Common use of Biometrics Clause in Contracts

Biometrics. The Parties are jointly responsible for developing global strategies needed to manage data, statistical programming, and biostatistics for each Joint Global Study. The Parties agree that each Joint Global Study shall have one clinical database, one Statistical Analysis Plan (“SAP”) and one Clinical Study Report (“CSR”). The SAP shall define all the statistical methods and outputs which will be included in the CSR, in the IIS/IST, and submitted to Regulatory Authorities as part of the submission package. A detailed SAP review is of fundamental importance to clarify any misunderstandings as early as possible and to produce high-quality programming deliverables. SAPs must be carefully reviewed by highly qualified staff for clarity, comprehension and to ensure sufficient detail is present to unambiguously construct analysis data sets and prepare planned tables, figures, and listings (“TFLs”). Notwithstanding, A▇▇▇▇▇▇▇ will initiate and coordinate all efforts for statistical programing, data management and biostatistics, in each Joint Global Study, specifically for the following deliverable(s) or as mutually agreed by the Joint Project Team. The deliverables are not considered finalized until the Joint Project Team has reviewed and approved: (i) Case Report Form (“CRF”) used by the sponsor of the clinical trial to collect data from each participating patient; (ii) Electronic Data Capture (“EDC”) database; (iii) Statistical Analysis Plan (“SAP”); (iv) Clinical Study Report (“CSR”); (v) Tables, Figures, and Listings (“TLFs”) for the CSR and ISS/ISE Integrated summary of safety and integrated summary of efficacy, respectively. These documents comprise of integrated analyses of the safety and effectiveness of the study drug from all clinical trials performed as a whole, producing integrated statistical results; (vi) Clinical Data Interchange Standards Consortium (“CDISC”) data sets which standards support transparency in the process of medical research from the protocol phase to the reporting of data and results; and