PRIVILEGED & CONFIDENTIAL — ATTORNEY WORK PRODUCT
Team,
Happy to report that the Clinical Trial Agreement for the Cadence-3 Trial between Thornwick Medical Research Institute, Inc. (TMRI) and Hargrove University Medical Center, Inc. (HUMC) was fully executed as of today, March 2, 2026. The agreement was signed by Dr. Ansel R. Varnham (President & CEO, TMRI) and Dr. Priya Anand-Kessler (President & CEO, HUMC). Total agreement value: $6,000,000.
Well done to all of you. From engagement opening on January 15 through execution today, this was a tight timeline, and the negotiation with Pemberton, Yates & Caldwell (Rebecca Norcross and Daniel Huang) on HUMC's behalf involved several substantive issues that required careful handling. We got to a strong result for the client.
For everyone's reference, here's a summary of where the key contested provisions landed:
**Indemnification**
The aggregate indemnification cap settled at $15,000,000 — a compromise between our initial position of $10,000,000 (matching the per-occurrence limit under the Commonwealth Specialty Underwriters policy, CTL-2025-08843) and HUMC's push for $25,000,000 (matching the aggregate policy limit) or uncapped. We did concede on scope: the final formulation covers all claims "arising from or relating to" the investigational device (ThornValve MV-200 System), moving beyond our original "design, manufacture, or inherent defect" language. This was HUMC's key ask, and we were comfortable with it given the cap.
Notice period landed at 20 business days (we proposed 15; HUMC sought 30). TMRI retains the right to control defense and settlement. HUMC has the right to participate with separate counsel at TMRI's expense, but only where an actual conflict of interest exists — that formulation was negotiated and is tighter than HUMC's original request.
On mutual indemnification, HUMC indemnifies TMRI for claims arising from HUMC's negligence, protocol deviation, failure to obtain informed consent, or willful misconduct. We held the line on ordinary negligence as the standard — HUMC initially pushed for gross negligence only, but withdrew that position in the final round.
**intellectual Property**
TMRI retains sole ownership of all Trial Data (clinical data, safety data, imaging, biomarker results). HUMC and the PI (Dr. Julian M. Castañeda) received a broad non-exclusive license for academic, non-commercial research and teaching use of Trial Data — no TMRI consent required for such use.
TMRI receives an exclusive license to all HUMC/PI foreground IP conceived or reduced to practice in performance of the Protocol, subject to a reasonable royalty obligation if commercially exploited. For jointly conceived inventions, TMRI retains a right of first negotiation for an exclusive commercial license. HUMC accepted the ROFN structure in exchange for the reasonable royalty term on foreground IP — a package deal that worked well.
Background IP remains solely with TMRI.
**Publication Rights**
The publication review period landed at 30 days for initial review plus one 45-day extension (75 days total). This was a compromise between our original position of 45+60 days (105 total) and HUMC's 30+30 days (60 total). Dr. Castañeda retains final editorial control, subject to an obligation to remove TMRI confidential commercial information upon reasonable request. TMRI retains the right to request a delay for patent application filing during the extension period.
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Now, next steps. We need to move quickly — the IDE supplement deadline is real, and first patient enrollment is still targeted for April 7.
**Amy — Closing Binder (due by end of day Friday, March 6)**
Please prepare the closing binder for the fully executed CTA. This should include:
- Execution copies of the CTA with all exhibits (Exhibit A — Study Budget reflecting the $6,000,000 total; Exhibit B — Protocol Synopsis for Cadence-3) - Certificates of insurance: Commonwealth Specialty Underwriters (Policy CTL-2025-08843, $10M per occurrence / $25M aggregate, naming HUMC as additional insured) and Pinnacle Mutual Insurance Company (Policy PML-HU-2025-4471, $5M per occurrence / $15M aggregate, naming TMRI as additional insured) - IRB approval letter (HUMC-IRB-2025-0847, dated December 18, 2025) - PI conflict of interest disclosure from Dr. Castañeda - Institutional FWA confirmation - Wire instructions for the $300,000 upfront activation fee - DSMB charter confirmation (Dr. Garrett P. Lindholm, Chair) - CRO agreement confirmation (Meridian Clinical Sciences, Inc.; contact Victoria Reeves)
Please cross-reference against the closing checklist you prepared and confirm that every item is checked off. I'd like the binder finalized and circulated to the team no later than March 6.
**Christopher — IDE Supplement Filing Support**
With the CTA executed, please transition your focus to supporting TMRI on the IDE supplement filing with the FDA, targeting March 15, 2026. You'll be working primarily with Marcus Pruitt (General Counsel) and Dr. Elaine Sutherland (VP of Clinical Development) on the TMRI side. IDE reference number is G260012.
The executed CTA and budget are among the documents FDA will require in the supplement, so coordinate with Amy on timing for the closing binder. Additionally, please coordinate with Meridian Clinical Sciences (Victoria Reeves) on data management agreement documentation that may need to accompany the filing.
One additional item: the ClinicalTrials.gov registration (NCT06198234) should be updated to reflect site activation status once the IDE supplement is accepted. Please flag this for Dr. Sutherland so it stays on TMRI's radar.
Estimated first patient enrollment remains April 7, 2026. That timeline is tight, so the IDE supplement needs priority attention this week and next.
**Miriam — Billing / Matter Administration**
Please close out the billing for the CTA negotiation phase of Matter No. 1029-00001. The IDE supplement support work and any ongoing CTA administration will continue under the same matter number unless Marcus Pruitt prefers a separate matter — Christopher, please confirm with Marcus when you connect with him. Final invoice for the negotiation phase should be prepared and sent to Marcus Pruitt at TMRI, 280 Longmeadow Drive, Cambridge, MA 02139.
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Thanks again to the full team. This was a well-executed engagement and a good outcome for the client. As you all know, the Cadence-3 Trial is a critical milestone for TMRI's ThornValve MV-200 program — a successful feasibility study is the foundation for the future pivotal trial, so our continued support on the IDE supplement matters. Let's keep the momentum going.
Christopher — would you please schedule a brief debrief call with Marcus and Dr. Sutherland for later this week? I'd like to walk through post-execution logistics and the IDE supplement timeline while everything is fresh.
Best,
Joel
--- Joel Strauss Partner Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP One Post Office Square, Suite 4100 Boston, MA 02109