DGF [*] Report definition
DGF [*] Report has the meaning set forth in the Option Agreement.
DGF [*] Report means the complete, signed, detailed, data cleaned, statistically analyzed, unbiased, unblinded and cGCP audited and compliant interim report(s) of the DGF Phase II Trial setting forth patient outcomes for [*] following dosing based on a fully monitored, cleaned, QA/QC assessed and locked database, the format and content of which shall be in accordance with the ICH E3 Guidelines, and which shall include all available raw data in a user-friendly electronic format, as well as primary and secondary efficacy endpoint data, all efficacy, safety, clinical and medical data, and any other information related thereto, including all available top line data relating to patient and graft survival, Serious Adverse Event (SAE) listings (including biopsy proven acute rejections) and adverse events (AE) listings based on the unlocked database for the period beyond the [*] locked data.
Examples of DGF [*] Report in a sentence
Quark shall promptly respond in writing to any questions Novartis may have regarding the DGF DMC Top Line Interim Report, the AKI First Interpretable Results, the DGF [*] Report or the AKI Final Report, as applicable, and the report provided under Section 3.5(b), and shall promptly provide or make available any additional information relating thereto requested by Novartis, in any case, within [*] following any such questions and/or request.