Common use of Clinical and Regulatory Audits Clause in Contracts

Clinical and Regulatory Audits. Each of BioMarin and Genzyme shall permit BioMarin/Genzyme LLC and the other Party or the representatives of BioMarin/Genzyme LLC or the other Party to have access during regular business hours and upon reasonable advance notice, at the auditing Party’s own expense and no more than once in each calendar year during the Term, to the non-auditing Party’s records and facilities relating to the Development Program for the purpose of monitoring compliance with Good Clinical Practice and other applicable requirements of the Regulatory Scheme in connection with such Party’s performance of its obligations hereunder.

Clinical and Regulatory Audits. Each of BioMarin and Genzyme ------------------------------ shall permit BioMarin/Genzyme LLC and the other Party or the representatives of BioMarin/Genzyme LLC or the other Party to have access during regular business hours and upon reasonable advance notice, at the auditing Party’s 's own expense and no more than once in each calendar year during the Termterm of this Agreement, to the non-auditing Party’s 's records and facilities relating to the Development Program for the purpose of monitoring compliance with Good Clinical Practice and other applicable requirements of the Regulatory Scheme in connection with such Party’s performance of its obligations hereunderScheme.