Clinical Data Package Clause Samples
Clinical Data Package. The “Clinical Data Package” is defined as all information in OPKO’s possession or control, and all information available through access provided to Pfizer that can be obtained by OPKO using Commercially Reasonable Efforts including all non-clinical trial and clinical trial data that relates to the Development of any Compound or Licensed Product, including provision of the following to Pfizer by OPKO (a) the definitions and attributes that comprise the Clinical Data Package, (b) the data quality management and validation processes that underlie the clinical trials in the Clinical Data Package and any database in which such Clinical Data Package is maintained, (c) the methodologies that have been utilized in converting source data into output (derived) data in connection with the Clinical Data Package, (d) the relevant statistical analysis assumptions or plans for the clinical trials in the Clinical Data Package, (e) audit history of the clinical trials in the Clinical Data Package and the database in which it is maintained, (f) all data, including appropriately de-identified subject-level records, raw datasets, compiled data (derived statistical data sets) and trial master files (including other documentation as determined by Pfizer clinical data management, including versions of medical coding dictionaries used, statistical programs to produce tables, listings, and figures, Statistical Analysis Plan, Data Management Plan, statistical programming plan and other Trial Master File documents) and (g) all databases, including the safety database and non-clinical and clinical databases used for development through the clinical trials.
Clinical Data Package. The “Clinical Data Package” is defined as all information in OPKO’s possession or control, and all information available through access provided to Pfizer that can be obtained by OPKO using Commercially Reasonable Efforts including all Non-Clinical Trial and Clinical Trial data that relates to the Development of *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. any Compound or Licensed Product, including provision of the following to Pfizer by OPKO (a) the definitions and attributes that comprise the Clinical Data Package, (b) the data quality management and validation processes that underlie the clinical trials in the Clinical Data Package and any database in which such Clinical Data Package is maintained, (c) the methodologies that have been utilized in converting source data into output (derived) data in connection with the Clinical Data Package, (d) the relevant statistical analysis assumptions or plans for the clinical trials in the Clinical Data Package, (e) audit history of the clinical trials in the Clinical Data Package and the database in which it is maintained,
Clinical Data Package. The “Clinical Data Package” is defined as all information in OPKO’s possession or control, and all information available through access provided to Pfizer that can be obtained by OPKO using Commercially Reasonable Efforts including all Non-Clinical Trial and Clinical Trial data that relates to the Development of *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. any Compound or Licensed Product, including provision of the following to Pfizer by OPKO (a) the definitions and attributes that comprise the Clinical Data Package, (b) the data quality management and validation processes that underlie the clinical trials in the Clinical Data Package and any database in which such Clinical Data Package is maintained, (c) the methodologies that have been utilized in converting source data into output (derived) data in connection with the Clinical Data Package, (d) the relevant statistical analysis assumptions or plans for the clinical trials in the Clinical Data Package, (e) audit history of the clinical trials in the Clinical Data Package and the database in which it is maintained, (f) all data, including appropriately de-identified subject-level records, raw datasets, compiled data (derived statistical data sets), trial master files (including other documentation as determined by Pfizer clinical data management, including versions of medical coding dictionaries used, statistical programs to produce tables, listings, and figures, statistical analysis plan, Data Management Plan, statistical programming plan and other Trial Master File documents) and (g) all databases, including the safety database and non-clinical and clinical databases for used for development through the Clinical Trials.