Contract analysis

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 t

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 w

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 Att

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 a

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 p

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 investi

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

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

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.

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 containi

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 comm

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 circumstanc

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, Sui

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 cou

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 do

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 perso

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

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 lega

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 ass

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

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 s

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 harm

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 e

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

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 Protoc

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 t

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 evalua

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'

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 memb

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. T

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. Thes

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,

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 th

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, evaluat

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 o

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 cont

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 privileg

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.