Marketed Product. Seller has initiated marketing in the United States of the rare pediatric disease product for which the Priority Review Voucher was awarded within the 365-day period beginning on the date of the FDA approval of such rare pediatric disease product and has marketed such product in the United States since such initiation.
Marketed Product. Seller has initiated marketing in the United States of the rare pediatric disease product for which the Priority Review Voucher was awarded within the three hundred sixty five (365)-day period beginning on the date of the FDA approval of such rare pediatric disease product and has continuously marketed such product in the United States since Seller initiated marketing of such product. The rare pediatric disease product application for which the Priority Review Voucher was awarded was not submitted by Seller to the FDA prior to the date that is ninety (90) days after the date of enactment of the Prescription Drug User Fee Amendments of 2012.
Marketed Product. Any AE, the nature, severity or frequency of which is inconsistent with the most current SmPC for within the EU; U.S. PI for within the U.S.; or Local Package Insert for countries outside the EU/U.S. This includes reports of adverse events which add significant information on the specificity of an already known adverse event. Events considered more severe or specific than those in the SmPC, U.S. PI or Local PI constitute unexpected events. For example:
Marketed Product. BPI has initiated marketing in the United States of the rare pediatric disease product for which the Priority Review Voucher was awarded within the 365-day period beginning on the date of the FDA approval of such rare pediatric disease product and has continuously marketed such product in the United States since its approval. The rare pediatric disease product application for which the Priority Review Voucher was awarded was not submitted by BPI to the FDA prior to the date that is 90 days after the date of enactment of the Prescription Drug User Fee Amendments of 2012.
Marketed Product. Seller has initiated, and since initiation has continued, Marketing in the United States of the product that was the subject of the Rare Pediatric Disease Product Application for which the Priority Review Voucher was awarded.
Marketed Product. 3.3 Cempra agrees to provide, in a timely fashion, Toyama all SAE reports, including lack of efficacy and pregnancy, received from any source other than Toyama. The reports will be sent as promptly as possible, but in no event later than [*] Calendar Days of notification of the SAE to Cempra.
