Product Regulatory Filings definition

Product Regulatory Filings means all submissions to a Governmental Authority for products or substances, including raw materials to make the products, including but not limited to new chemical, substance, biocide or pesticide notifications and registrations under TSCA, FIFRA, Canadian new substance notifications, biocide or pesticide notifications and registrations, pre-registrations and registrations under REACH, China new substance notifications or other foreign jurisdictional equivalents.
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Product Regulatory Filings means Investigational New Drug Application No. 25,512 and the (rejected) New Drug Application No. 19,203, as filed with the FDA, and all supplements, amendments and revisions thereto.
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Product Regulatory Filings has the meaning set forth in Section 2.2.6.
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Examples of Product Regulatory Filings in a sentence

  • The NPV of debt makes it possible to sum up loans with different maturities.

  • Issues regarding the interpretation or application of this policy are to be referred to the Toronto Office of Partnerships.

  • On the Closing Date, each of the parties hereto shall take any actions necessary to effect the transfer of the INDs included in the Product Regulatory Filings from Seller to Purchaser, including notices to the FDA regarding such transfer from Seller to Purchaser.

  • For clarity, Catalyst shall have no obligation to maintain any of the Licensed Product Regulatory Filings transferred to Catalyst hereunder.

  • Figure 7: (a) Q, Rg and (b) Q, Ehb scatter plots at the folding temperature (kF = 0.658).

  • In addition to the foregoing, and to the extent permitted by Third Party confidentiality obligations and applicable laws and regulations, Glenveigh shall use Commercially Reasonable Efforts to disclose to Protherics in good faith any findings of which it becomes aware regarding digoxin immune Fab, and Protherics may use such findings regarding digoxin immune Fab to support Product Regulatory Filings, and for marketing and other commercialization activities pertaining to the Product.

  • It is the goal of the Project to use the Program Data as clinical support for Product Regulatory Filings and to gain approval to commercialize the Product for the Indication in the Territory.

  • Jacobus shall be entitled to retain a copy of the Licensed Product Regulatory Filings transferred to Catalyst hereunder and if Catalyst does not maintain such Regulatory Filings, Catalyst will provide Jacobus a copy of any sequences Catalyst files after the Closing Date for the Firdapse NDA and any INDs for Firdapse.

  • Protherics may (i) reprint such Product-related analyses, Data, Product-related reports and Regulatory Filings of Glenveigh for use and/or incorporation into Product Regulatory Filings of Protherics; and (ii) quote or describe data and information contained in such Product-related analyses, Data, Product-related reports and Regulatory Filings of Glenveigh in Product Regulatory Filings of Protherics; in all cases subject to Third-Party confidentiality restrictions as may exist.

  • Culture is often partitioned between different language groups; the existence of separate language implies a separation of culture.

Related to Product Regulatory Filings

  • 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.

  • 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.

  • 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.

  • Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.

  • 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 Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • 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.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Regulatory Documentation means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that include Clinical 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.

  • Product Labeling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • 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.

  • 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.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Regulatory Documents means the prospectus, annual report, semi-annual report and any other document required under applicable federal securities law to be delivered by the Trust to Fund shareholders.

  • Marketing Materials has the meaning ascribed thereto in NI 41-101;

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Product Approval(s) means any approvals, 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, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

  • Study Data shall have the meaning set forth in Section 8.1.

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • FDA means the United States Food and Drug Administration and any successor agency thereto.