Each Party shall maintain complete, current and accurate records of all work conducted by it under the Initial Development Plan or other Development Plan prepared pursuant to Section 4.8, and all Data resulting from such work.  Such records shall fully and properly reflect all work done and results achieved in the performance of such development plan in good scientific manner appropriate for regulatory purposes.  Each Party shall document all preclinical studies and clinical trials in formal written study reports according to applicable national and international ( e.g. , ICH, GCP, GLP, and GMP) guidelines.  Each Party shall have the right to review such records maintained by the other Party at reasonable times, upon written request, which shall not exceed once a year. Each Party shall present reports in English at the JSC meetings on its Development and regulatory activities with respect to the Licensed Product, including without limitation any significant formal or informal meetings between such Party and the Regulatory Authority in its Territory, at a level of detail to be agreed by the JSC; provided, however, that any such presentation shall include at least a summary of the resulting Data for, all preclinical studies and all clinical trials conducted by such Party with the Licensed Product.