definiens: means, the written plan for, and budget applicable to, the activities to be conducted by the Parties, to Develop each Collaboration Antibody or Development Candidate through Completion of a Proof of Concept Phase 1 Clinical Trial . Such written plan, which may be amended in accordance with Section 4.2 . will contain, inter alia : ( a ) the Development objectives for the applicable Collaboration Antihody or Developmcnt Candidate, and the Development Activities to be perfonned in connection therewith ; ( b ) the Part)- . ' responsible for such activitics : ( c ) a timelinc for such activities ; and ( d ) a budget with respect to such activities to be conducted ( the ) . The Development Activities in the Development Plan will include : ( i ) the in vitro, ex vivo or in vivo animal 1110del studies expected to be conducted, and the cstimated ti1l1cline for such studies ; ( ii ) the Clinical Trials expected to be conducted, the estimated time line for such Clinical Trials, and the Clinical Trial design and endpoints ; ( iii ) the regulatory affairs activities to be conduetcd and the estimated timetable for such activities ; and ( iv ) the Manufacturing strategy and estimated 5 FOIA CONFIDENTIAL TREATMENT REQUESTED BY ENCMERAL BIOMEDICAL HOLDINGS, IJ'iC