definiens: means a United States New Drug Application ( as deﬁned in the U.S. Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. Section 301 et . seq . ) ( the ) and the regulations promulgated thereunder ) pursuant to Section 505 of theAct ( 21 U.S.C. Section 355 ) and the regulations promulgated thereunder submitted to the FDA for approval to market a pharmaceutical drug orproduct in the United States or, for registrations sought outside of the United States, any similar regulatory requirements in such jurisdictions . Asthe sponsor of the Product NDA, Purinix shall ensure that the results of its study are supported by source documentation, shall include reports onserious adverse events ( SAE ), and, where required, ﬁlings to the FDA at a pre - IND meeting, pre - NDA meeting, and/or in the NDA submissionwith respect to the Product shall include relevant Patient Records data