; (II) the United States Court of Appeals for the circuit in which the ultimate parent entity, as defined in section 801.1(a)(3) of title 16, Code of Federal Regulations, or any successor thereto, of the NDA or BLA holder (if any such holder is a party to such order) is incorporated as of the date that the application described in subparagraph (A) or (B) of subsection (g)(8) or an approved application that is deemed to be a license for a biological product under section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ) pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 ( Public Law 111–148 ; 124 Stat. 817) is submitted to the Commissioner of Food and Drugs; or (III) the United States Court of Appeals for the circuit in which the ultimate parent entity, as so defined, of any subsequent filer that is a party to such order is incorporated as of the date that the application described in subparagraph (A) or (B) of subsection (g)(8) is submitted to the Commissioner of Food and Drugs; and (ii) the petition for review shall be filed in the court not later than 30 days after such order is served on the party seeking review. (3) Additional enforcement authority (A) Civil penalty The Commission may commence a civil action to recover a civil penalty in a district court of the United States against any NDA or BLA holder or subsequent filer that violates this section. (B) Special rule for recovery of penalty if cease and desist order issued (i) In general If the Commission has issued a cease and desist order in a proceeding under section 5 of the Federal Trade Commission Act ( 15 U.S.C. 45 ) for violation of this section— (I) the Commission may commence a civil action under subparagraph (A) to recover a civil penalty against any party to such order at any time before the expiration of the 1-year period beginning on the date on which such order becomes final under section 5(g) of such Act ( 15 U.S.C. 45(g) )