definiens: means a United States New Drug Application ( asdeﬁned in the U.S. Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. Section 301 et . seq . ) ( the ) and the regulations promulgatedthereunder ) pursuant to Section 505 of the Act ( 21 U.S.C. Section 355 ) and the regulations promulgated thereunder submitted to the FDAfor approval to market a pharmaceutical drug or product in the United States or, for registrations sought outside of the United States, anysimilar regulatory requirements in such jurisdictions . As the sponsor of the Product NDA, Purinix shall ensure that the results of its studyare supported by source documentation, shall include reports on serious adverse events ( SAE ), and, where required, filings to the FDA at apre - IND meeting, pre - NDA meeting, and/or in the NDA submission with respect to the Product shall include relevant Patient Records data