Registration Dossiers definition

Registration Dossiers means any and all information, processes, techniques, and data relating to the Product that are necessary to obtain a Marketing Authorization.
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Registration Dossiers means and include dossiers filed by Organon in the Territory with the relevant government institutions for the purpose of obtaining marketing approval for the Product in the name of Organon or its Affiliated Companies.
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Registration Dossiers means any and all information, processes, techniques, and data in Agent's possession relating to the Finished Products as far as required to obtain Product Approval.
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Examples of Registration Dossiers in a sentence

  • In all cases, the payments indicated cover access, as specified, to the Registration Dossiers and/or Information as these stand only, and with no guarantee of their validity or acceptance by the Agency.

  • In all cases, no rights of access to the Registration Dossiers or to any other Information can be claimed by a Non-Lead Member purchasing access rights, until: - all payments due have been effectively made and received; - the Non-Lead Member has given its consent to this Agreement and to the conditions of access.

  • Esperion shall provide to DS, [***] basis through the JCC, an update on the progress of the Pre-Approval Clinical Studies and the preparation for the Registration Dossiers in South Korea and Taiwan.

  • Plus, in accordance with the new requirements of IUCLID 6, the LR will also submit a ‘boundary composition’ detailing the composition as specified in the relevant SIP.(WW)  Only applicable for classified substances: This information is not included in the Registration Dossiers submitted for the IP or STPP Consortia for 2010 substances (using IUCLID 5.3).

  • To obtain access to the Registration Dossier(s) developed by the IP Consortium, the Non- Lead Member party must pay the Joint Registration Compensation (in effect, the cost of Letter of Access) consisting of the total of the following two amounts as defined below:  the Advantage Compensation Payment,  and the Dossier Costs Contribution (Pro Rata Share), both calculated for each of the IP Consortium substance dossier(s) to which the Member wishes to have access.

  • The Lead Registrants shall ensure that all confidential information in the Registration Dossiers is marked as such and shall submit to the Agency any requested justification for non-disclosure of Registration Dossier information.

  • The Steering Committee shall be authorised to negotiate and grant licenses to Third Parties to use or refer to Data, Studies and/or the Registration Dossiers for appropriate compensation pursuant to Section 13.

  • The prize is not transferable, but may be exchanged for cash or a cheque at the winner’s election.

  • This is supported by the fact that, as stated in the Registration Dossiers for Pigment Blue 15 and Pigment Green 7, “the National Toxicology Program (NTP) decided not to conduct a long term bioassay on phthalocyanine blue and green pigments based upon the results of their own 90-day feeding study conducted on mice and rats.

  • The license shall entitle the licensee to obtain a copy of the Registration Dossiers, to refer to and use the Registration Dossiers as well as all Data and/or Studies acquired, licensed, developed or contracted or obliged for by the Consortium pursuant to Section 10 as necessary to obtain such Registrations or approvals that are required to manufacture, sell or import the Substances in or into the EU or in or into other jurisdictions or otherwise to prepare any data, subject to the terms of the NDA.


More Definitions of Registration Dossiers

Registration Dossiers means any and all the files, dossiers, authorizations, approvals and any documents of any kind whatsoever required by the competent authorities to grant the Marketing Authorizations.
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Registration Dossiers means any and all scientific, technical and manufacturing data and documentation owned or controlled by the Seller that is necessary or otherwise useful to obtain, maintain and renew the Regulatory Approvals and to manufacture and commercialize the Products.
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Registration Dossiers in Common Technical Document (CTD) format, shall mean the dossier(s) of scientific documentation, qualitative and quantitative data, preclinical and clinical information that is required by Registration Authorities as documented evidence of the safety and efficacy of the Product when used for its intended purpose(s).
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Related to Registration Dossiers

  • 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;

  • Registration Document means a written instrument issued by the department to publicly document that the registrant has complied with this chapter and the applicable rules and standards as prescribed by the department.

  • Registration Data means certain personal and financial information that you are required to provide in order to complete the Account Opening Application Form and become our Client, such information can include without limitation a copy of your passport, driving license and/or Photo identity card.

  • Registration decal means an adhesive sticker produced by the department and issued by the

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

  • Registration Books means the records maintained by the Trustee pursuant to Section 2.08 for the registration and transfer of ownership of the Bonds.

  • Registration Form means a book voter registration form and a by-mail voter

  • Registration Filing Date means the date that is 60 days after date of the final closing of the PPO.

  • 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.

  • 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;

  • 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).

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

  • registration refer to a registration effected by preparing and filing a registration statement in compliance with the Securities Act, and the declaration or ordering of the effectiveness of such registration statement.

  • 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.

  • 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.

  • 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.

  • Registration Rights Agreements means that certain Registration Rights Agreement dated as of the Closing Date by and between the Parent and Laurus and each other registration rights agreement by and between the Parent and Laurus, as each of the same may be amended, modified and supplemented from time to time.

  • Registration Rights Agreement means the Registration Rights Agreement, dated the date hereof, among the Company and the Purchasers, in the form of Exhibit B attached hereto.

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

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

  • 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.

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

  • Registration Notice has the meaning specified in Section 2.1(a).

  • S-3 Registration has the meaning set forth in Section 5(a) of this Agreement.

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

  • Registration Statement means any registration statement that covers the Registrable Securities pursuant to the provisions of this Agreement, including the Prospectus included in such registration statement, amendments (including post-effective amendments) and supplements to such registration statement, and all exhibits to and all material incorporated by reference in such registration statement.