Product Regulatory Materials definition

Product Regulatory Materials means all written notices, submissions, reports, documentation, medical letters, the Product safety database, and correspondence between Sellers, on the one hand, and Governmental Entities in the United States, including the FDA, on the other hand, in each case only to the extent the material and (i) is necessary for the development, manufacture, distribution, marketing or sale of the Product in the United States as such activities are conducted by Sellers as of immediately prior to the Closing, (ii) relates solely to the MA or the Product, and (iii) is maintained by or otherwise in the possession of Sellers as of the Closing Date or which are received by Sellers subsequent to the Closing Date.
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Product Regulatory Materials means (a) all adverse event reports and other data, information and materials relating to adverse experiences with respect to each Product; (b) all written notices, filings, communications or other correspondence between any Endo Company, on the one hand, and any Governmental Authority, on the other hand, relating to each Product, including any safety reports or updates, complaint files and product quality reviews, and clinical or pre-clinical data derived from clinical studies conducted or sponsored by an Endo Company, which data relates to each Product; (c) all other information regarding activities pertaining to each Product’s compliance with any law or regulation of any jurisdiction, including audit reports, corrective and preventive action documentation and reports, and relevant data and correspondence, maintained by or otherwise in the possession of any Endo Company as of the date hereof and (d) all Product Approvals.
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Product Regulatory Materials means all Regulatory Materials developed by DRL or any of its Affiliates, solely, or jointly with Journey, in the execution of the Development Plan, and any Regulatory Materials developed by DRL and submitted to FDA in connection with Regulatory Authority approval for Products (which, for the avoidance of doubt, includes the 20 mg and 40 mg products described in the IND), including all Regulatory Materials that reference the IND and that were developed prior to the Transfer Date.
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Examples of Product Regulatory Materials in a sentence

  • As soon as practical after the Closing Date and in no event more than sixty (60) days following the Closing Date, Seller shall deliver to Buyer or to an Affiliate of Buyer as directed by Buyer, in physical and electronic form, the Product Regulatory Materials and Books and Records.

  • KKUS shall be entitled to retain copies of the NDA, the IND, Product Records, Product Regulatory Materials and Marketing and Promotional Material in order to comply with its legal obligations.

  • Neither any Credit Party nor any of its Restricted Subsidiaries is in violation, in any material respect, of (a) the Trading with the Enemy Act, (b) any of the foreign assets control regulations of the United States Treasury Department (31 CFR, Subtitle B, Chapter V, as amended) or any enabling legislation or executive order relating thereto, (c) the USA PATRIOT ACT (Title III of Pub.


More Definitions of Product Regulatory Materials

Product Regulatory Materials means all written notices, submissions, reports, documentation, medical letters, the Product safety database, and correspondence between KKUS, on the one hand, and Governmental Authorities in the Territory, including the FDA, on the other hand, in each case only to the extent the material (i) is necessary for the development, manufacture, distribution, marketing or sale of the Product in the Territory as such activities are conducted by KKUS as of sixty (60) days prior to the Effective Date, (ii) relates solely to the NDA or the Product, and (iii) is maintained by or otherwise in the possession of KKUS as of the Closing Date or which are received by KKUS subsequent to the Closing Date.
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Product Regulatory Materials means (a) all adverse event reports and other data, information and materials relating to adverse experiences with respect to the Product in the Territory; and (b) all written notices, communications or other correspondence between Seller, on the one hand, and any Governmental Entity, on the other hand, relating to the Product in the Territory, including any safety reports or updates, complaint files and product quality reviews, all clinical or pre-clinical data derived from clinical studies conducted or sponsored by Seller, which data relates to the Product in the Territory and is maintained by or otherwise in the possession of Seller as of the Closing Date.
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Product Regulatory Materials means (a) all adverse event reports and other data, information and materials relating to adverse experiences with respect to each Product in the Territory; (b) all written notices, filings, communications or other correspondence between Seller, on the one hand, and any Governmental Entity, on the other hand, relating to each Product in the Territory, including any safety reports or updates, complaint files and product quality reviews, and clinical or pre-clinical data derived from clinical studies conducted or sponsored by Seller, which data relates to each Product in the Territory; and (c) all other information regarding activities pertaining to each Product’s compliance with any law or regulation of any jurisdiction in the Territory, including audit reports, corrective and preventive action documentation and reports, and relevant data and correspondence, maintained by or otherwise in the possession of Seller as of the Closing Date.
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Related to Product Regulatory Materials

  • 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).

  • 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 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.

  • 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.

  • 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 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.

  • 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.

  • IP Materials has the meaning given to it in clause E8.1 (Intellectual Property Rights).

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

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

  • 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.

  • API means American Petroleum Institute.

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

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

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

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

  • 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.