Duties and Rights of Inamed Sample Clauses

Duties and Rights of Inamed. General • Provide advice to Genzyme regarding the conduct of Regulatory Activities, and the right to request Genzyme to make changes and incorporate suggestions regarding the approach to the FDA and the overall conduct of Regulatory Activities • Consult with Genzyme regarding the outcomes of audits and other examinations of the Regulatory Activities, and collaborate on resolving issues that could have an effect on Inamed's ability to meet its regulatory obligations with respect to the Hylaform clinical trial • Right to participate in a timely and substantive manner in all scheduled interactions with the FDA PMA Application, Submission and Prosecution • Participate in a timely and substantive manner in the preparation and review of the PMA (including the review of interim drafts of the PMA), and provide comments on the PMA prior to submission • Right to review copies of all correspondence between Genzyme and the FDA and the right to receive reasonable advance notice of all scheduled telephone calls and meetings with the FDA, and upon request to Genzyme, meaningful participation in all such telephone calls and meetings to the extent such participation will not result in the disclosure of Genzyme Confidential Information relating to Hylaform CMC and manufacturing • Right to participate in a timely manner in preparing and conducting the presentation of clinical results to the FDA panel, including appearing, under Genzyme's leadership, as a joint presenter before the FDA panel Adverse Event Reporting • Adopt all practices and procedures, and furnish all supporting information, reasonably requested by Genzyme to meet FDA adverse event reporting requirements