definiens: means a complete, detailed, data - cleaned, unbiased and unblended data package that contains theresults of the first Proof of Concept Study in the following form : ( i ) a statistical analysis of results ; ( ii ) analysis tables, datalistings and illustrative figures ; ( iii ) the table of adverse events ; ( iv ) case report forms ( CRFs ) in hard copy or electronic form, or, alternatively, available for review by [COMPANY] Idec employees during normal business hours at the principal office of AVEOin the United States, commencing upon delivery of the other parts of the Data Package ; and ( v ) a narrative description ofserious adverse events, in each case in the format compiled by AVEO, which shall be cGCP compliant and otherwise consistentwith industry standards . The Data Package shall also contain ( x ) a copy ( or rights of access for purposes of clause ( iv ) above)of the relevant IND and the information specified in clauses ( i ) – ( v ) for any Phase 1 Clinical Trial or any other Phase 2Clinical Trial completed prior to completion of the first Proof of Concept Study, as well as all regulatory correspondencerelating thereto, ( y ) copies of all AVEO In - Licenses entered into between the period commencing after the Effective Datethrough the date of delivery of the Data Package and ( z ) a copy of the initial Development Plan