1037-00002 · Client 1037 · Correspondence

coordination-letter-pinnacle.docx DOCUMENT Finance & Banking

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PRIVILEGED & CONFIDENTIAL

CALDERWOOD & HARKNESS LLP Attorneys at Law

1401 K Street NW, Suite 900 Washington, D.C. 20005 Telephone: (202) 555-8400 Facsimile: (202) 555-8401

Healthcare & Life Sciences Practice Group

May 2, 2025

Dr. Sandra Ellison, Managing Director Thomas Greenbaum, RAC, Senior Regulatory Specialist Pinnacle Regulatory Consulting Group LLC 9500 Medical Center Drive, Suite 210 Rockville, MD 20850

Re: Coordination of Regulatory Advisory Services — Solstice Lumina™ CGM System; FDA Pre-Submission and 510(k) Strategy; Calderwood & Harkness Engagement Ref. No. 1037-00002

Dear Dr. Ellison and Mr. Greenbaum:

1. Purpose and Background

Calderwood & Harkness LLP ("C&H" or the "Firm") has been engaged by Solstice Biomedical Inc. ("SBI"), the U.S. subsidiary of Solstice Biomedical Devices Ltd. ("Solstice" or "SBD"), to provide legal counsel on FDA regulatory strategy for the Solstice Lumina™ Continuous Glucose Monitoring System (the "Lumina CGM System" or the "Device"). Our engagement was formally opened on April 22, 2025, and our retainer was received on April 28, 2025. We write to you now to formalize the coordination framework between our respective organizations in support of SBI's FDA Pre-Submission ("Pre-Sub") meeting preparation and subsequent traditional 510(k) submission.

SBI is a Delaware corporation (File No. 7834291), with its principal offices located at 220 Westbrook Drive, Suite 400, Cambridge, Massachusetts 02142. SBI will serve as the intended 510(k) holder and the U.S. legal manufacturer of record for the Device. SBI is a wholly owned subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company (CRO No. 648231), headquartered at Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland. SBD serves as the parent entity for global operations, including device design, development, and manufacturing, and retains ultimate strategic authority over the regulatory program.

The Lumina CGM System encompasses two principal device variants that are intended to be submitted as a single system under a traditional 510(k) pathway: (i) the Lumina C14, an implantable continuous glucose sensor designed for subcutaneous insertion with a fourteen-day wear period, and (ii) the Lumina R7, a wearable reader and transmitter unit that communicates wirelessly with the C14 sensor and transmits processed glucose data to the patient's mobile device and compatible electronic health record systems. Together, the C14 and R7 constitute an integrated continuous glucose monitoring system intended for use by adult patients (18 years and older) with Type 1 or Type 2 diabetes mellitus for the management of diabetes through real-time and retrospective glucose monitoring.

We understand that Pinnacle Regulatory Consulting Group LLC ("Pinnacle") has been independently retained by Solstice since January 15, 2025, pursuant to a Statement of Work dated the same day, to prepare technical summaries, performance testing protocols, biocompatibility assessments, and related scientific and technical documentation in support of the 510(k) submission. Pinnacle's expertise in medical device regulatory consulting — and specifically Dr. Ellison's prior experience as a reviewer in CDRH's Division of Chemistry and Toxicology Devices — is a valuable asset to this program.

The purpose of this letter is to formalize coordination protocols between C&H and Pinnacle, delineate the respective roles and responsibilities of each party, establish work product sharing procedures, and address privilege and confidentiality considerations. Our overarching goal is to ensure efficient, well-integrated collaboration throughout the Pre-Sub meeting preparation process, the Pre-Sub meeting itself, and the subsequent preparation and filing of the 510(k) submission, ultimately supporting Solstice's objective of obtaining FDA clearance and achieving U.S. commercial launch in Q4 2026. We believe that a clearly defined coordination framework from the outset will minimize duplication of effort, prevent inadvertent disclosure of privileged materials, and enable both teams to deliver the highest quality work product to our mutual client.

2. Engagement Team Identification

To facilitate effective communication and ensure accountability, we set forth below the key team members from each organization who will be involved in this engagement.

2.1 Calderwood & Harkness Team

The C&H team for this engagement consists of the following individuals:

• Miriam Calloway — Responsible Partner. Ms. Calloway brings twenty-two years of FDA regulatory law experience, including service as senior counsel at FDA's Center for Devices and Radiological Health (CDRH), where she advised on device classification, Pre-Sub strategy, and 510(k) review processes. Ms. Calloway will serve as the primary point of contact for all coordination matters between C&H and Pinnacle and will exercise overall supervisory responsibility for legal strategy and privilege management.

• Joel Strauss — Billing Partner. Mr. Strauss's practice focuses on medical device regulatory strategy and reimbursement. He will maintain oversight of engagement economics, budgetary coordination, and billing matters, and will provide strategic counsel on reimbursement-related regulatory considerations that may bear on 510(k) positioning.

• Amy Whitfield — Lead Associate. Ms. Whitfield has six years of experience in FDA regulatory law with a particular focus on 510(k) and premarket approval (PMA) submissions. She will serve as the day-to-day drafting lead for the Pre-Sub meeting request package, the 510(k) application, and related legal documents, and will be the primary C&H contact for routine operational communications with Pinnacle.

• Sean Morrissey — Working Associate. Mr. Morrissey has three years of experience in pre-submission strategy and device classification. He will support the engagement through research and analysis, including predicate device analysis, classification research, special controls evaluation, and preparation of supporting memoranda.

2.2 Pinnacle Team

Based on our understanding of Pinnacle's engagement with Solstice, the following individuals will serve as the primary Pinnacle contacts:

• Dr. Sandra Ellison — Managing Director. Dr. Ellison will serve as the overall coordination lead for Pinnacle's engagement and will be the primary escalation contact on Pinnacle's side. Her background as a former CDRH reviewer in the Division of Chemistry and Toxicology Devices provides invaluable perspective on anticipated FDA review approaches.

• Thomas Greenbaum, RAC — Senior Regulatory Specialist. Mr. Greenbaum will serve as the technical document preparation lead for Pinnacle's deliverables, including technical summaries, device descriptions, testing protocols, and other scientific documentation.

We respectfully request that Pinnacle confirm whether additional team members will be involved in this engagement and, if so, provide their names, titles, and areas of responsibility so that we may update our coordination records accordingly.

2.3 Client Contacts

The following individuals at Solstice have been designated as key client contacts for this engagement:

• Dr. Niamh Tierney — Vice President of Regulatory Affairs, Solstice Biomedical Devices Ltd. (Dublin HQ). Dr. Tierney serves as the primary regulatory contact for the client and holds approval authority over submission strategy and final regulatory documents.

• Marcus Hale — Vice President of U.S. Operations, Solstice Biomedical Inc. (Cambridge, MA). Mr. Hale is responsible for U.S. operational coordination, including budget approvals and coordination of U.S.-based activities.

• Dr. Aisling Burke — Chief Technology Officer, Solstice Biomedical Devices Ltd. (Dublin HQ). Dr. Burke is the primary contact for technical and engineering queries relating to the Lumina C14 sensor, the Lumina R7 reader/transmitter, the PtIr-4G electrode technology, and the LuminaPredict algorithm.

• Fiona Drennan — Quality Assurance Director, Solstice Biomedical Devices Ltd. (Dublin HQ). Ms. Drennan oversees the quality management system (QMS) and is responsible for testing documentation, ISO 13485:2016 compliance, and design history file management.

All substantive communications between the advisory teams and the client should generally be channeled through Dr. Tierney or Marcus Hale, unless the specific nature of the inquiry warrants direct engagement with Dr. Burke or Ms. Drennan.

3. Scope of Engagement and Delineation of Roles

The following section sets forth the respective responsibilities of C&H and Pinnacle. Clear delineation of roles is essential to avoid duplication of effort, ensure work product integrity, and maintain appropriate privilege protections. Both parties should promptly raise any questions regarding role assignments with their respective coordination leads.

3.1 Calderwood & Harkness Responsibilities (Legal Counsel)

C&H's responsibilities encompass the full scope of legal and regulatory strategy counsel for the Lumina CGM System FDA program, including but not limited to the following:

Overall Regulatory Legal Strategy and Risk Assessment. C&H will develop and advise on the overarching FDA regulatory legal strategy, including assessment of the optimal regulatory pathway, identification of legal risks, and preparation of contingency plans in the event of unfavorable FDA feedback or additional information requests.

Predicate Device Analysis and Substantial Equivalence Legal Framework. C&H will conduct the legal analysis supporting the substantial equivalence determination, including evaluation of the proposed primary predicate device — the NovaSense GlucoTrack NX-500 (510(k) No. K211034, cleared June 18, 2022) — and the proposed secondary predicate device — the NovaSense GlucoTrack NX-700 (510(k) No. K230489, cleared March 7, 2024). C&H will prepare the legal argumentation demonstrating that the Lumina CGM System has the same intended use and the same or substantially equivalent technological characteristics as the identified predicate devices, or, where differences in technological characteristics exist, that such differences do not raise new questions of safety or effectiveness.

Device Classification Legal Analysis. C&H will confirm the applicable device classification for the Lumina CGM System under product code QKQ, 21 C.F.R. § 862.1355, Class II, and advise on any classification nuances that may affect the submission strategy.

iCGM Special Controls Analysis. C&H will analyze the applicability of the integrated continuous glucose monitoring (iCGM) special controls classification (De Novo classification DEN170088 and subsequent reclassification) and advise Solstice on the strategic benefits and requirements of seeking iCGM classification for the Lumina CGM System, including the performance accuracy criteria and interoperability requirements established under 21 C.F.R. § 862.1355.

Pre-Sub Meeting Request and Package. C&H will prepare and conduct legal review of the Pre-Sub meeting request cover letter and FDA Form 3514, lead overall assembly of the Pre-Sub meeting package, and conduct legal review and finalization of all Pre-Sub meeting package components, including the device description, proposed testing plan, clinical protocol summary, and substantial equivalence discussion, prior to submission to FDA.

Pre-Sub Questions for FDA. C&H will prepare the specific questions for FDA feedback to be included in the Pre-Sub meeting package. Anticipated question topics include, but are not limited to: predicate device acceptance, clinical study design and endpoints, IDE exemption applicability, software documentation expectations, cybersecurity submission requirements, biocompatibility testing scope, and iCGM classification eligibility.

Clinical Study Legal Matters. C&H will advise on all legal aspects of the planned LUMINA-US clinical study, including analysis of IDE exemption under 21 C.F.R. § 812.2(c)(3), review and negotiation of the clinical research organization agreement with Veltrano Clinical Research Organization Inc., IRB submission strategy with Clearwater Institutional Review Board LLC (IRB Registration No. IRB-2019-04821), and review of informed consent documents for compliance with 21 C.F.R. Part 50 and applicable ethical standards.

Freedom-to-Operate Coordination. C&H will coordinate with Crestline IP Advisory LLC (Dr. Raymond Cho) on the separate freedom-to-operate ("FTO") analysis for the Lumina CGM System. This engagement is conducted under separate engagement terms, and FTO work product is subject to heightened privilege protections. As discussed further in Section 5.3 below, Pinnacle does not have and will not be granted access to FTO work product.

Labeling Compliance Review. C&H will review all proposed labeling materials — including the Instructions for Use, packaging labels, and patient-facing materials — for compliance with 21 C.F.R. Part 801 and any applicable special controls.

510(k) Submission Legal Documents. C&H will prepare the 510(k) submission cover letter, the 510(k) summary pursuant to 21 C.F.R. § 807.92, and the Indications for Use statement on FDA Form 3881.

Post-Clearance Regulatory Obligations Counseling. C&H will advise Solstice on post-clearance regulatory obligations, including establishment registration, device listing, Medical Device Reporting (MDR), and any special controls or post-market surveillance requirements applicable to iCGM devices.

Privilege Management and Work Product Protection. C&H will exercise oversight of privilege management protocols throughout the engagement, including document marking, communication protocols, and work product protection as set forth in Section 6 of this letter.

3.2 Pinnacle Regulatory Responsibilities (Regulatory Consultant)

Pinnacle's responsibilities encompass the technical, scientific, and regulatory consulting services described in Pinnacle's Statement of Work with Solstice dated January 15, 2025, as supplemented by the coordination protocols set forth in this letter. These responsibilities include, but are not limited to, the following:

Technical Summaries and Device Description Documents. Pinnacle will prepare comprehensive technical summaries and device description documents for inclusion in the Pre-Sub meeting package and the 510(k) submission. These documents should describe the Lumina C14 implantable sensor and Lumina R7 wearable reader/transmitter in sufficient technical detail to enable FDA reviewers to understand the device's design, materials, principles of operation, and specifications.

Performance Testing Protocol Development. Pinnacle will develop bench testing protocols for the evaluation of sensor performance, including sensor accuracy (MARD analysis), linearity across the intended glucose measurement range, precision (within-sensor and between-sensor), interference testing, and sensor stability over the fourteen-day wear period.

Biocompatibility Assessment and Gap Analysis. Pinnacle will prepare a comprehensive biocompatibility assessment and gap analysis based on the ISO 10993 series of standards, in coordination with Whitmore Laboratories Inc. (1625 Shady Grove Road, Suite 300, Gaithersburg, Maryland 20878; A2LA Certificate No. 3847.01). Pinnacle will serve as the primary technical liaison with Whitmore Laboratories and will coordinate testing protocols, specimen preparation, and results analysis. The key contact at Whitmore Laboratories is Dr. James Haverford.

EMC Testing Protocol Support. Pinnacle will provide technical support for electromagnetic compatibility (EMC) and electrical safety testing protocols, also to be conducted at Whitmore Laboratories, ensuring compliance with applicable IEC 60601-1 and IEC 60601-1-2 standards.

Software Documentation Support. Pinnacle will support the preparation of software lifecycle documentation in accordance with IEC 62304:2006/A1:2015, including software level of concern justification (currently assessed as Major level of concern), software architecture and design documentation, and preparation of the Software Bill of Materials (SBOM).

Cybersecurity Documentation Support. Pinnacle will support the preparation of cybersecurity documentation for inclusion in the Pre-Sub package and 510(k) submission, including threat modeling using the STRIDE framework, vulnerability assessment documentation, and cybersecurity risk management documentation consistent with FDA's premarket cybersecurity guidance.

Compilation and Formatting of 510(k) Technical Sections. Pinnacle will compile, format, and organize the technical sections of the 510(k) submission into a submission-ready format, subject to C&H's legal review and finalization.

Regulatory intelligence. Pinnacle will provide ongoing regulatory intelligence regarding CDRH review practices, enforcement trends, and guidance document developments relevant to CGM devices classified under product code QKQ, including any updates to iCGM special controls or related performance standards.

3.3 Shared and Collaborative Responsibilities

Certain deliverables require close collaboration between C&H and Pinnacle. The following sets forth the division of labor for key shared work streams:

Pre-Sub Meeting Package. C&H will lead overall package assembly, legal review, and finalization. Pinnacle will prepare the technical content, including the device description, proposed testing plan, and clinical protocol summary. Both parties will collaborate on the substantial equivalence discussion, with Pinnacle providing the technical comparison analysis and C&H providing the legal argumentation and framing. The final Pre-Sub meeting package will be reviewed and approved by Miriam Calloway (C&H) and Dr. Niamh Tierney (Solstice) prior to filing with FDA.

510(k) Submission. C&H will lead the preparation of legal and regulatory framework sections, including the cover letter, 510(k) summary, Indications for Use statement, substantial equivalence discussion, and regulatory history. Pinnacle will prepare the technical and scientific content sections, including the device description, performance data summaries, biocompatibility data summaries, software and cybersecurity documentation, and sterilization and shelf-life data. Both parties will participate in a joint quality review of the complete submission package before filing.

Predicate Device Comparison Table. Pinnacle will prepare the initial technical comparison table identifying similarities and differences between the Lumina CGM System and the proposed predicate devices (NovaSense GlucoTrack NX-500 and NX-700) with respect to design, materials, technological characteristics, performance specifications, and intended use parameters. C&H will review the comparison table for legal sufficiency and refine the argumentation to support the substantial equivalence determination.

Post-Pre-Sub Meeting Analysis. Following the Pre-Sub meeting with FDA, both C&H and Pinnacle will participate in a joint analysis of FDA's feedback, including the formal meeting minutes issued by FDA. Based on this analysis, both parties will collaborate on adjustments to the submission strategy, testing protocols, clinical study design, or documentation scope, as warranted by FDA's recommendations or requests.

4. Regulatory Timeline and Key Milestones

A detailed master regulatory timeline and milestone tracker has been prepared and is maintained jointly by C&H and Solstice's regulatory affairs team. A summary excerpt of that tracker is enclosed with this letter. The following key dates are particularly relevant to the coordination between C&H and Pinnacle:

Given these deadlines, we wish to emphasize the importance of timely deliverable completion. In particular, Pinnacle is requested to provide draft technical sections of the Pre-Sub meeting package to C&H no later than May 26, 2025, to allow sufficient time for C&H legal review, integration with legal and regulatory framework sections, and any necessary revisions before the June 16, 2025 package submission date. This timeline provides approximately three weeks between Pinnacle's initial draft delivery and the FDA filing date.

For all Pinnacle-prepared technical documents, we anticipate a minimum of two rounds of C&H legal review before finalization. The first review round will focus on substantive legal sufficiency, completeness, and consistency with the overall regulatory strategy. The second review round will address any revisions from the first round, formatting, and final quality assurance. We ask that Pinnacle accommodate this iterative review process in its internal work planning and allocate appropriate time for revisions between review cycles.

Any anticipated delays in deliverable completion should be communicated immediately to both Miriam Calloway (C&H) and Dr. Niamh Tierney (Solstice) so that the overall timeline can be reassessed and, if necessary, adjusted in coordination with all stakeholders.

5. Work Product Sharing Protocols

5.1 Document Exchange Procedures

To ensure the security and integrity of all documents exchanged between C&H and Pinnacle during this engagement, the following document exchange procedures shall be observed:

Secure File-Sharing Platform. All draft documents, working papers, and related materials shall be exchanged via a secure, encrypted file-sharing platform designated by SBI. The specific platform and access credentials will be confirmed by Marcus Hale (VP of U.S. Operations, Solstice Biomedical Inc.) and communicated to both C&H and Pinnacle separately. Under no circumstances should draft regulatory documents, technical summaries, testing protocols, or other substantive work product be transmitted via unencrypted email. Routine scheduling communications, meeting logistics, and non-substantive administrative messages may be transmitted via standard email, but any attachments containing work product or confidential information must be transmitted through the secure platform.

Document Marking. All documents in development should be clearly marked with the following header: "DRAFT — PRIVILEGED & CONFIDENTIAL — ATTORNEY WORK PRODUCT." Additional marking conventions related to privilege protection are set forth in Section 6.2 below.

Version Control. To avoid confusion and ensure that all parties are working from the most current version of each document, all documents shall follow the following naming convention:

[Document Title]\[Author Initials]\[Version Number]\_[Date in YYYYMMDD Format]

For example, a second-version draft of the device description prepared by Thomas Greenbaum (Pinnacle) on May 20, 2025, would be named:

DeviceDescription\TG\v2\_20250520

Each party shall maintain a version log for its respective deliverables and shall clearly indicate in each new version the changes made from the prior version, either through redline/track-changes functionality or through an accompanying change summary.

Final Approval. Final versions of all documents intended for FDA submission shall be reviewed and approved by Miriam Calloway (C&H) and Dr. Niamh Tierney (Solstice) before filing. No document shall be submitted to FDA without both approvals.

5.2 Meetings and Communication

Bi-Weekly Coordination Calls. C&H proposes that the C&H and Pinnacle teams hold bi-weekly coordination calls throughout the duration of the engagement. We suggest scheduling these calls for Tuesdays at 2:00 PM Eastern Time, subject to availability. Client representatives, specifically Dr. Niamh Tierney and Marcus Hale, should be invited to attend each coordination call. The purpose of these calls is to review progress against the timeline, discuss open issues, coordinate upcoming deliverables, and address any questions or concerns. As the Pre-Sub filing date approaches, we may propose increasing the frequency of these calls to weekly or more frequent intervals.

Ad Hoc Communications. Day-to-day operational questions and communications should be directed between Amy Whitfield (C&H) and Thomas Greenbaum (Pinnacle) as the designated day-to-day contacts. Issues that cannot be resolved at the working level, or that involve strategic, legal, or privilege-related considerations, should be escalated to Miriam Calloway (C&H) and Dr. Sandra Ellison (Pinnacle) as appropriate.

Meeting Minutes. Meeting minutes for each coordination call shall be prepared by the party hosting the call and circulated to all attendees within forty-eight (48) hours of the call's conclusion. Minutes should capture key discussion topics, decisions made, action items assigned (with responsible party and due date), and any open issues. Meeting minutes shall be maintained as part of the engagement file and shall be marked in accordance with the document marking protocols described herein.

5.3 Information Barriers — FTO/IP Work Product

C&H wishes to emphasize the following information barrier protocols with respect to the freedom-to-operate and intellectual property analysis being conducted under a separate engagement with Crestline IP Advisory LLC (Dr. Raymond Cho):

No Access for Pinnacle. Pinnacle will not receive, review, or have access to any work product prepared by Crestline IP Advisory LLC, or any FTO analysis, patent landscape assessment, patent claim mapping, or related intellectual property analysis prepared in connection with the Lumina CGM System. This restriction applies to all members of the Pinnacle team, without exception.

Flagging Protocol. If, in the course of its technical work, Pinnacle encounters patent-related considerations, intellectual property issues, or potential freedom-to-operate concerns — including, but not limited to, identification of third-party patents that may be relevant to the Lumina CGM System's technology — Pinnacle should promptly flag the issue to C&H (specifically to Miriam Calloway or Amy Whitfield) without conducting any independent legal or technical analysis of the intellectual property issue. Pinnacle should not include patent-related analysis, opinions, or commentary in any of its technical deliverables.

Rationale. This information barrier protocol is necessary to protect the integrity of the attorney-client privilege and work product doctrine over the FTO analysis. Dissemination of FTO work product to non-attorney consultants who are not operating under the direction of counsel for purposes of the FTO analysis could risk waiver of applicable privilege protections. We appreciate Pinnacle's cooperation in maintaining this barrier.

6. Privilege and Confidentiality Considerations

6.1 Attorney-Client Privilege and Work Product Doctrine

Pinnacle is engaged by Solstice as a regulatory consultant and is not engaged as legal counsel. Accordingly, Pinnacle's work product is not independently protected by the attorney-client privilege, and communications between Pinnacle and Solstice are not, standing alone, privileged communications.

However, we wish to structure the coordination between C&H and Pinnacle in a manner that maximizes applicable privilege protections to the extent permitted by law. To the extent that Pinnacle is assisting C&H in rendering legal advice to Solstice — for example, by providing technical expertise that enables C&H to formulate legal opinions regarding regulatory strategy, substantial equivalence, or compliance — certain work product prepared at C&H's direction may be protected under the attorney work product doctrine (Federal Rule of Civil Procedure 26(b)(3)) or the consultant extension of the attorney-client privilege recognized in United States v. Kovel, 296 F.2d 918 (2d Cir. 1961), and its progeny. The availability of such protection depends on the specific facts and circumstances, including whether the communication or work product was made or prepared at the direction of counsel for the purpose of facilitating legal advice.

To maximize the likelihood of privilege protection, we request that Pinnacle observe the following protocols:

(a) All communications between Pinnacle and C&H regarding regulatory strategy, anticipated FDA positions, submission risks, or legal considerations should be channeled through C&H attorneys (Miriam Calloway, Amy Whitfield, or Sean Morrissey). Pinnacle should avoid engaging in direct discussions with Solstice personnel regarding legal strategy, legal risks, or legal opinions without C&H involvement.

(b) Work product prepared by Pinnacle at C&H's specific request or direction — as distinguished from work product prepared by Pinnacle independently under its own engagement with Solstice — should be labeled "Prepared at the Direction of Counsel — Privileged and Confidential" in addition to the standard draft markings.

(c) Pinnacle should not independently communicate regulatory legal opinions, legal strategy recommendations, or assessments of legal risk to Solstice. To the extent Pinnacle develops views on legal or regulatory strategy matters, those views should be communicated to C&H for evaluation and, if appropriate, incorporation into C&H's legal advice to the client.

We recognize that the line between regulatory consulting advice and legal advice is not always bright, and we appreciate Pinnacle's willingness to collaborate with us in maintaining appropriate boundaries. If Pinnacle has any questions about whether a particular communication or work product should be channeled through C&H, we encourage Pinnacle to err on the side of caution and route the communication through C&H.

6.2 Document Marking Protocol

To support the privilege framework described above, the following document marking conventions shall be observed:

Draft Documents. All draft documents — including technical summaries, testing protocols, strategy memoranda, analysis documents, and internal correspondence — shall bear the following marking prominently on each page:

"DRAFT — PRIVILEGED & CONFIDENTIAL — ATTORNEY WORK PRODUCT — PREPARED AT THE DIRECTION OF CALDERWOOD & HARKNESS LLP"

Final Documents for FDA Submission. All privilege markings must be removed from documents before they are filed with FDA. Once filed, FDA submissions become part of the public record (subject to applicable trade secret and confidential commercial information protections under 21 C.F.R. Part 20) and cannot be maintained as privileged. C&H will coordinate the removal of privilege markings from final submission-ready documents as part of the finalization process.

Internal Strategy Memoranda. Internal strategy memoranda, analyses of anticipated FDA positions, contingency planning documents, and other materials reflecting legal strategy or mental impressions shall be maintained as privileged and shall not be disclosed outside the legal team or to third parties without C&H's prior written approval. These materials should be stored separately from submission-ready documents to avoid inadvertent disclosure.

6.3 Confidentiality Obligations

Pinnacle's existing confidentiality obligations under its engagement with Solstice, as set forth in the Pinnacle Statement of Work dated January 15, 2025, and any associated non-disclosure agreement, remain in full force and effect and are not modified by this letter.

In addition, we wish to emphasize the following specific confidentiality considerations:

Pinnacle shall not disclose any information relating to the Solstice engagement — including the existence of the engagement itself, the identity of the Device, the regulatory strategy, or any technical or commercial information — to any third party without the prior written consent of both Solstice and C&H. This prohibition extends specifically and without limitation to NovaSense Medical Technologies Inc. (4800 Innovation Parkway, San Diego, California 92121) and any of its representatives, employees, agents, consultants, or legal counsel.

All Solstice proprietary information shall be treated as strictly confidential. This includes, without limitation, technical details relating to the PtIr-4G electrode technology, the LuminaPredict algorithm v2.1 specifications, firmware versions and source code, clinical data from EU and U.S. studies, manufacturing processes, quality system documentation, and business plans relating to the U.S. commercial launch.

7. Third-Party Coordination

The Lumina CGM System regulatory program involves several third-party service providers in addition to C&H and Pinnacle. The following section describes Pinnacle's coordination responsibilities with each such third party. Unless otherwise stated, all communications between Pinnacle and third parties should be conducted in Pinnacle's capacity as the technical regulatory consultant for Solstice, and any legal or privilege-related issues should be referred to C&H before engaging with third parties.

Whitmore Laboratories Inc. (1625 Shady Grove Road, Suite 300, Gaithersburg, Maryland 20878; A2LA Certificate No. 3847.01). Pinnacle will serve as the primary technical liaison with Whitmore Laboratories for biocompatibility testing under the ISO 10993 series and for electromagnetic compatibility (EMC) and electrical safety testing under applicable IEC 60601 standards. Pinnacle's responsibilities include coordination of testing protocols, specimen preparation requirements, testing schedules, and review of test results and final reports. The approved budget for biocompatibility testing is $485,000, and the approved budget for EMC and electrical safety testing is $175,000. Target completion for all Whitmore testing is August 31, 2025. The key contact at Whitmore Laboratories is Dr. James Haverford. Pinnacle should copy C&H on any correspondence with Whitmore that raises legal, regulatory, or privilege-related issues.

Veltrano Clinical Research Organization Inc. (500 North Capitol Street, Suite 700, Indianapolis, Indiana 46204). Veltrano has been engaged as the clinical research organization (CRO) for the planned LUMINA-US clinical study. Pinnacle will provide technical input to the clinical protocol (SBD-LUM-CL-001), including device-specific performance endpoints, sensor accuracy assessment methodology, and clinical study design considerations. C&H will lead all legal review of the CRO agreement, informed consent documents, and IRB submissions to Clearwater Institutional Review Board LLC. The key contact at Veltrano is Dr. Lisa Fontaine. Any legal or contractual matters arising from Pinnacle's interactions with Veltrano should be referred to C&H.

Hargrove & Endicott LLP (38 Fitzwilliam Square East, Dublin D02 NH85, Ireland; contact: Ciara Brennan). Hargrove & Endicott serves as Irish legal counsel to Solstice and has been involved in EU MDR compliance, including the CE marking process for the Lumina CGM System. In the course of preparing the U.S. submission, Pinnacle may need to coordinate with Hargrove & Endicott on EU MDR documentation, including the CE certificate (MCA-2024-07319), EU clinical evaluation reports, and related technical documentation that may support substantial equivalence arguments referencing EU clinical data. All communications between Pinnacle and Hargrove & Endicott should be routed through C&H (specifically through Miriam Calloway or Amy Whitfield) to ensure proper coordination and privilege management across jurisdictions.

Meridian Conformity Assessment GmbH (Notified Body 0483). Meridian serves as the EU Notified Body for the Lumina CGM System under the EU MDR. In the course of preparing the 510(k) submission, Pinnacle may need to request ISO 13485:2016 certification documentation or excerpts from the EU MDR technical file from Solstice. C&H should review any such documentation before it is included in or referenced by the FDA submission to ensure consistency with the U.S. regulatory strategy and to address any privilege or confidentiality concerns. Requests for Notified Body documentation should be coordinated through Dr. Niamh Tierney and Fiona Drennan at Solstice.

8. Submission Budget Context

We wish to provide brief context regarding the overall regulatory budget for this program. The total estimated external regulatory costs for the Lumina CGM System U.S. FDA program are approximately $6,127,417. This figure encompasses all external professional fees, testing costs, clinical study expenses, and related expenditures. Within this total:

• Pinnacle consulting fees are budgeted at $380,000, as set forth in the Pinnacle Statement of Work dated January 15, 2025.

• C&H estimated legal fees are budgeted at approximately $650,000, to be incurred on an hourly basis over the course of the engagement.

Given the scale of this investment and the multiple work streams involved, efficient coordination between C&H and Pinnacle is essential to avoid duplication of effort, minimize unnecessary expenditures, and manage costs within the approved budget. Both parties should be mindful of their respective scopes of work and should not undertake work that falls within the other party's designated responsibilities without prior coordination.

Any scope expansions, additional deliverables, or changes in work plans that would result in costs exceeding the agreed budgets must be approved in advance by Dr. Niamh Tierney and Marcus Hale before work commences. Both C&H and Pinnacle should provide advance notice to the client if it appears that their respective budgets may be at risk of being exceeded.

9. Conflict of Interest Disclosure Request

Consistent with professional best practices and the client's expectations, C&H respectfully requests that Pinnacle confirm, in writing, that it has no current or recent engagements — including any engagements concluded within the past twenty-four (24) months — with any of the following entities or their affiliates:

(a) NovaSense Medical Technologies Inc. (4800 Innovation Parkway, San Diego, California 92121), including any subsidiary, affiliate, or successor entity;

(b) Marlowe Asset Management Patent Group LLP, or any of its attorneys, agents, or consultants; or

(c) Any other entity that could present a conflict of interest, an appearance of a conflict of interest, or a duty of loyalty or confidentiality obligation that could impair Pinnacle's ability to serve Solstice's interests in connection with this engagement.

In the event that Pinnacle has had or currently has any such engagement, we request that Pinnacle disclose the nature and scope of the engagement so that we may assess, in coordination with Solstice, whether any conflict management measures are necessary.

Pinnacle is further requested to notify C&H promptly if any potential conflict of interest arises at any point during the engagement, including the acceptance of any new engagement that could create a conflict with Pinnacle's obligations to Solstice.

10. Points of Contact Summary

For ease of reference, the following table summarizes the primary contacts for each organization involved in this engagement:

Direct contact information, including email addresses and telephone numbers, will be exchanged separately via secure channel to avoid inclusion of personal contact data in a document that may be stored across multiple systems. We ask that Pinnacle provide its team's preferred contact details through the secure platform once it has been established.

11. Acknowledgment and Next Steps

We respectfully request that Pinnacle acknowledge receipt of this letter and confirm its agreement with the coordination protocols set forth herein. Such acknowledgment may be provided by return letter, email confirmation from Dr. Ellison, or a countersigned copy of this letter, at Pinnacle's preference. If Pinnacle has any suggested modifications to the protocols described herein, we welcome the opportunity to discuss them and, if appropriate, memorialize any agreed changes in a supplemental coordination letter.

Upon receipt of Pinnacle's acknowledgment, we propose scheduling the first coordination call within one week, with the primary agenda being a detailed discussion of the Pre-Sub meeting package preparation timeline, deliverable assignments, and the anticipated content and format of each component of the Pre-Sub package.

Following the first coordination call, C&H will circulate a detailed Pre-Sub deliverables matrix identifying each deliverable, the responsible party (or parties), the content specifications, the internal due date, the review cycle schedule, and the final filing deadline. This matrix will serve as the working project management tool for the Pre-Sub workstream and will be updated on a rolling basis.

We appreciate the opportunity to work collaboratively with Pinnacle on this important engagement. We recognize and value the technical expertise that Dr. Ellison, Mr. Greenbaum, and the broader Pinnacle team bring to this program, and we are confident that the complementary capabilities of our respective organizations will serve Solstice's interests well throughout this regulatory process.

We look forward to working closely with Pinnacle to achieve a successful Pre-Sub meeting and 510(k) clearance for the Solstice Lumina™ CGM System.

Please do not hesitate to contact me directly with any questions regarding this letter or the coordination framework described herein.

Very truly yours,

CALDERWOOD & HARKNESS LLP

By: ________

Miriam Calloway Partner, Healthcare & Life Sciences 1401 K Street NW, Suite 900 Washington, D.C. 20005

cc:

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

Marcus Hale, Vice President of U.S. Operations, Solstice Biomedical Inc.

Joel Strauss, Partner, Calderwood & Harkness LLP

Amy Whitfield, Associate, Calderwood & Harkness LLP

Sean Morrissey, Associate, Calderwood & Harkness LLP

Encl:

Regulatory Timeline and Milestone Tracker (summary excerpt)

Milestone	Target Date
Pre-Sub meeting request submission to FDA	June 2, 2025
Pre-Sub meeting package submission to FDA (60 days before meeting)	June 16, 2025
Pre-Sub meeting with FDA (CDRH, OHT2 — Division of Chemistry and Toxicology Devices)	August 14, 2025
Biocompatibility testing complete (Whitmore Laboratories)	August 31, 2025
LUMINA-US clinical study commenced	September 15, 2025
LUMINA-US clinical study completed	March 15, 2026
510(k) submission to FDA	April 30, 2026
Target FDA clearance	Q3 2026
Target U.S. commercial launch	Q4 2026
Organization	Name	Role	Function
Calderwood & Harkness LLP	Miriam Calloway	Partner	Overall coordination, escalation, privilege management
Calderwood & Harkness LLP	Amy Whitfield	Lead Associate	Day-to-day operational coordination, drafting lead
Calderwood & Harkness LLP	Sean Morrissey	Working Associate	Research support, classification analysis
Pinnacle Regulatory Consulting	Dr. Sandra Ellison	Managing Director	Overall coordination, escalation
Pinnacle Regulatory Consulting	Thomas Greenbaum, RAC	Senior Regulatory Specialist	Day-to-day technical, document preparation
Solstice Biomedical Devices Ltd.	Dr. Niamh Tierney	VP Regulatory Affairs	Regulatory strategy approval (Dublin HQ)
Solstice Biomedical Inc.	Marcus Hale	VP U.S. Operations	U.S. operational coordination (Cambridge, MA)
Solstice Biomedical Devices Ltd.	Dr. Aisling Burke	Chief Technology Officer	Technical/engineering queries (Dublin HQ)
Solstice Biomedical Devices Ltd.	Fiona Drennan	Quality Assurance Director	QMS, testing documentation (Dublin HQ)

PRIVILEGED & CONFIDENTIAL
CALDERWOOD & HARKNESS LLP Attorneys at Law
1401 K Street NW, Suite 900 Washington, D.C. 20005 Telephone: (202) 555-8400 Facsimile: (202) 555-8401
Healthcare & Life Sciences Practice Group
May 2, 2025
Dr. Sandra Ellison, Managing Director Thomas Greenbaum, RAC, Senior Regulatory Specialist Pinnacle Regulatory Consulting Group LLC 9500 Medical Center Drive, Suite 210 Rockville, MD 20850
Re: Coordination of Regulatory Advisory Services — Solstice Lumina™ CGM System; FDA Pre-Submission and 510(k) Strategy; Calderwood & Harkness Engagement Ref. No. 1037-00002
Dear Dr. Ellison and Mr. Greenbaum:
1. Purpose and Background
Calderwood & Harkness LLP ("C&H" or the "Firm") has been engaged by Solstice Biomedical Inc. ("SBI"), the U.S. subsidiary of Solstice Biomedical Devices Ltd. ("Solstice" or "SBD"), to provide legal counsel on FDA regulatory strategy for the Solstice Lumina™ Continuous Glucose Monitoring System (the "Lumina CGM System" or the "Device"). Our engagement was formally opened on April 22, 2025, and our retainer was received on April 28, 2025. We write to you now to formalize the coordination framework between our respective organizations in support of SBI's FDA Pre-Submission ("Pre-Sub") meeting preparation and subsequent traditional 510(k) submission.
SBI is a Delaware corporation (File No. 7834291), with its principal offices located at 220 Westbrook Drive, Suite 400, Cambridge, Massachusetts 02142. SBI will serve as the intended 510(k) holder and the U.S. legal manufacturer of record for the Device. SBI is a wholly owned subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company (CRO No. 648231), headquartered at Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland. SBD serves as the parent entity for global operations, including device design, development, and manufacturing, and retains ultimate strategic authority over the regulatory program.
The Lumina CGM System encompasses two principal device variants that are intended to be submitted as a single system under a traditional 510(k) pathway: (i) the Lumina C14, an implantable continuous glucose sensor designed for subcutaneous insertion with a fourteen-day wear period, and (ii) the Lumina R7, a wearable reader and transmitter unit that communicates wirelessly with the C14 sensor and transmits processed glucose data to the patient's mobile device and compatible electronic health record systems. Together, the C14 and R7 constitute an integrated continuous glucose monitoring system intended for use by adult patients (18 years and older) with Type 1 or Type 2 diabetes mellitus for the management of diabetes through real-time and retrospective glucose monitoring.
We understand that Pinnacle Regulatory Consulting Group LLC ("Pinnacle") has been independently retained by Solstice since January 15, 2025, pursuant to a Statement of Work dated the same day, to prepare technical summaries, performance testing protocols, biocompatibility assessments, and related scientific and technical documentation in support of the 510(k) submission. Pinnacle's expertise in medical device regulatory consulting — and specifically Dr. Ellison's prior experience as a reviewer in CDRH's Division of Chemistry and Toxicology Devices — is a valuable asset to this program.
The purpose of this letter is to formalize coordination protocols between C&H and Pinnacle, delineate the respective roles and responsibilities of each party, establish work product sharing procedures, and address privilege and confidentiality considerations. Our overarching goal is to ensure efficient, well-integrated collaboration throughout the Pre-Sub meeting preparation process, the Pre-Sub meeting itself, and the subsequent preparation and filing of the 510(k) submission, ultimately supporting Solstice's objective of obtaining FDA clearance and achieving U.S. commercial launch in Q4 2026. We believe that a clearly defined coordination framework from the outset will minimize duplication of effort, prevent inadvertent disclosure of privileged materials, and enable both teams to deliver the highest quality work product to our mutual client.
2. Engagement Team Identification
To facilitate effective communication and ensure accountability, we set forth below the key team members from each organization who will be involved in this engagement.
2.1 Calderwood & Harkness Team
The C&H team for this engagement consists of the following individuals:
• Miriam Calloway — Responsible Partner. Ms. Calloway brings twenty-two years of FDA regulatory law experience, including service as senior counsel at FDA's Center for Devices and Radiological Health (CDRH), where she advised on device classification, Pre-Sub strategy, and 510(k) review processes. Ms. Calloway will serve as the primary point of contact for all coordination matters between C&H and Pinnacle and will exercise overall supervisory responsibility for legal strategy and privilege management.
• Joel Strauss — Billing Partner. Mr. Strauss's practice focuses on medical device regulatory strategy and reimbursement. He will maintain oversight of engagement economics, budgetary coordination, and billing matters, and will provide strategic counsel on reimbursement-related regulatory considerations that may bear on 510(k) positioning.
• Amy Whitfield — Lead Associate. Ms. Whitfield has six years of experience in FDA regulatory law with a particular focus on 510(k) and premarket approval (PMA) submissions. She will serve as the day-to-day drafting lead for the Pre-Sub meeting request package, the 510(k) application, and related legal documents, and will be the primary C&H contact for routine operational communications with Pinnacle.
• Sean Morrissey — Working Associate. Mr. Morrissey has three years of experience in pre-submission strategy and device classification. He will support the engagement through research and analysis, including predicate device analysis, classification research, special controls evaluation, and preparation of supporting memoranda.
2.2 Pinnacle Team
Based on our understanding of Pinnacle's engagement with Solstice, the following individuals will serve as the primary Pinnacle contacts:
• Dr. Sandra Ellison — Managing Director. Dr. Ellison will serve as the overall coordination lead for Pinnacle's engagement and will be the primary escalation contact on Pinnacle's side. Her background as a former CDRH reviewer in the Division of Chemistry and Toxicology Devices provides invaluable perspective on anticipated FDA review approaches.
• Thomas Greenbaum, RAC — Senior Regulatory Specialist. Mr. Greenbaum will serve as the technical document preparation lead for Pinnacle's deliverables, including technical summaries, device descriptions, testing protocols, and other scientific documentation.
We respectfully request that Pinnacle confirm whether additional team members will be involved in this engagement and, if so, provide their names, titles, and areas of responsibility so that we may update our coordination records accordingly.
2.3 Client Contacts
The following individuals at Solstice have been designated as key client contacts for this engagement:
• Dr. Niamh Tierney — Vice President of Regulatory Affairs, Solstice Biomedical Devices Ltd. (Dublin HQ). Dr. Tierney serves as the primary regulatory contact for the client and holds approval authority over submission strategy and final regulatory documents.
• Marcus Hale — Vice President of U.S. Operations, Solstice Biomedical Inc. (Cambridge, MA). Mr. Hale is responsible for U.S. operational coordination, including budget approvals and coordination of U.S.-based activities.
• Dr. Aisling Burke — Chief Technology Officer, Solstice Biomedical Devices Ltd. (Dublin HQ). Dr. Burke is the primary contact for technical and engineering queries relating to the Lumina C14 sensor, the Lumina R7 reader/transmitter, the PtIr-4G electrode technology, and the LuminaPredict algorithm.
• Fiona Drennan — Quality Assurance Director, Solstice Biomedical Devices Ltd. (Dublin HQ). Ms. Drennan oversees the quality management system (QMS) and is responsible for testing documentation, ISO 13485:2016 compliance, and design history file management.
All substantive communications between the advisory teams and the client should generally be channeled through Dr. Tierney or Marcus Hale, unless the specific nature of the inquiry warrants direct engagement with Dr. Burke or Ms. Drennan.
3. Scope of Engagement and Delineation of Roles
The following section sets forth the respective responsibilities of C&H and Pinnacle. Clear delineation of roles is essential to avoid duplication of effort, ensure work product integrity, and maintain appropriate privilege protections. Both parties should promptly raise any questions regarding role assignments with their respective coordination leads.
3.1 Calderwood & Harkness Responsibilities (Legal Counsel)
C&H's responsibilities encompass the full scope of legal and regulatory strategy counsel for the Lumina CGM System FDA program, including but not limited to the following:
Overall Regulatory Legal Strategy and Risk Assessment. C&H will develop and advise on the overarching FDA regulatory legal strategy, including assessment of the optimal regulatory pathway, identification of legal risks, and preparation of contingency plans in the event of unfavorable FDA feedback or additional information requests.
Predicate Device Analysis and Substantial Equivalence Legal Framework. C&H will conduct the legal analysis supporting the substantial equivalence determination, including evaluation of the proposed primary predicate device — the NovaSense GlucoTrack NX-500 (510(k) No. K211034, cleared June 18, 2022) — and the proposed secondary predicate device — the NovaSense GlucoTrack NX-700 (510(k) No. K230489, cleared March 7, 2024). C&H will prepare the legal argumentation demonstrating that the Lumina CGM System has the same intended use and the same or substantially equivalent technological characteristics as the identified predicate devices, or, where differences in technological characteristics exist, that such differences do not raise new questions of safety or effectiveness.
Device Classification Legal Analysis. C&H will confirm the applicable device classification for the Lumina CGM System under product code QKQ, 21 C.F.R. § 862.1355, Class II, and advise on any classification nuances that may affect the submission strategy.
iCGM Special Controls Analysis. C&H will analyze the applicability of the integrated continuous glucose monitoring (iCGM) special controls classification (De Novo classification DEN170088 and subsequent reclassification) and advise Solstice on the strategic benefits and requirements of seeking iCGM classification for the Lumina CGM System, including the performance accuracy criteria and interoperability requirements established under 21 C.F.R. § 862.1355.
Pre-Sub Meeting Request and Package. C&H will prepare and conduct legal review of the Pre-Sub meeting request cover letter and FDA Form 3514, lead overall assembly of the Pre-Sub meeting package, and conduct legal review and finalization of all Pre-Sub meeting package components, including the device description, proposed testing plan, clinical protocol summary, and substantial equivalence discussion, prior to submission to FDA.
Pre-Sub Questions for FDA. C&H will prepare the specific questions for FDA feedback to be included in the Pre-Sub meeting package. Anticipated question topics include, but are not limited to: predicate device acceptance, clinical study design and endpoints, IDE exemption applicability, software documentation expectations, cybersecurity submission requirements, biocompatibility testing scope, and iCGM classification eligibility.
Clinical Study Legal Matters. C&H will advise on all legal aspects of the planned LUMINA-US clinical study, including analysis of IDE exemption under 21 C.F.R. § 812.2(c)(3), review and negotiation of the clinical research organization agreement with Veltrano Clinical Research Organization Inc., IRB submission strategy with Clearwater Institutional Review Board LLC (IRB Registration No. IRB-2019-04821), and review of informed consent documents for compliance with 21 C.F.R. Part 50 and applicable ethical standards.
Freedom-to-Operate Coordination. C&H will coordinate with Crestline IP Advisory LLC (Dr. Raymond Cho) on the separate freedom-to-operate ("FTO") analysis for the Lumina CGM System. This engagement is conducted under separate engagement terms, and FTO work product is subject to heightened privilege protections. As discussed further in Section 5.3 below, Pinnacle does not have and will not be granted access to FTO work product.
Labeling Compliance Review. C&H will review all proposed labeling materials — including the Instructions for Use, packaging labels, and patient-facing materials — for compliance with 21 C.F.R. Part 801 and any applicable special controls.
510(k) Submission Legal Documents. C&H will prepare the 510(k) submission cover letter, the 510(k) summary pursuant to 21 C.F.R. § 807.92, and the Indications for Use statement on FDA Form 3881.
Post-Clearance Regulatory Obligations Counseling. C&H will advise Solstice on post-clearance regulatory obligations, including establishment registration, device listing, Medical Device Reporting (MDR), and any special controls or post-market surveillance requirements applicable to iCGM devices.
Privilege Management and Work Product Protection. C&H will exercise oversight of privilege management protocols throughout the engagement, including document marking, communication protocols, and work product protection as set forth in Section 6 of this letter.
3.2 Pinnacle Regulatory Responsibilities (Regulatory Consultant)
Pinnacle's responsibilities encompass the technical, scientific, and regulatory consulting services described in Pinnacle's Statement of Work with Solstice dated January 15, 2025, as supplemented by the coordination protocols set forth in this letter. These responsibilities include, but are not limited to, the following:
Technical Summaries and Device Description Documents. Pinnacle will prepare comprehensive technical summaries and device description documents for inclusion in the Pre-Sub meeting package and the 510(k) submission. These documents should describe the Lumina C14 implantable sensor and Lumina R7 wearable reader/transmitter in sufficient technical detail to enable FDA reviewers to understand the device's design, materials, principles of operation, and specifications.
Performance Testing Protocol Development. Pinnacle will develop bench testing protocols for the evaluation of sensor performance, including sensor accuracy (MARD analysis), linearity across the intended glucose measurement range, precision (within-sensor and between-sensor), interference testing, and sensor stability over the fourteen-day wear period.
Biocompatibility Assessment and Gap Analysis. Pinnacle will prepare a comprehensive biocompatibility assessment and gap analysis based on the ISO 10993 series of standards, in coordination with Whitmore Laboratories Inc. (1625 Shady Grove Road, Suite 300, Gaithersburg, Maryland 20878; A2LA Certificate No. 3847.01). Pinnacle will serve as the primary technical liaison with Whitmore Laboratories and will coordinate testing protocols, specimen preparation, and results analysis. The key contact at Whitmore Laboratories is Dr. James Haverford.
EMC Testing Protocol Support. Pinnacle will provide technical support for electromagnetic compatibility (EMC) and electrical safety testing protocols, also to be conducted at Whitmore Laboratories, ensuring compliance with applicable IEC 60601-1 and IEC 60601-1-2 standards.
Software Documentation Support. Pinnacle will support the preparation of software lifecycle documentation in accordance with IEC 62304:2006/A1:2015, including software level of concern justification (currently assessed as Major level of concern), software architecture and design documentation, and preparation of the Software Bill of Materials (SBOM).
Cybersecurity Documentation Support. Pinnacle will support the preparation of cybersecurity documentation for inclusion in the Pre-Sub package and 510(k) submission, including threat modeling using the STRIDE framework, vulnerability assessment documentation, and cybersecurity risk management documentation consistent with FDA's premarket cybersecurity guidance.
Compilation and Formatting of 510(k) Technical Sections. Pinnacle will compile, format, and organize the technical sections of the 510(k) submission into a submission-ready format, subject to C&H's legal review and finalization.
Regulatory intelligence. Pinnacle will provide ongoing regulatory intelligence regarding CDRH review practices, enforcement trends, and guidance document developments relevant to CGM devices classified under product code QKQ, including any updates to iCGM special controls or related performance standards.
3.3 Shared and Collaborative Responsibilities
Certain deliverables require close collaboration between C&H and Pinnacle. The following sets forth the division of labor for key shared work streams:
Pre-Sub Meeting Package. C&H will lead overall package assembly, legal review, and finalization. Pinnacle will prepare the technical content, including the device description, proposed testing plan, and clinical protocol summary. Both parties will collaborate on the substantial equivalence discussion, with Pinnacle providing the technical comparison analysis and C&H providing the legal argumentation and framing. The final Pre-Sub meeting package will be reviewed and approved by Miriam Calloway (C&H) and Dr. Niamh Tierney (Solstice) prior to filing with FDA.
510(k) Submission. C&H will lead the preparation of legal and regulatory framework sections, including the cover letter, 510(k) summary, Indications for Use statement, substantial equivalence discussion, and regulatory history. Pinnacle will prepare the technical and scientific content sections, including the device description, performance data summaries, biocompatibility data summaries, software and cybersecurity documentation, and sterilization and shelf-life data. Both parties will participate in a joint quality review of the complete submission package before filing.
Predicate Device Comparison Table. Pinnacle will prepare the initial technical comparison table identifying similarities and differences between the Lumina CGM System and the proposed predicate devices (NovaSense GlucoTrack NX-500 and NX-700) with respect to design, materials, technological characteristics, performance specifications, and intended use parameters. C&H will review the comparison table for legal sufficiency and refine the argumentation to support the substantial equivalence determination.
Post-Pre-Sub Meeting Analysis. Following the Pre-Sub meeting with FDA, both C&H and Pinnacle will participate in a joint analysis of FDA's feedback, including the formal meeting minutes issued by FDA. Based on this analysis, both parties will collaborate on adjustments to the submission strategy, testing protocols, clinical study design, or documentation scope, as warranted by FDA's recommendations or requests.
4. Regulatory Timeline and Key Milestones
A detailed master regulatory timeline and milestone tracker has been prepared and is maintained jointly by C&H and Solstice's regulatory affairs team. A summary excerpt of that tracker is enclosed with this letter. The following key dates are particularly relevant to the coordination between C&H and Pinnacle:
Given these deadlines, we wish to emphasize the importance of timely deliverable completion. In particular, Pinnacle is requested to provide draft technical sections of the Pre-Sub meeting package to C&H no later than May 26, 2025, to allow sufficient time for C&H legal review, integration with legal and regulatory framework sections, and any necessary revisions before the June 16, 2025 package submission date. This timeline provides approximately three weeks between Pinnacle's initial draft delivery and the FDA filing date.
For all Pinnacle-prepared technical documents, we anticipate a minimum of two rounds of C&H legal review before finalization. The first review round will focus on substantive legal sufficiency, completeness, and consistency with the overall regulatory strategy. The second review round will address any revisions from the first round, formatting, and final quality assurance. We ask that Pinnacle accommodate this iterative review process in its internal work planning and allocate appropriate time for revisions between review cycles.
Any anticipated delays in deliverable completion should be communicated immediately to both Miriam Calloway (C&H) and Dr. Niamh Tierney (Solstice) so that the overall timeline can be reassessed and, if necessary, adjusted in coordination with all stakeholders.
5. Work Product Sharing Protocols
5.1 Document Exchange Procedures
To ensure the security and integrity of all documents exchanged between C&H and Pinnacle during this engagement, the following document exchange procedures shall be observed:
Secure File-Sharing Platform. All draft documents, working papers, and related materials shall be exchanged via a secure, encrypted file-sharing platform designated by SBI. The specific platform and access credentials will be confirmed by Marcus Hale (VP of U.S. Operations, Solstice Biomedical Inc.) and communicated to both C&H and Pinnacle separately. Under no circumstances should draft regulatory documents, technical summaries, testing protocols, or other substantive work product be transmitted via unencrypted email. Routine scheduling communications, meeting logistics, and non-substantive administrative messages may be transmitted via standard email, but any attachments containing work product or confidential information must be transmitted through the secure platform.
Document Marking. All documents in development should be clearly marked with the following header: "DRAFT — PRIVILEGED & CONFIDENTIAL — ATTORNEY WORK PRODUCT." Additional marking conventions related to privilege protection are set forth in Section 6.2 below.
Version Control. To avoid confusion and ensure that all parties are working from the most current version of each document, all documents shall follow the following naming convention:
[Document Title]\[Author Initials]\[Version Number]\_[Date in YYYYMMDD Format]
For example, a second-version draft of the device description prepared by Thomas Greenbaum (Pinnacle) on May 20, 2025, would be named:
DeviceDescription\TG\v2\_20250520
Each party shall maintain a version log for its respective deliverables and shall clearly indicate in each new version the changes made from the prior version, either through redline/track-changes functionality or through an accompanying change summary.
Final Approval. Final versions of all documents intended for FDA submission shall be reviewed and approved by Miriam Calloway (C&H) and Dr. Niamh Tierney (Solstice) before filing. No document shall be submitted to FDA without both approvals.
5.2 Meetings and Communication
Bi-Weekly Coordination Calls. C&H proposes that the C&H and Pinnacle teams hold bi-weekly coordination calls throughout the duration of the engagement. We suggest scheduling these calls for Tuesdays at 2:00 PM Eastern Time, subject to availability. Client representatives, specifically Dr. Niamh Tierney and Marcus Hale, should be invited to attend each coordination call. The purpose of these calls is to review progress against the timeline, discuss open issues, coordinate upcoming deliverables, and address any questions or concerns. As the Pre-Sub filing date approaches, we may propose increasing the frequency of these calls to weekly or more frequent intervals.
Ad Hoc Communications. Day-to-day operational questions and communications should be directed between Amy Whitfield (C&H) and Thomas Greenbaum (Pinnacle) as the designated day-to-day contacts. Issues that cannot be resolved at the working level, or that involve strategic, legal, or privilege-related considerations, should be escalated to Miriam Calloway (C&H) and Dr. Sandra Ellison (Pinnacle) as appropriate.
Meeting Minutes. Meeting minutes for each coordination call shall be prepared by the party hosting the call and circulated to all attendees within forty-eight (48) hours of the call's conclusion. Minutes should capture key discussion topics, decisions made, action items assigned (with responsible party and due date), and any open issues. Meeting minutes shall be maintained as part of the engagement file and shall be marked in accordance with the document marking protocols described herein.
5.3 Information Barriers — FTO/IP Work Product
C&H wishes to emphasize the following information barrier protocols with respect to the freedom-to-operate and intellectual property analysis being conducted under a separate engagement with Crestline IP Advisory LLC (Dr. Raymond Cho):
No Access for Pinnacle. Pinnacle will not receive, review, or have access to any work product prepared by Crestline IP Advisory LLC, or any FTO analysis, patent landscape assessment, patent claim mapping, or related intellectual property analysis prepared in connection with the Lumina CGM System. This restriction applies to all members of the Pinnacle team, without exception.
Flagging Protocol. If, in the course of its technical work, Pinnacle encounters patent-related considerations, intellectual property issues, or potential freedom-to-operate concerns — including, but not limited to, identification of third-party patents that may be relevant to the Lumina CGM System's technology — Pinnacle should promptly flag the issue to C&H (specifically to Miriam Calloway or Amy Whitfield) without conducting any independent legal or technical analysis of the intellectual property issue. Pinnacle should not include patent-related analysis, opinions, or commentary in any of its technical deliverables.
Rationale. This information barrier protocol is necessary to protect the integrity of the attorney-client privilege and work product doctrine over the FTO analysis. Dissemination of FTO work product to non-attorney consultants who are not operating under the direction of counsel for purposes of the FTO analysis could risk waiver of applicable privilege protections. We appreciate Pinnacle's cooperation in maintaining this barrier.
6. Privilege and Confidentiality Considerations
6.1 Attorney-Client Privilege and Work Product Doctrine
Pinnacle is engaged by Solstice as a regulatory consultant and is not engaged as legal counsel. Accordingly, Pinnacle's work product is not independently protected by the attorney-client privilege, and communications between Pinnacle and Solstice are not, standing alone, privileged communications.
However, we wish to structure the coordination between C&H and Pinnacle in a manner that maximizes applicable privilege protections to the extent permitted by law. To the extent that Pinnacle is assisting C&H in rendering legal advice to Solstice — for example, by providing technical expertise that enables C&H to formulate legal opinions regarding regulatory strategy, substantial equivalence, or compliance — certain work product prepared at C&H's direction may be protected under the attorney work product doctrine (Federal Rule of Civil Procedure 26(b)(3)) or the consultant extension of the attorney-client privilege recognized in United States v. Kovel, 296 F.2d 918 (2d Cir. 1961), and its progeny. The availability of such protection depends on the specific facts and circumstances, including whether the communication or work product was made or prepared at the direction of counsel for the purpose of facilitating legal advice.
To maximize the likelihood of privilege protection, we request that Pinnacle observe the following protocols:
(a) All communications between Pinnacle and C&H regarding regulatory strategy, anticipated FDA positions, submission risks, or legal considerations should be channeled through C&H attorneys (Miriam Calloway, Amy Whitfield, or Sean Morrissey). Pinnacle should avoid engaging in direct discussions with Solstice personnel regarding legal strategy, legal risks, or legal opinions without C&H involvement.
(b) Work product prepared by Pinnacle at C&H's specific request or direction — as distinguished from work product prepared by Pinnacle independently under its own engagement with Solstice — should be labeled "Prepared at the Direction of Counsel — Privileged and Confidential" in addition to the standard draft markings.
(c) Pinnacle should not independently communicate regulatory legal opinions, legal strategy recommendations, or assessments of legal risk to Solstice. To the extent Pinnacle develops views on legal or regulatory strategy matters, those views should be communicated to C&H for evaluation and, if appropriate, incorporation into C&H's legal advice to the client.
We recognize that the line between regulatory consulting advice and legal advice is not always bright, and we appreciate Pinnacle's willingness to collaborate with us in maintaining appropriate boundaries. If Pinnacle has any questions about whether a particular communication or work product should be channeled through C&H, we encourage Pinnacle to err on the side of caution and route the communication through C&H.
6.2 Document Marking Protocol
To support the privilege framework described above, the following document marking conventions shall be observed:
Draft Documents. All draft documents — including technical summaries, testing protocols, strategy memoranda, analysis documents, and internal correspondence — shall bear the following marking prominently on each page:
"DRAFT — PRIVILEGED & CONFIDENTIAL — ATTORNEY WORK PRODUCT — PREPARED AT THE DIRECTION OF CALDERWOOD & HARKNESS LLP"
Final Documents for FDA Submission. All privilege markings must be removed from documents before they are filed with FDA. Once filed, FDA submissions become part of the public record (subject to applicable trade secret and confidential commercial information protections under 21 C.F.R. Part 20) and cannot be maintained as privileged. C&H will coordinate the removal of privilege markings from final submission-ready documents as part of the finalization process.
Internal Strategy Memoranda. Internal strategy memoranda, analyses of anticipated FDA positions, contingency planning documents, and other materials reflecting legal strategy or mental impressions shall be maintained as privileged and shall not be disclosed outside the legal team or to third parties without C&H's prior written approval. These materials should be stored separately from submission-ready documents to avoid inadvertent disclosure.
6.3 Confidentiality Obligations
Pinnacle's existing confidentiality obligations under its engagement with Solstice, as set forth in the Pinnacle Statement of Work dated January 15, 2025, and any associated non-disclosure agreement, remain in full force and effect and are not modified by this letter.
In addition, we wish to emphasize the following specific confidentiality considerations:
Pinnacle shall not disclose any information relating to the Solstice engagement — including the existence of the engagement itself, the identity of the Device, the regulatory strategy, or any technical or commercial information — to any third party without the prior written consent of both Solstice and C&H. This prohibition extends specifically and without limitation to NovaSense Medical Technologies Inc. (4800 Innovation Parkway, San Diego, California 92121) and any of its representatives, employees, agents, consultants, or legal counsel.
All Solstice proprietary information shall be treated as strictly confidential. This includes, without limitation, technical details relating to the PtIr-4G electrode technology, the LuminaPredict algorithm v2.1 specifications, firmware versions and source code, clinical data from EU and U.S. studies, manufacturing processes, quality system documentation, and business plans relating to the U.S. commercial launch.
7. Third-Party Coordination
The Lumina CGM System regulatory program involves several third-party service providers in addition to C&H and Pinnacle. The following section describes Pinnacle's coordination responsibilities with each such third party. Unless otherwise stated, all communications between Pinnacle and third parties should be conducted in Pinnacle's capacity as the technical regulatory consultant for Solstice, and any legal or privilege-related issues should be referred to C&H before engaging with third parties.
Whitmore Laboratories Inc. (1625 Shady Grove Road, Suite 300, Gaithersburg, Maryland 20878; A2LA Certificate No. 3847.01). Pinnacle will serve as the primary technical liaison with Whitmore Laboratories for biocompatibility testing under the ISO 10993 series and for electromagnetic compatibility (EMC) and electrical safety testing under applicable IEC 60601 standards. Pinnacle's responsibilities include coordination of testing protocols, specimen preparation requirements, testing schedules, and review of test results and final reports. The approved budget for biocompatibility testing is $485,000, and the approved budget for EMC and electrical safety testing is $175,000. Target completion for all Whitmore testing is August 31, 2025. The key contact at Whitmore Laboratories is Dr. James Haverford. Pinnacle should copy C&H on any correspondence with Whitmore that raises legal, regulatory, or privilege-related issues.
Veltrano Clinical Research Organization Inc. (500 North Capitol Street, Suite 700, Indianapolis, Indiana 46204). Veltrano has been engaged as the clinical research organization (CRO) for the planned LUMINA-US clinical study. Pinnacle will provide technical input to the clinical protocol (SBD-LUM-CL-001), including device-specific performance endpoints, sensor accuracy assessment methodology, and clinical study design considerations. C&H will lead all legal review of the CRO agreement, informed consent documents, and IRB submissions to Clearwater Institutional Review Board LLC. The key contact at Veltrano is Dr. Lisa Fontaine. Any legal or contractual matters arising from Pinnacle's interactions with Veltrano should be referred to C&H.
Hargrove & Endicott LLP (38 Fitzwilliam Square East, Dublin D02 NH85, Ireland; contact: Ciara Brennan). Hargrove & Endicott serves as Irish legal counsel to Solstice and has been involved in EU MDR compliance, including the CE marking process for the Lumina CGM System. In the course of preparing the U.S. submission, Pinnacle may need to coordinate with Hargrove & Endicott on EU MDR documentation, including the CE certificate (MCA-2024-07319), EU clinical evaluation reports, and related technical documentation that may support substantial equivalence arguments referencing EU clinical data. All communications between Pinnacle and Hargrove & Endicott should be routed through C&H (specifically through Miriam Calloway or Amy Whitfield) to ensure proper coordination and privilege management across jurisdictions.
Meridian Conformity Assessment GmbH (Notified Body 0483). Meridian serves as the EU Notified Body for the Lumina CGM System under the EU MDR. In the course of preparing the 510(k) submission, Pinnacle may need to request ISO 13485:2016 certification documentation or excerpts from the EU MDR technical file from Solstice. C&H should review any such documentation before it is included in or referenced by the FDA submission to ensure consistency with the U.S. regulatory strategy and to address any privilege or confidentiality concerns. Requests for Notified Body documentation should be coordinated through Dr. Niamh Tierney and Fiona Drennan at Solstice.
8. Submission Budget Context
We wish to provide brief context regarding the overall regulatory budget for this program. The total estimated external regulatory costs for the Lumina CGM System U.S. FDA program are approximately $6,127,417. This figure encompasses all external professional fees, testing costs, clinical study expenses, and related expenditures. Within this total:
• Pinnacle consulting fees are budgeted at $380,000, as set forth in the Pinnacle Statement of Work dated January 15, 2025.
• C&H estimated legal fees are budgeted at approximately $650,000, to be incurred on an hourly basis over the course of the engagement.
Given the scale of this investment and the multiple work streams involved, efficient coordination between C&H and Pinnacle is essential to avoid duplication of effort, minimize unnecessary expenditures, and manage costs within the approved budget. Both parties should be mindful of their respective scopes of work and should not undertake work that falls within the other party's designated responsibilities without prior coordination.
Any scope expansions, additional deliverables, or changes in work plans that would result in costs exceeding the agreed budgets must be approved in advance by Dr. Niamh Tierney and Marcus Hale before work commences. Both C&H and Pinnacle should provide advance notice to the client if it appears that their respective budgets may be at risk of being exceeded.
9. Conflict of Interest Disclosure Request
Consistent with professional best practices and the client's expectations, C&H respectfully requests that Pinnacle confirm, in writing, that it has no current or recent engagements — including any engagements concluded within the past twenty-four (24) months — with any of the following entities or their affiliates:
(a) NovaSense Medical Technologies Inc. (4800 Innovation Parkway, San Diego, California 92121), including any subsidiary, affiliate, or successor entity;
(b) Marlowe Asset Management Patent Group LLP, or any of its attorneys, agents, or consultants; or
(c) Any other entity that could present a conflict of interest, an appearance of a conflict of interest, or a duty of loyalty or confidentiality obligation that could impair Pinnacle's ability to serve Solstice's interests in connection with this engagement.
In the event that Pinnacle has had or currently has any such engagement, we request that Pinnacle disclose the nature and scope of the engagement so that we may assess, in coordination with Solstice, whether any conflict management measures are necessary.
Pinnacle is further requested to notify C&H promptly if any potential conflict of interest arises at any point during the engagement, including the acceptance of any new engagement that could create a conflict with Pinnacle's obligations to Solstice.
10. Points of Contact Summary
For ease of reference, the following table summarizes the primary contacts for each organization involved in this engagement:
Direct contact information, including email addresses and telephone numbers, will be exchanged separately via secure channel to avoid inclusion of personal contact data in a document that may be stored across multiple systems. We ask that Pinnacle provide its team's preferred contact details through the secure platform once it has been established.
11. Acknowledgment and Next Steps
We respectfully request that Pinnacle acknowledge receipt of this letter and confirm its agreement with the coordination protocols set forth herein. Such acknowledgment may be provided by return letter, email confirmation from Dr. Ellison, or a countersigned copy of this letter, at Pinnacle's preference. If Pinnacle has any suggested modifications to the protocols described herein, we welcome the opportunity to discuss them and, if appropriate, memorialize any agreed changes in a supplemental coordination letter.
Upon receipt of Pinnacle's acknowledgment, we propose scheduling the first coordination call within one week, with the primary agenda being a detailed discussion of the Pre-Sub meeting package preparation timeline, deliverable assignments, and the anticipated content and format of each component of the Pre-Sub package.
Following the first coordination call, C&H will circulate a detailed Pre-Sub deliverables matrix identifying each deliverable, the responsible party (or parties), the content specifications, the internal due date, the review cycle schedule, and the final filing deadline. This matrix will serve as the working project management tool for the Pre-Sub workstream and will be updated on a rolling basis.
We appreciate the opportunity to work collaboratively with Pinnacle on this important engagement. We recognize and value the technical expertise that Dr. Ellison, Mr. Greenbaum, and the broader Pinnacle team bring to this program, and we are confident that the complementary capabilities of our respective organizations will serve Solstice's interests well throughout this regulatory process.
We look forward to working closely with Pinnacle to achieve a successful Pre-Sub meeting and 510(k) clearance for the Solstice Lumina™ CGM System.
Please do not hesitate to contact me directly with any questions regarding this letter or the coordination framework described herein.
Very truly yours,
CALDERWOOD & HARKNESS LLP
By: ________
Miriam Calloway Partner, Healthcare & Life Sciences 1401 K Street NW, Suite 900 Washington, D.C. 20005
cc:
Dr. Niamh Tierney, Vice President of Regulatory Affairs, Solstice Biomedical Devices Ltd.
Marcus Hale, Vice President of U.S. Operations, Solstice Biomedical Inc.
Joel Strauss, Partner, Calderwood & Harkness LLP
Amy Whitfield, Associate, Calderwood & Harkness LLP
Sean Morrissey, Associate, Calderwood & Harkness LLP
Encl:
Regulatory Timeline and Milestone Tracker (summary excerpt)
Milestone | Target Date
Pre-Sub meeting request submission to FDA | June 2, 2025
Pre-Sub meeting package submission to FDA (60 days before meeting) | June 16, 2025
Pre-Sub meeting with FDA (CDRH, OHT2 — Division of Chemistry and Toxicology Devices) | August 14, 2025
Biocompatibility testing complete (Whitmore Laboratories) | August 31, 2025
LUMINA-US clinical study commenced | September 15, 2025
LUMINA-US clinical study completed | March 15, 2026
510(k) submission to FDA | April 30, 2026
Target FDA clearance | Q3 2026
Target U.S. commercial launch | Q4 2026
Organization | Name | Role | Function
Calderwood & Harkness LLP | Miriam Calloway | Partner | Overall coordination, escalation, privilege management
Calderwood & Harkness LLP | Amy Whitfield | Lead Associate | Day-to-day operational coordination, drafting lead
Calderwood & Harkness LLP | Sean Morrissey | Working Associate | Research support, classification analysis
Pinnacle Regulatory Consulting | Dr. Sandra Ellison | Managing Director | Overall coordination, escalation
Pinnacle Regulatory Consulting | Thomas Greenbaum, RAC | Senior Regulatory Specialist | Day-to-day technical, document preparation
Solstice Biomedical Devices Ltd. | Dr. Niamh Tierney | VP Regulatory Affairs | Regulatory strategy approval (Dublin HQ)
Solstice Biomedical Inc. | Marcus Hale | VP U.S. Operations | U.S. operational coordination (Cambridge, MA)
Solstice Biomedical Devices Ltd. | Dr. Aisling Burke | Chief Technology Officer | Technical/engineering queries (Dublin HQ)
Solstice Biomedical Devices Ltd. | Fiona Drennan | Quality Assurance Director | QMS, testing documentation (Dublin HQ)

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