Recognition of Contractor Control Over Development Program Sample Clauses

Recognition of Contractor Control Over Development Program. As the drug sponsor, Contractor shall have sole discretion over the development of exebecase and regarding how to respond to Government’s comments concerning deliverables hereunder. The Government shall not require Contractor to change a submission to FDA or other submission that may impact the development of exebecase. An FDA-specified deadline and/or IND reporting timelines will override any BARDA review, comment, approval, response, availability, etc. if waiting for such action by Contractor would result in the deadline being missed.