Common use of FDA Approval Clause in Contracts

FDA Approval. Upon application to the United States Food and Drug Administration for the commercial sale of an in vitro diagnostic kit developed by LICENSEE that incorporates a Licensed Product as defined in Section 1.F.above, LICENSEE shall pay MAYO a one-time “Application Fee” of $25,000 within thirty (30) days of such FDA application by LICENSEE. Upon approval from the United States Food and Drug Administration for the commercial sale of an in vitro diagnostic kit developed by LICENSEE that incorporates a Licensed Product as defined in Section l.F.above, LICENSEE shall pay MAYO a one-time “Approval Fee” of $25,000 within thirty (30) days of such FDA approval.