Extract to table

| Requirement / Obligation | Statutory / Regulatory Citation | Applicable MCTA Provision | Responsible Party | Compliance Action Required | Status | Due Date | Notes / Comments AKS-01 | All payments to investigators and sites must reflect fair market value (FMV) for services rendered | 42 U

AKS-02 | Investigator compensation must not be tied to enrollment volume in a manner that constitutes inducement for referrals | 42 U

AKS-04 | Start-up fees must reflect actual costs and FMV of site activation services | 42 U

§ 1320a-7b(b); OIG Guidance | Exhibit B — Start-up fees: $75,000/site × 38 sites = $2,850,000 | Penterra (Samantha Novak) | Confirm start-up fee of $75,000/site ($37,500 upon site activation, $37,500 upon first patient enrolled) reflects documented costs of site initiation activities | Pending | Prior to MCTA execution | Payment split into two installments mitigates inducement risk AKS-05 | Annual site maintenance fees must reflect FMV of ongoing site operational support | 42 U

5 avg years = $5,320,000 | Penterra (Samantha Novak) | Document basis for $40,000/site/year maintenance fee; benchmark against industry comparables | Pending | Prior to MCTA execution | Paid annually in advance on each site-activation anniversary AKS-06 | Network coordination/administrative fee must reflect FMV of Veridian central administration services | 42 U

§ 1320a-7b(b) | Exhibit B — Network coordination fee: $300,000/quarter × 14 quarters = $4,200,000 | Penterra (Rebecca Liang); Calderwood & Harkness | Assess Veridian central coordination services scope and confirm $4,200,000 fee is FMV; include in FMV memorandum | Pending | Prior to MCTA execution | Veridian is a 501(c)(3) tax-exempt research organization (EIN: 23-4178205); fee covers coordination across 38 sites in 14 states AKS-07 | Investigator grants for publication/academic support must be for legitimate purposes and at FMV | 42 U