1029-00001 · Thornwick Medical Research Institute, Inc · Engagement

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CALDERWOOD & HARKNESS LLP Attorneys at Law

One Post Office Square, Suite 4100 Boston, Massachusetts 02109

Telephone: (617) 555-4200 Facsimile: (617) 555-4201 www.calderwoodharkness.com

January 15, 2026

Marcus D. Pruitt, J.D. General Counsel Thornwick Medical Research Institute, Inc. 280 Longmeadow Drive Cambridge, Massachusetts 02139

Re: Engagement of Calderwood & Harkness LLP by Thornwick Medical Research Institute, Inc. Matter: Negotiation and Execution of Clinical Trial Agreement with Hargrove University Medical Center, Inc. — Cadence-3 Trial (ThornValve MV-200 System) Matter Number: 1029-00001

Dear Mr. Pruitt:

1. Purpose and Confirmation of Engagement

Calderwood & Harkness LLP ("Calderwood & Harkness" or the "Firm") is pleased to confirm its engagement by Thornwick Medical Research Institute, Inc. ("TMRI"), a Massachusetts nonprofit corporation, as outside legal counsel in connection with the matter described more fully in Section 2 below. This engagement shall be effective as of January 15, 2026.

This letter (the "Engagement Letter") sets forth the terms and conditions governing the attorney-client relationship between Calderwood & Harkness and TMRI in connection with this matter. We ask that you review this Engagement Letter carefully and, if the terms are acceptable, execute and return a copy as provided in Section 14 below. In the event of any inconsistency between oral discussions regarding the scope or terms of this engagement and the terms set forth in this Engagement Letter, the terms of this Engagement Letter shall control.

We appreciate TMRI's confidence in selecting Calderwood & Harkness to serve as its outside counsel in this important matter, and we are committed to providing TMRI with the highest quality of legal representation.

2. Scope of Representation

Calderwood & Harkness will represent TMRI in its capacity as sponsor of an investigator-initiated clinical trial known as "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" (the "Trial" or "Cadence-3 Trial"). Specifically, the scope of our representation in this matter shall include the following:

(a) Clinical Trial Agreement. Drafting, negotiation, and finalization of a Clinical Trial Agreement (the "CTA") between TMRI, as sponsor, and Hargrove University Medical Center, Inc. ("HUMC"), a Connecticut nonprofit corporation located at 1400 Sterling Heights Boulevard, New Haven, Connecticut 06510, as the clinical trial site and the institution at which the principal investigator will conduct the Trial.

(b) Indemnification Provisions. Negotiation of indemnification provisions within the CTA, including without limitation the scope of indemnification obligations owed by each party, aggregate cap amounts and any applicable deductibles or self-insured retentions, notice requirements for indemnifiable claims, allocation of defense and settlement control rights between the parties, and the structure and terms of any mutual indemnification provisions.

(c) intellectual Property Provisions. Negotiation of intellectual property ownership and licensing provisions within the CTA, including without limitation the ownership of Trial Data (including clinical data, source data, and case report forms), the delineation and protection of each party's Background intellectual Property, the allocation of ownership rights in Foreground intellectual Property arising from the conduct of the Trial, the treatment of jointly conceived inventions and the inventorship determination process, and the negotiation of licensing structures (including any exclusive or non-exclusive licenses, field-of-use restrictions, sublicensing rights, and royalty or milestone-based consideration).

(d) Publication Rights. Negotiation of publication rights provisions within the CTA, including without limitation the establishment of manuscript and presentation review periods, patent filing delay rights to permit the filing of patent applications prior to public disclosure, redaction rights with respect to confidential or proprietary information, and editorial control and authorship determination procedures consistent with the International Committee of Medical Journal Editors guidelines.

(e) Ancillary Documents. Preparation and negotiation of ancillary documents to be attached as exhibits to the CTA, including the Study Budget (to be attached as Exhibit A to the CTA) and the Protocol Synopsis (to be attached as Exhibit B to the CTA), in each case in coordination with TMRI's clinical and financial personnel.

(f) Coordination with HUMC's Counsel. Coordination and communication with HUMC's outside counsel, Pemberton, Yates & Caldwell LLP, regarding all aspects of the CTA negotiation, including the exchange of drafts, redlines, issues lists, and term sheets, and participation in negotiation sessions (whether in person, by videoconference, or by telephone).

(g) Insurance Requirements. Review and coordination of insurance requirements under the CTA, including the review of certificates of insurance to be provided by Commonwealth Specialty Underwriters, Inc. (TMRI's clinical trial liability insurer) and Pinnacle Mutual Insurance Company (HUMC's professional liability insurer), and negotiation of insurance-related provisions within the CTA (including minimum coverage amounts, additional insured endorsements, and notice of cancellation requirements).

(h) Regulatory Compliance Provisions. Support for regulatory compliance aspects of the CTA, including the drafting and negotiation of provisions relating to the Investigational Device Exemption issued by the U.S. Food and Drug Administration bearing IDE number G260012, Institutional Review Board approval under Protocol No. HUMC-IRB-2025-0847, and other applicable regulatory requirements, including compliance with 21 C.F.R. Parts 50, 56, 812, and 814, as applicable, as well as applicable provisions of the Health Insurance Portability and Accountability Act and corresponding regulations.

(i) Closing Deliverables. Preparation of closing deliverables, including execution versions of the CTA and all exhibits and schedules thereto, signature pages, officer's certificates (if applicable), and closing checklists, and coordination of execution logistics among the parties and their respective counsel.

Notwithstanding the foregoing, the scope of this engagement does not include any of the following:

(i) Representation of TMRI in connection with any submissions to, or communications with, the U.S. Food and Drug Administration, including without limitation any IDE supplement submissions, premarket approval applications, or other regulatory filings relating to the ThornValve MV-200 System or the Cadence-3 Trial;

(ii) Representation of TMRI in connection with TMRI's separate agreement with Meridian Clinical Sciences, Inc., its contract research organization ("CRO"), or any other agreements with CROs, contract manufacturers, or other third-party service providers;

(iii) Representation of TMRI in connection with any litigation, arbitration, mediation, or other dispute resolution proceeding, whether arising out of or related to the CTA, the Cadence-3 Trial, or otherwise; and

(iv) The provision of any tax advice, including advice regarding TMRI's tax-exempt status under Section 501(c)(3) of the Internal Revenue Code, unrelated business taxable income, or any other tax matters.

Any expansion of the scope of this engagement beyond the matters described in this Section 2 shall be agreed upon in writing by the Firm and TMRI prior to the commencement of any such additional work.

3. Client Identification

The client in this engagement is Thornwick Medical Research Institute, Inc. (EIN: 04-3871256), a Massachusetts nonprofit corporation organized and operated exclusively for scientific, educational, and charitable purposes within the meaning of Section 501(c)(3) of the Internal Revenue Code of 1986, as amended. All duties of loyalty, confidentiality, and zealous representation arising out of the attorney-client relationship created by this Engagement Letter are owed exclusively to TMRI as an entity.

Calderwood & Harkness does not represent, and will not be deemed to represent, any individual officer, director, employee, agent, or affiliate of TMRI in their personal capacity in connection with this matter. Without limiting the generality of the foregoing, Calderwood & Harkness does not represent any member of TMRI's Board of Directors, any member of TMRI's scientific advisory board, or any investigator participating in the Cadence-3 Trial in their individual or personal capacity.

Calderwood & Harkness does not represent Hargrove University Medical Center, Inc., Pemberton, Yates & Caldwell LLP, or any other party to the contemplated transaction, and nothing in this Engagement Letter shall be construed to create an attorney-client relationship between Calderwood & Harkness and any such party.

4. Staffing

The following attorneys have been assigned to this engagement and will be primarily responsible for the legal services described in Section 2:

Responsible Partner: Joel Strauss, Partner, Healthcare & Life Sciences Practice Group. Mr. Strauss will have overall supervision of and strategic direction over the engagement. He will serve as the primary relationship partner for TMRI and will be available for consultations with TMRI's General Counsel, executive leadership, and Board of Directors (as appropriate) regarding material negotiation issues and engagement strategy.

Billing Partner: Miriam Calloway, Partner, Healthcare & Life Sciences Practice Group. Ms. Calloway will be responsible for all matters relating to billing, invoicing, and fee arrangements under this engagement, including the preparation and review of monthly invoices and the resolution of any billing inquiries. Ms. Calloway will also participate in substantive aspects of the engagement as needed, including the review and negotiation of indemnification and insurance provisions.

Lead Associate: Christopher Aiken, Healthcare & Life Sciences Practice Group. Mr. Aiken will be responsible for the day-to-day management of the engagement, including the initial drafting and subsequent revision of the CTA, participation in and preparation for negotiation sessions with Pemberton, Yates & Caldwell LLP, and coordination with TMRI's General Counsel and Vice President of Clinical Development, Dr. Elaine K. Sutherland, M.D., regarding clinical, regulatory, and operational matters bearing on the CTA.

Working Associate: Amy Whitfield, Healthcare & Life Sciences Practice Group. Ms. Whitfield will provide research and document preparation support throughout the engagement, including the preparation of comparison charts and redline summaries for use in negotiation sessions, the preparation of the closing checklist and closing deliverables, and general support for negotiation sessions and client communications.

Additional attorneys, paralegals, or other professional staff may be assigned to the engagement from time to time as the Firm determines appropriate in order to ensure the timely and efficient delivery of legal services. TMRI will be notified of any material changes in staffing. All personnel assigned to the engagement will bill at the rates specified in Section 5 below, or at rates applicable to their respective billing categories.

5. Billing Rates and Fee Arrangements

Fees for legal services rendered in connection with this engagement will be billed on an hourly basis at the following current standard billing rates for the Firm's Healthcare & Life Sciences Practice Group:

The specific hourly rates applicable to the attorneys currently assigned to this engagement are as follows:

The Firm's standard billing rates are subject to annual adjustment, which typically takes effect on January 1 of each calendar year. TMRI will receive advance written notice of not less than thirty (30) days prior to the effective date of any rate changes. Any rate adjustments will apply only to services rendered on or after the effective date of such adjustments.

Based on our current understanding of the scope and complexity of the CTA negotiation and the anticipated number of negotiation sessions with HUMC and its counsel, we estimate that the total professional fees for this engagement will be in the range of $85,000 to $125,000. This estimate is provided for budgeting purposes only and is not a cap, ceiling, or fixed fee. Actual fees may be higher or lower than the estimated range depending on a number of factors, including without limitation the complexity of the issues arising during negotiation, the number of rounds of drafts and redlines exchanged between the parties, the responsiveness of the counterparty and its counsel, the extent of involvement of TMRI's internal stakeholders, and whether any unanticipated legal issues arise during the course of the engagement.

Calderwood & Harkness will endeavor to provide efficient staffing and to avoid unnecessary duplication of effort. To that end, we will assign tasks to the most junior attorney or professional staff member whose experience and expertise are appropriate for the task, consistent with the Firm's obligation to deliver high-quality legal services and its commitment to meeting TMRI's expectations.

6. Expenses and Disbursements

In addition to professional fees, TMRI will reimburse Calderwood & Harkness for reasonable out-of-pocket costs and disbursements incurred in connection with this engagement. Such costs and disbursements may include, but are not limited to, the following:

• Travel expenses (including airfare, ground transportation, lodging, and meals) incurred in connection with in-person negotiation sessions or meetings with TMRI personnel, HUMC, or HUMC's counsel;

• Messenger and courier charges;

• Long-distance telephone and videoconference charges;

• Photocopying and document production costs;

• Printing and binding charges;

• Filing fees and recording costs (if applicable);

• Computerized legal research charges (including Westmark Data Systems and Sundial Solutions research charges); and

• FedEx, Harborline Partners LLC, and other express delivery charges.

All expenses and disbursements will be itemized on the Firm's monthly invoices, and supporting documentation will be made available upon request. The Firm will use commercially reasonable efforts to minimize out-of-pocket costs and will obtain TMRI's advance approval before incurring any single expense in excess of $2,500.

7. Billing and Payment Terms

Calderwood & Harkness will submit monthly invoices to TMRI for professional fees earned and disbursements incurred during the preceding calendar month. Each invoice will contain a reasonably detailed description of the legal services rendered, the identity of the billing attorney or professional, the number of hours billed, the applicable hourly rate, and an itemization of disbursements.

All invoices are due and payable within thirty (30) days of receipt. Invoices will reference Matter Number 1029-00001, and TMRI is requested to include this matter number on all remittances to facilitate proper crediting of payments.

TMRI's primary billing contact for purposes of this engagement shall be:

Marcus D. Pruitt, J.D. General Counsel Thornwick Medical Research Institute, Inc. 280 Longmeadow Drive Cambridge, Massachusetts 02139

All invoices will be directed to Mr. Pruitt at the address set forth above, unless TMRI notifies the Firm in writing of an alternative billing address or contact. Any questions or inquiries regarding invoices, billing matters, or fee arrangements should be directed to Miriam Calloway, Partner, at (617) 555-4218 or mcalloway@calderwoodharkness.com.

In the event that any invoice is not paid within the time period specified above, Calderwood & Harkness reserves the right to charge interest on the unpaid balance at a rate of one percent (1%) per month, or the maximum rate permitted by applicable law, whichever is less. In addition, the Firm reserves the right, upon reasonable notice to TMRI, to suspend work on the engagement if invoices remain unpaid for more than sixty (60) days, subject to the Firm's ethical obligations under the Massachusetts Rules of Professional Conduct.

8. Conflicts of Interest

Calderwood & Harkness has conducted a conflicts check in its electronic conflicts database in connection with this engagement, utilizing the names and identifying information of TMRI, Hargrove University Medical Center, Inc., Pemberton, Yates & Caldwell LLP, and other relevant parties and individuals identified by TMRI in its intake materials.

Based on the information currently available to the Firm, Calderwood & Harkness has not identified any conflicts of interest that would preclude the Firm's representation of TMRI in this matter under Rule 1.7 or Rule 1.9 of the Massachusetts Rules of Professional Conduct.

TMRI is aware that Calderwood & Harkness is a large, multi-office law firm that represents a significant number of clients across a wide range of industries, including the healthcare, life sciences, pharmaceutical, and medical device sectors. TMRI acknowledges and agrees that Calderwood & Harkness's representation of TMRI in this matter does not preclude Calderwood & Harkness from representing other clients in matters unrelated to this engagement, including matters that may be adverse to TMRI, provided that such matters are not substantially related to this engagement and do not involve the use of TMRI's confidential information. This paragraph constitutes an advance waiver of potential future conflicts of interest to the extent described herein, and TMRI's execution of this Engagement Letter shall be deemed consent to such waiver.

In the event that a conflict of interest arises during the course of this engagement, whether due to new information becoming available, changes in the parties' relationships, or otherwise, Calderwood & Harkness will promptly notify TMRI and discuss appropriate measures to address the conflict, which may include the implementation of an ethical screen within the Firm, the engagement of separate counsel for a discrete aspect of the matter, or, if the conflict cannot be adequately resolved, withdrawal from the engagement in accordance with Section 12 below and applicable rules of professional conduct.

9. Confidentiality

Calderwood & Harkness will maintain the confidentiality of all information provided by TMRI to the Firm in connection with this engagement, including without limitation proprietary business information, financial data, clinical trial data, regulatory strategy, trade secrets, and any other information that TMRI designates as confidential or that is of a nature that a reasonable attorney would understand to be confidential. The Firm's confidentiality obligations shall be governed by Rule 1.6 of the Massachusetts Rules of Professional Conduct and shall survive the termination of this engagement.

Information that is subject to the attorney-client privilege, the work product doctrine, or any other applicable privilege or protection shall be treated in accordance with the standards and procedures required to preserve such privilege or protection. Calderwood & Harkness will not voluntarily disclose any privileged or protected information without TMRI's prior written consent, except as may be required by law or as necessary for the Firm to defend itself in any proceeding relating to its representation of TMRI.

TMRI acknowledges that, in the ordinary course of the CTA negotiation process, certain confidential information of TMRI may need to be shared with counterparties, including HUMC and its outside counsel, Pemberton, Yates & Caldwell LLP, in order to facilitate the negotiation, drafting, and finalization of the CTA. TMRI hereby authorizes Calderwood & Harkness to disclose such confidential information to HUMC and its counsel as is reasonably necessary in connection with the CTA negotiation, subject to the protections afforded by any confidentiality or non-disclosure agreement that may be in place between TMRI and HUMC.

10. Document Retention

Calderwood & Harkness will maintain files and records related to this engagement, whether in paper or electronic form, in accordance with the Firm's document retention policy then in effect. The Firm's current policy provides for the retention of closed matter files for a period of ten (10) years following the conclusion of the engagement, after which time the files may be destroyed in the ordinary course without further notice to the client.

At the conclusion of the engagement, TMRI may request the return of original documents that TMRI provided to the Firm during the engagement. Calderwood & Harkness reserves the right to retain copies of all documents, correspondence, work product, and other materials in its files for its own records, subject to the Firm's continuing obligations of confidentiality as set forth in Section 9 above. Any request for return of original documents should be made in writing to the Responsible Partner or Billing Partner within ninety (90) days following the conclusion of the engagement.

11. Governing Law

This Engagement Letter and the attorney-client relationship between Calderwood & Harkness LLP and TMRI arising hereunder shall be governed by, and construed in accordance with, the laws of the Commonwealth of Massachusetts, including the Massachusetts Rules of Professional Conduct as adopted by the Supreme Judicial Court of Massachusetts, without regard to any conflict of laws principles that would require the application of the laws of any other jurisdiction.

12. Termination of Engagement

Either Calderwood & Harkness or TMRI may terminate this engagement at any time upon written notice to the other party. In the case of termination by the Firm, Calderwood & Harkness will comply with its obligations under Rule 1.16 of the Massachusetts Rules of Professional Conduct and will take all steps reasonably necessary to avoid prejudice to TMRI's interests.

Upon termination of this engagement by either party, TMRI will remain responsible for the payment of all professional fees earned and expenses incurred by the Firm through the date of termination, in accordance with the billing and payment terms set forth in Sections 5, 6, and 7 above. Calderwood & Harkness will render a final invoice within thirty (30) days following the effective date of termination.

In the event of termination, Calderwood & Harkness will take reasonable steps to protect TMRI's interests during any transition period and will cooperate in the orderly transfer of the matter to successor counsel, if any, including the prompt transfer of files, documents, and work product (subject to the Firm's right to retain copies as set forth in Section 10 above and subject to any lien rights the Firm may have under applicable law for unpaid fees and expenses).

13. Limitation of Scope

As set forth in Section 2 above, the Firm's representation of TMRI is limited to the specific matter described therein — namely, the negotiation and execution of the CTA with HUMC in connection with the Cadence-3 Trial. This engagement does not create a general or ongoing attorney-client relationship between Calderwood & Harkness and TMRI beyond the scope described in this Engagement Letter. Calderwood & Harkness does not undertake any obligation to advise TMRI with respect to matters outside the scope of this engagement, nor does the Firm undertake any obligation to monitor legal developments, regulatory changes, or other events that may affect TMRI's interests outside the scope of this matter.

Any future matters for which TMRI may wish to retain Calderwood & Harkness as counsel will require a separate engagement agreement, which will set forth the scope, terms, and conditions applicable to such future engagement.

14. Agreement and Acceptance

If the terms and conditions set forth in this Engagement Letter are acceptable to TMRI, please have an authorized representative of TMRI execute this letter in the space provided below and return a fully executed copy to the undersigned at the address set forth above. This Engagement Letter may be executed in counterparts, each of which shall be deemed an original, and may be delivered by electronic mail (PDF) or facsimile transmission, with originals to follow by regular mail or courier.

This Engagement Letter, together with any amendments or modifications agreed to in writing by the parties, constitutes the entire agreement between Calderwood & Harkness and TMRI with respect to the terms and conditions of the Firm's engagement in connection with the matter described herein, and supersedes all prior oral or written communications, negotiations, or agreements relating to the subject matter hereof.

We look forward to working with you and your team on this important matter. The Cadence-3 Trial represents a significant milestone for TMRI, and we are committed to providing the focused, efficient, and high-quality legal counsel that TMRI deserves as it advances the ThornValve MV-200 System through this critical stage of clinical development. Please do not hesitate to contact Joel Strauss at (617) 555-4212 or jstrauss@calderwoodharkness.com, or Christopher Aiken at (617) 555-4237 or caiken@calderwoodharkness.com, with any questions regarding this Engagement Letter or the engagement generally.

Very truly yours,

CALDERWOOD & HARKNESS LLP

By: ________

Joel Strauss, Partner Healthcare & Life Sciences Practice Group Responsible Partner

Date: January 15, 2026

By: ________

Miriam Calloway, Partner Healthcare & Life Sciences Practice Group Billing Partner

Date: January 15, 2026

AGREED AND ACCEPTED:

THORNWICK MEDICAL RESEARCH INSTITUTE, INC.

By: ________

Name: Marcus D. Pruitt, J.D.

Title: General Counsel

Date: ________

cc: Dr. Ansel R. Varnham, M.D., Ph.D., President & CEO, Thornwick Medical Research Institute, Inc.

cc: Dr. Elaine K. Sutherland, M.D., Vice President of Clinical Development, Thornwick Medical Research Institute, Inc.

Billing Category	Hourly Rate
Partners	$1,150 per hour
Senior Associates	$825 per hour
Associates	$650 per hour
Paralegals / Legal Assistants	$375 per hour
Attorney	Role	Hourly Rate
Joel Strauss	Partner — Responsible Partner	$1,150 per hour
Miriam Calloway	Partner — Billing Partner	$1,150 per hour
Christopher Aiken	Lead Associate	$825 per hour
Amy Whitfield	Working Associate	$650 per hour

CALDERWOOD & HARKNESS LLP Attorneys at Law
One Post Office Square, Suite 4100 Boston, Massachusetts 02109
Telephone: (617) 555-4200 Facsimile: (617) 555-4201 www.calderwoodharkness.com
January 15, 2026
Marcus D. Pruitt, J.D. General Counsel Thornwick Medical Research Institute, Inc. 280 Longmeadow Drive Cambridge, Massachusetts 02139
Re: Engagement of Calderwood & Harkness LLP by Thornwick Medical Research Institute, Inc. Matter: Negotiation and Execution of Clinical Trial Agreement with Hargrove University Medical Center, Inc. — Cadence-3 Trial (ThornValve MV-200 System) Matter Number: 1029-00001
Dear Mr. Pruitt:
1. Purpose and Confirmation of Engagement
Calderwood & Harkness LLP ("Calderwood & Harkness" or the "Firm") is pleased to confirm its engagement by Thornwick Medical Research Institute, Inc. ("TMRI"), a Massachusetts nonprofit corporation, as outside legal counsel in connection with the matter described more fully in Section 2 below. This engagement shall be effective as of January 15, 2026.
This letter (the "Engagement Letter") sets forth the terms and conditions governing the attorney-client relationship between Calderwood & Harkness and TMRI in connection with this matter. We ask that you review this Engagement Letter carefully and, if the terms are acceptable, execute and return a copy as provided in Section 14 below. In the event of any inconsistency between oral discussions regarding the scope or terms of this engagement and the terms set forth in this Engagement Letter, the terms of this Engagement Letter shall control.
We appreciate TMRI's confidence in selecting Calderwood & Harkness to serve as its outside counsel in this important matter, and we are committed to providing TMRI with the highest quality of legal representation.
2. Scope of Representation
Calderwood & Harkness will represent TMRI in its capacity as sponsor of an investigator-initiated clinical trial known as "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" (the "Trial" or "Cadence-3 Trial"). Specifically, the scope of our representation in this matter shall include the following:
(a) Clinical Trial Agreement. Drafting, negotiation, and finalization of a Clinical Trial Agreement (the "CTA") between TMRI, as sponsor, and Hargrove University Medical Center, Inc. ("HUMC"), a Connecticut nonprofit corporation located at 1400 Sterling Heights Boulevard, New Haven, Connecticut 06510, as the clinical trial site and the institution at which the principal investigator will conduct the Trial.
(b) Indemnification Provisions. Negotiation of indemnification provisions within the CTA, including without limitation the scope of indemnification obligations owed by each party, aggregate cap amounts and any applicable deductibles or self-insured retentions, notice requirements for indemnifiable claims, allocation of defense and settlement control rights between the parties, and the structure and terms of any mutual indemnification provisions.
(c) intellectual Property Provisions. Negotiation of intellectual property ownership and licensing provisions within the CTA, including without limitation the ownership of Trial Data (including clinical data, source data, and case report forms), the delineation and protection of each party's Background intellectual Property, the allocation of ownership rights in Foreground intellectual Property arising from the conduct of the Trial, the treatment of jointly conceived inventions and the inventorship determination process, and the negotiation of licensing structures (including any exclusive or non-exclusive licenses, field-of-use restrictions, sublicensing rights, and royalty or milestone-based consideration).
(d) Publication Rights. Negotiation of publication rights provisions within the CTA, including without limitation the establishment of manuscript and presentation review periods, patent filing delay rights to permit the filing of patent applications prior to public disclosure, redaction rights with respect to confidential or proprietary information, and editorial control and authorship determination procedures consistent with the International Committee of Medical Journal Editors guidelines.
(e) Ancillary Documents. Preparation and negotiation of ancillary documents to be attached as exhibits to the CTA, including the Study Budget (to be attached as Exhibit A to the CTA) and the Protocol Synopsis (to be attached as Exhibit B to the CTA), in each case in coordination with TMRI's clinical and financial personnel.
(f) Coordination with HUMC's Counsel. Coordination and communication with HUMC's outside counsel, Pemberton, Yates & Caldwell LLP, regarding all aspects of the CTA negotiation, including the exchange of drafts, redlines, issues lists, and term sheets, and participation in negotiation sessions (whether in person, by videoconference, or by telephone).
(g) Insurance Requirements. Review and coordination of insurance requirements under the CTA, including the review of certificates of insurance to be provided by Commonwealth Specialty Underwriters, Inc. (TMRI's clinical trial liability insurer) and Pinnacle Mutual Insurance Company (HUMC's professional liability insurer), and negotiation of insurance-related provisions within the CTA (including minimum coverage amounts, additional insured endorsements, and notice of cancellation requirements).
(h) Regulatory Compliance Provisions. Support for regulatory compliance aspects of the CTA, including the drafting and negotiation of provisions relating to the Investigational Device Exemption issued by the U.S. Food and Drug Administration bearing IDE number G260012, Institutional Review Board approval under Protocol No. HUMC-IRB-2025-0847, and other applicable regulatory requirements, including compliance with 21 C.F.R. Parts 50, 56, 812, and 814, as applicable, as well as applicable provisions of the Health Insurance Portability and Accountability Act and corresponding regulations.
(i) Closing Deliverables. Preparation of closing deliverables, including execution versions of the CTA and all exhibits and schedules thereto, signature pages, officer's certificates (if applicable), and closing checklists, and coordination of execution logistics among the parties and their respective counsel.
Notwithstanding the foregoing, the scope of this engagement does not include any of the following:
(i) Representation of TMRI in connection with any submissions to, or communications with, the U.S. Food and Drug Administration, including without limitation any IDE supplement submissions, premarket approval applications, or other regulatory filings relating to the ThornValve MV-200 System or the Cadence-3 Trial;
(ii) Representation of TMRI in connection with TMRI's separate agreement with Meridian Clinical Sciences, Inc., its contract research organization ("CRO"), or any other agreements with CROs, contract manufacturers, or other third-party service providers;
(iii) Representation of TMRI in connection with any litigation, arbitration, mediation, or other dispute resolution proceeding, whether arising out of or related to the CTA, the Cadence-3 Trial, or otherwise; and
(iv) The provision of any tax advice, including advice regarding TMRI's tax-exempt status under Section 501(c)(3) of the Internal Revenue Code, unrelated business taxable income, or any other tax matters.
Any expansion of the scope of this engagement beyond the matters described in this Section 2 shall be agreed upon in writing by the Firm and TMRI prior to the commencement of any such additional work.
3. Client Identification
The client in this engagement is Thornwick Medical Research Institute, Inc. (EIN: 04-3871256), a Massachusetts nonprofit corporation organized and operated exclusively for scientific, educational, and charitable purposes within the meaning of Section 501(c)(3) of the Internal Revenue Code of 1986, as amended. All duties of loyalty, confidentiality, and zealous representation arising out of the attorney-client relationship created by this Engagement Letter are owed exclusively to TMRI as an entity.
Calderwood & Harkness does not represent, and will not be deemed to represent, any individual officer, director, employee, agent, or affiliate of TMRI in their personal capacity in connection with this matter. Without limiting the generality of the foregoing, Calderwood & Harkness does not represent any member of TMRI's Board of Directors, any member of TMRI's scientific advisory board, or any investigator participating in the Cadence-3 Trial in their individual or personal capacity.
Calderwood & Harkness does not represent Hargrove University Medical Center, Inc., Pemberton, Yates & Caldwell LLP, or any other party to the contemplated transaction, and nothing in this Engagement Letter shall be construed to create an attorney-client relationship between Calderwood & Harkness and any such party.
4. Staffing
The following attorneys have been assigned to this engagement and will be primarily responsible for the legal services described in Section 2:
Responsible Partner: Joel Strauss, Partner, Healthcare & Life Sciences Practice Group. Mr. Strauss will have overall supervision of and strategic direction over the engagement. He will serve as the primary relationship partner for TMRI and will be available for consultations with TMRI's General Counsel, executive leadership, and Board of Directors (as appropriate) regarding material negotiation issues and engagement strategy.
Billing Partner: Miriam Calloway, Partner, Healthcare & Life Sciences Practice Group. Ms. Calloway will be responsible for all matters relating to billing, invoicing, and fee arrangements under this engagement, including the preparation and review of monthly invoices and the resolution of any billing inquiries. Ms. Calloway will also participate in substantive aspects of the engagement as needed, including the review and negotiation of indemnification and insurance provisions.
Lead Associate: Christopher Aiken, Healthcare & Life Sciences Practice Group. Mr. Aiken will be responsible for the day-to-day management of the engagement, including the initial drafting and subsequent revision of the CTA, participation in and preparation for negotiation sessions with Pemberton, Yates & Caldwell LLP, and coordination with TMRI's General Counsel and Vice President of Clinical Development, Dr. Elaine K. Sutherland, M.D., regarding clinical, regulatory, and operational matters bearing on the CTA.
Working Associate: Amy Whitfield, Healthcare & Life Sciences Practice Group. Ms. Whitfield will provide research and document preparation support throughout the engagement, including the preparation of comparison charts and redline summaries for use in negotiation sessions, the preparation of the closing checklist and closing deliverables, and general support for negotiation sessions and client communications.
Additional attorneys, paralegals, or other professional staff may be assigned to the engagement from time to time as the Firm determines appropriate in order to ensure the timely and efficient delivery of legal services. TMRI will be notified of any material changes in staffing. All personnel assigned to the engagement will bill at the rates specified in Section 5 below, or at rates applicable to their respective billing categories.
5. Billing Rates and Fee Arrangements
Fees for legal services rendered in connection with this engagement will be billed on an hourly basis at the following current standard billing rates for the Firm's Healthcare & Life Sciences Practice Group:
The specific hourly rates applicable to the attorneys currently assigned to this engagement are as follows:
The Firm's standard billing rates are subject to annual adjustment, which typically takes effect on January 1 of each calendar year. TMRI will receive advance written notice of not less than thirty (30) days prior to the effective date of any rate changes. Any rate adjustments will apply only to services rendered on or after the effective date of such adjustments.
Based on our current understanding of the scope and complexity of the CTA negotiation and the anticipated number of negotiation sessions with HUMC and its counsel, we estimate that the total professional fees for this engagement will be in the range of $85,000 to $125,000. This estimate is provided for budgeting purposes only and is not a cap, ceiling, or fixed fee. Actual fees may be higher or lower than the estimated range depending on a number of factors, including without limitation the complexity of the issues arising during negotiation, the number of rounds of drafts and redlines exchanged between the parties, the responsiveness of the counterparty and its counsel, the extent of involvement of TMRI's internal stakeholders, and whether any unanticipated legal issues arise during the course of the engagement.
Calderwood & Harkness will endeavor to provide efficient staffing and to avoid unnecessary duplication of effort. To that end, we will assign tasks to the most junior attorney or professional staff member whose experience and expertise are appropriate for the task, consistent with the Firm's obligation to deliver high-quality legal services and its commitment to meeting TMRI's expectations.
6. Expenses and Disbursements
In addition to professional fees, TMRI will reimburse Calderwood & Harkness for reasonable out-of-pocket costs and disbursements incurred in connection with this engagement. Such costs and disbursements may include, but are not limited to, the following:
•  Travel expenses (including airfare, ground transportation, lodging, and meals) incurred in connection with in-person negotiation sessions or meetings with TMRI personnel, HUMC, or HUMC's counsel;
•  Messenger and courier charges;
•  Long-distance telephone and videoconference charges;
•  Photocopying and document production costs;
•  Printing and binding charges;
•  Filing fees and recording costs (if applicable);
•  Computerized legal research charges (including Westmark Data Systems and Sundial Solutions research charges); and
•  FedEx, Harborline Partners LLC, and other express delivery charges.
All expenses and disbursements will be itemized on the Firm's monthly invoices, and supporting documentation will be made available upon request. The Firm will use commercially reasonable efforts to minimize out-of-pocket costs and will obtain TMRI's advance approval before incurring any single expense in excess of $2,500.
7. Billing and Payment Terms
Calderwood & Harkness will submit monthly invoices to TMRI for professional fees earned and disbursements incurred during the preceding calendar month. Each invoice will contain a reasonably detailed description of the legal services rendered, the identity of the billing attorney or professional, the number of hours billed, the applicable hourly rate, and an itemization of disbursements.
All invoices are due and payable within thirty (30) days of receipt. Invoices will reference Matter Number 1029-00001, and TMRI is requested to include this matter number on all remittances to facilitate proper crediting of payments.
TMRI's primary billing contact for purposes of this engagement shall be:
Marcus D. Pruitt, J.D. General Counsel Thornwick Medical Research Institute, Inc. 280 Longmeadow Drive Cambridge, Massachusetts 02139
All invoices will be directed to Mr. Pruitt at the address set forth above, unless TMRI notifies the Firm in writing of an alternative billing address or contact. Any questions or inquiries regarding invoices, billing matters, or fee arrangements should be directed to Miriam Calloway, Partner, at (617) 555-4218 or mcalloway@calderwoodharkness.com.
In the event that any invoice is not paid within the time period specified above, Calderwood & Harkness reserves the right to charge interest on the unpaid balance at a rate of one percent (1%) per month, or the maximum rate permitted by applicable law, whichever is less. In addition, the Firm reserves the right, upon reasonable notice to TMRI, to suspend work on the engagement if invoices remain unpaid for more than sixty (60) days, subject to the Firm's ethical obligations under the Massachusetts Rules of Professional Conduct.
8. Conflicts of Interest
Calderwood & Harkness has conducted a conflicts check in its electronic conflicts database in connection with this engagement, utilizing the names and identifying information of TMRI, Hargrove University Medical Center, Inc., Pemberton, Yates & Caldwell LLP, and other relevant parties and individuals identified by TMRI in its intake materials.
Based on the information currently available to the Firm, Calderwood & Harkness has not identified any conflicts of interest that would preclude the Firm's representation of TMRI in this matter under Rule 1.7 or Rule 1.9 of the Massachusetts Rules of Professional Conduct.
TMRI is aware that Calderwood & Harkness is a large, multi-office law firm that represents a significant number of clients across a wide range of industries, including the healthcare, life sciences, pharmaceutical, and medical device sectors. TMRI acknowledges and agrees that Calderwood & Harkness's representation of TMRI in this matter does not preclude Calderwood & Harkness from representing other clients in matters unrelated to this engagement, including matters that may be adverse to TMRI, provided that such matters are not substantially related to this engagement and do not involve the use of TMRI's confidential information. This paragraph constitutes an advance waiver of potential future conflicts of interest to the extent described herein, and TMRI's execution of this Engagement Letter shall be deemed consent to such waiver.
In the event that a conflict of interest arises during the course of this engagement, whether due to new information becoming available, changes in the parties' relationships, or otherwise, Calderwood & Harkness will promptly notify TMRI and discuss appropriate measures to address the conflict, which may include the implementation of an ethical screen within the Firm, the engagement of separate counsel for a discrete aspect of the matter, or, if the conflict cannot be adequately resolved, withdrawal from the engagement in accordance with Section 12 below and applicable rules of professional conduct.
9. Confidentiality
Calderwood & Harkness will maintain the confidentiality of all information provided by TMRI to the Firm in connection with this engagement, including without limitation proprietary business information, financial data, clinical trial data, regulatory strategy, trade secrets, and any other information that TMRI designates as confidential or that is of a nature that a reasonable attorney would understand to be confidential. The Firm's confidentiality obligations shall be governed by Rule 1.6 of the Massachusetts Rules of Professional Conduct and shall survive the termination of this engagement.
Information that is subject to the attorney-client privilege, the work product doctrine, or any other applicable privilege or protection shall be treated in accordance with the standards and procedures required to preserve such privilege or protection. Calderwood & Harkness will not voluntarily disclose any privileged or protected information without TMRI's prior written consent, except as may be required by law or as necessary for the Firm to defend itself in any proceeding relating to its representation of TMRI.
TMRI acknowledges that, in the ordinary course of the CTA negotiation process, certain confidential information of TMRI may need to be shared with counterparties, including HUMC and its outside counsel, Pemberton, Yates & Caldwell LLP, in order to facilitate the negotiation, drafting, and finalization of the CTA. TMRI hereby authorizes Calderwood & Harkness to disclose such confidential information to HUMC and its counsel as is reasonably necessary in connection with the CTA negotiation, subject to the protections afforded by any confidentiality or non-disclosure agreement that may be in place between TMRI and HUMC.
10. Document Retention
Calderwood & Harkness will maintain files and records related to this engagement, whether in paper or electronic form, in accordance with the Firm's document retention policy then in effect. The Firm's current policy provides for the retention of closed matter files for a period of ten (10) years following the conclusion of the engagement, after which time the files may be destroyed in the ordinary course without further notice to the client.
At the conclusion of the engagement, TMRI may request the return of original documents that TMRI provided to the Firm during the engagement. Calderwood & Harkness reserves the right to retain copies of all documents, correspondence, work product, and other materials in its files for its own records, subject to the Firm's continuing obligations of confidentiality as set forth in Section 9 above. Any request for return of original documents should be made in writing to the Responsible Partner or Billing Partner within ninety (90) days following the conclusion of the engagement.
11. Governing Law
This Engagement Letter and the attorney-client relationship between Calderwood & Harkness LLP and TMRI arising hereunder shall be governed by, and construed in accordance with, the laws of the Commonwealth of Massachusetts, including the Massachusetts Rules of Professional Conduct as adopted by the Supreme Judicial Court of Massachusetts, without regard to any conflict of laws principles that would require the application of the laws of any other jurisdiction.
12. Termination of Engagement
Either Calderwood & Harkness or TMRI may terminate this engagement at any time upon written notice to the other party. In the case of termination by the Firm, Calderwood & Harkness will comply with its obligations under Rule 1.16 of the Massachusetts Rules of Professional Conduct and will take all steps reasonably necessary to avoid prejudice to TMRI's interests.
Upon termination of this engagement by either party, TMRI will remain responsible for the payment of all professional fees earned and expenses incurred by the Firm through the date of termination, in accordance with the billing and payment terms set forth in Sections 5, 6, and 7 above. Calderwood & Harkness will render a final invoice within thirty (30) days following the effective date of termination.
In the event of termination, Calderwood & Harkness will take reasonable steps to protect TMRI's interests during any transition period and will cooperate in the orderly transfer of the matter to successor counsel, if any, including the prompt transfer of files, documents, and work product (subject to the Firm's right to retain copies as set forth in Section 10 above and subject to any lien rights the Firm may have under applicable law for unpaid fees and expenses).
13. Limitation of Scope
As set forth in Section 2 above, the Firm's representation of TMRI is limited to the specific matter described therein — namely, the negotiation and execution of the CTA with HUMC in connection with the Cadence-3 Trial. This engagement does not create a general or ongoing attorney-client relationship between Calderwood & Harkness and TMRI beyond the scope described in this Engagement Letter. Calderwood & Harkness does not undertake any obligation to advise TMRI with respect to matters outside the scope of this engagement, nor does the Firm undertake any obligation to monitor legal developments, regulatory changes, or other events that may affect TMRI's interests outside the scope of this matter.
Any future matters for which TMRI may wish to retain Calderwood & Harkness as counsel will require a separate engagement agreement, which will set forth the scope, terms, and conditions applicable to such future engagement.
14. Agreement and Acceptance
If the terms and conditions set forth in this Engagement Letter are acceptable to TMRI, please have an authorized representative of TMRI execute this letter in the space provided below and return a fully executed copy to the undersigned at the address set forth above. This Engagement Letter may be executed in counterparts, each of which shall be deemed an original, and may be delivered by electronic mail (PDF) or facsimile transmission, with originals to follow by regular mail or courier.
This Engagement Letter, together with any amendments or modifications agreed to in writing by the parties, constitutes the entire agreement between Calderwood & Harkness and TMRI with respect to the terms and conditions of the Firm's engagement in connection with the matter described herein, and supersedes all prior oral or written communications, negotiations, or agreements relating to the subject matter hereof.
We look forward to working with you and your team on this important matter. The Cadence-3 Trial represents a significant milestone for TMRI, and we are committed to providing the focused, efficient, and high-quality legal counsel that TMRI deserves as it advances the ThornValve MV-200 System through this critical stage of clinical development. Please do not hesitate to contact Joel Strauss at (617) 555-4212 or jstrauss@calderwoodharkness.com, or Christopher Aiken at (617) 555-4237 or caiken@calderwoodharkness.com, with any questions regarding this Engagement Letter or the engagement generally.
Very truly yours,
CALDERWOOD & HARKNESS LLP
By: ________
Joel Strauss, Partner Healthcare & Life Sciences Practice Group Responsible Partner
Date: January 15, 2026
By: ________
Miriam Calloway, Partner Healthcare & Life Sciences Practice Group Billing Partner
Date: January 15, 2026
AGREED AND ACCEPTED:
THORNWICK MEDICAL RESEARCH INSTITUTE, INC.
By: ________
Name: Marcus D. Pruitt, J.D.
Title: General Counsel
Date: ________
cc: Dr. Ansel R. Varnham, M.D., Ph.D., President & CEO, Thornwick Medical Research Institute, Inc.
cc: Dr. Elaine K. Sutherland, M.D., Vice President of Clinical Development, Thornwick Medical Research Institute, Inc.
Billing Category | Hourly Rate
Partners | $1,150 per hour
Senior Associates | $825 per hour
Associates | $650 per hour
Paralegals / Legal Assistants | $375 per hour
Attorney | Role | Hourly Rate
Joel Strauss | Partner — Responsible Partner | $1,150 per hour
Miriam Calloway | Partner — Billing Partner | $1,150 per hour
Christopher Aiken | Lead Associate | $825 per hour
Amy Whitfield | Working Associate | $650 per hour

CALDERWOOD & HARKNESS LLP Attorneys at Law

CALDERWOOD & HARKNESS LLP

AGREED AND ACCEPTED:

THORNWICK MEDICAL RESEARCH INSTITUTE, INC.

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