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.

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.

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.

• No such changes shall be implemented without TransMedics’s prior written approval, which shall not be unreasonably withheld and, to the extent required, any applicable REGULATORY APPROVALS; provided, however, that Fresenius shall manufacture a sufficient amount of TransMedics’s requirements of PRODUCT for the reasonable period required by TransMedics’s to amend its Regulatory Dossiers.

• 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.

• 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.

• 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.

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

• Any amounts received by Actavis and its Affiliates in connection with the sublicensing or transfer of the Licensed Technology or Development Technology shall, after deduction from such revenues of any costs incurred by Actavis and its Affiliates relating to such transaction (including but not limited to costs relating to the registration of duplicate Regulatory Dossiers and the transaction giving rise to the revenues received), be included in Net Profits hereunder.

• Adamis shall use Commercially Reasonable Efforts to (i) file the NDA and any other applicable Regulatory Dossier for the 0.30 mg Product and, subject to completion of development of the [*] Product in accordance with Article 3, the [*] Product with the FDA and any other applicable Regulatory Authority in the Territory as soon as reasonably practicable, and (ii) maintain each such NDA and other applicable Regulatory Dossiers after the FDA’s and/or other applicable Regulatory Authority’s approval thereof.

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

More Definitions of Regulatory Dossiers

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.

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.