be transferred to, or used for, a drug with respect to which all patents and exclusivities have expired as of the date of the transfer. (C) Notification of transfer Each person to whom a voucher is transferred shall notify the Secretary of such change in ownership of the voucher not later than 30 calendar days after such transfer. (D) Prohibition on additional fees The Secretary shall not apply a fee for the exercise of a voucher under this section. The preceding sentence shall not affect the authority of the Secretary to apply fees with respect to a neonatal drug application that are otherwise applicable under law. (E) Revocation of voucher The Secretary may revoke any neonatal exclusivity voucher if the neonatal drug product for which such voucher was awarded is not marketed in the United States within the 365-day period beginning on the date of the approval of such drug under section 505 of this Act or section 351 of the Public Health Service Act. (3) Limitations (A) No award for prior approved application A sponsor of a neonatal drug may not receive a voucher under this section if the neonatal drug application was submitted to the Secretary prior to the date of enactment of this section. (B) Required Pediatric Research The Secretary shall limit grants of exclusivity under this section to drugs that are not required to complete neonatal studies under section 505B. (C) No combining vouchers A sponsor may not use a neonatal exclusivity voucher on a product for which the sponsor also intends to use a voucher obtained or purchased pursuant to section 524 or section 529. (4) Notification of intent to use voucher (A) Notification by sponsor The sponsor of a human drug application intending to use a voucher awarded or transferred under this section shall notify the Secretary not later than 15 months prior to loss of patent and exclusivities on the drug for which the voucher will be redeemed, in such form as the Secretary may require. (B) Notification by Secretary Within 30 calendar days of such notification to the