Regulatory Dossiers definition

Regulatory Dossiers means all registrations, permits licenses, authorizations, approvals, presentations, notifications or filings (together with all applications therefor), which are filed with or granted by the governing health authority of any country, as well as the EMEA and which are required to develop, make, use, sell, import or export the Product.
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Regulatory Dossiers means all registrations, permits, licenses, authorizations, approvals, presentations, notifications or filings (together with all applications therefor), which are filed with or granted by the governing health authority of any country, and which are required to develop, make, use, sell, import or export the Commercial Products, other than the Drug Master File.
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Regulatory Dossiers means all registrations, permits, licenses, authorizations, approvals, presentations, notifications or filings (together with all applications therefor), which are filed with or granted by the FDA or other governing health authority of any country, and which are required to develop, make, use, sell, import or export the Product or the API, including without limitation, the Product ANDA and those set forth in the Disclosure Letter, and any supporting data, studies or documents thereto; provided, however, that notwithstanding the foregoing Regulatory Dossiers shall not include the Drug Master File.
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Examples of Regulatory Dossiers in a sentence

  • To the extent permitted by Law, EISAI will promptly assign to EPIZYME all Regulatory Approvals, Regulatory Dossiers and Regulatory Materials for Licensed Products in the EISAI Territory.

  • Nevertheless, DAEWOONG, or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product in the Territoy.

  • Regulatory Dossiers and Regulatory Documentation relating to the Product and Optional Product shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements in each countries of the Territory.

  • As between Felicitex and Selvita, Felicitex shall own and maintain all regulatory submissions, Regulatory Dossiers, Regulatory Material and Regulatory Approvals for the Products, including all INDs and XXXx.

  • In the United States and Europe, Ista shall prepare, file, maintain and own Regulatory Dossiers for the Product.

  • Outside the United States and Europe, Ista shall give Allergan the right to prepare, file, and maintain Regulatory Dossiers for the Product in Allergan's name, and Allergan shall do so in such countries in which it markets the Product pursuant to Section 9.

  • Actavis shall prepare, at its sole cost and expense, the ANDA and any other Regulatory Dossiers required to be made in connection with obtaining and maintaining Regulatory Approval of the Finished Product and any Additional Product in any country in the Territory.

  • To the extent permitted by Law, EISAI will promptly assign to EPIZYME all Regulatory Approvals, Regulatory Dossiers and Regulatory Materials for Licensed Products.

  • Watsxx xxxll have the nonexclusive right to reference the Drug Master File in all applicable Regulatory Dossiers for Commercial Products.

  • Each Party hereby grants to the other Party a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) in the United States, or an equivalent right of access/reference in any other jurisdiction, to any Data, including such Party’s or its Affiliates’ Regulatory Dossiers, Controlled by such Party or such Affiliates that relate to a Licensed Product for use by such other Party to Develop and Commercialize the Licensed Products in the Field pursuant to this Agreement.


More Definitions of Regulatory Dossiers

Regulatory Dossiers means, in relation to each type of Product, (i) the information, documentation (including, without limitation, all technical and other documentation) and data submitted to the Relevant Regulatory Authorities for the purposes of applying for, maintaining, varying and/or renewing Regulatory Authorisations, and (ii) the information, documentation (including, without limitation, all technical and other documentation) and data required by Law to be made available to Relevant Regulatory Authorities on request.
Sample 1
Regulatory Dossiers means all registration, permits, licenses, authorizations, approvals, presentations, notifications or filings (together with all applications therefore), which are filed with or granted by the governing health authority of any country, and which are required to develop, make, use, or sell the Product.
Sample 1

Related to Regulatory Dossiers

  • 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 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 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 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 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).

  • 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 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 Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Regulatory Authorities means the Commissions and the Exchange;

  • 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.

  • 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 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.

  • 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).

  • Licensed Territory means worldwide.

  • 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 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.

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • 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.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • FDA means the United States Food and Drug Administration.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • 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;