Phase I/II Clinical Data Package definition

Phase I/II Clinical Data Package means the package containing all clinical study reports (including the final clinical study report), results and other data related to the completed Phase I/II Clinical Trial, including the Data Package Elements.
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Phase I/II Clinical Data Package means the package containing all clinical study reports (including the clinical study report prepared by Sangamo based on the clinical data as of the applicable database lock, either interim or final, prior to the first EOP2 Meeting), results and other data in existence as of the applicable database lock, either interim or final, prior to the first EOP2 Meeting (including but not limited to the trial master file and associated quality documentation and attestations to quality procedures) that is generated pursuant to the SB-525 Phase I/II Trial, including the data and documents set forth in Exhibit E (the “Data Package Elements”).
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Examples of Phase I/II Clinical Data Package in a sentence

  • Spark will be solely responsible for the assembly and delivery of the Phase I/II Clinical Data Package to Pfizer.

  • Upon conclusion of the Phase I/II Clinical Trial, Spark will prepare, complete and deliver to Pfizer the Phase I/II Clinical Data Package, including, with respect to the Phase I/II Clinical Trials, all elements set forth in Exhibit B (the “Data Package Elements”).

  • Upon [*], or as otherwise directed by the JSC, Sangamo shall begin preparation of the Phase I/II Clinical Data Package; Sangamo shall deliver the Phase I/II Clinical Data Package to Pfizer promptly following completion of the Phase I/II Clinical Data Package.

  • As between the Parties, Sangamo will be solely responsible for the assembly and delivery to Pfizer of the Phase I/II Clinical Data Package.