Common use of Initial Development Plan Clause in Contracts

Initial Development Plan. As soon as AVEO has prepared the initial Development Plan (even if prior to delivery of the Data Package), AVEO shall deliver to Biogen Idec the initial Development Plan. During the period between Data Package delivery by AVEO and Option Exercise Date, AVEO and Biogen Idec, including appropriate members of the clinical development and regulatory teams of both AVEO and Biogen Idec shall meet to discuss the initial Development Plan, including the design thereof as well as the indication being studied, and the Development activities and timelines contemplated thereunder. In anticipation of Biogen Idec’s exercise of the Option, AVEO shall (x) consider in good faith all reasonable Biogen Idec proposals to such initial Development Plan and (y) deliver to Biogen Idec a revised initial Development Plan (or if no revised initial Development Plan is delivered, the initial Development Plan shall be deemed re-delivered) no less than thirty (30) days prior to the end of the Option Exercise Period (the “Delivered Initial Development Plan”). The Delivered Initial Development Plan shall meet the following criteria: (i) such Delivered Initial Development Plan shall be directed only to the indication that was the subject of the Proof of Concept Study; (ii) the size of the pivotal trial included in such Delivered Initial Development Plan shall be reasonable given the scope of the indication, in light of then prevailing industry standards and regulatory guidance; (iii) such Delivered Initial Development Plan shall in addition include, at a minimum, study designs, assignment of responsibilities (both among the Parties and Third Parties), timelines, decision criteria, supply plans, quality standards, expected resources, costs and a budget for Development Costs; and (iv) the budget for Development Costs in such Delivered Initial Development Plan shall be for no longer than through the end of completion of the pivotal trial for the indication that was the subject of the Proof of Concept Study.

Initial Development Plan. As soon as AVEO has prepared the initial Development Plan (even if prior to delivery of the Data Package), AVEO shall deliver to Biogen Idec the initial Development Plan. During the period between Data Package delivery by AVEO and Option Exercise Date, AVEO and Biogen Idec, including appropriate members of the clinical development and regulatory teams of both AVEO and Biogen Idec shall meet to discuss the initial Development Plan, including the design thereof as well as the indication being studied, and the Development activities and timelines contemplated thereunder. In anticipation of Biogen Idec’s exercise of the Option, AVEO shall (x) consider in good faith all reasonable Biogen Idec proposals to such initial Development Plan and (y) deliver to Biogen Idec a revised initial Development Plan (or if no revised initial Development Plan is delivered, the initial 18 Development Plan shall be deemed re-delivered) no less than thirty (30) days prior to the end of the Option Exercise Period (the “Delivered Initial Development Plan”). The Delivered Initial Development Plan shall meet the following criteria: (i) such Delivered Initial Development Plan shall be directed only to the indication that was the subject of the Proof of Concept Study; (ii) the size of the pivotal trial included in such Delivered Initial Development Plan shall be reasonable given the scope of the indication, in light of then prevailing industry standards and regulatory guidance; (iii) such Delivered Initial Development Plan shall in addition include, at a minimum, study designs, assignment of responsibilities (both among the Parties and Third Parties), timelines, decision criteria, supply plans, quality standards, expected resources, costs and a budget for Development Costs; and (iv) the budget for Development Costs in such Delivered Initial Development Plan shall be for no longer than through the end of completion of the pivotal trial for the indication that was the subject of the Proof of Concept Study.