definiens: as that term isdefined in 21 C.F.R. § 314.3(b ) ( or any successor rule ) to [ * * * ] and all other Regulatory Materials related to such IND to the extent necessaryto exercise the rights granted under Section 2.1, and such right shall be sublicensable in conjunction with the sublicense of any of the rightsgranted under Section 2.1 . In addition, [COMPANY] shall take all actions and execute all documents ( e.g. Certificates of PharmaceuticalProducts ( CPPs ) ) reasonably requested by BDSI in its exercise of the foregoing rights . Without limiting the foregoing, [COMPANY] shall submita letter of authorization permitting the FDA to reference such IND on behalf of BDSI and its Affiliates in connection with the activities underthis Agreement . For clarity, the rights granted by [COMPANY] under this Agreement shall not include any rights ( i ) other than as specificallyoutlined in Article 4, to Develop Symproic, Naldemedine, or any product, ( ii ) to Commercialize any product incorporating Naldemedine ( or anyanalog or derivative thereof ) other than Symproic, or ( iii ) except for any new indication the development of which is expressly authorized bythe JDC pursuant to Article 4, with respect to any indications other than the Field