1037-00002 · Client 1037 · Engagement

engagement-letter-solstice.docx DOCUMENT Finance & Banking

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CALDERWOOD & HARKNESS LLP Attorneys at Law

1401 K Street NW, Suite 900 Washington, D.C. 20005

Telephone: (202) 555-7100 Facsimile: (202) 555-7199 www.calderwoodharkness.com

April 22, 2025

Engagement Reference No.: 1037-00002

Mr. Marcus Hale Vice President of U.S. Operations Solstice Biomedical Inc. 220 Westbrook Drive, Suite 400 Cambridge, MA 02142

Re: Engagement of Calderwood & Harkness LLP — FDA Pre-Submission Strategy, 510(k) Planning, and Related Regulatory Filings for the Solstice Lumina™ CGM System Engagement Reference No. 1037-00002

Dear Mr. Hale:

1. Introduction and Purpose

Calderwood & Harkness LLP ("C&H" or the "Firm") is pleased to confirm its engagement by Solstice Biomedical Inc. ("SBI" or the "Client"), a corporation organized and existing under the laws of the State of Delaware (Secretary of State File No. 7834291), to serve as outside legal counsel in connection with the matters described in this engagement letter. SBI is a wholly-owned U.S. subsidiary of Solstice Biomedical Devices Ltd., a private limited company incorporated under the laws of Ireland (Companies Registration Office No. 648231), with its registered office at Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland (the "Parent"). SBI is the intended holder of the 510(k) premarket notification for the Solstice Lumina™ Continuous Glucose Monitoring System (the "Lumina CGM System" or the "Device").

This engagement letter sets forth the terms and conditions under which C&H will provide legal services to SBI. By countersigning this letter, SBI confirms its agreement to these terms and authorizes the Firm to commence work on the matters described herein. The terms set forth in this letter are supplemented by the Firm's Standard Terms and Conditions of Engagement, which are enclosed as Attachment A and incorporated herein by reference. In the event of any conflict between this letter and Attachment A, the terms of this letter shall control.

We wish to confirm that the Firm's conflict-of-interest review was completed on April 18, 2025, in accordance with the District of Columbia Rules of Professional Conduct and the Firm's internal conflicts procedures. Based on that review, no conflicts of interest were identified that would prevent C&H from undertaking this engagement. Additional information regarding conflicts is set forth in Section 11 below.

We are enthusiastic about the opportunity to work with the Solstice Biomedical team and to support SBI's efforts to bring the Lumina CGM System to the U.S. market through a well-planned and strategically sound regulatory pathway.

2. Scope of Engagement

C&H will provide legal counsel and regulatory strategy advisory services to SBI in connection with the matters set forth in this Section 2. The scope of the engagement is organized into the following categories of work. The Firm's services are limited to the matters described below and in the specific exclusions set forth in Section 2.4; any expansion of scope requires the written agreement of the parties in accordance with Section 16 of this letter.

2.1 FDA Pre-Submission (Pre-Sub) Strategy

C&H will advise and assist SBI in the preparation, submission, and strategic management of a Q-Submission (Pre-Submission or "Pre-Sub") meeting request with the U.S. Food and Drug Administration ("FDA"), Center for Devices and Radiological Health ("CDRH"), Office of Health Technology 2 ("OHT2"), Division of Chemistry and Toxicology Devices. The Pre-Sub process is a critical milestone for establishing early dialogue with FDA regarding the proposed regulatory pathway, testing strategy, and clinical study design for the Lumina CGM System.

Specifically, the Firm's services in connection with the Pre-Sub will include:

(a) Preparation and Filing of Pre-Sub Meeting Request. C&H will prepare and file a formal Q-Submission meeting request with CDRH in accordance with FDA Guidance, "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" (most recent revision). The meeting request will be submitted through the FDA Electronic Submissions Gateway (ESG) or such other submission portal as FDA may designate.

(b) Preparation of the Pre-Sub Meeting Package. The Firm will prepare, in coordination with SBI and its regulatory affairs consultants, a comprehensive Pre-Sub meeting package for submission to CDRH. The meeting package is anticipated to include the following components:

(i) An executive summary describing the Lumina CGM System, the intended regulatory pathway, and the purpose of the Pre-Sub meeting;

(ii) A detailed device description, covering both the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter components of the system, including descriptions of design, materials, software, algorithms, and intended use;

(iii) A predicate device comparison and substantial equivalence discussion, identifying and analyzing proposed primary and secondary predicate devices (as further described in Section 2.2 below);

(iv) A proposed performance testing plan, setting forth the bench testing, analytical performance, and biocompatibility testing SBI intends to conduct in support of the 510(k) submission;

(v) A proposed clinical study protocol summary for Protocol SBD-LUM-CL-001 ("LUMINA-US"), including study objectives, endpoints, patient population, sample size, and statistical analysis plan;

(vi) Specific questions for FDA review and feedback, addressing regulatory pathway, predicate selection, testing sufficiency, iCGM special controls applicability, clinical study design, and any other topics identified by SBI and the engagement team; and

(vii) Any additional supporting documentation that may be advisable or appropriate for inclusion in the Pre-Sub package.

(c) Pre-Sub Meeting Attendance and Support. C&H attorneys will attend and provide legal and strategic support during the Pre-Sub meeting with CDRH. The Pre-Sub meeting is currently targeted for August 14, 2025, although the actual meeting date will depend on FDA scheduling and the timing of the Pre-Sub request submission. C&H will assist in preparing SBI's presentation materials and talking points for the meeting, participate in any pre-meeting preparation sessions with SBI and its advisors, and serve as legal counsel during the meeting itself.

(d) Post-Meeting Analysis and Strategic Advice. Following receipt of FDA's written meeting minutes and any additional feedback provided during or after the Pre-Sub meeting, C&H will prepare a detailed analysis of FDA's responses and recommendations and advise SBI on the strategic implications for the 510(k) submission pathway, testing plan, and clinical study design. The Firm will provide a memorandum summarizing key takeaways, action items, and recommended next steps.

2.2 510(k) Submission Planning

C&H will provide legal counsel and regulatory strategy advisory services in connection with SBI's planned traditional 510(k) premarket notification submission for the Lumina CGM System. The 510(k) submission is intended to cover the complete system, encompassing both the Lumina C14 implantable sensor component and the Lumina R7 wearable reader/transmitter component. The Firm's services in this area will include the following:

(a) Device Classification Analysis. C&H will analyze and advise on the classification of the Lumina CGM System under FDA's device classification framework. Based on our preliminary assessment, the Device is expected to be classified under product code QKQ, corresponding to the generic device type "Electrode, Glucose, Continuous Monitoring System," regulated under 21 C.F.R. § 862.1355 as a Class II medical device requiring 510(k) premarket notification. The Firm will confirm the appropriateness of this classification and advise on any alternative or supplemental classification considerations that may arise during the course of the engagement.

(b) Predicate Device Analysis and Substantial Equivalence Strategy. C&H will analyze and advise on SBI's predicate device strategy, including the identification, selection, and analysis of primary and secondary predicate devices. Based on our preliminary discussions with SBI and review of available information, the proposed predicate strategy is as follows:

(i) Primary Predicate: NovaSense GlucoTrack NX-500 (510(k) No. K211034), a continuous glucose monitoring system cleared by FDA through the traditional 510(k) pathway; and

(ii) Secondary Predicate: NovaSense GlucoTrack NX-700 (510(k) No. K230489), a next-generation continuous glucose monitoring system cleared by FDA, which may provide additional support for specific technological features or indications for use of the Lumina CGM System.

The Firm will prepare a detailed substantial equivalence analysis comparing the Lumina CGM System to the identified predicate devices across all relevant parameters, including intended use, technological characteristics, performance characteristics, biocompatibility, and labeling. C&H will also advise on the identification of any additional reference devices or split-predicate strategies that may strengthen the submission.

(c) iCGM Special Controls and Classification Pathway Considerations. C&H will assess the applicability of the integrated continuous glucose monitoring (iCGM) classification and associated special controls established by FDA under De Novo classification order DEN170088, codified at 21 C.F.R. § 862.1355. The Firm will advise SBI on whether pursuing iCGM classification — which carries specific accuracy and performance requirements, as well as the ability to integrate with other devices and automated insulin dosing systems — is strategically advantageous for the Lumina CGM System, and on the additional regulatory requirements and testing burdens associated with iCGM classification.

(d) Clinical Study Design Review. C&H will review and advise on the design of SBI's planned clinical study, Protocol SBD-LUM-CL-001 ("LUMINA-US"), as it relates to the regulatory strategy for the 510(k) submission. This includes an assessment of whether the proposed clinical study qualifies for an exemption from the Investigational Device Exemption ("IDE") requirements under 21 C.F.R. § 812.2(c)(3), which provides an exemption for certain investigations of devices cleared or approved for marketing that are conducted in accordance with existing labeling and other conditions. C&H will also advise on the implications of the clinical study design for the substantial equivalence analysis, the sufficiency of the proposed clinical endpoints and sample size, and any FDA guidance documents or precedent decisions that may inform the clinical study approach.

(e) Biocompatibility Testing Strategy Review. C&H will review and advise on SBI's biocompatibility testing strategy for the Lumina C14 implantable sensor, including the selection of appropriate ISO 10993-series testing and FDA biocompatibility guidance considerations, with particular attention to the proprietary PtIr-4G electrode coating material. The Firm's review will focus on the regulatory and strategic aspects of the testing strategy; C&H does not provide scientific or laboratory testing services.

(f) Software Documentation Requirements. C&H will review and advise on the software documentation requirements applicable to the Lumina CGM System, including the Level of Concern determination, software development lifecycle documentation, and any applicable requirements under FDA's guidance on "Content of Premarket Submissions for Device Software Functions" and related guidance documents. The Firm will also advise on any cybersecurity-related software documentation considerations.

(g) Cybersecurity Premarket Submission Compliance Analysis. C&H will analyze and advise on the cybersecurity requirements applicable to the Lumina CGM System in the premarket submission context, including compliance with Section 524B of the Federal Food, Drug, and Cosmetic Act (as amended by the Consolidated Appropriations Act, 2023) and FDA's guidance on "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." The Firm will assess the adequacy of SBI's cybersecurity documentation and threat modeling as presented for inclusion in the 510(k) submission.

(h) Preparation and Review of Draft 510(k) Submission Documents. C&H will prepare, draft, and/or review the following key components of the 510(k) submission:

(i) Cover letter to CDRH;

(ii) 510(k) summary prepared in accordance with 21 C.F.R. § 807.92;

(iii) Indications for Use statement (FDA Form 3881);

(iv) Substantial equivalence comparison table;

(v) Labeling review, including review of the proposed device labeling for compliance with the Federal Food, Drug, and Cosmetic Act ("FD&C Act"), FDA labeling regulations, and applicable guidance documents; and

(vi) Such other components of the 510(k) submission as may be identified during the course of the engagement and agreed upon by the parties.

(i) Submission Timeline. The target date for submission of the 510(k) premarket notification to FDA is April 30, 2026. C&H will work with SBI and its regulatory affairs consultants to develop and maintain a detailed submission timeline and to identify and address any potential delays or issues that could affect the target submission date.

2.3 Related Regulatory Filings and Advisory

In addition to the Pre-Sub and 510(k) planning matters described above, C&H will provide legal counsel and advisory services to SBI in connection with the following related regulatory matters:

(a) Establishment Registration and Device Listing. C&H will advise SBI on the requirements for U.S. establishment registration and medical device listing with FDA under 21 C.F.R. Part 807, Subparts B, C, and D, including the timing and procedural requirements for initial registration and listing, annual registration renewal, and any changes or updates to establishment or listing information.

(b) MDUFA User Fee Analysis. C&H will analyze the applicable Medical Device User Fee Amendments ("MDUFA") user fees for the 510(k) submission, including the standard review fee and any applicable surcharges or adjustments. The Firm will also assess whether SBI qualifies for the MDUFA small business qualification, which may entitle SBI to reduced user fee rates, and will advise on the application process and required certifications for small business status.

(c) Post-Clearance Regulatory Obligations Advisory. C&H will provide advisory services regarding the regulatory obligations that will apply to SBI following FDA clearance of the Lumina CGM System, including but not limited to Medical Device Reporting ("MDR") requirements under 21 C.F.R. Part 803, Quality System Regulation ("QSR") compliance under 21 C.F.R. Part 820, and requirements for corrections and removals under 21 C.F.R. Part 806. This advisory is intended to assist SBI in planning and preparing for post-clearance compliance in advance of the anticipated clearance date.

(d) Coordination with Third-Party Advisors. As further described in Section 10 of this letter, C&H will coordinate with SBI's other retained advisors — including Pinnacle Regulatory Consulting Group LLC (regulatory affairs consultancy) and Crestline IP Advisory LLC (patent/FTO counsel) — as directed by the Client and as necessary to ensure alignment between the legal, regulatory, and intellectual property strategies for the Lumina CGM System. The Firm's coordination role is limited to matters within the scope of this engagement and does not extend to supervision or management of third-party advisors' work.

(e) Review of CRO and IRB Engagement Documents. C&H will review contracts, agreements, and other engagement documents between SBI and its contract research organization ("CRO") and institutional review board ("IRB") as they relate to the regulatory strategy for the Lumina CGM System, including any provisions affecting the 510(k) submission, clinical data ownership, regulatory submissions, or FDA communications.

(f) Promotional Claims and Labeling Compliance. C&H will advise SBI on the development and review of promotional claims and labeling for the Lumina CGM System to ensure compliance with the FD&C Act, FDA regulations, and applicable guidance documents. This includes review of proposed marketing materials, promotional language, and labeling claims for consistency with the intended cleared indications for use and applicable legal requirements.

2.4 Exclusions from Scope

The following matters are expressly excluded from the scope of this engagement:

(a) Patent and intellectual Property Matters. This engagement does not include patent prosecution, freedom-to-operate ("FTO") analysis or litigation, patent invalidity proceedings, patent licensing negotiations, or other intellectual property matters. The Firm understands that Crestline IP Advisory LLC has been separately retained by SBI for FTO analysis related to the Lumina CGM System, and that Crestline delivered a preliminary FTO assessment on April 10, 2025.

(b) Irish and EU Regulatory Matters. This engagement does not include legal advice or representation with respect to Irish or European Union regulatory matters, including CE marking, EU Medical Device Regulation (MDR) (EU) 2017/745 compliance, Notified Body submissions, or any other non-U.S. regulatory matters. The Firm understands that Hargrove & Endicott LLP serves as Irish corporate and regulatory counsel to the Parent.

(c) Clinical Trial Operations. This engagement does not include clinical trial operations, CRO management, direct IRB submission preparation, clinical site management, or clinical data management. C&H's role with respect to clinical matters is limited to legal and regulatory strategy advice as described in Section 2.2 above.

(d) Enforcement and Litigation Matters. This engagement does not include FDA enforcement defense (including Warning Letter responses, consent decrees, or seizure or injunction proceedings), product liability litigation, insurance coverage matters, or any other litigation or dispute resolution matters.

(e) Scope Expansion. Any expansion of the scope of this engagement beyond the matters described in Sections 2.1 through 2.3 above requires the prior written agreement of both parties, which may be effected through a supplemental engagement letter or written amendment to this letter.

3. Engagement Team

The following attorneys will be primarily responsible for providing legal services to SBI in connection with this engagement:

Detailed biographies for each member of the engagement team are enclosed as Attachment B.

C&H may assign additional attorneys, paralegals, regulatory analysts, or other professionals to this engagement as reasonably necessary to ensure the efficient and effective delivery of legal services. The Client will be informed of any material changes to the composition of the engagement team, including the addition or departure of any partner or lead associate assigned to the matter. The Firm will endeavor to maintain continuity of staffing throughout the engagement.

Miriam Calloway will serve as the primary point of contact for all Client communications regarding this engagement. All significant strategic decisions, deliverables, and substantive communications with FDA will be reviewed and approved by Ms. Calloway prior to issuance. Day-to-day inquiries may also be directed to Amy Whitfield as the Lead Associate on the matter.

4. Client Contacts

The Firm's primary client contacts for this engagement are:

(a) Marcus Hale, Vice President of U.S. Operations, Solstice Biomedical Inc., 220 Westbrook Drive, Suite 400, Cambridge, MA 02142. Mr. Hale shall serve as the principal point of contact for business and operational matters, engagement administration, and billing inquiries.

(b) Dr. Niamh Tierney, Vice President of Regulatory Affairs, Solstice Biomedical Devices Ltd., Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland. Dr. Tierney shall serve as the designated regulatory affairs liaison between the Client and the Firm, and shall be authorized to provide direction and instructions to C&H on regulatory strategy matters in coordination with Mr. Hale.

The Client shall promptly notify C&H in writing of any changes to the authorized contacts designated above, including the addition or removal of individuals authorized to provide instructions to the Firm or to receive privileged communications. The Firm will rely on instructions received from the designated contacts and is not obligated to verify the authorization of instructions received from such individuals unless C&H has reason to believe that the instructions are unauthorized.

5. Fees and Billing Rates

5.1 Hourly Rate Structure

Fees for legal services rendered by C&H in connection with this engagement will be calculated on an hourly basis at the following current rates:

Based on the anticipated allocation of work among the engagement team members, the blended effective hourly rate for the engagement is estimated at approximately $725 per hour. This blended rate is provided for informational purposes only and does not constitute a cap or guarantee; actual fees will reflect the time expended by each attorney at his or her applicable individual hourly rate.

Paralegals and legal assistants assigned to the engagement will be billed at rates ranging from $250 to $375 per hour, depending on the individual's experience and qualifications. The Firm will identify any paralegals or legal assistants assigned to the matter on invoices.

Hourly rates are subject to adjustment on an annual basis, typically effective January 1 of each calendar year. The Client will be notified in writing of any rate adjustments at least thirty (30) days in advance of the effective date of such adjustments. Rate adjustments will apply prospectively only and will not affect fees for services rendered prior to the effective date of the adjustment.

5.2 Estimated Total Legal Fees

Based on the anticipated scope of work described in Section 2 of this letter, C&H estimates total legal fees for this engagement of approximately Six Hundred Fifty Thousand Dollars ($650,000) through the conclusion of the FDA 510(k) clearance process, which is currently targeted for the third quarter of calendar year 2026 (approximately Q3 2026).

This estimate is provided for planning and budgeting purposes only and is not a cap, guarantee, fixed fee, or binding commitment. Actual fees will be based on the time expended by the engagement team at the applicable hourly rates and will be influenced by range factors, including the complexity of FDA's feedback during the Pre-Sub process, the scope of testing and clinical data issues, the extent of revisions and iterations required for submission documents, and any changes to the scope of the engagement. C&H will promptly advise the Client if, at any point during the engagement, it appears that total fees will materially exceed this estimate, and the Firm and the Client will discuss the basis for any variance and any appropriate adjustments to the work plan or budget.

5.3 Retainer. Upon execution of this engagement letter, the Client shall pay a retainer in the amount of Seventy-Five Thousand Dollars ($75,000). The retainer will be deposited into the Firm's client trust account (IOLTA account) maintained in accordance with the District of Columbia Rules of Professional Conduct and will be held in trust for the benefit of the Client.

The retainer will be applied against the final invoice or invoices rendered by C&H in connection with this engagement. Until applied, the retainer will remain in the Firm's client trust account and will not be commingled with Firm operating funds. The retainer is not an estimate of total fees for the engagement and does not limit the Client's obligation to pay for all legal services rendered and expenses incurred in accordance with the terms of this letter.

Note: The retainer of $75,000 was received on April 28, 2025, and has been deposited into the Firm's client trust account.

6. Expenses and Disbursements

In addition to legal fees, the Client will be responsible for the reimbursement of all reasonable out-of-pocket costs and disbursements incurred by C&H 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 FDA meetings, client meetings, or other travel required by the engagement;

• Filing fees and government charges;

• Courier, express delivery, and overnight shipping charges;

• Photocopying, printing, and document production costs;

• Online legal research and database charges (e.g., Westmark Data Systems, Sundial Solutions, FDA databases);

• Long-distance telecommunications charges;

• Expert consultant fees, to the extent pre-approved by the Client; and

• Other miscellaneous out-of-pocket expenses reasonably incurred in the performance of services under this engagement.

Expenses in the aggregate amount of up to Fifteen Thousand Dollars ($15,000) may be incurred by C&H without prior Client approval. Any individual expense exceeding Fifteen Thousand Dollars ($15,000), or cumulative expenses that would cause total disbursements to exceed Fifteen Thousand Dollars ($15,000) in the aggregate, require prior written approval from the Client before being incurred.

FDA User Fees. The Client acknowledges that the 510(k) premarket notification submission will be subject to FDA user fees assessed under the Medical Device User Fee Amendments ("MDUFA"). For the current fiscal year (FY2025), the standard 510(k) review fee is $22,417 (subject to adjustment for small business qualification, if applicable). FDA user fees are the Client's direct responsibility and are not included in the Firm's fee estimate set forth in Section 5.2. C&H may assist in facilitating the user fee payment process and advise on applicable fee amounts and deadlines, but all such fees are payable directly by SBI to FDA.

7. Billing and Payment Terms

7.1 Billing Frequency

The Firm will issue invoices to the Client on a monthly basis. Each invoice will reflect fees for legal services rendered and expenses incurred during the preceding calendar month. Invoices will include a description of services performed, the attorney or professional who performed each service, the time expended, the applicable hourly rate, and an itemization of expenses and disbursements. The Firm will issue invoices in electronic format to the Client's designated billing contact.

7.2 Payment Terms

Invoices are due and payable within thirty (30) days of the invoice date. Payments should be made by wire transfer or check to the account or address specified on the invoice. Late payments on outstanding balances that are past due may be subject to interest at the rate of one percent (1.0%) per month (twelve percent (12%) per annum), calculated on the unpaid balance from the date payment was due until the date payment is received, to the extent permitted by applicable law. The Firm reserves the right to suspend services in the event of material non-payment, subject to the requirements of applicable rules of professional conduct and the provisions of Section 12.3 below.

7.3 Billing Inquiries

Any questions, concerns, or disputes regarding invoices should be directed to Joel Strauss, Billing Partner, at (202) 555-7124 or jstrauss@calderwoodharkness.com. The Firm encourages the Client to raise any billing questions promptly so that they may be addressed in a timely manner.

8. Confidentiality

C&H will maintain the confidentiality of all information received from or on behalf of the Client in connection with this engagement, in accordance with the District of Columbia Rules of Professional Conduct and the Firm's internal confidentiality policies and procedures. Confidential information includes, without limitation, all documents, data, communications, technical information, business strategies, financial information, trade secrets, and other information provided to or obtained by the Firm in the course of the representation, regardless of the form or medium in which such information is maintained.

Client information will be shared within C&H only on a need-to-know basis among members of the engagement team and supporting personnel (including administrative assistants, information technology staff, and conflicts personnel) who require access to such information in order to perform their functions in connection with the engagement. The Firm maintains appropriate physical, technical, and administrative safeguards to protect Client information from unauthorized access, disclosure, or use.

The Firm acknowledges that this engagement may involve access to highly sensitive technical, commercial, and regulatory information relating to the Solstice Lumina™ CGM System, including but not limited to proprietary technology (including the PtIr-4G electrode coating technology), clinical data, device design specifications, software algorithms, manufacturing processes, trade secrets, competitive intelligence, and business plans. C&H will treat all such information with the highest degree of care and will not disclose such information to any third party except as authorized by the Client, required by law or court order, or permitted under applicable rules of professional conduct.

The Firm's confidentiality obligations are subject to the exceptions set forth in the District of Columbia Rules of Professional Conduct, including without limitation the exceptions for disclosures required by law, disclosures necessary to prevent reasonably certain death or substantial bodily harm, and disclosures necessary to comply with other law or a court order.

9. Attorney-Client Privilege and Work Product

Communications between C&H and the Client in connection with this engagement are protected by the attorney-client privilege. This privilege belongs to the Client and protects confidential communications made between the Client and the Firm for the purpose of obtaining or providing legal advice. The Firm will take reasonable measures to preserve the attorney-client privilege with respect to all engagement-related communications.

Work product prepared by C&H in connection with this engagement — including memoranda, analyses, draft submissions, strategy documents, and other materials reflecting the Firm's mental impressions, conclusions, opinions, and legal theories — is protected by the attorney work product doctrine. The work product doctrine provides important protections against compelled disclosure of the Firm's work product in litigation or other adversarial proceedings.

The Client should take care to preserve these protections when sharing C&H communications or work product with third parties. In particular, the Client is advised that sharing privileged communications or attorney work product with third-party consultants and advisors — including, without limitation, Pinnacle Regulatory Consulting Group LLC, Crestline IP Advisory LLC, Whitmore Laboratories Inc., and Veltrano Clinical Research Organization Inc. — may, in certain circumstances, result in a waiver of the attorney-client privilege or work product protection. C&H will advise the Client on appropriate protocols to minimize the risk of privilege waiver, including the use of common interest agreements, joint defense agreements, or other protective arrangements where appropriate.

C&H will issue separate written guidelines on privilege and work product protection procedures for this engagement, which will be provided to the Client's designated contacts within thirty (30) days of the execution of this letter.

10. Coordination with Third-Party Advisors

C&H understands that, in connection with the development and U.S. market entry of the Lumina CGM System, the Client has retained the following third-party advisors:

(a) Pinnacle Regulatory Consulting Group LLC — Regulatory affairs consultancy. The engagement with Pinnacle commenced on January 15, 2025. Key contacts: Dr. Sandra Ellison, Managing Director, and Thomas Greenbaum, Senior Regulatory Specialist. Address: 9500 Medical Center Drive, Suite 210, Rockville, MD 20850. Pinnacle is providing regulatory affairs support, including assistance with technical documentation, performance testing strategy, and submission preparation.

(b) Crestline IP Advisory LLC — Patent and freedom-to-operate ("FTO") counsel. A preliminary FTO assessment was delivered by Crestline on April 10, 2025. Key contact: Dr. Raymond Cho, Patent Attorney. Address: 75 Federal Street, Suite 1800, Boston, MA 02110. Crestline is providing patent landscape analysis, FTO assessment, and intellectual property strategy advice.

(c) Hargrove & Endicott LLP — Irish corporate and regulatory counsel. Key contact: Ciara Brennan, Partner. Address: 38 Fitzwilliam Square East, Dublin D02 NH85, Ireland. Hargrove & Endicott serves as legal counsel to the Parent on Irish corporate matters and EU regulatory matters.

(d) Whitmore Laboratories Inc. — Contract testing laboratory. The engagement with Whitmore commenced on March 3, 2025. Key contact: Dr. James Haverford. Address: 1625 Shady Grove Road, Suite 300, Gaithersburg, MD 20878. Whitmore is conducting biocompatibility testing, analytical performance testing, and other laboratory testing in support of the 510(k) submission.

(e) Veltrano Clinical Research Organization Inc. — Contract research organization ("CRO") for the LUMINA-US clinical study (Protocol SBD-LUM-CL-001). Key contact: Dr. Lisa Fontaine, Vice President of Clinical Operations. Address: 500 North Capitol Street, Suite 700, Indianapolis, IN 46204. Veltrano is responsible for clinical trial management, site selection, patient enrollment, and clinical data collection for the LUMINA-US study.

C&H will coordinate with these third-party advisors as directed by the Client and as reasonably necessary to ensure alignment between the legal, regulatory, and technical strategies for the Lumina CGM System. The Firm's role in such coordination is limited to legal counsel and regulatory strategy advisory services within the scope of this engagement. C&H does not assume responsibility for the work product, deliverables, opinions, or recommendations of any third-party advisor, and the Client acknowledges that each third-party advisor is independently retained and is solely responsible for the services it provides.

C&H will issue a coordination letter to Pinnacle Regulatory Consulting Group LLC, in form and substance approved by the Client, outlining the respective roles, responsibilities, and work product sharing protocols between C&H and Pinnacle for the duration of the engagement. The coordination letter will address, among other things, division of responsibilities for the Pre-Sub meeting package and 510(k) submission preparation, protocols for sharing draft documents and work product, and procedures for preserving attorney-client privilege and work product protections in the context of collaborative work.

11. Conflicts of Interest

C&H has conducted a comprehensive conflict-of-interest review as of April 18, 2025, in accordance with the District of Columbia Rules of Professional Conduct (Rules 1.7 through 1.10) and the Firm's internal conflicts policies and procedures. Based on that review, no conflicts of interest were identified that would prevent the Firm from undertaking this engagement or that would require disclosure to or consent from the Client.

The Client acknowledges that C&H is a large, multi-office law firm with a diverse client base and may currently represent, or in the future may undertake to represent, other clients in matters unrelated to this engagement. The Client consents to such representations, provided that they do not involve a direct adverse conflict with SBI or Solstice Biomedical Devices Ltd. in connection with the subject matter of this engagement — namely, the FDA regulatory strategy, 510(k) submission planning, and related regulatory matters for the Solstice Lumina™ CGM System.

C&H confirms that it does not currently represent NovaSense Medical Technologies Inc. or any of its affiliates in any matter. The Firm will not undertake any representation adverse to SBI or Solstice Biomedical Devices Ltd. in matters related to the Lumina CGM System, the predicate devices identified in Section 2.2 (including the NovaSense GlucoTrack NX-500 and NovaSense GlucoTrack NX-700), or the subject matter of this engagement, without the Client's informed written consent.

If a conflict of interest arises during the course of this engagement, C&H will promptly notify the Client and take appropriate steps to address the conflict in accordance with applicable rules of professional conduct, which may include seeking the Client's informed consent, implementing an ethical screen, or, if necessary, withdrawing from the engagement.

12. Term and Termination

12.1 Effective Date

This engagement is effective as of April 22, 2025, and shall continue until the earlier of (i) the completion of the services described in Section 2 of this letter, (ii) termination by the Client in accordance with Section 12.2, (iii) withdrawal by the Firm in accordance with Section 12.3, or (iv) such other date as the parties may agree upon in writing.

12.2 Termination by Client

The Client may terminate this engagement at any time, with or without cause, upon written notice to C&H. Such notice should be directed to Miriam Calloway at the Firm's address set forth above. Termination by the Client shall be effective upon the Firm's receipt of written notice or such later date as may be specified in the notice. Upon termination, the Client remains responsible for payment of all fees for services rendered and all expenses and disbursements incurred through the effective date of termination, in accordance with the terms of this letter.

12.3 Termination by the Firm

C&H may withdraw from this engagement upon reasonable written notice to the Client and in accordance with the applicable rules of professional conduct, including the District of Columbia Rules of Professional Conduct, Rule 1.16. Circumstances that may give rise to the Firm's withdrawal include, without limitation:

(a) Continued representation would result in a violation of the Firm's ethical obligations under applicable rules of professional conduct;

(b) The Client fails to pay invoices when due and does not cure such failure within a reasonable period after written notice from the Firm;

(c) The Client fails to cooperate with the Firm in the representation, including failure to provide information, documents, or instructions reasonably necessary for the Firm to perform its services;

(d) The Client insists upon taking action that the Firm considers repugnant or with which the Firm has a fundamental disagreement; or

(e) Other good cause exists for withdrawal, as determined in the Firm's reasonable professional judgment.

12.4 Post-Termination Obligations

Upon termination of this engagement, whether by the Client or by the Firm, C&H will take reasonable steps to protect the Client's interests, including the timely return of Client files and documents and reasonable cooperation in the transition of the matter to successor counsel, if applicable. The Firm may retain copies of Client files and engagement records for its own files, subject to the Firm's confidentiality obligations under this letter and applicable rules of professional conduct. The Firm's right to retain copies is subject to any applicable lien on files for unpaid fees, to the extent permitted by applicable law and rules of professional conduct.

13. Document Retention

C&H will retain engagement files — including correspondence, memoranda, work product, and other documents generated or received in connection with this engagement — in accordance with the Firm's document retention policy. The Firm's current policy provides for retention of closed engagement files for a period of seven (7) years following the conclusion of the engagement, unless a longer retention period is required by applicable law, regulation, or court order, or unless the Client requests in writing that the Firm retain files for a longer period.

After the expiration of the applicable retention period, the Firm may destroy or dispose of engagement files without further notice to the Client. The Client is encouraged to request the return of any original documents or materials that it wishes to retain at the conclusion of the engagement or at any time during the retention period.

14. Limitation of Liability

To the fullest extent permitted by applicable law and the District of Columbia Rules of Professional Conduct, the Firm's aggregate liability to the Client arising out of or in connection with this engagement — whether based on contract, tort, negligence, strict liability, or any other legal or equitable theory — shall not exceed the total fees actually paid by the Client to C&H under this engagement letter. This limitation applies to all claims arising out of or relating to the Firm's services under this engagement, including claims against individual attorneys, partners, associates, employees, or agents of the Firm.

In no event shall C&H be liable to the Client for any consequential, incidental, indirect, special, or punitive damages arising out of or in connection with this engagement, regardless of whether such damages were foreseeable or whether the Firm was advised of the possibility of such damages.

Nothing in this Section 14 is intended to limit or modify any rights or obligations arising under applicable rules of professional conduct or to disclaim liability to the extent such disclaimer is prohibited by applicable law.

15. Governing Law and Dispute Resolution

This engagement letter shall be governed by and construed in accordance with the laws of the District of Columbia, without regard to its conflict-of-laws principles. The parties agree that any dispute, controversy, or claim arising out of or relating to this engagement letter, the Firm's services under this engagement, or the attorney-client relationship between the parties shall be resolved through the following process:

(a) Good-Faith Negotiation. The parties shall first attempt to resolve any dispute through good-faith negotiation between senior representatives of each party for a period of not less than thirty (30) days following written notice of the dispute.

(b) Mediation. If the dispute cannot be resolved through negotiation, either party may initiate mediation by providing written notice to the other party. Mediation shall be conducted before a mutually agreed-upon mediator in Washington, D.C., and the costs of mediation shall be shared equally by the parties.

(c) Binding Arbitration. If mediation is unsuccessful within sixty (60) days of the initiation of mediation (or such longer period as the parties may agree), either party may submit the dispute to binding arbitration under the rules of a mutually agreed-upon arbitration body. Arbitration shall be conducted in Washington, D.C., before a single arbitrator with experience in legal malpractice or attorney-client disputes. The arbitrator's award shall be final and binding on the parties, and judgment on the award may be entered in any court of competent jurisdiction.

16. Entire Agreement; Amendments

This engagement letter, together with the Firm's Standard Terms and Conditions of Engagement (Attachment A), constitutes the entire agreement between C&H and the Client regarding the engagement described herein and supersedes all prior or contemporaneous oral or written communications, negotiations, representations, or agreements between the parties with respect to the subject matter of this letter.

This engagement letter may be amended, modified, or supplemented only by a written instrument signed by an authorized representative of each party. No waiver of any provision of this letter shall be effective unless made in writing and signed by the party granting the waiver.

17. Acceptance

We are delighted to have the opportunity to represent Solstice Biomedical Inc. in connection with these important regulatory matters and look forward to working closely with your team to achieve a successful outcome.

Please confirm your acceptance of the terms and conditions set forth in this engagement letter by having an authorized representative of SBI countersign this letter in the space provided below and return an executed copy to:

Miriam Calloway Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005

Email: mcalloway@calderwoodharkness.com

Please also remit the retainer of Seventy-Five Thousand Dollars ($75,000) upon execution, payable by wire transfer to the Firm's client trust account (wire instructions will be provided separately upon request) or by check payable to "Calderwood & Harkness LLP Client Trust Account."

If you have any questions regarding this engagement letter or the terms set forth herein, please do not hesitate to contact me directly at (202) 555-7112 or mcalloway@calderwoodharkness.com.

With kind regards,

CALDERWOOD & HARKNESS LLP

By: ________

Name: Miriam Calloway

Title: Partner, Healthcare & Life Sciences Practice

Date: ________

ACKNOWLEDGED AND AGREED SOLSTICE BIOMEDICAL INC.

By executing this engagement letter below, the undersigned, on behalf of Solstice Biomedical Inc., confirms that he or she is duly authorized to execute this letter and agrees to the terms and conditions set forth herein.

SOLSTICE BIOMEDICAL INC.

By: ________

Name: Marcus Hale

Title: Vice President of U.S. Operations

Date: ________

Enclosures:

Attachment A: Calderwood & Harkness LLP Standard Terms and Conditions of Engagement (referenced and incorporated herein; not reproduced in this letter)

Attachment B: Engagement Team Biographies

cc:

Dr. Niamh Tierney, Vice President of Regulatory Affairs, Solstice Biomedical Devices Ltd., Dublin, Ireland

Dr. Eoin Gallagher, Chief Executive Officer, Solstice Biomedical Devices Ltd., Dublin, Ireland

Joel Strauss, Billing Partner, Calderwood & Harkness LLP

Attorney	Role	Experience Summary
Miriam Calloway	Responsible Partner, Healthcare & Life Sciences Practice	22 years of experience in FDA regulatory law, with a focus on medical device submissions, enforcement matters, and regulatory strategy. Ms. Calloway served as Senior Counsel at FDA's Center for Devices and Radiological Health (CDRH) from 2005 to 2011, where she advised on premarket review policy, device classification, and substantial equivalence determinations.
Joel Strauss	Billing Partner, Healthcare & Life Sciences Practice	Specializes in medical device regulatory strategy, reimbursement, and healthcare compliance. Mr. Strauss advises medical device companies at all stages of the product lifecycle, from classification and premarket submission through post-market surveillance and commercial launch.
Amy Whitfield	Lead Associate, Healthcare & Life Sciences Practice	6 years of experience with a focus on 510(k) premarket notifications, PMA applications, and De Novo classification requests. Ms. Whitfield has prepared and filed over forty 510(k) submissions across multiple device categories, including in vitro diagnostics and cardiovascular devices.
Sean Morrissey	Working Associate, Healthcare & Life Sciences Practice	3 years of experience with a focus on pre-submission strategy, device classification analysis, and FDA guidance interpretation. Mr. Morrissey holds an M.S. in Biomedical Engineering and brings technical expertise to the team's regulatory strategy work.
Attorney / Professional	Hourly Rate
Miriam Calloway (Responsible Partner)	$1,150 per hour
Joel Strauss (Billing Partner)	$1,050 per hour
Amy Whitfield (Lead Associate)	$625 per hour
Sean Morrissey (Working Associate)	$475 per hour

CALDERWOOD & HARKNESS LLP Attorneys at Law
1401 K Street NW, Suite 900 Washington, D.C. 20005
Telephone: (202) 555-7100 Facsimile: (202) 555-7199 www.calderwoodharkness.com
April 22, 2025
Engagement Reference No.: 1037-00002
Mr. Marcus Hale Vice President of U.S. Operations Solstice Biomedical Inc. 220 Westbrook Drive, Suite 400 Cambridge, MA 02142
Re: Engagement of Calderwood & Harkness LLP — FDA Pre-Submission Strategy, 510(k) Planning, and Related Regulatory Filings for the Solstice Lumina™ CGM System Engagement Reference No. 1037-00002
Dear Mr. Hale:
1. Introduction and Purpose
Calderwood & Harkness LLP ("C&H" or the "Firm") is pleased to confirm its engagement by Solstice Biomedical Inc. ("SBI" or the "Client"), a corporation organized and existing under the laws of the State of Delaware (Secretary of State File No. 7834291), to serve as outside legal counsel in connection with the matters described in this engagement letter. SBI is a wholly-owned U.S. subsidiary of Solstice Biomedical Devices Ltd., a private limited company incorporated under the laws of Ireland (Companies Registration Office No. 648231), with its registered office at Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland (the "Parent"). SBI is the intended holder of the 510(k) premarket notification for the Solstice Lumina™ Continuous Glucose Monitoring System (the "Lumina CGM System" or the "Device").
This engagement letter sets forth the terms and conditions under which C&H will provide legal services to SBI. By countersigning this letter, SBI confirms its agreement to these terms and authorizes the Firm to commence work on the matters described herein. The terms set forth in this letter are supplemented by the Firm's Standard Terms and Conditions of Engagement, which are enclosed as Attachment A and incorporated herein by reference. In the event of any conflict between this letter and Attachment A, the terms of this letter shall control.
We wish to confirm that the Firm's conflict-of-interest review was completed on April 18, 2025, in accordance with the District of Columbia Rules of Professional Conduct and the Firm's internal conflicts procedures. Based on that review, no conflicts of interest were identified that would prevent C&H from undertaking this engagement. Additional information regarding conflicts is set forth in Section 11 below.
We are enthusiastic about the opportunity to work with the Solstice Biomedical team and to support SBI's efforts to bring the Lumina CGM System to the U.S. market through a well-planned and strategically sound regulatory pathway.
2. Scope of Engagement
C&H will provide legal counsel and regulatory strategy advisory services to SBI in connection with the matters set forth in this Section 2. The scope of the engagement is organized into the following categories of work. The Firm's services are limited to the matters described below and in the specific exclusions set forth in Section 2.4; any expansion of scope requires the written agreement of the parties in accordance with Section 16 of this letter.
2.1 FDA Pre-Submission (Pre-Sub) Strategy
C&H will advise and assist SBI in the preparation, submission, and strategic management of a Q-Submission (Pre-Submission or "Pre-Sub") meeting request with the U.S. Food and Drug Administration ("FDA"), Center for Devices and Radiological Health ("CDRH"), Office of Health Technology 2 ("OHT2"), Division of Chemistry and Toxicology Devices. The Pre-Sub process is a critical milestone for establishing early dialogue with FDA regarding the proposed regulatory pathway, testing strategy, and clinical study design for the Lumina CGM System.
Specifically, the Firm's services in connection with the Pre-Sub will include:
(a) Preparation and Filing of Pre-Sub Meeting Request. C&H will prepare and file a formal Q-Submission meeting request with CDRH in accordance with FDA Guidance, "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" (most recent revision). The meeting request will be submitted through the FDA Electronic Submissions Gateway (ESG) or such other submission portal as FDA may designate.
(b) Preparation of the Pre-Sub Meeting Package. The Firm will prepare, in coordination with SBI and its regulatory affairs consultants, a comprehensive Pre-Sub meeting package for submission to CDRH. The meeting package is anticipated to include the following components:
(i) An executive summary describing the Lumina CGM System, the intended regulatory pathway, and the purpose of the Pre-Sub meeting;
(ii) A detailed device description, covering both the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter components of the system, including descriptions of design, materials, software, algorithms, and intended use;
(iii) A predicate device comparison and substantial equivalence discussion, identifying and analyzing proposed primary and secondary predicate devices (as further described in Section 2.2 below);
(iv) A proposed performance testing plan, setting forth the bench testing, analytical performance, and biocompatibility testing SBI intends to conduct in support of the 510(k) submission;
(v) A proposed clinical study protocol summary for Protocol SBD-LUM-CL-001 ("LUMINA-US"), including study objectives, endpoints, patient population, sample size, and statistical analysis plan;
(vi) Specific questions for FDA review and feedback, addressing regulatory pathway, predicate selection, testing sufficiency, iCGM special controls applicability, clinical study design, and any other topics identified by SBI and the engagement team; and
(vii) Any additional supporting documentation that may be advisable or appropriate for inclusion in the Pre-Sub package.
(c) Pre-Sub Meeting Attendance and Support. C&H attorneys will attend and provide legal and strategic support during the Pre-Sub meeting with CDRH. The Pre-Sub meeting is currently targeted for August 14, 2025, although the actual meeting date will depend on FDA scheduling and the timing of the Pre-Sub request submission. C&H will assist in preparing SBI's presentation materials and talking points for the meeting, participate in any pre-meeting preparation sessions with SBI and its advisors, and serve as legal counsel during the meeting itself.
(d) Post-Meeting Analysis and Strategic Advice. Following receipt of FDA's written meeting minutes and any additional feedback provided during or after the Pre-Sub meeting, C&H will prepare a detailed analysis of FDA's responses and recommendations and advise SBI on the strategic implications for the 510(k) submission pathway, testing plan, and clinical study design. The Firm will provide a memorandum summarizing key takeaways, action items, and recommended next steps.
2.2 510(k) Submission Planning
C&H will provide legal counsel and regulatory strategy advisory services in connection with SBI's planned traditional 510(k) premarket notification submission for the Lumina CGM System. The 510(k) submission is intended to cover the complete system, encompassing both the Lumina C14 implantable sensor component and the Lumina R7 wearable reader/transmitter component. The Firm's services in this area will include the following:
(a) Device Classification Analysis. C&H will analyze and advise on the classification of the Lumina CGM System under FDA's device classification framework. Based on our preliminary assessment, the Device is expected to be classified under product code QKQ, corresponding to the generic device type "Electrode, Glucose, Continuous Monitoring System," regulated under 21 C.F.R. § 862.1355 as a Class II medical device requiring 510(k) premarket notification. The Firm will confirm the appropriateness of this classification and advise on any alternative or supplemental classification considerations that may arise during the course of the engagement.
(b) Predicate Device Analysis and Substantial Equivalence Strategy. C&H will analyze and advise on SBI's predicate device strategy, including the identification, selection, and analysis of primary and secondary predicate devices. Based on our preliminary discussions with SBI and review of available information, the proposed predicate strategy is as follows:
(i) Primary Predicate: NovaSense GlucoTrack NX-500 (510(k) No. K211034), a continuous glucose monitoring system cleared by FDA through the traditional 510(k) pathway; and
(ii) Secondary Predicate: NovaSense GlucoTrack NX-700 (510(k) No. K230489), a next-generation continuous glucose monitoring system cleared by FDA, which may provide additional support for specific technological features or indications for use of the Lumina CGM System.
The Firm will prepare a detailed substantial equivalence analysis comparing the Lumina CGM System to the identified predicate devices across all relevant parameters, including intended use, technological characteristics, performance characteristics, biocompatibility, and labeling. C&H will also advise on the identification of any additional reference devices or split-predicate strategies that may strengthen the submission.
(c) iCGM Special Controls and Classification Pathway Considerations. C&H will assess the applicability of the integrated continuous glucose monitoring (iCGM) classification and associated special controls established by FDA under De Novo classification order DEN170088, codified at 21 C.F.R. § 862.1355. The Firm will advise SBI on whether pursuing iCGM classification — which carries specific accuracy and performance requirements, as well as the ability to integrate with other devices and automated insulin dosing systems — is strategically advantageous for the Lumina CGM System, and on the additional regulatory requirements and testing burdens associated with iCGM classification.
(d) Clinical Study Design Review. C&H will review and advise on the design of SBI's planned clinical study, Protocol SBD-LUM-CL-001 ("LUMINA-US"), as it relates to the regulatory strategy for the 510(k) submission. This includes an assessment of whether the proposed clinical study qualifies for an exemption from the Investigational Device Exemption ("IDE") requirements under 21 C.F.R. § 812.2(c)(3), which provides an exemption for certain investigations of devices cleared or approved for marketing that are conducted in accordance with existing labeling and other conditions. C&H will also advise on the implications of the clinical study design for the substantial equivalence analysis, the sufficiency of the proposed clinical endpoints and sample size, and any FDA guidance documents or precedent decisions that may inform the clinical study approach.
(e) Biocompatibility Testing Strategy Review. C&H will review and advise on SBI's biocompatibility testing strategy for the Lumina C14 implantable sensor, including the selection of appropriate ISO 10993-series testing and FDA biocompatibility guidance considerations, with particular attention to the proprietary PtIr-4G electrode coating material. The Firm's review will focus on the regulatory and strategic aspects of the testing strategy; C&H does not provide scientific or laboratory testing services.
(f) Software Documentation Requirements. C&H will review and advise on the software documentation requirements applicable to the Lumina CGM System, including the Level of Concern determination, software development lifecycle documentation, and any applicable requirements under FDA's guidance on "Content of Premarket Submissions for Device Software Functions" and related guidance documents. The Firm will also advise on any cybersecurity-related software documentation considerations.
(g) Cybersecurity Premarket Submission Compliance Analysis. C&H will analyze and advise on the cybersecurity requirements applicable to the Lumina CGM System in the premarket submission context, including compliance with Section 524B of the Federal Food, Drug, and Cosmetic Act (as amended by the Consolidated Appropriations Act, 2023) and FDA's guidance on "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." The Firm will assess the adequacy of SBI's cybersecurity documentation and threat modeling as presented for inclusion in the 510(k) submission.
(h) Preparation and Review of Draft 510(k) Submission Documents. C&H will prepare, draft, and/or review the following key components of the 510(k) submission:
(i) Cover letter to CDRH;
(ii) 510(k) summary prepared in accordance with 21 C.F.R. § 807.92;
(iii) Indications for Use statement (FDA Form 3881);
(iv) Substantial equivalence comparison table;
(v) Labeling review, including review of the proposed device labeling for compliance with the Federal Food, Drug, and Cosmetic Act ("FD&C Act"), FDA labeling regulations, and applicable guidance documents; and
(vi) Such other components of the 510(k) submission as may be identified during the course of the engagement and agreed upon by the parties.
(i) Submission Timeline. The target date for submission of the 510(k) premarket notification to FDA is April 30, 2026. C&H will work with SBI and its regulatory affairs consultants to develop and maintain a detailed submission timeline and to identify and address any potential delays or issues that could affect the target submission date.
2.3 Related Regulatory Filings and Advisory
In addition to the Pre-Sub and 510(k) planning matters described above, C&H will provide legal counsel and advisory services to SBI in connection with the following related regulatory matters:
(a) Establishment Registration and Device Listing. C&H will advise SBI on the requirements for U.S. establishment registration and medical device listing with FDA under 21 C.F.R. Part 807, Subparts B, C, and D, including the timing and procedural requirements for initial registration and listing, annual registration renewal, and any changes or updates to establishment or listing information.
(b) MDUFA User Fee Analysis. C&H will analyze the applicable Medical Device User Fee Amendments ("MDUFA") user fees for the 510(k) submission, including the standard review fee and any applicable surcharges or adjustments. The Firm will also assess whether SBI qualifies for the MDUFA small business qualification, which may entitle SBI to reduced user fee rates, and will advise on the application process and required certifications for small business status.
(c) Post-Clearance Regulatory Obligations Advisory. C&H will provide advisory services regarding the regulatory obligations that will apply to SBI following FDA clearance of the Lumina CGM System, including but not limited to Medical Device Reporting ("MDR") requirements under 21 C.F.R. Part 803, Quality System Regulation ("QSR") compliance under 21 C.F.R. Part 820, and requirements for corrections and removals under 21 C.F.R. Part 806. This advisory is intended to assist SBI in planning and preparing for post-clearance compliance in advance of the anticipated clearance date.
(d) Coordination with Third-Party Advisors. As further described in Section 10 of this letter, C&H will coordinate with SBI's other retained advisors — including Pinnacle Regulatory Consulting Group LLC (regulatory affairs consultancy) and Crestline IP Advisory LLC (patent/FTO counsel) — as directed by the Client and as necessary to ensure alignment between the legal, regulatory, and intellectual property strategies for the Lumina CGM System. The Firm's coordination role is limited to matters within the scope of this engagement and does not extend to supervision or management of third-party advisors' work.
(e) Review of CRO and IRB Engagement Documents. C&H will review contracts, agreements, and other engagement documents between SBI and its contract research organization ("CRO") and institutional review board ("IRB") as they relate to the regulatory strategy for the Lumina CGM System, including any provisions affecting the 510(k) submission, clinical data ownership, regulatory submissions, or FDA communications.
(f) Promotional Claims and Labeling Compliance. C&H will advise SBI on the development and review of promotional claims and labeling for the Lumina CGM System to ensure compliance with the FD&C Act, FDA regulations, and applicable guidance documents. This includes review of proposed marketing materials, promotional language, and labeling claims for consistency with the intended cleared indications for use and applicable legal requirements.
2.4 Exclusions from Scope
The following matters are expressly excluded from the scope of this engagement:
(a) Patent and intellectual Property Matters. This engagement does not include patent prosecution, freedom-to-operate ("FTO") analysis or litigation, patent invalidity proceedings, patent licensing negotiations, or other intellectual property matters. The Firm understands that Crestline IP Advisory LLC has been separately retained by SBI for FTO analysis related to the Lumina CGM System, and that Crestline delivered a preliminary FTO assessment on April 10, 2025.
(b) Irish and EU Regulatory Matters. This engagement does not include legal advice or representation with respect to Irish or European Union regulatory matters, including CE marking, EU Medical Device Regulation (MDR) (EU) 2017/745 compliance, Notified Body submissions, or any other non-U.S. regulatory matters. The Firm understands that Hargrove & Endicott LLP serves as Irish corporate and regulatory counsel to the Parent.
(c) Clinical Trial Operations. This engagement does not include clinical trial operations, CRO management, direct IRB submission preparation, clinical site management, or clinical data management. C&H's role with respect to clinical matters is limited to legal and regulatory strategy advice as described in Section 2.2 above.
(d) Enforcement and Litigation Matters. This engagement does not include FDA enforcement defense (including Warning Letter responses, consent decrees, or seizure or injunction proceedings), product liability litigation, insurance coverage matters, or any other litigation or dispute resolution matters.
(e) Scope Expansion. Any expansion of the scope of this engagement beyond the matters described in Sections 2.1 through 2.3 above requires the prior written agreement of both parties, which may be effected through a supplemental engagement letter or written amendment to this letter.
3. Engagement Team
The following attorneys will be primarily responsible for providing legal services to SBI in connection with this engagement:
Detailed biographies for each member of the engagement team are enclosed as Attachment B.
C&H may assign additional attorneys, paralegals, regulatory analysts, or other professionals to this engagement as reasonably necessary to ensure the efficient and effective delivery of legal services. The Client will be informed of any material changes to the composition of the engagement team, including the addition or departure of any partner or lead associate assigned to the matter. The Firm will endeavor to maintain continuity of staffing throughout the engagement.
Miriam Calloway will serve as the primary point of contact for all Client communications regarding this engagement. All significant strategic decisions, deliverables, and substantive communications with FDA will be reviewed and approved by Ms. Calloway prior to issuance. Day-to-day inquiries may also be directed to Amy Whitfield as the Lead Associate on the matter.
4. Client Contacts
The Firm's primary client contacts for this engagement are:
(a) Marcus Hale, Vice President of U.S. Operations, Solstice Biomedical Inc., 220 Westbrook Drive, Suite 400, Cambridge, MA 02142. Mr. Hale shall serve as the principal point of contact for business and operational matters, engagement administration, and billing inquiries.
(b) Dr. Niamh Tierney, Vice President of Regulatory Affairs, Solstice Biomedical Devices Ltd., Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland. Dr. Tierney shall serve as the designated regulatory affairs liaison between the Client and the Firm, and shall be authorized to provide direction and instructions to C&H on regulatory strategy matters in coordination with Mr. Hale.
The Client shall promptly notify C&H in writing of any changes to the authorized contacts designated above, including the addition or removal of individuals authorized to provide instructions to the Firm or to receive privileged communications. The Firm will rely on instructions received from the designated contacts and is not obligated to verify the authorization of instructions received from such individuals unless C&H has reason to believe that the instructions are unauthorized.
5. Fees and Billing Rates
5.1 Hourly Rate Structure
Fees for legal services rendered by C&H in connection with this engagement will be calculated on an hourly basis at the following current rates:
Based on the anticipated allocation of work among the engagement team members, the blended effective hourly rate for the engagement is estimated at approximately $725 per hour. This blended rate is provided for informational purposes only and does not constitute a cap or guarantee; actual fees will reflect the time expended by each attorney at his or her applicable individual hourly rate.
Paralegals and legal assistants assigned to the engagement will be billed at rates ranging from $250 to $375 per hour, depending on the individual's experience and qualifications. The Firm will identify any paralegals or legal assistants assigned to the matter on invoices.
Hourly rates are subject to adjustment on an annual basis, typically effective January 1 of each calendar year. The Client will be notified in writing of any rate adjustments at least thirty (30) days in advance of the effective date of such adjustments. Rate adjustments will apply prospectively only and will not affect fees for services rendered prior to the effective date of the adjustment.
5.2 Estimated Total Legal Fees
Based on the anticipated scope of work described in Section 2 of this letter, C&H estimates total legal fees for this engagement of approximately Six Hundred Fifty Thousand Dollars ($650,000) through the conclusion of the FDA 510(k) clearance process, which is currently targeted for the third quarter of calendar year 2026 (approximately Q3 2026).
This estimate is provided for planning and budgeting purposes only and is not a cap, guarantee, fixed fee, or binding commitment. Actual fees will be based on the time expended by the engagement team at the applicable hourly rates and will be influenced by range factors, including the complexity of FDA's feedback during the Pre-Sub process, the scope of testing and clinical data issues, the extent of revisions and iterations required for submission documents, and any changes to the scope of the engagement. C&H will promptly advise the Client if, at any point during the engagement, it appears that total fees will materially exceed this estimate, and the Firm and the Client will discuss the basis for any variance and any appropriate adjustments to the work plan or budget.
5.3 Retainer.  Upon execution of this engagement letter, the Client shall pay a retainer in the amount of Seventy-Five Thousand Dollars ($75,000). The retainer will be deposited into the Firm's client trust account (IOLTA account) maintained in accordance with the District of Columbia Rules of Professional Conduct and will be held in trust for the benefit of the Client.
The retainer will be applied against the final invoice or invoices rendered by C&H in connection with this engagement. Until applied, the retainer will remain in the Firm's client trust account and will not be commingled with Firm operating funds. The retainer is not an estimate of total fees for the engagement and does not limit the Client's obligation to pay for all legal services rendered and expenses incurred in accordance with the terms of this letter.
Note: The retainer of $75,000 was received on April 28, 2025, and has been deposited into the Firm's client trust account.
6. Expenses and Disbursements
In addition to legal fees, the Client will be responsible for the reimbursement of all reasonable out-of-pocket costs and disbursements incurred by C&H 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 FDA meetings, client meetings, or other travel required by the engagement;
•  Filing fees and government charges;
•  Courier, express delivery, and overnight shipping charges;
•  Photocopying, printing, and document production costs;
•  Online legal research and database charges (e.g., Westmark Data Systems, Sundial Solutions, FDA databases);
•  Long-distance telecommunications charges;
•  Expert consultant fees, to the extent pre-approved by the Client; and
•  Other miscellaneous out-of-pocket expenses reasonably incurred in the performance of services under this engagement.
Expenses in the aggregate amount of up to Fifteen Thousand Dollars ($15,000) may be incurred by C&H without prior Client approval. Any individual expense exceeding Fifteen Thousand Dollars ($15,000), or cumulative expenses that would cause total disbursements to exceed Fifteen Thousand Dollars ($15,000) in the aggregate, require prior written approval from the Client before being incurred.
FDA User Fees. The Client acknowledges that the 510(k) premarket notification submission will be subject to FDA user fees assessed under the Medical Device User Fee Amendments ("MDUFA"). For the current fiscal year (FY2025), the standard 510(k) review fee is $22,417 (subject to adjustment for small business qualification, if applicable). FDA user fees are the Client's direct responsibility and are not included in the Firm's fee estimate set forth in Section 5.2. C&H may assist in facilitating the user fee payment process and advise on applicable fee amounts and deadlines, but all such fees are payable directly by SBI to FDA.
7. Billing and Payment Terms
7.1 Billing Frequency
The Firm will issue invoices to the Client on a monthly basis. Each invoice will reflect fees for legal services rendered and expenses incurred during the preceding calendar month. Invoices will include a description of services performed, the attorney or professional who performed each service, the time expended, the applicable hourly rate, and an itemization of expenses and disbursements. The Firm will issue invoices in electronic format to the Client's designated billing contact.
7.2 Payment Terms
Invoices are due and payable within thirty (30) days of the invoice date. Payments should be made by wire transfer or check to the account or address specified on the invoice. Late payments on outstanding balances that are past due may be subject to interest at the rate of one percent (1.0%) per month (twelve percent (12%) per annum), calculated on the unpaid balance from the date payment was due until the date payment is received, to the extent permitted by applicable law. The Firm reserves the right to suspend services in the event of material non-payment, subject to the requirements of applicable rules of professional conduct and the provisions of Section 12.3 below.
7.3 Billing Inquiries
Any questions, concerns, or disputes regarding invoices should be directed to Joel Strauss, Billing Partner, at (202) 555-7124 or jstrauss@calderwoodharkness.com. The Firm encourages the Client to raise any billing questions promptly so that they may be addressed in a timely manner.
8. Confidentiality
C&H will maintain the confidentiality of all information received from or on behalf of the Client in connection with this engagement, in accordance with the District of Columbia Rules of Professional Conduct and the Firm's internal confidentiality policies and procedures. Confidential information includes, without limitation, all documents, data, communications, technical information, business strategies, financial information, trade secrets, and other information provided to or obtained by the Firm in the course of the representation, regardless of the form or medium in which such information is maintained.
Client information will be shared within C&H only on a need-to-know basis among members of the engagement team and supporting personnel (including administrative assistants, information technology staff, and conflicts personnel) who require access to such information in order to perform their functions in connection with the engagement. The Firm maintains appropriate physical, technical, and administrative safeguards to protect Client information from unauthorized access, disclosure, or use.
The Firm acknowledges that this engagement may involve access to highly sensitive technical, commercial, and regulatory information relating to the Solstice Lumina™ CGM System, including but not limited to proprietary technology (including the PtIr-4G electrode coating technology), clinical data, device design specifications, software algorithms, manufacturing processes, trade secrets, competitive intelligence, and business plans. C&H will treat all such information with the highest degree of care and will not disclose such information to any third party except as authorized by the Client, required by law or court order, or permitted under applicable rules of professional conduct.
The Firm's confidentiality obligations are subject to the exceptions set forth in the District of Columbia Rules of Professional Conduct, including without limitation the exceptions for disclosures required by law, disclosures necessary to prevent reasonably certain death or substantial bodily harm, and disclosures necessary to comply with other law or a court order.
9. Attorney-Client Privilege and Work Product
Communications between C&H and the Client in connection with this engagement are protected by the attorney-client privilege. This privilege belongs to the Client and protects confidential communications made between the Client and the Firm for the purpose of obtaining or providing legal advice. The Firm will take reasonable measures to preserve the attorney-client privilege with respect to all engagement-related communications.
Work product prepared by C&H in connection with this engagement — including memoranda, analyses, draft submissions, strategy documents, and other materials reflecting the Firm's mental impressions, conclusions, opinions, and legal theories — is protected by the attorney work product doctrine. The work product doctrine provides important protections against compelled disclosure of the Firm's work product in litigation or other adversarial proceedings.
The Client should take care to preserve these protections when sharing C&H communications or work product with third parties. In particular, the Client is advised that sharing privileged communications or attorney work product with third-party consultants and advisors — including, without limitation, Pinnacle Regulatory Consulting Group LLC, Crestline IP Advisory LLC, Whitmore Laboratories Inc., and Veltrano Clinical Research Organization Inc. — may, in certain circumstances, result in a waiver of the attorney-client privilege or work product protection. C&H will advise the Client on appropriate protocols to minimize the risk of privilege waiver, including the use of common interest agreements, joint defense agreements, or other protective arrangements where appropriate.
C&H will issue separate written guidelines on privilege and work product protection procedures for this engagement, which will be provided to the Client's designated contacts within thirty (30) days of the execution of this letter.
10. Coordination with Third-Party Advisors
C&H understands that, in connection with the development and U.S. market entry of the Lumina CGM System, the Client has retained the following third-party advisors:
(a) Pinnacle Regulatory Consulting Group LLC — Regulatory affairs consultancy. The engagement with Pinnacle commenced on January 15, 2025. Key contacts: Dr. Sandra Ellison, Managing Director, and Thomas Greenbaum, Senior Regulatory Specialist. Address: 9500 Medical Center Drive, Suite 210, Rockville, MD 20850. Pinnacle is providing regulatory affairs support, including assistance with technical documentation, performance testing strategy, and submission preparation.
(b) Crestline IP Advisory LLC — Patent and freedom-to-operate ("FTO") counsel. A preliminary FTO assessment was delivered by Crestline on April 10, 2025. Key contact: Dr. Raymond Cho, Patent Attorney. Address: 75 Federal Street, Suite 1800, Boston, MA 02110. Crestline is providing patent landscape analysis, FTO assessment, and intellectual property strategy advice.
(c) Hargrove & Endicott LLP — Irish corporate and regulatory counsel. Key contact: Ciara Brennan, Partner. Address: 38 Fitzwilliam Square East, Dublin D02 NH85, Ireland. Hargrove & Endicott serves as legal counsel to the Parent on Irish corporate matters and EU regulatory matters.
(d) Whitmore Laboratories Inc. — Contract testing laboratory. The engagement with Whitmore commenced on March 3, 2025. Key contact: Dr. James Haverford. Address: 1625 Shady Grove Road, Suite 300, Gaithersburg, MD 20878. Whitmore is conducting biocompatibility testing, analytical performance testing, and other laboratory testing in support of the 510(k) submission.
(e) Veltrano Clinical Research Organization Inc. — Contract research organization ("CRO") for the LUMINA-US clinical study (Protocol SBD-LUM-CL-001). Key contact: Dr. Lisa Fontaine, Vice President of Clinical Operations. Address: 500 North Capitol Street, Suite 700, Indianapolis, IN 46204. Veltrano is responsible for clinical trial management, site selection, patient enrollment, and clinical data collection for the LUMINA-US study.
C&H will coordinate with these third-party advisors as directed by the Client and as reasonably necessary to ensure alignment between the legal, regulatory, and technical strategies for the Lumina CGM System. The Firm's role in such coordination is limited to legal counsel and regulatory strategy advisory services within the scope of this engagement. C&H does not assume responsibility for the work product, deliverables, opinions, or recommendations of any third-party advisor, and the Client acknowledges that each third-party advisor is independently retained and is solely responsible for the services it provides.
C&H will issue a coordination letter to Pinnacle Regulatory Consulting Group LLC, in form and substance approved by the Client, outlining the respective roles, responsibilities, and work product sharing protocols between C&H and Pinnacle for the duration of the engagement. The coordination letter will address, among other things, division of responsibilities for the Pre-Sub meeting package and 510(k) submission preparation, protocols for sharing draft documents and work product, and procedures for preserving attorney-client privilege and work product protections in the context of collaborative work.
11. Conflicts of Interest
C&H has conducted a comprehensive conflict-of-interest review as of April 18, 2025, in accordance with the District of Columbia Rules of Professional Conduct (Rules 1.7 through 1.10) and the Firm's internal conflicts policies and procedures. Based on that review, no conflicts of interest were identified that would prevent the Firm from undertaking this engagement or that would require disclosure to or consent from the Client.
The Client acknowledges that C&H is a large, multi-office law firm with a diverse client base and may currently represent, or in the future may undertake to represent, other clients in matters unrelated to this engagement. The Client consents to such representations, provided that they do not involve a direct adverse conflict with SBI or Solstice Biomedical Devices Ltd. in connection with the subject matter of this engagement — namely, the FDA regulatory strategy, 510(k) submission planning, and related regulatory matters for the Solstice Lumina™ CGM System.
C&H confirms that it does not currently represent NovaSense Medical Technologies Inc. or any of its affiliates in any matter. The Firm will not undertake any representation adverse to SBI or Solstice Biomedical Devices Ltd. in matters related to the Lumina CGM System, the predicate devices identified in Section 2.2 (including the NovaSense GlucoTrack NX-500 and NovaSense GlucoTrack NX-700), or the subject matter of this engagement, without the Client's informed written consent.
If a conflict of interest arises during the course of this engagement, C&H will promptly notify the Client and take appropriate steps to address the conflict in accordance with applicable rules of professional conduct, which may include seeking the Client's informed consent, implementing an ethical screen, or, if necessary, withdrawing from the engagement.
12. Term and Termination
12.1 Effective Date
This engagement is effective as of April 22, 2025, and shall continue until the earlier of (i) the completion of the services described in Section 2 of this letter, (ii) termination by the Client in accordance with Section 12.2, (iii) withdrawal by the Firm in accordance with Section 12.3, or (iv) such other date as the parties may agree upon in writing.
12.2 Termination by Client
The Client may terminate this engagement at any time, with or without cause, upon written notice to C&H. Such notice should be directed to Miriam Calloway at the Firm's address set forth above. Termination by the Client shall be effective upon the Firm's receipt of written notice or such later date as may be specified in the notice. Upon termination, the Client remains responsible for payment of all fees for services rendered and all expenses and disbursements incurred through the effective date of termination, in accordance with the terms of this letter.
12.3 Termination by the Firm
C&H may withdraw from this engagement upon reasonable written notice to the Client and in accordance with the applicable rules of professional conduct, including the District of Columbia Rules of Professional Conduct, Rule 1.16. Circumstances that may give rise to the Firm's withdrawal include, without limitation:
(a) Continued representation would result in a violation of the Firm's ethical obligations under applicable rules of professional conduct;
(b) The Client fails to pay invoices when due and does not cure such failure within a reasonable period after written notice from the Firm;
(c) The Client fails to cooperate with the Firm in the representation, including failure to provide information, documents, or instructions reasonably necessary for the Firm to perform its services;
(d) The Client insists upon taking action that the Firm considers repugnant or with which the Firm has a fundamental disagreement; or
(e) Other good cause exists for withdrawal, as determined in the Firm's reasonable professional judgment.
12.4 Post-Termination Obligations
Upon termination of this engagement, whether by the Client or by the Firm, C&H will take reasonable steps to protect the Client's interests, including the timely return of Client files and documents and reasonable cooperation in the transition of the matter to successor counsel, if applicable. The Firm may retain copies of Client files and engagement records for its own files, subject to the Firm's confidentiality obligations under this letter and applicable rules of professional conduct. The Firm's right to retain copies is subject to any applicable lien on files for unpaid fees, to the extent permitted by applicable law and rules of professional conduct.
13. Document Retention
C&H will retain engagement files — including correspondence, memoranda, work product, and other documents generated or received in connection with this engagement — in accordance with the Firm's document retention policy. The Firm's current policy provides for retention of closed engagement files for a period of seven (7) years following the conclusion of the engagement, unless a longer retention period is required by applicable law, regulation, or court order, or unless the Client requests in writing that the Firm retain files for a longer period.
After the expiration of the applicable retention period, the Firm may destroy or dispose of engagement files without further notice to the Client. The Client is encouraged to request the return of any original documents or materials that it wishes to retain at the conclusion of the engagement or at any time during the retention period.
14. Limitation of Liability
To the fullest extent permitted by applicable law and the District of Columbia Rules of Professional Conduct, the Firm's aggregate liability to the Client arising out of or in connection with this engagement — whether based on contract, tort, negligence, strict liability, or any other legal or equitable theory — shall not exceed the total fees actually paid by the Client to C&H under this engagement letter. This limitation applies to all claims arising out of or relating to the Firm's services under this engagement, including claims against individual attorneys, partners, associates, employees, or agents of the Firm.
In no event shall C&H be liable to the Client for any consequential, incidental, indirect, special, or punitive damages arising out of or in connection with this engagement, regardless of whether such damages were foreseeable or whether the Firm was advised of the possibility of such damages.
Nothing in this Section 14 is intended to limit or modify any rights or obligations arising under applicable rules of professional conduct or to disclaim liability to the extent such disclaimer is prohibited by applicable law.
15. Governing Law and Dispute Resolution
This engagement letter shall be governed by and construed in accordance with the laws of the District of Columbia, without regard to its conflict-of-laws principles. The parties agree that any dispute, controversy, or claim arising out of or relating to this engagement letter, the Firm's services under this engagement, or the attorney-client relationship between the parties shall be resolved through the following process:
(a) Good-Faith Negotiation. The parties shall first attempt to resolve any dispute through good-faith negotiation between senior representatives of each party for a period of not less than thirty (30) days following written notice of the dispute.
(b) Mediation. If the dispute cannot be resolved through negotiation, either party may initiate mediation by providing written notice to the other party. Mediation shall be conducted before a mutually agreed-upon mediator in Washington, D.C., and the costs of mediation shall be shared equally by the parties.
(c) Binding Arbitration. If mediation is unsuccessful within sixty (60) days of the initiation of mediation (or such longer period as the parties may agree), either party may submit the dispute to binding arbitration under the rules of a mutually agreed-upon arbitration body. Arbitration shall be conducted in Washington, D.C., before a single arbitrator with experience in legal malpractice or attorney-client disputes. The arbitrator's award shall be final and binding on the parties, and judgment on the award may be entered in any court of competent jurisdiction.
16. Entire Agreement; Amendments
This engagement letter, together with the Firm's Standard Terms and Conditions of Engagement (Attachment A), constitutes the entire agreement between C&H and the Client regarding the engagement described herein and supersedes all prior or contemporaneous oral or written communications, negotiations, representations, or agreements between the parties with respect to the subject matter of this letter.
This engagement letter may be amended, modified, or supplemented only by a written instrument signed by an authorized representative of each party. No waiver of any provision of this letter shall be effective unless made in writing and signed by the party granting the waiver.
17. Acceptance
We are delighted to have the opportunity to represent Solstice Biomedical Inc. in connection with these important regulatory matters and look forward to working closely with your team to achieve a successful outcome.
Please confirm your acceptance of the terms and conditions set forth in this engagement letter by having an authorized representative of SBI countersign this letter in the space provided below and return an executed copy to:
Miriam Calloway Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005
Email: mcalloway@calderwoodharkness.com
Please also remit the retainer of Seventy-Five Thousand Dollars ($75,000) upon execution, payable by wire transfer to the Firm's client trust account (wire instructions will be provided separately upon request) or by check payable to "Calderwood & Harkness LLP Client Trust Account."
If you have any questions regarding this engagement letter or the terms set forth herein, please do not hesitate to contact me directly at (202) 555-7112 or mcalloway@calderwoodharkness.com.
With kind regards,
CALDERWOOD & HARKNESS LLP
By: ________
Name: Miriam Calloway
Title: Partner, Healthcare & Life Sciences Practice
Date: ________
ACKNOWLEDGED AND AGREED SOLSTICE BIOMEDICAL INC.
By executing this engagement letter below, the undersigned, on behalf of Solstice Biomedical Inc., confirms that he or she is duly authorized to execute this letter and agrees to the terms and conditions set forth herein.
SOLSTICE BIOMEDICAL INC.
By: ________
Name: Marcus Hale
Title: Vice President of U.S. Operations
Date: ________
Enclosures:
Attachment A: Calderwood & Harkness LLP Standard Terms and Conditions of Engagement (referenced and incorporated herein; not reproduced in this letter)
Attachment B: Engagement Team Biographies
cc:
Dr. Niamh Tierney, Vice President of Regulatory Affairs, Solstice Biomedical Devices Ltd., Dublin, Ireland
Dr. Eoin Gallagher, Chief Executive Officer, Solstice Biomedical Devices Ltd., Dublin, Ireland
Joel Strauss, Billing Partner, Calderwood & Harkness LLP
Attorney | Role | Experience Summary
Miriam Calloway | Responsible Partner, Healthcare & Life Sciences Practice | 22 years of experience in FDA regulatory law, with a focus on medical device submissions, enforcement matters, and regulatory strategy. Ms. Calloway served as Senior Counsel at FDA's Center for Devices and Radiological Health (CDRH) from 2005 to 2011, where she advised on premarket review policy, device classification, and substantial equivalence determinations.
Joel Strauss | Billing Partner, Healthcare & Life Sciences Practice | Specializes in medical device regulatory strategy, reimbursement, and healthcare compliance. Mr. Strauss advises medical device companies at all stages of the product lifecycle, from classification and premarket submission through post-market surveillance and commercial launch.
Amy Whitfield | Lead Associate, Healthcare & Life Sciences Practice | 6 years of experience with a focus on 510(k) premarket notifications, PMA applications, and De Novo classification requests. Ms. Whitfield has prepared and filed over forty 510(k) submissions across multiple device categories, including in vitro diagnostics and cardiovascular devices.
Sean Morrissey | Working Associate, Healthcare & Life Sciences Practice | 3 years of experience with a focus on pre-submission strategy, device classification analysis, and FDA guidance interpretation. Mr. Morrissey holds an M.S. in Biomedical Engineering and brings technical expertise to the team's regulatory strategy work.
Attorney / Professional | Hourly Rate
Miriam Calloway (Responsible Partner) | $1,150 per hour
Joel Strauss (Billing Partner) | $1,050 per hour
Amy Whitfield (Lead Associate) | $625 per hour
Sean Morrissey (Working Associate) | $475 per hour

CALDERWOOD & HARKNESS LLP Attorneys at Law

CALDERWOOD & HARKNESS LLP

ACKNOWLEDGED AND AGREED SOLSTICE BIOMEDICAL INC.

SOLSTICE BIOMEDICAL INC.

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