Contract analysis

I. PURPOSE AND SCOPE This memorandum has been prepared by Calderwood & Harkness LLP ("C&H") to advise Solstice Biomedical Devices Ltd. ("Solstice," "SBD," or the "Company"), an Irish-headquartered private limited company incorporated under the laws of Ireland (Companies Registration Office No. 648231), and its wholly owned U.S. subsidiary, Solstice Biomedical Inc. ("SBI"), a corporation organized and existing under t

II. EXECUTIVE SUMMARY The following summarizes the principal conclusions and recommendations set forth in this memorandum: Domestic Registration (SBI). SBI must register as a domestic establishment with FDA prior to commencing commercial distribution of the Solstice Lumina™ CGM System in the United States. SBI's anticipated activities — including receiving imported finished devices from SBD's Dublin manufacturing fac

III. REGULATORY FRAMEWORK — 21 C.F.R. PART 807 A. Statutory and Regulatory Basis The establishment registration and device listing requirements applicable to manufacturers and distributors of medical devices in the United States are rooted in Section 510 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act"), codified at 21 U.S.C. § 360. Section 510 requires, in relevant part, that every person who owns or operates

IV. DOMESTIC ESTABLISHMENT REGISTRATION — SOLSTICE BIOMEDICAL INC. A. Registration Obligation SBI, as the domestic entity responsible for importing, labeling, warehousing, and distributing the Solstice Lumina™ CGM System in the United States, must register its establishment with FDA. The establishment to be registered is located at 220 Westbrook Drive, Suite 400, Cambridge, Massachusetts 02142, which serves as SBI's

V. FOREIGN ESTABLISHMENT REGISTRATION — SOLSTICE BIOMEDICAL DEVICES LTD. A. Registration Obligation SBD, as the foreign manufacturer of the Solstice Lumina™ CGM System, is required to register its manufacturing establishment with FDA under 21 C.F.R. § 807.40. The foreign establishment registration requirement applies to any establishment located outside the United States that manufactures, prepares, propagates, compo

VI. DEVICE LISTING REQUIREMENTS A. General Obligation Under 21 C.F.R. § 807.20(a), each establishment that registers with FDA must also list with the Agency every device that is manufactured, prepared, propagated, compounded, assembled, or processed at that establishment for commercial distribution in the United States. Device listing is an integral component of the establishment registration process and is submitted

1. Complete establishment registration for both SBI and SBD in advance of 510(k) clearance (as discussed in Sections IV and V above).

2. Upon receipt of 510(k) clearance (targeted Q3 2026), promptly complete the device listing for the Lumina C14 and Lumina R7 in FURLS/DRLM, including the newly assigned 510(k) number and all required device information.

3. Ensure that the device listing is finalized and active in FDA's database prior to the commencement of any commercial distribution activity in Q4 2026. This sequencing ensures compliance with the regulatory timing requirements while avoiding the submission of incomplete device listing information (e.g., a listing without a 510(k) number) that would need to be amended after clearance. E. Updates and Amendments Devic

VII. FURLS/DRLM SUBMISSION PROCEDURES A. Overview of FURLS The FDA Unified Registration and Listing System ("FURLS") is FDA's electronic platform for establishment registration and device listing. FURLS replaced the prior paper-based registration and listing system and is now the exclusive means by which domestic and foreign establishments may register with FDA and list their devices. Within FURLS, the specific modul

1. Create or Verify FIS Account. Access https://www.access.fda.gov and create a new FIS account for the designated account administrator, or verify that an existing FIS account (from prior GlucoStrip RX-200 registration activity) is still active and accessible. If an existing account is used, confirm that the user credentials are current and that the associated organizational affiliation is correct.

2. Access DRLM Module Within FURLS. Once logged into the FIS account, navigate to the FURLS system and select the Device Registration and Listing Module (DRLM). The DRLM module provides separate workflows for establishment registration and device listing.

3. Enter Establishment Information. For the domestic establishment (SBI), enter the establishment's legal name, physical address, DUNS number, owner/operator information, and Official Correspondent designation. For the foreign establishment (SBD), enter the same categories of information plus the identity and contact information of the U.S. agent.

4. Designate U.S. Agent (Foreign Establishment Only). For SBD's foreign establishment registration, designate SBI as the U.S. agent and enter Marcus Hale's name, title, address, telephone number, and email address as the named individual contact.

5. Enter Device Listing Information for Each Device. For each device to be listed, enter the proprietary (trade) name, product code, device class, regulation number, 510(k) number (if available), establishment registration number(s), activities performed at each establishment, and any contract manufacturer or sterilizer information. As noted above, the Lumina CGM System device listing should be completed upon receipt

6. Pay Applicable MDUFA Annual Registration Fee. The MDUFA annual establishment registration fee must be paid for each registered establishment. Payment is typically made through FDA's MDUFA fee payment system, which is linked to the FURLS/DRLM submission. The registration cannot be activated until the fee payment has been processed and confirmed.

7. Submit Registration and Listing Electronically. After all required information has been entered and the MDUFA fee has been paid, submit the registration and listing electronically through the DRLM module. The system will generate a confirmation of submission.

8. Receive FDA Confirmation and Registration Number. Upon processing the submission, FDA will assign a unique registration number to each registered establishment and provide confirmation that the registration and listing have been recorded. The registration number should be retained for all future regulatory interactions. D. Common Pitfalls Based on C&H's experience with FURLS submissions for medical device clients,

VIII. COORDINATION WITH OTHER REGULATORY REQUIREMENTS A. Relationship to 510(k) Submission Establishment registration and device listing under 21 C.F.R. Part 807 are not formal prerequisites for the filing of a 510(k) premarket notification with FDA. An applicant may submit a 510(k) without having first registered its establishment or listed the subject device. However, as a practical matter, FDA may cross-reference

IX. RECOMMENDED ACTION ITEMS AND TIMELINE The following table summarizes the key action items, responsible parties, and recommended deadlines for completing the establishment registration and device listing process for SBI and SBD: C&H will monitor progress against this timeline and will provide periodic status updates to SBI and SBD. Any deviations from the recommended deadlines should be promptly communicated to C&

X. CONCLUSION Establishment registration and device listing under 21 C.F.R. Part 807 are foundational regulatory requirements that must be satisfied before Solstice Biomedical Inc. can lawfully distribute the Solstice Lumina™ CGM System in the United States. These requirements are not merely administrative formalities; they represent the reg