Product Registration Data definition

Product Registration Data means (i) all regulatory files relating to the registration of the Business Products in Seller’s possession or control, including any licenses, minutes of meetings and telephone conferences with any Governmental Entity, validation data, data from and documentation related to preclinical and clinical studies and tests of the Business Products, including original data, case report forms, study files relating to the aforementioned studies and tests, and all audit reports of clinical studies, plus all applications (and amendments thereto) for regulatory approvals, annual reports and safety reports associated therewith, drug master files, trial master files and all written correspondence with Governmental Entities regarding the marketing status of the Business Products; and (ii) all records maintained under cGMPs or other record keeping or reporting requirements of Governmental Entities, including all written correspondence and communications with Governmental Entities regarding the manufacture of the Business Products, adverse event files, complaint files and manufacturing records.
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Product Registration Data means, to the extent solely related to a Product and owned by and in the possession and control of Sellers as of the Closing Date, the following (including electronic copies where no hard copies exist): (i) all regulatory files relating thereto, other than the Marketing Authorizations, Purchased DMFs and Purchased INDs, including, but not limited to, any Permits (to the extent transferable), and minutes of meetings and telephone conferences with the FDA, validation data, preclinical and clinical studies and tests related to the applicable Product, and all audit reports of clinical studies, plus all annual reports and safety reports associated therewith, drug master files, FDA approvals for export, documents relating to Phase IV studies and pediatric studies, and all correspondence with the FDA regarding the marketing status of such applicable Product; and (ii) all records maintained under current good manufacturing practices or other record keeping or reporting requirements of the FDA, the DEA, the Occupational Safety and Health Administration or any other Governmental Body, including, but not limited to, FDA warning letters, FDA Notices of Adverse Finding Letters, FDA audit reports (including any comments on such reports), all other correspondence and communications with regulatory agencies in connection with such Product (including any advertising and promotion documents and 2253 forms), adverse event files, complaint files and manufacturing records.
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Product Registration Data means the data, information and studies relating to a particular active ingredient and its formulations, including its impurities or metabolites, which have been submitted to a Governmental Body in support of an application for a Product Registration.
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Examples of Product Registration Data in a sentence

  • Seller is the sole and exclusive owner of all Regulatory Filings and Product Registration Data.

  • The Product Registration Data constitutes all data included in the Regulatory Filings.

  • EpiCept possesses or controls all material EpiCept Product Registration Data.

  • BioZone possesses or controls all material BioZone Product Registration Data.

  • Sellers possess or control all Product Registration Data except for Product Registration Data which, if not possessed or controlled by Sellers, would not have a Material Adverse Effect.

  • After the Effective Date of Termination, Immune shall retain exclusive rights to EpiCept Improvements, EpiCept Product Registration Data, EpiCept Technology, and EpiCept Trademarks .

  • Each party shall cooperate with the other party in good faith in connection with obtaining and maintaining all Regulatory Approvals as described in this Section 3.1(a), including, in the case of EpiCept, providing all EpiCept Product Registration Data and other information reasonably requested by MEDA to prepare applications for Regulatory Approvals and assisting MEDA in responding to any inquiries from Regulatory Authorities.


More Definitions of Product Registration Data

Product Registration Data shall have the meaning set forth in Section 2.1(e).
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Product Registration Data means the existing and available dossiers used by Novartis and/or its Affiliates at the Closing Date to obtain and maintain the Transferred Product Registrations in the Territory.
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Product Registration Data means (a) the trial master file and all regulatory files relating to the Licensed Product, including any licenses (to the extent transferable), and minutes of meetings and telephone conferences with any Regulatory Authorities, validation data, preclinical and clinical studies and tests (and their respective study files), original data, case report forms, and all audit reports of clinical studies, plus all applications (and amendments thereto) for Regulatory Approvals, annual reports and safety reports associated therewith, drug master files, which in each such case are in the possession or control of Pipex or its Affiliates, and all correspondence with Regulatory Authorities regarding the marketing status of the Licensed Product; and (b) all records maintained under cGCP or other record keeping or reporting requirements of Regulatory Authorities in the Territory, including all correspondence and communications with Regulatory Authorities in connection with the Licensed Product (including any advertising and promotion documents), adverse event files, complaint files, manufacturing records.
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Related to Product Registration Data

  • Product Registrations means all registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, or sale of the Product within the Geographic Territory, including all Applications in existence for the Product as of the Closing Date.

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

  • Central Contractor Registration (CCR) database means the primary Government repository for Contractor information required for the conduct of business with the Government.

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.

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

  • DMF means a drug master file, as provided for in 21 CFR § 314.420 or similar submission to or file maintained with the FDA or other Governmental Authority or Regulatory Authority that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Product Trademark means (a) any trademark or trade name, whether or not registered, or any trademark application, renewal, extension or modification thereto, in the Territory, or any trade dress and packaging, that is applied to or used with Products by Xxxxxx and (b) all goodwill associated therewith, and any promotional materials relating thereto.

  • Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.

  • Regulatory Materials means, with respect to a Licensed Product for any particular indication in any particular jurisdiction, regulatory applications and submissions (and any supplements or amendments thereto), and any notifications, communications, correspondence, registrations, drug master files, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority, including BLAs and INDs, as applicable, that relate to such Licensed Product in such jurisdiction. Regulatory Materials also include presentations, responses, and applications for Regulatory Approvals.

  • Direct Registration System means the system for the uncertificated registration of ownership of securities established by The Depository Trust Company ("DTC") and utilized by the Depositary pursuant to which the Depositary may record the ownership of ADRs without the issuance of a certificate, which ownership shall be evidenced by periodic statements issued by the Depositary to the Holders entitled thereto. For purposes hereof, the Direct Registration System shall include access to the Profile Modification System maintained by DTC which provides for automated transfer of ownership between DTC and the Depositary.

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • End User Data means any information or data of any kind that personally identifies (or that can be used, together with other information or data, to personally identify) an End User.

  • 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;

  • Product Trademarks means the trademarks, service marks, accompanying logos, trade dress and indicia of origin used in connection with the distribution, marketing, Promotion and sale of each Licensed Product in the Territory. For purposes of clarity, the term Product Trademarks shall not include the corporate names and logos of either Party and shall include any internet domain names incorporating such Product Trademarks.

  • UNICEF Data means any and all information or data in digital form or processed or held in digital form that

  • Target Registration Date shall have the meaning set forth in Section 2(d) hereof.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Direct Registration ADR means an ADR, the ownership of which is recorded on the Direct Registration System. References to "ADRs" shall include certificated ADRs and Direct Registration ADRs, unless the context otherwise requires. The form of ADR is hereby incorporated herein and made a part hereof; the provisions of the form of ADR shall be binding upon the parties hereto.

  • 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 Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Licensed Data means the data licensed by the LME to the Licensee set out in the Order Form and further defined in Schedule 1 (Licensed Data);

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

  • Licensee Data means, other than Resultant Data, information, data and other content, in any form or medium, that is collected, downloaded or otherwise received, directly or indirectly from Licensee or an Authorized User by or through the Services.

  • Drug Master File or “DMF” is described in 21 C.F.R. Part 314.420. A DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.