MEMORANDUM
PRIVILEGED AND CONFIDENTIAL — ATTORNEY WORK PRODUCT
CALDERWOOD & HARKNESS LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005
April 18, 2025
TO: File — Matter No. 1037-00002
FROM: Miriam Calloway, Responsible Partner, Healthcare & Life Sciences Practice Group
RE: Conflict of Interest Check — Proposed Engagement with Solstice Biomedical Devices Ltd. and Solstice Biomedical Inc. (FDA Regulatory Strategy for Solstice Lumina™ CGM System)
CONFIDENTIALITY NOTICE: This memorandum is prepared for internal Calderwood & Harkness LLP use only and is subject to attorney-client privilege and work product protection. It contains confidential information concerning the firm's internal conflict clearance procedures and the results of a conflicts analysis conducted in connection with a proposed new client engagement. This memorandum is not for distribution outside the firm. Any unauthorized disclosure, copying, or distribution of this memorandum, or any action taken in reliance upon it by persons other than authorized Calderwood & Harkness LLP personnel, is strictly prohibited.
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-2023-007, as amended), the District of Columbia Rules of Professional Conduct (Rules 1.7, 1.9, and 1.10), and the American Bar Association Model Rules of Professional Conduct, as applicable.
The proposed engagement concerns the provision of FDA pre-submission strategy counsel, 510(k) submission planning, and related regulatory filings for the Solstice Lumina™ CGM System, a continuous glucose monitoring device under development by the prospective client. The Solstice Lumina™ CGM System is an electrochemical, sensor-based wearable medical device intended for real-time and retrospective continuous glucose monitoring in adult patients (age 18 and older) with Type 1 and Type 2 diabetes mellitus. The device received EU MDR CE marking in September 2024 and is now seeking U.S. market authorization via the FDA's 510(k) premarket notification pathway.
The proposed client entities are:
(a) Solstice Biomedical Devices Ltd. ("Solstice" or "SBD"), a private limited company incorporated under the laws of Ireland, Companies Registration Office Number 648231, with its registered office at Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland; and
(b) Solstice Biomedical Inc. ("SBI"), a corporation organized under the laws of the State of Delaware, File Number 7834291, with its principal place of business at 220 Westbrook Drive, Suite 400, Cambridge, Massachusetts 02142, United States. SBI is a wholly-owned subsidiary of SBD and will serve as the intended 510(k) holder and designated U.S. agent for purposes of FDA communications and submissions.
The proposed engagement is to be opened under the direction of Miriam Calloway (Responsible Partner, Healthcare & Life Sciences Practice Group) and Joel Strauss (Billing Partner, Healthcare & Life Sciences Practice Group). The initial staffing plan contemplates that Amy Whitfield (Lead Associate) and Sean Morrissey (Working Associate) will be assigned to the matter, with additional personnel to be added as the scope of the engagement requires.
The engagement letter reference number assigned to this matter is 1037-00002, and the anticipated date for issuance of the engagement letter is April 22, 2025.
The conflict of interest check was initiated on April 14, 2025, upon receipt of the new matter intake form and supporting documentation from the prospective client, and was completed on April 18, 2025, following the search, review, and analysis procedures described in this memorandum.
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 to the proposed engagement.
A. Client Entities
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 intellectual property rights in the Lumina technology platform, including design and utility patents filed in multiple jurisdictions, and is the legal manufacturer for purposes of the EU Medical Devices Regulation (MDR 2017/745). SBD is a privately held company; no shares are publicly traded.
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 entity responsible for U.S. commercial distribution of the Lumina CGM System upon regulatory clearance. SBI maintains the U.S. establishment registration and device listing with the FDA.
B. Client Key Personnel
The following individuals were identified as key personnel of the prospective client entities who are expected to be involved in or have material knowledge related to the proposed engagement:
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: Corporation organized under the laws of the State of Delaware
• Delaware Division of Corporations File No.: 5429876
• Headquarters: 4800 Innovation Parkway, San Diego, CA 92121
• Description: NovaSense is identified as the manufacturer of both the primary and secondary predicate devices that Solstice intends to reference in its 510(k) premarket notification submission:
(i) GlucoTrack NX-500 — 510(k) No. K211034, cleared by the FDA on June 18, 2022; intended use as a prescription, real-time continuous glucose monitoring system for adults with diabetes; classified under 21 C.F.R. § 862.1355 (product code QBJ).
(ii) GlucoTrack NX-700 — 510(k) No. K230489, cleared by the FDA on March 7, 2024; a second-generation CGM system with enhanced sensor accuracy and extended wear duration.
• Patent Portfolio: NovaSense holds a portfolio of fourteen (14) U.S. utility patents related to continuous glucose monitoring technology, including patents covering electrochemical sensor designs, glucose oxidase enzyme immobilization techniques, signal processing algorithms, and wireless data transmission protocols for wearable biosensors. Specific patents potentially relevant to freedom-to-operate considerations include, but are not limited to, U.S. Patent Nos. 10,847,221; 11,234,567; and 11,502,893.
• Financial Profile: NovaSense reported annual revenue of approximately $1.24 billion for fiscal year 2024. NovaSense is a publicly traded company on the NASDAQ exchange (ticker symbol: NVSM).
• Relevance to Engagement: NovaSense is identified as a potentially interested or adverse party because (a) it is the manufacturer of the predicate devices to be cited in the 510(k) submission, (b) it holds patents that may be implicated in a freedom-to-operate analysis relating to the Lumina™ CGM System, and (c) it is a direct competitor of Solstice in the CGM market. At this time, there are no pending or threatened adversarial proceedings between Solstice and NovaSense.
The following individuals associated with NovaSense were included in the conflicts search:
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 Group LLP serves as outside patent prosecution and enforcement counsel to NovaSense Medical Technologies Inc. Marlowe Asset Management Patent Group is identified as a potentially relevant party due to the overlap between NovaSense's patent portfolio and the Lumina™ CGM System technology, and the possibility that freedom-to-operate issues may arise during or subsequent to the proposed engagement.
• Key Contact: Patricia Langford, Partner, Marlowe Asset Management Patent Group LLP. Ms. Langford is the lead patent attorney responsible for the NovaSense CGM patent portfolio.
E. Related Third-Party Service Providers and Counsel Retained by Solstice
The following third-party service providers and external counsel have been identified as parties currently retained by or working in coordination with Solstice in connection with the Lumina™ CGM System regulatory program. These parties were included in the conflicts search because the Firm may interact, coordinate, or share information with them during the course of the proposed engagement.
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 Lumina™ CGM System. Pinnacle's scope of work includes preparation of the pre-submission (Q-Sub) meeting request package, drafting of portions of the 510(k) summary, and coordination with the FDA's Center for Devices and Radiological Health (CDRH), Division of Chemistry and Toxicology Devices (DChTD).
• Key Contacts: Dr. Sandra Ellison, Managing Director; Thomas Greenbaum, Senior Regulatory Specialist.
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 Lumina™ device. Crestline's engagement is separate from and independent of the proposed Calderwood & Harkness engagement; Calderwood & Harkness will not be providing patent or FTO advice as part of the proposed engagement.
• Key Contact: Dr. Raymond Cho, Patent Attorney.
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 corporate governance.
• Key Contact: Ciara Brennan, Partner.
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 accordance with ISO 10993-1:2018 and FDA guidance) and electromagnetic compatibility (EMC) testing (in accordance with IEC 60601-1-2:2014+A1:2020) for the Lumina™ CGM System.
• Key Contact: Dr. James Haverford.
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 MDR CE certificate for the Solstice Lumina™ CGM System (Certificate No. MCA-2024-07319, dated September 12, 2024), confirming conformity with the applicable requirements of Annex I (General Safety and Performance Requirements) of the MDR.
• Key Contact: Dr. Henrik Vogt.
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 (product liability and clinical trial liability).
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 prospective, multi-center, non-randomized, single-arm accuracy study intended to generate clinical performance data supporting the 510(k) submission. The study is expected to enroll approximately 100 adult subjects with Type 1 and Type 2 diabetes at up to five clinical sites in the United States.
• Key Contact: Dr. Lisa Fontaine, Vice President of Clinical Operations.
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 review board designated to provide ethical oversight and approval for the planned LUMINA-US clinical study.
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 the General Counsel and is updated on a continuous basis as new matters are opened, existing matters are modified, and matters are closed.
The search was conducted by the Firm's conflicts clearance team, operating under the supervision of the Office of the General Counsel, in accordance with the Firm's Conflicts of Interest Policy (Policy No. GC-2023-007, as amended October 1, 2024).
All parties identified in Section II of this memorandum were searched in the conflicts management database. Searches were conducted using the following data points for each party, as applicable:
(a) Full legal entity name, including all known variations, abbreviations, trade names, and d/b/a designations;
(b) Individual name (surname and given name, including known variations, maiden names, and alternative spellings);
(c) Jurisdiction of incorporation or organization;
(d) Registered office or principal place of business address;
(e) Key identifier numbers, including Companies Registration Office (CRO) No. 648231 (for SBD), Delaware Division of Corporations File No. 7834291 (for SBI), and Delaware Division of Corporations File No. 5429876 (for NovaSense); and
(f) Known affiliations and parent-subsidiary relationships.
In addition to the internal conflicts management database, the search results were cross-referenced against active and closed matter records for the preceding seven (7) years (i.e., matters opened, active, or closed from April 2018 through April 2025) in the following Calderwood & Harkness practice groups, which were identified as the most likely to have had contact with any of the parties listed in Section II:
(a) Healthcare & Life Sciences Practice Group;
(b) intellectual Property Practice Group;
(c) Corporate & Transactional Practice Group; and
(d) Litigation Practice Group.
B. Search Parameters
The conflicts clearance team executed the following categories of searches against the Firm's conflicts management database:
Exact-Match and Fuzzy/Phonetic Searches. Each entity and individual name listed in Section II was searched using both exact-match algorithms and fuzzy/phonetic matching algorithms (including Soundex and Levenshtein distance matching) to capture potential matches involving misspellings, transliterations, or alternative renderings of names.
Individual Name Searches. All individual names listed in Section II were searched independently, including first name, last name, and, where known, middle name or initial. Searches were conducted for the following individuals: Dr. Eoin Gallagher, Dr. Niamh Tierney, Marcus Hale, Dr. Aisling Burke, Fiona Drennan, David Reinhardt, Dr. Karen Nishimura, Patricia Langford, Dr. Sandra Ellison, Thomas Greenbaum, Dr. Raymond Cho, Ciara Brennan, Dr. James Haverford, Dr. Henrik Vogt, Declan Murray, Dr. Lisa Fontaine, and all variations thereof.
Wildcard and Keyword Searches. The following wildcard and keyword searches were executed to capture potential matches that might not appear under formal entity or individual name searches:
• "Solstice" (and variations including "Solstice Bio," "Solstice Biomed," "Solstice Biomedical")
• "NovaSense" (and variations including "Nova Sense," "Nova-Sense," "NovaSense Medical")
• "GlucoTrack" (and variations including "Gluco Track," "Gluco-Track")
• "Lumina" (and variations including "Lumina CGM," "Solstice Lumina")
• "Pinnacle Regulatory" (and variations)
• "Crestline IP" (and variations including "Crestline IP Advisory")
• "Marlowe Asset Management Patent" (and variations including "Marlowe Asset Management Patent Group")
• "Whitmore Lab" (and variations including "Whitmore Laboratories")
• "Meridian Conformity" (and variations including "Meridian Conformity Assessment")
• "Atlas Underwriting" (and variations including "Atlas Underwriting Partners")
• "Broadleaf" (and variations including "Broadleaf Accounting")
• "Veltrano" (and variations including "Veltrano Clinical," "Veltrano CRO")
• "Clearwater IRB" (and variations including "Clearwater Institutional Review Board")
Industry Filter Searches. An additional set of searches was executed using industry classification and subject-matter tags to identify any Firm matters within potentially relevant technology and industry categories. The following industry and subject-matter tags were used:
• Medical devices
• Continuous glucose monitoring / CGM
• Biosensors
• Electrochemical sensors
• Wearable diagnostics
• FDA 510(k) / premarket notification
• FDA pre-submission / Q-Sub
• In vitro diagnostics (IVD)
C. Personnel Consulted
In addition to the database searches described above, the following Firm personnel were consulted as part of the conflict clearance process:
Miriam Calloway (Responsible Partner, Healthcare & Life Sciences Practice Group) — As the partner initiating the new matter request, Ms. Calloway was consulted regarding her personal knowledge of any prior representation of, adverse relationship with, or other connection to any of the parties listed in Section II. Ms. Calloway confirmed that she has no personal knowledge of any such prior representation, adverse relationship, or other connection that would give rise to a conflict of interest.
Joel Strauss (Billing Partner, Healthcare & Life Sciences Practice Group) — Mr. Strauss was consulted regarding his personal knowledge of any prior representation of, adverse relationship with, or other connection to any of the parties listed in Section II. Mr. Strauss confirmed that he has no personal knowledge of any such prior representation, adverse relationship, or other connection.
Office of the General Counsel — The Firm's Office of the General Counsel reviewed the complete search results, confirmed the adequacy and completeness of the searches conducted, and provided signoff on the conflict clearance on April 18, 2025.
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 results for either Solstice Biomedical Devices Ltd. or Solstice Biomedical Inc. Specifically:
(a) No prior representation of either entity was identified in the Firm's conflicts database, including in any capacity (as a client, co-client, or affiliate of a client) in any practice group or office of the Firm.
(b) No prior adverse representation against either entity was identified, including in any litigation, regulatory, transactional, or advisory matter.
(c) No prior matter involving either entity in any capacity — whether as a party, witness, interested party, or other participant — was identified in the Firm's records.
Both Solstice Biomedical Devices Ltd. and Solstice Biomedical Inc. are new to the Firm and have not previously been the subject of any matter opened at Calderwood & Harkness LLP.
B. NovaSense Medical Technologies Inc.
A comprehensive search of the Firm's conflicts management database returned no results for NovaSense Medical Technologies Inc. Specifically:
(a) No current or prior representation of NovaSense was identified in the Firm's conflicts database.
(b) No current or prior adverse representation against NovaSense was identified.
(c) No matter on behalf of any party adverse to NovaSense was identified.
Analytical Note: NovaSense Medical Technologies Inc. is identified in this memorandum as a potentially interested or adverse party because it is the manufacturer of the primary and secondary predicate devices (GlucoTrack NX-500 and GlucoTrack NX-700) that Solstice intends to reference in its 510(k) submission, and because NovaSense holds a portfolio of U.S. utility patents that may be implicated in a freedom-to-operate analysis with respect to the Lumina™ CGM System. However, the proposed Calderwood & Harkness engagement is limited to FDA regulatory advisory services — specifically, pre-submission strategy, 510(k) submission planning, and related regulatory filings — and does not involve the initiation or prosecution of litigation, adversarial patent proceedings, or any other formal dispute against NovaSense. At this time, no formal dispute or adversarial proceeding exists between Solstice and NovaSense. The freedom-to-operate analysis concerning NovaSense's patent portfolio is being handled exclusively by Crestline IP Advisory LLC, a separate outside counsel retained independently by Solstice, and Calderwood & Harkness will have no involvement in that analysis.
C. Marlowe Asset Management Patent Group LLP and Patricia Langford
A comprehensive search of the Firm's conflicts management database returned no results for Marlowe Asset Management Patent Group LLP or Patricia Langford. No current or prior co-counsel relationship, adverse relationship, or other connection between Calderwood & Harkness and Marlowe Asset Management Patent Group LLP or Ms. Langford was identified.
D. Pinnacle Regulatory Consulting Group LLC, Dr. Sandra Ellison, and Thomas Greenbaum
A comprehensive search of the Firm's conflicts management database returned no results for Pinnacle Regulatory Consulting Group LLC, Dr. Sandra Ellison, or Thomas Greenbaum. No conflicts were identified. Pinnacle Regulatory Consulting Group is a co-advisor alongside Calderwood & Harkness on the Solstice engagement and is not adverse to the Firm or to any Firm client. No adverse relationship was identified.
E. Crestline IP Advisory LLC and Dr. Raymond Cho
A comprehensive search of the Firm's conflicts management database returned no results for Crestline IP Advisory LLC or Dr. Raymond Cho. No conflicts were identified. Crestline IP Advisory LLC is separately retained by Solstice for patent and freedom-to-operate work and is not adverse to the Firm or to any Firm client. No adverse relationship was identified.
F. Hargrove & Endicott LLP and Ciara Brennan
A comprehensive search of the Firm's conflicts management database returned no results for Hargrove & Endicott LLP or Ciara Brennan. No conflicts were identified. Hargrove & Endicott LLP serves as Irish corporate and regulatory counsel to Solstice and is not adverse to the Firm or to any Firm client. No adverse relationship was identified.
G. Whitmore Laboratories Inc. and Dr. James Haverford
A comprehensive search of the Firm's conflicts management database returned no results for Whitmore Laboratories Inc. or Dr. James Haverford. No conflicts were identified.
H. Meridian Conformity Assessment GmbH and Dr. Henrik Vogt
A comprehensive search of the Firm's conflicts management database returned no results for Meridian Conformity Assessment GmbH or Dr. Henrik Vogt. No conflicts were identified.
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. Veltrano Clinical Research Organization Inc. and Dr. Lisa Fontaine
A comprehensive search of the Firm's conflicts management database returned no results for Veltrano Clinical Research Organization Inc. or Dr. Lisa Fontaine. No conflicts were identified.
L. Clearwater Institutional Review Board LLC
A comprehensive search of the Firm's conflicts management database returned no results for Clearwater Institutional Review Board LLC. No conflicts were identified.
M. Individual Personnel of Client
Searches were conducted for each of the following individuals identified as key personnel of the prospective client entities:
• Dr. Eoin Gallagher — No conflicts identified.
• Dr. Niamh Tierney — No conflicts identified.
• Marcus Hale — No conflicts identified.
• Dr. Aisling Burke — No conflicts identified.
• Fiona Drennan — No conflicts identified.
None of the above individuals appeared in the Firm's conflicts management database in any capacity — as a client, former client, adverse party, witness, or other participant in any matter.
N. Individual Personnel of NovaSense
Searches were conducted for each of the following individuals identified as key personnel of NovaSense Medical Technologies Inc.:
• David Reinhardt — No conflicts identified.
• Dr. Karen Nishimura — No conflicts identified.
Neither individual appeared in the Firm's conflicts management database in any capacity.