may make such distribution.
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Related to regulatory document

  • Regulatory Documents means the prospectus, annual report, semi-annual report and any other document required under applicable federal securities law to be delivered by the Trust to Fund shareholders.

  • Regulatory Documentation means all applications, registrations, licenses, authorizations and approvals (including all Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), all supporting documents and all Clinical Trials and tests, including the manufacturing batch records, relating to a Product, and all data contained in any of the foregoing, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture, market, sell or otherwise commercialize a product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, XXXx and NDAs (as applications, but not the approvals with respect thereto).

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • Regulatory Filing means any approvals, licenses, registrations, submissions and authorizations, and applications therefor, including IND, NDA, BLA, drug dossier or drug master file filed, or Marketing Approval obtained, with respect to an Option Product, Licensed Product or Companion Diagnostic, as applicable, in the Field, including all amendments, supplements, annual reports and the like thereof or therefor filed with or otherwise provided to the applicable Regulatory Authority.

  • 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.

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

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

  • Regulatory entity means any board, commission, agency,

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • 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 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.

  • Product Know-How means Know-How

  • Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights granted by a Regulatory Authority (other than Patents) with respect to a Licensed Product sold in a given country, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity or pediatric exclusivity.

  • Regulatory Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

  • Third Party Material means software, software development tools, methodologies, ideas, methods, processes, concepts and techniques owned by, or licensed to a third party and used by the Service Provider in the performance of the Services;

  • DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

  • Regulatory Authority means, with respect to any national, supra-national, regional, state or local regulatory jurisdiction, any agency, department, bureau, commission, council or other governmental entity involved in the granting of a Regulatory Approval for such jurisdiction.

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

  • Product Approval(s) means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

  • Regulatory Floodway means the channel of a river or other watercourse and the adjacent land areas that must be reserved in order to discharge the base flood without cumulatively increasing the water surface elevation more than a designated height.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • 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;

  • WTO GPA country end product means an article that—

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.