Extract to table

Notice Period for Claims — the time frame within which HUMC must notify TMRI of claims or threatened claims triggering indemnification; 4

This date is driven by TMRI's need to include the fully executed CTA as part of its IDE supplement filing with the FDA, which must be submitted by March 15, 2026, to avoid delays to the Cobalt Ridge Health IT-3 enrollment timeline

This dual exposure is a central factor in the indemnification negotiation, as it means that TMRI cannot credibly disclaim responsibility for the safety characteristics of the device and must accept some level of device-related indemnification beyond narrow defect claims

TMRI's rationale for aligning the cap with the per-occurrence limit is straightforward: as a nonprofit research institution with finite financial resources, TMRI must limit its contractual indemnification exposure to amounts that are fully insured

Large teaching hospitals and research institutions typically have multi-tiered risk management structures in which potential claims must be identified, evaluated, and escalated through several departments before a formal notice of claim is issued to a contractual indemnitor

We therefore recommend that TMRI accommodate HUMC's request for conflict-of-interest participation rights, subject to the following guardrails designed to prevent abuse and manage costs: (a) The conflict of interest must be actual, not merely theoretical or speculative