FDA Approval Letters definition

FDA Approval Letters means, collectively: (a) that certain FDA Accelerated Approval letter, dated January 23, 2020, with respect to the new drug application 211723 for TAZVERIK (tazemetostat) tablets, 200mg, submitted by Borrower under section 505(b) of the FDCA; and (b) that certain FDA Accelerated Approval letter, dated June 18, 2020, with respect to the new drug application 213400 for TAZVERIK (tazemetostat) tablet, submitted by Borrower under section 505(b) of the FDCA.