Process Modifications. Spark shall not be entitled to modify the process employed in the manufacture of the Product as set out in the DMF without first having consulted with Genable and then only with Genable’s prior written agreement and also in compliance with all applicable regulatory requirements in the United States and EU with respect to such modification.
Appears in 2 contracts
Sources: Manufacturing Agreement (Spark Therapeutics, Inc.), Manufacturing Agreement (Spark Therapeutics, Inc.)