Contract analysis

I. PURPOSE OF MEMORANDUM The purpose of this memorandum is to document the completion and results of the conflict of interest check conducted by Calderwood & Harkness LLP ("the Firm" or "C&H") in connection with a proposed new client engagement involving the provision of FDA regulatory advisory services. This memorandum has been prepared in accordance with the Firm's Conflicts of Interest Policy (Policy No. GC-2023-0

II. IDENTIFIED PARTIES SEARCHED The following parties were identified as requiring inclusion in the conflicts search based on the information provided in the new matter intake form, the prospective client's engagement request materials, publicly available information, and preliminary discussions with the prospective client's representatives. The parties have been categorized according to their role and relationship t

1. Solstice Biomedical Devices Ltd. ("Solstice" or "SBD") • Entity Type: Private limited company (Ltd.) incorporated under the laws of Ireland • Companies Registration Office (CRO) No.: 648231 • Registered Office: Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland • Description: SBD is the parent entity and the primary developer and manufacturer of the Solstice Lumina™ CGM System. SBD holds the int

2. Solstice Biomedical Inc. ("SBI") • Entity Type: Corporation organized under the laws of the State of Delaware • Delaware Division of Corporations File No.: 7834291 • Principal Place of Business: 220 Westbrook Drive, Suite 400, Cambridge, MA 02142 • Description: SBI is the wholly-owned U.S. subsidiary of SBD. SBI will serve as the intended 510(k) holder, the designated U.S. agent for FDA correspondence, and the ent

1. Dr. Eoin Gallagher — Chief Executive Officer, Solstice Biomedical Devices Ltd. Dr. Gallagher is the co-founder of Solstice and the individual with primary authority over the engagement.

2. Dr. Niamh Tierney — Vice President of Regulatory Affairs, Solstice Biomedical Devices Ltd. Dr. Tierney is the primary regulatory point of contact for the engagement and will serve as the day-to-day liaison with Calderwood & Harkness.

3. Marcus Hale — Vice President of U.S. Operations, Solstice Biomedical Inc. Mr. Hale oversees SBI's U.S. regulatory, commercial, and operational functions and will be the principal contact at the U.S. subsidiary.

4. Dr. Aisling Burke — Chief Technology Officer, Solstice Biomedical Devices Ltd. Dr. Burke leads the engineering and product development teams and possesses detailed knowledge of the Lumina™ device architecture, including its sensor chemistry, algorithm design, and hardware specifications.

5. Fiona Drennan — Quality Assurance Director, Solstice Biomedical Devices Ltd. Ms. Drennan is responsible for Solstice's quality management system (QMS), including compliance with 21 C.F.R. Part 820 (Quality System Regulation), ISO 13485:2016, and the EU MDR quality requirements. C. Adverse and Interested Parties — Predicate Device Manufacturer NovaSense Medical Technologies Inc. ("NovaSense") • Entity Type: Corpora

1. David Reinhardt — Chief Executive Officer, NovaSense Medical Technologies Inc.

2. Dr. Karen Nishimura — Vice President of Regulatory Affairs, NovaSense Medical Technologies Inc. D. Adverse and Interested Parties — NovaSense Patent Counsel Marlowe Asset Management Patent Group LLP • Entity Type: Limited liability partnership organized under the laws of the Commonwealth of Virginia • Address: 2200 Wilson Boulevard, Suite 1100, Arlington, VA 22201 • Description: Marlowe Asset Management Patent Gro

1. Pinnacle Regulatory Consulting Group LLC • Entity Type: Limited liability company organized under the laws of the State of Delaware • Address: 9500 Medical Center Drive, Suite 210, Rockville, MD 20850 • Description: Pinnacle Regulatory Consulting Group LLC is a specialized regulatory affairs consultancy retained by Solstice since January 15, 2025, to provide pre-submission and 510(k) preparation support for the Lu

2. Crestline IP Advisory LLC • Entity Type: Limited liability company organized under the laws of the State of Delaware • Address: 75 Federal Street, Suite 1800, Boston, MA 02110 • Description: Crestline IP Advisory LLC is a patent advisory firm retained by Solstice to conduct a freedom-to-operate (FTO) analysis with respect to NovaSense's CGM patent portfolio and other third-party patents potentially relevant to the

3. Hargrove & Endicott LLP • Entity Type: Partnership organized under the laws of Ireland • Address: 38 Fitzwilliam Square East, Dublin D02 NH85, Ireland • Description: Hargrove & Endicott LLP serves as Irish corporate, commercial, and regulatory counsel to Solstice Biomedical Devices Ltd. Hargrove & Endicott advises Solstice on matters of Irish company law, EU MDR compliance, data protection (GDPR), and general corp

4. Whitmore Laboratories Inc. • Entity Type: Corporation organized under the laws of the State of Delaware • Address: 1625 Shady Grove Road, Suite 300, Gaithersburg, MD 20878 • Description: Whitmore Laboratories Inc. is an FDA-recognized, ISO 17025-accredited contract testing laboratory (A2LA Certificate No. 3847.01) that has been engaged by Solstice since March 3, 2025, to perform biocompatibility testing (in accord

5. Meridian Conformity Assessment GmbH • Entity Type: Gesellschaft mit beschränkter Haftung (GmbH) organized under the laws of the Federal Republic of Germany • Address: Landsberger Allee 44, 10249 Berlin, Germany • Description: Meridian Conformity Assessment GmbH is an EU notified body (Notified Body Identification No. 0483) designated under the EU Medical Devices Regulation (MDR 2017/745). Meridian issued the EU MD

6. Atlas Underwriting Partners Ltd. • Entity Type: Limited company incorporated under the laws of England and Wales (United Kingdom) • Address: 25 Fenchurch Avenue, London EC3M 5AD, United Kingdom • Description: Atlas Underwriting Partners Ltd. provides product liability and clinical trial insurance coverage for Solstice Biomedical Devices Ltd. and its subsidiaries. • Relevant Policy: Policy No. AUP-PL-2024-00893 (pr

7. Broadleaf Accounting Partners LLP • Entity Type: Limited liability partnership organized under the laws of Ireland • Address: 12 Harcourt Street, Dublin D02 P890, Ireland • Description: Broadleaf Accounting Partners LLP serves as the external auditors for Solstice Biomedical Devices Ltd. • Key Contact: Declan Murray, Audit Partner.

8. Veltrano Clinical Research Organization Inc. • Entity Type: Corporation organized under the laws of the State of Indiana • Address: 500 North Capitol Street, Suite 700, Indianapolis, IN 46204 • Description: Veltrano Clinical Research Organization Inc. is a contract research organization (CRO) retained by Solstice to manage and conduct the planned LUMINA-US clinical study (Protocol No. SBD-LUM-CL-001), a prospectiv

9. Clearwater Institutional Review Board LLC • Entity Type: Limited liability company organized under the laws of the State of Florida • Address: 3200 Bayshore Boulevard, Tampa, FL 33629 • IRB Registration No.: IRB-2019-04821 (registered with the U.S. Department of Health and Human Services, Office for Human Research Protections) • Description: Clearwater Institutional Review Board LLC is the central institutional re

III. SEARCH METHODOLOGY A. Databases and Systems Searched The conflict of interest check was conducted using the Firm's internal conflicts management database, which consolidates client, matter, and party information across all Calderwood & Harkness LLP offices, including the Washington, D.C., New York, Boston, San Francisco, and London offices. The conflicts management system is maintained by the Firm's Office of th

IV. SEARCH RESULTS The following summarizes the results of the conflict of interest searches conducted in accordance with the methodology described in Section III above. Results are organized by party, corresponding to the categories set forth in Section II. A. Client Entities — Solstice Biomedical Devices Ltd. and Solstice Biomedical Inc. A comprehensive search of the Firm's conflicts management database returned no

I. Atlas Underwriting Partners Ltd. A comprehensive search of the Firm's conflicts management database returned no results for Atlas Underwriting Partners Ltd. No conflicts were identified. J. Broadleaf Accounting Partners LLP and Declan Murray A comprehensive search of the Firm's conflicts management database returned no results for Broadleaf Accounting Partners LLP or Declan Murray. No conflicts were identified. K.

V. ANALYSIS AND CONCLUSION A. Conflict Determination Based on the comprehensive conflict of interest search conducted in accordance with the methodology described in Section III of this memorandum, and after thorough review and analysis of the search results summarized in Section IV, the undersigned has determined that no conflict of interest has been identified that would preclude Calderwood & Harkness LLP from unde

VI. RECORD OF APPROVAL PREPARED BY: By: ________ Name: Miriam Calloway Title: Responsible Partner, Healthcare & Life Sciences Practice Group Date: April 18, 2025 REVIEWED AND APPROVED BY: By: ________ Name: Jonathan R. Aldridge Title: General Counsel, Calderwood & Harkness LLP Date: ________ APPENDIX A Conflicts Database Search Results — Summary Note: This appendix provides a summary listing of all search strings exe