Shared Development Costs. Within sixty (60) days after exercising its Option Right with respect to each of Program 2 and Program 4, Roche shall provide BPM with an initial Development Plan and a budget for such Program outlining the planned activities and related Development Costs (“Shared Development Cost Budget”) for such Development Plan. The Shared Development Cost Budget shall include the anticipated Development Costs pursuant to the Development Plan for the remainder of the then current Calendar Year and each of the next two (2) Calendar Years expected to be incurred by each Party and in total. Thereafter, annually, the Development Plan and the Shared Development Cost Budget shall be updated by the JDC such that the Shared Development Cost Budget shall always reflect the planned activities under the Development Plan for three (3) Calendar Years. If a Party’s actually incurred Development Costs for the current Calendar Year exceeds […***…] of its portion of the Shared Development Cost Budget, such excess portion of Development Costs shall be entirely borne by the Party that exceeded its portion of the Shared Development Cost Budget provided that (A) BPM approved the amount included in the Shared Development Cost Budget specifically attributable to the activities conducted by BPM under such Shared Development Cost Budget, and (B) the JDC shall have the right during a Calendar Year to update the Shared Development Cost Budget in the event of (i) faster than planned Clinical Study enrollment, (ii) written guidance or requirements from a Regulatory Authority that would result in amendments to the Development Plan or (iii) mutual agreement by the Parties to amend the Development Plan, each of (i), (ii) and (iii) an “Allowable Exception”. Additional Development Costs incurred in a Calendar Year resulting from an Allowable Exception shall be subject to sharing of Development Costs pursuant to Section 12.6.
Appears in 2 contracts
Sources: Collaboration and License Agreement (Blueprint Medicines Corp), Collaboration and License Agreement (Blueprint Medicines Corp)
Shared Development Costs. Within sixty (60) days after exercising its Option Right with respect to each of Program 2 and Program 4, Roche shall provide BPM with an initial Development Plan and a budget for such Program outlining the planned activities and related Development Costs (“Shared Development Cost Budget”) for such Development Plan. The Shared Development Cost Budget shall include the anticipated Development Costs pursuant to the Development Plan for the remainder of the then current Calendar Year and each of the next two (2) Calendar Years expected to be incurred by each Party and in total. Thereafter, annually, the Development Plan and the Shared Development Cost Budget shall be updated by the JDC such that the Shared Development Cost Budget shall always reflect the planned activities under the Development Plan for three (3) Calendar Years. If a Party’s actually incurred Development Costs for the current Calendar Year exceeds […***…] of its portion of the Shared Development Cost Budget, such excess portion of Development Costs shall be entirely borne by the Party that exceeded its portion of the Shared Development Cost Budget provided that (A) BPM approved the amount included in the Shared Development Cost Budget specifically attributable to the activities conducted by BPM under such Shared Development Cost Budget, and (B) the JDC shall have the right during a Calendar Year to update the Shared Development Cost Budget in the event of (i) faster than planned Clinical Study enrollment, (ii) written guidance or requirements from a Regulatory Authority that would result in amendments to the Development Plan or (iii) mutual agreement by the Parties to amend the Development Plan, each of (i), (ii) and (iii) an “Allowable Exception”. Additional Development Costs incurred in a Calendar Year resulting from an Allowable Exception shall be subject to sharing of Development Costs pursuant to Section 12.6.
Appears in 1 contract
Sources: Collaboration and License Agreement (Blueprint Medicines Corp)