FRI Data Package definition

FRI Data Package means non-clinical data, clinical data, quality data, and any other related information generated and controlled by FRI at any time and related to the Product, including without limitation, protocols, data analyses and reports for the Study, and pharmacology, toxicology, absorption, distribution, metabolism and excretion (ADME) and safety information or regulatory information related to the Product.
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Related to FRI Data Package

  • Data Package has the meaning set forth in Section 2.9(a).

  • Clinical Data means the information with respect to the Licensed Product or the Licensed Compound made, collected or otherwise generated under or in connection with pre-clinical, clinical, or the post-Approval studies for the Licensed Compound or Licensed Product, including any data, reports and results with respect to any of the foregoing.

  • 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.

  • Work package means a major sub-division of the proposed project.

  • Third-party filer means an entity that submits a Product filing to the Commission on behalf of an Insurer.