definiens: shall mean ( i ) AVEO ’s NDA for the LicensedCompound submitted to the FDA in 2012 ; ( ii ) the regulatory dossier, or MAA, for the RCCindication in electronic CTD format that is suitable for immediate submission to the EMA(provided that the Parties agree that for all purposes under this Agreement the MAA shall bedeemed suitable for immediate submission to the EMA upon such submission by Partner, andthat the subsequent evaluation of such MAA by the EMA shall have no bearing on suchsuitability ) ; and ( iii ) AVEO ’s completed manufacturing process validation protocols, final reports, and master validation for the Licensed Products, and ( iv ) to the extent relating to the LicensedCompound and necessary for Partner ’s exercise of its rights under this Agreement ( a ) any and allother INDs, registrations, licenses, authorizations and approvals ; ( b ) reports and materialcorrespondence submitted to or received from Regulatory Authorities and supporting documentswith respect thereto, in each case ( a ) and ( b ) that are in the possession, custody or controlof AVEO and existing at the Effective Date- 11 - 1.81 has the meaning given it in Section 5.4(i)(ii)(A )