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 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. 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 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 such initiation to meet the requirements of such productthe Priority Review Voucher. 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. Seller has Sellers have 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 Sellers initiated marketing of such product. The rare pediatric disease product application for which the Priority Review Voucher was awarded was not submitted by Seller Sellers 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.