Product Filings definition

Product Filings means all filings, written representations, declarations, listings, registrations, reports or submissions with or to any Governmental Entity, including adverse event reports and all submitted data relating to each Product;
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Product Filings means all INDs, NDAs, XXXx, Regulatory Approvals, and other filings with, and formal submissions to, Regulatory Authorities, in each case, with respect to Product in any country or other jurisdiction.
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Product Filings shall have the meaning set forth in Section 1.1.
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Examples of Product Filings in a sentence

  • Mix and Match: These standards are available to be used in combination with State Product Components as described in Section 111(b) of the Operating Procedure for the Filing and Approval of Product Filings.

  • Mix and Match: These standards are available to be used in combination with State Product Components as described in Section 110(b) of the Operating Procedure for the Filing and Approval of Product Filings.

  • Failure to submit a plan of action to the IIPRC within 60 days or to comply with the time frame stated in the plan of action constitutes grounds for the IIPRC to withdraw or modify its approval of the Product Filing pursuant to Section 108 of the Operating Procedure for the Filing and Approval of Product Filings.

  • This Rule shall apply to the filing and approval of all Product Filings, except to the extent specifically provided herein.

  • The Commission hereby adopts the requirements and procedures established by SERFF with respect to Product Filings, as such may be amended from time to time, unless otherwise disapproved or modified by the Management Committee of the Commission.

  • Mix and Match: These standards are not available to be used in combination with State Product Components as described in Section 110(b) of the Operating Procedure for the Filing and Approval of Product Filings.

  • Mix and Match: These standards are available to be used in combination with State Product Components as described in § 111(b) of the Operating Procedure for the Filing and Approval of Product Filings.

  • Mix and Match: These standards are not available to be used in combination with State Product Components as described in § 111(b) of the Operating Procedure for the Filing and Approval of Product Filings.

  • Pursuant to Article X of the Model Interstate Insurance Product Regulation Compact (“Compact”), as enacted into law by each Compacting State, and Article III of the Bylaws of the Interstate Insurance Product Regulation Commission, this Operating Procedure (the "Rule") establishes the procedures for filing and approval of Product Filings with the Commission.

  • Required Findings: These standards are available for use in combination with State Product Components in accordance with the Operating Procedure for the Filing and Approval of Product Filings.


More Definitions of Product Filings

Product Filings means all applications in connection with Clinical Studies (including INDs), NDAs, BLAs, MAAs, Marketing Authorizations and Marketing Authorization Applications, Regulatory Approvals, establishment license applications, drug master files, applications for designation (including as an “Orphan Product(s)” under the Orphan Drug Act, for “Fast Track” status under Section 506 of the FD&C Act (21 U.S.C. § 356) or for a Special Protocol Assessment under Section 505(b)(4)(B) and (C) of the FD&C Act (21 U.S.C. § 355(b)(4)(B))), applications for pricing approval, any Patent-related filings with any Regulatory Authority or other Governmental Authority (including Patent offices) such as those in connection with a patent term extension or supplementary protection certificate, confirmed meeting requests, meeting minutes and correspondence, and other filings with, and formal submissions to, Regulatory Authorities, all supplements and amendments to any of the foregoing, and all other similar counterparts of any of the foregoing in any country or region in the Territory, in each case, with respect to the development, manufacture, and marketing and sale of Compound or Product in any country or other jurisdiction. 1.108 “Product Trademark” has the meaning set forth in Section 10.5.1. 1.109 “Prosecution and Maintenance” or “Prosecute and Maintain” means, with respect to a Patent, the preparation, filing, prosecution and maintenance of such Patent (including conducting and defending any opposition proceedings, interference proceedings, reissue proceedings, reexaminations, post-grant proceedings, supplemental examinations, inter partes review proceedings, derivation proceedings, and other similar administrative proceedings), but for clarity excluding any enforcement action with respect thereto. 1.110 “Receiving Party” has the meaning set forth in Section 9.1.
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Product Filings has the meaning ascribed to such term in Section 3.1.2.
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Product Filings means INDs, BLAs and Regulatory Approvals (including all amendments and supplements to any of the foregoing) and other filings with, and formal submissions to, the FDA or other applicable Regulatory Authorities, in each case with respect to the Product.
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Product Filings means all INDs, NDAs, MAAs, Regulatory Approvals, and other filings with, and formal submissions to, Regulatory Authorities, in each case, with respect to Product in any country or other jurisdiction.
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Product Filings means any Product Regulatory Documents that, as at Closing, are not Marketing Approvals.
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Related to Product Filings

  • Company Filings means all documents of the Company publicly filed under the profile of the Company on the System for Electronic Document Analysis Retrieval (SEDAR).

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • SEC Filings has the meaning set forth in Section 4.6.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture, market, sell or otherwise commercialize a product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, XXXx and NDAs (as applications, but not the approvals with respect thereto).

  • 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.

  • Regulatory Filing means all approvals, clearances, licenses, registrations, submissions and authorizations made to or received from a Regulatory Authority necessary for the development, manufacture or commercialization of a medical device and/or pharmaceutical product, including any investigational new drug applications, clinical trial applications, drug master files, device master files and Marketing Approvals.

  • Product Know-How means Know-How

  • Course Materials means lectures, exercises designed for online collaboration, multimedia developed for Web distribution, notes, outlines, syllabi, bibliographies, tests, instructional handouts, videotaped presentations and any like materials and documents (whether in electronic or other medium) that a member of the bargaining unit authors or creates in connection with the preparation or teaching of a course at a University.

  • Product Information has the meaning specified in Section 10.12(a).

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • Study Data means all data, databases, documents, reports and other information resulting from, collected or developed in the performance of the Study;

  • 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.

  • SAP Materials means any software, programs, tools, systems, data, or other materials made available by SAP or any other member of the SAP Group to Partner or to an End User (either directly or indirectly via Partner) prior to or in the course of the performance under any part of this Agreement including, but not limited to, the other SAP Products.

  • Filings the filing or recording of (i) the Financing Statements as set forth in Schedule 3, (ii) this Agreement or a notice thereof with respect to Intellectual Property as set forth in Schedule 3, and (iii) any filings after the Closing Date in any other jurisdiction as may be necessary under any Requirement of Law.

  • Third Party Materials means any materials and information, including documents, data, know-how, ideas, methodologies, specifications, software, content, and technology, in any form or media, in which any Person other than the State or Contractor owns any Intellectual Property Right, but excluding Open-Source Components.

  • 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 Documentation means all applications, registrations, licenses, authorizations and approvals (including all Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), all supporting documents and all Clinical Trials and tests, including the manufacturing batch records, relating to a Product, and all data contained in any of the foregoing, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.

  • 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).

  • Third Party Material means software, software development tools, methodologies, ideas, methods, processes, concepts and techniques owned by, or licensed to a third party and used by the Service Provider in the performance of the Services;