[sheet: Closing Checklist]

Item No.	Category	Deliverable Description	Responsible Party	Due Date	Status	Date Completed	Notes / Reference
1	Agreement Execution	Execution of Clinical Trial Agreement by Dr. Ansel R. Varnham, M.D., Ph.D. (President & CEO) on behalf of Thornwick Medical Research Institute, Inc. (Sponsor)	TMRI / Marcus D. Pruitt, J.D. (General Counsel)	March 2, 2026	In Progress	Four original signature copies prepared; CTA dated March 2, 2026; total agreement value $6,000,000
2	Agreement Execution	Execution of Clinical Trial Agreement by Dr. Priya Anand-Kessler, M.D., MBA (President & CEO) on behalf of Hargrove University Medical Center, Inc. (Institution)	HUMC / Pemberton, Yates & Caldwell LLP (Rebecca S. Norcross)	March 2, 2026	In Progress	Execution version transmitted to PY&C on February 28, 2026; four signature copies enclosed; two fully executed originals to be returned to C&H
3	Agreement Execution	Return of two (2) fully executed original CTA counterparts to Calderwood & Harkness LLP	Pemberton, Yates & Caldwell LLP (Rebecca S. Norcross / Daniel F. Huang)	March 2, 2026	Pending	To be returned to C&H, One Post Office Square, Suite 4100, Boston, MA 02109
4	Exhibits	Exhibit A — Study Budget (finalized)	Amy Whitfield (C&H) / Dr. Elaine K. Sutherland (TMRI VP Clinical Development)	March 2, 2026	Complete	February 24, 2026	Budget reflects $6,000,000 total: $300,000 upfront activation fee; $95,000 × 45 subjects = $4,275,000 per-subject payments; $237,500/yr × 4 yrs = $950,000 infrastructure support; $200,000 publication fund; $275,000 max screen failure allowance. Reconciled to TMRI Grant Award No. TMRI-CV-2025-018
5	Exhibits	Exhibit B — Cadence-3 Protocol Synopsis (finalized)	Dr. Elaine K. Sutherland (TMRI) / Dr. Julian M. Castañeda (PI, HUMC)	March 2, 2026	Complete	February 24, 2026	Prospective, single-arm, open-label feasibility study; ThornValve MV-200 System; 45 subjects; 24-month follow-up; ClinicalTrials.gov NCT06198234; IDE G260012; PI: Dr. Castañeda; Sub-I: Dr. Hannah L. Forsberg
6	Insurance	Certificate of Insurance from Commonwealth Specialty Underwriters, Inc. — TMRI Clinical Trial Liability Policy (Policy No. CTL-2025-08843) naming Hargrove University Medical Center, Inc. as additional insured	Christopher Aiken (C&H) / Commonwealth Specialty Underwriters, Inc.	March 2, 2026	In Progress	Coverage: $10,000,000 per occurrence / $25,000,000 aggregate; Policy period: January 1, 2026 – December 31, 2027; Request letter sent by C&H
7	Insurance	Certificate of Insurance from Pinnacle Mutual Insurance Company — HUMC Professional Liability Policy (Policy No. PML-HU-2025-4471) naming Thornwick Medical Research Institute, Inc. as additional insured	Pemberton, Yates & Caldwell LLP (Rebecca S. Norcross) / Pinnacle Mutual Insurance Company	March 2, 2026	Pending	Coverage: $5,000,000 per occurrence / $15,000,000 aggregate; Requested in transmittal letter dated February 28, 2026
8	Regulatory & IRB	IRB Approval Letter — HUMC Institutional Review Board (Protocol No. HUMC-IRB-2025-0847)	Leonard B. Ostrowski, Ph.D. (SVP Research Administration, HUMC)	March 2, 2026	Complete	December 18, 2025	IRB approval granted December 18, 2025; copy on file; approval covers Cadence-3 Protocol at HUMC site
9	Regulatory & IRB	Principal Investigator Conflict of Interest Disclosure — Dr. Julian M. Castañeda, M.D., FACC	Dr. Julian M. Castañeda / Leonard B. Ostrowski (HUMC)	March 2, 2026	In Progress	COI disclosure required under CTA and HUMC institutional policy; to be submitted through HUMC Research Administration
10	Regulatory & IRB	Institutional Federalwide Assurance (FWA) Confirmation — HUMC	Leonard B. Ostrowski, Ph.D. (HUMC)	March 2, 2026	Pending	Confirmation that HUMC maintains active FWA registration with HHS/OHRP
11	Financial	Wire transfer instructions for upfront institutional activation fee payment of $300,000 to HUMC	HUMC Finance / Leonard B. Ostrowski (HUMC)	March 2, 2026	Pending	Activation fee = 5.0% of $6,000,000 total CTA value; payable upon execution per CTA terms
12	Regulatory & IRB	IDE Supplement Filing Materials — preparation for submission to FDA by March 15, 2026	Christopher Aiken (C&H) / Dr. Elaine K. Sutherland (TMRI)	March 15, 2026	In Progress	IDE No. G260012; supplement to include executed CTA, updated investigator information for Dr. Castañeda and Dr. Forsberg, and site qualification data for HUMC (~650 transcatheter valve procedures annually)
13	Third-Party Confirmations	CRO Data Management Agreement Confirmation — Meridian Clinical Sciences, Inc.	Dr. Elaine K. Sutherland (TMRI) / Victoria Reeves (Meridian, VP Cardiovascular Programs)	March 2, 2026	In Progress	Separate agreement between TMRI and Meridian Clinical Sciences, Inc. (900 Weston Parkway, Suite 400, Cary, NC 27513) for data management, biostatistical analysis, and safety monitoring; confirmation of executed agreement required
14	Third-Party Confirmations	Data Safety Monitoring Board (DSMB) Charter Confirmation	Dr. Elaine K. Sutherland (TMRI) / Dr. Garrett P. Lindholm, M.D., Ph.D. (DSMB Chair, Ellsworth University)	March 2, 2026	In Progress	DSMB constituted November 2025; charter executed separately; confirmation of charter finalization and DSMB readiness required prior to first enrollment (est. April 7, 2026)

STATUS SUMMARY

Complete	3
In Progress	7
Pending	4
N/A	0
Total Items	14

[sheet: Reference Information]

Field	Value
Matter Number	1029-00001
Client	Thornwick Medical Research Institute, Inc.
Client Address	280 Longmeadow Drive, Cambridge, MA 02139
Client EIN	04-3871256
Client Contact — General Counsel	Marcus D. Pruitt, J.D.
Client Contact — VP Clinical Development	Dr. Elaine K. Sutherland, M.D.
Client Contact — President & CEO	Dr. Ansel R. Varnham, M.D., Ph.D.
Counterparty	Hargrove University Medical Center, Inc.
Counterparty Address	1400 Sterling Heights Boulevard, New Haven, CT 06510
Counterparty EIN	06-2194738
Counterparty Contact — President & CEO	Dr. Priya Anand-Kessler, M.D., MBA
Counterparty Contact — SVP Research Admin	Leonard B. Ostrowski, Ph.D.
Counterparty Counsel	Pemberton, Yates & Caldwell LLP
Counterparty Counsel Address	55 Church Street, Suite 1200, New Haven, CT 06510
Counterparty Counsel Lead	Rebecca S. Norcross, Partner
Counterparty Counsel Associate	Daniel F. Huang
Principal Investigator	Dr. Julian M. Castañeda, M.D., FACC
Sub-Investigator	Dr. Hannah L. Forsberg, M.D.
Trial Name	Cadence-3
Investigational Device	ThornValve MV-200 System (Transcatheter Mitral Valve Repair Device)
ClinicalTrials.gov Identifier	NCT06198234
IDE Number	G260012
IRB Protocol No.	HUMC-IRB-2025-0847
Internal Grant Award No.	TMRI-CV-2025-018

Total CTA Value	$6,000,000
TMRI Insurance — Carrier	Commonwealth Specialty Underwriters, Inc.
TMRI Insurance — Policy No.	CTL-2025-08843
TMRI Insurance — Per Occurrence / Aggregate	$10,000,000 / $25,000,000
HUMC Insurance — Carrier	Pinnacle Mutual Insurance Company
HUMC Insurance — Policy No.	PML-HU-2025-4471
HUMC Insurance — Per Occurrence / Aggregate	$5,000,000 / $15,000,000
CRO	Meridian Clinical Sciences, Inc.
CRO Address	900 Weston Parkway, Suite 400, Cary, NC 27513
CRO Contact	Victoria Reeves, VP Cardiovascular Programs
DSMB Chair	Dr. Garrett P. Lindholm, M.D., Ph.D. (Ellsworth University)
TMRI Auditor	Whitman, Sadler & Co. LLP
Governing Law	Commonwealth of Massachusetts
Dispute Resolution	Negotiation → Mediation (AAA, Boston, MA) → Litigation (Suffolk County, MA)
Planned Enrollment	45 subjects
Follow-Up Period	24 months per subject
Estimated Study Duration	36 months from first enrollment
C&H Responsible Partner	Joel Strauss
C&H Billing Partner	Miriam Calloway
C&H Lead Associate	Christopher Aiken
C&H Working Associate / Checklist Prepared By	Amy Whitfield

[sheet: Key Dates]

Date	Event	Status
December 18, 2025	HUMC IRB Approval of Cadence-3 Protocol (HUMC-IRB-2025-0847)	Complete
January 15, 2026	Calderwood & Harkness LLP engagement opened (Matter No. 1029-00001)	Complete
January 28, 2026	First draft CTA circulated by Calderwood & Harkness to Pemberton, Yates & Caldwell	Complete
February 7, 2026	HUMC first redline received from Pemberton, Yates & Caldwell	Complete
February 12, 2026	Negotiation call — indemnification terms	Complete
February 14, 2026	Second draft CTA circulated by Calderwood & Harkness	Complete
February 19, 2026	HUMC second redline received from Pemberton, Yates & Caldwell	Complete
February 21, 2026	Negotiation call — IP and publication rights terms	Complete
February 24, 2026	Third (near-final) draft CTA circulated by Calderwood & Harkness; Exhibit A (Study Budget) and Exhibit B (Protocol Synopsis) finalized	Complete
February 26, 2026	HUMC comments on third draft received	Complete
February 28, 2026	Transmittal of execution version CTA to Pemberton, Yates & Caldwell	Complete
March 2, 2026	Target CTA execution / signing date	Target
March 15, 2026	IDE supplement filing target (IDE G260012) with FDA	Upcoming
April 7, 2026	Estimated first patient enrollment	Upcoming
June 30, 2027	Estimated last patient enrollment	Upcoming
June 30, 2029	Estimated study completion (last patient, last visit)	Upcoming

[sheet: Closing Checklist]
Item No. | Category | Deliverable Description | Responsible Party | Due Date | Status | Date Completed | Notes / Reference
1 | Agreement Execution | Execution of Clinical Trial Agreement by Dr. Ansel R. Varnham, M.D., Ph.D. (President & CEO) on behalf of Thornwick Medical Research Institute, Inc. (Sponsor) | TMRI / Marcus D. Pruitt, J.D. (General Counsel) | March 2, 2026 | In Progress | Four original signature copies prepared; CTA dated March 2, 2026; total agreement value $6,000,000
2 | Agreement Execution | Execution of Clinical Trial Agreement by Dr. Priya Anand-Kessler, M.D., MBA (President & CEO) on behalf of Hargrove University Medical Center, Inc. (Institution) | HUMC / Pemberton, Yates & Caldwell LLP (Rebecca S. Norcross) | March 2, 2026 | In Progress | Execution version transmitted to PY&C on February 28, 2026; four signature copies enclosed; two fully executed originals to be returned to C&H
3 | Agreement Execution | Return of two (2) fully executed original CTA counterparts to Calderwood & Harkness LLP | Pemberton, Yates & Caldwell LLP (Rebecca S. Norcross / Daniel F. Huang) | March 2, 2026 | Pending | To be returned to C&H, One Post Office Square, Suite 4100, Boston, MA 02109
4 | Exhibits | Exhibit A — Study Budget (finalized) | Amy Whitfield (C&H) / Dr. Elaine K. Sutherland (TMRI VP Clinical Development) | March 2, 2026 | Complete | February 24, 2026 | Budget reflects $6,000,000 total: $300,000 upfront activation fee; $95,000 × 45 subjects = $4,275,000 per-subject payments; $237,500/yr × 4 yrs = $950,000 infrastructure support; $200,000 publication fund; $275,000 max screen failure allowance. Reconciled to TMRI Grant Award No. TMRI-CV-2025-018
5 | Exhibits | Exhibit B — Cadence-3 Protocol Synopsis (finalized) | Dr. Elaine K. Sutherland (TMRI) / Dr. Julian M. Castañeda (PI, HUMC) | March 2, 2026 | Complete | February 24, 2026 | Prospective, single-arm, open-label feasibility study; ThornValve MV-200 System; 45 subjects; 24-month follow-up; ClinicalTrials.gov NCT06198234; IDE G260012; PI: Dr. Castañeda; Sub-I: Dr. Hannah L. Forsberg
6 | Insurance | Certificate of Insurance from Commonwealth Specialty Underwriters, Inc. — TMRI Clinical Trial Liability Policy (Policy No. CTL-2025-08843) naming Hargrove University Medical Center, Inc. as additional insured | Christopher Aiken (C&H) / Commonwealth Specialty Underwriters, Inc. | March 2, 2026 | In Progress | Coverage: $10,000,000 per occurrence / $25,000,000 aggregate; Policy period: January 1, 2026 – December 31, 2027; Request letter sent by C&H
7 | Insurance | Certificate of Insurance from Pinnacle Mutual Insurance Company — HUMC Professional Liability Policy (Policy No. PML-HU-2025-4471) naming Thornwick Medical Research Institute, Inc. as additional insured | Pemberton, Yates & Caldwell LLP (Rebecca S. Norcross) / Pinnacle Mutual Insurance Company | March 2, 2026 | Pending | Coverage: $5,000,000 per occurrence / $15,000,000 aggregate; Requested in transmittal letter dated February 28, 2026
8 | Regulatory & IRB | IRB Approval Letter — HUMC Institutional Review Board (Protocol No. HUMC-IRB-2025-0847) | Leonard B. Ostrowski, Ph.D. (SVP Research Administration, HUMC) | March 2, 2026 | Complete | December 18, 2025 | IRB approval granted December 18, 2025; copy on file; approval covers Cadence-3 Protocol at HUMC site
9 | Regulatory & IRB | Principal Investigator Conflict of Interest Disclosure — Dr. Julian M. Castañeda, M.D., FACC | Dr. Julian M. Castañeda / Leonard B. Ostrowski (HUMC) | March 2, 2026 | In Progress | COI disclosure required under CTA and HUMC institutional policy; to be submitted through HUMC Research Administration
10 | Regulatory & IRB | Institutional Federalwide Assurance (FWA) Confirmation — HUMC | Leonard B. Ostrowski, Ph.D. (HUMC) | March 2, 2026 | Pending | Confirmation that HUMC maintains active FWA registration with HHS/OHRP
11 | Financial | Wire transfer instructions for upfront institutional activation fee payment of $300,000 to HUMC | HUMC Finance / Leonard B. Ostrowski (HUMC) | March 2, 2026 | Pending | Activation fee = 5.0% of $6,000,000 total CTA value; payable upon execution per CTA terms
12 | Regulatory & IRB | IDE Supplement Filing Materials — preparation for submission to FDA by March 15, 2026 | Christopher Aiken (C&H) / Dr. Elaine K. Sutherland (TMRI) | March 15, 2026 | In Progress | IDE No. G260012; supplement to include executed CTA, updated investigator information for Dr. Castañeda and Dr. Forsberg, and site qualification data for HUMC (~650 transcatheter valve procedures annually)
13 | Third-Party Confirmations | CRO Data Management Agreement Confirmation — Meridian Clinical Sciences, Inc. | Dr. Elaine K. Sutherland (TMRI) / Victoria Reeves (Meridian, VP Cardiovascular Programs) | March 2, 2026 | In Progress | Separate agreement between TMRI and Meridian Clinical Sciences, Inc. (900 Weston Parkway, Suite 400, Cary, NC 27513) for data management, biostatistical analysis, and safety monitoring; confirmation of executed agreement required
14 | Third-Party Confirmations | Data Safety Monitoring Board (DSMB) Charter Confirmation | Dr. Elaine K. Sutherland (TMRI) / Dr. Garrett P. Lindholm, M.D., Ph.D. (DSMB Chair, Ellsworth University) | March 2, 2026 | In Progress | DSMB constituted November 2025; charter executed separately; confirmation of charter finalization and DSMB readiness required prior to first enrollment (est. April 7, 2026)
STATUS SUMMARY
Complete | 3
In Progress | 7
Pending | 4
N/A | 0
Total Items | 14
[sheet: Reference Information]
Field | Value
Matter Number | 1029-00001
Client | Thornwick Medical Research Institute, Inc.
Client Address | 280 Longmeadow Drive, Cambridge, MA 02139
Client EIN | 04-3871256
Client Contact — General Counsel | Marcus D. Pruitt, J.D.
Client Contact — VP Clinical Development | Dr. Elaine K. Sutherland, M.D.
Client Contact — President & CEO | Dr. Ansel R. Varnham, M.D., Ph.D.
Counterparty | Hargrove University Medical Center, Inc.
Counterparty Address | 1400 Sterling Heights Boulevard, New Haven, CT 06510
Counterparty EIN | 06-2194738
Counterparty Contact — President & CEO | Dr. Priya Anand-Kessler, M.D., MBA
Counterparty Contact — SVP Research Admin | Leonard B. Ostrowski, Ph.D.
Counterparty Counsel | Pemberton, Yates & Caldwell LLP
Counterparty Counsel Address | 55 Church Street, Suite 1200, New Haven, CT 06510
Counterparty Counsel Lead | Rebecca S. Norcross, Partner
Counterparty Counsel Associate | Daniel F. Huang
Principal Investigator | Dr. Julian M. Castañeda, M.D., FACC
Sub-Investigator | Dr. Hannah L. Forsberg, M.D.
Trial Name | Cadence-3
Investigational Device | ThornValve MV-200 System (Transcatheter Mitral Valve Repair Device)
ClinicalTrials.gov Identifier | NCT06198234
IDE Number | G260012
IRB Protocol No. | HUMC-IRB-2025-0847
Internal Grant Award No. | TMRI-CV-2025-018
Total CTA Value | $6,000,000
TMRI Insurance — Carrier | Commonwealth Specialty Underwriters, Inc.
TMRI Insurance — Policy No. | CTL-2025-08843
TMRI Insurance — Per Occurrence / Aggregate | $10,000,000 / $25,000,000
HUMC Insurance — Carrier | Pinnacle Mutual Insurance Company
HUMC Insurance — Policy No. | PML-HU-2025-4471
HUMC Insurance — Per Occurrence / Aggregate | $5,000,000 / $15,000,000
CRO | Meridian Clinical Sciences, Inc.
CRO Address | 900 Weston Parkway, Suite 400, Cary, NC 27513
CRO Contact | Victoria Reeves, VP Cardiovascular Programs
DSMB Chair | Dr. Garrett P. Lindholm, M.D., Ph.D. (Ellsworth University)
TMRI Auditor | Whitman, Sadler & Co. LLP
Governing Law | Commonwealth of Massachusetts
Dispute Resolution | Negotiation → Mediation (AAA, Boston, MA) → Litigation (Suffolk County, MA)
Planned Enrollment | 45 subjects
Follow-Up Period | 24 months per subject
Estimated Study Duration | 36 months from first enrollment
C&H Responsible Partner | Joel Strauss
C&H Billing Partner | Miriam Calloway
C&H Lead Associate | Christopher Aiken
C&H Working Associate / Checklist Prepared By | Amy Whitfield
[sheet: Key Dates]
Date | Event | Status
December 18, 2025 | HUMC IRB Approval of Cadence-3 Protocol (HUMC-IRB-2025-0847) | Complete
January 15, 2026 | Calderwood & Harkness LLP engagement opened (Matter No. 1029-00001) | Complete
January 28, 2026 | First draft CTA circulated by Calderwood & Harkness to Pemberton, Yates & Caldwell | Complete
February 7, 2026 | HUMC first redline received from Pemberton, Yates & Caldwell | Complete
February 12, 2026 | Negotiation call — indemnification terms | Complete
February 14, 2026 | Second draft CTA circulated by Calderwood & Harkness | Complete
February 19, 2026 | HUMC second redline received from Pemberton, Yates & Caldwell | Complete
February 21, 2026 | Negotiation call — IP and publication rights terms | Complete
February 24, 2026 | Third (near-final) draft CTA circulated by Calderwood & Harkness; Exhibit A (Study Budget) and Exhibit B (Protocol Synopsis) finalized | Complete
February 26, 2026 | HUMC comments on third draft received | Complete
February 28, 2026 | Transmittal of execution version CTA to Pemberton, Yates & Caldwell | Complete
March 2, 2026 | Target CTA execution / signing date | Target
March 15, 2026 | IDE supplement filing target (IDE G260012) with FDA | Upcoming
April 7, 2026 | Estimated first patient enrollment | Upcoming
June 30, 2027 | Estimated last patient enrollment | Upcoming
June 30, 2029 | Estimated study completion (last patient, last visit) | Upcoming

[sheet: Closing Checklist]

STATUS SUMMARY

Record

Parties

Dates

Amounts