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PRIVILEGED AND CONFIDENTIAL — ATTORNEY-CLIENT PRIVILEGED / ATTORNEY WORK PRODUCT — FOR INTERNAL CALDERWOOD & HARKNESS LLP USE ONLY — NOT FOR DISTRIBUTION OUTSIDE THE FIRM WITHOUT PRIOR AUTHORIZATION

CALDERWOOD & HARKNESS LLP INTERNAL MEMORANDUM

FROM: Miriam Calloway, Responsible Partner, Healthcare & Life Sciences Practice, Calderwood & Harkness LLP

TO: Joel Strauss, Billing Partner, Healthcare & Life Sciences Practice Amy Whitfield, Lead Associate, Healthcare & Life Sciences Practice Sean Morrissey, Working Associate, Healthcare & Life Sciences Practice

DATE: April 25, 2025

RE: Privilege and Work Product Protection Guidelines — Solstice Biomedical Devices Ltd. / Solstice Biomedical Inc. FDA Pre-Submission and 510(k) Engagement (Engagement Ref. No. 1037-00002)

CLIENT: Solstice Biomedical Devices Ltd. (Ireland, CRO No. 648231) and Solstice Biomedical Inc. (Delaware, File No. 7834291)

MATTER: FDA Pre-Submission Strategy, 510(k) Planning, and Related Regulatory Filings — Solstice Lumina™ CGM System

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I. Purpose and Scope of This Memorandum

This memorandum establishes binding internal guidelines for all members of the Calderwood & Harkness LLP ("C&H") engagement team working on the Solstice Biomedical FDA regulatory engagement referenced above. Every member of the team is expected to read this memorandum in its entirety, to adhere to the protocols set forth herein, and to consult with me before taking any action that could jeopardize the privileged or protected status of any communication or document generated in connection with this engagement. These guidelines are not advisory; they are mandatory, and deviation from any protocol described below requires my express, advance authorization.

Engagement Context. Our firm has been retained by Solstice Biomedical Devices Ltd. ("SBD"), an Irish medical device company (CRO No. 648231), and its wholly owned U.S. subsidiary, Solstice Biomedical Inc. ("SBI") (Delaware corporation, File No. 7834291), to provide legal counsel in connection with the U.S. regulatory pathway for the Solstice Lumina™ Continuous Glucose Monitoring ("CGM") System. The Lumina CGM System consists of two principal components: (i) the Lumina C14, an implantable subcutaneous glucose sensor with a platinum-iridium fourth-generation enzyme coating architecture (designated internally as "PtIr-4G"), and (ii) the Lumina R7, a wearable reader/transmitter device that communicates with the implanted sensor via near-field communication and Bluetooth Low Energy protocols, processes glucose measurements, and transmits data to the patient's smartphone application and, optionally, to a healthcare provider's cloud-based monitoring platform.

The scope of this engagement encompasses the following interrelated workstreams:

(a) Pre-Submission ("Pre-Sub") Strategy — Preparation and submission of a Pre-Submission meeting request and meeting package to the FDA's Center for Devices and Radiological Health ("CDRH"), Office of Health Technology 2 ("OHT2"), Division of Chemistry and Toxicology Devices, with a target Pre-Sub meeting date of August 14, 2025;

(b) Predicate Device Analysis — Identification and evaluation of legally marketed predicate devices to support a substantial equivalence determination, including analysis of NovaSense Medical Technologies Inc.'s GlucoTrack NX-500 (K211034) and GlucoTrack NX-700 (K230489);

(c) 510(k) Submission Planning — Development of a comprehensive strategy for the preparation and filing of a 510(k) premarket notification (target submission April 30, 2026; target clearance Q3 2026);

(d) Clinical Study Legal Support — Legal review of the LUMINA-US clinical study protocol (Protocol SBD-LUM-CL-001), informed consent documents, CRO and site agreements, and analysis of Investigational Device Exemption ("IDE") exemption applicability under 21 C.F.R. § 812.2(c)(3);

(e) FTO/IP Coordination — Coordination with intellectual property counsel regarding freedom-to-operate ("FTO") analysis concerning NovaSense Medical Technologies Inc.'s U.S. patent portfolio; and

(f) Related Regulatory Filings — Advice on labeling, promotional claims, iCGM special controls classification implications, and post-clearance regulatory obligations.

Third-Party Coordination and Associated Privilege Risks. This engagement involves extensive coordination with multiple third-party consultants, advisors, and service providers, each of which presents distinct privilege considerations that must be carefully managed. The following third parties are currently involved in the Solstice Lumina regulatory program:

1. Pinnacle Regulatory Consulting Group LLC — A regulatory affairs consultancy located at 9500 Medical Center Drive, Suite 210, Rockville, MD 20850. Pinnacle was retained directly by Solstice, with its engagement commencing January 15, 2025. Key contacts are Dr. Sandra Ellison (Managing Director, former CDRH reviewer) and Thomas Greenbaum (Senior Regulatory Specialist, RAC-certified). Pinnacle is assisting Solstice with regulatory strategy input, technical summary preparation, and 510(k) submission coordination.

2. Crestline IP Advisory LLC — A patent and intellectual property legal advisory firm located at 75 Federal Street, Suite 1800, Boston, MA 02110. Crestline has been retained by Solstice to conduct freedom-to-operate analysis regarding NovaSense Medical Technologies Inc.'s U.S. patent portfolio, with particular focus on U.S. Patent Nos. 10,847,221; 11,234,567; and 11,502,893. Key contact is Dr. Raymond Cho, Patent Attorney.

3. Hargrove & Endicott LLP — Irish corporate and regulatory counsel to SBD, located at 38 Fitzwilliam Square East, Dublin D02 NH85, Ireland. Hargrove & Endicott is advising on European Union Medical Device Regulation ("EU MDR") compliance and its interface with FDA strategy. Key contact is Ciara Brennan, Partner.

4. Whitmore Laboratories Inc. — An FDA-recognized, ISO 17025-accredited (A2LA Certificate No. 3847.01) contract testing laboratory located at 1625 Shady Grove Road, Suite 300, Gaithersburg, MD 20878. Whitmore is performing biocompatibility testing and electromagnetic compatibility ("EMC") and electrical safety testing in support of the 510(k) submission. Key contact is Dr. James Haverford.

5. Veltrano Clinical Research Organization Inc. — A contract research organization ("CRO") located at 500 North Capitol Street, Suite 700, Indianapolis, IN 46204. Veltrano is conducting the LUMINA-US clinical study under Protocol SBD-LUM-CL-001. Key contact is Dr. Lisa Fontaine.

6. Clearwater Institutional Review Board LLC — An independent institutional review board ("IRB") located at 3200 Bayshore Boulevard, Tampa, FL 33629, IRB Registration No. IRB-2019-04821. Clearwater serves as the central IRB for the LUMINA-US clinical study.

Critical Importance of These Guidelines. Rigorous adherence to the protocols set forth in this memorandum is critical to preserving the confidentiality of legal advice, strategic assessments, and work product throughout the full lifecycle of this engagement — from the current Pre-Sub preparation phase through the anticipated 510(k) clearance (target Q3 2026), potential post-clearance matters, and U.S. commercial launch (target Q4 2026). Any failure to observe these protocols could result in the inadvertent waiver of privilege or work product protection, potentially exposing C&H's legal strategy, risk assessments, and mental impressions to adverse parties — including, most critically, NovaSense Medical Technologies Inc. and its patent counsel, Marlowe Asset Management Patent Group LLP.

The FTO analysis related to NovaSense's patent portfolio warrants particular vigilance. NovaSense holds at least three U.S. patents of direct relevance to the Lumina CGM System: U.S. Patent No. 10,847,221 (directed to enzyme coating architectures for implantable glucose sensors), U.S. Patent No. 11,234,567 (directed to signal processing algorithms for continuous glucose measurement), and U.S. Patent No. 11,502,893 (directed to wireless communication protocols for implantable sensor-reader systems). The intersection between Solstice's PtIr-4G enzyme coating technology and the claims of U.S. Patent No. 10,847,221 is a matter of heightened sensitivity. All attorney mental impressions, strategic assessments, and legal conclusions regarding infringement risk constitute opinion work product entitled to near-absolute protection under the work product doctrine. The need to safeguard these materials cannot be overstated.

II. Identification of Privileged and Protected Categories of Communications

II.A. Attorney-Client Privilege

The attorney-client privilege protects confidential communications made between a client and its attorney, in connection with the provision of legal advice, and intended to remain confidential. In this engagement, the privilege attaches to communications between members of the C&H engagement team and authorized representatives of the client entities.

Identification of the Client. For purposes of this engagement, the "client" encompasses both Solstice Biomedical Devices Ltd. (the Irish parent entity, CRO No. 648231) and Solstice Biomedical Inc. (the U.S. subsidiary and intended 510(k) holder, Delaware File No. 7834291). Privilege attaches to communications with authorized representatives of both entities. SBI is the entity that will appear as the applicant on all FDA submissions, but SBD retains ultimate decision-making authority over regulatory strategy and product development, and key technical and scientific personnel are based at SBD's Dublin headquarters. Accordingly, the privilege must extend to communications with both entities to ensure comprehensive legal representation.

Authorized Client Contacts. The following individuals are authorized to communicate with C&H on privileged matters and to receive privileged legal advice on behalf of Solstice:

• Dr. Niamh Tierney, Vice President of Regulatory Affairs, SBD (Dublin HQ) — Primary regulatory contact for this engagement; responsible for coordinating all regulatory submissions and FDA interactions on behalf of Solstice.

• Marcus Hale, Vice President of U.S. Operations, SBI (Cambridge, MA) — Principal U.S.-based client contact; responsible for operational aspects of the U.S. regulatory and commercial launch strategy.

• Dr. Eoin Gallagher, Chief Executive Officer, SBD — Ultimate executive authority over strategic decisions regarding the Lumina CGM System program.

• Dr. Aisling Burke, Chief Technology Officer, SBD — Responsible for all technical and engineering aspects of the Lumina CGM System, including the PtIr-4G enzyme coating architecture; Dr. Burke's technical expertise is essential to the FTO analysis.

• Fiona Drennan, Quality Assurance Director, SBD — Responsible for quality management system oversight, design history file maintenance, and compliance with design controls under 21 C.F.R. Part 820.

Communications with other Solstice employees — including, without limitation, bench scientists, clinical affairs staff, manufacturing engineers, and sales and marketing personnel — should be directed through the above-listed authorized contacts unless I have specifically authorized direct communication with a particular individual. When it is necessary for C&H attorneys to communicate directly with Solstice employees outside the authorized contact list for the purpose of gathering factual information to inform our legal analysis, the functional equivalent doctrine applies: a corporate employee who communicates with corporate counsel at the direction of a corporate superior, for the purpose of enabling counsel to provide legal advice to the corporation, is treated as the functional equivalent of the client for privilege purposes. See Upjohn Co. v. United States, 449 U.S. 383 (1981). In such circumstances, the C&H attorney should clearly communicate to the employee that the communication is made in connection with the provision of legal advice, is confidential, and should not be disclosed to persons outside the company without authorization.

Categories of Privileged Communications. The following types of communications in this engagement are protected by the attorney-client privilege, provided the requisite elements of confidentiality and purpose are maintained:

(a) Regulatory Pathway Selection Advice — Legal advice regarding the selection of the appropriate FDA regulatory pathway for the Lumina CGM System, including analysis of the relative merits and risks of the 510(k) pathway, the Premarket Approval ("PMA") pathway, and the De Novo classification pathway. Our current recommendation — that the 510(k) pathway is the most appropriate and efficient route to market — is itself privileged legal advice.

(b) Predicate Device Strategy — Strategic assessments of predicate device selection, including our analysis of the strengths and vulnerabilities of relying on NovaSense's GlucoTrack NX-500 (K211034) and GlucoTrack NX-700 (K230489) as primary and secondary predicates, respectively, and the implications of alternative predicate strategies.

(c) Clinical Study Design and IDE Exemption Analysis — Legal advice regarding the design and legal framework for the LUMINA-US clinical study, including our analysis of whether the study qualifies for an IDE exemption under 21 C.F.R. § 812.2(c)(3) as a study of a non-significant risk device, or whether a full IDE application will be required.

(d) iCGM Special Controls Classification — Assessment of the implications of seeking integrated continuous glucose monitoring ("iCGM") classification under the FDA's special controls guidance (product code QBJ), including the impact on performance standards, labeling requirements, and interoperability with automated insulin delivery systems.

(e) FTO and Patent Infringement Risk — Legal advice coordinated with Crestline IP Advisory regarding freedom-to-operate with respect to NovaSense's patent portfolio, including infringement risk assessments, claim chart analyses, and design-around strategies.

(f) Promotional Claims and Labeling Compliance — Advice on permissible marketing claims, labeling content, and compliance with FDA requirements for device labeling under 21 C.F.R. Part 801 and advertising under 21 C.F.R. Part 802.

(g) Post-Clearance Regulatory Obligations — Legal assessments of post-clearance compliance requirements, including Medical Device Reporting under 21 C.F.R. Part 803, corrections and removals under 21 C.F.R. Part 806, and post-market surveillance obligations.

II.B. Attorney Work Product Doctrine

The attorney work product doctrine, established in Hickman v. Taylor, 329 U.S. 495 (1947), and codified in Federal Rule of Civil Procedure 26(b)(3), protects documents and tangible things prepared in anticipation of litigation or for trial by or for a party or its representative. The doctrine provides two tiers of protection: fact work product (documents reflecting factual investigation in anticipation of litigation), which may be obtained upon a showing of substantial need and inability to obtain the substantial equivalent without undue hardship, and opinion work product (documents reflecting an attorney's mental impressions, conclusions, opinions, and legal theories), which is afforded near-absolute protection and is virtually undiscoverable.

Applicability to This Engagement. While the Solstice engagement is primarily a regulatory advisory matter, the work product doctrine is directly applicable in at least two respects:

First, and most significantly, the FTO analysis regarding NovaSense's patent portfolio — particularly U.S. Patent No. 10,847,221, which is directed to enzyme coating architectures for implantable glucose sensors and which intersects directly with Solstice's proprietary PtIr-4G technology — presents a scenario in which litigation is reasonably foreseeable. NovaSense is a direct competitor in the CGM market, holds patents that facially relate to the Lumina CGM System's core technology, and is represented by experienced patent litigation counsel (Marlowe Asset Management Patent Group LLP). Although no formal dispute or litigation has been initiated as of the date of this memorandum, Crestline's preliminary FTO assessment (delivered April 10, 2025) identified a "low-to-moderate" infringement risk regarding the claims of U.S. Patent No. 10,847,221, and a further detailed claim chart analysis is ongoing. All attorney mental impressions, conclusions, and strategic recommendations regarding infringement risk — whether prepared by Crestline, by C&H, or jointly — constitute opinion work product entitled to near-absolute protection.

Second, several categories of documents prepared by C&H in connection with the regulatory engagement reflect legal analysis and strategic thinking that would warrant work product protection even in the absence of a specific litigation threat. Documents prepared by attorneys that embody legal analysis and strategic assessments in connection with the provision of legal advice may qualify for work product protection under the broader interpretation of the doctrine adopted by many courts. See, e.g., In re Cendant Corp. Sec. Litig., 343 F.3d 658, 662 (3d Cir. 2003); United States v. Adlman, 134 F.3d 1194 (2d Cir. 1998).

Categories of Work Product in This Engagement. The following categories of documents are work product and should be treated with corresponding protection:

(a) Internal C&H Strategy Memoranda — Including, without limitation, the Pre-Sub Strategy and Anticipated FDA Feedback memorandum (currently in preparation), the FTO/IP Risk Assessment Summary, the regulatory pathway selection analysis, and any memoranda analyzing likely FDA responses to our submissions and evaluating contingency strategies.

(b) Claim Chart Analyses and Design-Around Assessments — All claim charts, infringement analyses, validity assessments, and design-around strategy documents prepared by Crestline IP Advisory or by C&H in coordination with Crestline. These documents reflect the core of the attorneys' mental impressions regarding patent risk and are entitled to the highest level of protection.

(c) Legal Risk Assessments Regarding FDA Regulatory Outcomes — Documents analyzing the probability and consequences of various FDA actions, including potential requests for additional information, deficiency letters, not substantially equivalent ("NSE") determinations, and alternative regulatory pathways.

(d) Draft Submissions with Legal Strategy Annotations — Draft Pre-Sub packages, draft 510(k) sections, draft labeling, and other submission-related documents that have been annotated by C&H attorneys with legal strategy comments, recommended revisions, or risk assessments. The annotations themselves are privileged work product, even though the underlying factual content may ultimately be submitted to FDA in an unprivileged form.

(e) Internal Emails Among C&H Team Members — Emails exchanged among Miriam Calloway, Joel Strauss, Amy Whitfield, and Sean Morrissey (and any additional team members who may join the engagement) that contain legal analysis, strategy discussions, or mental impressions related to the engagement.

II.C. Common Interest Doctrine

The common interest doctrine (also referred to as the "joint defense" doctrine, though it is not limited to the defensive context) permits parties with a shared legal interest to exchange privileged communications without waiving the attorney-client privilege or work product protection, provided certain conditions are met. The doctrine is particularly relevant to this engagement in the context of communications between C&H and Crestline IP Advisory LLC.

C&H and Crestline IP Advisory. Both C&H and Crestline serve as legal counsel to Solstice on matters that overlap significantly. C&H is providing regulatory strategy advice for the Lumina CGM System's U.S. market authorization, while Crestline is providing FTO analysis and design-around advice regarding NovaSense's patent portfolio. These two workstreams are deeply interconnected: Solstice's regulatory strategy (including predicate device selection, substantial equivalence arguments, and device design specifications reflected in the 510(k) submission) directly affects the FTO analysis, and conversely, the FTO analysis may inform design modifications that have regulatory implications. All three parties — C&H, Crestline, and Solstice — share a common legal interest in protecting Solstice's ability to commercialize the Lumina CGM System in the United States without infringing NovaSense's patents and without jeopardizing the FDA clearance pathway.

To avail ourselves of the common interest doctrine, I recommend the execution of a formal Common Interest Agreement among C&H, Crestline, and Solstice. This agreement will memorialize the shared legal interest, establish the scope of information sharing, and confirm that the exchange of privileged materials does not constitute a waiver of privilege. Amy Whitfield will prepare a draft of this agreement, as reflected in the Action Items table in Section IX below, with a target circulation date of May 9, 2025.

Hargrove & Endicott LLP. A similar common interest arrangement may be appropriate for communications between C&H and Hargrove & Endicott LLP, Solstice's Irish corporate and regulatory counsel, to the extent that our regulatory strategies in the U.S. and EU are being coordinated. I will address this directly with Ciara Brennan.

Limitations of the Common Interest Doctrine. It is essential to understand that the common interest doctrine does not automatically extend to non-lawyer consultants such as Pinnacle Regulatory Consulting Group or testing laboratories such as Whitmore Laboratories. The doctrine operates to preserve the attorney-client privilege in communications between attorneys (and their respective clients) who share a common legal interest. Non-lawyer consultants do not participate in an attorney-client relationship, and their mere involvement in a common project does not bring them within the scope of the common interest doctrine. Any communications with Pinnacle, Whitmore, Veltrano, or Clearwater must be evaluated separately under the principles discussed in Section IV below.

III. Document Marking and Labeling Standards

III.A. Mandatory Privilege Legends

Consistent and accurate document marking is the first line of defense in protecting privileged communications and work product. Proper marking serves two functions: it communicates the confidential and privileged nature of the document to all recipients, and it creates a contemporaneous record of the parties' intent to maintain confidentiality — a factor courts consider in assessing whether a privilege has been waived.

The following marking standards apply to all documents generated in connection with this engagement:

1. All memoranda, letters, and written communications containing legal advice from C&H to the client or within C&H must bear the following legend prominently at the top of the first page:

PRIVILEGED AND CONFIDENTIAL — ATTORNEY-CLIENT COMMUNICATION

2. All internal C&H analytical documents — including strategy memoranda, legal risk assessments, research memoranda, and draft submissions containing attorney annotations — must additionally bear the following legend:

ATTORNEY WORK PRODUCT — PREPARED IN ANTICIPATION OF LITIGATION AND/OR IN CONNECTION WITH THE PROVISION OF LEGAL ADVICE

3. Draft documents prepared for submission to FDA — including draft Pre-Sub meeting packages, draft 510(k) cover letters, draft Indications for Use statements, draft substantial equivalence comparison tables, and draft labeling — should be marked:

DRAFT — PRIVILEGED AND CONFIDENTIAL

This marking should be maintained on all draft versions of submission documents until the document is finalized for filing with the FDA. Once a document is finalized and submitted to the FDA, the submitted version is no longer privileged, as it has been voluntarily disclosed to a government agency. However, prior drafts reflecting legal strategy choices, attorney redlines, strategic annotations, and internal deliberation remain protected as work product and/or privileged attorney-client communications. The distinction between the "final-as-filed" version and prior drafts containing legal analysis is critical and must be scrupulously maintained in the document management system.

4. Documents exchanged under the common interest arrangement with Crestline IP Advisory should include the additional notation:

COMMON INTEREST PRIVILEGE — SHARED PURSUANT TO COMMON INTEREST AGREEMENT

III.B. Email Subject Line Conventions

Email is the predominant mode of communication in this engagement, and email chains present unique risks for inadvertent privilege waiver — particularly when external parties are added to existing threads, when chains are forwarded, or when "reply all" responses inadvertently include non-privileged recipients. The following email conventions are mandatory:

(a) All emails containing legal advice, legal analysis, or work product must include the prefix "[PRIVILEGED]" or "[ATTORNEY-CLIENT PRIVILEGED]" in the subject line. For example:

Subject: [PRIVILEGED] Pre-Sub Strategy — Predicate Device Selection Analysis

(b) All emails sent to client contacts (Dr. Tierney, Marcus Hale, Dr. Gallagher, Dr. Burke, Fiona Drennan) must include the following footer notice, which should be included in the C&H email signature block for all team members working on this matter:

"This communication is protected by the attorney-client privilege and/or as attorney work product. It is intended solely for the use of the individual(s) to whom it is addressed. If you are not the intended recipient, you are hereby notified that any review, disclosure, copying, distribution, or use of this communication or the information contained herein is strictly prohibited. If you have received this communication in error, please notify the sender immediately by telephone and delete this communication and all copies from your system. Thank you."

(c) Emails exchanged between C&H and Crestline IP Advisory on FTO, patent, or infringement-related matters should include the prefix:

Subject: [COMMON INTEREST / PRIVILEGED] FTO Analysis — NovaSense Patent Portfolio

(d) Emails that are purely factual or technical in nature — for example, scheduling emails, transmittal of test reports from Whitmore Laboratories, or coordination of clinical study logistics with Veltrano CRO — should not be marked as privileged. Over-designation of non-privileged documents as privileged can undermine privilege claims and create credibility issues in the event of future litigation or privilege disputes.

III.C. Document Management and Filing

All documents generated in connection with this engagement — whether privileged or non-privileged — must be stored in the designated matter folder on the C&H document management system under Matter No. 1037-00002. Within this matter folder, the following subfolder structure must be maintained:

• 01-Privileged — Legal Analysis and Strategy — For all privileged attorney-client communications, legal memoranda, strategy documents, and work product. This folder should contain subfolders for specific workstreams (e.g., "01A-Pre-Sub Strategy," "01B-510(k) Planning," "01C-Clinical Study Legal Support," "01D-Labeling and Promotional Claims").

• 02-Privileged — FTO/IP Materials (RESTRICTED ACCESS) — For all Crestline FTO assessments, claim chart analyses, design-around evaluations, and related materials. Access to this subfolder is restricted to Miriam Calloway, Joel Strauss, Amy Whitfield, and Sean Morrissey. See Section VI.D below for additional access controls.

• 03-Common Interest Materials — For documents exchanged under the common interest arrangement with Crestline and Hargrove & Endicott.

• 04-Non-Privileged — Technical and Regulatory — For non-privileged technical documents, testing reports from Whitmore Laboratories, clinical study documents (protocols, consent forms), regulatory submissions (final versions as filed with FDA), and correspondence with non-lawyer third parties.

• 05-Privilege Log — For maintenance of the running privilege log for this engagement.

It is imperative that privileged legal analysis documents be segregated from non-privileged factual or technical documents. Commingling privileged and non-privileged materials in the same folders or filing locations creates confusion, increases the risk of inadvertent production, and can complicate privilege review in the event of future litigation or government investigation.

Amy Whitfield is designated as the privilege log coordinator for this engagement. She is responsible for maintaining a contemporaneous privilege log that identifies all documents withheld or redacted on the basis of privilege or work product protection. The privilege log should be initiated promptly (see Action Items, Section IX) and updated on a rolling basis as new privileged documents are created. Each entry in the privilege log must include, at a minimum: (i) the date of the document; (ii) the author; (iii) the recipient(s); (iv) a general description of the document's subject matter (sufficient to support the privilege claim without revealing privileged content); and (v) the basis for the privilege assertion (attorney-client privilege, work product, common interest, or a combination thereof).

IV. Communications Protocols with Third-Party Consultants

The involvement of multiple third-party consultants and advisors in this engagement creates the most significant privilege risks we face. The general rule is that disclosure of privileged information to a third party waives the privilege unless an exception applies. Each third party must be assessed individually to determine whether, and under what circumstances, communications with that party may retain their privileged status. This section provides specific guidance for each third party currently involved in the engagement.

IV.A. Pinnacle Regulatory Consulting Group LLC

Key Facts. Pinnacle Regulatory Consulting Group LLC is a regulatory affairs consultancy — it is not a law firm, and its consultants do not hold themselves out as providing legal advice. Pinnacle was retained directly by Solstice (not by C&H) pursuant to a consulting agreement dated January 15, 2025. Pinnacle's principal office is located at 9500 Medical Center Drive, Suite 210, Rockville, MD 20850. The key contacts for this engagement are Dr. Sandra Ellison (Managing Director; former reviewer at CDRH's Division of Chemistry and Toxicology Devices, where she spent eleven years before entering the private sector) and Thomas Greenbaum (Senior Regulatory Specialist, RAC-certified). Pinnacle is assisting Solstice with a range of regulatory consulting tasks, including preparation of technical summaries, performance testing protocol design, biocompatibility assessment coordination, Pre-Sub meeting package preparation, and general regulatory strategy input.

Privilege Risk Assessment. Communications between Solstice and Pinnacle are generally NOT protected by the attorney-client privilege because Pinnacle is not a law firm and the consultant-client relationship is not a legal one. Similarly, communications between C&H and Pinnacle are not automatically privileged. If C&H were to share privileged legal strategy, FTO analysis, or attorney work product with Pinnacle, that disclosure would ordinarily constitute a waiver of the privilege with respect to the disclosed materials.

The Kovel Exception. Under the doctrine established in United States v. Kovel, 296 F.2d 918 (2d Cir. 1961), and its progeny, communications with a non-lawyer consultant may be privileged if three conditions are met: (i) the consultant is retained to assist counsel (not the client independently) in providing legal advice; (ii) the communications are made for the purpose of facilitating the rendition of legal advice by counsel; and (iii) the consultant is functioning as a "translator" or "interpreter" of complex technical or specialized information that counsel needs to understand in order to provide informed legal advice. When these conditions are satisfied, the consultant is treated as an agent of the attorney, and the privilege extends to the three-way communications between attorney, consultant, and client.

Application to This Engagement. There are circumstances in this engagement where the Kovel doctrine may apply to specific Pinnacle communications. For example, if I direct Pinnacle to prepare a technical summary of the Lumina C14 sensor's enzyme coating architecture specifically to enable me to assess the substantial equivalence argument for the Pre-Sub meeting package — that is, to "translate" complex bioengineering concepts into a form that allows me to render informed legal advice — that communication may be privileged under Kovel. However, when Pinnacle is performing its independent regulatory consulting services for Solstice (e.g., preparing a 510(k) technical summary for direct inclusion in the submission, designing performance testing protocols, or coordinating biocompatibility testing with Whitmore Laboratories), those work products are created in the ordinary course of Pinnacle's consulting engagement and are not privileged.

Mandatory Guidelines for Communications with Pinnacle:

1. Kovel-Directed Work. Where C&H directly retains or directs Pinnacle's work for the specific purpose of enabling C&H to render legal advice to Solstice, the communication should be channeled through C&H and marked with appropriate privilege legends. The C&H coordination letter to Pinnacle (which I am currently preparing; see Action Items, Section IX) will delineate which tasks are performed "at the direction of counsel" and which are independent consulting tasks. Until that letter is finalized and executed, team members should not attempt to invoke the Kovel framework without consulting me.

2. Independent Consulting Work. Pinnacle's independent consulting deliverables — technical summaries, regulatory strategy memos, protocol designs, biocompatibility assessment plans, and similar work products prepared for Solstice's direct use — are not privileged and should be treated as non-privileged technical documents filed in the "04-Non-Privileged" subfolder.

3. No Sharing of Privileged Materials. C&H team members must not share internal legal strategy memoranda, FTO assessments, patent claim chart analyses, regulatory risk assessments, or any other privileged attorney work product with Pinnacle personnel unless specifically authorized by Miriam Calloway and unless the communication can be structured to maintain privilege under the Kovel framework or another applicable doctrine. If there is any doubt, do not share.

4. Separate Communications for Technical Input. If C&H requires technical input from Pinnacle — for example, to inform our legal analysis of predicate device comparisons or testing strategies — the request should be framed as a factual or technical inquiry in a separate communication from any legal strategy discussion. Do not pose questions that embed or reference our legal strategy, and do not include Pinnacle personnel on email chains that contain legal advice or privileged analysis. The appropriate approach is to send a standalone email to Dr. Ellison or Thomas Greenbaum requesting the specific factual or technical information needed, without explaining the legal purpose for which it is being sought.

5. Email Thread Separation. Never add Pinnacle personnel (Dr. Ellison, Thomas Greenbaum, or any other Pinnacle employee) to an existing email chain that contains privileged content. If Pinnacle's input is needed on a topic that has been the subject of a privileged email thread, start a new, clean email thread addressed to the appropriate Pinnacle contact, containing only non-privileged factual content.

IV.B. Crestline IP Advisory LLC

Key Facts. Crestline IP Advisory LLC is a law firm specializing in patent and intellectual property law. Dr. Raymond Cho, a registered patent attorney and Crestline's lead contact for this engagement, is licensed to practice before the United States Patent and Trademark Office and is a member of the Massachusetts bar. Crestline's principal office is located at 75 Federal Street, Suite 1800, Boston, MA 02110. Crestline was retained by Solstice to perform a comprehensive freedom-to-operate analysis regarding NovaSense Medical Technologies Inc.'s U.S. patent portfolio, with particular attention to:

• U.S. Patent No. 10,847,221 — Directed to enzyme coating architectures for implantable electrochemical glucose sensors; this patent is of greatest concern due to the potential overlap with Solstice's PtIr-4G technology.

• U.S. Patent No. 11,234,567 — Directed to signal processing algorithms for continuous glucose measurement, including methods for compensating for sensor drift and biofouling effects.

• U.S. Patent No. 11,502,893 — Directed to wireless communication protocols for data transmission between an implantable sensor and an external reader device in a continuous glucose monitoring system.

Privilege Status. Communications between Crestline and Solstice are independently protected by the attorney-client privilege, as Crestline is legal counsel to Solstice. Communications between C&H and Crestline may be protected under the common interest doctrine, provided the conditions discussed in Section II.C are met and a formal Common Interest Agreement is executed.

Mandatory Guidelines for Communications with Crestline:

1. Common Interest Agreement. As noted above, a Common Interest Agreement among C&H, Crestline, and Solstice should be executed as promptly as practicable. Amy Whitfield will prepare the initial draft, with a target circulation date of May 9, 2025. Until this agreement is executed, exercise heightened caution in sharing C&H work product with Crestline, though the exchange of information necessary for coordinated legal representation may proceed on the understanding that a common legal interest exists. Once executed, the agreement will formalize the shared privilege and establish the ground rules for information sharing.

2. Sensitivity of FTO Materials. Crestline's FTO preliminary assessment (delivered April 10, 2025) and all subsequent deliverables — including detailed claim chart analyses for each of the three NovaSense patents, infringement risk assessments, validity assessments, design-around evaluations, and prosecution history analyses — represent among the most sensitive documents in this entire engagement. The preliminary assessment concluded that the risk of infringement of U.S. Patent No. 10,847,221 is "low-to-moderate," with significant questions remaining regarding the scope of independent claim 1 and dependent claims 3, 7, and 12 in light of Solstice's PtIr-4G architecture. Further analysis is ongoing and will be refined as Solstice's device design is finalized.

3. Distribution Restrictions. Crestline FTO materials must be distributed only on a need-to-know basis. Within C&H, access is limited to the four members of the engagement team named in this memorandum. Within Solstice, distribution is limited to Dr. Niamh Tierney, Dr. Aisling Burke, and Marcus Hale, unless Dr. Gallagher specifically requests access. Under no circumstances should FTO materials be shared with Pinnacle, Whitmore Laboratories, Veltrano CRO, Clearwater IRB, or any other non-legal third party.

4. Common Interest Privilege Markings. All joint communications between C&H and Crestline should bear the following marking in addition to the standard privilege legend:

COMMON INTEREST PRIVILEGE — CONFIDENTIAL COMMUNICATION BETWEEN CO-COUNSEL PURSUANT TO COMMON INTEREST AGREEMENT

IV.C. Hargrove & Endicott LLP (Irish Counsel)

Key Facts. Hargrove & Endicott LLP is Solstice Biomedical Devices Ltd.'s Irish corporate and regulatory counsel. The firm is located at 38 Fitzwilliam Square East, Dublin D02 NH85, Ireland. The key contact is Ciara Brennan, Partner, who heads the firm's life sciences regulatory practice. Hargrove & Endicott is advising SBD on EU MDR compliance and its interface with FDA strategy, including issues related to the CE certificate for the Lumina CGM System (Certificate No. MCA-2024-07319, issued by Meridian Conformity Assessment GmbH, Notified Body No. 0483, on September 12, 2024) and the alignment of EU and U.S. clinical data requirements.

Privilege Status. Communications between Hargrove & Endicott and SBD are privileged under Irish law. The concept of legal professional privilege in Ireland encompasses both legal advice privilege and litigation privilege, broadly analogous to the U.S. attorney-client privilege and work product doctrine. Communications between C&H and Hargrove & Endicott may be protected under the common interest doctrine, to the extent that both firms share a common legal interest in Solstice's regulatory compliance strategy across jurisdictions.

Mandatory Guidelines for Communications with Hargrove & Endicott:

1. Common Interest Arrangement. I will confirm in writing with Ciara Brennan the shared privilege understanding and, if appropriate, execute a common interest arrangement analogous to the agreement with Crestline. Target date: May 15, 2025 (see Action Items, Section IX).

2. Relevant Interface Topics. The primary areas of overlap between C&H's work and Hargrove & Endicott's work include: (a) the EU MDR CE certificate and its evidentiary value in the FDA submission context; (b) alignment of clinical performance evaluation data under the EU MDR with FDA clinical evidence requirements; (c) coordination of labeling content between EU and U.S. markets; and (d) post-market surveillance harmonization.

3. Cross-Border Privilege Considerations. Team members should be aware that privilege law differs between the United States and Ireland, and between common law and civil law jurisdictions more broadly. A communication that is privileged under U.S. law may not be privileged under Irish law, and vice versa. For example, Irish law generally does not recognize a work product doctrine as broad as the U.S. doctrine. When exchanging documents or communications with Hargrove & Endicott, consider the privilege implications under both jurisdictions and mark communications appropriately. If there is uncertainty about whether a particular communication or document would be privileged under Irish law, consult with me before sharing.

IV.D. Whitmore Laboratories Inc. (Contract Testing Lab)

Key Facts. Whitmore Laboratories Inc. is an FDA-recognized, ISO 17025-accredited (A2LA Certificate No. 3847.01) contract testing laboratory. Whitmore is located at 1625 Shady Grove Road, Suite 300, Gaithersburg, MD 20878. The engagement with Whitmore commenced on March 3, 2025. The key contact is Dr. James Haverford, Director of Biocompatibility Testing Services. Whitmore is performing two categories of testing in support of the Lumina CGM System 510(k) submission: (i) biocompatibility testing (budget: $485,000), encompassing cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, and hemocompatibility studies consistent with the FDA-recognized standard ISO 10993-1:2018; and (ii) electromagnetic compatibility ("EMC") and electrical safety testing (budget: $175,000), consistent with IEC 60601-1 and IEC 60601-1-2.

Privilege Status. Whitmore is a testing laboratory, not legal counsel. Communications with Whitmore are generally NOT privileged. Whitmore's testing protocols, raw data, laboratory reports, and final test results are factual technical documents that will become part of the 510(k) submission and are inherently non-privileged.

Mandatory Guidelines for Communications with Whitmore:

1. Do not share C&H legal strategy, FTO analysis, patent claim charts, regulatory risk assessments, or any privileged communications with Whitmore personnel.

2. Testing protocols, results, and reports received from Whitmore should be filed in the "04-Non-Privileged — Technical and Regulatory" subfolder in the document management system.

3. If C&H needs to communicate with Whitmore regarding the scope of testing — for example, to inform the biocompatibility testing strategy memorandum we are preparing for the client — those communications must be limited to factual and technical inquiries. Do not explain the legal rationale behind a particular testing approach, and do not reference legal strategy or risk assessments.

4. In the event that C&H's analysis of Whitmore's test results identifies a legally significant issue (e.g., a biocompatibility result that could affect the substantial equivalence argument), that legal analysis should be communicated to the client in a separate privileged memorandum, not in a communication directed to Whitmore.

IV.E. Veltrano Clinical Research Organization Inc. and Clearwater Institutional Review Board LLC

Key Facts.

Veltrano CRO. Veltrano Clinical Research Organization Inc. is located at 500 North Capitol Street, Suite 700, Indianapolis, IN 46204. The key contact is Dr. Lisa Fontaine, Executive Vice President of Clinical Operations. Veltrano has been retained by Solstice to conduct the LUMINA-US clinical study under Protocol SBD-LUM-CL-001. The study is a prospective, multicenter, single-arm, pivotal study designed to evaluate the accuracy, safety, and reliability of the Lumina CGM System in adults with type 1 and type 2 diabetes mellitus. The study will enroll 350 subjects at six U.S. clinical sites, with a study budget of approximately $4,200,000. Study commencement is currently targeted for September 15, 2025.

Clearwater IRB. Clearwater Institutional Review Board LLC is located at 3200 Bayshore Boulevard, Tampa, FL 33629. IRB Registration No. IRB-2019-04821. Clearwater serves as the central IRB for the LUMINA-US study and is responsible for initial and continuing review of the study protocol, informed consent documents, and investigator qualifications.

Privilege Status. Neither Veltrano nor Clearwater is legal counsel, and communications with either entity are generally not privileged. The CRO is a vendor performing clinical study execution services, and the IRB is an independent oversight body performing regulatory functions.

Mandatory Guidelines:

1. CRO Agreement and Consent Form Review. C&H's review of the CRO agreement (including indemnification provisions, liability allocation, data ownership terms, and regulatory compliance representations) and the informed consent templates constitutes privileged legal advice to Solstice. Drafts and redlines of these documents reflecting C&H's legal comments are privileged. However, the final executed CRO agreement and the final approved informed consent forms (as submitted to Clearwater IRB and provided to study subjects) are not privileged.

2. No Sharing of Legal Memoranda. Do not share C&H's internal legal memoranda with Veltrano or Clearwater. This includes, in particular, our analysis of IDE exemption applicability under 21 C.F.R. § 812.2(c)(3), our clinical study strategy assessments, and any legal advice regarding informed consent content or regulatory risk.

3. Regulatory Record Status. Protocol submissions, informed consent documents, IRB correspondence, adverse event reports, and other documents submitted to the IRB or maintained as part of the clinical study regulatory record are non-privileged. These documents should be filed in the "04-Non-Privileged" subfolder.

IV.F. NovaSense Medical Technologies Inc. and Marlowe Asset Management Patent Group LLP

Key Facts.

NovaSense Medical Technologies Inc. is located at 4800 Innovation Parkway, San Diego, CA 92121. NovaSense's CEO is David Reinhardt and its VP of Regulatory Affairs is Dr. Karen Nishimura. NovaSense is a manufacturer of continuous glucose monitoring systems and holds FDA clearances for two devices that Solstice is evaluating as potential predicate devices: the GlucoTrack NX-500 (510(k) No. K211034) and the GlucoTrack NX-700 (510(k) No. K230489). NovaSense is also the assignee of the three U.S. patents that are the subject of Crestline's FTO analysis.

Marlowe Asset Management Patent Group LLP is NovaSense's patent counsel, located at 2200 Wilson Boulevard, Suite 1100, Arlington, VA 22201. The lead partner is Patricia Langford. Marlowe Asset Management is known for aggressive patent enforcement in the medical device sector.

Privilege Status and Guidelines. NovaSense and Marlowe Asset Management are potential adversaries. Although no formal dispute or litigation has been initiated as of this date, the ongoing FTO analysis and the competitive dynamic between Solstice and NovaSense in the CGM market create a reasonable basis for anticipating future adversarial interaction.

1. Absolute Prohibition on Disclosure. Under no circumstances shall any privileged information, work product, FTO analysis, claim chart, design-around strategy, regulatory strategy, or confidential client communication be shared with, or made accessible to, NovaSense or Marlowe Asset Management Patent Group.

2. Predicate Device References. The predicate device analysis necessarily references NovaSense's cleared devices (K211034 and K230489) by name, as these are publicly available FDA clearance records. References to NovaSense's cleared devices in FDA submissions — including the Pre-Sub meeting package and the 510(k) substantial equivalence comparison — are factual and non-problematic. However, any analysis of NovaSense's patent claims, potential infringement risk, design-around strategies, or patent validity is highly privileged and must be strictly segregated from the predicate device analysis. Do not intermingle patent-related analysis with regulatory submission materials.

3. No Contact Without Authorization. No member of the C&H engagement team shall have any communication — whether written, oral, electronic, or otherwise — with any representative of NovaSense Medical Technologies Inc. or Marlowe Asset Management Patent Group LLP regarding the Solstice engagement or any related matter without the express, advance authorization of Miriam Calloway and Dr. Niamh Tierney. If any team member receives an unsolicited communication from NovaSense or Marlowe Asset Management, it should be immediately forwarded to me without substantive response.

V. Specific Privilege Considerations for FDA Submissions and Communications

V.A. Pre-Submission (Pre-Sub) Package and Meeting

The Pre-Submission process is a critical milestone in the Solstice engagement. The Pre-Sub meeting provides Solstice with the opportunity to obtain informal, non-binding feedback from CDRH on the proposed regulatory pathway, predicate device selection, clinical study design, and testing strategy before committing the resources necessary for a full 510(k) submission. The engagement team should understand the privilege implications at each stage of the Pre-Sub process.

Timeline and Key Dates:

• Pre-Sub Meeting Request: Target submission date June 2, 2025

• Pre-Sub Meeting Package: Target submission date June 16, 2025 (60 calendar days prior to meeting)

• Pre-Sub Meeting: Target date August 14, 2025, with CDRH OHT2, Division of Chemistry and Toxicology Devices

• FDA Written Feedback: Anticipated within 30 days of meeting (mid-September 2025)

Privilege Analysis:

1. The Pre-Sub meeting request (a brief letter identifying the device, the regulatory pathway, and the general topics for discussion), the Pre-Sub meeting package (containing the detailed device description, predicate comparison, proposed testing plan, clinical protocol summary, and questions for FDA), and the FDA's written feedback all become part of the regulatory record once submitted to or received from FDA. These documents are NOT privileged once they are in the FDA's possession.

2. However, internal strategy documents prepared by C&H analyzing anticipated FDA feedback, evaluating contingency plans, and assessing legal risk in connection with the Pre-Sub process remain privileged. For example, our internal memorandum analyzing the likelihood that FDA will accept the proposed primary predicate (NovaSense GlucoTrack NX-500, K211034) versus requesting identification of an alternative predicate, and our analysis of the implications of either outcome for the overall 510(k) strategy, is privileged work product that reflects attorney mental impressions and legal analysis.

3. Draft Pre-Sub packages circulated among C&H team members for internal review, with strategic annotations such as "FDA may push back on this predicate comparison — consider strengthening the argument regarding technological characteristics" or "Flag for Dr. Tierney: this section may need revision depending on Crestline's updated claim chart analysis," are work product. All such annotations must be removed before the draft is finalized and submitted to FDA. The final version submitted to FDA must be a clean document containing only factual and technical content.

4. The Distinction. The Pre-Sub package itself — including the device description, predicate device comparison table, proposed testing plan, clinical protocol summary, and questions for FDA — is factual and technical in nature. It represents Solstice's presentation of its device and regulatory proposal to the agency. C&H's internal memorandum analyzing the likely FDA responses to each question in the package, evaluating the strongest and weakest elements of the submission, and developing contingency strategies, is privileged work product reflecting our professional judgment and legal analysis.

V.B. 510(k) Submission Materials

The 510(k) premarket notification (target submission date: April 30, 2026) will represent the culmination of the regulatory workstream. The privilege considerations applicable to the 510(k) submission largely parallel those applicable to the Pre-Sub process, but the volume and complexity of documents is substantially greater.

1. The final 510(k) submission — including the 510(k) summary prepared pursuant to 21 C.F.R. § 807.92, the Indications for Use statement (FDA Form 3881), the substantial equivalence comparison, the device description, the performance testing data, the clinical study report, the biocompatibility evaluation, the EMC and electrical safety test reports, the software documentation, the labeling, and all other components of the submission package — will be submitted to FDA and is not privileged once filed.

2. Draft versions of 510(k) sections that contain C&H attorney comments, tracked changes reflecting legal advice (e.g., "Delete this sentence — it could be construed as an impermissible expanded indication"), redlines, and strategic annotations are privileged as attorney work product and/or attorney-client communications. The privilege attaches to the annotations and legal analysis, not to the underlying factual content. It is therefore essential to maintain clean version control: the "final-for-filing" version must be separated from annotated drafts, and annotated drafts must be retained in the privileged subfolder.

3. C&H Advisory Memoranda. Our labeling review memorandum (analyzing the proposed labeling content against FDA requirements and identifying potential deficiencies or enforcement risks), our promotional claims memorandum (analyzing the permissibility of specific marketing claims under the cleared indications for use), and all other advisory memoranda from C&H to Solstice regarding the 510(k) submission remain privileged as legal advice, regardless of whether the underlying submission is eventually filed with FDA.

V.C. Clinical Study Documents

1. The LUMINA-US clinical protocol (Protocol SBD-LUM-CL-001), informed consent forms, case report forms, IRB submissions, and related clinical study documents are part of the regulatory record and become non-privileged upon submission to the IRB, clinical sites, or FDA.

2. C&H's review and markup of informed consent forms — including tracked changes reflecting our legal advice on informed consent content (e.g., recommendations regarding risk disclosure language, subject compensation descriptions, data privacy provisions, and regulatory compliance statements) — is privileged legal advice. The tracked-change version reflecting our legal comments should be retained in the privileged subfolder. The clean final version submitted to Clearwater IRB for approval is not privileged.

3. C&H's memorandum analyzing IDE exemption applicability under 21 C.F.R. § 812.2(c)(3) — specifically, our analysis of whether the LUMINA-US study qualifies as a study of a non-significant risk device that is exempt from the IDE requirements of 21 C.F.R. Part 812 — is privileged legal advice. This memorandum reflects our legal judgment regarding the classification of the Lumina CGM System for IDE purposes, the application of the non-significant risk criteria, and the risk factors that could affect FDA's assessment. It should not be shared with Veltrano CRO, Clearwater IRB, or any clinical site.

4. Adverse Event Reports and Safety Communications. In the event that adverse events or unanticipated adverse device effects occur during the clinical study, C&H may be called upon to advise on reporting obligations under 21 C.F.R. Part 803 and FDA's Good Clinical Practice requirements. Our legal advice regarding reporting obligations is privileged; the adverse event reports themselves, once filed with FDA and/or the IRB, are not.

VI. Best Practices for Avoiding Inadvertent Waiver

Inadvertent disclosure of privileged materials can result in the waiver of privilege — not only as to the specific document disclosed, but potentially as to all communications on the same subject matter. While Federal Rule of Evidence 502(b) provides some protection against inadvertent waiver in the context of federal proceedings (requiring courts to consider the reasonableness of the precautions taken, among other factors), the best protection is to prevent inadvertent disclosure from occurring in the first place. The following best practices are mandatory for all team members.

VI.A. Email Discipline

Email is the communication medium most susceptible to inadvertent privilege waiver, because of the ease of forwarding, the "reply all" function, the auto-complete feature in email addressing, and the tendency to build long chains that accumulate privileged content over time. The following rules apply:

1. Do not forward internal C&H emails containing legal analysis to non-attorney third parties (Pinnacle, Whitmore, Veltrano, Clearwater) without first stripping all privileged content. If an email chain contains a mixture of privileged and non-privileged content, the appropriate procedure is to extract only the non-privileged factual content and include it in a new, clean email to the third party.

2. Use separate email threads for legal strategy discussions versus factual/technical coordination. Do not embed legal strategy commentary in an email thread that is being used for technical coordination with non-lawyer third parties. If a technical coordination thread raises a legal issue, start a new, separate thread with "PRIVILEGED" in the subject line, addressed only to C&H team members and/or authorized client contacts.

3. Before adding any external party to an email chain, review the entire thread for privileged content. This includes scrolling to the bottom of the chain to review all prior messages. Do not rely on the assumption that earlier messages in the chain were non-privileged; review the entire chain before forwarding or adding a new recipient.

4. Use BCC rather than CC for client contacts when third parties are on the same email to avoid "reply all" disclosures. When sending an email that includes both a non-privileged third party (e.g., Dr. Ellison at Pinnacle) and a client contact (e.g., Dr. Tierney), consider whether the client contact should be

PRIVILEGED AND CONFIDENTIAL — ATTORNEY-CLIENT PRIVILEGED / ATTORNEY WORK PRODUCT — FOR INTERNAL CALDERWOOD & HARKNESS LLP USE ONLY — NOT FOR DISTRIBUTION OUTSIDE THE FIRM WITHOUT PRIOR AUTHORIZATION
CALDERWOOD & HARKNESS LLP INTERNAL MEMORANDUM
FROM: Miriam Calloway, Responsible Partner, Healthcare & Life Sciences Practice, Calderwood & Harkness LLP
TO: Joel Strauss, Billing Partner, Healthcare & Life Sciences Practice Amy Whitfield, Lead Associate, Healthcare & Life Sciences Practice Sean Morrissey, Working Associate, Healthcare & Life Sciences Practice
DATE: April 25, 2025
RE: Privilege and Work Product Protection Guidelines — Solstice Biomedical Devices Ltd. / Solstice Biomedical Inc. FDA Pre-Submission and 510(k) Engagement (Engagement Ref. No. 1037-00002)
CLIENT: Solstice Biomedical Devices Ltd. (Ireland, CRO No. 648231) and Solstice Biomedical Inc. (Delaware, File No. 7834291)
MATTER: FDA Pre-Submission Strategy, 510(k) Planning, and Related Regulatory Filings — Solstice Lumina™ CGM System
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I. Purpose and Scope of This Memorandum
This memorandum establishes binding internal guidelines for all members of the Calderwood & Harkness LLP ("C&H") engagement team working on the Solstice Biomedical FDA regulatory engagement referenced above. Every member of the team is expected to read this memorandum in its entirety, to adhere to the protocols set forth herein, and to consult with me before taking any action that could jeopardize the privileged or protected status of any communication or document generated in connection with this engagement. These guidelines are not advisory; they are mandatory, and deviation from any protocol described below requires my express, advance authorization.
Engagement Context. Our firm has been retained by Solstice Biomedical Devices Ltd. ("SBD"), an Irish medical device company (CRO No. 648231), and its wholly owned U.S. subsidiary, Solstice Biomedical Inc. ("SBI") (Delaware corporation, File No. 7834291), to provide legal counsel in connection with the U.S. regulatory pathway for the Solstice Lumina™ Continuous Glucose Monitoring ("CGM") System. The Lumina CGM System consists of two principal components: (i) the Lumina C14, an implantable subcutaneous glucose sensor with a platinum-iridium fourth-generation enzyme coating architecture (designated internally as "PtIr-4G"), and (ii) the Lumina R7, a wearable reader/transmitter device that communicates with the implanted sensor via near-field communication and Bluetooth Low Energy protocols, processes glucose measurements, and transmits data to the patient's smartphone application and, optionally, to a healthcare provider's cloud-based monitoring platform.
The scope of this engagement encompasses the following interrelated workstreams:
(a) Pre-Submission ("Pre-Sub") Strategy — Preparation and submission of a Pre-Submission meeting request and meeting package to the FDA's Center for Devices and Radiological Health ("CDRH"), Office of Health Technology 2 ("OHT2"), Division of Chemistry and Toxicology Devices, with a target Pre-Sub meeting date of August 14, 2025;
(b) Predicate Device Analysis — Identification and evaluation of legally marketed predicate devices to support a substantial equivalence determination, including analysis of NovaSense Medical Technologies Inc.'s GlucoTrack NX-500 (K211034) and GlucoTrack NX-700 (K230489);
(c) 510(k) Submission Planning — Development of a comprehensive strategy for the preparation and filing of a 510(k) premarket notification (target submission April 30, 2026; target clearance Q3 2026);
(d) Clinical Study Legal Support — Legal review of the LUMINA-US clinical study protocol (Protocol SBD-LUM-CL-001), informed consent documents, CRO and site agreements, and analysis of Investigational Device Exemption ("IDE") exemption applicability under 21 C.F.R. § 812.2(c)(3);
(e) FTO/IP Coordination — Coordination with intellectual property counsel regarding freedom-to-operate ("FTO") analysis concerning NovaSense Medical Technologies Inc.'s U.S. patent portfolio; and
(f) Related Regulatory Filings — Advice on labeling, promotional claims, iCGM special controls classification implications, and post-clearance regulatory obligations.
Third-Party Coordination and Associated Privilege Risks. This engagement involves extensive coordination with multiple third-party consultants, advisors, and service providers, each of which presents distinct privilege considerations that must be carefully managed. The following third parties are currently involved in the Solstice Lumina regulatory program:
1.  Pinnacle Regulatory Consulting Group LLC — A regulatory affairs consultancy located at 9500 Medical Center Drive, Suite 210, Rockville, MD 20850. Pinnacle was retained directly by Solstice, with its engagement commencing January 15, 2025. Key contacts are Dr. Sandra Ellison (Managing Director, former CDRH reviewer) and Thomas Greenbaum (Senior Regulatory Specialist, RAC-certified). Pinnacle is assisting Solstice with regulatory strategy input, technical summary preparation, and 510(k) submission coordination.
2.  Crestline IP Advisory LLC — A patent and intellectual property legal advisory firm located at 75 Federal Street, Suite 1800, Boston, MA 02110. Crestline has been retained by Solstice to conduct freedom-to-operate analysis regarding NovaSense Medical Technologies Inc.'s U.S. patent portfolio, with particular focus on U.S. Patent Nos. 10,847,221; 11,234,567; and 11,502,893. Key contact is Dr. Raymond Cho, Patent Attorney.
3.  Hargrove & Endicott LLP — Irish corporate and regulatory counsel to SBD, located at 38 Fitzwilliam Square East, Dublin D02 NH85, Ireland. Hargrove & Endicott is advising on European Union Medical Device Regulation ("EU MDR") compliance and its interface with FDA strategy. Key contact is Ciara Brennan, Partner.
4.  Whitmore Laboratories Inc. — An FDA-recognized, ISO 17025-accredited (A2LA Certificate No. 3847.01) contract testing laboratory located at 1625 Shady Grove Road, Suite 300, Gaithersburg, MD 20878. Whitmore is performing biocompatibility testing and electromagnetic compatibility ("EMC") and electrical safety testing in support of the 510(k) submission. Key contact is Dr. James Haverford.
5.  Veltrano Clinical Research Organization Inc. — A contract research organization ("CRO") located at 500 North Capitol Street, Suite 700, Indianapolis, IN 46204. Veltrano is conducting the LUMINA-US clinical study under Protocol SBD-LUM-CL-001. Key contact is Dr. Lisa Fontaine.
6.  Clearwater Institutional Review Board LLC — An independent institutional review board ("IRB") located at 3200 Bayshore Boulevard, Tampa, FL 33629, IRB Registration No. IRB-2019-04821. Clearwater serves as the central IRB for the LUMINA-US clinical study.
Critical Importance of These Guidelines. Rigorous adherence to the protocols set forth in this memorandum is critical to preserving the confidentiality of legal advice, strategic assessments, and work product throughout the full lifecycle of this engagement — from the current Pre-Sub preparation phase through the anticipated 510(k) clearance (target Q3 2026), potential post-clearance matters, and U.S. commercial launch (target Q4 2026). Any failure to observe these protocols could result in the inadvertent waiver of privilege or work product protection, potentially exposing C&H's legal strategy, risk assessments, and mental impressions to adverse parties — including, most critically, NovaSense Medical Technologies Inc. and its patent counsel, Marlowe Asset Management Patent Group LLP.
The FTO analysis related to NovaSense's patent portfolio warrants particular vigilance. NovaSense holds at least three U.S. patents of direct relevance to the Lumina CGM System: U.S. Patent No. 10,847,221 (directed to enzyme coating architectures for implantable glucose sensors), U.S. Patent No. 11,234,567 (directed to signal processing algorithms for continuous glucose measurement), and U.S. Patent No. 11,502,893 (directed to wireless communication protocols for implantable sensor-reader systems). The intersection between Solstice's PtIr-4G enzyme coating technology and the claims of U.S. Patent No. 10,847,221 is a matter of heightened sensitivity. All attorney mental impressions, strategic assessments, and legal conclusions regarding infringement risk constitute opinion work product entitled to near-absolute protection under the work product doctrine. The need to safeguard these materials cannot be overstated.
II. Identification of Privileged and Protected Categories of Communications
II.A. Attorney-Client Privilege
The attorney-client privilege protects confidential communications made between a client and its attorney, in connection with the provision of legal advice, and intended to remain confidential. In this engagement, the privilege attaches to communications between members of the C&H engagement team and authorized representatives of the client entities.
Identification of the Client. For purposes of this engagement, the "client" encompasses both Solstice Biomedical Devices Ltd. (the Irish parent entity, CRO No. 648231) and Solstice Biomedical Inc. (the U.S. subsidiary and intended 510(k) holder, Delaware File No. 7834291). Privilege attaches to communications with authorized representatives of both entities. SBI is the entity that will appear as the applicant on all FDA submissions, but SBD retains ultimate decision-making authority over regulatory strategy and product development, and key technical and scientific personnel are based at SBD's Dublin headquarters. Accordingly, the privilege must extend to communications with both entities to ensure comprehensive legal representation.
Authorized Client Contacts. The following individuals are authorized to communicate with C&H on privileged matters and to receive privileged legal advice on behalf of Solstice:
•  Dr. Niamh Tierney, Vice President of Regulatory Affairs, SBD (Dublin HQ) — Primary regulatory contact for this engagement; responsible for coordinating all regulatory submissions and FDA interactions on behalf of Solstice.
•  Marcus Hale, Vice President of U.S. Operations, SBI (Cambridge, MA) — Principal U.S.-based client contact; responsible for operational aspects of the U.S. regulatory and commercial launch strategy.
•  Dr. Eoin Gallagher, Chief Executive Officer, SBD — Ultimate executive authority over strategic decisions regarding the Lumina CGM System program.
•  Dr. Aisling Burke, Chief Technology Officer, SBD — Responsible for all technical and engineering aspects of the Lumina CGM System, including the PtIr-4G enzyme coating architecture; Dr. Burke's technical expertise is essential to the FTO analysis.
•  Fiona Drennan, Quality Assurance Director, SBD — Responsible for quality management system oversight, design history file maintenance, and compliance with design controls under 21 C.F.R. Part 820.
Communications with other Solstice employees — including, without limitation, bench scientists, clinical affairs staff, manufacturing engineers, and sales and marketing personnel — should be directed through the above-listed authorized contacts unless I have specifically authorized direct communication with a particular individual. When it is necessary for C&H attorneys to communicate directly with Solstice employees outside the authorized contact list for the purpose of gathering factual information to inform our legal analysis, the functional equivalent doctrine applies: a corporate employee who communicates with corporate counsel at the direction of a corporate superior, for the purpose of enabling counsel to provide legal advice to the corporation, is treated as the functional equivalent of the client for privilege purposes. See Upjohn Co. v. United States, 449 U.S. 383 (1981). In such circumstances, the C&H attorney should clearly communicate to the employee that the communication is made in connection with the provision of legal advice, is confidential, and should not be disclosed to persons outside the company without authorization.
Categories of Privileged Communications. The following types of communications in this engagement are protected by the attorney-client privilege, provided the requisite elements of confidentiality and purpose are maintained:
(a) Regulatory Pathway Selection Advice — Legal advice regarding the selection of the appropriate FDA regulatory pathway for the Lumina CGM System, including analysis of the relative merits and risks of the 510(k) pathway, the Premarket Approval ("PMA") pathway, and the De Novo classification pathway. Our current recommendation — that the 510(k) pathway is the most appropriate and efficient route to market — is itself privileged legal advice.
(b) Predicate Device Strategy — Strategic assessments of predicate device selection, including our analysis of the strengths and vulnerabilities of relying on NovaSense's GlucoTrack NX-500 (K211034) and GlucoTrack NX-700 (K230489) as primary and secondary predicates, respectively, and the implications of alternative predicate strategies.
(c) Clinical Study Design and IDE Exemption Analysis — Legal advice regarding the design and legal framework for the LUMINA-US clinical study, including our analysis of whether the study qualifies for an IDE exemption under 21 C.F.R. § 812.2(c)(3) as a study of a non-significant risk device, or whether a full IDE application will be required.
(d) iCGM Special Controls Classification — Assessment of the implications of seeking integrated continuous glucose monitoring ("iCGM") classification under the FDA's special controls guidance (product code QBJ), including the impact on performance standards, labeling requirements, and interoperability with automated insulin delivery systems.
(e) FTO and Patent Infringement Risk — Legal advice coordinated with Crestline IP Advisory regarding freedom-to-operate with respect to NovaSense's patent portfolio, including infringement risk assessments, claim chart analyses, and design-around strategies.
(f) Promotional Claims and Labeling Compliance — Advice on permissible marketing claims, labeling content, and compliance with FDA requirements for device labeling under 21 C.F.R. Part 801 and advertising under 21 C.F.R. Part 802.
(g) Post-Clearance Regulatory Obligations — Legal assessments of post-clearance compliance requirements, including Medical Device Reporting under 21 C.F.R. Part 803, corrections and removals under 21 C.F.R. Part 806, and post-market surveillance obligations.
II.B. Attorney Work Product Doctrine
The attorney work product doctrine, established in Hickman v. Taylor, 329 U.S. 495 (1947), and codified in Federal Rule of Civil Procedure 26(b)(3), protects documents and tangible things prepared in anticipation of litigation or for trial by or for a party or its representative. The doctrine provides two tiers of protection: fact work product (documents reflecting factual investigation in anticipation of litigation), which may be obtained upon a showing of substantial need and inability to obtain the substantial equivalent without undue hardship, and opinion work product (documents reflecting an attorney's mental impressions, conclusions, opinions, and legal theories), which is afforded near-absolute protection and is virtually undiscoverable.
Applicability to This Engagement. While the Solstice engagement is primarily a regulatory advisory matter, the work product doctrine is directly applicable in at least two respects:
First, and most significantly, the FTO analysis regarding NovaSense's patent portfolio — particularly U.S. Patent No. 10,847,221, which is directed to enzyme coating architectures for implantable glucose sensors and which intersects directly with Solstice's proprietary PtIr-4G technology — presents a scenario in which litigation is reasonably foreseeable. NovaSense is a direct competitor in the CGM market, holds patents that facially relate to the Lumina CGM System's core technology, and is represented by experienced patent litigation counsel (Marlowe Asset Management Patent Group LLP). Although no formal dispute or litigation has been initiated as of the date of this memorandum, Crestline's preliminary FTO assessment (delivered April 10, 2025) identified a "low-to-moderate" infringement risk regarding the claims of U.S. Patent No. 10,847,221, and a further detailed claim chart analysis is ongoing. All attorney mental impressions, conclusions, and strategic recommendations regarding infringement risk — whether prepared by Crestline, by C&H, or jointly — constitute opinion work product entitled to near-absolute protection.
Second, several categories of documents prepared by C&H in connection with the regulatory engagement reflect legal analysis and strategic thinking that would warrant work product protection even in the absence of a specific litigation threat. Documents prepared by attorneys that embody legal analysis and strategic assessments in connection with the provision of legal advice may qualify for work product protection under the broader interpretation of the doctrine adopted by many courts. See, e.g., In re Cendant Corp. Sec. Litig., 343 F.3d 658, 662 (3d Cir. 2003); United States v. Adlman, 134 F.3d 1194 (2d Cir. 1998).
Categories of Work Product in This Engagement. The following categories of documents are work product and should be treated with corresponding protection:
(a) Internal C&H Strategy Memoranda — Including, without limitation, the Pre-Sub Strategy and Anticipated FDA Feedback memorandum (currently in preparation), the FTO/IP Risk Assessment Summary, the regulatory pathway selection analysis, and any memoranda analyzing likely FDA responses to our submissions and evaluating contingency strategies.
(b) Claim Chart Analyses and Design-Around Assessments — All claim charts, infringement analyses, validity assessments, and design-around strategy documents prepared by Crestline IP Advisory or by C&H in coordination with Crestline. These documents reflect the core of the attorneys' mental impressions regarding patent risk and are entitled to the highest level of protection.
(c) Legal Risk Assessments Regarding FDA Regulatory Outcomes — Documents analyzing the probability and consequences of various FDA actions, including potential requests for additional information, deficiency letters, not substantially equivalent ("NSE") determinations, and alternative regulatory pathways.
(d) Draft Submissions with Legal Strategy Annotations — Draft Pre-Sub packages, draft 510(k) sections, draft labeling, and other submission-related documents that have been annotated by C&H attorneys with legal strategy comments, recommended revisions, or risk assessments. The annotations themselves are privileged work product, even though the underlying factual content may ultimately be submitted to FDA in an unprivileged form.
(e) Internal Emails Among C&H Team Members — Emails exchanged among Miriam Calloway, Joel Strauss, Amy Whitfield, and Sean Morrissey (and any additional team members who may join the engagement) that contain legal analysis, strategy discussions, or mental impressions related to the engagement.
II.C. Common Interest Doctrine
The common interest doctrine (also referred to as the "joint defense" doctrine, though it is not limited to the defensive context) permits parties with a shared legal interest to exchange privileged communications without waiving the attorney-client privilege or work product protection, provided certain conditions are met. The doctrine is particularly relevant to this engagement in the context of communications between C&H and Crestline IP Advisory LLC.
C&H and Crestline IP Advisory. Both C&H and Crestline serve as legal counsel to Solstice on matters that overlap significantly. C&H is providing regulatory strategy advice for the Lumina CGM System's U.S. market authorization, while Crestline is providing FTO analysis and design-around advice regarding NovaSense's patent portfolio. These two workstreams are deeply interconnected: Solstice's regulatory strategy (including predicate device selection, substantial equivalence arguments, and device design specifications reflected in the 510(k) submission) directly affects the FTO analysis, and conversely, the FTO analysis may inform design modifications that have regulatory implications. All three parties — C&H, Crestline, and Solstice — share a common legal interest in protecting Solstice's ability to commercialize the Lumina CGM System in the United States without infringing NovaSense's patents and without jeopardizing the FDA clearance pathway.
To avail ourselves of the common interest doctrine, I recommend the execution of a formal Common Interest Agreement among C&H, Crestline, and Solstice. This agreement will memorialize the shared legal interest, establish the scope of information sharing, and confirm that the exchange of privileged materials does not constitute a waiver of privilege. Amy Whitfield will prepare a draft of this agreement, as reflected in the Action Items table in Section IX below, with a target circulation date of May 9, 2025.
Hargrove & Endicott LLP. A similar common interest arrangement may be appropriate for communications between C&H and Hargrove & Endicott LLP, Solstice's Irish corporate and regulatory counsel, to the extent that our regulatory strategies in the U.S. and EU are being coordinated. I will address this directly with Ciara Brennan.
Limitations of the Common Interest Doctrine. It is essential to understand that the common interest doctrine does not automatically extend to non-lawyer consultants such as Pinnacle Regulatory Consulting Group or testing laboratories such as Whitmore Laboratories. The doctrine operates to preserve the attorney-client privilege in communications between attorneys (and their respective clients) who share a common legal interest. Non-lawyer consultants do not participate in an attorney-client relationship, and their mere involvement in a common project does not bring them within the scope of the common interest doctrine. Any communications with Pinnacle, Whitmore, Veltrano, or Clearwater must be evaluated separately under the principles discussed in Section IV below.
III. Document Marking and Labeling Standards
III.A. Mandatory Privilege Legends
Consistent and accurate document marking is the first line of defense in protecting privileged communications and work product. Proper marking serves two functions: it communicates the confidential and privileged nature of the document to all recipients, and it creates a contemporaneous record of the parties' intent to maintain confidentiality — a factor courts consider in assessing whether a privilege has been waived.
The following marking standards apply to all documents generated in connection with this engagement:
1.  All memoranda, letters, and written communications containing legal advice from C&H to the client or within C&H must bear the following legend prominently at the top of the first page:
PRIVILEGED AND CONFIDENTIAL — ATTORNEY-CLIENT COMMUNICATION
2.  All internal C&H analytical documents — including strategy memoranda, legal risk assessments, research memoranda, and draft submissions containing attorney annotations — must additionally bear the following legend:
ATTORNEY WORK PRODUCT — PREPARED IN ANTICIPATION OF LITIGATION AND/OR IN CONNECTION WITH THE PROVISION OF LEGAL ADVICE
3.  Draft documents prepared for submission to FDA — including draft Pre-Sub meeting packages, draft 510(k) cover letters, draft Indications for Use statements, draft substantial equivalence comparison tables, and draft labeling — should be marked:
DRAFT — PRIVILEGED AND CONFIDENTIAL
This marking should be maintained on all draft versions of submission documents until the document is finalized for filing with the FDA. Once a document is finalized and submitted to the FDA, the submitted version is no longer privileged, as it has been voluntarily disclosed to a government agency. However, prior drafts reflecting legal strategy choices, attorney redlines, strategic annotations, and internal deliberation remain protected as work product and/or privileged attorney-client communications. The distinction between the "final-as-filed" version and prior drafts containing legal analysis is critical and must be scrupulously maintained in the document management system.
4.  Documents exchanged under the common interest arrangement with Crestline IP Advisory should include the additional notation:
COMMON INTEREST PRIVILEGE — SHARED PURSUANT TO COMMON INTEREST AGREEMENT
III.B. Email Subject Line Conventions
Email is the predominant mode of communication in this engagement, and email chains present unique risks for inadvertent privilege waiver — particularly when external parties are added to existing threads, when chains are forwarded, or when "reply all" responses inadvertently include non-privileged recipients. The following email conventions are mandatory:
(a) All emails containing legal advice, legal analysis, or work product must include the prefix "[PRIVILEGED]" or "[ATTORNEY-CLIENT PRIVILEGED]" in the subject line. For example:
Subject: [PRIVILEGED] Pre-Sub Strategy — Predicate Device Selection Analysis
(b) All emails sent to client contacts (Dr. Tierney, Marcus Hale, Dr. Gallagher, Dr. Burke, Fiona Drennan) must include the following footer notice, which should be included in the C&H email signature block for all team members working on this matter:
"This communication is protected by the attorney-client privilege and/or as attorney work product. It is intended solely for the use of the individual(s) to whom it is addressed. If you are not the intended recipient, you are hereby notified that any review, disclosure, copying, distribution, or use of this communication or the information contained herein is strictly prohibited. If you have received this communication in error, please notify the sender immediately by telephone and delete this communication and all copies from your system. Thank you."
(c) Emails exchanged between C&H and Crestline IP Advisory on FTO, patent, or infringement-related matters should include the prefix:
Subject: [COMMON INTEREST / PRIVILEGED] FTO Analysis — NovaSense Patent Portfolio
(d) Emails that are purely factual or technical in nature — for example, scheduling emails, transmittal of test reports from Whitmore Laboratories, or coordination of clinical study logistics with Veltrano CRO — should not be marked as privileged. Over-designation of non-privileged documents as privileged can undermine privilege claims and create credibility issues in the event of future litigation or privilege disputes.
III.C. Document Management and Filing
All documents generated in connection with this engagement — whether privileged or non-privileged — must be stored in the designated matter folder on the C&H document management system under Matter No. 1037-00002. Within this matter folder, the following subfolder structure must be maintained:
•  01-Privileged — Legal Analysis and Strategy — For all privileged attorney-client communications, legal memoranda, strategy documents, and work product. This folder should contain subfolders for specific workstreams (e.g., "01A-Pre-Sub Strategy," "01B-510(k) Planning," "01C-Clinical Study Legal Support," "01D-Labeling and Promotional Claims").
•  02-Privileged — FTO/IP Materials (RESTRICTED ACCESS) — For all Crestline FTO assessments, claim chart analyses, design-around evaluations, and related materials. Access to this subfolder is restricted to Miriam Calloway, Joel Strauss, Amy Whitfield, and Sean Morrissey. See Section VI.D below for additional access controls.
•  03-Common Interest Materials — For documents exchanged under the common interest arrangement with Crestline and Hargrove & Endicott.
•  04-Non-Privileged — Technical and Regulatory — For non-privileged technical documents, testing reports from Whitmore Laboratories, clinical study documents (protocols, consent forms), regulatory submissions (final versions as filed with FDA), and correspondence with non-lawyer third parties.
•  05-Privilege Log — For maintenance of the running privilege log for this engagement.
It is imperative that privileged legal analysis documents be segregated from non-privileged factual or technical documents. Commingling privileged and non-privileged materials in the same folders or filing locations creates confusion, increases the risk of inadvertent production, and can complicate privilege review in the event of future litigation or government investigation.
Amy Whitfield is designated as the privilege log coordinator for this engagement. She is responsible for maintaining a contemporaneous privilege log that identifies all documents withheld or redacted on the basis of privilege or work product protection. The privilege log should be initiated promptly (see Action Items, Section IX) and updated on a rolling basis as new privileged documents are created. Each entry in the privilege log must include, at a minimum: (i) the date of the document; (ii) the author; (iii) the recipient(s); (iv) a general description of the document's subject matter (sufficient to support the privilege claim without revealing privileged content); and (v) the basis for the privilege assertion (attorney-client privilege, work product, common interest, or a combination thereof).
IV. Communications Protocols with Third-Party Consultants
The involvement of multiple third-party consultants and advisors in this engagement creates the most significant privilege risks we face. The general rule is that disclosure of privileged information to a third party waives the privilege unless an exception applies. Each third party must be assessed individually to determine whether, and under what circumstances, communications with that party may retain their privileged status. This section provides specific guidance for each third party currently involved in the engagement.
IV.A. Pinnacle Regulatory Consulting Group LLC
Key Facts. Pinnacle Regulatory Consulting Group LLC is a regulatory affairs consultancy — it is not a law firm, and its consultants do not hold themselves out as providing legal advice. Pinnacle was retained directly by Solstice (not by C&H) pursuant to a consulting agreement dated January 15, 2025. Pinnacle's principal office is located at 9500 Medical Center Drive, Suite 210, Rockville, MD 20850. The key contacts for this engagement are Dr. Sandra Ellison (Managing Director; former reviewer at CDRH's Division of Chemistry and Toxicology Devices, where she spent eleven years before entering the private sector) and Thomas Greenbaum (Senior Regulatory Specialist, RAC-certified). Pinnacle is assisting Solstice with a range of regulatory consulting tasks, including preparation of technical summaries, performance testing protocol design, biocompatibility assessment coordination, Pre-Sub meeting package preparation, and general regulatory strategy input.
Privilege Risk Assessment. Communications between Solstice and Pinnacle are generally NOT protected by the attorney-client privilege because Pinnacle is not a law firm and the consultant-client relationship is not a legal one. Similarly, communications between C&H and Pinnacle are not automatically privileged. If C&H were to share privileged legal strategy, FTO analysis, or attorney work product with Pinnacle, that disclosure would ordinarily constitute a waiver of the privilege with respect to the disclosed materials.
The Kovel Exception. Under the doctrine established in United States v. Kovel, 296 F.2d 918 (2d Cir. 1961), and its progeny, communications with a non-lawyer consultant may be privileged if three conditions are met: (i) the consultant is retained to assist counsel (not the client independently) in providing legal advice; (ii) the communications are made for the purpose of facilitating the rendition of legal advice by counsel; and (iii) the consultant is functioning as a "translator" or "interpreter" of complex technical or specialized information that counsel needs to understand in order to provide informed legal advice. When these conditions are satisfied, the consultant is treated as an agent of the attorney, and the privilege extends to the three-way communications between attorney, consultant, and client.
Application to This Engagement. There are circumstances in this engagement where the Kovel doctrine may apply to specific Pinnacle communications. For example, if I direct Pinnacle to prepare a technical summary of the Lumina C14 sensor's enzyme coating architecture specifically to enable me to assess the substantial equivalence argument for the Pre-Sub meeting package — that is, to "translate" complex bioengineering concepts into a form that allows me to render informed legal advice — that communication may be privileged under Kovel. However, when Pinnacle is performing its independent regulatory consulting services for Solstice (e.g., preparing a 510(k) technical summary for direct inclusion in the submission, designing performance testing protocols, or coordinating biocompatibility testing with Whitmore Laboratories), those work products are created in the ordinary course of Pinnacle's consulting engagement and are not privileged.
Mandatory Guidelines for Communications with Pinnacle:
1.  Kovel-Directed Work. Where C&H directly retains or directs Pinnacle's work for the specific purpose of enabling C&H to render legal advice to Solstice, the communication should be channeled through C&H and marked with appropriate privilege legends. The C&H coordination letter to Pinnacle (which I am currently preparing; see Action Items, Section IX) will delineate which tasks are performed "at the direction of counsel" and which are independent consulting tasks. Until that letter is finalized and executed, team members should not attempt to invoke the Kovel framework without consulting me.
2.  Independent Consulting Work. Pinnacle's independent consulting deliverables — technical summaries, regulatory strategy memos, protocol designs, biocompatibility assessment plans, and similar work products prepared for Solstice's direct use — are not privileged and should be treated as non-privileged technical documents filed in the "04-Non-Privileged" subfolder.
3.  No Sharing of Privileged Materials. C&H team members must not share internal legal strategy memoranda, FTO assessments, patent claim chart analyses, regulatory risk assessments, or any other privileged attorney work product with Pinnacle personnel unless specifically authorized by Miriam Calloway and unless the communication can be structured to maintain privilege under the Kovel framework or another applicable doctrine. If there is any doubt, do not share.
4.  Separate Communications for Technical Input. If C&H requires technical input from Pinnacle — for example, to inform our legal analysis of predicate device comparisons or testing strategies — the request should be framed as a factual or technical inquiry in a separate communication from any legal strategy discussion. Do not pose questions that embed or reference our legal strategy, and do not include Pinnacle personnel on email chains that contain legal advice or privileged analysis. The appropriate approach is to send a standalone email to Dr. Ellison or Thomas Greenbaum requesting the specific factual or technical information needed, without explaining the legal purpose for which it is being sought.
5.  Email Thread Separation. Never add Pinnacle personnel (Dr. Ellison, Thomas Greenbaum, or any other Pinnacle employee) to an existing email chain that contains privileged content. If Pinnacle's input is needed on a topic that has been the subject of a privileged email thread, start a new, clean email thread addressed to the appropriate Pinnacle contact, containing only non-privileged factual content.
IV.B. Crestline IP Advisory LLC
Key Facts. Crestline IP Advisory LLC is a law firm specializing in patent and intellectual property law. Dr. Raymond Cho, a registered patent attorney and Crestline's lead contact for this engagement, is licensed to practice before the United States Patent and Trademark Office and is a member of the Massachusetts bar. Crestline's principal office is located at 75 Federal Street, Suite 1800, Boston, MA 02110. Crestline was retained by Solstice to perform a comprehensive freedom-to-operate analysis regarding NovaSense Medical Technologies Inc.'s U.S. patent portfolio, with particular attention to:
•  U.S. Patent No. 10,847,221 — Directed to enzyme coating architectures for implantable electrochemical glucose sensors; this patent is of greatest concern due to the potential overlap with Solstice's PtIr-4G technology.
•  U.S. Patent No. 11,234,567 — Directed to signal processing algorithms for continuous glucose measurement, including methods for compensating for sensor drift and biofouling effects.
•  U.S. Patent No. 11,502,893 — Directed to wireless communication protocols for data transmission between an implantable sensor and an external reader device in a continuous glucose monitoring system.
Privilege Status. Communications between Crestline and Solstice are independently protected by the attorney-client privilege, as Crestline is legal counsel to Solstice. Communications between C&H and Crestline may be protected under the common interest doctrine, provided the conditions discussed in Section II.C are met and a formal Common Interest Agreement is executed.
Mandatory Guidelines for Communications with Crestline:
1.  Common Interest Agreement. As noted above, a Common Interest Agreement among C&H, Crestline, and Solstice should be executed as promptly as practicable. Amy Whitfield will prepare the initial draft, with a target circulation date of May 9, 2025. Until this agreement is executed, exercise heightened caution in sharing C&H work product with Crestline, though the exchange of information necessary for coordinated legal representation may proceed on the understanding that a common legal interest exists. Once executed, the agreement will formalize the shared privilege and establish the ground rules for information sharing.
2.  Sensitivity of FTO Materials. Crestline's FTO preliminary assessment (delivered April 10, 2025) and all subsequent deliverables — including detailed claim chart analyses for each of the three NovaSense patents, infringement risk assessments, validity assessments, design-around evaluations, and prosecution history analyses — represent among the most sensitive documents in this entire engagement. The preliminary assessment concluded that the risk of infringement of U.S. Patent No. 10,847,221 is "low-to-moderate," with significant questions remaining regarding the scope of independent claim 1 and dependent claims 3, 7, and 12 in light of Solstice's PtIr-4G architecture. Further analysis is ongoing and will be refined as Solstice's device design is finalized.
3.  Distribution Restrictions. Crestline FTO materials must be distributed only on a need-to-know basis. Within C&H, access is limited to the four members of the engagement team named in this memorandum. Within Solstice, distribution is limited to Dr. Niamh Tierney, Dr. Aisling Burke, and Marcus Hale, unless Dr. Gallagher specifically requests access. Under no circumstances should FTO materials be shared with Pinnacle, Whitmore Laboratories, Veltrano CRO, Clearwater IRB, or any other non-legal third party.
4.  Common Interest Privilege Markings. All joint communications between C&H and Crestline should bear the following marking in addition to the standard privilege legend:
COMMON INTEREST PRIVILEGE — CONFIDENTIAL COMMUNICATION BETWEEN CO-COUNSEL PURSUANT TO COMMON INTEREST AGREEMENT
IV.C. Hargrove & Endicott LLP (Irish Counsel)
Key Facts. Hargrove & Endicott LLP is Solstice Biomedical Devices Ltd.'s Irish corporate and regulatory counsel. The firm is located at 38 Fitzwilliam Square East, Dublin D02 NH85, Ireland. The key contact is Ciara Brennan, Partner, who heads the firm's life sciences regulatory practice. Hargrove & Endicott is advising SBD on EU MDR compliance and its interface with FDA strategy, including issues related to the CE certificate for the Lumina CGM System (Certificate No. MCA-2024-07319, issued by Meridian Conformity Assessment GmbH, Notified Body No. 0483, on September 12, 2024) and the alignment of EU and U.S. clinical data requirements.
Privilege Status. Communications between Hargrove & Endicott and SBD are privileged under Irish law. The concept of legal professional privilege in Ireland encompasses both legal advice privilege and litigation privilege, broadly analogous to the U.S. attorney-client privilege and work product doctrine. Communications between C&H and Hargrove & Endicott may be protected under the common interest doctrine, to the extent that both firms share a common legal interest in Solstice's regulatory compliance strategy across jurisdictions.
Mandatory Guidelines for Communications with Hargrove & Endicott:
1.  Common Interest Arrangement. I will confirm in writing with Ciara Brennan the shared privilege understanding and, if appropriate, execute a common interest arrangement analogous to the agreement with Crestline. Target date: May 15, 2025 (see Action Items, Section IX).
2.  Relevant Interface Topics. The primary areas of overlap between C&H's work and Hargrove & Endicott's work include: (a) the EU MDR CE certificate and its evidentiary value in the FDA submission context; (b) alignment of clinical performance evaluation data under the EU MDR with FDA clinical evidence requirements; (c) coordination of labeling content between EU and U.S. markets; and (d) post-market surveillance harmonization.
3.  Cross-Border Privilege Considerations. Team members should be aware that privilege law differs between the United States and Ireland, and between common law and civil law jurisdictions more broadly. A communication that is privileged under U.S. law may not be privileged under Irish law, and vice versa. For example, Irish law generally does not recognize a work product doctrine as broad as the U.S. doctrine. When exchanging documents or communications with Hargrove & Endicott, consider the privilege implications under both jurisdictions and mark communications appropriately. If there is uncertainty about whether a particular communication or document would be privileged under Irish law, consult with me before sharing.
IV.D. Whitmore Laboratories Inc. (Contract Testing Lab)
Key Facts. Whitmore Laboratories Inc. is an FDA-recognized, ISO 17025-accredited (A2LA Certificate No. 3847.01) contract testing laboratory. Whitmore is located at 1625 Shady Grove Road, Suite 300, Gaithersburg, MD 20878. The engagement with Whitmore commenced on March 3, 2025. The key contact is Dr. James Haverford, Director of Biocompatibility Testing Services. Whitmore is performing two categories of testing in support of the Lumina CGM System 510(k) submission: (i) biocompatibility testing (budget: $485,000), encompassing cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, and hemocompatibility studies consistent with the FDA-recognized standard ISO 10993-1:2018; and (ii) electromagnetic compatibility ("EMC") and electrical safety testing (budget: $175,000), consistent with IEC 60601-1 and IEC 60601-1-2.
Privilege Status. Whitmore is a testing laboratory, not legal counsel. Communications with Whitmore are generally NOT privileged. Whitmore's testing protocols, raw data, laboratory reports, and final test results are factual technical documents that will become part of the 510(k) submission and are inherently non-privileged.
Mandatory Guidelines for Communications with Whitmore:
1.  Do not share C&H legal strategy, FTO analysis, patent claim charts, regulatory risk assessments, or any privileged communications with Whitmore personnel.
2.  Testing protocols, results, and reports received from Whitmore should be filed in the "04-Non-Privileged — Technical and Regulatory" subfolder in the document management system.
3.  If C&H needs to communicate with Whitmore regarding the scope of testing — for example, to inform the biocompatibility testing strategy memorandum we are preparing for the client — those communications must be limited to factual and technical inquiries. Do not explain the legal rationale behind a particular testing approach, and do not reference legal strategy or risk assessments.
4.  In the event that C&H's analysis of Whitmore's test results identifies a legally significant issue (e.g., a biocompatibility result that could affect the substantial equivalence argument), that legal analysis should be communicated to the client in a separate privileged memorandum, not in a communication directed to Whitmore.
IV.E. Veltrano Clinical Research Organization Inc. and Clearwater Institutional Review Board LLC
Key Facts.
Veltrano CRO. Veltrano Clinical Research Organization Inc. is located at 500 North Capitol Street, Suite 700, Indianapolis, IN 46204. The key contact is Dr. Lisa Fontaine, Executive Vice President of Clinical Operations. Veltrano has been retained by Solstice to conduct the LUMINA-US clinical study under Protocol SBD-LUM-CL-001. The study is a prospective, multicenter, single-arm, pivotal study designed to evaluate the accuracy, safety, and reliability of the Lumina CGM System in adults with type 1 and type 2 diabetes mellitus. The study will enroll 350 subjects at six U.S. clinical sites, with a study budget of approximately $4,200,000. Study commencement is currently targeted for September 15, 2025.
Clearwater IRB. Clearwater Institutional Review Board LLC is located at 3200 Bayshore Boulevard, Tampa, FL 33629. IRB Registration No. IRB-2019-04821. Clearwater serves as the central IRB for the LUMINA-US study and is responsible for initial and continuing review of the study protocol, informed consent documents, and investigator qualifications.
Privilege Status. Neither Veltrano nor Clearwater is legal counsel, and communications with either entity are generally not privileged. The CRO is a vendor performing clinical study execution services, and the IRB is an independent oversight body performing regulatory functions.
Mandatory Guidelines:
1.  CRO Agreement and Consent Form Review. C&H's review of the CRO agreement (including indemnification provisions, liability allocation, data ownership terms, and regulatory compliance representations) and the informed consent templates constitutes privileged legal advice to Solstice. Drafts and redlines of these documents reflecting C&H's legal comments are privileged. However, the final executed CRO agreement and the final approved informed consent forms (as submitted to Clearwater IRB and provided to study subjects) are not privileged.
2.  No Sharing of Legal Memoranda. Do not share C&H's internal legal memoranda with Veltrano or Clearwater. This includes, in particular, our analysis of IDE exemption applicability under 21 C.F.R. § 812.2(c)(3), our clinical study strategy assessments, and any legal advice regarding informed consent content or regulatory risk.
3.  Regulatory Record Status. Protocol submissions, informed consent documents, IRB correspondence, adverse event reports, and other documents submitted to the IRB or maintained as part of the clinical study regulatory record are non-privileged. These documents should be filed in the "04-Non-Privileged" subfolder.
IV.F. NovaSense Medical Technologies Inc. and Marlowe Asset Management Patent Group LLP
Key Facts.
NovaSense Medical Technologies Inc. is located at 4800 Innovation Parkway, San Diego, CA 92121. NovaSense's CEO is David Reinhardt and its VP of Regulatory Affairs is Dr. Karen Nishimura. NovaSense is a manufacturer of continuous glucose monitoring systems and holds FDA clearances for two devices that Solstice is evaluating as potential predicate devices: the GlucoTrack NX-500 (510(k) No. K211034) and the GlucoTrack NX-700 (510(k) No. K230489). NovaSense is also the assignee of the three U.S. patents that are the subject of Crestline's FTO analysis.
Marlowe Asset Management Patent Group LLP is NovaSense's patent counsel, located at 2200 Wilson Boulevard, Suite 1100, Arlington, VA 22201. The lead partner is Patricia Langford. Marlowe Asset Management is known for aggressive patent enforcement in the medical device sector.
Privilege Status and Guidelines. NovaSense and Marlowe Asset Management are potential adversaries. Although no formal dispute or litigation has been initiated as of this date, the ongoing FTO analysis and the competitive dynamic between Solstice and NovaSense in the CGM market create a reasonable basis for anticipating future adversarial interaction.
1.  Absolute Prohibition on Disclosure. Under no circumstances shall any privileged information, work product, FTO analysis, claim chart, design-around strategy, regulatory strategy, or confidential client communication be shared with, or made accessible to, NovaSense or Marlowe Asset Management Patent Group.
2.  Predicate Device References. The predicate device analysis necessarily references NovaSense's cleared devices (K211034 and K230489) by name, as these are publicly available FDA clearance records. References to NovaSense's cleared devices in FDA submissions — including the Pre-Sub meeting package and the 510(k) substantial equivalence comparison — are factual and non-problematic. However, any analysis of NovaSense's patent claims, potential infringement risk, design-around strategies, or patent validity is highly privileged and must be strictly segregated from the predicate device analysis. Do not intermingle patent-related analysis with regulatory submission materials.
3.  No Contact Without Authorization. No member of the C&H engagement team shall have any communication — whether written, oral, electronic, or otherwise — with any representative of NovaSense Medical Technologies Inc. or Marlowe Asset Management Patent Group LLP regarding the Solstice engagement or any related matter without the express, advance authorization of Miriam Calloway and Dr. Niamh Tierney. If any team member receives an unsolicited communication from NovaSense or Marlowe Asset Management, it should be immediately forwarded to me without substantive response.
V. Specific Privilege Considerations for FDA Submissions and Communications
V.A. Pre-Submission (Pre-Sub) Package and Meeting
The Pre-Submission process is a critical milestone in the Solstice engagement. The Pre-Sub meeting provides Solstice with the opportunity to obtain informal, non-binding feedback from CDRH on the proposed regulatory pathway, predicate device selection, clinical study design, and testing strategy before committing the resources necessary for a full 510(k) submission. The engagement team should understand the privilege implications at each stage of the Pre-Sub process.
Timeline and Key Dates:
•  Pre-Sub Meeting Request: Target submission date June 2, 2025
•  Pre-Sub Meeting Package: Target submission date June 16, 2025 (60 calendar days prior to meeting)
•  Pre-Sub Meeting: Target date August 14, 2025, with CDRH OHT2, Division of Chemistry and Toxicology Devices
•  FDA Written Feedback: Anticipated within 30 days of meeting (mid-September 2025)
Privilege Analysis:
1.  The Pre-Sub meeting request (a brief letter identifying the device, the regulatory pathway, and the general topics for discussion), the Pre-Sub meeting package (containing the detailed device description, predicate comparison, proposed testing plan, clinical protocol summary, and questions for FDA), and the FDA's written feedback all become part of the regulatory record once submitted to or received from FDA. These documents are NOT privileged once they are in the FDA's possession.
2.  However, internal strategy documents prepared by C&H analyzing anticipated FDA feedback, evaluating contingency plans, and assessing legal risk in connection with the Pre-Sub process remain privileged. For example, our internal memorandum analyzing the likelihood that FDA will accept the proposed primary predicate (NovaSense GlucoTrack NX-500, K211034) versus requesting identification of an alternative predicate, and our analysis of the implications of either outcome for the overall 510(k) strategy, is privileged work product that reflects attorney mental impressions and legal analysis.
3.  Draft Pre-Sub packages circulated among C&H team members for internal review, with strategic annotations such as "FDA may push back on this predicate comparison — consider strengthening the argument regarding technological characteristics" or "Flag for Dr. Tierney: this section may need revision depending on Crestline's updated claim chart analysis," are work product. All such annotations must be removed before the draft is finalized and submitted to FDA. The final version submitted to FDA must be a clean document containing only factual and technical content.
4.  The Distinction. The Pre-Sub package itself — including the device description, predicate device comparison table, proposed testing plan, clinical protocol summary, and questions for FDA — is factual and technical in nature. It represents Solstice's presentation of its device and regulatory proposal to the agency. C&H's internal memorandum analyzing the likely FDA responses to each question in the package, evaluating the strongest and weakest elements of the submission, and developing contingency strategies, is privileged work product reflecting our professional judgment and legal analysis.
V.B. 510(k) Submission Materials
The 510(k) premarket notification (target submission date: April 30, 2026) will represent the culmination of the regulatory workstream. The privilege considerations applicable to the 510(k) submission largely parallel those applicable to the Pre-Sub process, but the volume and complexity of documents is substantially greater.
1.  The final 510(k) submission — including the 510(k) summary prepared pursuant to 21 C.F.R. § 807.92, the Indications for Use statement (FDA Form 3881), the substantial equivalence comparison, the device description, the performance testing data, the clinical study report, the biocompatibility evaluation, the EMC and electrical safety test reports, the software documentation, the labeling, and all other components of the submission package — will be submitted to FDA and is not privileged once filed.
2.  Draft versions of 510(k) sections that contain C&H attorney comments, tracked changes reflecting legal advice (e.g., "Delete this sentence — it could be construed as an impermissible expanded indication"), redlines, and strategic annotations are privileged as attorney work product and/or attorney-client communications. The privilege attaches to the annotations and legal analysis, not to the underlying factual content. It is therefore essential to maintain clean version control: the "final-for-filing" version must be separated from annotated drafts, and annotated drafts must be retained in the privileged subfolder.
3.  C&H Advisory Memoranda. Our labeling review memorandum (analyzing the proposed labeling content against FDA requirements and identifying potential deficiencies or enforcement risks), our promotional claims memorandum (analyzing the permissibility of specific marketing claims under the cleared indications for use), and all other advisory memoranda from C&H to Solstice regarding the 510(k) submission remain privileged as legal advice, regardless of whether the underlying submission is eventually filed with FDA.
V.C. Clinical Study Documents
1.  The LUMINA-US clinical protocol (Protocol SBD-LUM-CL-001), informed consent forms, case report forms, IRB submissions, and related clinical study documents are part of the regulatory record and become non-privileged upon submission to the IRB, clinical sites, or FDA.
2.  C&H's review and markup of informed consent forms — including tracked changes reflecting our legal advice on informed consent content (e.g., recommendations regarding risk disclosure language, subject compensation descriptions, data privacy provisions, and regulatory compliance statements) — is privileged legal advice. The tracked-change version reflecting our legal comments should be retained in the privileged subfolder. The clean final version submitted to Clearwater IRB for approval is not privileged.
3.  C&H's memorandum analyzing IDE exemption applicability under 21 C.F.R. § 812.2(c)(3) — specifically, our analysis of whether the LUMINA-US study qualifies as a study of a non-significant risk device that is exempt from the IDE requirements of 21 C.F.R. Part 812 — is privileged legal advice. This memorandum reflects our legal judgment regarding the classification of the Lumina CGM System for IDE purposes, the application of the non-significant risk criteria, and the risk factors that could affect FDA's assessment. It should not be shared with Veltrano CRO, Clearwater IRB, or any clinical site.
4.  Adverse Event Reports and Safety Communications. In the event that adverse events or unanticipated adverse device effects occur during the clinical study, C&H may be called upon to advise on reporting obligations under 21 C.F.R. Part 803 and FDA's Good Clinical Practice requirements. Our legal advice regarding reporting obligations is privileged; the adverse event reports themselves, once filed with FDA and/or the IRB, are not.
VI. Best Practices for Avoiding Inadvertent Waiver
Inadvertent disclosure of privileged materials can result in the waiver of privilege — not only as to the specific document disclosed, but potentially as to all communications on the same subject matter. While Federal Rule of Evidence 502(b) provides some protection against inadvertent waiver in the context of federal proceedings (requiring courts to consider the reasonableness of the precautions taken, among other factors), the best protection is to prevent inadvertent disclosure from occurring in the first place. The following best practices are mandatory for all team members.
VI.A. Email Discipline
Email is the communication medium most susceptible to inadvertent privilege waiver, because of the ease of forwarding, the "reply all" function, the auto-complete feature in email addressing, and the tendency to build long chains that accumulate privileged content over time. The following rules apply:
1.  Do not forward internal C&H emails containing legal analysis to non-attorney third parties (Pinnacle, Whitmore, Veltrano, Clearwater) without first stripping all privileged content. If an email chain contains a mixture of privileged and non-privileged content, the appropriate procedure is to extract only the non-privileged factual content and include it in a new, clean email to the third party.
2.  Use separate email threads for legal strategy discussions versus factual/technical coordination. Do not embed legal strategy commentary in an email thread that is being used for technical coordination with non-lawyer third parties. If a technical coordination thread raises a legal issue, start a new, separate thread with "PRIVILEGED" in the subject line, addressed only to C&H team members and/or authorized client contacts.
3.  Before adding any external party to an email chain, review the entire thread for privileged content. This includes scrolling to the bottom of the chain to review all prior messages. Do not rely on the assumption that earlier messages in the chain were non-privileged; review the entire chain before forwarding or adding a new recipient.
4.  Use BCC rather than CC for client contacts when third parties are on the same email to avoid "reply all" disclosures. When sending an email that includes both a non-privileged third party (e.g., Dr. Ellison at Pinnacle) and a client contact (e.g., Dr. Tierney), consider whether the client contact should be

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