Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).
Personnel Records (A) There shall be only one official personnel file for each employee, which shall be maintained by the employing agency. Information in an employee’s official personnel file may be maintained in electronic as well as paper form.
Work The definition of work, for overtime purposes only, includes: