1037-00005 · Solstice Biomedical Devices Ltd · Engagement

engagement-letter-patent-prosecution-2021.docx DOCUMENT Litigation

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CALDERWOOD & HARKNESS LLP Attorneys at Law

600 Lexington Avenue, 22nd Floor New York, NY 10022 Telephone: (212) 554-7000 Facsimile: (212) 554-7001 www.calderwoodharkness.com

October 5, 2021

VIA E-MAIL AND INTERNATIONAL COURIER

Mr. Ronan Gallagher General Counsel & Company Secretary Solstice Biomedical Devices Ltd. Unit 4, Liffey Innovation Campus Parkgate Street Dublin 8, D08 XR29 Ireland

Re: Engagement for U.S. Patent Prosecution Services — CryoNova Cryoablation Catheter Patent Family Our Matter No.: SBD-IP-2021-003

Dear Mr. Gallagher:

1. Introduction and Purpose

Calderwood & Harkness LLP ("C&H" or the "Firm") is pleased to confirm its engagement by Solstice Biomedical Devices Ltd. ("Solstice," "SBD," or the "Client"), an Irish private limited company (Companies Registration Office No. 647832), to provide U.S. patent prosecution services in connection with SBD's CryoNova cryoablation catheter technology, as more fully described in Section 3 below.

We appreciate the confidence that you and the leadership team at Solstice have placed in our Firm, and we look forward to a productive working relationship. This letter (the "Engagement Letter") memorializes the terms and conditions of the attorney-client relationship between C&H and SBD with respect to the matters described herein. This Engagement Letter is effective as of the date first set forth above.

Please review this Engagement Letter carefully and contact me if you have any questions. To confirm your agreement to the terms set forth herein, please countersign where indicated below and return a copy of this letter to the Firm at your earliest convenience.

2. Identification of the Client

For purposes of this engagement, the "Client" is Solstice Biomedical Devices Ltd., a private limited company organized and existing under the laws of Ireland (CRO No. 647832), with its principal offices located at Unit 4, Liffey Innovation Campus, Parkgate Street, Dublin 8, D08 XR29, Ireland.

We understand that SBD has a U.S. subsidiary, Solstice Biomedical Inc., a corporation organized under the laws of the State of Delaware (DE File No. 7291456), with offices at 200 Chestnut Ridge Road, Suite 310, Woodcliff Lake, NJ 07677. Unless you instruct us otherwise in writing, for purposes of all filings with the United States Patent and Trademark Office ("USPTO"), including patent applications, assignments, and related documents, the applicant and assignee of record will be Solstice Biomedical Devices Ltd. (the Irish parent entity). Any correspondence regarding matters relating to the U.S. subsidiary should be coordinated through the General Counsel to ensure consistency across all filings and corporate records.

The primary client contact for this engagement will be:

Mr. Ronan Gallagher General Counsel & Company Secretary Solstice Biomedical Devices Ltd. E-mail: rgallagher@solsticebiomed.ie Telephone: +353 1 677 4200

In addition, the following individuals are authorized to communicate with C&H and to provide instructions in connection with this engagement:

Dr. Fiona Tierney Chief Executive Officer & Co-Founder Solstice Biomedical Devices Ltd. E-mail: ftierney@solsticebiomed.ie Telephone: +353 1 677 4201

Dr. Aisling Connolly Vice President of Research & Development Solstice Biomedical Devices Ltd. E-mail: aconnolly@solsticebiomed.ie Telephone: +353 1 677 4215

C&H will accept instructions from any of the above-named individuals in connection with this engagement. The Client may add or remove authorized contacts by providing written notice to the Responsible Partner identified in Section 4 below.

3. Scope of Representation

C&H is engaged to represent SBD in connection with the prosecution of United States patent applications directed to SBD's "CryoNova" cryoablation catheter system for the treatment of atrial fibrillation and related cardiac arrhythmias. The scope of this engagement specifically includes the following:

(a) Continuation and Related Applications. Preparation, filing, and prosecution of continuation applications, and any continuation-in-part or divisional applications as may be mutually agreed, claiming the benefit of U.S. Patent Application No. 16/914,337 (the "Parent Application"), filed June 28, 2021, entitled "Cryoablation Catheter System with Variable-Zone Cooling," assigned to Art Unit 3794 (Surgical Instruments — Cryotherapy) at the USPTO.

(b) Office Action Responses and Prosecution Correspondence. Responding to USPTO Office Actions (including non-final rejections, final rejections, advisory actions, and restrictions/elections), participating in examiner interviews, and preparing and filing all related prosecution correspondence, including amendments, arguments, requests for continued examination, and appeals to the Patent Trial and Appeal Board, as appropriate.

(c) Formal Documents. Preparing and filing formal documents as required during prosecution, including but not limited to assignments, powers of attorney, inventor declarations and oaths, information disclosure statements ("IDSs"), petitions (including petitions to make special, petitions to revive, and petitions for extension of time), and any other documents required or advisable for the prosecution of the subject patent applications.

(d) Strategic Advice. Advising on patent prosecution strategy, including claim scope and drafting, specification support, prior-art considerations, prosecution history estoppel, and the interplay between U.S. prosecution and corresponding foreign filings.

(e) Prior-Art Coordination. Coordinating with SBD's prior-art search vendors as needed, including reviewing search results, identifying relevant references for IDS submission, and analyzing cited art in the context of prosecution strategy.

(f) Docketing and Deadline Management. Monitoring and calendaring all USPTO deadlines for applications within the scope of this engagement, as further described in Section 10 below.

The named inventors on the CryoNova patent family currently include Dr. Aisling Connolly, Dr. Tomás Brennan, and Dr. Henrik Paulsen. The Client acknowledges that inventorship must be determined on a per-application and per-claim basis in accordance with 35 U.S.C. § 116, and the Firm will work with the Client to confirm inventorship for each application filed under this engagement.

Exclusions from Scope. The scope of this engagement expressly excludes the following matters, unless separately agreed in a written amendment to this Engagement Letter or a separate engagement letter:

(i) Contested Proceedings. Patent litigation in any forum, inter partes review ("IPR"), post-grant review ("PGR"), ex parte reexamination, or any other contested proceedings before the USPTO, the Patent Trial and Appeal Board, or any court.

(ii) Opinions. Freedom-to-operate opinions, invalidity opinions, non-infringement opinions, or patentability opinions (each of which would require a separate engagement letter with its own scope, terms, and fee arrangements).

(iii) Foreign Patent Prosecution. Prosecution of patent applications outside the United States. The Firm understands that corresponding European (EP) and Patent Cooperation Treaty (PCT) filings are handled by Dunmore & Firth Patent Attorneys, Dublin, Ireland, and that Japanese national-phase prosecution is handled by Takeda & Morioka Patent Office, Tokyo, Japan. C&H will coordinate with such foreign counsel upon the Client's request but does not assume any responsibility for the preparation, filing, prosecution, or maintenance of foreign patent applications. Any coordination activities undertaken at the Client's request will be billed in accordance with the fee arrangements set forth in Section 5.

(iv) Trademark, Copyright, and Trade Secret. Any matters relating to trademark registration or enforcement, copyright registration or enforcement, or trade-secret protection.

(v) Regulatory Matters. Any regulatory matters, including filings with the U.S. Food and Drug Administration ("FDA"), clinical-trial-related submissions, or matters relating to SBD's Investigational Device Exemption (IDE No. G210047), or any corresponding regulatory filings in the European Union, Japan, or any other jurisdiction.

Should any matter arise during the course of this engagement that falls outside the scope described above, C&H will be pleased to discuss whether such matter may be addressed under a separate engagement or an amendment to this Engagement Letter.

4. Engagement Team

The following attorneys and patent professionals will comprise the primary engagement team for this matter:

Responsible Partner: Alan Ngo, intellectual Property Practice Group; registered USPTO patent attorney (Registration No. 58,412). Mr. Ngo will have overall supervisory responsibility for this engagement and will serve as the primary relationship partner. Mr. Ngo's background includes extensive experience in the prosecution of patents relating to medical devices, interventional cardiology, and biomedical engineering. All significant strategic decisions and client communications will be overseen or approved by Mr. Ngo.

Billing Partner: Marcus Delgado, intellectual Property Practice Group; registered USPTO patent attorney (Registration No. 51,987). Mr. Delgado will oversee the billing and financial aspects of this engagement, including the preparation and review of monthly invoices. Mr. Delgado will be available to address any billing questions or concerns that may arise.

Lead Associate: Peter Vassiliev, intellectual Property Practice Group; registered USPTO patent attorney (Registration No. 72,340). Mr. Vassiliev will serve as the day-to-day lead on prosecution matters, including drafting responses to Office Actions, preparing IDS submissions, coordinating examiner interviews, and serving as the primary point of contact for routine prosecution matters. Mr. Vassiliev will work under the supervision of Mr. Ngo.

Working Associate: Wendy Schultz, intellectual Property Practice Group; registered USPTO patent attorney (Registration No. 78,115). Ms. Schultz will assist with claim drafting, prior-art analysis, preparation of formal filings, and other tasks as assigned. Ms. Schultz will work under the supervision of Mr. Vassiliev and Mr. Ngo.

In addition, the Firm may engage Dr. Claire Nakamura, Patent Agent (Of Counsel), Biomedical Engineering Technical Specialist; registered USPTO patent agent (Registration No. 66,203), to provide technical analysis and support on matters requiring specialized biomedical engineering expertise. Dr. Nakamura holds a Ph.D. in Biomedical Engineering from Columbia University and has particular expertise in catheter-based interventional technologies, cryogenic systems, and cardiac-device design.

C&H reserves the right to assign other qualified attorneys, patent agents, patent technical advisors, and support staff to work on matters within the scope of this engagement as needed to ensure the timely and competent handling of the Client's matters. The Firm will provide notice to the Client of any material changes to the composition of the engagement team, including the assignment of any new partners or associates who will be performing substantive work on the Client's matters.

Biographical summaries and USPTO registration numbers for each member of the engagement team are set forth in Schedule A attached hereto.

5. Fees and Billing Arrangements

5.1 Hourly Rates

Professional fees for services rendered under this engagement will be billed on an hourly basis at the Firm's standard rates in effect at the time the services are performed. The current hourly rates for the members of the engagement team, effective as of the date of this Engagement Letter, are as follows:

The rates stated above are the Firm's current rates for 2021 and are subject to periodic adjustment, typically on an annual basis effective January 1 of each calendar year. C&H will provide the Client with written notice of any rate adjustments at least thirty (30) days prior to their effective date. Time will be recorded and billed in increments of one-tenth (0.1) of an hour. In the event that paralegals or other support staff perform billable work on this engagement, their time will be billed at the Firm's then-current rates for such professionals, which currently range from $250.00 to $325.00 per hour.

5.2 Government Fees and Disbursements

In addition to professional fees, the Client will be responsible for all government fees payable to the USPTO in connection with the prosecution and maintenance of patent applications within the scope of this engagement. Such fees include, but are not limited to, filing fees, search fees, examination fees, excess-claim fees, issue fees, maintenance fees, extension-of-time fees, petition fees, and any other fees required or assessed by the USPTO.

Entity-Size Status. Based on the information provided by the Client, SBD qualifies as a "small entity" within the meaning of 37 C.F.R. § 1.27 (i.e., SBD has fewer than 500 employees globally and is not under any obligation to assign or license the subject inventions to an entity that would not itself qualify as a small entity). Accordingly, C&H will claim small-entity status on all USPTO filings made on behalf of the Client, which entitles the Client to a fifty percent (50%) reduction in most USPTO fees. The Client represents and warrants that the information provided regarding its entity-size status is accurate and complete, and the Client agrees to promptly notify C&H if there is any change in circumstances that would affect SBD's eligibility for small-entity or micro-entity status. The Client understands that the improper claiming of small-entity status may result in the unenforceability of any patent obtained with the benefit of reduced fees, and that the Client bears ultimate responsibility for the accuracy of its entity-size representations.

The Client is also responsible for the reimbursement of disbursements and out-of-pocket expenses incurred by C&H in connection with this engagement, including but not limited to charges for patent-drawing preparation, courier and express-delivery services, certified copies of USPTO records, long-distance telephone charges, travel expenses (if any, subject to the Client's prior approval), photocopying and printing charges, and other reasonable out-of-pocket costs.

5.3 Third-Party Vendor Costs

From time to time during the course of this engagement, C&H may recommend the engagement of third-party vendors to perform services on behalf of the Client, such as prior-art search firms, technical illustrators, translators, or other specialists. Any such third-party engagement will be subject to the Client's prior written approval. Invoices from third-party vendors will be passed through to the Client at cost, without markup by the Firm.

The Firm currently anticipates that the following third-party vendor may be engaged during the course of this representation:

Caravel Prior Art Services LLC 8500 Leesburg Pike, Suite 700 Tysons, VA 22182 Contact: Daniel Yoon, Senior Search Analyst E-mail: dyoon@caravelpriorart.com Telephone: (703) 556-8100

Caravel Prior Art Services LLC provides prior-art landscape searches, novelty searches, and freedom-to-operate search services. Any engagement of Caravel or any other vendor will be discussed with the Client in advance, and the Client will have the opportunity to approve the scope and estimated cost of any vendor engagement before it is initiated.

5.4 Billing and Payment Terms

C&H will render invoices on a monthly basis, typically within fifteen (15) days following the end of each calendar month in which services were performed. Each invoice will include a detailed description of the services rendered, the name and billing rate of each professional who performed services during the billing period, the time spent on each task (in tenths of an hour), the total professional fees for the period, any government fees advanced on behalf of the Client, and any disbursements or vendor charges incurred.

Invoices are payable within thirty (30) days of the invoice date. Payments should be made by wire transfer to the Firm's client trust account, the details of which will be provided separately. C&H reserves the right to require advance payment of government fees prior to filing deadlines, particularly for fees that are time-sensitive and non-refundable.

Late payments will bear interest at the rate of one percent (1.0%) per month (equivalent to twelve percent (12%) per annum), or the maximum rate permitted by applicable law, whichever is less. The Client agrees that C&H may apply any payments received first to outstanding interest and disbursements and then to the oldest outstanding professional fees, unless the Client designates otherwise at the time of payment.

In the event that any invoice remains unpaid for more than sixty (60) days after the invoice date, C&H reserves the right, after providing written notice and a reasonable opportunity to cure, to suspend work on the engagement or to withdraw from the representation in accordance with applicable professional-responsibility rules and the provisions of Section 11 below.

5.5 Fee Estimates

Any fee estimates, budgets, or cost projections provided by C&H in connection with this engagement, whether orally or in writing, are provided as good-faith projections only and are based on the Firm's experience with similar matters and the information available at the time the estimate is provided. Such estimates do not constitute fee caps, fixed-fee arrangements, or guaranteed maximum fees unless expressly agreed in a separate writing signed by both parties. Actual fees may vary, sometimes significantly, based on range factors, including the complexity of the prosecution, the number and nature of Office Actions received, the volume and relevance of prior art, changes in claim scope, the need for appeals or petitions, and other circumstances beyond the Firm's control. C&H will endeavor to keep the Client informed of material developments that may affect the overall cost of the engagement.

6. Client Responsibilities

The effectiveness of C&H's representation depends in significant part on the timely cooperation of the Client. Accordingly, the Client agrees to the following:

(a) Technical Disclosures and Information. The Client will provide timely, complete, and accurate technical disclosures, inventor information, prior-art references, and other materials known to the Client that are relevant to the preparation and prosecution of patent applications within the scope of this engagement. The Client understands that the quality and completeness of the information provided directly affects the Firm's ability to prepare and prosecute patent applications effectively.

(b) Duty of Candor. The Client will comply with, and will cause each named inventor to comply with, the duty of candor and good faith owed to the USPTO under 37 C.F.R. § 1.56, including the obligation to disclose to the USPTO all information known to be material to patentability. The Client will promptly bring to C&H's attention any prior-art references, publications, public disclosures, sales, offers for sale, or other events that may be material to the patentability of the subject inventions. The Client acknowledges that failure to comply with the duty of candor may result in the unenforceability of any patent obtained.

(c) Timely Responses. The Client will respond promptly to C&H's requests for information, instructions, approvals, and decisions, particularly with respect to time-sensitive USPTO deadlines. The Client understands that many USPTO deadlines are statutory and cannot be extended, and that late responses may result in the abandonment of applications or the need to incur additional fees for extensions of time.

(d) Changes in Status. The Client will promptly notify C&H of any changes in inventorship, assignment of rights, entity-size status, corporate name or address, correspondence address, or any other change in circumstances that may affect the prosecution of the patent applications.

(e) Fee Payments. The Client will authorize and fund USPTO fee payments in advance of applicable deadlines, as requested by C&H, and will timely pay all invoices in accordance with the terms set forth in Section 5.4 above.

(f) Third-Party Communications. The Client will promptly notify C&H of any third-party communications or actions that may affect the patent applications within the scope of this engagement, including but not limited to prior-art submissions by third parties under 35 U.S.C. § 122(e), third-party challenges or protestations, licensing inquiries, demands for disclosure, or threats of litigation or interference proceedings.

7. Conflicts of Interest

C&H has conducted a thorough conflicts-of-interest review in accordance with the applicable rules of professional conduct and has identified no conflicts of interest that would prevent the Firm from undertaking this engagement on behalf of SBD.

The Client acknowledges that C&H is a large, multi-practice law firm with offices in multiple jurisdictions and that the Firm represents a diverse client base across a wide range of industries, including clients in the medical-device, life-sciences, pharmaceutical, and biotechnology sectors. C&H will comply at all times with all applicable rules of professional conduct regarding conflicts of interest, including Rules 1.7 and 1.9 of the New York Rules of Professional Conduct (or the corresponding rules of any other jurisdiction that may apply).

The Client agrees that the Firm's representation of SBD in this engagement does not preclude the Firm from representing other clients in matters that are unrelated to this engagement, even if such other clients are competitors of SBD or operate in the same industry, provided that such representations do not involve a direct adverse conflict with respect to the specific patent applications that are the subject of this engagement. In the event that a potential conflict of interest arises during the course of this engagement, C&H will promptly notify the Client and will take appropriate steps to address the conflict in accordance with applicable rules, which may include seeking the Client's informed written consent or, if necessary, withdrawing from one or more conflicting representations.

8. Confidentiality

C&H will maintain the confidentiality of all information provided by the Client in connection with this engagement, in accordance with all applicable rules of professional conduct, including Rule 1.6 of the New York Rules of Professional Conduct, and the principles of attorney-client privilege and work-product protection. The Firm will implement reasonable measures to safeguard the Client's confidential information against unauthorized disclosure, including the use of secure file-storage systems, access controls, and encrypted communications as appropriate.

The Client acknowledges that the prosecution of patent applications before the USPTO necessarily requires the disclosure of certain information that might otherwise be considered confidential. Such disclosures include, without limitation, the content of patent-application specifications and claims, prior-art references cited in information disclosure statements, inventor declarations and oaths, assignment records, and other documents filed with or submitted to the USPTO. The Client authorizes C&H to make all such disclosures as are necessary or advisable in connection with the prosecution of the patent applications within the scope of this engagement.

Privileged communications regarding prosecution strategy, legal analysis, and attorney work product prepared in connection with this engagement will be maintained as confidential attorney-client privileged communications and will not be disclosed to third parties without the Client's prior written consent, except as may be required by law or court order.

9. Intellectual Property Ownership

All patent applications prepared, filed, and prosecuted by C&H in connection with this engagement, and all patents issuing therefrom, are and shall at all times remain the exclusive property of the Client (or its assignee or designee, as applicable). C&H claims no ownership interest, lien, or other proprietary interest in any inventions, patent applications, patents, or other intellectual property developed, prosecuted, or obtained on behalf of SBD, except for any attorney's lien that may arise by operation of law with respect to unpaid fees and costs, as further described in Section 11.4 below.

Nothing in this Engagement Letter shall be construed as an assignment, license, or other transfer of any intellectual-property rights from the Client to the Firm.

10. Docketing and Deadline Management

C&H will maintain an internal docketing system to monitor and calendar all USPTO deadlines, due dates, and significant milestones for patent applications within the scope of this engagement. The Firm's docketing system employs multiple levels of redundancy, including automated reminders and manual verification, to reduce the risk of missed deadlines.

Notwithstanding the foregoing, the Client acknowledges that the Firm's internal docketing system is maintained as an internal administrative tool, and that ultimate responsibility for meeting USPTO deadlines is shared between the Firm and the Client. The Client is strongly encouraged to maintain its own independent docket of all pending patent applications and associated deadlines, or to engage a reputable third-party docketing and patent-annuity service for this purpose.

C&H will provide the Client with reasonable advance notice of upcoming deadlines, including statutory and absolute deadlines, shortened statutory periods, and extension-of-time deadlines. The Firm will seek the Client's instructions before taking any substantive prosecution action or incurring significant fees. In the ordinary course, C&H will endeavor to provide at least two (2) weeks' advance notice of upcoming response deadlines, although shorter notice periods may apply in the event of newly issued Office Actions or other time-sensitive communications from the USPTO.

In the event that the Client fails to provide timely instructions in response to the Firm's requests, C&H will use commercially reasonable efforts to contact the Client (including through the authorized contacts identified in Section 2) and will attempt to obtain instructions before any applicable deadline expires. However, C&H shall not be liable for missed deadlines, abandonments, or other adverse consequences resulting from the Client's failure to respond to the Firm's requests for instructions in a timely manner, provided that the Firm has used commercially reasonable efforts to contact the Client and to alert the Client to the applicable deadline.

11. Term and Termination

11.1 Term. This engagement shall commence as of the date of this Engagement Letter and shall remain in effect until terminated by either party in accordance with this Section 11. The engagement is not for a fixed term, and the continued representation of the Client is subject to the Firm's ongoing ability to represent the Client without conflict or other impediment, the Client's timely payment of fees and costs, and the Client's compliance with its obligations under this Engagement Letter.

11.2 Termination by Client

The Client may terminate this engagement at any time, with or without cause, by providing written notice to the Responsible Partner (Alan Ngo) at the address set forth in the letterhead above or at such other address as C&H may designate in writing. Termination by the Client shall be effective upon the Firm's receipt of such written notice. Upon termination by the Client, the Client shall remain responsible for payment of all professional fees, government fees, disbursements, and other costs incurred through the effective date of termination, including any fees and costs incurred in connection with the orderly transfer of the Client's matters to successor counsel.

11.3 Termination by Firm

C&H may withdraw from this engagement upon reasonable written notice to the Client and in compliance with all applicable rules of professional conduct, including Rule 1.16 of the New York Rules of Professional Conduct. Circumstances that may give rise to the Firm's withdrawal include, but are not limited to, the Client's failure to pay fees and costs in a timely manner, the Client's failure to cooperate with the Firm or to provide necessary information, the emergence of a conflict of interest that cannot be resolved through consent or other appropriate measures, or other circumstances that would make continued representation unreasonable or impractical.

Upon withdrawal, C&H will take reasonable steps to protect the Client's interests, including cooperating in the transfer of files and work product to the Client or its designated successor counsel, providing reasonable notice of upcoming USPTO deadlines, and, subject to the Client's payment of all outstanding invoices, taking such actions as may be necessary to meet any imminent USPTO deadlines that would otherwise result in the abandonment of a patent application.

11.4 Effect of Termination

Upon termination of this engagement, whether by the Client or by the Firm, C&H will promptly return all original client files, documents, and correspondence to the Client or its designated successor counsel, in such format as may be reasonably requested. The Firm may retain copies of such files and documents for its own records in accordance with applicable professional-responsibility rules, the Firm's document-retention policies, and any applicable legal or regulatory requirements.

All unpaid professional fees, government fees, disbursements, and other costs incurred through the effective date of termination shall remain due and payable in full. The Firm's obligation to return client files is subject to any retaining lien or other rights that may be available to the Firm under applicable law with respect to unpaid fees and costs, to the extent permitted by the applicable rules of professional conduct.

The provisions of Sections 5 (Fees and Billing Arrangements), 8 (Confidentiality), 9 (Intellectual Property Ownership), 12 (Limitation of Liability), and 13 (Governing Law and Dispute Resolution) shall survive the termination of this engagement.

12. Limitation of Liability

To the fullest extent permitted by applicable law and the applicable rules of professional conduct, C&H's aggregate liability to the Client for any and all claims, losses, damages, costs, or expenses arising out of or relating to this engagement, whether in contract, tort (including negligence), or otherwise, shall not exceed the total amount of professional fees actually paid by the Client to C&H under this Engagement Letter. This limitation of liability shall not apply to claims arising from the Firm's willful misconduct or gross negligence.

The Client acknowledges that patent prosecution involves inherent uncertainties, including the unpredictability of USPTO examination, the possibility of unknown prior art, and the potential for changes in patent law or USPTO practice. C&H does not guarantee or warrant any particular outcome with respect to the patent applications prosecuted under this engagement, including the issuance of any patent or the validity or enforceability of any claims.

13. Governing Law and Dispute Resolution

This Engagement Letter shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to its conflict-of-laws principles. The parties agree that Delaware law shall apply to all issues relating to the interpretation and enforcement of this Engagement Letter, as well as to the rights and obligations of the parties hereunder.

Any dispute, controversy, or claim arising out of or relating to this engagement, this Engagement Letter, or the breach, termination, or validity hereof, shall first be submitted to good-faith negotiation between senior representatives of the parties for a period of not less than thirty (30) days following written notice of the dispute. If the dispute is not resolved through negotiation within such period, the dispute shall be submitted to final and binding arbitration administered in accordance with the rules of a mutually agreed arbitration body (or, in the absence of such agreement, the American Arbitration Association), with the arbitration to be conducted in New York, New York, before a single arbitrator with experience in legal-malpractice or professional-responsibility matters. The award rendered by the arbitrator shall be final and binding on the parties and may be entered as a judgment in any court of competent jurisdiction.

Each party shall bear its own costs and attorneys' fees in connection with any dispute resolution proceeding, unless the arbitrator determines otherwise. The existence and substance of any arbitration proceeding, including any award, shall be treated as confidential by both parties.

14. Entire Agreement and Amendments

This Engagement Letter, together with the Schedules attached hereto and incorporated herein by reference, constitutes the entire agreement between C&H and SBD with respect to the engagement described herein and supersedes all prior or contemporaneous negotiations, discussions, understandings, representations, and agreements, whether written or oral, relating to the subject matter hereof.

Any modifications, amendments, or supplements to the terms of this Engagement Letter must be in writing and signed by both parties. No waiver of any term or condition of this Engagement Letter shall be effective unless made in writing and signed by the party against whom enforcement of the waiver is sought. A failure or delay by either party in exercising any right under this Engagement Letter shall not operate as a waiver of such right.

15. Acceptance

We are grateful for the opportunity to serve as patent counsel to Solstice Biomedical Devices Ltd. and look forward to working with you and your team on the CryoNova patent portfolio. If the terms and conditions set forth in this Engagement Letter are acceptable, please indicate your acceptance by countersigning a copy of this letter in the space provided below and returning it to the undersigned at your earliest convenience. A scanned copy transmitted by e-mail to ango@calderwoodharkness.com will be accepted as an original for purposes of confirming the engagement, followed by a hard copy via international courier.

Please do not hesitate to contact me at (212) 554-7120 or at ango@calderwoodharkness.com if you have any questions regarding this Engagement Letter or any other matter. We look forward to your response.

Very truly yours,

CALDERWOOD & HARKNESS LLP

By: ________

Name: Alan Ngo

Title: Partner, intellectual Property Practice Group

Registered USPTO Patent Attorney (Reg. No. 58,412)

Date: ________

ACKNOWLEDGED AND AGREED

By signing below, the undersigned, on behalf of Solstice Biomedical Devices Ltd., acknowledges receipt of this Engagement Letter, confirms that the undersigned is duly authorized to execute this Engagement Letter on behalf of the Client, and agrees to all of the terms and conditions set forth herein.

SOLSTICE BIOMEDICAL DEVICES LTD.

By: ________

Name: Ronan Gallagher

Title: General Counsel & Company Secretary

Date: ________

SCHEDULE A

ENGAGEMENT TEAM BIOGRAPHIES AND USPTO REGISTRATION NUMBERS

The following professionals comprise the engagement team for Matter No. SBD-IP-2021-003. Biographical summaries and USPTO registration numbers are provided below.

Alan Ngo — Responsible Partner Intellectual Property Practice Group USPTO Patent Attorney, Registration No. 58,412

Mr. Ngo is a partner in the intellectual Property Practice Group of Calderwood & Harkness LLP. His practice focuses on patent prosecution and strategic patent counseling for clients in the medical-device, life-sciences, and biomedical-engineering industries. Mr. Ngo has extensive experience in the preparation, filing, and prosecution of patent applications before the USPTO, including applications directed to catheter-based interventional systems, cardiac-rhythm management devices, surgical instruments, and drug-delivery technologies. Mr. Ngo received his J.D. from Georgetown University Law Center and his B.S. in Mechanical Engineering from the University of Michigan.

Marcus Delgado — Billing Partner Intellectual Property Practice Group USPTO Patent Attorney, Registration No. 51,987

Mr. Delgado is a partner in the intellectual Property Practice Group of Calderwood & Harkness LLP. His practice encompasses patent prosecution, portfolio management, and intellectual-property due diligence for clients in the medical-device and technology sectors. Mr. Delgado has extensive experience managing large patent portfolios for multinational companies and advising on prosecution strategy in connection with complex patent families involving multiple continuation and divisional applications. Mr. Delgado received his J.D. from New York University School of Law and his B.S. in Electrical Engineering from Cornell University.

Peter Vassiliev — Lead Associate Intellectual Property Practice Group USPTO Patent Attorney, Registration No. 72,340

Mr. Vassiliev is a senior associate in the intellectual Property Practice Group of Calderwood & Harkness LLP. His practice focuses on the prosecution of patent applications in the medical-device and biomedical-engineering fields, with a particular emphasis on minimally invasive surgical devices, ablation technologies, and diagnostic imaging systems. Mr. Vassiliev has substantial experience drafting and prosecuting patent applications, responding to Office Actions, and conducting examiner interviews. Mr. Vassiliev received his J.D. from Fordham University School of Law and his M.S. in Biomedical Engineering from Johns Hopkins University.

Wendy Schultz — Working Associate Intellectual Property Practice Group USPTO Patent Attorney, Registration No. 78,115

Ms. Schultz is an associate in the intellectual Property Practice Group of Calderwood & Harkness LLP. Her practice focuses on patent prosecution and prior-art analysis for clients in the medical-device, pharmaceutical, and biotechnology sectors. Ms. Schultz has experience preparing patent applications, drafting claims, analyzing prior art, and preparing information disclosure statements. Ms. Schultz received her J.D. from Boston University School of Law and her B.S. in Chemical Engineering from the Massachusetts Institute of Technology.

Dr. Claire Nakamura — Patent Agent (Of Counsel), Biomedical Engineering Technical Specialist Intellectual Property Practice Group USPTO Patent Agent, Registration No. 66,203

Dr. Nakamura is Of Counsel in the intellectual Property Practice Group of Calderwood & Harkness LLP, where she serves as a biomedical-engineering technical specialist. Dr. Nakamura provides technical analysis and support on patent matters involving catheter-based interventional devices, cryogenic systems, cardiac electrophysiology, and implantable medical devices. Dr. Nakamura holds a Ph.D. in Biomedical Engineering from Columbia University, an M.S. in Mechanical Engineering from Stanford University, and a B.S. in Physics from the University of California, Berkeley. Prior to joining the Firm, Dr. Nakamura spent seven years as a research engineer at a leading medical-device company, where she was a named inventor on multiple U.S. patents relating to cryoablation technology.

SCHEDULE B

PATENT APPLICATION DOCKET — INITIAL SCOPE

Matter No.: SBD-IP-2021-003 Client: Solstice Biomedical Devices Ltd.

1. Parent Application

Note: Inventorship is to be confirmed on a per-application basis in accordance with 35 U.S.C. § 116. The named inventors listed above are the initial inventors of record for the Parent Application. Inventorship for any continuation, continuation-in-part, or divisional applications filed during the course of this engagement will be determined at the time of filing based on the claims presented in each such application.

2. Continuation and Related Applications

Continuation applications, continuation-in-part applications, and divisional applications to be filed during the course of this engagement will be added to this docket upon filing. Each new application will be assigned a sub-matter number under Matter No. SBD-IP-2021-003 and will be tracked in the Firm's internal docketing system.

3. Corresponding Foreign Filings (Outside Scope of This Engagement)

The following corresponding foreign filings are noted for reference and coordination purposes only. These filings are not within the scope of this engagement and are being handled by the foreign counsel indicated below:

C&H will coordinate with the above-referenced foreign counsel upon the Client's request, but does not assume any responsibility for the preparation, filing, prosecution, or maintenance of the above foreign applications. Any coordination efforts undertaken by C&H will be billed in accordance with the fee arrangements set forth in Section 5 of this Engagement Letter.

This Schedule B is current as of the date of the Engagement Letter (October 5, 2021) and will be updated periodically as new applications are filed or the status of existing applications changes. The Client will be provided with updated docket reports on a quarterly basis or upon request.

cc: Dr. Fiona Tierney, CEO & Co-Founder, Solstice Biomedical Devices Ltd. Marcus Delgado, Partner, Calderwood & Harkness LLP

Professional	Title	USPTO Reg. No.	Hourly Rate
Alan Ngo	Partner	58,412	$895.00
Marcus Delgado	Partner	51,987	$875.00
Peter Vassiliev	Lead Associate	72,340	$625.00
Wendy Schultz	Working Associate	78,115	$510.00
Dr. Claire Nakamura	Patent Agent (Of Counsel)	66,203	$475.00
Field	Details
Application No.	U.S. 16/914,337
Filing Date	June 28, 2021
Title	Cryoablation Catheter System with Variable-Zone Cooling
Applicant/Assignee	Solstice Biomedical Devices Ltd.
Named Inventors	Dr. Aisling Connolly; Dr. Tomás Brennan; Dr. Henrik Paulsen
Art Unit	3794 (Surgical Instruments — Cryotherapy)
Entity Size	Small Entity (37 C.F.R. § 1.27)
Status	Pending
Application	Filing / National Phase	Foreign Counsel
PCT/EP2021/067891	PCT International Application	Dunmore & Firth Patent Attorneys, Dublin, Ireland
EP Application No. 21 741 632.8	European Regional Phase	Dunmore & Firth Patent Attorneys, Dublin, Ireland
JP Application No. 2023-500714	Japanese National Phase	Takeda & Morioka Patent Office, Tokyo, Japan

CALDERWOOD & HARKNESS LLP Attorneys at Law
600 Lexington Avenue, 22nd Floor New York, NY 10022 Telephone: (212) 554-7000 Facsimile: (212) 554-7001 www.calderwoodharkness.com
October 5, 2021
VIA E-MAIL AND INTERNATIONAL COURIER
Mr. Ronan Gallagher General Counsel & Company Secretary Solstice Biomedical Devices Ltd. Unit 4, Liffey Innovation Campus Parkgate Street Dublin 8, D08 XR29 Ireland
Re: Engagement for U.S. Patent Prosecution Services — CryoNova Cryoablation Catheter Patent Family Our Matter No.: SBD-IP-2021-003
Dear Mr. Gallagher:
1. Introduction and Purpose
Calderwood & Harkness LLP ("C&H" or the "Firm") is pleased to confirm its engagement by Solstice Biomedical Devices Ltd. ("Solstice," "SBD," or the "Client"), an Irish private limited company (Companies Registration Office No. 647832), to provide U.S. patent prosecution services in connection with SBD's CryoNova cryoablation catheter technology, as more fully described in Section 3 below.
We appreciate the confidence that you and the leadership team at Solstice have placed in our Firm, and we look forward to a productive working relationship. This letter (the "Engagement Letter") memorializes the terms and conditions of the attorney-client relationship between C&H and SBD with respect to the matters described herein. This Engagement Letter is effective as of the date first set forth above.
Please review this Engagement Letter carefully and contact me if you have any questions. To confirm your agreement to the terms set forth herein, please countersign where indicated below and return a copy of this letter to the Firm at your earliest convenience.
2. Identification of the Client
For purposes of this engagement, the "Client" is Solstice Biomedical Devices Ltd., a private limited company organized and existing under the laws of Ireland (CRO No. 647832), with its principal offices located at Unit 4, Liffey Innovation Campus, Parkgate Street, Dublin 8, D08 XR29, Ireland.
We understand that SBD has a U.S. subsidiary, Solstice Biomedical Inc., a corporation organized under the laws of the State of Delaware (DE File No. 7291456), with offices at 200 Chestnut Ridge Road, Suite 310, Woodcliff Lake, NJ 07677. Unless you instruct us otherwise in writing, for purposes of all filings with the United States Patent and Trademark Office ("USPTO"), including patent applications, assignments, and related documents, the applicant and assignee of record will be Solstice Biomedical Devices Ltd. (the Irish parent entity). Any correspondence regarding matters relating to the U.S. subsidiary should be coordinated through the General Counsel to ensure consistency across all filings and corporate records.
The primary client contact for this engagement will be:
Mr. Ronan Gallagher General Counsel & Company Secretary Solstice Biomedical Devices Ltd. E-mail: rgallagher@solsticebiomed.ie Telephone: +353 1 677 4200
In addition, the following individuals are authorized to communicate with C&H and to provide instructions in connection with this engagement:
Dr. Fiona Tierney Chief Executive Officer & Co-Founder Solstice Biomedical Devices Ltd. E-mail: ftierney@solsticebiomed.ie Telephone: +353 1 677 4201
Dr. Aisling Connolly Vice President of Research & Development Solstice Biomedical Devices Ltd. E-mail: aconnolly@solsticebiomed.ie Telephone: +353 1 677 4215
C&H will accept instructions from any of the above-named individuals in connection with this engagement. The Client may add or remove authorized contacts by providing written notice to the Responsible Partner identified in Section 4 below.
3. Scope of Representation
C&H is engaged to represent SBD in connection with the prosecution of United States patent applications directed to SBD's "CryoNova" cryoablation catheter system for the treatment of atrial fibrillation and related cardiac arrhythmias. The scope of this engagement specifically includes the following:
(a) Continuation and Related Applications. Preparation, filing, and prosecution of continuation applications, and any continuation-in-part or divisional applications as may be mutually agreed, claiming the benefit of U.S. Patent Application No. 16/914,337 (the "Parent Application"), filed June 28, 2021, entitled "Cryoablation Catheter System with Variable-Zone Cooling," assigned to Art Unit 3794 (Surgical Instruments — Cryotherapy) at the USPTO.
(b) Office Action Responses and Prosecution Correspondence. Responding to USPTO Office Actions (including non-final rejections, final rejections, advisory actions, and restrictions/elections), participating in examiner interviews, and preparing and filing all related prosecution correspondence, including amendments, arguments, requests for continued examination, and appeals to the Patent Trial and Appeal Board, as appropriate.
(c) Formal Documents. Preparing and filing formal documents as required during prosecution, including but not limited to assignments, powers of attorney, inventor declarations and oaths, information disclosure statements ("IDSs"), petitions (including petitions to make special, petitions to revive, and petitions for extension of time), and any other documents required or advisable for the prosecution of the subject patent applications.
(d) Strategic Advice. Advising on patent prosecution strategy, including claim scope and drafting, specification support, prior-art considerations, prosecution history estoppel, and the interplay between U.S. prosecution and corresponding foreign filings.
(e) Prior-Art Coordination. Coordinating with SBD's prior-art search vendors as needed, including reviewing search results, identifying relevant references for IDS submission, and analyzing cited art in the context of prosecution strategy.
(f) Docketing and Deadline Management. Monitoring and calendaring all USPTO deadlines for applications within the scope of this engagement, as further described in Section 10 below.
The named inventors on the CryoNova patent family currently include Dr. Aisling Connolly, Dr. Tomás Brennan, and Dr. Henrik Paulsen. The Client acknowledges that inventorship must be determined on a per-application and per-claim basis in accordance with 35 U.S.C. § 116, and the Firm will work with the Client to confirm inventorship for each application filed under this engagement.
Exclusions from Scope. The scope of this engagement expressly excludes the following matters, unless separately agreed in a written amendment to this Engagement Letter or a separate engagement letter:
(i) Contested Proceedings. Patent litigation in any forum, inter partes review ("IPR"), post-grant review ("PGR"), ex parte reexamination, or any other contested proceedings before the USPTO, the Patent Trial and Appeal Board, or any court.
(ii) Opinions. Freedom-to-operate opinions, invalidity opinions, non-infringement opinions, or patentability opinions (each of which would require a separate engagement letter with its own scope, terms, and fee arrangements).
(iii) Foreign Patent Prosecution. Prosecution of patent applications outside the United States. The Firm understands that corresponding European (EP) and Patent Cooperation Treaty (PCT) filings are handled by Dunmore & Firth Patent Attorneys, Dublin, Ireland, and that Japanese national-phase prosecution is handled by Takeda & Morioka Patent Office, Tokyo, Japan. C&H will coordinate with such foreign counsel upon the Client's request but does not assume any responsibility for the preparation, filing, prosecution, or maintenance of foreign patent applications. Any coordination activities undertaken at the Client's request will be billed in accordance with the fee arrangements set forth in Section 5.
(iv) Trademark, Copyright, and Trade Secret. Any matters relating to trademark registration or enforcement, copyright registration or enforcement, or trade-secret protection.
(v) Regulatory Matters. Any regulatory matters, including filings with the U.S. Food and Drug Administration ("FDA"), clinical-trial-related submissions, or matters relating to SBD's Investigational Device Exemption (IDE No. G210047), or any corresponding regulatory filings in the European Union, Japan, or any other jurisdiction.
Should any matter arise during the course of this engagement that falls outside the scope described above, C&H will be pleased to discuss whether such matter may be addressed under a separate engagement or an amendment to this Engagement Letter.
4. Engagement Team
The following attorneys and patent professionals will comprise the primary engagement team for this matter:
Responsible Partner: Alan Ngo, intellectual Property Practice Group; registered USPTO patent attorney (Registration No. 58,412). Mr. Ngo will have overall supervisory responsibility for this engagement and will serve as the primary relationship partner. Mr. Ngo's background includes extensive experience in the prosecution of patents relating to medical devices, interventional cardiology, and biomedical engineering. All significant strategic decisions and client communications will be overseen or approved by Mr. Ngo.
Billing Partner: Marcus Delgado, intellectual Property Practice Group; registered USPTO patent attorney (Registration No. 51,987). Mr. Delgado will oversee the billing and financial aspects of this engagement, including the preparation and review of monthly invoices. Mr. Delgado will be available to address any billing questions or concerns that may arise.
Lead Associate: Peter Vassiliev, intellectual Property Practice Group; registered USPTO patent attorney (Registration No. 72,340). Mr. Vassiliev will serve as the day-to-day lead on prosecution matters, including drafting responses to Office Actions, preparing IDS submissions, coordinating examiner interviews, and serving as the primary point of contact for routine prosecution matters. Mr. Vassiliev will work under the supervision of Mr. Ngo.
Working Associate: Wendy Schultz, intellectual Property Practice Group; registered USPTO patent attorney (Registration No. 78,115). Ms. Schultz will assist with claim drafting, prior-art analysis, preparation of formal filings, and other tasks as assigned. Ms. Schultz will work under the supervision of Mr. Vassiliev and Mr. Ngo.
In addition, the Firm may engage Dr. Claire Nakamura, Patent Agent (Of Counsel), Biomedical Engineering Technical Specialist; registered USPTO patent agent (Registration No. 66,203), to provide technical analysis and support on matters requiring specialized biomedical engineering expertise. Dr. Nakamura holds a Ph.D. in Biomedical Engineering from Columbia University and has particular expertise in catheter-based interventional technologies, cryogenic systems, and cardiac-device design.
C&H reserves the right to assign other qualified attorneys, patent agents, patent technical advisors, and support staff to work on matters within the scope of this engagement as needed to ensure the timely and competent handling of the Client's matters. The Firm will provide notice to the Client of any material changes to the composition of the engagement team, including the assignment of any new partners or associates who will be performing substantive work on the Client's matters.
Biographical summaries and USPTO registration numbers for each member of the engagement team are set forth in Schedule A attached hereto.
5. Fees and Billing Arrangements
5.1 Hourly Rates
Professional fees for services rendered under this engagement will be billed on an hourly basis at the Firm's standard rates in effect at the time the services are performed. The current hourly rates for the members of the engagement team, effective as of the date of this Engagement Letter, are as follows:
The rates stated above are the Firm's current rates for 2021 and are subject to periodic adjustment, typically on an annual basis effective January 1 of each calendar year. C&H will provide the Client with written notice of any rate adjustments at least thirty (30) days prior to their effective date. Time will be recorded and billed in increments of one-tenth (0.1) of an hour. In the event that paralegals or other support staff perform billable work on this engagement, their time will be billed at the Firm's then-current rates for such professionals, which currently range from $250.00 to $325.00 per hour.
5.2 Government Fees and Disbursements
In addition to professional fees, the Client will be responsible for all government fees payable to the USPTO in connection with the prosecution and maintenance of patent applications within the scope of this engagement. Such fees include, but are not limited to, filing fees, search fees, examination fees, excess-claim fees, issue fees, maintenance fees, extension-of-time fees, petition fees, and any other fees required or assessed by the USPTO.
Entity-Size Status. Based on the information provided by the Client, SBD qualifies as a "small entity" within the meaning of 37 C.F.R. § 1.27 (i.e., SBD has fewer than 500 employees globally and is not under any obligation to assign or license the subject inventions to an entity that would not itself qualify as a small entity). Accordingly, C&H will claim small-entity status on all USPTO filings made on behalf of the Client, which entitles the Client to a fifty percent (50%) reduction in most USPTO fees. The Client represents and warrants that the information provided regarding its entity-size status is accurate and complete, and the Client agrees to promptly notify C&H if there is any change in circumstances that would affect SBD's eligibility for small-entity or micro-entity status. The Client understands that the improper claiming of small-entity status may result in the unenforceability of any patent obtained with the benefit of reduced fees, and that the Client bears ultimate responsibility for the accuracy of its entity-size representations.
The Client is also responsible for the reimbursement of disbursements and out-of-pocket expenses incurred by C&H in connection with this engagement, including but not limited to charges for patent-drawing preparation, courier and express-delivery services, certified copies of USPTO records, long-distance telephone charges, travel expenses (if any, subject to the Client's prior approval), photocopying and printing charges, and other reasonable out-of-pocket costs.
5.3 Third-Party Vendor Costs
From time to time during the course of this engagement, C&H may recommend the engagement of third-party vendors to perform services on behalf of the Client, such as prior-art search firms, technical illustrators, translators, or other specialists. Any such third-party engagement will be subject to the Client's prior written approval. Invoices from third-party vendors will be passed through to the Client at cost, without markup by the Firm.
The Firm currently anticipates that the following third-party vendor may be engaged during the course of this representation:
Caravel Prior Art Services LLC 8500 Leesburg Pike, Suite 700 Tysons, VA 22182 Contact: Daniel Yoon, Senior Search Analyst E-mail: dyoon@caravelpriorart.com Telephone: (703) 556-8100
Caravel Prior Art Services LLC provides prior-art landscape searches, novelty searches, and freedom-to-operate search services. Any engagement of Caravel or any other vendor will be discussed with the Client in advance, and the Client will have the opportunity to approve the scope and estimated cost of any vendor engagement before it is initiated.
5.4 Billing and Payment Terms
C&H will render invoices on a monthly basis, typically within fifteen (15) days following the end of each calendar month in which services were performed. Each invoice will include a detailed description of the services rendered, the name and billing rate of each professional who performed services during the billing period, the time spent on each task (in tenths of an hour), the total professional fees for the period, any government fees advanced on behalf of the Client, and any disbursements or vendor charges incurred.
Invoices are payable within thirty (30) days of the invoice date. Payments should be made by wire transfer to the Firm's client trust account, the details of which will be provided separately. C&H reserves the right to require advance payment of government fees prior to filing deadlines, particularly for fees that are time-sensitive and non-refundable.
Late payments will bear interest at the rate of one percent (1.0%) per month (equivalent to twelve percent (12%) per annum), or the maximum rate permitted by applicable law, whichever is less. The Client agrees that C&H may apply any payments received first to outstanding interest and disbursements and then to the oldest outstanding professional fees, unless the Client designates otherwise at the time of payment.
In the event that any invoice remains unpaid for more than sixty (60) days after the invoice date, C&H reserves the right, after providing written notice and a reasonable opportunity to cure, to suspend work on the engagement or to withdraw from the representation in accordance with applicable professional-responsibility rules and the provisions of Section 11 below.
5.5 Fee Estimates
Any fee estimates, budgets, or cost projections provided by C&H in connection with this engagement, whether orally or in writing, are provided as good-faith projections only and are based on the Firm's experience with similar matters and the information available at the time the estimate is provided. Such estimates do not constitute fee caps, fixed-fee arrangements, or guaranteed maximum fees unless expressly agreed in a separate writing signed by both parties. Actual fees may vary, sometimes significantly, based on range factors, including the complexity of the prosecution, the number and nature of Office Actions received, the volume and relevance of prior art, changes in claim scope, the need for appeals or petitions, and other circumstances beyond the Firm's control. C&H will endeavor to keep the Client informed of material developments that may affect the overall cost of the engagement.
6. Client Responsibilities
The effectiveness of C&H's representation depends in significant part on the timely cooperation of the Client. Accordingly, the Client agrees to the following:
(a) Technical Disclosures and Information. The Client will provide timely, complete, and accurate technical disclosures, inventor information, prior-art references, and other materials known to the Client that are relevant to the preparation and prosecution of patent applications within the scope of this engagement. The Client understands that the quality and completeness of the information provided directly affects the Firm's ability to prepare and prosecute patent applications effectively.
(b) Duty of Candor. The Client will comply with, and will cause each named inventor to comply with, the duty of candor and good faith owed to the USPTO under 37 C.F.R. § 1.56, including the obligation to disclose to the USPTO all information known to be material to patentability. The Client will promptly bring to C&H's attention any prior-art references, publications, public disclosures, sales, offers for sale, or other events that may be material to the patentability of the subject inventions. The Client acknowledges that failure to comply with the duty of candor may result in the unenforceability of any patent obtained.
(c) Timely Responses. The Client will respond promptly to C&H's requests for information, instructions, approvals, and decisions, particularly with respect to time-sensitive USPTO deadlines. The Client understands that many USPTO deadlines are statutory and cannot be extended, and that late responses may result in the abandonment of applications or the need to incur additional fees for extensions of time.
(d) Changes in Status. The Client will promptly notify C&H of any changes in inventorship, assignment of rights, entity-size status, corporate name or address, correspondence address, or any other change in circumstances that may affect the prosecution of the patent applications.
(e) Fee Payments. The Client will authorize and fund USPTO fee payments in advance of applicable deadlines, as requested by C&H, and will timely pay all invoices in accordance with the terms set forth in Section 5.4 above.
(f) Third-Party Communications. The Client will promptly notify C&H of any third-party communications or actions that may affect the patent applications within the scope of this engagement, including but not limited to prior-art submissions by third parties under 35 U.S.C. § 122(e), third-party challenges or protestations, licensing inquiries, demands for disclosure, or threats of litigation or interference proceedings.
7. Conflicts of Interest
C&H has conducted a thorough conflicts-of-interest review in accordance with the applicable rules of professional conduct and has identified no conflicts of interest that would prevent the Firm from undertaking this engagement on behalf of SBD.
The Client acknowledges that C&H is a large, multi-practice law firm with offices in multiple jurisdictions and that the Firm represents a diverse client base across a wide range of industries, including clients in the medical-device, life-sciences, pharmaceutical, and biotechnology sectors. C&H will comply at all times with all applicable rules of professional conduct regarding conflicts of interest, including Rules 1.7 and 1.9 of the New York Rules of Professional Conduct (or the corresponding rules of any other jurisdiction that may apply).
The Client agrees that the Firm's representation of SBD in this engagement does not preclude the Firm from representing other clients in matters that are unrelated to this engagement, even if such other clients are competitors of SBD or operate in the same industry, provided that such representations do not involve a direct adverse conflict with respect to the specific patent applications that are the subject of this engagement. In the event that a potential conflict of interest arises during the course of this engagement, C&H will promptly notify the Client and will take appropriate steps to address the conflict in accordance with applicable rules, which may include seeking the Client's informed written consent or, if necessary, withdrawing from one or more conflicting representations.
8. Confidentiality
C&H will maintain the confidentiality of all information provided by the Client in connection with this engagement, in accordance with all applicable rules of professional conduct, including Rule 1.6 of the New York Rules of Professional Conduct, and the principles of attorney-client privilege and work-product protection. The Firm will implement reasonable measures to safeguard the Client's confidential information against unauthorized disclosure, including the use of secure file-storage systems, access controls, and encrypted communications as appropriate.
The Client acknowledges that the prosecution of patent applications before the USPTO necessarily requires the disclosure of certain information that might otherwise be considered confidential. Such disclosures include, without limitation, the content of patent-application specifications and claims, prior-art references cited in information disclosure statements, inventor declarations and oaths, assignment records, and other documents filed with or submitted to the USPTO. The Client authorizes C&H to make all such disclosures as are necessary or advisable in connection with the prosecution of the patent applications within the scope of this engagement.
Privileged communications regarding prosecution strategy, legal analysis, and attorney work product prepared in connection with this engagement will be maintained as confidential attorney-client privileged communications and will not be disclosed to third parties without the Client's prior written consent, except as may be required by law or court order.
9. Intellectual Property Ownership
All patent applications prepared, filed, and prosecuted by C&H in connection with this engagement, and all patents issuing therefrom, are and shall at all times remain the exclusive property of the Client (or its assignee or designee, as applicable). C&H claims no ownership interest, lien, or other proprietary interest in any inventions, patent applications, patents, or other intellectual property developed, prosecuted, or obtained on behalf of SBD, except for any attorney's lien that may arise by operation of law with respect to unpaid fees and costs, as further described in Section 11.4 below.
Nothing in this Engagement Letter shall be construed as an assignment, license, or other transfer of any intellectual-property rights from the Client to the Firm.
10. Docketing and Deadline Management
C&H will maintain an internal docketing system to monitor and calendar all USPTO deadlines, due dates, and significant milestones for patent applications within the scope of this engagement. The Firm's docketing system employs multiple levels of redundancy, including automated reminders and manual verification, to reduce the risk of missed deadlines.
Notwithstanding the foregoing, the Client acknowledges that the Firm's internal docketing system is maintained as an internal administrative tool, and that ultimate responsibility for meeting USPTO deadlines is shared between the Firm and the Client. The Client is strongly encouraged to maintain its own independent docket of all pending patent applications and associated deadlines, or to engage a reputable third-party docketing and patent-annuity service for this purpose.
C&H will provide the Client with reasonable advance notice of upcoming deadlines, including statutory and absolute deadlines, shortened statutory periods, and extension-of-time deadlines. The Firm will seek the Client's instructions before taking any substantive prosecution action or incurring significant fees. In the ordinary course, C&H will endeavor to provide at least two (2) weeks' advance notice of upcoming response deadlines, although shorter notice periods may apply in the event of newly issued Office Actions or other time-sensitive communications from the USPTO.
In the event that the Client fails to provide timely instructions in response to the Firm's requests, C&H will use commercially reasonable efforts to contact the Client (including through the authorized contacts identified in Section 2) and will attempt to obtain instructions before any applicable deadline expires. However, C&H shall not be liable for missed deadlines, abandonments, or other adverse consequences resulting from the Client's failure to respond to the Firm's requests for instructions in a timely manner, provided that the Firm has used commercially reasonable efforts to contact the Client and to alert the Client to the applicable deadline.
11. Term and Termination
11.1 Term.  This engagement shall commence as of the date of this Engagement Letter and shall remain in effect until terminated by either party in accordance with this Section 11. The engagement is not for a fixed term, and the continued representation of the Client is subject to the Firm's ongoing ability to represent the Client without conflict or other impediment, the Client's timely payment of fees and costs, and the Client's compliance with its obligations under this Engagement Letter.
11.2 Termination by Client
The Client may terminate this engagement at any time, with or without cause, by providing written notice to the Responsible Partner (Alan Ngo) at the address set forth in the letterhead above or at such other address as C&H may designate in writing. Termination by the Client shall be effective upon the Firm's receipt of such written notice. Upon termination by the Client, the Client shall remain responsible for payment of all professional fees, government fees, disbursements, and other costs incurred through the effective date of termination, including any fees and costs incurred in connection with the orderly transfer of the Client's matters to successor counsel.
11.3 Termination by Firm
C&H may withdraw from this engagement upon reasonable written notice to the Client and in compliance with all applicable rules of professional conduct, including Rule 1.16 of the New York Rules of Professional Conduct. Circumstances that may give rise to the Firm's withdrawal include, but are not limited to, the Client's failure to pay fees and costs in a timely manner, the Client's failure to cooperate with the Firm or to provide necessary information, the emergence of a conflict of interest that cannot be resolved through consent or other appropriate measures, or other circumstances that would make continued representation unreasonable or impractical.
Upon withdrawal, C&H will take reasonable steps to protect the Client's interests, including cooperating in the transfer of files and work product to the Client or its designated successor counsel, providing reasonable notice of upcoming USPTO deadlines, and, subject to the Client's payment of all outstanding invoices, taking such actions as may be necessary to meet any imminent USPTO deadlines that would otherwise result in the abandonment of a patent application.
11.4 Effect of Termination
Upon termination of this engagement, whether by the Client or by the Firm, C&H will promptly return all original client files, documents, and correspondence to the Client or its designated successor counsel, in such format as may be reasonably requested. The Firm may retain copies of such files and documents for its own records in accordance with applicable professional-responsibility rules, the Firm's document-retention policies, and any applicable legal or regulatory requirements.
All unpaid professional fees, government fees, disbursements, and other costs incurred through the effective date of termination shall remain due and payable in full. The Firm's obligation to return client files is subject to any retaining lien or other rights that may be available to the Firm under applicable law with respect to unpaid fees and costs, to the extent permitted by the applicable rules of professional conduct.
The provisions of Sections 5 (Fees and Billing Arrangements), 8 (Confidentiality), 9 (Intellectual Property Ownership), 12 (Limitation of Liability), and 13 (Governing Law and Dispute Resolution) shall survive the termination of this engagement.
12. Limitation of Liability
To the fullest extent permitted by applicable law and the applicable rules of professional conduct, C&H's aggregate liability to the Client for any and all claims, losses, damages, costs, or expenses arising out of or relating to this engagement, whether in contract, tort (including negligence), or otherwise, shall not exceed the total amount of professional fees actually paid by the Client to C&H under this Engagement Letter. This limitation of liability shall not apply to claims arising from the Firm's willful misconduct or gross negligence.
The Client acknowledges that patent prosecution involves inherent uncertainties, including the unpredictability of USPTO examination, the possibility of unknown prior art, and the potential for changes in patent law or USPTO practice. C&H does not guarantee or warrant any particular outcome with respect to the patent applications prosecuted under this engagement, including the issuance of any patent or the validity or enforceability of any claims.
13. Governing Law and Dispute Resolution
This Engagement Letter shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to its conflict-of-laws principles. The parties agree that Delaware law shall apply to all issues relating to the interpretation and enforcement of this Engagement Letter, as well as to the rights and obligations of the parties hereunder.
Any dispute, controversy, or claim arising out of or relating to this engagement, this Engagement Letter, or the breach, termination, or validity hereof, shall first be submitted to good-faith negotiation between senior representatives of the parties for a period of not less than thirty (30) days following written notice of the dispute. If the dispute is not resolved through negotiation within such period, the dispute shall be submitted to final and binding arbitration administered in accordance with the rules of a mutually agreed arbitration body (or, in the absence of such agreement, the American Arbitration Association), with the arbitration to be conducted in New York, New York, before a single arbitrator with experience in legal-malpractice or professional-responsibility matters. The award rendered by the arbitrator shall be final and binding on the parties and may be entered as a judgment in any court of competent jurisdiction.
Each party shall bear its own costs and attorneys' fees in connection with any dispute resolution proceeding, unless the arbitrator determines otherwise. The existence and substance of any arbitration proceeding, including any award, shall be treated as confidential by both parties.
14. Entire Agreement and Amendments
This Engagement Letter, together with the Schedules attached hereto and incorporated herein by reference, constitutes the entire agreement between C&H and SBD with respect to the engagement described herein and supersedes all prior or contemporaneous negotiations, discussions, understandings, representations, and agreements, whether written or oral, relating to the subject matter hereof.
Any modifications, amendments, or supplements to the terms of this Engagement Letter must be in writing and signed by both parties. No waiver of any term or condition of this Engagement Letter shall be effective unless made in writing and signed by the party against whom enforcement of the waiver is sought. A failure or delay by either party in exercising any right under this Engagement Letter shall not operate as a waiver of such right.
15. Acceptance
We are grateful for the opportunity to serve as patent counsel to Solstice Biomedical Devices Ltd. and look forward to working with you and your team on the CryoNova patent portfolio. If the terms and conditions set forth in this Engagement Letter are acceptable, please indicate your acceptance by countersigning a copy of this letter in the space provided below and returning it to the undersigned at your earliest convenience. A scanned copy transmitted by e-mail to ango@calderwoodharkness.com will be accepted as an original for purposes of confirming the engagement, followed by a hard copy via international courier.
Please do not hesitate to contact me at (212) 554-7120 or at ango@calderwoodharkness.com if you have any questions regarding this Engagement Letter or any other matter. We look forward to your response.
Very truly yours,
CALDERWOOD & HARKNESS LLP
CALDERWOOD & HARKNESS LLP
By: ________
Name: Alan Ngo
Title: Partner, intellectual Property Practice Group
Registered USPTO Patent Attorney (Reg. No. 58,412)
Date: ________
ACKNOWLEDGED AND AGREED
By signing below, the undersigned, on behalf of Solstice Biomedical Devices Ltd., acknowledges receipt of this Engagement Letter, confirms that the undersigned is duly authorized to execute this Engagement Letter on behalf of the Client, and agrees to all of the terms and conditions set forth herein.
SOLSTICE BIOMEDICAL DEVICES LTD.
By: ________
Name: Ronan Gallagher
Title: General Counsel & Company Secretary
Date: ________
SCHEDULE A
ENGAGEMENT TEAM BIOGRAPHIES AND USPTO REGISTRATION NUMBERS
The following professionals comprise the engagement team for Matter No. SBD-IP-2021-003. Biographical summaries and USPTO registration numbers are provided below.
Alan Ngo — Responsible Partner Intellectual Property Practice Group USPTO Patent Attorney, Registration No. 58,412
Mr. Ngo is a partner in the intellectual Property Practice Group of Calderwood & Harkness LLP. His practice focuses on patent prosecution and strategic patent counseling for clients in the medical-device, life-sciences, and biomedical-engineering industries. Mr. Ngo has extensive experience in the preparation, filing, and prosecution of patent applications before the USPTO, including applications directed to catheter-based interventional systems, cardiac-rhythm management devices, surgical instruments, and drug-delivery technologies. Mr. Ngo received his J.D. from Georgetown University Law Center and his B.S. in Mechanical Engineering from the University of Michigan.
Marcus Delgado — Billing Partner Intellectual Property Practice Group USPTO Patent Attorney, Registration No. 51,987
Mr. Delgado is a partner in the intellectual Property Practice Group of Calderwood & Harkness LLP. His practice encompasses patent prosecution, portfolio management, and intellectual-property due diligence for clients in the medical-device and technology sectors. Mr. Delgado has extensive experience managing large patent portfolios for multinational companies and advising on prosecution strategy in connection with complex patent families involving multiple continuation and divisional applications. Mr. Delgado received his J.D. from New York University School of Law and his B.S. in Electrical Engineering from Cornell University.
Peter Vassiliev — Lead Associate Intellectual Property Practice Group USPTO Patent Attorney, Registration No. 72,340
Mr. Vassiliev is a senior associate in the intellectual Property Practice Group of Calderwood & Harkness LLP. His practice focuses on the prosecution of patent applications in the medical-device and biomedical-engineering fields, with a particular emphasis on minimally invasive surgical devices, ablation technologies, and diagnostic imaging systems. Mr. Vassiliev has substantial experience drafting and prosecuting patent applications, responding to Office Actions, and conducting examiner interviews. Mr. Vassiliev received his J.D. from Fordham University School of Law and his M.S. in Biomedical Engineering from Johns Hopkins University.
Wendy Schultz — Working Associate Intellectual Property Practice Group USPTO Patent Attorney, Registration No. 78,115
Ms. Schultz is an associate in the intellectual Property Practice Group of Calderwood & Harkness LLP. Her practice focuses on patent prosecution and prior-art analysis for clients in the medical-device, pharmaceutical, and biotechnology sectors. Ms. Schultz has experience preparing patent applications, drafting claims, analyzing prior art, and preparing information disclosure statements. Ms. Schultz received her J.D. from Boston University School of Law and her B.S. in Chemical Engineering from the Massachusetts Institute of Technology.
Dr. Claire Nakamura — Patent Agent (Of Counsel), Biomedical Engineering Technical Specialist Intellectual Property Practice Group USPTO Patent Agent, Registration No. 66,203
Dr. Nakamura is Of Counsel in the intellectual Property Practice Group of Calderwood & Harkness LLP, where she serves as a biomedical-engineering technical specialist. Dr. Nakamura provides technical analysis and support on patent matters involving catheter-based interventional devices, cryogenic systems, cardiac electrophysiology, and implantable medical devices. Dr. Nakamura holds a Ph.D. in Biomedical Engineering from Columbia University, an M.S. in Mechanical Engineering from Stanford University, and a B.S. in Physics from the University of California, Berkeley. Prior to joining the Firm, Dr. Nakamura spent seven years as a research engineer at a leading medical-device company, where she was a named inventor on multiple U.S. patents relating to cryoablation technology.
SCHEDULE B
PATENT APPLICATION DOCKET — INITIAL SCOPE
Matter No.: SBD-IP-2021-003 Client: Solstice Biomedical Devices Ltd.
1. Parent Application
Note: Inventorship is to be confirmed on a per-application basis in accordance with 35 U.S.C. § 116. The named inventors listed above are the initial inventors of record for the Parent Application. Inventorship for any continuation, continuation-in-part, or divisional applications filed during the course of this engagement will be determined at the time of filing based on the claims presented in each such application.
2. Continuation and Related Applications
Continuation applications, continuation-in-part applications, and divisional applications to be filed during the course of this engagement will be added to this docket upon filing. Each new application will be assigned a sub-matter number under Matter No. SBD-IP-2021-003 and will be tracked in the Firm's internal docketing system.
3. Corresponding Foreign Filings (Outside Scope of This Engagement)
The following corresponding foreign filings are noted for reference and coordination purposes only. These filings are not within the scope of this engagement and are being handled by the foreign counsel indicated below:
C&H will coordinate with the above-referenced foreign counsel upon the Client's request, but does not assume any responsibility for the preparation, filing, prosecution, or maintenance of the above foreign applications. Any coordination efforts undertaken by C&H will be billed in accordance with the fee arrangements set forth in Section 5 of this Engagement Letter.
This Schedule B is current as of the date of the Engagement Letter (October 5, 2021) and will be updated periodically as new applications are filed or the status of existing applications changes. The Client will be provided with updated docket reports on a quarterly basis or upon request.
cc: Dr. Fiona Tierney, CEO & Co-Founder, Solstice Biomedical Devices Ltd. Marcus Delgado, Partner, Calderwood & Harkness LLP
Professional | Title | USPTO Reg. No. | Hourly Rate
Alan Ngo | Partner | 58,412 | $895.00
Marcus Delgado | Partner | 51,987 | $875.00
Peter Vassiliev | Lead Associate | 72,340 | $625.00
Wendy Schultz | Working Associate | 78,115 | $510.00
Dr. Claire Nakamura | Patent Agent (Of Counsel) | 66,203 | $475.00
Field | Details
Application No. | U.S. 16/914,337
Filing Date | June 28, 2021
Title | Cryoablation Catheter System with Variable-Zone Cooling
Applicant/Assignee | Solstice Biomedical Devices Ltd.
Named Inventors | Dr. Aisling Connolly; Dr. Tomás Brennan; Dr. Henrik Paulsen
Art Unit | 3794 (Surgical Instruments — Cryotherapy)
Entity Size | Small Entity (37 C.F.R. § 1.27)
Status | Pending
Application | Filing / National Phase | Foreign Counsel
PCT/EP2021/067891 | PCT International Application | Dunmore & Firth Patent Attorneys, Dublin, Ireland
EP Application No. 21 741 632.8 | European Regional Phase | Dunmore & Firth Patent Attorneys, Dublin, Ireland
JP Application No. 2023-500714 | Japanese National Phase | Takeda & Morioka Patent Office, Tokyo, Japan

CALDERWOOD & HARKNESS LLP Attorneys at Law

VIA E-MAIL AND INTERNATIONAL COURIER

CALDERWOOD & HARKNESS LLP

CALDERWOOD & HARKNESS LLP

ACKNOWLEDGED AND AGREED

SOLSTICE BIOMEDICAL DEVICES LTD.

SCHEDULE A

ENGAGEMENT TEAM BIOGRAPHIES AND USPTO REGISTRATION NUMBERS

SCHEDULE B

Record

Parties

Dates

Amounts