Regulatory Rights. The Contractor agrees to the following: a. Regulatory Data. Regeneron shall provide to the OTTR and OTAS copies of formal FDA submissions pertaining to the scope of the project, no later than 10 business days before submission to the FDA. For clarity, CMC Data included in such submissions shall be subject to Section 7.3.b.
Appears in 8 contracts
Samples: Project Agreement (Regeneron Pharmaceuticals, Inc.), Project Agreement (Regeneron Pharmaceuticals, Inc.), Project Agreement (Regeneron Pharmaceuticals, Inc.)
