Supporting Data definition
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 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 means all data and information in the possession of either Party or Sublicensee relating to (i) the pharmacological or toxicological properties of any Licensed Product, (ii) pre-clinical or clinical testing and experience in relation to any 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 the Licensed Products.
Examples of Supporting Data in a sentence
Appendix A Request for: Date: Building: Contact Person: The Proposal: Data Providing Evidence of Need: Supporting Data for the Proposal: Cost of the Proposal (Initial and On-going): Other Options Considered and Why They Were Rejected: Follow-up Date and Data to be Provided: Date: May 16, 2007 Building: Elementary Contact Person: Super-Teacher ▇▇▇▇▇▇ scores have shown that an average of 20% of students score lower in the fall on the basic reading skills vs.
Supporting Data: Because the Product is being sold by Seller to Buyer to facilitate Buyer’s compliance with the California Renewables Portfolio Standard, including the requirements of Section 399.13(b) of the California Public Utilities Code and CPUC Decision D.▇▇-▇▇-▇▇▇, Seller will use reasonable efforts to assist Buyer, if necessary, in timely providing required data and/or documentation, as requested by jurisdictional regulatory authorities, to support Buyer’s compliance.
On an annual basis, within sixty (60) calendar days of receiving the District’s Annual Enrollment determination and Reasonable Supporting Data, (subject to the dispute resolution provisions as provided herein), Stanford shall provide the Per Pupil Payment to the District.
The contractor shall ensure that Information presented is consistent with information provided in the Monthly Invoice Supporting Data Report.
In the event that Supporting Data are not provided within this time period, Cell-Matrix may delay payment of [***] from the portion of the License Issue Fee that would otherwise be payable within thirty (30) days following the Effective Date under Section 6(a)(1) of this Agreement until such time as all of Supporting Data are received by Cell-Matrix.
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 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:
(i) the pharmacological or toxicological properties of any Product;
(ii) any pre-clinical or clinical testing and experience in relation to any Product, including but not limited to the clinical treatment authority records and all manufacturing and other information, including formulation and batch records, necessary for DOV to file a CTA to conduct a fed/fasted study of any Product that Biovail and any of its Affiliates have worked to develop since the effective date of the 2001 Agreement and efficiently to secure the services of a formulation and production vendor;
(iii) the chemical composition, manufacturing processes and quality control testing of any Product; and
(iv) all other discoveries, inventions, formulations, processes, methods, know-how, techniques, formulae, compositions, compounds, or applications, etc., relating to the DOV Patent made after the effective date of the 2001 Agreement.
Supporting Data means all data and information 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, synthesis, formulation, compounding, and manufacturing and quality control testing of any Licensed Product, to the extent reasonably required for purposes of any application for Marketing Authorization for a Licensed Product. 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 any Licensed Product, as well as, in general, data or information 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 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 shall have the meaning ascribed to that term in Section 5.01(a).
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.