Common use of Marketed Product Clause in Contracts

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 365-day period beginning on the date of the FDA approval of such rare pediatric disease product. The rare pediatric disease product and has marketed such product in application for which the United States since such initiationPriority Review Voucher was awarded was not submitted by Seller to the FDA prior to October 7, 2012.

Marketed Product. Seller has initiated marketing or will initiate, and subsequently continue, Marketing in the United States of the rare pediatric disease Rare Pediatric Disease product for which the Priority Review Voucher was awarded within the three hundred and sixty five (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 initiationRare Pediatric Disease product.

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 continuously marketed such product in the United States since such initiationits approval. The rare pediatric disease product application for which the Priority Review Voucher was awarded was not submitted by Seller or Asklepion 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.