Completed Regulatory Filings definition

Completed Regulatory Filings means any and all filings, reports, registrations or other communications made with any Governmental Authority in order to obtain or maintain Regulatory Approvals of the Product.
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Examples of Completed Regulatory Filings in a sentence

  • Subject to Section 4.4, should Purchaser elect to modify its Completed Regulatory Filings with respect to the Product that would impact Manufacturer’s rights, duties or obligations hereunder, Purchaser shall inform Manufacturer of any such changes in a timely manner to allow both parties to develop a joint strategy to secure the appropriate regulatory approvals prior to filing such changes with the applicable Governmental Authority.

  • Subject to Section 4.4, should Manufacturer elect to modify its Completed Regulatory Filings (including the DMF) with respect to the Product, Manufacturer shall inform Purchaser of any such changes in a timely manner to allow both parties to develop a joint strategy to secure the appropriate regulatory approvals prior to filing such changes with the applicable Governmental Authority.

  • If such modification by Purchaser increases Manufacturer’s cost with respect to the Product, including testing, retesting, or reprocessing, or would require a modification to Manufacturer’s Completed Regulatory Filings with respect to the Product, such costs shall be borne by Purchaser.

  • If such modification by Manufacturer increases Purchaser’s cost with respect to the Product, including testing, retesting, or reprocessing, or would require a modification to Purchaser’s Completed Regulatory Filings with respect to the Product, such costs shall be borne by Manufacturer.

  • It is the responsibility of a maintainer to ensure that patches are reviewed and to provide anack or nack of those patches as appropriate.

  • Subject to Section 4.4, should Purchaser elect to modify its Completed Regulatory Filings with respect to the Product that would impact Packager’s rights, duties or obligations hereunder, Purchaser shall inform Packager of any such changes in a timely manner to allow both parties to develop a joint strategy to secure the appropriate regulatory approval(s) prior to filing such changes with the applicable Governmental Authority.

  • If such modification by Purchaser increases Packager’s cost with respect to the Product, including testing, retesting, or reprocessing, or would require a modification to Packager’s Completed Regulatory Filings with respect to the Product, such costs shall be borne by Purchaser.

  • Subject to Section 4.4, should Packager elect to modify its Completed Regulatory Filings with respect to the Product, Packager shall inform Purchaser of any such changes in a timely manner to allow both parties to develop a joint strategy to secure the appropriate regulatory approval(s) prior to filing such changes with the applicable Governmental Authority.

Related to Completed Regulatory Filings

  • 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 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.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required 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 Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • 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.

  • IND means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the equivalent agency in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

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

  • 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).

  • 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).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

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

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

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • 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.

  • 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.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

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

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.