Common use of FDA Clearance Clause in Contracts

FDA Clearance. 5.01. INTRACEL shall, at its own expense, obtain all necessary clearances from governmental agencies to market each Product. Said request for market clearance shall be filed with the necessary governmental agencies by INTRACEL as soon as reasonably practical after a commercial embodiment of such Product is developed by or for INTRACEL. TJU agrees to cooperate with INTRACEL and to provide reasonable assistance where appropriate in obtaining any such clearance. INTRACEL shall indemnify, defend, and hold harmless TJU, its trustees, officers, staff and agents from any and all liability, judgments or expenses arising from failure to obtain any such clearance or violation of any governmental regulation related to the Product(s).