International Registration Dossier definition

International Registration Dossier. ("IRF") shall mean the Product registration file compiled by Xxxxxxx Pharmaceutica N.V., Beerse, Belgium on behalf of Xxxxxxx, the contents and format being such that it can be submitted as such to national health authorities or be used as a basis for a national application for marketing authorization for the Products in the specific format required by such national health authorities. Xxxxxxx-Medisorb Page 2 License Agreement
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International Registration Dossier means the collection of Information comprising the requirements for applications for Registration of Collaboration Products under the FDCA and any regulations promulgated thereunder, and as required by the Committee for Proprietary Medicinal Products representing the medicine authorities of the European Community member states.
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International Registration Dossier. ("IRF") shall mean the Product registration file compiled by Janssen Pharmaceutica N.V., Beerse, Belgium on behalf of Janssen, the contents and format being such that it can be submitted as such to national health authorities or be used as a basis for a national application for marketing authorization for the Products in the specific format required by such national health authorities.
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Examples of International Registration Dossier in a sentence

  • In fact, by virtue of CCI being granted full membership, Maharashtra has garnered as many as four out of the total 30 votes on the Board.

  • No later than six (6) months prior to the filing of the International Registration Dossier for the first Collaboration Product, the Parties will negotiate in good faith a commercialization plan for Collaboration Products including an agreement on the appropriate royalty payments and shares of Sublicensing Revenue due to each Party, recognizing the guiding principle of a 50/50 collaboration with equal sharing of expenses and returns.

  • For each SAC selected by the JRC for joint development as a Collaboration Product hereunder by mutual written agreement, SGX and UG agree that they will collaborate to generate an International Registration Dossier, and will conduct, or have conducted, all Preclinical Development and Clinical Development on such Collaboration Product in accordance with the Preclinical and Clinical Development Plans developed by the JDC for such Collaboration Product.

Related to International Registration Dossier

  • international registration means the registration of a mark effected under the Agreement or the Protocol or both, as the case may be;

  • International registration plan means a reciprocal agreement of member jurisdictions that is endorsed by the American association of motor vehicle administrators, and that promotes and encourages the fullest possible use of the highway system by authorizing apportioned registration of fleets of vehicles and recognizing registration of vehicles apportioned in member jurisdictions.

  • International Registry means the international registry established pursuant to the Cape Town Treaty.

  • Provisional registration means a building official, plan reviewer, or inspector who is registered subject to his or her completion of the amount of training, education, and experience required by the commission and the appropriate advisory board and described in section 1007(2).

  • International Register means the official collection of data concerning international registrations maintained by the International Bureau, which data the Agreement, the Protocol or the Regulations require or permit to be recorded, irrespective of the medium in which such data are stored;

  • Special Registration means the registration of (A) equity securities and/or options or other rights in respect thereof solely registered on Form S-4 or Form S-8 (or successor form) or (B) shares of equity securities and/or options or other rights in respect thereof to be offered to directors, members of management, employees, consultants, customers, lenders or vendors of the Company or Company Subsidiaries or in connection with dividend reinvestment plans.

  • Original Registration Statement. As used in this Agreement, the terms “amendment” or “supplement” when applied to the Registration Statement or the Prospectus shall be deemed to include the filing by the Company with the Commission of any document under the Exchange Act after the date hereof that is or is deemed to be incorporated therein by reference. All references in this Agreement to financial statements and schedules and other information which is “contained,” “included” or “stated” in the Registration Statement or the Prospectus (and all other references of like import) shall be deemed to mean and include all such financial statements and schedules and other information which is or is deemed to be incorporated by reference in or otherwise deemed under the Securities Act to be a part of or included in the Registration Statement or the Prospectus, as the case may be, as of any specified date; and all references in this Agreement to amendments or supplements to the Registration Statement or the Prospectus shall be deemed to mean and include, without limitation, the filing of any document under the Exchange Act which is or is deemed to be incorporated by reference in or otherwise deemed under the Securities Act to be a part of or included in the Registration Statement or the Prospectus, as the case may be, as of any specified date. At the time the Registration Statement was or will be originally declared effective and at the time the Company’s most recent annual report on Form 10-K was filed with the Commission, if later, the Company met the then-applicable requirements for use of Form S-3 under the Securities Act. During the Agency Period, each time the Company files an annual report on Form 10-K the Company will meet the then-applicable requirements for use of Form S-3 under the Securities Act.

  • National Registry means the National Registry of Practising Lawyers established under the National Mobility Agreement;

  • Registration Application means an application for registration of this Agreement as a planning agreement on the title of the Land pursuant to Section 7.6 of the Act in a form approved by the Registrar General;

  • Business registration means a business registration certificate issued by the Department of the Treasury or such other form or verification that a contractor or subcontractor is registered with the Department of Treasury;

  • Registration Agency on labour standards shall mean the Industrial Training Branch, Ministry of Labour. "Registration Agency" for the apprentice as a student, covering related instruction.

  • Product Registrations shall have the meaning set forth in Section 5.10 hereof.

  • Additional Registration Statement means a registration statement or registration statements of the Company filed under the 1933 Act covering any Additional Registrable Securities.

  • Special Registration Statement means (i) a registration statement relating to any employee benefit plan or (ii) with respect to any corporate reorganization or transaction under Rule 145 of the Securities Act, any registration statements related to the issuance or resale of securities issued in such a transaction or (iii) a registration related to stock issued upon conversion of debt securities.

  • Original Registration Rights Agreement has the meaning set forth in the recitals to this Agreement.

  • Initial Registration Statement means the initial Registration Statement filed pursuant to this Agreement.

  • Company IP Registrations means all Company Intellectual Property that is subject to any issuance registration, application or other filing by, to or with any Governmental Authority or authorized private registrar in any jurisdiction, including registered trademarks, domain names and copyrights, issued and reissued patents and pending applications for any of the foregoing.

  • New Registration Statement has the meaning set forth in Section 2(a).

  • Rule 462(b) Registration Statement means any registration statement prepared by the Company registering additional Securities, which was filed with the Commission on or prior to the date hereof and became automatically effective pursuant to Rule 462(b) promulgated by the Commission pursuant to the Securities Act.

  • Form S-4 Registration Statement means the registration statement on Form S-4 to be filed with the SEC by Parent in connection with issuance of Parent Common Stock in the Merger, as said registration statement may be amended prior to the time it is declared effective by the SEC.

  • certificate of registration means registration with the CPSBC that allows the Participant to practice medicine in British Columbia, other than the certificate of registration which allowed the Participant to enrol in Postgraduate Medical Education;

  • Central registry means the system maintained at the department that is used to keep a record of all reports filed with the department under this act in which relevant and accurate evidence of child abuse or child neglect is found to exist.

  • National Register has the same meaning as in section 3 of the National Act. National RTO Standards means the Standards for Registered Training Organisations (RTOs) 2015 (Cth) and its User Guide.

  • State of Registration means, in relation to an Aircraft at any time, the country or state on whose national register such Aircraft is registered at that time under the laws of such country or state in accordance with the applicable provisions of any Lease relating to such Aircraft or, in the absence of any such provisions, Applicable Law.

  • national regulatory authority means the body or bodies charged by a Member State with any of the regulatory tasks assigned in this Directive and the Specific Directives;

  • National Register of Historic Places means the list of districts, sites, buildings, structures and objects significant in American history, architecture, archaeology, engineering and culture, authorized by the National Historic Preservation Act of 1966, as amended, and administered by the U.S. Department of the Interior, National Park Service. The list of Properties on the National Register of Historic Places in Florida is available from the Division.