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.
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2
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.
Sample 1Sample 2

Examples of Product Regulatory Materials in a sentence

  • 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.

  • Commission Determination‌ We are not persuaded by the arguments raised on rehearing.

  • 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.


More Definitions of Product Regulatory Materials

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.
Sample 1
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.
Sample 1

Related to Product Regulatory Materials

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • 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.

  • 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 Filings means all applications, filings, dossiers and the like submitted to a Regulatory Authority in a particular jurisdiction for the purpose of obtaining Regulatory Approval of a Licensed Product from that regulatory authority with respect to such jurisdiction. Regulatory Filings shall include, but not be limited to, all INDs and Drug Approval Applications for Licensed Product.

  • 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, 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 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.

  • SAP Materials means any materials (including statistical reports) provided, developed or made available by SAP (independently or with Customer’s cooperation) in the course of performance under the Agreement, including in the delivery of any support or Professional Services to Customer. SAP Materials do not include the Customer Data, Customer Confidential Information or the Cloud Service. SAP Materials may also be referred to in the Agreement as “Cloud Materials”.

  • 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 Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study, but excluding the Institution’s ordinary patient records.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

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

  • DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • 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;

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

  • Product Know-How means Know-How to the extent related to the properties, manufacture or use of any products.

  • 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 the American Petroleum Institute.

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

  • 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.

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

  • Third Party Materials means materials and information, in any form or medium, including any software, documents, data, content, specifications, products, equipment or components of or relating to the Services that are not proprietary to NCIT.

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