definiens: means the complete data package compiled upon completion of the 301 Study, including ( i ) a detailed summary of all data generated or compiled in connection with the 301 Study ( including electronic or other reasonable access to all raw data, including case report fonns ), ( ii ) all results and analyses of the 301 Study, including all analyses perfonned in accordance with the statistical plan agreed to by MAP and the FDA and any other analyses conducted by or on behalf of MAP in connection with the 301 Study, ( iii ) any regulatory submissions made to the FDA or any other Regulatory Authority by or on behalf of MAP with respect to the 301 Study or that are othexwise reasonably necessary to evaluate the 301 Study, and ( iv ) such other material information relating to the 301 Study or that is otherwise - 1 -CERT AJN CONFIDENTIAL INFORMATION CONT AlNED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH 11{E SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OFreE SECURITIES EXCHANGE Acr OF 1934, AS AMENDED . reasonably necessary to evaluate the 301 Study in the Control of MAP as [COMPANY] may reasonably request . For the avoidance of doubt, all data, results and analyses, whether compiled by Jv1AP, its Affiliates, its contractors or its consultants in connection with the 301 Study or any other study perfonned by or on behalf of MAP or its Affiliates that is necessary to evaluate the 301 Study shall be included or summarized in the 301 Data Package