definiens: is defined as all information in OPKO ’s possession or control, and all information availabl e through access provided to [COMPANY] that can be obt ained by OPKO using Commercially Reasonable Efforts includin g all non - clinical trial and clinical trial data th at relates to the Development of any Compound or Licensed Product, including provision of the following to [COMPANY] by OPKO ( a ) the definitions and attributes that comprise th e Clinical Data Package, ( b ) the data quality manag ement and validation processes that underlie the clinical tri als in the Clinical Data Package and any database i n which such Clinical Data Package is maintained, ( c ) the method ologies that have been utilized in converting sourc e data into output ( derived ) data in connection with the Clinic al Data Package, ( d ) the relevant statistical analy sis assumptions or plans for the clinical trials in the Clinical Da ta Package, ( e ) audit history of the clinical trial s in the Clinical Data Package and the database in which it is maintained, ( f ) all data, including appropriately de - identifie d subject - level records, raw datasets, compiled data ( derived stati stical data sets ) and trial master files ( including other documentation as determined by [COMPANY] 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 o ther Trial Master File documents ) and ( g ) all datab ases, including the safety database and non - clinical and clinical databases used for development through the clinical trials