[sheet: Budget Summary]

Budget Category	Description	Unit Rate	Units / Quantity	Duration / Cap	Category Total	% of Total Agreement Value
Upfront Institutional Activation Fee	One-time payment upon CTA execution and site activation	$300,000.00	1	Lump sum	$300,000.00	5.00%
Per-Subject Payments	Payment per enrolled and evaluable subject (see Per-Subject Payment Schedule sheet for installment detail)	$95,000.00	45	45 subjects maximum	$4,275,000.00	71.25%
Annual Site Infrastructure Support	Annual payment for site infrastructure, personnel, and operational support	$237,500.00	4	4 years (Year 1–Year 4)	$950,000.00	15.83%
Publication and Manuscript Preparation Fund	Funding for preparation, submission, and publication of trial results and manuscripts	$200,000.00	1	Lump sum over study duration	$200,000.00	3.33%
Screen Failure Allowance	Payment per screen failure, capped at maximum of 45 screen failures	$6,111.11	Up to 45	Capped at $275,000	$275,000.00	4.58%
TOTAL AGREEMENT VALUE (MAXIMUM)	$6,000,000.00	100.00%

[sheet: Per-Subject Payment Schedule]

Installment	Payment Milestone	Percentage of Per-Subject Payment	Amount Per Subject	Number of Subjects	Subtotal All Subjects
Installment 1	Subject Enrollment (Successful enrollment and device implantation per Protocol)	40%	$38,000.00	45	$1,710,000.00
Installment 2	12-Month Follow-Up Visit Completed	30%	$28,500.00	45	$1,282,500.00
Installment 3	24-Month Follow-Up Visit Completed	30%	$28,500.00	45	$1,282,500.00
TOTAL PER-SUBJECT PAYMENTS	100%	$95,000.00	45	$4,275,000.00

[sheet: Annual Infrastructure Support]

Year	Period Start Date	Period End Date	Annual Amount	Payment Timing
Year 1	April 7, 2026	April 6, 2027	$237,500.00	Payable within 30 days of period start date
Year 2	April 7, 2027	April 6, 2028	$237,500.00	Payable within 30 days of period start date
Year 3	April 7, 2028	April 6, 2029	$237,500.00	Payable within 30 days of period start date
Year 4	April 7, 2029	June 30, 2029 (or study closeout, whichever is earlier)	$237,500.00	Payable within 30 days of period start date; pro-rated if study closes early
TOTAL	$950,000.00

[sheet: Payment Milestone Timeline]

Milestone / Event	Estimated Date	Payment Category	Payment Amount	Cumulative Payments to Date	Notes
CTA Execution	March 2, 2026	Upfront Institutional Activation Fee	$300,000.00	$300,000.00	Due upon execution of CTA
First Patient Enrollment (Subject 1 — Installment 1)	April 7, 2026	Per-Subject Payment (Enrollment)	$38,000.00	$338,000.00	40% of per-subject payment at enrollment
Year 1 Infrastructure Support	April 7, 2026	Annual Site Infrastructure Support	$237,500.00	$575,500.00	Year 1 payment due within 30 days of first enrollment
Enrollment Phase (Subjects 2–45 — Installment 1)	April 2026 – June 2027	Per-Subject Payment (Enrollment)	$1,672,000.00	$2,247,500.00	44 remaining subjects × $38,000 each
Last Patient Enrollment (Subject 45 — Installment 1)	June 30, 2027	Per-Subject Payment (Enrollment)	Included above	$2,247,500.00	Estimated last patient enrolled
Year 2 Infrastructure Support	April 7, 2027	Annual Site Infrastructure Support	$237,500.00	$2,485,000.00	Year 2 payment
12-Month Follow-Up Visits Begin (Subject 1 — Installment 2)	April 2027	Per-Subject Payment (12-mo)	$28,500.00	$2,513,500.00	30% of per-subject payment at 12-month follow-up
12-Month Follow-Up Visits (Subjects 2–45 — Installment 2)	April 2027 – June 2028	Per-Subject Payment (12-mo)	$1,254,000.00	$3,767,500.00	44 remaining subjects × $28,500 each
Year 3 Infrastructure Support	April 7, 2028	Annual Site Infrastructure Support	$237,500.00	$4,005,000.00	Year 3 payment
12-Month Follow-Up Visits Complete (Subject 45)	June 2028	Per-Subject Payment (12-mo)	Included above	$4,005,000.00	All 12-month installments disbursed
24-Month Follow-Up Visits Begin (Subject 1 — Installment 3)	April 2028	Per-Subject Payment (24-mo)	$28,500.00	$4,033,500.00	30% of per-subject payment at 24-month follow-up
24-Month Follow-Up Visits (Subjects 2–45 — Installment 3)	April 2028 – June 2029	Per-Subject Payment (24-mo)	$1,254,000.00	$5,287,500.00	44 remaining subjects × $28,500 each
Year 4 Infrastructure Support	April 7, 2029	Annual Site Infrastructure Support	$237,500.00	$5,525,000.00	Year 4 payment (may be pro-rated)
24-Month Follow-Up Visits Complete / Study Completion	June 30, 2029	Per-Subject Payment (24-mo)	Included above	$5,525,000.00	All 24-month installments disbursed; estimated study completion
Screen Failure Payments	Ongoing (as incurred)	Screen Failure Allowance	Up to $275,000.00	$5,800,000.00	$6,111.11 per screen failure; capped at 45 failures / $275,000
Publication Fund Disbursement	Per approved requests	Publication and Manuscript Preparation Fund	$200,000.00	$6,000,000.00	Disbursed upon submission of publication-related expenses
TOTAL MAXIMUM PAYMENTS	Through June 30, 2029	All Categories	$6,000,000.00	$6,000,000.00	Maximum total CTA value

[sheet: Screen Failure Detail]

Item	Value
Per Screen Failure Payment	$6,111.11
Maximum Number of Screen Failures Eligible	45
Maximum Screen Failure Allowance (Cap)	$275,000.00
Calculation	$6,111.11 × 45 = $274,999.95 (rounded to $275,000 cap)
Eligibility	Subject who signs informed consent and undergoes screening procedures but is not enrolled due to failure to meet inclusion/exclusion criteria per Protocol
Documentation Required	Screen failure CRF completed and submitted to Meridian Clinical Sciences, Inc. (CRO) for verification
Payment Timing	Within 45 days of verified screen failure documentation

[sheet: Funding Reference & Terms]

Item	Detail
Clinical Trial Agreement Date	March 2, 2026
Sponsor	Thornwick Medical Research Institute, Inc. (TMRI)
Sponsor Address	280 Longmeadow Drive, Cambridge, MA 02139
Sponsor EIN	04-3871256
Institution	Hargrove University Medical Center, Inc. (HUMC)
Institution Address	1400 Sterling Heights Boulevard, New Haven, CT 06510
Institution EIN	06-2194738
Trial Name	Cadence-3: A Prospective, Single-Arm, Open-Label Feasibility Study of the ThornValve MV-200 System for Transcatheter Mitral Valve Repair in Patients with Moderate-to-Severe Mitral Regurgitation
ClinicalTrials.gov Identifier	NCT06198234
IDE Number	G260012
IRB Protocol No.	HUMC-IRB-2025-0847
Internal Grant Award No.	TMRI-CV-2025-018
Principal Investigator	Dr. Julian M. Castañeda, M.D., FACC
Sub-Investigator	Dr. Hannah L. Forsberg, M.D.
CRO (Data Management)	Meridian Clinical Sciences, Inc.
Planned Enrollment	45 subjects
Follow-Up Period	24 months per subject
Estimated Study Duration	36 months from first patient enrollment
Estimated First Patient Enrollment	April 7, 2026
Estimated Last Patient Enrollment	June 30, 2027
Estimated Study Completion	June 30, 2029
Total Agreement Value	$6,000,000.00
Payment Terms	Invoices submitted by HUMC to TMRI; payment due within 30 days of receipt of complete and accurate invoice
Wire Transfer Instructions	To be provided by HUMC upon CTA execution

Sponsor Clinical Trial Liability Insurance	Commonwealth Specialty Underwriters, Inc. — Policy No. CTL-2025-08843 — $10,000,000 per occurrence / $25,000,000 aggregate
Institution Professional Liability Insurance	Pinnacle Mutual Insurance Company — Policy No. PML-HU-2025-4471 — $5,000,000 per occurrence / $15,000,000 aggregate
Budget Reconciliation	All amounts funded from TMRI Internal Grant Award No. TMRI-CV-2025-018 (Cardiovascular Device Development Program)
Governing Law	Commonwealth of Massachusetts

[sheet: Budget Summary]
Budget Category | Description | Unit Rate | Units / Quantity | Duration / Cap | Category Total | % of Total Agreement Value
Upfront Institutional Activation Fee | One-time payment upon CTA execution and site activation | $300,000.00 | 1 | Lump sum | $300,000.00 | 5.00%
Per-Subject Payments | Payment per enrolled and evaluable subject (see Per-Subject Payment Schedule sheet for installment detail) | $95,000.00 | 45 | 45 subjects maximum | $4,275,000.00 | 71.25%
Annual Site Infrastructure Support | Annual payment for site infrastructure, personnel, and operational support | $237,500.00 | 4 | 4 years (Year 1–Year 4) | $950,000.00 | 15.83%
Publication and Manuscript Preparation Fund | Funding for preparation, submission, and publication of trial results and manuscripts | $200,000.00 | 1 | Lump sum over study duration | $200,000.00 | 3.33%
Screen Failure Allowance | Payment per screen failure, capped at maximum of 45 screen failures | $6,111.11 | Up to 45 | Capped at $275,000 | $275,000.00 | 4.58%
TOTAL AGREEMENT VALUE (MAXIMUM) | $6,000,000.00 | 100.00%
[sheet: Per-Subject Payment Schedule]
Installment | Payment Milestone | Percentage of Per-Subject Payment | Amount Per Subject | Number of Subjects | Subtotal All Subjects
Installment 1 | Subject Enrollment (Successful enrollment and device implantation per Protocol) | 40% | $38,000.00 | 45 | $1,710,000.00
Installment 2 | 12-Month Follow-Up Visit Completed | 30% | $28,500.00 | 45 | $1,282,500.00
Installment 3 | 24-Month Follow-Up Visit Completed | 30% | $28,500.00 | 45 | $1,282,500.00
TOTAL PER-SUBJECT PAYMENTS | 100% | $95,000.00 | 45 | $4,275,000.00
[sheet: Annual Infrastructure Support]
Year | Period Start Date | Period End Date | Annual Amount | Payment Timing
Year 1 | April 7, 2026 | April 6, 2027 | $237,500.00 | Payable within 30 days of period start date
Year 2 | April 7, 2027 | April 6, 2028 | $237,500.00 | Payable within 30 days of period start date
Year 3 | April 7, 2028 | April 6, 2029 | $237,500.00 | Payable within 30 days of period start date
Year 4 | April 7, 2029 | June 30, 2029 (or study closeout, whichever is earlier) | $237,500.00 | Payable within 30 days of period start date; pro-rated if study closes early
TOTAL | $950,000.00
[sheet: Payment Milestone Timeline]
Milestone / Event | Estimated Date | Payment Category | Payment Amount | Cumulative Payments to Date | Notes
CTA Execution | March 2, 2026 | Upfront Institutional Activation Fee | $300,000.00 | $300,000.00 | Due upon execution of CTA
First Patient Enrollment (Subject 1 — Installment 1) | April 7, 2026 | Per-Subject Payment (Enrollment) | $38,000.00 | $338,000.00 | 40% of per-subject payment at enrollment
Year 1 Infrastructure Support | April 7, 2026 | Annual Site Infrastructure Support | $237,500.00 | $575,500.00 | Year 1 payment due within 30 days of first enrollment
Enrollment Phase (Subjects 2–45 — Installment 1) | April 2026 – June 2027 | Per-Subject Payment (Enrollment) | $1,672,000.00 | $2,247,500.00 | 44 remaining subjects × $38,000 each
Last Patient Enrollment (Subject 45 — Installment 1) | June 30, 2027 | Per-Subject Payment (Enrollment) | Included above | $2,247,500.00 | Estimated last patient enrolled
Year 2 Infrastructure Support | April 7, 2027 | Annual Site Infrastructure Support | $237,500.00 | $2,485,000.00 | Year 2 payment
12-Month Follow-Up Visits Begin (Subject 1 — Installment 2) | April 2027 | Per-Subject Payment (12-mo) | $28,500.00 | $2,513,500.00 | 30% of per-subject payment at 12-month follow-up
12-Month Follow-Up Visits (Subjects 2–45 — Installment 2) | April 2027 – June 2028 | Per-Subject Payment (12-mo) | $1,254,000.00 | $3,767,500.00 | 44 remaining subjects × $28,500 each
Year 3 Infrastructure Support | April 7, 2028 | Annual Site Infrastructure Support | $237,500.00 | $4,005,000.00 | Year 3 payment
12-Month Follow-Up Visits Complete (Subject 45) | June 2028 | Per-Subject Payment (12-mo) | Included above | $4,005,000.00 | All 12-month installments disbursed
24-Month Follow-Up Visits Begin (Subject 1 — Installment 3) | April 2028 | Per-Subject Payment (24-mo) | $28,500.00 | $4,033,500.00 | 30% of per-subject payment at 24-month follow-up
24-Month Follow-Up Visits (Subjects 2–45 — Installment 3) | April 2028 – June 2029 | Per-Subject Payment (24-mo) | $1,254,000.00 | $5,287,500.00 | 44 remaining subjects × $28,500 each
Year 4 Infrastructure Support | April 7, 2029 | Annual Site Infrastructure Support | $237,500.00 | $5,525,000.00 | Year 4 payment (may be pro-rated)
24-Month Follow-Up Visits Complete / Study Completion | June 30, 2029 | Per-Subject Payment (24-mo) | Included above | $5,525,000.00 | All 24-month installments disbursed; estimated study completion
Screen Failure Payments | Ongoing (as incurred) | Screen Failure Allowance | Up to $275,000.00 | $5,800,000.00 | $6,111.11 per screen failure; capped at 45 failures / $275,000
Publication Fund Disbursement | Per approved requests | Publication and Manuscript Preparation Fund | $200,000.00 | $6,000,000.00 | Disbursed upon submission of publication-related expenses
TOTAL MAXIMUM PAYMENTS | Through June 30, 2029 | All Categories | $6,000,000.00 | $6,000,000.00 | Maximum total CTA value
[sheet: Screen Failure Detail]
Item | Value
Per Screen Failure Payment | $6,111.11
Maximum Number of Screen Failures Eligible | 45
Maximum Screen Failure Allowance (Cap) | $275,000.00
Calculation | $6,111.11 × 45 = $274,999.95 (rounded to $275,000 cap)
Eligibility | Subject who signs informed consent and undergoes screening procedures but is not enrolled due to failure to meet inclusion/exclusion criteria per Protocol
Documentation Required | Screen failure CRF completed and submitted to Meridian Clinical Sciences, Inc. (CRO) for verification
Payment Timing | Within 45 days of verified screen failure documentation
[sheet: Funding Reference & Terms]
Item | Detail
Clinical Trial Agreement Date | March 2, 2026
Sponsor | Thornwick Medical Research Institute, Inc. (TMRI)
Sponsor Address | 280 Longmeadow Drive, Cambridge, MA 02139
Sponsor EIN | 04-3871256
Institution | Hargrove University Medical Center, Inc. (HUMC)
Institution Address | 1400 Sterling Heights Boulevard, New Haven, CT 06510
Institution EIN | 06-2194738
Trial Name | Cadence-3: A Prospective, Single-Arm, Open-Label Feasibility Study of the ThornValve MV-200 System for Transcatheter Mitral Valve Repair in Patients with Moderate-to-Severe Mitral Regurgitation
ClinicalTrials.gov Identifier | NCT06198234
IDE Number | G260012
IRB Protocol No. | HUMC-IRB-2025-0847
Internal Grant Award No. | TMRI-CV-2025-018
Principal Investigator | Dr. Julian M. Castañeda, M.D., FACC
Sub-Investigator | Dr. Hannah L. Forsberg, M.D.
CRO (Data Management) | Meridian Clinical Sciences, Inc.
Planned Enrollment | 45 subjects
Follow-Up Period | 24 months per subject
Estimated Study Duration | 36 months from first patient enrollment
Estimated First Patient Enrollment | April 7, 2026
Estimated Last Patient Enrollment | June 30, 2027
Estimated Study Completion | June 30, 2029
Total Agreement Value | $6,000,000.00
Payment Terms | Invoices submitted by HUMC to TMRI; payment due within 30 days of receipt of complete and accurate invoice
Wire Transfer Instructions | To be provided by HUMC upon CTA execution
Sponsor Clinical Trial Liability Insurance | Commonwealth Specialty Underwriters, Inc. — Policy No. CTL-2025-08843 — $10,000,000 per occurrence / $25,000,000 aggregate
Institution Professional Liability Insurance | Pinnacle Mutual Insurance Company — Policy No. PML-HU-2025-4471 — $5,000,000 per occurrence / $15,000,000 aggregate
Budget Reconciliation | All amounts funded from TMRI Internal Grant Award No. TMRI-CV-2025-018 (Cardiovascular Device Development Program)
Governing Law | Commonwealth of Massachusetts

[sheet: Budget Summary]

Record

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Amounts