Common use of Operational Policies and Procedures Clause in Contracts

Operational Policies and Procedures. The Operations Agreement shall provide that ICC shall adopt and enforce policies and procedures for the operation of the OncoVax Center during the Operational Phase, which such policies and procedures shall be consistent with, and require ICC and its employees and agents to comply with, Lehigh's Facility Policies, Rules and Regulations. Intracel shall, in accordance with the terms of the Operations Agreement, have the right to review, amend and approve all of ICC's operational policies and procedures including those related to compliance with FDA requirements, and any amendments thereto before such policies and procedures are implemented by ICC. Lehigh shall have the right to review all such policies and procedures and any amendments thereto and Intracel shall take any concerns into consideration prior to approving any such policies and procedures. The Operations Agreement shall provide that ICC shall accept all amendments submitted by Intracel to ICC in connection with those operational policies and procedures related to compliance with FDA requirements. Intracel shall maintain ultimate responsibility for compliance with all applicable FDA product requirements.