definiens: means, collectively : ( a ) all INDs, NDAs, BLAs, est ablishment license applications, drug master files, applications for d esignation as an under the Orphan Drug Act, for status under Section 506 of the FD CA ( 21 U.S.C. § 356 ) or for a Special Protocol Asse ssment under Section 505(b)(4)(B ) and ( C ) of the FDCA ( 21 U.S.C. § 355(b)(4)(B ) ) or all other similar filings ( including MAAs and counterparts to any of the fore going in any country or region in the Territory ) as may be required by any Regulatory Authority for the Develo pment or Commercialization of a Licensed Product in the Portions of this Exhibit, indicated by the mark were omitted and have been filed separately w ith the Securities and Exchange Commission pursuant to the Registrant ’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended