Duties and Rights of Genzyme Sample Clauses

Duties and Rights of Genzyme. General • Provide timely advice to Inamed regarding all Clinical Activities Clinical Trial • Maintain original copies of all study documents and materials received, generated or used by Inamed or Genzyme in conducting the Clinical Activities • Deliver to Inamed copies of all documents and materials necessary for Inamed to conduct and supervise the clinical trial • Upon reasonable notice to Inamed, to perform ordinary and customary audits (using Genzyme personnel or agents) of the clinical sites, investigators, trial data and study files wherever located, including the study files maintained at Inamed, and if required by the FDA, to furnish the results of such audits to the FDA • Upon written request to Inamed, receive from Inamed copies of all third party invoices and related back-up materials to the invoices submitted to Inamed pursuant to the Clinical Agreements Data Management • Provide advice regarding adverse event coding and reconciliation and data base quality control • Upon written request to Inamed, the right to receive and review, and the right to disclose to regulatory authorities if deemed necessary by Genzyme, all data related to the Clinical Activities, including all audit reports specifically pertaining to Clinical Activities, whether prepared by Inamed or vendors working with Inamed Biostatistical Analysis • Review of interim drafts of the CSR and necessary appendices, and approve the final CSR and all necessary appendices prior to issuance • Conduct the statistical analysis of the Zyplast study data. • Responsible for analysis of the first IPR training data.
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