Representations and Warranties of Akorn. Akorn agrees that in performing the Processing services hereunder, it shall comply with applicable GMPs and that it shall use its best efforts to maintain the Facility in such a fashion as to be in compliance with all applicable federal, state and local rules and regulations. Akorn agrees that it shall maintain all licenses and permits required by any applicable federal, state or local agency, including but not limited to the FDA, in order to operate the Facility and provide the Processing services required hereunder. Without limiting the generality of the foregoing, Akorn agrees that it will cause its employees and agents to follow all procedures developed and implemented in connection with the removal of the warning letter sanctions pursuant to Form 483 or current GMP regulations issued or imposed by the FDA with regard to the Facility. Akorn also agrees to store all manufacturing and laboratory records on the site where the Processing is performed and to keep such records readily available. Further, Akorn represents and warrants that it shall use its best efforts to insure that all filtration, filling and lyophilization of the Product by Akorn shall be done in an aseptic processing environment and in accordance with the Processing Parameters.
Representations and Warranties of Akorn. Akorn represents and warrants to the Trust as of the date hereof as follows:
