Contract analysis

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, inc

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 Stud

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-

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 unavailab

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,

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

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 t

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. S

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 th

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

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 Protoc

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

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

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 (Investigationa

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 wi

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, IR

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

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 cooper

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

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 procedure

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 corresponden

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 regulat

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.

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 s

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 mile

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-exem

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 Par

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 hav

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, judgm

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, act

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 Instit

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-te

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-I

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 (2

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

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 Mil

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:

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 Artic

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 Dat

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 th

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

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 requir

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 lo

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-existin

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.

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

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 oth

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