Extract to table

Both sub-conditions must be satisfied on or before the applicable deadline

Similarly, receipt of reimbursement under a miscellaneous or unassigned code does not satisfy the milestone requirement — the reimbursement must be received under the unique HCPCS code issued specifically for OncuPath-HER3™ or its successor assay

Buyer must maintain adequate staffing of the OncuPath-HER3™ regulatory and development team, including the key transferred personnel (Dr

Buyer may not voluntarily withdraw or abandon the PMA supplement (P230014) without Seller's prior written consent, which consent shall not be unreasonably withheld, conditioned, or delayed if Buyer demonstrates a bona fide scientific, regulatory, or safety basis for such withdrawal

Following FDA clearance or approval of the OncuPath-HER3™ assay, Buyer must prepare and submit the HCPCS code application to CMS within a commercially reasonable time, and in any event within 90 days of FDA clearance or approval

Buyer shall not take any affirmative action with the primary purpose or effect of preventing or delaying the achievement of any earnout milestone