definiens: as that term is defined in 21 C.F.R§314.3(b ) in the Territory, with the right to grant sublicenses ( solely in accordance with Section 6.3 ), underPOZEN ’s and its Affiliates ’ rights, title and interests in and to the NDA for the Initial Products and all otherRegulatory Filings in respect of the Initial Products, to Develop, Manufacture and Commercialize in theTerritory as permitted under this Agreement, which co - exclusive license and right shall automatically becomean exclusive ( including with regard to POZEN and its Affiliates but subject to POZEN ’s in Section 4.3.2 ) right and license thereunder, to the extent the NDA for the Initial Products and such otherRegulatory Filings are not assigned pursuant to Section 4.1.2, upon NDA Approval of the Initial Products