[sheet: Cover]

Field	Value
Document Title	Redline Comparison Chart — TMRI vs. HUMC Positions on Key Contested Terms
Matter	Thornwick Medical Research Institute, Inc. — CADENCE-3 Clinical Trial Agreement
Matter Number	1029-00001
Prepared By	Amy Whitfield, Working Associate, Calderwood & Harkness LLP
Reviewed By	Christopher Aiken, Lead Associate, Calderwood & Harkness LLP
Date Prepared	February 22, 2026
Last Updated	February 26, 2026
Sponsor (Client)	Thornwick Medical Research Institute, Inc. (TMRI)
Institution	Hargrove University Medical Center, Inc. (HUMC)
Sponsor's Counsel	Calderwood & Harkness LLP (One Post Office Square, Suite 4100, Boston, MA 02109)
Institution's Counsel	Pemberton, Yates & Caldwell LLP (55 Church Street, Suite 1200, New Haven, CT 06510)
Lead Counsel for HUMC	Rebecca S. Norcross, Partner; Daniel F. Huang, Associate
Total CTA Value	$6,000,000
Investigational Device	ThornValve MV-200 System (Transcatheter Mitral Valve Repair Device)
Trial Name	CADENCE-3
IDE Number	G260012
ClinicalTrials.gov ID	NCT06198234
Target Execution Date	March 2, 2026
Sources	HUMC First Redline (February 7, 2026); HUMC Second Redline (February 19, 2026); February 12 Negotiation Call (Indemnity); February 21 Negotiation Call (IP & Publication); HUMC Comments on Third Draft (February 26, 2026)

[sheet: Indemnification Provisions]

Item No.	Provision	CTA Section Reference	TMRI Position — First Draft (Jan 28, 2026)	HUMC Position — First Redline (Feb 7, 2026)	HUMC Position — Second Redline (Feb 19, 2026)	C&H Recommended Compromise	Rationale / Notes	Status	Resolved In Draft
1	Indemnification Scope	Section 10.1	TMRI indemnifies HUMC, PI (Dr. Julian M. Castañeda), Sub-Investigator (Dr. Hannah L. Forsberg), and study staff for third-party claims arising from: (a) design, manufacture, or inherent defect of the ThornValve MV-200 System; and (b) TMRI's negligence or willful misconduct. Excludes claims arising from HUMC's or PI's negligence, deviation from Protocol, failure to obtain informed consent, or willful misconduct.	Broadened indemnification to cover all claims 'arising out of or relating to' the investigational device, not limited to design/manufacture/defect. Retains exclusions for HUMC/PI willful misconduct only (deletes negligence and protocol deviation exclusions).	Maintained broadened 'arising out of or relating to' language. Agreed to restore protocol deviation exclusion but continued to reject ordinary negligence exclusion for HUMC.	Accept broadened 'arising out of or relating to' language for device-related claims to cover unexpected categories of harm. Retain exclusions for: (i) HUMC/PI negligence, (ii) protocol deviation, (iii) failure to obtain informed consent, and (iv) willful misconduct. This protects TMRI against site-level errors while providing HUMC meaningful coverage for device-inherent risks. Compromise language: indemnification covers 'claims arising out of or relating to the design, manufacture, supply, or use of the ThornValve MV-200 System in accordance with the Protocol.'	Broadened scope is reasonable given TMRI's role as device sponsor. Retaining negligence exclusion is standard in investigator-initiated trials. The compromise ties broad device coverage to Protocol compliance, which aligns incentives. Commonwealth Specialty Underwriters policy CTL-2025-08843 covers device-related claims broadly. Feb 12 call: HUMC counsel (Norcross) indicated flexibility if scope language captures device-use claims.	Resolved — Agreed in Third Draft (Feb 24, 2026)	Third Draft
2	Indemnification Cap	Section 10.1(d)	Aggregate indemnification cap of $10,000,000, matching TMRI's per-occurrence limit under Commonwealth Specialty Underwriters clinical trial liability policy (Policy No. CTL-2025-08843).	Removal of aggregate indemnification cap entirely, or in the alternative, increase to $25,000,000 to match TMRI's aggregate policy limit under the same Commonwealth Specialty policy.	Maintained request for $25,000,000 cap (dropped uncapped request). Indicated on Feb 12 call willingness to consider $15,000,000 as compromise.	Accept $15,000,000 aggregate indemnification cap. This is midpoint between TMRI's $10M per-occurrence limit and HUMC's requested $25M aggregate limit. The $15M cap remains within TMRI's aggregate policy coverage of $25,000,000 and provides HUMC meaningful protection for a 45-subject feasibility trial with inherent procedural risks.	$15M is commercially reasonable for a $6M CTA involving transcatheter cardiac intervention. TMRI's aggregate policy of $25M covers multiple trials; reserving $15M for CADENCE-3 still leaves headroom. HUMC's Pinnacle Mutual professional liability coverage (Policy PML-HU-2025-4471, $5M/$15M) provides additional HUMC-side protection. Feb 12 call: HUMC signaled $15M is acceptable.	Resolved — Agreed at $15,000,000 in Third Draft (Feb 24, 2026)	Third Draft
3	Notice Period for Indemnification Claims	Section 10.2(a)	HUMC must provide prompt written notice to TMRI within 15 business days of knowledge of a claim or threatened claim.	30 business days for written notice.	Maintained 30 business days; argued institutional bureaucracy requires additional time for internal review and legal assessment before formal notification.	Compromise at 20 business days. Provides HUMC reasonable time for internal review while ensuring TMRI can timely engage defense counsel and notify Commonwealth Specialty Underwriters under policy notification requirements.	20 business days balances institutional administrative reality with TMRI's need for prompt notice. Insurance policy likely requires 'prompt' notice; 20 business days is defensible. Standard range in academic medical center CTAs is 15–30 days.	Resolved — Agreed at 20 business days in Third Draft (Feb 24, 2026)	Third Draft
4	Defense Control and Right to Participate	Section 10.2(b)–(c)	TMRI has sole right to control defense and settlement of any indemnified claim. HUMC to cooperate and not settle without TMRI's prior written consent.	HUMC demands right to participate in defense with separate counsel at TMRI's expense in all cases. HUMC consent required for any settlement that (i) imposes non-monetary obligations on HUMC, (ii) does not include full release of HUMC, or (iii) exceeds $500,000.	Maintained right to participate with separate counsel at TMRI's expense. Narrowed trigger: only when a bona fide conflict of interest exists between TMRI and HUMC. Maintained HUMC consent requirements for settlement.	Accept HUMC's right to participate in defense with separate counsel at TMRI's expense, but only when an actual conflict of interest exists as reasonably determined by TMRI's counsel (Calderwood & Harkness LLP). HUMC consent required for settlements that (i) impose non-monetary obligations on HUMC or PI, or (ii) do not include a full and unconditional release of HUMC, PI, and study staff. Remove the $500,000 threshold for consent — TMRI should retain flexibility on monetary settlement amounts to manage defense efficiently.	Conflict-of-interest trigger for separate counsel is standard. Removing the $500K consent threshold avoids micromanagement of defense strategy. HUMC's protection is adequately served by consent rights over non-monetary terms and release requirements. Feb 12 call: Norcross agreed to conflict-of-interest trigger; Huang indicated $500K threshold is negotiable.	Resolved — Agreed in Third Draft (Feb 24, 2026)	Third Draft
5	Mutual Indemnification Standard	Section 10.3	HUMC indemnifies TMRI for claims arising from HUMC's or PI's negligence (including ordinary negligence), protocol deviation, failure to obtain informed consent, or willful misconduct.	HUMC will indemnify TMRI only for claims arising from HUMC's or PI's gross negligence or willful misconduct. Rejects ordinary negligence standard for HUMC's reciprocal indemnification obligation.	Maintained gross negligence/willful misconduct standard. Argued that PI and study staff should not bear indemnification risk for ordinary negligence given academic medical center context and HUMC's own professional liability coverage.	Accept negligence standard (not limited to gross negligence) for HUMC's indemnification of TMRI, but add a carve-out providing that HUMC's obligation does not apply to claims arising primarily from the design or inherent characteristics of the ThornValve MV-200 System. This preserves TMRI's protection against site-level errors while acknowledging that HUMC should not bear device-design risk.	Ordinary negligence is the appropriate standard for an institution performing procedures. HUMC carries professional liability coverage through Pinnacle Mutual ($5M per occurrence / $15M aggregate) that covers negligent acts. The device-design carve-out addresses HUMC's legitimate concern about bearing responsibility for device-inherent issues. Massachusetts law generally enforces contractual indemnification for negligence if clearly stated.	Resolved — Agreed (negligence standard with device-design carve-out) in Third Draft (Feb 24, 2026)	Third Draft

[sheet: IP Provisions]

Item No.	Provision	CTA Section Reference	TMRI Position — First Draft (Jan 28, 2026)	HUMC Position — First Redline (Feb 7, 2026)	HUMC Position — Second Redline (Feb 19, 2026)	C&H Recommended Compromise	Rationale / Notes	Status	Resolved In Draft
6	Trial Data Ownership	Section 11.1	All Trial Data (clinical data, safety data, imaging, biomarker results) generated at HUMC in performance of the CADENCE-3 Protocol owned solely by TMRI as Sponsor. TMRI has unrestricted right to use Trial Data for regulatory submissions (including IDE G260012 supplement and future pivotal trial), publications, and commercialization.	HUMC seeks ownership of all Trial Data generated at its site. TMRI would receive a license to use site-generated data for regulatory and commercial purposes.	Maintained HUMC ownership position but signaled flexibility on Feb 21 call. Willing to accept TMRI ownership if PI receives broad license for academic use.	TMRI retains sole ownership of all Trial Data. HUMC and PI (Dr. Castañeda) receive a non-exclusive, royalty-free, perpetual license to use Trial Data for academic, non-commercial research and teaching purposes, subject to TMRI's publication review rights (see Item 10). License does not extend to regulatory submissions or commercial exploitation by HUMC or PI.	Sponsor ownership of trial data is standard for sponsor-initiated and investigator-initiated trials funded by the sponsor. TMRI needs clear ownership for IDE G260012 supplement filing (target March 15, 2026) and future pivotal trial submission. Bayh-Dole Act has limited applicability here — trial is funded internally through TMRI-CV-2025-018, not by federal grant. Academic license for PI preserves academic freedom and publication rights. Feb 21 call: HUMC agreed to this framework.	Resolved — Agreed in Third Draft (Feb 24, 2026)	Third Draft
7	Foreground IP Licensing	Section 11.3	HUMC and PI grant TMRI an exclusive, royalty-free, perpetual, worldwide license to all HUMC/PI foreground IP (inventions, discoveries, improvements conceived or reduced to practice in performance of the Protocol) for regulatory submissions, commercialization, and sublicensing.	No exclusive license to TMRI for HUMC foreground IP. Non-exclusive license only. HUMC and PI retain right to license foreground IP to third parties.	Maintained non-exclusive position in second redline. On Feb 21 call, HUMC agreed to exclusive license if reasonable royalty paid upon commercial exploitation.	HUMC and PI grant TMRI an exclusive, worldwide, perpetual license to all HUMC/PI foreground IP for regulatory, research, and commercial purposes including sublicensing. License is royalty-free for non-commercial and regulatory uses. If TMRI or a sublicensee commercially exploits foreground IP (i.e., generates revenue from product sales incorporating the foreground IP), TMRI will pay HUMC a reasonable royalty to be negotiated in good faith, with disputes resolved under the CTA's dispute resolution provisions (negotiation → mediation via AAA in Boston → litigation in Suffolk County).	Exclusive license is critical for TMRI to maintain freedom to operate in future commercial licensing of ThornValve MV-200. Non-exclusive would create blocking IP risk. Reasonable royalty for commercial exploitation is fair to HUMC and PI as co-innovators. Royalty-free for regulatory use ensures no barrier to IDE/PMA submissions. Feb 21 call: Norcross confirmed HUMC accepts this structure.	Resolved — Agreed in Third Draft (Feb 24, 2026)	Third Draft
8	Jointly Owned IP Rights	Section 11.4	Inventions jointly conceived by TMRI and HUMC/PI personnel are jointly owned. TMRI has right of first negotiation for an exclusive commercial license to any jointly owned IP, exercisable within 90 days of disclosure.	Jointly conceived inventions require mutual written consent for any licensing to third parties. No right of first negotiation for TMRI.	Accepted joint ownership framework. Continued to reject right of first negotiation; proposed good-faith negotiation with no exclusivity commitment.	Jointly owned inventions: each party may use for internal, non-commercial research without the other's consent. For commercial licensing, TMRI has a right of first negotiation exercisable within 120 days of written disclosure of the invention. If TMRI exercises the right, parties negotiate in good faith for 90 days toward an exclusive license on commercially reasonable terms. If no agreement is reached, either party may license to third parties, subject to the other party's co-ownership rights and a right to match any bona fide third-party offer within 30 days.	Right of first negotiation is important to TMRI's commercial strategy for ThornValve MV-200 — a third-party licensee could complicate TMRI's regulatory and commercialization pathway. Extended 90-day to 120-day exercise period to address HUMC's concern about adequate evaluation time. Right-to-match provision gives TMRI a backstop without permanently blocking HUMC. Feb 21 call: HUMC willing to accept structured first-negotiation right with adequate timeframes.	Resolved — Agreed in Third Draft (Feb 24, 2026)	Third Draft
9	Right of First Negotiation (Standalone)	Section 11.5	TMRI has right of first negotiation for exclusive commercial license to any solely owned HUMC/PI foreground IP (in addition to jointly owned IP per Section 11.4). Exercise period: 60 days from disclosure.	Right of first negotiation rejected entirely. Replaced with obligation to negotiate in good faith with no exclusivity commitment and no exercise period.	Maintained rejection. Argued academic institution cannot grant preferential commercial rights without faculty governance review.	Withdraw standalone right of first negotiation for solely owned HUMC/PI foreground IP (Section 11.5). TMRI's interests are adequately protected by the exclusive license under Section 11.3 (foreground IP) and the first-negotiation right for jointly owned IP under Section 11.4. Solely owned HUMC/PI inventions outside the scope of Protocol performance are not subject to TMRI's license or negotiation rights.	Conceding this point simplifies the agreement and removes a significant friction point. The exclusive license for foreground IP (Item 7) already captures inventions conceived in performance of the Protocol. Solely owned HUMC inventions outside Protocol scope are unlikely to be directly relevant to ThornValve MV-200. Concession may facilitate closure on remaining open items. Feb 21 call: Norcross indicated this was a priority for HUMC faculty governance.	Resolved — TMRI withdrew Section 11.5 in Third Draft (Feb 24, 2026)	Third Draft

[sheet: Publication Rights]

Item No.	Provision	CTA Section Reference	TMRI Position — First Draft (Jan 28, 2026)	HUMC Position — First Redline (Feb 7, 2026)	HUMC Position — Second Redline (Feb 19, 2026)	C&H Recommended Compromise	Rationale / Notes	Status	Resolved In Draft
10	Publication Review Period	Section 12.1	45-day advance review period for all manuscripts, abstracts, and presentations. TMRI may request up to an additional 60-day delay (105 days total from submission to TMRI) to allow filing of patent applications protecting inventions disclosed in the manuscript.	30-day review period with a single 30-day extension (60 days total). No further extensions permitted.	Maintained 30+30 day position. On Feb 21 call, HUMC indicated willingness to extend total period modestly if initial review period remains 30 days.	30-day initial review period. TMRI may request one extension of up to 45 days (75 days total) for purposes of filing patent applications. Extension request must be made in writing before expiration of initial 30-day period and must identify the specific patentable subject matter requiring protection. No further extensions.	75 days total is a reasonable compromise between TMRI's 105-day request and HUMC's 60-day position. 30-day initial review is standard in academic CTA practice and sufficient for editorial/confidentiality review. 45-day extension provides adequate time for provisional patent application preparation. Requiring identification of patentable subject matter prevents pretextual delays. Feb 21 call: HUMC agreed to 30+45 framework.	Resolved — Agreed at 30+45 days (75 total) in Third Draft (Feb 24, 2026)	Third Draft
11	Editorial Control	Section 12.2	TMRI retains right to review and comment on all manuscripts. TMRI may require removal of TMRI Confidential Information and patentable subject matter prior to submission. TMRI and PI to use good-faith efforts to resolve disagreements, but TMRI has final authority to require delay or modification to protect IP and confidential information.	PI (Dr. Castañeda) has final editorial control over all publications. TMRI review is advisory only. TMRI may not require modifications beyond removal of patentable inventions identified during the review period.	Maintained PI final editorial control. Agreed that TMRI may identify confidential commercial information for removal but PI makes final determination on editorial content and scientific conclusions.	PI retains final editorial control over scientific content, conclusions, and presentation of Trial Data. TMRI may require removal of: (i) TMRI Confidential Information (as defined in Section 13 — Confidentiality) and (ii) patentable subject matter identified during the review period. Disputes over what constitutes Confidential Information vs. scientific findings to be resolved by the parties in good faith; if unresolved within 15 days, either party may invoke the dispute resolution mechanism (Section 15 — negotiation, mediation via AAA in Boston, litigation in Suffolk County, Massachusetts).	PI editorial control over scientific content is consistent with academic norms and ICMJE guidelines. TMRI's interest is in protecting trade secrets and securing patent filings — not in controlling scientific narrative. Clear definition of Confidential Information in Section 13 and a dispute resolution mechanism prevent abuse by either side. Feb 21 call: both sides agreed to this framework in principle.	Resolved — Agreed in Third Draft (Feb 24, 2026)	Third Draft
12	Redaction Rights	Section 12.3	TMRI may redact confidential commercial information from any manuscript or presentation, including device specifications, manufacturing processes, and proprietary analytical methods. Redaction is at TMRI's sole discretion.	No right to redact beyond patentable inventions identified during the review/extension period. TMRI may not redact Trial Data results, safety data, or clinical outcomes under any circumstances.	Maintained position. Added explicit language that redaction may not be used to suppress unfavorable safety or efficacy findings.	TMRI may redact from manuscripts: (i) device manufacturing specifications and proprietary processes constituting trade secrets; (ii) proprietary analytical methods not necessary for scientific reproducibility; and (iii) patentable subject matter during the extension period. TMRI may not redact: (a) Trial Data results, (b) clinical outcomes, (c) safety data or adverse event information, or (d) any information required to be disclosed under FDA regulations, ClinicalTrials.gov (NCT06198234) reporting obligations, or ICMJE requirements. Disagreements resolved per Section 15.	Clear delineation between protectable commercial information and scientific/safety data is critical. TMRI's legitimate interests in trade secrets are protected. Prohibition on redacting safety data aligns with FDA regulatory expectations under IDE G260012, ClinicalTrials.gov obligations, and public health considerations. Explicit carve-out for regulatory disclosures avoids conflict with TMRI's FDA obligations. Feb 21 call: agreed in principle.	Resolved — Agreed in Third Draft (Feb 24, 2026)	Third Draft

[sheet: Resolution Summary]

Item No.	Provision	Category	First Draft Position (Jan 28)	First Redline Status (Feb 7)	Feb 12 Call — Indemnity	Second Draft (Feb 14)	Second Redline (Feb 19)	Feb 21 Call — IP/Publication	Third Draft (Feb 24)	HUMC Comments (Feb 26)	Final Status for Execution Version (Mar 2)
1	Indemnification Scope	Indemnification	TMRI position stated	HUMC redline — open	Discussed; movement on scope language	Revised — compromise proposed	HUMC partial acceptance	N/A (indemnity addressed Feb 12)	Agreed — broadened scope with Protocol-compliance tie	Confirmed	RESOLVED
2	Indemnification Cap	Indemnification	TMRI position: $10M cap	HUMC redline: $25M or uncapped	$15M compromise discussed	Revised to $15M	HUMC accepted $15M	N/A	Agreed — $15M aggregate cap	Confirmed	RESOLVED
3	Notice Period	Indemnification	TMRI position: 15 business days	HUMC redline: 30 business days	Discussed; HUMC firm on 30	Revised to 20 business days	HUMC accepted 20 days	N/A	Agreed — 20 business days	Confirmed	RESOLVED
4	Defense Control / Right to Participate	Indemnification	TMRI sole control	HUMC: participate at TMRI cost; settlement consent	Discussed; conflict-of-interest trigger agreed	Revised — conflict trigger; settlement consent narrowed	HUMC accepted revised terms	N/A	Agreed	Confirmed	RESOLVED
5	Mutual Indemnification Standard	Indemnification	TMRI: ordinary negligence	HUMC: gross negligence only	Discussed; device-design carve-out proposed	Revised — negligence with device carve-out	HUMC accepted	N/A	Agreed	Confirmed	RESOLVED
6	Trial Data Ownership	Intellectual Property	TMRI sole ownership	HUMC ownership with TMRI license	N/A	No change (awaiting IP call)	HUMC maintained position	Discussed; HUMC accepts TMRI ownership with PI academic license	Agreed — TMRI ownership; PI non-exclusive academic license	Confirmed	RESOLVED
7	Foreground IP Licensing	Intellectual Property	Exclusive, royalty-free to TMRI	Non-exclusive only	N/A	No change	Maintained non-exclusive	Discussed; exclusive with reasonable royalty for commercial use	Agreed — exclusive license; royalty on commercial exploitation	Confirmed	RESOLVED
8	Jointly Owned IP Rights	Intellectual Property	TMRI right of first negotiation (90 days)	Mutual consent; no first negotiation	N/A	No change	Good-faith negotiation, no exclusivity	Discussed; structured first-negotiation with right to match	Agreed — 120-day first negotiation; 90-day good-faith period; 30-day match right	Confirmed	RESOLVED
9	Right of First Negotiation (Standalone)	Intellectual Property	TMRI first negotiation for solely owned HUMC IP (60 days)	Rejected entirely	N/A	No change	Maintained rejection	Discussed; C&H recommended withdrawal	Withdrawn by TMRI	Confirmed	RESOLVED — TMRI conceded
10	Publication Review Period	Publication Rights	45 + 60 days (105 total)	30 + 30 days (60 total)	N/A	No change	Maintained 30 + 30	Discussed; agreed 30 + 45 days (75 total)	Agreed — 30 + 45 days	Confirmed	RESOLVED
11	Editorial Control	Publication Rights	TMRI final authority	PI final editorial control	N/A	No change	PI final control; TMRI may identify confidential info	Discussed; PI control with TMRI removal of confidential info	Agreed — PI final on science; TMRI removal of confidential/patentable info	Confirmed	RESOLVED
12	Redaction Rights	Publication Rights	TMRI sole discretion to redact	No redaction beyond patentable inventions	N/A	No change	No redaction of safety data; added anti-suppression language	Discussed; agreed categories of protectable vs. non-redactable info	Agreed — trade secrets redactable; safety/outcomes not redactable	Confirmed	RESOLVED
SUMMARY	12 provisions stated	12 open	5 indemnity items discussed	5 indemnity items revised	5 indemnity resolved; 7 IP/pub open	7 IP/pub items discussed	12 of 12 resolved	12 of 12 confirmed	All 12 provisions resolved as of Third Draft (February 24, 2026), confirmed by HUMC comments (February 26, 2026). Execution version prepared for March 2, 2026 signing.

[sheet: Key Reference Data]

Reference Item	Details	Relevance to Negotiation
TMRI Clinical Trial Liability Insurance — Per Occurrence	$10,000,000 (Commonwealth Specialty Underwriters, Inc., Policy CTL-2025-08843)	TMRI's initial indemnification cap of $10M matched this limit
TMRI Clinical Trial Liability Insurance — Aggregate	$25,000,000 (same policy)	HUMC's requested cap of $25M matched this aggregate limit; compromise at $15M
HUMC Professional Liability Insurance — Per Occurrence	$5,000,000 (Pinnacle Mutual Insurance Company, Policy PML-HU-2025-4471)	Supports HUMC's obligation under mutual indemnification; covers negligent acts
HUMC Professional Liability Insurance — Aggregate	$15,000,000 (same policy)	Additional layer of institutional coverage
Total CTA Value	$6,000,000	Proportionality consideration for indemnification cap
Internal Grant Award	TMRI-CV-2025-018	Internal funding — Bayh-Dole limited applicability (no federal funding)
IDE Number	G260012	Regulatory submission context for IP and data ownership
ClinicalTrials.gov Identifier	NCT06198234	Publication and data disclosure obligations
IRB Approval	HUMC-IRB-2025-0847 (December 18, 2025)	Protocol approved; CTA execution is gating item
Target CTA Execution	March 2, 2026	Drives negotiation timeline
IDE Supplement Filing Target	March 15, 2026	Requires executed CTA and finalized data ownership terms
Governing Law	Commonwealth of Massachusetts	Applicable to indemnification enforceability analysis
Dispute Resolution	Negotiation → Mediation (AAA, Boston) → Litigation (Suffolk County, MA)	Referenced in editorial control and royalty dispute provisions
Principal Investigator	Dr. Julian M. Castañeda, M.D., FACC — Director, Structural Heart Interventions Program, HUMC	PI editorial control and foreground IP considerations
Sub-Investigator	Dr. Hannah L. Forsberg, M.D. — Associate Director, Structural Heart Interventions Program, HUMC	Covered under indemnification and IP provisions
CRO	Meridian Clinical Sciences, Inc. (Victoria Reeves, VP Cardiovascular Programs)	Separate data management agreement; Trial Data flows to TMRI as owner
DSMB Chair	Dr. Garrett P. Lindholm, M.D., Ph.D. (Ellsworth University)	Independent safety oversight; safety data publication implications

[sheet: Cover]
Field | Value
Document Title | Redline Comparison Chart — TMRI vs. HUMC Positions on Key Contested Terms
Matter | Thornwick Medical Research Institute, Inc. — CADENCE-3 Clinical Trial Agreement
Matter Number | 1029-00001
Prepared By | Amy Whitfield, Working Associate, Calderwood & Harkness LLP
Reviewed By | Christopher Aiken, Lead Associate, Calderwood & Harkness LLP
Date Prepared | February 22, 2026
Last Updated | February 26, 2026
Sponsor (Client) | Thornwick Medical Research Institute, Inc. (TMRI)
Institution | Hargrove University Medical Center, Inc. (HUMC)
Sponsor's Counsel | Calderwood & Harkness LLP (One Post Office Square, Suite 4100, Boston, MA 02109)
Institution's Counsel | Pemberton, Yates & Caldwell LLP (55 Church Street, Suite 1200, New Haven, CT 06510)
Lead Counsel for HUMC | Rebecca S. Norcross, Partner; Daniel F. Huang, Associate
Total CTA Value | $6,000,000
Investigational Device | ThornValve MV-200 System (Transcatheter Mitral Valve Repair Device)
Trial Name | CADENCE-3
IDE Number | G260012
ClinicalTrials.gov ID | NCT06198234
Target Execution Date | March 2, 2026
Sources | HUMC First Redline (February 7, 2026); HUMC Second Redline (February 19, 2026); February 12 Negotiation Call (Indemnity); February 21 Negotiation Call (IP & Publication); HUMC Comments on Third Draft (February 26, 2026)
[sheet: Indemnification Provisions]
Item No. | Provision | CTA Section Reference | TMRI Position — First Draft (Jan 28, 2026) | HUMC Position — First Redline (Feb 7, 2026) | HUMC Position — Second Redline (Feb 19, 2026) | C&H Recommended Compromise | Rationale / Notes | Status | Resolved In Draft
1 | Indemnification Scope | Section 10.1 | TMRI indemnifies HUMC, PI (Dr. Julian M. Castañeda), Sub-Investigator (Dr. Hannah L. Forsberg), and study staff for third-party claims arising from: (a) design, manufacture, or inherent defect of the ThornValve MV-200 System; and (b) TMRI's negligence or willful misconduct. Excludes claims arising from HUMC's or PI's negligence, deviation from Protocol, failure to obtain informed consent, or willful misconduct. | Broadened indemnification to cover all claims 'arising out of or relating to' the investigational device, not limited to design/manufacture/defect. Retains exclusions for HUMC/PI willful misconduct only (deletes negligence and protocol deviation exclusions). | Maintained broadened 'arising out of or relating to' language. Agreed to restore protocol deviation exclusion but continued to reject ordinary negligence exclusion for HUMC. | Accept broadened 'arising out of or relating to' language for device-related claims to cover unexpected categories of harm. Retain exclusions for: (i) HUMC/PI negligence, (ii) protocol deviation, (iii) failure to obtain informed consent, and (iv) willful misconduct. This protects TMRI against site-level errors while providing HUMC meaningful coverage for device-inherent risks. Compromise language: indemnification covers 'claims arising out of or relating to the design, manufacture, supply, or use of the ThornValve MV-200 System in accordance with the Protocol.' | Broadened scope is reasonable given TMRI's role as device sponsor. Retaining negligence exclusion is standard in investigator-initiated trials. The compromise ties broad device coverage to Protocol compliance, which aligns incentives. Commonwealth Specialty Underwriters policy CTL-2025-08843 covers device-related claims broadly. Feb 12 call: HUMC counsel (Norcross) indicated flexibility if scope language captures device-use claims. | Resolved — Agreed in Third Draft (Feb 24, 2026) | Third Draft
2 | Indemnification Cap | Section 10.1(d) | Aggregate indemnification cap of $10,000,000, matching TMRI's per-occurrence limit under Commonwealth Specialty Underwriters clinical trial liability policy (Policy No. CTL-2025-08843). | Removal of aggregate indemnification cap entirely, or in the alternative, increase to $25,000,000 to match TMRI's aggregate policy limit under the same Commonwealth Specialty policy. | Maintained request for $25,000,000 cap (dropped uncapped request). Indicated on Feb 12 call willingness to consider $15,000,000 as compromise. | Accept $15,000,000 aggregate indemnification cap. This is midpoint between TMRI's $10M per-occurrence limit and HUMC's requested $25M aggregate limit. The $15M cap remains within TMRI's aggregate policy coverage of $25,000,000 and provides HUMC meaningful protection for a 45-subject feasibility trial with inherent procedural risks. | $15M is commercially reasonable for a $6M CTA involving transcatheter cardiac intervention. TMRI's aggregate policy of $25M covers multiple trials; reserving $15M for CADENCE-3 still leaves headroom. HUMC's Pinnacle Mutual professional liability coverage (Policy PML-HU-2025-4471, $5M/$15M) provides additional HUMC-side protection. Feb 12 call: HUMC signaled $15M is acceptable. | Resolved — Agreed at $15,000,000 in Third Draft (Feb 24, 2026) | Third Draft
3 | Notice Period for Indemnification Claims | Section 10.2(a) | HUMC must provide prompt written notice to TMRI within 15 business days of knowledge of a claim or threatened claim. | 30 business days for written notice. | Maintained 30 business days; argued institutional bureaucracy requires additional time for internal review and legal assessment before formal notification. | Compromise at 20 business days. Provides HUMC reasonable time for internal review while ensuring TMRI can timely engage defense counsel and notify Commonwealth Specialty Underwriters under policy notification requirements. | 20 business days balances institutional administrative reality with TMRI's need for prompt notice. Insurance policy likely requires 'prompt' notice; 20 business days is defensible. Standard range in academic medical center CTAs is 15–30 days. | Resolved — Agreed at 20 business days in Third Draft (Feb 24, 2026) | Third Draft
4 | Defense Control and Right to Participate | Section 10.2(b)–(c) | TMRI has sole right to control defense and settlement of any indemnified claim. HUMC to cooperate and not settle without TMRI's prior written consent. | HUMC demands right to participate in defense with separate counsel at TMRI's expense in all cases. HUMC consent required for any settlement that (i) imposes non-monetary obligations on HUMC, (ii) does not include full release of HUMC, or (iii) exceeds $500,000. | Maintained right to participate with separate counsel at TMRI's expense. Narrowed trigger: only when a bona fide conflict of interest exists between TMRI and HUMC. Maintained HUMC consent requirements for settlement. | Accept HUMC's right to participate in defense with separate counsel at TMRI's expense, but only when an actual conflict of interest exists as reasonably determined by TMRI's counsel (Calderwood & Harkness LLP). HUMC consent required for settlements that (i) impose non-monetary obligations on HUMC or PI, or (ii) do not include a full and unconditional release of HUMC, PI, and study staff. Remove the $500,000 threshold for consent — TMRI should retain flexibility on monetary settlement amounts to manage defense efficiently. | Conflict-of-interest trigger for separate counsel is standard. Removing the $500K consent threshold avoids micromanagement of defense strategy. HUMC's protection is adequately served by consent rights over non-monetary terms and release requirements. Feb 12 call: Norcross agreed to conflict-of-interest trigger; Huang indicated $500K threshold is negotiable. | Resolved — Agreed in Third Draft (Feb 24, 2026) | Third Draft
5 | Mutual Indemnification Standard | Section 10.3 | HUMC indemnifies TMRI for claims arising from HUMC's or PI's negligence (including ordinary negligence), protocol deviation, failure to obtain informed consent, or willful misconduct. | HUMC will indemnify TMRI only for claims arising from HUMC's or PI's gross negligence or willful misconduct. Rejects ordinary negligence standard for HUMC's reciprocal indemnification obligation. | Maintained gross negligence/willful misconduct standard. Argued that PI and study staff should not bear indemnification risk for ordinary negligence given academic medical center context and HUMC's own professional liability coverage. | Accept negligence standard (not limited to gross negligence) for HUMC's indemnification of TMRI, but add a carve-out providing that HUMC's obligation does not apply to claims arising primarily from the design or inherent characteristics of the ThornValve MV-200 System. This preserves TMRI's protection against site-level errors while acknowledging that HUMC should not bear device-design risk. | Ordinary negligence is the appropriate standard for an institution performing procedures. HUMC carries professional liability coverage through Pinnacle Mutual ($5M per occurrence / $15M aggregate) that covers negligent acts. The device-design carve-out addresses HUMC's legitimate concern about bearing responsibility for device-inherent issues. Massachusetts law generally enforces contractual indemnification for negligence if clearly stated. | Resolved — Agreed (negligence standard with device-design carve-out) in Third Draft (Feb 24, 2026) | Third Draft
[sheet: IP Provisions]
Item No. | Provision | CTA Section Reference | TMRI Position — First Draft (Jan 28, 2026) | HUMC Position — First Redline (Feb 7, 2026) | HUMC Position — Second Redline (Feb 19, 2026) | C&H Recommended Compromise | Rationale / Notes | Status | Resolved In Draft
6 | Trial Data Ownership | Section 11.1 | All Trial Data (clinical data, safety data, imaging, biomarker results) generated at HUMC in performance of the CADENCE-3 Protocol owned solely by TMRI as Sponsor. TMRI has unrestricted right to use Trial Data for regulatory submissions (including IDE G260012 supplement and future pivotal trial), publications, and commercialization. | HUMC seeks ownership of all Trial Data generated at its site. TMRI would receive a license to use site-generated data for regulatory and commercial purposes. | Maintained HUMC ownership position but signaled flexibility on Feb 21 call. Willing to accept TMRI ownership if PI receives broad license for academic use. | TMRI retains sole ownership of all Trial Data. HUMC and PI (Dr. Castañeda) receive a non-exclusive, royalty-free, perpetual license to use Trial Data for academic, non-commercial research and teaching purposes, subject to TMRI's publication review rights (see Item 10). License does not extend to regulatory submissions or commercial exploitation by HUMC or PI. | Sponsor ownership of trial data is standard for sponsor-initiated and investigator-initiated trials funded by the sponsor. TMRI needs clear ownership for IDE G260012 supplement filing (target March 15, 2026) and future pivotal trial submission. Bayh-Dole Act has limited applicability here — trial is funded internally through TMRI-CV-2025-018, not by federal grant. Academic license for PI preserves academic freedom and publication rights. Feb 21 call: HUMC agreed to this framework. | Resolved — Agreed in Third Draft (Feb 24, 2026) | Third Draft
7 | Foreground IP Licensing | Section 11.3 | HUMC and PI grant TMRI an exclusive, royalty-free, perpetual, worldwide license to all HUMC/PI foreground IP (inventions, discoveries, improvements conceived or reduced to practice in performance of the Protocol) for regulatory submissions, commercialization, and sublicensing. | No exclusive license to TMRI for HUMC foreground IP. Non-exclusive license only. HUMC and PI retain right to license foreground IP to third parties. | Maintained non-exclusive position in second redline. On Feb 21 call, HUMC agreed to exclusive license if reasonable royalty paid upon commercial exploitation. | HUMC and PI grant TMRI an exclusive, worldwide, perpetual license to all HUMC/PI foreground IP for regulatory, research, and commercial purposes including sublicensing. License is royalty-free for non-commercial and regulatory uses. If TMRI or a sublicensee commercially exploits foreground IP (i.e., generates revenue from product sales incorporating the foreground IP), TMRI will pay HUMC a reasonable royalty to be negotiated in good faith, with disputes resolved under the CTA's dispute resolution provisions (negotiation → mediation via AAA in Boston → litigation in Suffolk County). | Exclusive license is critical for TMRI to maintain freedom to operate in future commercial licensing of ThornValve MV-200. Non-exclusive would create blocking IP risk. Reasonable royalty for commercial exploitation is fair to HUMC and PI as co-innovators. Royalty-free for regulatory use ensures no barrier to IDE/PMA submissions. Feb 21 call: Norcross confirmed HUMC accepts this structure. | Resolved — Agreed in Third Draft (Feb 24, 2026) | Third Draft
8 | Jointly Owned IP Rights | Section 11.4 | Inventions jointly conceived by TMRI and HUMC/PI personnel are jointly owned. TMRI has right of first negotiation for an exclusive commercial license to any jointly owned IP, exercisable within 90 days of disclosure. | Jointly conceived inventions require mutual written consent for any licensing to third parties. No right of first negotiation for TMRI. | Accepted joint ownership framework. Continued to reject right of first negotiation; proposed good-faith negotiation with no exclusivity commitment. | Jointly owned inventions: each party may use for internal, non-commercial research without the other's consent. For commercial licensing, TMRI has a right of first negotiation exercisable within 120 days of written disclosure of the invention. If TMRI exercises the right, parties negotiate in good faith for 90 days toward an exclusive license on commercially reasonable terms. If no agreement is reached, either party may license to third parties, subject to the other party's co-ownership rights and a right to match any bona fide third-party offer within 30 days. | Right of first negotiation is important to TMRI's commercial strategy for ThornValve MV-200 — a third-party licensee could complicate TMRI's regulatory and commercialization pathway. Extended 90-day to 120-day exercise period to address HUMC's concern about adequate evaluation time. Right-to-match provision gives TMRI a backstop without permanently blocking HUMC. Feb 21 call: HUMC willing to accept structured first-negotiation right with adequate timeframes. | Resolved — Agreed in Third Draft (Feb 24, 2026) | Third Draft
9 | Right of First Negotiation (Standalone) | Section 11.5 | TMRI has right of first negotiation for exclusive commercial license to any solely owned HUMC/PI foreground IP (in addition to jointly owned IP per Section 11.4). Exercise period: 60 days from disclosure. | Right of first negotiation rejected entirely. Replaced with obligation to negotiate in good faith with no exclusivity commitment and no exercise period. | Maintained rejection. Argued academic institution cannot grant preferential commercial rights without faculty governance review. | Withdraw standalone right of first negotiation for solely owned HUMC/PI foreground IP (Section 11.5). TMRI's interests are adequately protected by the exclusive license under Section 11.3 (foreground IP) and the first-negotiation right for jointly owned IP under Section 11.4. Solely owned HUMC/PI inventions outside the scope of Protocol performance are not subject to TMRI's license or negotiation rights. | Conceding this point simplifies the agreement and removes a significant friction point. The exclusive license for foreground IP (Item 7) already captures inventions conceived in performance of the Protocol. Solely owned HUMC inventions outside Protocol scope are unlikely to be directly relevant to ThornValve MV-200. Concession may facilitate closure on remaining open items. Feb 21 call: Norcross indicated this was a priority for HUMC faculty governance. | Resolved — TMRI withdrew Section 11.5 in Third Draft (Feb 24, 2026) | Third Draft
[sheet: Publication Rights]
Item No. | Provision | CTA Section Reference | TMRI Position — First Draft (Jan 28, 2026) | HUMC Position — First Redline (Feb 7, 2026) | HUMC Position — Second Redline (Feb 19, 2026) | C&H Recommended Compromise | Rationale / Notes | Status | Resolved In Draft
10 | Publication Review Period | Section 12.1 | 45-day advance review period for all manuscripts, abstracts, and presentations. TMRI may request up to an additional 60-day delay (105 days total from submission to TMRI) to allow filing of patent applications protecting inventions disclosed in the manuscript. | 30-day review period with a single 30-day extension (60 days total). No further extensions permitted. | Maintained 30+30 day position. On Feb 21 call, HUMC indicated willingness to extend total period modestly if initial review period remains 30 days. | 30-day initial review period. TMRI may request one extension of up to 45 days (75 days total) for purposes of filing patent applications. Extension request must be made in writing before expiration of initial 30-day period and must identify the specific patentable subject matter requiring protection. No further extensions. | 75 days total is a reasonable compromise between TMRI's 105-day request and HUMC's 60-day position. 30-day initial review is standard in academic CTA practice and sufficient for editorial/confidentiality review. 45-day extension provides adequate time for provisional patent application preparation. Requiring identification of patentable subject matter prevents pretextual delays. Feb 21 call: HUMC agreed to 30+45 framework. | Resolved — Agreed at 30+45 days (75 total) in Third Draft (Feb 24, 2026) | Third Draft
11 | Editorial Control | Section 12.2 | TMRI retains right to review and comment on all manuscripts. TMRI may require removal of TMRI Confidential Information and patentable subject matter prior to submission. TMRI and PI to use good-faith efforts to resolve disagreements, but TMRI has final authority to require delay or modification to protect IP and confidential information. | PI (Dr. Castañeda) has final editorial control over all publications. TMRI review is advisory only. TMRI may not require modifications beyond removal of patentable inventions identified during the review period. | Maintained PI final editorial control. Agreed that TMRI may identify confidential commercial information for removal but PI makes final determination on editorial content and scientific conclusions. | PI retains final editorial control over scientific content, conclusions, and presentation of Trial Data. TMRI may require removal of: (i) TMRI Confidential Information (as defined in Section 13 — Confidentiality) and (ii) patentable subject matter identified during the review period. Disputes over what constitutes Confidential Information vs. scientific findings to be resolved by the parties in good faith; if unresolved within 15 days, either party may invoke the dispute resolution mechanism (Section 15 — negotiation, mediation via AAA in Boston, litigation in Suffolk County, Massachusetts). | PI editorial control over scientific content is consistent with academic norms and ICMJE guidelines. TMRI's interest is in protecting trade secrets and securing patent filings — not in controlling scientific narrative. Clear definition of Confidential Information in Section 13 and a dispute resolution mechanism prevent abuse by either side. Feb 21 call: both sides agreed to this framework in principle. | Resolved — Agreed in Third Draft (Feb 24, 2026) | Third Draft
12 | Redaction Rights | Section 12.3 | TMRI may redact confidential commercial information from any manuscript or presentation, including device specifications, manufacturing processes, and proprietary analytical methods. Redaction is at TMRI's sole discretion. | No right to redact beyond patentable inventions identified during the review/extension period. TMRI may not redact Trial Data results, safety data, or clinical outcomes under any circumstances. | Maintained position. Added explicit language that redaction may not be used to suppress unfavorable safety or efficacy findings. | TMRI may redact from manuscripts: (i) device manufacturing specifications and proprietary processes constituting trade secrets; (ii) proprietary analytical methods not necessary for scientific reproducibility; and (iii) patentable subject matter during the extension period. TMRI may not redact: (a) Trial Data results, (b) clinical outcomes, (c) safety data or adverse event information, or (d) any information required to be disclosed under FDA regulations, ClinicalTrials.gov (NCT06198234) reporting obligations, or ICMJE requirements. Disagreements resolved per Section 15. | Clear delineation between protectable commercial information and scientific/safety data is critical. TMRI's legitimate interests in trade secrets are protected. Prohibition on redacting safety data aligns with FDA regulatory expectations under IDE G260012, ClinicalTrials.gov obligations, and public health considerations. Explicit carve-out for regulatory disclosures avoids conflict with TMRI's FDA obligations. Feb 21 call: agreed in principle. | Resolved — Agreed in Third Draft (Feb 24, 2026) | Third Draft
[sheet: Resolution Summary]
Item No. | Provision | Category | First Draft Position (Jan 28) | First Redline Status (Feb 7) | Feb 12 Call — Indemnity | Second Draft (Feb 14) | Second Redline (Feb 19) | Feb 21 Call — IP/Publication | Third Draft (Feb 24) | HUMC Comments (Feb 26) | Final Status for Execution Version (Mar 2)
1 | Indemnification Scope | Indemnification | TMRI position stated | HUMC redline — open | Discussed; movement on scope language | Revised — compromise proposed | HUMC partial acceptance | N/A (indemnity addressed Feb 12) | Agreed — broadened scope with Protocol-compliance tie | Confirmed | RESOLVED
2 | Indemnification Cap | Indemnification | TMRI position: $10M cap | HUMC redline: $25M or uncapped | $15M compromise discussed | Revised to $15M | HUMC accepted $15M | N/A | Agreed — $15M aggregate cap | Confirmed | RESOLVED
3 | Notice Period | Indemnification | TMRI position: 15 business days | HUMC redline: 30 business days | Discussed; HUMC firm on 30 | Revised to 20 business days | HUMC accepted 20 days | N/A | Agreed — 20 business days | Confirmed | RESOLVED
4 | Defense Control / Right to Participate | Indemnification | TMRI sole control | HUMC: participate at TMRI cost; settlement consent | Discussed; conflict-of-interest trigger agreed | Revised — conflict trigger; settlement consent narrowed | HUMC accepted revised terms | N/A | Agreed | Confirmed | RESOLVED
5 | Mutual Indemnification Standard | Indemnification | TMRI: ordinary negligence | HUMC: gross negligence only | Discussed; device-design carve-out proposed | Revised — negligence with device carve-out | HUMC accepted | N/A | Agreed | Confirmed | RESOLVED
6 | Trial Data Ownership | Intellectual Property | TMRI sole ownership | HUMC ownership with TMRI license | N/A | No change (awaiting IP call) | HUMC maintained position | Discussed; HUMC accepts TMRI ownership with PI academic license | Agreed — TMRI ownership; PI non-exclusive academic license | Confirmed | RESOLVED
7 | Foreground IP Licensing | Intellectual Property | Exclusive, royalty-free to TMRI | Non-exclusive only | N/A | No change | Maintained non-exclusive | Discussed; exclusive with reasonable royalty for commercial use | Agreed — exclusive license; royalty on commercial exploitation | Confirmed | RESOLVED
8 | Jointly Owned IP Rights | Intellectual Property | TMRI right of first negotiation (90 days) | Mutual consent; no first negotiation | N/A | No change | Good-faith negotiation, no exclusivity | Discussed; structured first-negotiation with right to match | Agreed — 120-day first negotiation; 90-day good-faith period; 30-day match right | Confirmed | RESOLVED
9 | Right of First Negotiation (Standalone) | Intellectual Property | TMRI first negotiation for solely owned HUMC IP (60 days) | Rejected entirely | N/A | No change | Maintained rejection | Discussed; C&H recommended withdrawal | Withdrawn by TMRI | Confirmed | RESOLVED — TMRI conceded
10 | Publication Review Period | Publication Rights | 45 + 60 days (105 total) | 30 + 30 days (60 total) | N/A | No change | Maintained 30 + 30 | Discussed; agreed 30 + 45 days (75 total) | Agreed — 30 + 45 days | Confirmed | RESOLVED
11 | Editorial Control | Publication Rights | TMRI final authority | PI final editorial control | N/A | No change | PI final control; TMRI may identify confidential info | Discussed; PI control with TMRI removal of confidential info | Agreed — PI final on science; TMRI removal of confidential/patentable info | Confirmed | RESOLVED
12 | Redaction Rights | Publication Rights | TMRI sole discretion to redact | No redaction beyond patentable inventions | N/A | No change | No redaction of safety data; added anti-suppression language | Discussed; agreed categories of protectable vs. non-redactable info | Agreed — trade secrets redactable; safety/outcomes not redactable | Confirmed | RESOLVED
SUMMARY | 12 provisions stated | 12 open | 5 indemnity items discussed | 5 indemnity items revised | 5 indemnity resolved; 7 IP/pub open | 7 IP/pub items discussed | 12 of 12 resolved | 12 of 12 confirmed | All 12 provisions resolved as of Third Draft (February 24, 2026), confirmed by HUMC comments (February 26, 2026). Execution version prepared for March 2, 2026 signing.
[sheet: Key Reference Data]
Reference Item | Details | Relevance to Negotiation
TMRI Clinical Trial Liability Insurance — Per Occurrence | $10,000,000 (Commonwealth Specialty Underwriters, Inc., Policy CTL-2025-08843) | TMRI's initial indemnification cap of $10M matched this limit
TMRI Clinical Trial Liability Insurance — Aggregate | $25,000,000 (same policy) | HUMC's requested cap of $25M matched this aggregate limit; compromise at $15M
HUMC Professional Liability Insurance — Per Occurrence | $5,000,000 (Pinnacle Mutual Insurance Company, Policy PML-HU-2025-4471) | Supports HUMC's obligation under mutual indemnification; covers negligent acts
HUMC Professional Liability Insurance — Aggregate | $15,000,000 (same policy) | Additional layer of institutional coverage
Total CTA Value | $6,000,000 | Proportionality consideration for indemnification cap
Internal Grant Award | TMRI-CV-2025-018 | Internal funding — Bayh-Dole limited applicability (no federal funding)
IDE Number | G260012 | Regulatory submission context for IP and data ownership
ClinicalTrials.gov Identifier | NCT06198234 | Publication and data disclosure obligations
IRB Approval | HUMC-IRB-2025-0847 (December 18, 2025) | Protocol approved; CTA execution is gating item
Target CTA Execution | March 2, 2026 | Drives negotiation timeline
IDE Supplement Filing Target | March 15, 2026 | Requires executed CTA and finalized data ownership terms
Governing Law | Commonwealth of Massachusetts | Applicable to indemnification enforceability analysis
Dispute Resolution | Negotiation → Mediation (AAA, Boston) → Litigation (Suffolk County, MA) | Referenced in editorial control and royalty dispute provisions
Principal Investigator | Dr. Julian M. Castañeda, M.D., FACC — Director, Structural Heart Interventions Program, HUMC | PI editorial control and foreground IP considerations
Sub-Investigator | Dr. Hannah L. Forsberg, M.D. — Associate Director, Structural Heart Interventions Program, HUMC | Covered under indemnification and IP provisions
CRO | Meridian Clinical Sciences, Inc. (Victoria Reeves, VP Cardiovascular Programs) | Separate data management agreement; Trial Data flows to TMRI as owner
DSMB Chair | Dr. Garrett P. Lindholm, M.D., Ph.D. (Ellsworth University) | Independent safety oversight; safety data publication implications

[sheet: Cover]

Record

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