definiens: ] is defined by reference to [ what ] it [ means ] to [ develop ] or [ eommercialize ] for a [ Pediatric Indication :] ( a ) To ] means to [ market ] and [ seU ] a [ 1 ' " CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 248 - 2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED . 46 . CONFIDENTIAL [ product for the treatment ] or [ prophylaxis ) of [ people who ] are [ eight ( 8) years old or younger ] pursuant to a [ regulatory approv ~ l ( me < lning a Rf, A or NDA in the U.S., and all filings having similar effect in other countries ) ] that provides that [ an approved, labeled indication for such product includes the treatment or prophylaxis ] of [ people who are eight ( 8) years old or younger, ] as a [ population distinct ] from [ older people