1029-00001 · Thornwick Medical Research Institute, Inc · Transaction Documents

clinical-trial-agreement-execution.docx DOCUMENT Finance & Banking

10 / 12 ← → ✕

CLINICAL TRIAL AGREEMENT

EXECUTION VERSION

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

Between

THORNWICK MEDICAL RESEARCH INSTITUTE, INC. ("Sponsor")

and

HARGROVE UNIVERSITY MEDICAL CENTER, INC. ("Institution")

Agreement Date: March 2, 2026

ClinicalTrials.gov Identifier: NCT06198234 IDE Number: G260012

Right-click to update Table of Contents

CLINICAL TRIAL AGREEMENT

This Clinical Trial Agreement (this "Agreement") is entered into as of March 2, 2026 (the "Effective Date"), by and between:

THORNWICK MEDICAL RESEARCH INSTITUTE, INC., a Massachusetts nonprofit corporation organized under Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, with its principal office located at 280 Longmeadow Drive, Cambridge, Massachusetts 02139, Employer Identification Number 04-3871256 ("TMRI" or "Sponsor");

and

HARGROVE UNIVERSITY MEDICAL CENTER, INC., a Connecticut nonprofit corporation, with its principal address at 1400 Sterling Heights Boulevard, New Haven, Connecticut 06510, Employer Identification Number 06-2194738 ("HUMC" or "Institution").

Sponsor and Institution are each referred to herein individually as a "Party" and collectively as the "Parties."

RECITALS. A. Sponsor Background. TMRI is an independent medical research institute specializing in structural heart disease therapies and cardiovascular medical device development, founded in 1987. TMRI has developed the ThornValve MV-200 System, a proprietary transcatheter mitral valve repair device (the "Investigational Device" or "Device"), which constitutes TMRI's lead device program. The Device is currently the subject of an Investigational Device Exemption (IDE No. G260012) granted by the United States Food and Drug Administration (the "FDA"). TMRI has devoted substantial resources over the past several years to the design, preclinical testing, and early clinical evaluation of the Device and now seeks to advance the Device through a pre-pivotal feasibility clinical study.

B. Institution Background. HUMC is a 726-bed academic medical center affiliated with Hargrove University, located in New Haven, Connecticut. HUMC operates one of the nation's leading structural heart disease programs; the HUMC Structural Heart Center performs approximately 650 transcatheter valve procedures annually across its catheterization laboratories and hybrid operating suites. HUMC possesses the clinical facilities, specialized equipment, medical expertise, and patient population appropriate for conducting the Study described herein.

C. Trial Purpose. Sponsor desires to engage Institution to conduct a prospective, single-arm, open-label feasibility study titled "Cadence-3" (the "Study" or "Trial") to evaluate the safety and performance of the ThornValve MV-200 System for transcatheter mitral valve repair in patients with moderate-to-severe mitral regurgitation. The Study is an investigator-initiated, pre-pivotal feasibility study and is the third in a series of clinical investigations designed to support a future pivotal trial submission to the FDA. The Study is registered at ClinicalTrials.gov under identifier NCT06198234.

D. IRB Approval. HUMC's Institutional Review Board (the "IRB") has reviewed and approved the Study Protocol under IRB Protocol No. HUMC-IRB-2025-0847, with initial approval granted on December 18, 2025. The IRB has determined that the Study meets all applicable requirements for the protection of human subjects, including those set forth in 21 C.F.R. Parts 50 and 56 and the Common Rule (45 C.F.R. Part 46).

E. Regulatory Status. The Study will be conducted under IDE No. G260012 issued by the FDA. Sponsor, as the IDE holder, intends to file an IDE supplement with the FDA by March 15, 2026, referencing this Agreement and adding HUMC as the clinical trial site for the Cadence-3 Study.

F. Intent. The Parties desire to set forth the terms and conditions under which Institution will conduct the Study, including provisions governing indemnification, intellectual property, publication rights, regulatory compliance, data management, insurance, payment, and other matters relevant to the conduct of a clinical investigation of a significant risk investigational medical device.

NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

ARTICLE 1 — DEFINITIONS

As used in this Agreement, the following terms shall have the meanings ascribed to them below. Capitalized terms used but not defined in this Article 1 shall have the meanings ascribed to them elsewhere in this Agreement.

1.1 "Adverse Event" or "AE" means any untoward medical occurrence in a Study Subject, whether or not considered related to the Investigational Device or Study procedures, including any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with participation in the Study.

1.2 "Background IP" means all intellectual property owned or controlled by a Party prior to the Effective Date or developed independently by a Party outside the scope of the Study, including, without limitation, in the case of Sponsor, all intellectual property relating to the Device design, specifications, manufacturing processes, software, algorithms, and all pre-existing patents, patent applications, trade secrets, know-how, and copyrights.

1.3 "Confidential Information" means any and all non-public, proprietary, or confidential information disclosed by one Party (the "Disclosing Party") to the other Party (the "Receiving Party") in connection with this Agreement or the Study, whether disclosed orally, in writing, electronically, or by any other means, including, without limitation, Study Data (prior to publication), Device specifications and design information, manufacturing processes, regulatory submissions, financial terms and the Study Budget, business plans, trade secrets, know-how, and any information designated as confidential by the Disclosing Party. Confidential Information shall not include information that falls within the exceptions set forth in Section 9.3.

1.4 "CRO" means Meridian Clinical Sciences, Inc., a Delaware corporation with offices at 900 Weston Parkway, Suite 400, Cary, North Carolina 27513, which is Sponsor's contracted clinical research organization engaged for data management, biostatistical analysis, and safety monitoring of the Study.

1.5 "Data Safety Monitoring Board" or "DSMB" means the independent data safety monitoring board constituted for the Study, chaired by Dr. Garrett P. Lindholm, M.D., Ph.D. (Professor of Biostatistics and Cardiology, Ellsworth University, Chicago, Illinois), operating under a separate DSMB charter dated November 2025.

1.6 "Device" or "Investigational Device" means the ThornValve MV-200 System (Transcatheter Mitral Valve Repair Device), as described in IDE No. G260012, including all components, accessories, delivery systems, and associated instructions for use supplied by Sponsor for use in the Study.

1.7 "Effective Date" means March 2, 2026.

1.8 "Foreground IP" means any and all inventions, discoveries, improvements, works of authorship, know-how, data, software, methods, techniques, compositions of matter, or other intellectual property conceived, created, developed, or first reduced to practice in the performance of the Study or as a direct result of activities conducted under this Agreement.

1.9 "Good Clinical Practice" or "GCP" means the ethical, scientific, and quality standards for designing, conducting, recording, and reporting clinical trials that involve the participation of human subjects, as set forth in the International Council for Harmonisation guideline ICH E6(R2), 21 C.F.R. Parts 50, 54, 56, and 812, and applicable FDA guidance documents.

1.10 "IDE" means Investigational Device Exemption No. G260012 granted by the FDA for the ThornValve MV-200 System, as supplemented or amended from time to time.

1.11 "Informed Consent" means the process and documentation by which a Study Subject voluntarily confirms his or her willingness to participate in the Study after having been informed of all aspects of the Study relevant to the subject's decision to participate, in accordance with 21 C.F.R. Part 50, the IRB-approved informed consent form, and applicable Connecticut and federal law.

1.12 "IRB" means Institution's Institutional Review Board, which has approved the Study under IRB Protocol No. HUMC-IRB-2025-0847.

1.13 "Joint Invention" means any Foreground IP that is jointly conceived or created by one or more individuals who are personnel of Sponsor and one or more individuals who are personnel of Institution, where inventorship is determined in accordance with applicable United States patent law.

1.14 "Principal Investigator" or "PI" means Dr. Julian M. Castañeda, M.D., FACC, Professor of Cardiovascular Medicine, Hargrove University School of Medicine, and Director, Structural Heart Interventions Program, HUMC, who is responsible for the conduct of the Study at Institution.

1.15 "Protocol" means the Study protocol titled "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," as approved by the IRB and as may be amended from time to time with all requisite approvals. A synopsis of the Protocol is attached hereto as Exhibit B and incorporated herein by reference.

1.16 "Serious Adverse Event" or "SAE" means any Adverse Event that meets the FDA regulatory criteria for seriousness, including any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, or requires medical or surgical intervention to prevent one of the foregoing outcomes.

1.17 "Study" or "Trial" means the Cadence-3 clinical trial as described in the Protocol and this Agreement.

1.18 "Study Budget" means the detailed budget for the Study attached hereto as Exhibit A and incorporated herein by reference, as may be amended from time to time by written agreement of the Parties.

1.19 "Study Data" means all clinical data, safety data, imaging data (including echocardiographic, angiographic, and computed tomography data), biomarker results, case report forms, electronic data capture records, source documents, laboratory results, patient-reported outcomes, and all other data generated in the conduct of the Study.

1.20 "Study Period" means the period commencing on the Effective Date and continuing until Study completion, which shall include the last patient's last visit, final database lock, and completion of all reporting obligations. The Study Period is estimated at approximately thirty-six (36) months from first patient enrollment, with an estimated Study completion date of June 30, 2029.

1.21 "Study Staff" means the Principal Investigator, the Sub-Investigator, study coordinators, research nurses, echocardiographic technicians, and all other HUMC personnel directly involved in the conduct of the Study.

1.22 "Study Subject" means an individual who has provided Informed Consent and has been enrolled in the Study in accordance with the Protocol.

1.23 "Sub-Investigator" means Dr. Hannah L. Forsberg, M.D., Associate Professor of Cardiovascular Medicine, Hargrove University School of Medicine, and Associate Director, Structural Heart Interventions Program, HUMC.

ARTICLE 2 — SCOPE OF WORK AND STUDY CONDUCT

Section 2.1 — Engagement and Study Conduct.

Sponsor hereby engages Institution, and Institution hereby agrees, to conduct the Study at Institution's facilities in accordance with the Protocol, this Agreement, all applicable federal, state, and local laws and regulations, Good Clinical Practice, the IDE regulations set forth in 21 C.F.R. Part 812, and all applicable IRB requirements. Institution shall perform all Study-related procedures, including but not limited to screening, enrollment, device implantation procedures, follow-up visits, data collection, and adverse event assessment, at HUMC's Structural Heart Center, located at 1400 Sterling Heights Boulevard, New Haven, Connecticut 06510. The Study is a single-site clinical investigation; Institution is the sole trial site for the Cadence-3 Study. Institution shall dedicate adequate personnel, facilities, equipment, and resources to perform the Study in a timely and professional manner consistent with the standards of care and academic rigor expected of a leading academic medical center.

Section 2.2 — Principal Investigator.

Institution hereby appoints Dr. Julian M. Castañeda, M.D., FACC, as the Principal Investigator for the Study at Institution. Dr. Castañeda is a board-certified interventional cardiologist with more than eighteen (18) years of experience in transcatheter valve therapies, has served as principal investigator on nine (9) prior medical device clinical trials, and is the author or co-author of over one hundred forty (140) peer-reviewed publications in the field of structural heart disease. The PI shall be personally responsible for the conduct of the Study at Institution, including but not limited to the enrollment of Study Subjects, performance of Study procedures, supervision of Study Staff, collection and recording of Study Data, reporting of Adverse Events and Serious Adverse Events, maintenance of regulatory compliance, and adherence to the Protocol. The PI shall devote sufficient time and effort to the Study to fulfill his obligations under this Agreement and the Protocol. The PI may not be replaced without the prior written consent of Sponsor, which consent shall not be unreasonably withheld or delayed. Any proposed replacement PI must be acceptable to Sponsor, the IRB, and the FDA, and Institution shall promptly notify Sponsor of any circumstances that may affect the PI's ability to fulfill his responsibilities under this Agreement, including but not limited to departure from Institution, disability, or conflict of interest.

Section 2.3 — Sub-Investigator.

Dr. Hannah L. Forsberg, M.D., is hereby designated as the Sub-Investigator and co-PI designate for the Study. The Sub-Investigator shall assist the PI in the conduct of the Study and may perform Study procedures, including device implantation, follow-up assessments, and adverse event evaluation, under the supervision and direction of the PI. In the event the PI is temporarily unavailable, the Sub-Investigator may serve as acting PI for a period not to exceed thirty (30) calendar days, provided that Sponsor is notified within forty-eight (48) hours of such substitution and that such arrangement is consistent with IRB and FDA requirements.

Section 2.4 — Enrollment.

The planned enrollment for the Study is forty-five (45) Study Subjects, as specified in the Protocol. Each Study Subject shall undergo a twenty-four (24)-month follow-up period following the index procedure. The estimated date for first patient enrollment is April 7, 2026. The estimated date for last patient enrollment is June 30, 2027. The estimated date for Study completion (last patient, last visit) is June 30, 2029. Institution shall use commercially reasonable efforts to meet the enrollment milestones and timelines set forth in the Protocol and this Agreement. If enrollment falls materially behind the projected timeline, Institution shall promptly notify Sponsor and the Parties shall discuss in good faith appropriate measures to address enrollment shortfalls, which may include extending the enrollment period, modifying inclusion and exclusion criteria (subject to IRB and FDA approval), or other mutually agreed measures.

Section 2.5 — Protocol Amendments.

Any amendment to the Protocol shall require the prior written agreement of both Parties, approval by the IRB, and, where required by applicable regulations, approval by the FDA via IDE supplement or other appropriate regulatory submission. Neither Party shall unilaterally modify the Protocol. Each Party shall cooperate with the other in the preparation, review, and submission of any proposed Protocol amendment. Institution shall not implement any Protocol amendment at the study site until all required approvals have been obtained, except where an immediate change is necessary to eliminate an apparent immediate hazard to Study Subjects, in which case Institution shall implement the change and promptly notify Sponsor, the IRB, and, where applicable, the FDA.

Section 2.6 — Informed Consent.

Institution and PI shall obtain proper Informed Consent from each Study Subject prior to the performance of any Study-specific procedures, in accordance with 21 C.F.R. Part 50, the IRB-approved informed consent form, and applicable Connecticut and federal law. The Informed Consent process shall be conducted by the PI, the Sub-Investigator, or other qualified Study Staff designated by the PI and approved by the IRB. Institution shall ensure that each Study Subject is provided adequate time and opportunity to consider the information presented and to ask questions before consenting to participate. Institution shall maintain complete and accurate documentation of the Informed Consent process for each Study Subject in accordance with applicable regulatory requirements and institutional policies, including a signed and dated copy of the informed consent form in each Study Subject's research file.

Section 2.7 — Study Staff Qualifications and Training.

Institution shall ensure that all Study Staff are appropriately qualified, licensed (where applicable), and trained on the Protocol, the Device (including device preparation, implantation technique, and post-procedural care), Good Clinical Practice, human subjects protection, and applicable regulatory requirements prior to participating in any Study activities. Sponsor shall provide initial training on the Device and associated procedures to the PI, Sub-Investigator, and other designated Study Staff, including a comprehensive device training program consisting of didactic instruction, bench model simulation, and proctored initial cases as specified in the Protocol. Sponsor shall also provide ongoing training as necessary to address Protocol amendments, Device modifications, or other developments relevant to the Study. Institution shall maintain current documentation of all training completed by Study Staff and shall make such documentation available to Sponsor and the CRO upon request.

ARTICLE 3 — INVESTIGATIONAL DEVICE SUPPLY

Section 3.1 — Device Supply.

Sponsor shall supply the ThornValve MV-200 System, including all components, accessories, delivery systems, and associated instructions for use, to Institution at no cost to Institution for use exclusively in the conduct of the Study. Sponsor shall supply Devices in quantities sufficient to meet the enrollment needs of the Study, as reasonably determined by Sponsor in consultation with the PI. All Devices supplied under this Agreement shall remain the sole and exclusive property of Sponsor at all times. Devices are supplied solely under the authority of IDE No. G260012 and may not be used for any purpose other than the conduct of the Study as described in the Protocol. Institution acknowledges that the Device is an investigational product that has not been approved or cleared for commercial distribution by the FDA, and Institution shall not represent, market, promote, sell, or otherwise distribute the Device outside the scope of the Study.

Section 3.2 — Device Handling and Storage.

Institution shall receive, store, handle, and account for all Devices in accordance with Sponsor's written instructions, the Protocol, and applicable FDA regulations, including 21 C.F.R. § 812.140. Institution shall designate a qualified individual to serve as the Device accountability officer and shall maintain accurate and complete Device accountability records, including documentation of receipt, storage conditions, dispensing to Study Subjects, condition upon use, and return or disposition of all Devices. Institution shall store all Devices in a secure, environmentally controlled location at Institution's facilities that meets the storage conditions specified by Sponsor. Institution shall promptly notify Sponsor of any Device that is damaged, defective, expired, or otherwise unsuitable for use.

Section 3.3 — Return or Disposition.

Upon completion of the Study or termination of this Agreement, whichever occurs first, Institution shall return all unused, unexpired Devices to Sponsor in accordance with Sponsor's written instructions and at Sponsor's expense. Any used Devices, explanted components, or Device-related materials shall be handled and disposed of in accordance with Sponsor's instructions, the Protocol, applicable biohazard and waste disposal regulations, and any applicable FDA requirements. Institution shall not destroy any Device or Device component without the prior written authorization of Sponsor, except where immediate destruction is required by applicable law or regulation.

ARTICLE 4 — REGULATORY COMPLIANCE

Section 4.1 — IDE Compliance.

The Study shall be conducted in compliance with IDE No. G260012 and all conditions and requirements imposed by the FDA in connection therewith. Sponsor is the holder of the IDE and shall be responsible for maintaining the IDE in good standing, filing all necessary IDE supplements (including the supplement adding HUMC as a study site, which Sponsor intends to file by March 15, 2026), and submitting all required reports to the FDA, including annual progress reports, safety reports, and any other submissions required under 21 C.F.R. Part 812. Institution shall cooperate with Sponsor in the preparation and filing of IDE supplements and reports and shall provide Sponsor with all information reasonably necessary for such submissions in a timely manner.

Section 4.2 — IRB Oversight.

Institution shall maintain continuous IRB approval for the Study throughout the Study Period under IRB Protocol No. HUMC-IRB-2025-0847. Institution shall timely submit all Protocol amendments, informed consent form revisions, safety reports, annual continuing review materials, and any other documents required by the IRB for review and approval. Institution shall comply with all conditions and requirements imposed by the IRB. Institution shall promptly notify Sponsor, in writing, of any IRB actions relating to the Study, including but not limited to approval of amendments, requests for additional information, imposition of restrictions or conditions, suspension of enrollment, or withdrawal or termination of IRB approval. Such notification shall be provided to Sponsor within five (5) business days of Institution's receipt of the IRB's action or correspondence.

Section 4.3 — Good Clinical Practice.

Both Parties shall conduct all Study-related activities in compliance with Good Clinical Practice, including but not limited to the standards set forth in the International Council for Harmonisation guideline ICH E6(R2), 21 C.F.R. Parts 50 (Protection of Human Subjects), 54 (Financial Disclosure by Clinical Investigators), 56 (Institutional Review Boards), and 812 (Investigational Device Exemptions), and all applicable FDA guidance documents. Each Party shall ensure that its employees, agents, and contractors involved in the Study are trained on and comply with GCP requirements.

Section 4.4 — Adverse Event Reporting.

Institution and PI shall identify, document, assess, and report all Adverse Events and Serious Adverse Events occurring during the Study in accordance with the Protocol, IDE requirements, GCP, and all applicable FDA regulations. All AEs shall be documented on the appropriate case report forms and reported to Sponsor and the CRO (Meridian Clinical Sciences, Inc.) in accordance with the timelines specified in the Protocol. All Serious Adverse Events shall be reported to Sponsor and the CRO within twenty-four (24) hours of the PI becoming aware of the event, using the SAE reporting form provided by Sponsor or the CRO. Institution shall also report SAEs and other safety events to the IRB and the FDA in accordance with applicable requirements, including 21 C.F.R. §§ 812.46 and 812.150. The PI shall exercise medical judgment in the assessment of causality, severity, and expectedness of all AEs and SAEs. Sponsor shall be responsible for the preparation and submission of all IDE safety reports to the FDA.

Section 4.5 — Regulatory Inspections.

Institution shall permit and fully cooperate with any inspection, audit, or investigation conducted by the FDA, the Department of Health and Human Services, or any other federal, state, or local regulatory authority relating to the Study. Such cooperation shall include providing access to Institution's facilities, Study records, source documents, Device accountability records, IRB records, and Study Staff for interview. Institution shall promptly notify Sponsor, in writing, of any regulatory inspection or inquiry relating to the Study, and in no event later than two (2) business days after Institution becomes aware of such inspection or inquiry. Institution shall provide Sponsor with copies of any inspection observations (including FDA Form 483), establishment inspection reports, warning letters, or other regulatory correspondence relating to the Study within five (5) business days of receipt.

Section 4.6 — Financial Disclosure.

The PI, the Sub-Investigator, and all Study Staff who are clinical investigators as defined in 21 C.F.R. Part 54 shall comply with FDA financial disclosure requirements. Institution shall ensure that all required financial disclosure forms (FDA Form 3454 and Form 3455, as applicable) are completed accurately and submitted to Sponsor at the commencement of the Study, annually during the Study, and within thirty (30) days of Study completion. Institution shall promptly notify Sponsor of any changes in the financial interests or arrangements of PI, Sub-Investigator, or Study Staff that could affect the accuracy of previously submitted financial disclosure forms.

Section 4.7 — ClinicalTrials.gov Registration.

Sponsor shall maintain registration of the Study on ClinicalTrials.gov under identifier NCT06198234 in accordance with the requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and 42 C.F.R. Part 11. Sponsor shall be responsible for the timely submission of results information to ClinicalTrials.gov. Institution and PI shall cooperate with Sponsor and provide information necessary for the accurate and timely maintenance of the ClinicalTrials.gov record.

ARTICLE 5 — DATA MANAGEMENT AND SAFETY MONITORING

Section 5.1 — Clinical Research Organization.

Sponsor has separately engaged Meridian Clinical Sciences, Inc. (the "CRO"), a Delaware corporation with offices at 900 Weston Parkway, Suite 400, Cary, North Carolina 27513, for the provision of data management, electronic data capture, biostatistical analysis, clinical monitoring, and safety monitoring services in connection with the Study. The primary point of contact at the CRO for purposes of the Study is Victoria Reeves, Vice President of Cardiovascular Programs. Institution shall cooperate with the CRO in the performance of all data management activities, including but not limited to the timely and accurate completion of case report forms (whether electronic or paper-based), resolution of data queries within the timelines specified in the data management plan, and provision of source documents and other records for review by CRO monitors. Institution acknowledges that the CRO acts on behalf of Sponsor and that information shared with the CRO in connection with the Study shall be treated as information shared with Sponsor for purposes of this Agreement.

Section 5.2 — Data Safety Monitoring Board.

An independent Data Safety Monitoring Board has been constituted for the Study, chaired by Dr. Garrett P. Lindholm, M.D., Ph.D., Professor of Biostatistics and Cardiology at Ellsworth University, Chicago, Illinois. The DSMB was constituted in November 2025 and operates under a separate DSMB charter that sets forth the DSMB's membership, meeting schedule, operating procedures, and decision-making framework. The DSMB shall conduct periodic reviews of unblinded safety data and efficacy data (as applicable) accumulated during the Study and may, in its discretion, recommend modification, suspension, or termination of the Study based on safety or efficacy considerations. Both Parties shall cooperate with DSMB requests for data, information, and analysis. Sponsor shall promptly communicate DSMB recommendations to Institution, and the Parties shall discuss in good faith any actions necessary to implement DSMB recommendations. In the event the DSMB recommends suspension or termination of the Study, Sponsor shall promptly notify Institution and the FDA in accordance with IDE requirements.

Section 5.3 — Source Documents and Record Retention.

Institution shall create, maintain, and preserve complete, accurate, and legible source documents and study records for each Study Subject and for the Study overall, including but not limited to informed consent forms, medical records, laboratory reports, imaging studies, case report forms, Device accountability logs, regulatory correspondence, and IRB correspondence. All source documents and study records shall be maintained in a secure location at Institution's facilities. Institution shall retain all Study records for the minimum period required by applicable law, which shall be the longer of: (a) two (2) years after the date on which an application for marketing approval for the Device is approved for the indication studied, or the date the investigation is terminated or completed and the FDA is so notified; (b) two (2) years after the date on which the IDE is terminated or final disposition of the IDE occurs; or (c) such other period as may be required by applicable federal, state, or local law or by the IRB. Institution shall not destroy or dispose of any Study records without prior written authorization from Sponsor, and shall notify Sponsor at least sixty (60) days prior to any proposed destruction, transfer, or relocation of Study records.

Section 5.4 — Monitoring and Auditing.

Sponsor and/or the CRO shall have the right to monitor and audit the conduct of the Study at Institution, including but not limited to conducting on-site monitoring visits, remote monitoring activities, review and verification of source documents against case report form entries, review of Device accountability records, review of informed consent documentation, review of regulatory files, and assessment of overall compliance with the Protocol, GCP, and this Agreement. Institution shall provide Sponsor and the CRO with reasonable access to Institution's facilities, Study records, and Study Staff for the purpose of conducting monitoring and auditing activities during normal business hours, upon reasonable advance notice (which shall be not less than five (5) business days for routine monitoring visits and not less than ten (10) business days for formal audits, except in cases of urgent safety concerns, in which case shorter notice may be provided). Institution shall cooperate fully with all monitoring and auditing activities and shall promptly implement any corrective actions identified during monitoring or auditing.

ARTICLE 6 — COMPENSATION AND PAYMENT

Section 6.1 — Total Agreement Value.

Total compensation payable by Sponsor to Institution under this Agreement shall not exceed Six Million Dollars ($6,000,000.00), as set forth in the Study Budget attached hereto as Exhibit A (the "Study Budget"). All payments under this Agreement are funded under TMRI Grant Award No. TMRI-CV-2025-018, Sponsor's internal cardiovascular device development program funding allocation. In no event shall the aggregate payments made by Sponsor to Institution under this Agreement exceed Six Million Dollars ($6,000,000.00) without a written amendment to this Agreement executed by both Parties.

Section 6.2 — Payment Components.

Compensation shall be paid to Institution as follows:

(a) Upfront Institutional Activation Fee. Three Hundred Thousand Dollars ($300,000.00), representing five percent (5.0%) of the total Agreement value, shall be payable within thirty (30) days of the Effective Date upon Sponsor's receipt of a proper invoice from Institution and written confirmation from Institution that the study site is ready to initiate enrollment, including confirmation of IRB approval, completion of site initiation visit, and readiness of all required facilities and personnel (collectively, "Site Readiness").

(b) Per-Subject Payments. Ninety-Five Thousand Dollars ($95,000.00) per enrolled and evaluable Study Subject, for up to forty-five (45) Study Subjects, for a maximum total of Four Million Two Hundred Seventy-Five Thousand Dollars ($4,275,000.00), representing seventy-one and one-quarter percent (71.25%) of the total Agreement value. Per-Subject payments shall be disbursed in three (3) installments per Study Subject as follows:

(i) Installment 1 — Enrollment: Thirty-Eight Thousand Dollars ($38,000.00), representing forty percent (40%) of the per-subject amount, payable upon enrollment of the Study Subject (defined as the date the Study Subject provides Informed Consent and meets all eligibility criteria as confirmed by the PI);

(ii) Installment 2 — Twelve-Month Follow-Up: Twenty-Eight Thousand Five Hundred Dollars ($28,500.00), representing thirty percent (30%) of the per-subject amount, payable upon completion of the twelve (12)-month follow-up visit by the Study Subject in accordance with the Protocol;

(iii) Installment 3 — Twenty-Four-Month Follow-Up: Twenty-Eight Thousand Five Hundred Dollars ($28,500.00), representing thirty percent (30%) of the per-subject amount, payable upon completion of the twenty-four (24)-month follow-up visit by the Study Subject in accordance with the Protocol.

(c) Annual Site Infrastructure Support. Two Hundred Thirty-Seven Thousand Five Hundred Dollars ($237,500.00) per year for a period of four (4) years, totaling Nine Hundred Fifty Thousand Dollars ($950,000.00), representing fifteen and eighty-three hundredths percent (15.83%) of the total Agreement value. Annual site infrastructure support payments are intended to offset Institution's costs of maintaining dedicated study infrastructure, including research coordinator salaries, catheterization laboratory time allocation, imaging core laboratory support, and institutional research overhead. Each annual payment shall be payable on the corresponding anniversary of the Effective Date upon receipt of a proper invoice from Institution.

(d) Publication and Manuscript Preparation Fund. Two Hundred Thousand Dollars ($200,000.00), representing three and one-third percent (3.33%) of the total Agreement value, shall be allocated for publication and manuscript preparation activities, payable in accordance with the milestones set forth in Exhibit A. This fund is intended to support the costs of manuscript preparation, statistical analysis for publications, journal submission fees, open access publication charges, and presentation expenses at scientific meetings.

(e) Screen Failure Allowance. Six Thousand One Hundred Eleven Dollars and Eleven Cents ($6,111.11) per screen failure, for up to forty-five (45) screen failures, capped at a maximum of Two Hundred Seventy-Five Thousand Dollars ($275,000.00), representing four and fifty-eight hundredths percent (4.58%) of the total Agreement value. A "screen failure" is defined as a prospective Study Subject who provides Informed Consent and undergoes screening procedures but who does not meet all eligibility criteria and is not enrolled in the Study.

Section 6.3 — Reconciliation.

For the avoidance of doubt, the aggregate maximum of all payment components set forth in Section 6.2 is as follows: $300,000.00 (Activation Fee) + $4,275,000.00 (Per-Subject Payments) + $950,000.00 (Annual Site Infrastructure Support) + $200,000.00 (Publication Fund) + $275,000.00 (Screen Failure Allowance) = $6,000,000.00. The total shall not exceed Six Million Dollars ($6,000,000.00).

Section 6.4 — Invoicing and Payment Terms.

Institution shall submit invoices to Sponsor for all earned payments on a quarterly basis, or upon achievement of payment milestones as set forth in Section 6.2, whichever occurs first. Each invoice shall include sufficient detail to identify the basis for the payment claimed, including the names or subject identification numbers of enrolled Study Subjects, the specific milestones achieved, and the corresponding payment amounts due. Invoices shall be submitted to Sponsor's Finance Department at the address specified in Section 17.1, or to such other address or electronic invoicing system as Sponsor may designate in writing. Sponsor shall pay all undisputed invoices within forty-five (45) days of receipt. If Sponsor disputes any portion of an invoice, Sponsor shall notify Institution in writing within fifteen (15) days of receipt of the invoice, specifying the nature of the dispute, and shall pay the undisputed portion within the forty-five (45)-day payment period. The Parties shall use good-faith efforts to resolve any invoice disputes promptly. All payments shall be made by wire transfer to a bank account designated by Institution in writing.

Section 6.5 — Taxes.

Each Party shall be responsible for its own tax obligations arising in connection with this Agreement, including but not limited to income taxes, employment taxes, and any applicable state or local taxes. Institution represents and warrants that it is a tax-exempt entity under Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, and shall provide Sponsor with a copy of its tax-exemption determination letter upon request. Neither Party shall be responsible for any tax obligations of the other Party.

Section 6.6 — No Additional Compensation.

The compensation set forth in this Article 6 constitutes the entire financial obligation of Sponsor to Institution for the conduct of the Study. No additional fees, overhead charges, indirect cost recovery, administrative surcharges, or other costs shall be payable by Sponsor except as expressly set forth in this Agreement or in a written amendment hereto executed by both Parties. Institution acknowledges that the payments set forth herein reflect fair market value for the services to be provided and have been determined through arm's-length negotiation between the Parties.

Section 6.7 — Financial Records and Audit Rights.

Institution shall maintain accurate, complete, and contemporaneous financial records of all Study-related expenditures, revenues, and allocations for a period of three (3) years following the completion of the Study or the termination of this Agreement, whichever is later. Sponsor, or its designated independent auditors (currently Whitman, Sadler & Co. LLP), shall have the right to audit such financial records upon not less than thirty (30) days' prior written notice to Institution. Such audits shall be conducted during normal business hours at Institution's facilities and shall be limited in scope to verification of the accuracy of invoices submitted to Sponsor and the proper use of Study funds. Institution shall cooperate fully with any such audit and shall provide reasonable access to its financial records, accounting systems, and relevant personnel. If an audit reveals an overpayment by Sponsor, Institution shall refund the overpayment to Sponsor within thirty (30) days of written notification. If an audit reveals an underpayment, Sponsor shall remit the balance due within thirty (30) days.

ARTICLE 7 — INDEMNIFICATION

Section 7.1 — Sponsor Indemnification of Institution.

Sponsor shall defend, indemnify, and hold harmless Institution, the Principal Investigator, the Sub-Investigator, Study Staff, and their respective officers, directors, trustees, employees, agents, successors, and assigns (collectively, the "Institution Indemnitees") from and against any and all claims, demands, actions, causes of action, suits, proceedings, judgments, damages, losses, liabilities, costs, and expenses (including reasonable attorneys' fees, expert witness fees, and court costs) (collectively, "Losses") asserted by any third party and arising out of or relating to:

(a) the design, manufacture, supply, labeling, packaging, transportation, or any inherent defect, malfunction, or failure of the ThornValve MV-200 System (Investigational Device), including but not limited to any product liability claim, strict liability claim, breach of warranty claim, or claim based on the design or manufacturing specifications of the Device;

(b) any other claim arising out of or relating to the Investigational Device or its use in the Study, to the extent such claim is not caused by or attributable to Institution's negligence, material deviation from the Protocol that was not approved in writing by Sponsor, failure to obtain Informed Consent, or willful misconduct; and

(c) the negligence or willful misconduct of Sponsor, its officers, directors, employees, agents, or contractors in connection with the Study or any activities performed under this Agreement.

Section 7.2 — Conditions to Sponsor Indemnification.

Sponsor's indemnification obligations under Section 7.1 are subject to the following conditions:

(a) Institution shall provide Sponsor with prompt written notice of any claim, demand, action, or threatened action for which indemnification is sought, and in no event later than twenty (20) business days after Institution first becomes aware of such claim, demand, action, or threatened action. Failure to provide timely notice shall not relieve Sponsor of its indemnification obligations except to the extent Sponsor is materially prejudiced by such failure.

(b) Sponsor shall have the right, but not the obligation, to assume and control the defense and settlement of any claim for which it provides indemnification under this Article 7, using legal counsel of Sponsor's selection. If Sponsor assumes the defense, Sponsor shall diligently prosecute such defense and shall keep Institution reasonably informed of the progress of such defense.

(c) Institution may participate in the defense of any claim for which Sponsor has assumed the defense, with separate legal counsel of Institution's own choosing and at Institution's own expense; provided, however, that if a bona fide conflict of interest exists between the interests of Sponsor and Institution in the defense of such claim such that joint representation would be inappropriate, Institution's reasonable costs and expenses of separate counsel shall be borne by Sponsor. Any determination of whether a bona fide conflict of interest exists shall be made in good faith by the Parties.

(d) No settlement of any claim that imposes any obligation, admission of liability, injunctive relief, or restriction on any Institution Indemnitee shall be entered into without Institution's prior written consent, which consent shall not be unreasonably withheld, conditioned, or delayed.

Section 7.3 — Exclusions from Sponsor Indemnification.

Notwithstanding Section 7.1, Sponsor's indemnification obligations under this Article 7 shall not extend to any Losses to the extent arising from or attributable to:

(a) the negligence or willful misconduct of Institution, the PI, the Sub-Investigator, or any member of Study Staff in the conduct of the Study;

(b) any material deviation from the Protocol by Institution, the PI, or Study Staff that was not approved in writing by Sponsor prior to or promptly following such deviation;

(c) the failure of Institution, the PI, or any member of Study Staff to obtain proper Informed Consent from a Study Subject in accordance with the requirements of this Agreement, the Protocol, 21 C.F.R. Part 50, and applicable law; or

(d) any material breach of this Agreement by Institution.

In the event a claim involves both matters for which Sponsor is obligated to indemnify under Section 7.1 and matters excluded under this Section 7.3, the Parties shall allocate responsibility for such claim in proportion to their respective fault, as determined by agreement of the Parties or, if the Parties are unable to agree, by a court of competent jurisdiction.

Section 7.4 — Aggregate Cap on Sponsor Indemnification.

Sponsor's aggregate liability for all indemnification obligations under this Article 7 shall not exceed Fifteen Million Dollars ($15,000,000.00) (the "Indemnification Cap"). This Indemnification Cap represents the total maximum aggregate amount payable by Sponsor under Sections 7.1 and 7.2 for all claims combined during the term of this Agreement and any post-termination survival period. The Indemnification Cap has been established by the Parties through arm's-length negotiation and is supported by Sponsor's clinical trial liability insurance aggregate coverage of Twenty-Five Million Dollars ($25,000,000.00) under Commonwealth Specialty Underwriters Policy No. CTL-2025-08843.

Section 7.5 — Institution Indemnification of Sponsor.

Institution shall defend, indemnify, and hold harmless Sponsor and its officers, directors, trustees, employees, agents, successors, and assigns (collectively, the "Sponsor Indemnitees") from and against any and all Losses asserted by any third party and arising out of or relating to:

(a) the gross negligence or willful misconduct of Institution, the PI, the Sub-Investigator, or any member of Study Staff in connection with the conduct of the Study or any activities performed under this Agreement; and

(b) a material breach of this Agreement by Institution.

Section 7.6 — Conditions to Institution Indemnification.

Institution's indemnification obligations under Section 7.5 are subject to the following conditions, which are analogous to those set forth in Section 7.2:

(a) Sponsor shall provide Institution with prompt written notice of any claim, demand, action, or threatened action for which indemnification is sought under Section 7.5, and in no event later than twenty (20) business days after Sponsor first becomes aware of such claim, demand, action, or threatened action. Failure to provide timely notice shall not relieve Institution of its indemnification obligations except to the extent Institution is materially prejudiced by such failure.

(b) Institution shall have the right, but not the obligation, to assume and control the defense and settlement of any claim for which it provides indemnification under Section 7.5, using legal counsel of Institution's selection.

(c) Sponsor may participate in the defense of any claim with separate counsel at its own expense, subject to the same conflict-of-interest provisions set forth in Section 7.2(c), mutatis mutandis.

(d) No settlement of any claim that imposes any obligation, admission of liability, injunctive relief, or restriction on any Sponsor Indemnitee shall be entered into without Sponsor's prior written consent, which consent shall not be unreasonably withheld, conditioned, or delayed.

Section 7.7 — Limitation.

NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE STUDY, REGARDLESS OF THE FORM OF ACTION OR THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, OR OTHERWISE, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THIS LIMITATION SHALL NOT APPLY TO (I) A PARTY'S INDEMNIFICATION OBLIGATIONS UNDER THIS ARTICLE 7, OR (II) A PARTY'S BREACH OF ITS CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE 9.

ARTICLE 8 — INSURANCE

Section 8.1 — Sponsor Insurance.

Sponsor shall procure and maintain, at its own expense, clinical trial liability insurance throughout the term of the Study and for a period of two (2) years following the completion of the Study or the termination of this Agreement, whichever is later, with the following minimum coverage limits:

Per occurrence: $10,000,000 (Ten Million Dollars)

Aggregate: $25,000,000 (Twenty-Five Million Dollars)

Sponsor's current clinical trial liability insurance carrier is Commonwealth Specialty Underwriters, Inc., Policy No. CTL-2025-08843, with a policy period of January 1, 2026 through December 31, 2027, to be renewed as necessary to provide continuous coverage throughout the required period. Sponsor shall cause Institution to be named as an additional insured under such clinical trial liability insurance policy, and shall provide Institution with a certificate of insurance evidencing such coverage, including additional insured status, within thirty (30) days of the Effective Date and promptly upon each policy renewal.

Section 8.2 — Institution Insurance.

Institution shall procure and maintain, at its own expense, professional liability (medical malpractice) insurance throughout the term of the Study and for a period of two (2) years following the completion of the Study or the termination of this Agreement, whichever is later, with the following minimum coverage limits:

Per occurrence: $5,000,000 (Five Million Dollars)

Aggregate: $15,000,000 (Fifteen Million Dollars)

Institution's current professional liability insurance carrier is Pinnacle Mutual Insurance Company, Policy No. PML-HU-2025-4471. Institution shall cause Sponsor to be named as an additional insured under such professional liability insurance policy, and shall provide Sponsor with a certificate of insurance evidencing such coverage, including additional insured status, within thirty (30) days of the Effective Date and promptly upon each policy renewal.

Section 8.3 — Notice of Changes.

Each Party shall provide the other Party with not less than thirty (30) days' prior written notice of any material change in, cancellation of, or non-renewal of its insurance coverage required under this Article 8. In the event of any such change, cancellation, or non-renewal, the affected Party shall promptly procure replacement coverage meeting the minimum requirements of this Article 8 and shall provide the other Party with a certificate of insurance evidencing such replacement coverage.

ARTICLE 9 — CONFIDENTIALITY

Section 9.1 — Confidential Information.

As used in this Agreement, "Confidential Information" means any and all non-public, proprietary, or confidential information disclosed by one Party (the "Disclosing Party") to the other Party (the "Receiving Party") in connection with this Agreement or the Study, in any form or medium, whether disclosed before or after the Effective Date, including but not limited to: Study Data (prior to publication in accordance with Article 11); Device specifications, design information, engineering drawings, manufacturing processes, and formulations; regulatory submissions, correspondence, and strategies; clinical trial results, analyses, and reports; financial terms of this Agreement and the Study Budget; business plans, marketing plans, and commercialization strategies; trade secrets and know-how; patient-level data and protected health information (subject to applicable privacy laws); and any other information that is identified or designated by the Disclosing Party as confidential, or that the Receiving Party knows or reasonably should know is confidential given the nature of the information and the circumstances of its disclosure.

Section 9.2 — Obligations.

Each Receiving Party shall: (a) hold all Confidential Information of the Disclosing Party in strict confidence and protect it with at least the same degree of care it uses to protect its own confidential information, but in no event less than a reasonable degree of care; (b) use Confidential Information solely for the purposes of performing its obligations and exercising its rights under this Agreement and the Study, and for no other purpose; (c) not disclose Confidential Information to any third party without the prior written consent of the Disclosing Party, except as permitted under this Article 9; and (d) limit access to Confidential Information to those of its employees, agents, contractors, and advisors who have a need to know such information for purposes of the Study and who are bound by confidentiality obligations no less restrictive than those set forth in this Article 9.

Section 9.3 — Exceptions.

The obligations of confidentiality and non-use set forth in Section 9.2 shall not apply to any information that the Receiving Party can demonstrate by competent evidence: (a) is or becomes publicly available through no fault or breach by the Receiving Party; (b) was known to the Receiving Party prior to disclosure by the Disclosing Party, as evidenced by the Receiving Party's written records; (c) is independently developed by the Receiving Party without use of or reference to the Disclosing Party's Confidential Information, as evidenced by the Receiving Party's written records; (d) is received by the Receiving Party from a third party that is not, to the Receiving Party's knowledge, under an obligation of confidentiality to the Disclosing Party with respect to such information; or (e) is required to be disclosed by applicable law, regulation, subpoena, court order, or governmental order, provided that the Receiving Party shall (to the extent legally permitted) provide the Disclosing Party with prompt written notice of such requirement prior to making such disclosure, shall disclose only that portion of the Confidential Information that is legally required to be disclosed, and shall use reasonable efforts to obtain confidential treatment or a protective order for such information.

Section 9.4 — Regulatory and IRB Disclosures.

Nothing in this Article 9 shall restrict or limit either Party's ability to make disclosures of Confidential Information to the FDA, the IRB, the DSMB, the CRO, or any other regulatory authority, institutional review board, or ethics committee, to the extent such disclosure is required or reasonably necessary for the conduct of the Study, compliance with regulatory requirements, or the protection of Study Subject safety.

Section 9.5 — Duration.

The obligations of confidentiality and non-use set forth in this Article 9 shall survive the termination or expiration of this Agreement for a period of five (5) years following the effective date of such termination or expiration; provided, however, that with respect to any Confidential Information that constitutes a trade secret under applicable law, such obligations shall continue for as long as such information remains a trade secret.

ARTICLE 10 — INTELLECTUAL PROPERTY

Section 10.1 — Background intellectual Property.

Each Party shall retain sole and exclusive ownership of its Background IP. TMRI retains sole and exclusive ownership of all Background IP related to the ThornValve MV-200 System, including but not limited to the Device design, engineering specifications, manufacturing processes, software algorithms, trade secrets, patents, patent applications, and all other pre-existing intellectual property of TMRI. No license, right, or interest in or to either Party's Background IP is granted under this Agreement except as expressly set forth herein. Institution and PI acknowledge and agree that the Device and all related Sponsor Background IP are the exclusive property of Sponsor, and nothing in this Agreement shall be construed to transfer, assign, or grant any right, title, or interest in Sponsor's Background IP to Institution, PI, or any third party.

Section 10.2 — Ownership of Study Data.

All Study Data generated in the conduct of the Study shall be owned solely and exclusively by Sponsor. Institution and PI hereby acknowledge and agree to Sponsor's sole ownership of all Study Data, including the right to use, analyze, publish, submit to regulatory authorities, and otherwise exploit Study Data for any purpose, subject to the publication provisions of Article 11. Subject to Section 10.6 and the publication and confidentiality provisions of this Agreement, Sponsor hereby grants to Institution and PI a non-exclusive, royalty-free, perpetual, irrevocable license to use Study Data for academic, non-commercial research, and teaching purposes. Such license shall not include the right to sublicense, assign, or transfer Study Data to any third party, nor shall it include the right to use Study Data for any commercial application or in support of any regulatory submission, without Sponsor's prior written consent.

Section 10.3 — Sole Inventions.

Any Foreground IP solely conceived or created by one or more individuals who are employees, agents, or contractors of Sponsor, without the inventive contribution of any personnel of Institution, shall be solely and exclusively owned by Sponsor. Any Foreground IP solely conceived or created by one or more individuals who are employees, agents, or contractors of Institution (including PI, Sub-Investigator, and Study Staff), without the inventive contribution of any personnel of Sponsor, shall be solely and exclusively owned by Institution. Each Party shall promptly disclose to the other Party any Foreground IP that may be relevant to the Study or the Device.

Section 10.4 — Joint Inventions.

Any Foreground IP that constitutes a Joint Invention — that is, Foreground IP jointly conceived or created by one or more individuals who are personnel of Sponsor and one or more individuals who are personnel of Institution — shall be jointly owned by the Parties. Each Party shall have an undivided interest in such Joint Invention. Neither Party shall license, assign, encumber, or otherwise dispose of its interest in any Joint Invention to any third party without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned, or delayed. The Parties shall cooperate in good faith to protect, maintain, and enforce any intellectual property rights arising from Joint Inventions, and shall share equally in the costs of obtaining and maintaining patent protection for Joint Inventions, unless otherwise agreed in writing.

Section 10.5 — License Grants.

(a) Exclusive License from Institution to Sponsor. Institution and PI hereby grant to Sponsor an exclusive, worldwide, perpetual, irrevocable license, with the right to grant sublicenses, under all Foreground IP solely owned by Institution pursuant to Section 10.3, for the purpose of making regulatory submissions, obtaining regulatory approvals, manufacturing, commercializing, marketing, distributing, selling, and further developing the Device and any products or technologies derived therefrom. In consideration of such exclusive license, if Sponsor commercially exploits such Foreground IP (through direct commercialization or through sublicense to a third party), Sponsor shall pay Institution a reasonable royalty on net revenues derived from such commercial exploitation. The specific royalty rate, payment terms, and other commercial terms shall be negotiated in good faith by the Parties within ninety (90) days following Sponsor's written notice to Institution of its intent to commercially exploit such Foreground IP. If the Parties are unable to reach agreement on royalty terms within such ninety (90)-day period, either Party may submit the matter to the dispute resolution procedures set forth in Article 16.

(b) License to Sponsor for Joint Inventions. With respect to any Joint Invention, Sponsor shall have a right of first negotiation for an exc

CLINICAL TRIAL AGREEMENT
EXECUTION VERSION
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
Between
THORNWICK MEDICAL RESEARCH INSTITUTE, INC. ("Sponsor")
and
HARGROVE UNIVERSITY MEDICAL CENTER, INC. ("Institution")
Agreement Date: March 2, 2026
ClinicalTrials.gov Identifier: NCT06198234 IDE Number: G260012
TABLE OF CONTENTS
Right-click to update Table of Contents
CLINICAL TRIAL AGREEMENT
This Clinical Trial Agreement (this "Agreement") is entered into as of March 2, 2026 (the "Effective Date"), by and between:
THORNWICK MEDICAL RESEARCH INSTITUTE, INC., a Massachusetts nonprofit corporation organized under Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, with its principal office located at 280 Longmeadow Drive, Cambridge, Massachusetts 02139, Employer Identification Number 04-3871256 ("TMRI" or "Sponsor");
and
HARGROVE UNIVERSITY MEDICAL CENTER, INC., a Connecticut nonprofit corporation, with its principal address at 1400 Sterling Heights Boulevard, New Haven, Connecticut 06510, Employer Identification Number 06-2194738 ("HUMC" or "Institution").
Sponsor and Institution are each referred to herein individually as a "Party" and collectively as the "Parties."
RECITALS. A. Sponsor Background. TMRI is an independent medical research institute specializing in structural heart disease therapies and cardiovascular medical device development, founded in 1987. TMRI has developed the ThornValve MV-200 System, a proprietary transcatheter mitral valve repair device (the "Investigational Device" or "Device"), which constitutes TMRI's lead device program. The Device is currently the subject of an Investigational Device Exemption (IDE No. G260012) granted by the United States Food and Drug Administration (the "FDA"). TMRI has devoted substantial resources over the past several years to the design, preclinical testing, and early clinical evaluation of the Device and now seeks to advance the Device through a pre-pivotal feasibility clinical study.
B. Institution Background. HUMC is a 726-bed academic medical center affiliated with Hargrove University, located in New Haven, Connecticut. HUMC operates one of the nation's leading structural heart disease programs; the HUMC Structural Heart Center performs approximately 650 transcatheter valve procedures annually across its catheterization laboratories and hybrid operating suites. HUMC possesses the clinical facilities, specialized equipment, medical expertise, and patient population appropriate for conducting the Study described herein.
C. Trial Purpose. Sponsor desires to engage Institution to conduct a prospective, single-arm, open-label feasibility study titled "Cadence-3" (the "Study" or "Trial") to evaluate the safety and performance of the ThornValve MV-200 System for transcatheter mitral valve repair in patients with moderate-to-severe mitral regurgitation. The Study is an investigator-initiated, pre-pivotal feasibility study and is the third in a series of clinical investigations designed to support a future pivotal trial submission to the FDA. The Study is registered at ClinicalTrials.gov under identifier NCT06198234.
D. IRB Approval. HUMC's Institutional Review Board (the "IRB") has reviewed and approved the Study Protocol under IRB Protocol No. HUMC-IRB-2025-0847, with initial approval granted on December 18, 2025. The IRB has determined that the Study meets all applicable requirements for the protection of human subjects, including those set forth in 21 C.F.R. Parts 50 and 56 and the Common Rule (45 C.F.R. Part 46).
E. Regulatory Status. The Study will be conducted under IDE No. G260012 issued by the FDA. Sponsor, as the IDE holder, intends to file an IDE supplement with the FDA by March 15, 2026, referencing this Agreement and adding HUMC as the clinical trial site for the Cadence-3 Study.
F. Intent. The Parties desire to set forth the terms and conditions under which Institution will conduct the Study, including provisions governing indemnification, intellectual property, publication rights, regulatory compliance, data management, insurance, payment, and other matters relevant to the conduct of a clinical investigation of a significant risk investigational medical device.
NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE 1 — DEFINITIONS
As used in this Agreement, the following terms shall have the meanings ascribed to them below. Capitalized terms used but not defined in this Article 1 shall have the meanings ascribed to them elsewhere in this Agreement.
1.1 "Adverse Event" or "AE" means any untoward medical occurrence in a Study Subject, whether or not considered related to the Investigational Device or Study procedures, including any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with participation in the Study.
1.2 "Background IP" means all intellectual property owned or controlled by a Party prior to the Effective Date or developed independently by a Party outside the scope of the Study, including, without limitation, in the case of Sponsor, all intellectual property relating to the Device design, specifications, manufacturing processes, software, algorithms, and all pre-existing patents, patent applications, trade secrets, know-how, and copyrights.
1.3 "Confidential Information" means any and all non-public, proprietary, or confidential information disclosed by one Party (the "Disclosing Party") to the other Party (the "Receiving Party") in connection with this Agreement or the Study, whether disclosed orally, in writing, electronically, or by any other means, including, without limitation, Study Data (prior to publication), Device specifications and design information, manufacturing processes, regulatory submissions, financial terms and the Study Budget, business plans, trade secrets, know-how, and any information designated as confidential by the Disclosing Party. Confidential Information shall not include information that falls within the exceptions set forth in Section 9.3.
1.4 "CRO" means Meridian Clinical Sciences, Inc., a Delaware corporation with offices at 900 Weston Parkway, Suite 400, Cary, North Carolina 27513, which is Sponsor's contracted clinical research organization engaged for data management, biostatistical analysis, and safety monitoring of the Study.
1.5 "Data Safety Monitoring Board" or "DSMB" means the independent data safety monitoring board constituted for the Study, chaired by Dr. Garrett P. Lindholm, M.D., Ph.D. (Professor of Biostatistics and Cardiology, Ellsworth University, Chicago, Illinois), operating under a separate DSMB charter dated November 2025.
1.6 "Device" or "Investigational Device" means the ThornValve MV-200 System (Transcatheter Mitral Valve Repair Device), as described in IDE No. G260012, including all components, accessories, delivery systems, and associated instructions for use supplied by Sponsor for use in the Study.
1.7 "Effective Date" means March 2, 2026.
1.8 "Foreground IP" means any and all inventions, discoveries, improvements, works of authorship, know-how, data, software, methods, techniques, compositions of matter, or other intellectual property conceived, created, developed, or first reduced to practice in the performance of the Study or as a direct result of activities conducted under this Agreement.
1.9 "Good Clinical Practice" or "GCP" means the ethical, scientific, and quality standards for designing, conducting, recording, and reporting clinical trials that involve the participation of human subjects, as set forth in the International Council for Harmonisation guideline ICH E6(R2), 21 C.F.R. Parts 50, 54, 56, and 812, and applicable FDA guidance documents.
1.10 "IDE" means Investigational Device Exemption No. G260012 granted by the FDA for the ThornValve MV-200 System, as supplemented or amended from time to time.
1.11 "Informed Consent" means the process and documentation by which a Study Subject voluntarily confirms his or her willingness to participate in the Study after having been informed of all aspects of the Study relevant to the subject's decision to participate, in accordance with 21 C.F.R. Part 50, the IRB-approved informed consent form, and applicable Connecticut and federal law.
1.12 "IRB" means Institution's Institutional Review Board, which has approved the Study under IRB Protocol No. HUMC-IRB-2025-0847.
1.13 "Joint Invention" means any Foreground IP that is jointly conceived or created by one or more individuals who are personnel of Sponsor and one or more individuals who are personnel of Institution, where inventorship is determined in accordance with applicable United States patent law.
1.14 "Principal Investigator" or "PI" means Dr. Julian M. Castañeda, M.D., FACC, Professor of Cardiovascular Medicine, Hargrove University School of Medicine, and Director, Structural Heart Interventions Program, HUMC, who is responsible for the conduct of the Study at Institution.
1.15 "Protocol" means the Study protocol titled "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," as approved by the IRB and as may be amended from time to time with all requisite approvals. A synopsis of the Protocol is attached hereto as Exhibit B and incorporated herein by reference.
1.16 "Serious Adverse Event" or "SAE" means any Adverse Event that meets the FDA regulatory criteria for seriousness, including any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, or requires medical or surgical intervention to prevent one of the foregoing outcomes.
1.17 "Study" or "Trial" means the Cadence-3 clinical trial as described in the Protocol and this Agreement.
1.18 "Study Budget" means the detailed budget for the Study attached hereto as Exhibit A and incorporated herein by reference, as may be amended from time to time by written agreement of the Parties.
1.19 "Study Data" means all clinical data, safety data, imaging data (including echocardiographic, angiographic, and computed tomography data), biomarker results, case report forms, electronic data capture records, source documents, laboratory results, patient-reported outcomes, and all other data generated in the conduct of the Study.
1.20 "Study Period" means the period commencing on the Effective Date and continuing until Study completion, which shall include the last patient's last visit, final database lock, and completion of all reporting obligations. The Study Period is estimated at approximately thirty-six (36) months from first patient enrollment, with an estimated Study completion date of June 30, 2029.
1.21 "Study Staff" means the Principal Investigator, the Sub-Investigator, study coordinators, research nurses, echocardiographic technicians, and all other HUMC personnel directly involved in the conduct of the Study.
1.22 "Study Subject" means an individual who has provided Informed Consent and has been enrolled in the Study in accordance with the Protocol.
1.23 "Sub-Investigator" means Dr. Hannah L. Forsberg, M.D., Associate Professor of Cardiovascular Medicine, Hargrove University School of Medicine, and Associate Director, Structural Heart Interventions Program, HUMC.
ARTICLE 2 — SCOPE OF WORK AND STUDY CONDUCT
Section 2.1 — Engagement and Study Conduct.
Sponsor hereby engages Institution, and Institution hereby agrees, to conduct the Study at Institution's facilities in accordance with the Protocol, this Agreement, all applicable federal, state, and local laws and regulations, Good Clinical Practice, the IDE regulations set forth in 21 C.F.R. Part 812, and all applicable IRB requirements. Institution shall perform all Study-related procedures, including but not limited to screening, enrollment, device implantation procedures, follow-up visits, data collection, and adverse event assessment, at HUMC's Structural Heart Center, located at 1400 Sterling Heights Boulevard, New Haven, Connecticut 06510. The Study is a single-site clinical investigation; Institution is the sole trial site for the Cadence-3 Study. Institution shall dedicate adequate personnel, facilities, equipment, and resources to perform the Study in a timely and professional manner consistent with the standards of care and academic rigor expected of a leading academic medical center.
Section 2.2 — Principal Investigator.
Institution hereby appoints Dr. Julian M. Castañeda, M.D., FACC, as the Principal Investigator for the Study at Institution. Dr. Castañeda is a board-certified interventional cardiologist with more than eighteen (18) years of experience in transcatheter valve therapies, has served as principal investigator on nine (9) prior medical device clinical trials, and is the author or co-author of over one hundred forty (140) peer-reviewed publications in the field of structural heart disease. The PI shall be personally responsible for the conduct of the Study at Institution, including but not limited to the enrollment of Study Subjects, performance of Study procedures, supervision of Study Staff, collection and recording of Study Data, reporting of Adverse Events and Serious Adverse Events, maintenance of regulatory compliance, and adherence to the Protocol. The PI shall devote sufficient time and effort to the Study to fulfill his obligations under this Agreement and the Protocol. The PI may not be replaced without the prior written consent of Sponsor, which consent shall not be unreasonably withheld or delayed. Any proposed replacement PI must be acceptable to Sponsor, the IRB, and the FDA, and Institution shall promptly notify Sponsor of any circumstances that may affect the PI's ability to fulfill his responsibilities under this Agreement, including but not limited to departure from Institution, disability, or conflict of interest.
Section 2.3 — Sub-Investigator.
Dr. Hannah L. Forsberg, M.D., is hereby designated as the Sub-Investigator and co-PI designate for the Study. The Sub-Investigator shall assist the PI in the conduct of the Study and may perform Study procedures, including device implantation, follow-up assessments, and adverse event evaluation, under the supervision and direction of the PI. In the event the PI is temporarily unavailable, the Sub-Investigator may serve as acting PI for a period not to exceed thirty (30) calendar days, provided that Sponsor is notified within forty-eight (48) hours of such substitution and that such arrangement is consistent with IRB and FDA requirements.
Section 2.4 — Enrollment.
The planned enrollment for the Study is forty-five (45) Study Subjects, as specified in the Protocol. Each Study Subject shall undergo a twenty-four (24)-month follow-up period following the index procedure. The estimated date for first patient enrollment is April 7, 2026. The estimated date for last patient enrollment is June 30, 2027. The estimated date for Study completion (last patient, last visit) is June 30, 2029. Institution shall use commercially reasonable efforts to meet the enrollment milestones and timelines set forth in the Protocol and this Agreement. If enrollment falls materially behind the projected timeline, Institution shall promptly notify Sponsor and the Parties shall discuss in good faith appropriate measures to address enrollment shortfalls, which may include extending the enrollment period, modifying inclusion and exclusion criteria (subject to IRB and FDA approval), or other mutually agreed measures.
Section 2.5 — Protocol Amendments.
Any amendment to the Protocol shall require the prior written agreement of both Parties, approval by the IRB, and, where required by applicable regulations, approval by the FDA via IDE supplement or other appropriate regulatory submission. Neither Party shall unilaterally modify the Protocol. Each Party shall cooperate with the other in the preparation, review, and submission of any proposed Protocol amendment. Institution shall not implement any Protocol amendment at the study site until all required approvals have been obtained, except where an immediate change is necessary to eliminate an apparent immediate hazard to Study Subjects, in which case Institution shall implement the change and promptly notify Sponsor, the IRB, and, where applicable, the FDA.
Section 2.6 — Informed Consent.
Institution and PI shall obtain proper Informed Consent from each Study Subject prior to the performance of any Study-specific procedures, in accordance with 21 C.F.R. Part 50, the IRB-approved informed consent form, and applicable Connecticut and federal law. The Informed Consent process shall be conducted by the PI, the Sub-Investigator, or other qualified Study Staff designated by the PI and approved by the IRB. Institution shall ensure that each Study Subject is provided adequate time and opportunity to consider the information presented and to ask questions before consenting to participate. Institution shall maintain complete and accurate documentation of the Informed Consent process for each Study Subject in accordance with applicable regulatory requirements and institutional policies, including a signed and dated copy of the informed consent form in each Study Subject's research file.
Section 2.7 — Study Staff Qualifications and Training.
Institution shall ensure that all Study Staff are appropriately qualified, licensed (where applicable), and trained on the Protocol, the Device (including device preparation, implantation technique, and post-procedural care), Good Clinical Practice, human subjects protection, and applicable regulatory requirements prior to participating in any Study activities. Sponsor shall provide initial training on the Device and associated procedures to the PI, Sub-Investigator, and other designated Study Staff, including a comprehensive device training program consisting of didactic instruction, bench model simulation, and proctored initial cases as specified in the Protocol. Sponsor shall also provide ongoing training as necessary to address Protocol amendments, Device modifications, or other developments relevant to the Study. Institution shall maintain current documentation of all training completed by Study Staff and shall make such documentation available to Sponsor and the CRO upon request.
ARTICLE 3 — INVESTIGATIONAL DEVICE SUPPLY
Section 3.1 — Device Supply.
Sponsor shall supply the ThornValve MV-200 System, including all components, accessories, delivery systems, and associated instructions for use, to Institution at no cost to Institution for use exclusively in the conduct of the Study. Sponsor shall supply Devices in quantities sufficient to meet the enrollment needs of the Study, as reasonably determined by Sponsor in consultation with the PI. All Devices supplied under this Agreement shall remain the sole and exclusive property of Sponsor at all times. Devices are supplied solely under the authority of IDE No. G260012 and may not be used for any purpose other than the conduct of the Study as described in the Protocol. Institution acknowledges that the Device is an investigational product that has not been approved or cleared for commercial distribution by the FDA, and Institution shall not represent, market, promote, sell, or otherwise distribute the Device outside the scope of the Study.
Section 3.2 — Device Handling and Storage.
Institution shall receive, store, handle, and account for all Devices in accordance with Sponsor's written instructions, the Protocol, and applicable FDA regulations, including 21 C.F.R. § 812.140. Institution shall designate a qualified individual to serve as the Device accountability officer and shall maintain accurate and complete Device accountability records, including documentation of receipt, storage conditions, dispensing to Study Subjects, condition upon use, and return or disposition of all Devices. Institution shall store all Devices in a secure, environmentally controlled location at Institution's facilities that meets the storage conditions specified by Sponsor. Institution shall promptly notify Sponsor of any Device that is damaged, defective, expired, or otherwise unsuitable for use.
Section 3.3 — Return or Disposition.
Upon completion of the Study or termination of this Agreement, whichever occurs first, Institution shall return all unused, unexpired Devices to Sponsor in accordance with Sponsor's written instructions and at Sponsor's expense. Any used Devices, explanted components, or Device-related materials shall be handled and disposed of in accordance with Sponsor's instructions, the Protocol, applicable biohazard and waste disposal regulations, and any applicable FDA requirements. Institution shall not destroy any Device or Device component without the prior written authorization of Sponsor, except where immediate destruction is required by applicable law or regulation.
ARTICLE 4 — REGULATORY COMPLIANCE
Section 4.1 — IDE Compliance.
The Study shall be conducted in compliance with IDE No. G260012 and all conditions and requirements imposed by the FDA in connection therewith. Sponsor is the holder of the IDE and shall be responsible for maintaining the IDE in good standing, filing all necessary IDE supplements (including the supplement adding HUMC as a study site, which Sponsor intends to file by March 15, 2026), and submitting all required reports to the FDA, including annual progress reports, safety reports, and any other submissions required under 21 C.F.R. Part 812. Institution shall cooperate with Sponsor in the preparation and filing of IDE supplements and reports and shall provide Sponsor with all information reasonably necessary for such submissions in a timely manner.
Section 4.2 — IRB Oversight.
Institution shall maintain continuous IRB approval for the Study throughout the Study Period under IRB Protocol No. HUMC-IRB-2025-0847. Institution shall timely submit all Protocol amendments, informed consent form revisions, safety reports, annual continuing review materials, and any other documents required by the IRB for review and approval. Institution shall comply with all conditions and requirements imposed by the IRB. Institution shall promptly notify Sponsor, in writing, of any IRB actions relating to the Study, including but not limited to approval of amendments, requests for additional information, imposition of restrictions or conditions, suspension of enrollment, or withdrawal or termination of IRB approval. Such notification shall be provided to Sponsor within five (5) business days of Institution's receipt of the IRB's action or correspondence.
Section 4.3 — Good Clinical Practice.
Both Parties shall conduct all Study-related activities in compliance with Good Clinical Practice, including but not limited to the standards set forth in the International Council for Harmonisation guideline ICH E6(R2), 21 C.F.R. Parts 50 (Protection of Human Subjects), 54 (Financial Disclosure by Clinical Investigators), 56 (Institutional Review Boards), and 812 (Investigational Device Exemptions), and all applicable FDA guidance documents. Each Party shall ensure that its employees, agents, and contractors involved in the Study are trained on and comply with GCP requirements.
Section 4.4 — Adverse Event Reporting.
Institution and PI shall identify, document, assess, and report all Adverse Events and Serious Adverse Events occurring during the Study in accordance with the Protocol, IDE requirements, GCP, and all applicable FDA regulations. All AEs shall be documented on the appropriate case report forms and reported to Sponsor and the CRO (Meridian Clinical Sciences, Inc.) in accordance with the timelines specified in the Protocol. All Serious Adverse Events shall be reported to Sponsor and the CRO within twenty-four (24) hours of the PI becoming aware of the event, using the SAE reporting form provided by Sponsor or the CRO. Institution shall also report SAEs and other safety events to the IRB and the FDA in accordance with applicable requirements, including 21 C.F.R. §§ 812.46 and 812.150. The PI shall exercise medical judgment in the assessment of causality, severity, and expectedness of all AEs and SAEs. Sponsor shall be responsible for the preparation and submission of all IDE safety reports to the FDA.
Section 4.5 — Regulatory Inspections.
Institution shall permit and fully cooperate with any inspection, audit, or investigation conducted by the FDA, the Department of Health and Human Services, or any other federal, state, or local regulatory authority relating to the Study. Such cooperation shall include providing access to Institution's facilities, Study records, source documents, Device accountability records, IRB records, and Study Staff for interview. Institution shall promptly notify Sponsor, in writing, of any regulatory inspection or inquiry relating to the Study, and in no event later than two (2) business days after Institution becomes aware of such inspection or inquiry. Institution shall provide Sponsor with copies of any inspection observations (including FDA Form 483), establishment inspection reports, warning letters, or other regulatory correspondence relating to the Study within five (5) business days of receipt.
Section 4.6 — Financial Disclosure.
The PI, the Sub-Investigator, and all Study Staff who are clinical investigators as defined in 21 C.F.R. Part 54 shall comply with FDA financial disclosure requirements. Institution shall ensure that all required financial disclosure forms (FDA Form 3454 and Form 3455, as applicable) are completed accurately and submitted to Sponsor at the commencement of the Study, annually during the Study, and within thirty (30) days of Study completion. Institution shall promptly notify Sponsor of any changes in the financial interests or arrangements of PI, Sub-Investigator, or Study Staff that could affect the accuracy of previously submitted financial disclosure forms.
Section 4.7 — ClinicalTrials.gov Registration.
Sponsor shall maintain registration of the Study on ClinicalTrials.gov under identifier NCT06198234 in accordance with the requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and 42 C.F.R. Part 11. Sponsor shall be responsible for the timely submission of results information to ClinicalTrials.gov. Institution and PI shall cooperate with Sponsor and provide information necessary for the accurate and timely maintenance of the ClinicalTrials.gov record.
ARTICLE 5 — DATA MANAGEMENT AND SAFETY MONITORING
Section 5.1 — Clinical Research Organization.
Sponsor has separately engaged Meridian Clinical Sciences, Inc. (the "CRO"), a Delaware corporation with offices at 900 Weston Parkway, Suite 400, Cary, North Carolina 27513, for the provision of data management, electronic data capture, biostatistical analysis, clinical monitoring, and safety monitoring services in connection with the Study. The primary point of contact at the CRO for purposes of the Study is Victoria Reeves, Vice President of Cardiovascular Programs. Institution shall cooperate with the CRO in the performance of all data management activities, including but not limited to the timely and accurate completion of case report forms (whether electronic or paper-based), resolution of data queries within the timelines specified in the data management plan, and provision of source documents and other records for review by CRO monitors. Institution acknowledges that the CRO acts on behalf of Sponsor and that information shared with the CRO in connection with the Study shall be treated as information shared with Sponsor for purposes of this Agreement.
Section 5.2 — Data Safety Monitoring Board.
An independent Data Safety Monitoring Board has been constituted for the Study, chaired by Dr. Garrett P. Lindholm, M.D., Ph.D., Professor of Biostatistics and Cardiology at Ellsworth University, Chicago, Illinois. The DSMB was constituted in November 2025 and operates under a separate DSMB charter that sets forth the DSMB's membership, meeting schedule, operating procedures, and decision-making framework. The DSMB shall conduct periodic reviews of unblinded safety data and efficacy data (as applicable) accumulated during the Study and may, in its discretion, recommend modification, suspension, or termination of the Study based on safety or efficacy considerations. Both Parties shall cooperate with DSMB requests for data, information, and analysis. Sponsor shall promptly communicate DSMB recommendations to Institution, and the Parties shall discuss in good faith any actions necessary to implement DSMB recommendations. In the event the DSMB recommends suspension or termination of the Study, Sponsor shall promptly notify Institution and the FDA in accordance with IDE requirements.
Section 5.3 — Source Documents and Record Retention.
Institution shall create, maintain, and preserve complete, accurate, and legible source documents and study records for each Study Subject and for the Study overall, including but not limited to informed consent forms, medical records, laboratory reports, imaging studies, case report forms, Device accountability logs, regulatory correspondence, and IRB correspondence. All source documents and study records shall be maintained in a secure location at Institution's facilities. Institution shall retain all Study records for the minimum period required by applicable law, which shall be the longer of: (a) two (2) years after the date on which an application for marketing approval for the Device is approved for the indication studied, or the date the investigation is terminated or completed and the FDA is so notified; (b) two (2) years after the date on which the IDE is terminated or final disposition of the IDE occurs; or (c) such other period as may be required by applicable federal, state, or local law or by the IRB. Institution shall not destroy or dispose of any Study records without prior written authorization from Sponsor, and shall notify Sponsor at least sixty (60) days prior to any proposed destruction, transfer, or relocation of Study records.
Section 5.4 — Monitoring and Auditing.
Sponsor and/or the CRO shall have the right to monitor and audit the conduct of the Study at Institution, including but not limited to conducting on-site monitoring visits, remote monitoring activities, review and verification of source documents against case report form entries, review of Device accountability records, review of informed consent documentation, review of regulatory files, and assessment of overall compliance with the Protocol, GCP, and this Agreement. Institution shall provide Sponsor and the CRO with reasonable access to Institution's facilities, Study records, and Study Staff for the purpose of conducting monitoring and auditing activities during normal business hours, upon reasonable advance notice (which shall be not less than five (5) business days for routine monitoring visits and not less than ten (10) business days for formal audits, except in cases of urgent safety concerns, in which case shorter notice may be provided). Institution shall cooperate fully with all monitoring and auditing activities and shall promptly implement any corrective actions identified during monitoring or auditing.
ARTICLE 6 — COMPENSATION AND PAYMENT
Section 6.1 — Total Agreement Value.
Total compensation payable by Sponsor to Institution under this Agreement shall not exceed Six Million Dollars ($6,000,000.00), as set forth in the Study Budget attached hereto as Exhibit A (the "Study Budget"). All payments under this Agreement are funded under TMRI Grant Award No. TMRI-CV-2025-018, Sponsor's internal cardiovascular device development program funding allocation. In no event shall the aggregate payments made by Sponsor to Institution under this Agreement exceed Six Million Dollars ($6,000,000.00) without a written amendment to this Agreement executed by both Parties.
Section 6.2 — Payment Components.
Compensation shall be paid to Institution as follows:
(a) Upfront Institutional Activation Fee. Three Hundred Thousand Dollars ($300,000.00), representing five percent (5.0%) of the total Agreement value, shall be payable within thirty (30) days of the Effective Date upon Sponsor's receipt of a proper invoice from Institution and written confirmation from Institution that the study site is ready to initiate enrollment, including confirmation of IRB approval, completion of site initiation visit, and readiness of all required facilities and personnel (collectively, "Site Readiness").
(b) Per-Subject Payments. Ninety-Five Thousand Dollars ($95,000.00) per enrolled and evaluable Study Subject, for up to forty-five (45) Study Subjects, for a maximum total of Four Million Two Hundred Seventy-Five Thousand Dollars ($4,275,000.00), representing seventy-one and one-quarter percent (71.25%) of the total Agreement value. Per-Subject payments shall be disbursed in three (3) installments per Study Subject as follows:
(i) Installment 1 — Enrollment: Thirty-Eight Thousand Dollars ($38,000.00), representing forty percent (40%) of the per-subject amount, payable upon enrollment of the Study Subject (defined as the date the Study Subject provides Informed Consent and meets all eligibility criteria as confirmed by the PI);
(ii) Installment 2 — Twelve-Month Follow-Up: Twenty-Eight Thousand Five Hundred Dollars ($28,500.00), representing thirty percent (30%) of the per-subject amount, payable upon completion of the twelve (12)-month follow-up visit by the Study Subject in accordance with the Protocol;
(iii) Installment 3 — Twenty-Four-Month Follow-Up: Twenty-Eight Thousand Five Hundred Dollars ($28,500.00), representing thirty percent (30%) of the per-subject amount, payable upon completion of the twenty-four (24)-month follow-up visit by the Study Subject in accordance with the Protocol.
(c) Annual Site Infrastructure Support. Two Hundred Thirty-Seven Thousand Five Hundred Dollars ($237,500.00) per year for a period of four (4) years, totaling Nine Hundred Fifty Thousand Dollars ($950,000.00), representing fifteen and eighty-three hundredths percent (15.83%) of the total Agreement value. Annual site infrastructure support payments are intended to offset Institution's costs of maintaining dedicated study infrastructure, including research coordinator salaries, catheterization laboratory time allocation, imaging core laboratory support, and institutional research overhead. Each annual payment shall be payable on the corresponding anniversary of the Effective Date upon receipt of a proper invoice from Institution.
(d) Publication and Manuscript Preparation Fund. Two Hundred Thousand Dollars ($200,000.00), representing three and one-third percent (3.33%) of the total Agreement value, shall be allocated for publication and manuscript preparation activities, payable in accordance with the milestones set forth in Exhibit A. This fund is intended to support the costs of manuscript preparation, statistical analysis for publications, journal submission fees, open access publication charges, and presentation expenses at scientific meetings.
(e) Screen Failure Allowance. Six Thousand One Hundred Eleven Dollars and Eleven Cents ($6,111.11) per screen failure, for up to forty-five (45) screen failures, capped at a maximum of Two Hundred Seventy-Five Thousand Dollars ($275,000.00), representing four and fifty-eight hundredths percent (4.58%) of the total Agreement value. A "screen failure" is defined as a prospective Study Subject who provides Informed Consent and undergoes screening procedures but who does not meet all eligibility criteria and is not enrolled in the Study.
Section 6.3 — Reconciliation.
For the avoidance of doubt, the aggregate maximum of all payment components set forth in Section 6.2 is as follows: $300,000.00 (Activation Fee) + $4,275,000.00 (Per-Subject Payments) + $950,000.00 (Annual Site Infrastructure Support) + $200,000.00 (Publication Fund) + $275,000.00 (Screen Failure Allowance) = $6,000,000.00. The total shall not exceed Six Million Dollars ($6,000,000.00).
Section 6.4 — Invoicing and Payment Terms.
Institution shall submit invoices to Sponsor for all earned payments on a quarterly basis, or upon achievement of payment milestones as set forth in Section 6.2, whichever occurs first. Each invoice shall include sufficient detail to identify the basis for the payment claimed, including the names or subject identification numbers of enrolled Study Subjects, the specific milestones achieved, and the corresponding payment amounts due. Invoices shall be submitted to Sponsor's Finance Department at the address specified in Section 17.1, or to such other address or electronic invoicing system as Sponsor may designate in writing. Sponsor shall pay all undisputed invoices within forty-five (45) days of receipt. If Sponsor disputes any portion of an invoice, Sponsor shall notify Institution in writing within fifteen (15) days of receipt of the invoice, specifying the nature of the dispute, and shall pay the undisputed portion within the forty-five (45)-day payment period. The Parties shall use good-faith efforts to resolve any invoice disputes promptly. All payments shall be made by wire transfer to a bank account designated by Institution in writing.
Section 6.5 — Taxes.
Each Party shall be responsible for its own tax obligations arising in connection with this Agreement, including but not limited to income taxes, employment taxes, and any applicable state or local taxes. Institution represents and warrants that it is a tax-exempt entity under Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, and shall provide Sponsor with a copy of its tax-exemption determination letter upon request. Neither Party shall be responsible for any tax obligations of the other Party.
Section 6.6 — No Additional Compensation.
The compensation set forth in this Article 6 constitutes the entire financial obligation of Sponsor to Institution for the conduct of the Study. No additional fees, overhead charges, indirect cost recovery, administrative surcharges, or other costs shall be payable by Sponsor except as expressly set forth in this Agreement or in a written amendment hereto executed by both Parties. Institution acknowledges that the payments set forth herein reflect fair market value for the services to be provided and have been determined through arm's-length negotiation between the Parties.
Section 6.7 — Financial Records and Audit Rights.
Institution shall maintain accurate, complete, and contemporaneous financial records of all Study-related expenditures, revenues, and allocations for a period of three (3) years following the completion of the Study or the termination of this Agreement, whichever is later. Sponsor, or its designated independent auditors (currently Whitman, Sadler & Co. LLP), shall have the right to audit such financial records upon not less than thirty (30) days' prior written notice to Institution. Such audits shall be conducted during normal business hours at Institution's facilities and shall be limited in scope to verification of the accuracy of invoices submitted to Sponsor and the proper use of Study funds. Institution shall cooperate fully with any such audit and shall provide reasonable access to its financial records, accounting systems, and relevant personnel. If an audit reveals an overpayment by Sponsor, Institution shall refund the overpayment to Sponsor within thirty (30) days of written notification. If an audit reveals an underpayment, Sponsor shall remit the balance due within thirty (30) days.
ARTICLE 7 — INDEMNIFICATION
Section 7.1 — Sponsor Indemnification of Institution.
Sponsor shall defend, indemnify, and hold harmless Institution, the Principal Investigator, the Sub-Investigator, Study Staff, and their respective officers, directors, trustees, employees, agents, successors, and assigns (collectively, the "Institution Indemnitees") from and against any and all claims, demands, actions, causes of action, suits, proceedings, judgments, damages, losses, liabilities, costs, and expenses (including reasonable attorneys' fees, expert witness fees, and court costs) (collectively, "Losses") asserted by any third party and arising out of or relating to:
(a) the design, manufacture, supply, labeling, packaging, transportation, or any inherent defect, malfunction, or failure of the ThornValve MV-200 System (Investigational Device), including but not limited to any product liability claim, strict liability claim, breach of warranty claim, or claim based on the design or manufacturing specifications of the Device;
(b) any other claim arising out of or relating to the Investigational Device or its use in the Study, to the extent such claim is not caused by or attributable to Institution's negligence, material deviation from the Protocol that was not approved in writing by Sponsor, failure to obtain Informed Consent, or willful misconduct; and
(c) the negligence or willful misconduct of Sponsor, its officers, directors, employees, agents, or contractors in connection with the Study or any activities performed under this Agreement.
Section 7.2 — Conditions to Sponsor Indemnification.
Sponsor's indemnification obligations under Section 7.1 are subject to the following conditions:
(a) Institution shall provide Sponsor with prompt written notice of any claim, demand, action, or threatened action for which indemnification is sought, and in no event later than twenty (20) business days after Institution first becomes aware of such claim, demand, action, or threatened action. Failure to provide timely notice shall not relieve Sponsor of its indemnification obligations except to the extent Sponsor is materially prejudiced by such failure.
(b) Sponsor shall have the right, but not the obligation, to assume and control the defense and settlement of any claim for which it provides indemnification under this Article 7, using legal counsel of Sponsor's selection. If Sponsor assumes the defense, Sponsor shall diligently prosecute such defense and shall keep Institution reasonably informed of the progress of such defense.
(c) Institution may participate in the defense of any claim for which Sponsor has assumed the defense, with separate legal counsel of Institution's own choosing and at Institution's own expense; provided, however, that if a bona fide conflict of interest exists between the interests of Sponsor and Institution in the defense of such claim such that joint representation would be inappropriate, Institution's reasonable costs and expenses of separate counsel shall be borne by Sponsor. Any determination of whether a bona fide conflict of interest exists shall be made in good faith by the Parties.
(d) No settlement of any claim that imposes any obligation, admission of liability, injunctive relief, or restriction on any Institution Indemnitee shall be entered into without Institution's prior written consent, which consent shall not be unreasonably withheld, conditioned, or delayed.
Section 7.3 — Exclusions from Sponsor Indemnification.
Notwithstanding Section 7.1, Sponsor's indemnification obligations under this Article 7 shall not extend to any Losses to the extent arising from or attributable to:
(a) the negligence or willful misconduct of Institution, the PI, the Sub-Investigator, or any member of Study Staff in the conduct of the Study;
(b) any material deviation from the Protocol by Institution, the PI, or Study Staff that was not approved in writing by Sponsor prior to or promptly following such deviation;
(c) the failure of Institution, the PI, or any member of Study Staff to obtain proper Informed Consent from a Study Subject in accordance with the requirements of this Agreement, the Protocol, 21 C.F.R. Part 50, and applicable law; or
(d) any material breach of this Agreement by Institution.
In the event a claim involves both matters for which Sponsor is obligated to indemnify under Section 7.1 and matters excluded under this Section 7.3, the Parties shall allocate responsibility for such claim in proportion to their respective fault, as determined by agreement of the Parties or, if the Parties are unable to agree, by a court of competent jurisdiction.
Section 7.4 — Aggregate Cap on Sponsor Indemnification.
Sponsor's aggregate liability for all indemnification obligations under this Article 7 shall not exceed Fifteen Million Dollars ($15,000,000.00) (the "Indemnification Cap"). This Indemnification Cap represents the total maximum aggregate amount payable by Sponsor under Sections 7.1 and 7.2 for all claims combined during the term of this Agreement and any post-termination survival period. The Indemnification Cap has been established by the Parties through arm's-length negotiation and is supported by Sponsor's clinical trial liability insurance aggregate coverage of Twenty-Five Million Dollars ($25,000,000.00) under Commonwealth Specialty Underwriters Policy No. CTL-2025-08843.
Section 7.5 — Institution Indemnification of Sponsor.
Institution shall defend, indemnify, and hold harmless Sponsor and its officers, directors, trustees, employees, agents, successors, and assigns (collectively, the "Sponsor Indemnitees") from and against any and all Losses asserted by any third party and arising out of or relating to:
(a) the gross negligence or willful misconduct of Institution, the PI, the Sub-Investigator, or any member of Study Staff in connection with the conduct of the Study or any activities performed under this Agreement; and
(b) a material breach of this Agreement by Institution.
Section 7.6 — Conditions to Institution Indemnification.
Institution's indemnification obligations under Section 7.5 are subject to the following conditions, which are analogous to those set forth in Section 7.2:
(a) Sponsor shall provide Institution with prompt written notice of any claim, demand, action, or threatened action for which indemnification is sought under Section 7.5, and in no event later than twenty (20) business days after Sponsor first becomes aware of such claim, demand, action, or threatened action. Failure to provide timely notice shall not relieve Institution of its indemnification obligations except to the extent Institution is materially prejudiced by such failure.
(b) Institution shall have the right, but not the obligation, to assume and control the defense and settlement of any claim for which it provides indemnification under Section 7.5, using legal counsel of Institution's selection.
(c) Sponsor may participate in the defense of any claim with separate counsel at its own expense, subject to the same conflict-of-interest provisions set forth in Section 7.2(c), mutatis mutandis.
(d) No settlement of any claim that imposes any obligation, admission of liability, injunctive relief, or restriction on any Sponsor Indemnitee shall be entered into without Sponsor's prior written consent, which consent shall not be unreasonably withheld, conditioned, or delayed.
Section 7.7 — Limitation.
NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE STUDY, REGARDLESS OF THE FORM OF ACTION OR THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, OR OTHERWISE, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THIS LIMITATION SHALL NOT APPLY TO (I) A PARTY'S INDEMNIFICATION OBLIGATIONS UNDER THIS ARTICLE 7, OR (II) A PARTY'S BREACH OF ITS CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE 9.
ARTICLE 8 — INSURANCE
Section 8.1 — Sponsor Insurance.
Sponsor shall procure and maintain, at its own expense, clinical trial liability insurance throughout the term of the Study and for a period of two (2) years following the completion of the Study or the termination of this Agreement, whichever is later, with the following minimum coverage limits:
Per occurrence: $10,000,000 (Ten Million Dollars)
Aggregate: $25,000,000 (Twenty-Five Million Dollars)
Sponsor's current clinical trial liability insurance carrier is Commonwealth Specialty Underwriters, Inc., Policy No. CTL-2025-08843, with a policy period of January 1, 2026 through December 31, 2027, to be renewed as necessary to provide continuous coverage throughout the required period. Sponsor shall cause Institution to be named as an additional insured under such clinical trial liability insurance policy, and shall provide Institution with a certificate of insurance evidencing such coverage, including additional insured status, within thirty (30) days of the Effective Date and promptly upon each policy renewal.
Section 8.2 — Institution Insurance.
Institution shall procure and maintain, at its own expense, professional liability (medical malpractice) insurance throughout the term of the Study and for a period of two (2) years following the completion of the Study or the termination of this Agreement, whichever is later, with the following minimum coverage limits:
Per occurrence: $5,000,000 (Five Million Dollars)
Aggregate: $15,000,000 (Fifteen Million Dollars)
Institution's current professional liability insurance carrier is Pinnacle Mutual Insurance Company, Policy No. PML-HU-2025-4471. Institution shall cause Sponsor to be named as an additional insured under such professional liability insurance policy, and shall provide Sponsor with a certificate of insurance evidencing such coverage, including additional insured status, within thirty (30) days of the Effective Date and promptly upon each policy renewal.
Section 8.3 — Notice of Changes.
Each Party shall provide the other Party with not less than thirty (30) days' prior written notice of any material change in, cancellation of, or non-renewal of its insurance coverage required under this Article 8. In the event of any such change, cancellation, or non-renewal, the affected Party shall promptly procure replacement coverage meeting the minimum requirements of this Article 8 and shall provide the other Party with a certificate of insurance evidencing such replacement coverage.
ARTICLE 9 — CONFIDENTIALITY
Section 9.1 — Confidential Information.
As used in this Agreement, "Confidential Information" means any and all non-public, proprietary, or confidential information disclosed by one Party (the "Disclosing Party") to the other Party (the "Receiving Party") in connection with this Agreement or the Study, in any form or medium, whether disclosed before or after the Effective Date, including but not limited to: Study Data (prior to publication in accordance with Article 11); Device specifications, design information, engineering drawings, manufacturing processes, and formulations; regulatory submissions, correspondence, and strategies; clinical trial results, analyses, and reports; financial terms of this Agreement and the Study Budget; business plans, marketing plans, and commercialization strategies; trade secrets and know-how; patient-level data and protected health information (subject to applicable privacy laws); and any other information that is identified or designated by the Disclosing Party as confidential, or that the Receiving Party knows or reasonably should know is confidential given the nature of the information and the circumstances of its disclosure.
Section 9.2 — Obligations.
Each Receiving Party shall: (a) hold all Confidential Information of the Disclosing Party in strict confidence and protect it with at least the same degree of care it uses to protect its own confidential information, but in no event less than a reasonable degree of care; (b) use Confidential Information solely for the purposes of performing its obligations and exercising its rights under this Agreement and the Study, and for no other purpose; (c) not disclose Confidential Information to any third party without the prior written consent of the Disclosing Party, except as permitted under this Article 9; and (d) limit access to Confidential Information to those of its employees, agents, contractors, and advisors who have a need to know such information for purposes of the Study and who are bound by confidentiality obligations no less restrictive than those set forth in this Article 9.
Section 9.3 — Exceptions.
The obligations of confidentiality and non-use set forth in Section 9.2 shall not apply to any information that the Receiving Party can demonstrate by competent evidence: (a) is or becomes publicly available through no fault or breach by the Receiving Party; (b) was known to the Receiving Party prior to disclosure by the Disclosing Party, as evidenced by the Receiving Party's written records; (c) is independently developed by the Receiving Party without use of or reference to the Disclosing Party's Confidential Information, as evidenced by the Receiving Party's written records; (d) is received by the Receiving Party from a third party that is not, to the Receiving Party's knowledge, under an obligation of confidentiality to the Disclosing Party with respect to such information; or (e) is required to be disclosed by applicable law, regulation, subpoena, court order, or governmental order, provided that the Receiving Party shall (to the extent legally permitted) provide the Disclosing Party with prompt written notice of such requirement prior to making such disclosure, shall disclose only that portion of the Confidential Information that is legally required to be disclosed, and shall use reasonable efforts to obtain confidential treatment or a protective order for such information.
Section 9.4 — Regulatory and IRB Disclosures.
Nothing in this Article 9 shall restrict or limit either Party's ability to make disclosures of Confidential Information to the FDA, the IRB, the DSMB, the CRO, or any other regulatory authority, institutional review board, or ethics committee, to the extent such disclosure is required or reasonably necessary for the conduct of the Study, compliance with regulatory requirements, or the protection of Study Subject safety.
Section 9.5 — Duration.
The obligations of confidentiality and non-use set forth in this Article 9 shall survive the termination or expiration of this Agreement for a period of five (5) years following the effective date of such termination or expiration; provided, however, that with respect to any Confidential Information that constitutes a trade secret under applicable law, such obligations shall continue for as long as such information remains a trade secret.
ARTICLE 10 — INTELLECTUAL PROPERTY
Section 10.1 — Background intellectual Property.
Each Party shall retain sole and exclusive ownership of its Background IP. TMRI retains sole and exclusive ownership of all Background IP related to the ThornValve MV-200 System, including but not limited to the Device design, engineering specifications, manufacturing processes, software algorithms, trade secrets, patents, patent applications, and all other pre-existing intellectual property of TMRI. No license, right, or interest in or to either Party's Background IP is granted under this Agreement except as expressly set forth herein. Institution and PI acknowledge and agree that the Device and all related Sponsor Background IP are the exclusive property of Sponsor, and nothing in this Agreement shall be construed to transfer, assign, or grant any right, title, or interest in Sponsor's Background IP to Institution, PI, or any third party.
Section 10.2 — Ownership of Study Data.
All Study Data generated in the conduct of the Study shall be owned solely and exclusively by Sponsor. Institution and PI hereby acknowledge and agree to Sponsor's sole ownership of all Study Data, including the right to use, analyze, publish, submit to regulatory authorities, and otherwise exploit Study Data for any purpose, subject to the publication provisions of Article 11. Subject to Section 10.6 and the publication and confidentiality provisions of this Agreement, Sponsor hereby grants to Institution and PI a non-exclusive, royalty-free, perpetual, irrevocable license to use Study Data for academic, non-commercial research, and teaching purposes. Such license shall not include the right to sublicense, assign, or transfer Study Data to any third party, nor shall it include the right to use Study Data for any commercial application or in support of any regulatory submission, without Sponsor's prior written consent.
Section 10.3 — Sole Inventions.
Any Foreground IP solely conceived or created by one or more individuals who are employees, agents, or contractors of Sponsor, without the inventive contribution of any personnel of Institution, shall be solely and exclusively owned by Sponsor. Any Foreground IP solely conceived or created by one or more individuals who are employees, agents, or contractors of Institution (including PI, Sub-Investigator, and Study Staff), without the inventive contribution of any personnel of Sponsor, shall be solely and exclusively owned by Institution. Each Party shall promptly disclose to the other Party any Foreground IP that may be relevant to the Study or the Device.
Section 10.4 — Joint Inventions.
Any Foreground IP that constitutes a Joint Invention — that is, Foreground IP jointly conceived or created by one or more individuals who are personnel of Sponsor and one or more individuals who are personnel of Institution — shall be jointly owned by the Parties. Each Party shall have an undivided interest in such Joint Invention. Neither Party shall license, assign, encumber, or otherwise dispose of its interest in any Joint Invention to any third party without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned, or delayed. The Parties shall cooperate in good faith to protect, maintain, and enforce any intellectual property rights arising from Joint Inventions, and shall share equally in the costs of obtaining and maintaining patent protection for Joint Inventions, unless otherwise agreed in writing.
Section 10.5 — License Grants.
(a) Exclusive License from Institution to Sponsor. Institution and PI hereby grant to Sponsor an exclusive, worldwide, perpetual, irrevocable license, with the right to grant sublicenses, under all Foreground IP solely owned by Institution pursuant to Section 10.3, for the purpose of making regulatory submissions, obtaining regulatory approvals, manufacturing, commercializing, marketing, distributing, selling, and further developing the Device and any products or technologies derived therefrom. In consideration of such exclusive license, if Sponsor commercially exploits such Foreground IP (through direct commercialization or through sublicense to a third party), Sponsor shall pay Institution a reasonable royalty on net revenues derived from such commercial exploitation. The specific royalty rate, payment terms, and other commercial terms shall be negotiated in good faith by the Parties within ninety (90) days following Sponsor's written notice to Institution of its intent to commercially exploit such Foreground IP. If the Parties are unable to reach agreement on royalty terms within such ninety (90)-day period, either Party may submit the matter to the dispute resolution procedures set forth in Article 16.
(b) License to Sponsor for Joint Inventions. With respect to any Joint Invention, Sponsor shall have a right of first negotiation for an exc

CLINICAL TRIAL AGREEMENT

EXECUTION VERSION

TABLE OF CONTENTS

CLINICAL TRIAL AGREEMENT

Record

Parties

Dates

Amounts