Common use of Milestone Events and Milestone Payments Clause in Contracts

Milestone Events and Milestone Payments. Subject to the terms and conditions of this Agreement, Buyer shall make each applicable payment (each a “Milestone Payment”) set forth below to the Seller promptly (and in any event no later than thirty (30) days) after the achievement by any member of the Buyer Rights Group of the relevant event listed below (each, a “Milestone Event”). (i) A one-time payment of Three Million Dollars ($3,000,000) upon the achievement of the primary endpoint (as set forth in the protocol for such study) in any registrational study (i.e., a study that is intended to be used as a pivotal study for purposes of filing an NDA or BLA if such primary endpoint is satisfied) of any Product or the determination by the applicable member of the Buyer Rights Group to proceed with the preparation of an NDA or BLA based on the results of any such study whether or not such primary endpoint is achieved; (ii) A one-time payment of [**] upon the acceptance for filing by the FDA or any other Governmental Entity of an NDA or BLA, with respect to any Product; (iii) A one-time payment of [**] upon Regulatory Approval by the FDA of any Product for any indication in the United States; (iv) A one-time payment of [**] upon the first occurrence of Pricing and Reimbursement Approval of any Product for any indication in any one of France, Germany, Italy, Spain or the United Kingdom; (v) A one-time payment of [**] upon Regulatory Approval by the PMDA of any Product for any indication in Japan; (vi) A one-time payment of [**] upon the cumulative Net Sales of all Products exceeding One Hundred Million Dollars ($100,000,000); (vii) A one-time payment of [**] upon the cumulative Net Sales of all Products exceeding Two Hundred Million Dollars ($200,000,000); and (viii) A one-time payment of [**] upon the cumulative Net Sales of all Products exceeding Three Hundred Million Dollars ($300,000,000).

Milestone Events and Milestone Payments. Subject to the terms and conditions of this Agreement, Buyer shall make each applicable payment (each a “Milestone Payment”) set forth below to the Seller promptly (and in any event no later than thirty (30) days) after the achievement by any member of the Buyer Rights Group of the relevant event listed below (each, a “Milestone Event”). (i) A one-time payment of Three Million Dollars ($3,000,000) upon the achievement of the primary endpoint (as set forth in the protocol for such study) in any registrational study (i.e., a study that is intended to be used as a pivotal study for purposes of filing an NDA or BLA if such primary endpoint is satisfied) of any Product or the determination by the applicable member of the Buyer Rights Group to proceed with the preparation of an NDA or BLA based on the results of any such study whether or not such primary endpoint is achieved; (ii) A one-time payment of [**] upon the acceptance for filing by the FDA or any other Governmental Entity of an NDA or BLA, with respect to any Product; (iii) A one-time payment of [**] upon Regulatory Approval by the FDA of any Product for any indication in the United States; (iv) A one-time payment of [**] upon the first occurrence of Pricing and Reimbursement Approval of any Product for any indication in any one of France, Germany, Italy, Spain or the United Kingdom; (v) A one-time payment of [**] upon Regulatory Approval by the PMDA of any Product for any indication in Japan; (vi) A one-time payment of [**] upon the cumulative Net Sales of all Products exceeding One Hundred Million Dollars ($100,000,000); (vii) A one-time payment of [**] upon the cumulative Net Sales of all Products exceeding Two Hundred Million Dollars ($200,000,000); and (viii) A one-time payment of [**] upon the cumulative Net Sales of all Products exceeding Three Hundred Million Dollars ($300,000,000).