Common use of Additional Compounds Clause in Contracts

Additional Compounds. (i) If (A) MyoKardia has Initiated a clinical trial of a Compound under a POC Development Plan and has not terminated Development thereof, (B) another Compound is designated as a Development Candidate for the same Program, and (C) either Party desires to conduct IND-enabling studies and clinical trials of such second Compound, such Party shall notify the other Party in writing. If both Parties desire to initiate such further Development activities, then the Parties shall revise the POC Development Plan and budget therein for such Program accordingly to include the Development of such second Compound, and Sanofi shall reimburse all such Pre-POC Development Costs on a Calendar Quarterly basis in accordance with Section 9.5(a), mutatis mutandis, and such additional costs (if incurred after 2018) will not count toward the Post-2018 POC Cost Cap. The estimated amount to be so reimbursed shall be provided by MyoKardia in advance of the decision whether to so initiate further Development thereof. If instead Sanofi does not elect to bear such costs, then MyoKardia shall have the right, but not obligation, to conduct such Development of such additional Compound under the POC Development Plan for such Program at its sole discretion and expense, provided that upon the earlier of (y) discontinuation of Development of the first Compound for the same Program or (z) completion of the final study report for a Phase 2a Clinical Trial of such second Compound and delivery of the results and an accounting of amounts required to be reimbursed, Sanofi shall reimburse all Pre-POC Development Costs then incurred by MyoKardia in the conduct of the Development of such second Compound after its designation as a Development Candidate, and thereafter Sanofi shall reimburse all Pre-POC Development Costs for such Compound subsequently incurred by MyoKardia on a Calendar Quarterly basis in accordance with Section 9.5(a), mutatis mutandis. For clarity, the requirement of reimbursement under this provision applies only with respect to one additional Compound per Program. In no event shall reimbursement be due to MyoKardia under this Section 5.4(b)(i) in the case in which Sanofi has delivered a notice of termination with respect to this Agreement in its entirety or with respect to the applicable Program prior to the delivery to Sanofi of such final study report. (ii) If instead MyoKardia does not elect to bear such costs with respect to a DCM1 Compound, then Sanofi shall have the right, but not obligation, to conduct such Development of such additional DCM1 Compound under the POC Development Plan for such the DCM1 Program at its sole discretion and expense, provided that upon the earlier of (A) discontinuation of Development of the first DCM1 Compound for the same Program; or (B) completion of the final study report for a Phase 2a Clinical Trial of such second Compound and delivery of the results and an accounting of amounts required to be reimbursed, either (x) MyoKardia shall reimburse all Pre-POC Development Costs previously incurred by Sanofi in the conduct of the Development of such second Compound after its designation as a Development Candidate (the “Reimbursable Amount”), or (y) if MyoKardia can demonstrate that it is not financially feasible to pay the Reimbursable Amount to Sanofi upfront (in whole or in part) at MyoKardia’s election, in lieu of such reimbursement, Sanofi shall reduce any future payments payable to MyoKardia under Article 9 until it has recouped in full the amount owed by MyoKardia under this Section 5.4(b)(ii). With regard to Pre-POC Development Costs incurred thereafter (other than the Reimbursable Amount), MyoKardia shall reimburse Sanofi on a Calendar Quarterly basis in accordance with Section 9.5(a), mutatis mutandis. For clarity, the requirement of reimbursement under this provision applies only with respect to one additional DCM1 Compound.