Common use of Additional Milestone Payments Clause in Contracts

Additional Milestone Payments. In addition to any payments made under Section 4.1 above, RELIANT will pay to PRONOVA additional milestone payments as follows: (a) USD [***] due and payable thirty (30) days after the date of FDA notification of FDA approval of “IgA nephropathy” as an additional indication for the Product (provided that RELIANT owns the Registration for the Product at such time); and (b) USD [***] due and payable thirty (30) days after the date of FDA notification of FDA approval of a label change for the Product containing the plaque stabilization data (Southampton Study) (provided that RELIANT owns the Registration for the Product at such time). RELIANT shall only be responsible for those costs directly related to the preparation and filing of the supplemental NDAs and similar documents required to be filed with the applicable Regulatory Authorities for the Regulatory Approvals related to the matters described in clauses (a) and (b) above, and RELIANT shall not be responsible for any other costs and expenses associated therewith, including any costs associated with clinical studies or data.

Additional Milestone Payments. In addition to any payments made under Section 4.1 above, RELIANT will pay to PRONOVA additional milestone payments as follows: (a) USD [***] due and payable thirty (30) days after the date of FDA notification of FDA approval of “IgA nephropathy” as an additional indication for the Product (provided that RELIANT owns the Registration for the Product at such time); and (b) USD [***] due and payable thirty (30) days after the date of FDA notification of FDA approval of a label change for the Product containing the plaque stabilization data (Southampton Study) (provided that RELIANT owns the Registration for the Product at such time). RELIANT shall only be responsible for those costs directly related to the preparation and filing of the supplemental NDAs and similar documents required to be filed with the applicable Regulatory Authorities for the Regulatory Approvals related to the matters described in clauses (a) and (b) above, and RELIANT shall not be responsible for any other costs and expenses associated therewith, including any costs associated with clinical studies or data.