Supporting Data means all data and information in the possession of either Party or any permitted sublicensee of a Party relating to (i) the pharmacological or toxicological properties of a Licensed Product, (ii) pre-clinical or clinical testing and experience in relation to a Licensed Product which is not included in any Health Registration Dossier and (iii) to the extent reasonably required for purposes of any application for Marketing Authorization, the chemical composition, manufacturing processes and quality control testing of a Licensed Product.
Supporting Data has the meaning specified in Section 3.03(d)(1) of the Loan Agreement.
Supporting Data means all data and information owned or controlled by Biovail and/or Biovail Labs relating to:
Examples of Supporting Data in a sentence
Excluding Confidential Information of {---Vendor Reference Name---} (as defined in this Contract), the City shall be permitted to reproduce, copy, duplicate, disclose, or use the Supporting Data for any purpose, and it shall be treated as a public record under North Carolina law.
Supporting Data Additional Supporting Information may be found in the online version of this article at the publisher’s web-site.
Understanding the integration of the Supporting Data, Logic Specification, and processing model.
Supporting Data Attached: Yes No Technical data, including laboratory tests, if applicable.
Differences between proposed substitution and specified product: Reason for not providing specified item: Similar Installation: Project: Architect: Address: Owner: Date Installed: Proposed substitution affects other parts of work: No Yes, Explain Supporting Data Attached: Drawings Product Data Samples Tests Reports Other The undersigned certifies: • Proposed substitution has been fully investigated and determined to be equal or superior in all respects to the specified product.
More Definitions of Supporting Data
Supporting Data means all data and information relating to (i) the pharmacological or toxicological properties of any Compound, (ii) any pre-clinical or clinical testing and experience in relation to any Compound and (iii) the chemical composition, synthesis, formulation, compounding, and manufacturing and quality control testing of any Product, to the extent reasonably required for purposes of any application for Regulatory Approval for a Product. Supporting Data will also include, but is not limited to, copies of annual reports, integrated study reports, protocols for clinical research and pre-clinical studies, protocol changes and amendments, Chemistry, Manufacturing and Control (CMC) sections and amendments, safety data, clinical databases, case report forms and access to patient records, toxicity, safety and metabolism reports and data, and pharmacokinetic data and reports and relating to any Product, as well as, in general, data or information which would typically be part of any submission to FDA or other Regulatory Agency for the purpose of obtaining approval of any Product for any indication.
Supporting Data means all data and information relating to (a) the pharmacological or toxicological properties of the Products, (b) any pre-clinical or clinical testing and experience in relation to the Products and (c) the chemical composition, synthesis, formulation, compounding, and Manufacturing and quality control testing of the Products, to the extent reasonably required for purposes of any application for Marketing Authorization for the Products. Supporting Data shall also include, but is not limited to, copies of annual reports, integrated study reports, protocols for clinical research and pre-clinical studies, protocol changes and amendments, Chemistry, Manufacturing and Control (“CMC”) sections and amendments, safety data, clinical databases, case report forms and access to patient records, toxicity, safety and metabolism reports and data, and pharmacokinetic data and reports and relating to the Products, as well as, in general, data or information * Denotes confidential information that has been omitted from the exhibit and filed separately, accompanied by a confidential treatment request, with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. which would typically be part of any submission to FDA or other Regulatory Authority for the purpose of obtaining approval of the Products for any indication.
Supporting Data means the documentation that forms the basis of the Construction Estimate including utility relocation informational plan sheets, Utility timetables and any Utility specifications;
Supporting Data. We refer to the data necessary to reproduce the published conclusions, including but not limited to original electron micrographs or particle images entering in the 3D reconstruction process, raw (time-domain) or processed (frequency-domain) NMR spectral data, diffraction data or other data arising from the use of X-ray sources;
Supporting Data means all data and information relating to (i) the pharmacological or toxicological properties of any Product, (ii) any pre-clinical or clinical testing and experience in relation to any Product and (iii) the chemical composition, synthesis, formulation, compounding, and manufacturing and quality control testing of any Product, to the extent reasonably required for purposes of any application for Regulatory Approval for a Product. Supporting Data will also include, but is not limited to, copies of annual reports, integrated study reports, protocols for clinical research and pre-clinical studies, protocol changes and amendments, Chemistry, Manufacturing and Control (CMC) sections and amendments, safety data, clinical databases, case report forms and access to patient records, toxicity, safety and metabolism reports and data, and pharmacokinetic data and reports and relating to any Product, as well as, in general, data or information which would typically be part of any submission to FDA or other Regulatory Agency for the purpose of obtaining approval of any Product for any indication.
Supporting Data means all data and information owned or controlled by either party or a sublicensee of either party relating to (i) the pharmacological or toxicological properties of any Licensed Product, (ii) any pre-clinical or clinical testing and experience in relation to any Licensed Product and (iii) the chemical composition, manufacturing processes and quality control testing of any Licensed Product, to the extent reasonably required for purposes of any application for Marketing Authorization. Supporting Data shall also include, but is not limited to, copies of annual reports, integrated study reports, protocols for clinical research and GLP pre-clinical studies, protocol changes and amendments, CMC sections and amendments, safety data, CRO databases, case report forms and access to patient records, GLP toxicity, safety and metabolism reports and data, and GLP pharmacokinetic data and reports owned or controlled by either party or a sublicensee of either party and relating to any Licensed Product, as well as, in general, data or information owned or controlled by either party or a sublicensee of either party which would be useful for a person pursuing clinical research and regulatory approval, or which would typically be part of any submission to FDA or other Regulatory Authority for the purpose of obtaining approval of any Licensed Product for any indication.
Supporting Data means all data and information owned or controlled by either Party relating to (i) the pharmacological or toxicological properties of any Product, (ii) any pre-clinical or clinical testing and experience in relation to any Product and (iii) the chemical composition, manufacturing processes and quality control testing of any Product, to the extent reasonably required for purposes of any application for Marketing Authorization. Supporting Data shall also include copies of annual reports, integrated study reports, protocols for clinical research and pre-clinical studies, protocol changes and amendments, safety data, contract research organization databases, case report forms and access to patient records, toxicity, safety and metabolism reports and data, and pharmacokinetic data and reports owned or controlled by DOV or a sublicensee of DOV and relating to any Product that would be useful for a person pursuing clinical research and regulatory approval, or that would typically be part of any submission to a Regulatory Authority for the purpose of obtaining approval of a Product for the indication in question.