Registration file definition

Registration file means the set of documents that were submitted according to the regulatory standards of the Territory in order to obtain the Marketing Authorizations in the Territory and approved as the reference documentation. «Регистрационное досье» означает комплект документов, предоставляемых (в соответствии с нормативными требованиями, действующими на Территории) для получения Регистрационных удостоверений на Территории, а также документы, одобренные в качестве нормативной документации.

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Registration file means the application for registration, supporting materials, annual reports, and amendments that constitute all information submitted and reviewed pertaining to a particular time-share program, time-share project, alternative purchase, exchange company, or time-share reseller registration. A document that has not been accepted for filing by the board is not part of the registration file.

Registration file means the application for registration, supporting materials, annual reports, and amendments that constitute all information submitted and reviewed pertaining to a particular condominium registration. A document that has not been accepted for filing by the board is not part of the registration file.

Examples of Registration file in a sentence

• If any Registrable Securities remain issued and outstanding after two (2) years following the initial effective date of such Shelf Registration, upon the request of Holder(s) of at least ten percent (10%) of the Registrable Securities then outstanding, the Company shall, prior to the expiration of such Shelf Registration, file a new Shelf Registration and shall thereafter use its commercially reasonable efforts to cause to be declared effective as promptly as practical, such new Shelf Registration.

• If any Registrable Securities remain issued 2 19572323.8 Execution Version Exhibit 4.1 and outstanding after three (3) years following the initial effective date of such Shelf Registration (the “Initial Shelf Effective Date”), the Company shall, prior to the expiration of such Shelf Registration, file a new Shelf Registration covering such Registrable Securities and shall thereafter use its reasonable best efforts to cause to be declared effective as promptly as practical, such new Shelf Registration.

• During the period (i) beginning on the date of a Request and (ii) ending on the date that is 90 days after the date that a Demand Registration Statement filed pursuant to such Request has been declared effective by the SEC, the Company shall not, without the consent of the Required Holders of the Registration, file a registration statement pertaining to any other securities of the Company (other than a registration on Form S-8 as promulgated under the 1933 Act).

• If any Registrable Securities remain issued and outstanding after three (3) years following the initial effective date of such Shelf Registration, upon the request of Holder(s) of at least ten percent (10%) of the Registrable Securities then outstanding, the Company shall, prior to the expiration of such Shelf Registration, file a new Shelf Registration and shall thereafter use its commercially reasonable efforts to cause to be declared effective as promptly as practical, such new Shelf Registration.

• The Company shall, as soon thereafter as practicable, but not more than thirty (30) days immediately after the Company’s receipt of the Demand Registration, file a Registration Statement with respect to the Registration of all Registrable Securities requested by CMB pursuant such Demand Registration, and use its reasonable best efforts to cause such Registration Statement to become effective as soon as reasonably practicable thereafter.

More Definitions of Registration file

Registration file means the application for registration, supporting materials, annual

Registration file means all the information, including regulatory, technical and clinical data, concerning the PRODUCT and that have been required to obtain the PRODUCT NDA.

Registration file means all the information, including regulatory, technical and clinical data, concerning the PRODUCT (including, but not limited to, all such information on which the FDA APPROVAL is based).

Registration file means all records, documents, emails and things in the custody or control of the college that are relevant to the subject matter of a review, whether or not they have previously been collected and organized into a single “file” and whether or not they have been placed before the registration committee;

Registration file means all written pertinent and necessary information regarding the Product (full approved consolidated dossier modules 2-5), which has been approved by the FDA (ANDA 211352), and that shall include, inter alia: ● Elite’s cGMP certificate; ● Elite’s manufacturing license; ● Elite’s QA audits of the API manufacturers; ● Any bio-studies and/or clinical studies available to Elite on the Effective Date hereof (each, a “BE Study”); ● A current, valid US Free Sale Certificate or US Certificate of Pharmaceutical Product (“CPP”) for the marketed Product; ● Certificate of compliance with good laboratory practice principles for the laboratories conducting the analytical tests for the BE Study. The certificate should be from a suitable authority in a recognized country (US, Canada etc.); ● Dissolution data of the reference product registered in Israel (Dexcel shall purchase and provide the samples of the reference product registered in Israel to Elite, at Dexcel’s cost; Elite shall perform the required studies, at Dexcel’s cost), (see Appendix 4).

Registration file means the file derived from the Dossier together with the results of any bioequivalence study and the stability study and any supplementary data required by the FDA in the Territory;

Registration file means an electronic file containing information relating to the registration of an individual passenger car;