Contract analysis

From: Christopher Aiken <caiken@calderwoodharkness.com> To: "Marcus D. Pruitt" <mpruitt@thornwick.org> Cc: Joel Strauss <jstrauss@calderwoodharkness.com> Date: Sat, 21 Feb 2026 05:47:00 -0000 Subject: Cadence-3 CTA — IP and Publication Rights: Summary of Today's Negotiation Call [C&H Matter No. 1029-00001]

I am writing to provide a summary of the negotiation call held earlier today with Rebecca S. Norcross and Daniel F. Huang of Pemberton, Yates & Caldwell LLP, outside counsel to Hargrove University Medical Center, Inc. ("HUMC"). Joel Strauss, Amy Whitfield, and I participated on behalf of Calderwood & Harkness and TMRI. The purpose of the call was to resolve the outstanding IP ownership, licensing, and publication rig

**1. Trial Data Ownership — Resolution Reached**

HUMC agreed to TMRI's sole ownership of all Trial Data — including clinical data, safety data, imaging, and biomarker results — generated under the Cadence-3 Protocol. This was TMRI's original position. HUMC's prior redlines (February 7 and February 19) had sought site-level ownership of Trial Data with a license back to TMRI, which we had flagged as problematic for TMRI's regulatory and commercialization pathways.

In exchange, HUMC and Dr. Julian M. Castañeda (Principal Investigator) will receive a broad, non-exclusive, royalty-free license to use Trial Data for academic, non-commercial research, and teaching purposes, without requiring TMRI's prior consent for each individual use. Importantly, this license does not extend to commercial exploitation or sublicensing. We believe this compromise effectively protects TMRI's regula

Both sides confirmed that TMRI retains sole ownership of all Background IP, including the ThornValve MV-200 System design, specifications, manufacturing processes, and all pre-existing intellectual property. This was not contested on the call and requires no further negotiation.

**3. Foreground IP Licensing — Resolution Reached with Royalty Provision**

HUMC accepted the grant to TMRI of an exclusive license to all HUMC/PI foreground IP (i.e., inventions conceived or reduced to practice solely by HUMC or PI personnel in performance of the Protocol) for regulatory submissions, commercialization, and sublicensing. As you know, TMRI's original position was an exclusive, royalty-free, perpetual, worldwide license, while HUMC's prior redline sought a non-exclusive licens

- HUMC agreed to an exclusive license, which was TMRI's priority. - However, HUMC insisted on a reasonable royalty, to be negotiated in good faith, if the foreground IP is commercially exploited — specifically, if it is incorporated into a product that receives regulatory clearance or approval and is sold or licensed to a commercial partner. - The license remains royalty-free for regulatory submission purposes and al

We view this as a favorable outcome. The exclusivity of the license — TMRI's principal concern — was secured, and the royalty obligation is contingent, deferred, and limited in scope. I would appreciate your confirmation that TMRI authorizes us to proceed on this basis, as discussed further under Next Steps below.

**4. Jointly Owned IP — Compromise Position**

For inventions jointly conceived by TMRI and HUMC/PI personnel, joint ownership has been confirmed by both sides. The principal area of negotiation was TMRI's access to commercial rights in jointly owned IP:

- TMRI's original position included a right of first negotiation for an exclusive commercial license to jointly owned IP. - HUMC had rejected this in favor of a general good-faith negotiation obligation with no exclusivity commitment. - The compromise discussed on today's call provides that TMRI retains a right of first negotiation (not a right of first refusal) for a commercial license to jointly owned IP, with a de

Norcross indicated this framework was acceptable in principle. Huang will confirm with Dr. Ostrowski (SVP for Research Administration at HUMC) and Dr. Castañeda. We expect to receive that confirmation early next week.

**5. Publication Rights — Compromise Reached**

*Review Period.* The parties compromised on a 30-calendar-day initial review period for TMRI to review any manuscript, abstract, or presentation, plus one extension of up to 45 calendar days if TMRI identifies patentable subject matter requiring a patent application filing — for a total maximum review period of 75 calendar days. For context, TMRI's original position was 45 days initial review plus a 60-day extension

*Editorial Control.* Dr. Castañeda retains final editorial control over the content and conclusions of publications, subject to the obligation to remove TMRI's confidential commercial information (as defined in the CTA's confidentiality provisions) upon TMRI's written request. TMRI's original position had included broader redaction rights for "confidential commercial information" exercisable at TMRI's discretion, whi

*Publication Fund.* The $200,000 publication and manuscript preparation fund was not contested and remains as set forth in Exhibit A (Study Budget).

Norcross confirmed HUMC's agreement to all of the above publication terms on the call.

As reflected in the internal IP memorandum currently being finalized (dated February 18, 2026), our analysis concluded that the Bayh-Dole Act has limited applicability here because the Cadence-3 Trial is funded internally through TMRI's cardiovascular device development program (Grant Award No. TMRI-CV-2025-018) rather than through a federal grant. Norcross agreed with this analysis on the call, which materially simp

The role of Meridian Clinical Sciences, Inc. (TMRI's separately engaged CRO for data management, biostatistics, and safety monitoring) was briefly discussed in the context of data access and handling. HUMC confirmed it is comfortable with Meridian's role and data handling protocols as described in the current CTA draft. No changes are needed to the CRO-related provisions.

- **Third Draft CTA:** Calderwood & Harkness will prepare the third (near-final) draft CTA incorporating all compromises reached on the February 12 call (indemnification — $15,000,000 aggregate cap, broadened scope for device-related claims, 20-business-day notice period) and today's call (IP and publication terms as outlined above). We are targeting circulation of this draft by **Tuesday, February 24, 2026**.

- **Redline Comparison Chart:** I will coordinate with Amy Whitfield to update the redline comparison chart to reflect all resolved and remaining items.

- **HUMC Response:** We anticipate receiving HUMC's comments on the third draft by approximately **Thursday, February 26, 2026**.

- **Target Execution Date:** The target execution date remains **Monday, March 2, 2026**. Maintaining this date is important to stay on track for the IDE supplement filing to the FDA by March 15, 2026, and to support the estimated first patient enrollment of April 7, 2026.

- **Client Authorization:** I would ask that you each review this summary and **confirm TMRI's authorization to proceed with the compromises described above** — particularly (a) the reasonable royalty provision for commercially exploited foreground IP (Section 3 above) and (b) the 75-day total publication review period (Section 5 above). If you have any concerns or would like to discuss modifications to any of these

For reference, the indemnification memorandum has already been circulated to you, and the IP and publication rights memorandum (dated February 18, 2026) is available if you wish to review the detailed legal analysis underlying the positions we advanced on today's call. The second draft CTA circulated on February 14 also remains available for your reference.

Please do not hesitate to call me directly if you would like to discuss any of the foregoing. I am available over the weekend and throughout the day on Monday.

Christopher Aiken Lead Associate Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP One Post Office Square, Suite 4100 Boston, MA 02109 T: (617) 555-0194 E: caiken@calderwoodharkness.com

CONFIDENTIALITY NOTICE: This email message and any attachments are intended solely for the use of the addressee(s) named above and may contain information that is privileged, confidential, and exempt from disclosure under applicable law, including attorney-client privileged communications and attorney work product. If you are not the intended recipient, or the employee or agent responsible for delivering this message