Contract analysis

Section 1: Executive Summary This Monthly Client Status Report covers the reporting period of [Month/Year] and provides a comprehensive overview of the current status of Calderwood & Harkness LLP's ("C&H") engagement with Solstice Biomedical Inc. ("SBI") and Solstice Biomedical Devices Ltd. ("SBD," and together with SBI, the "Client") regarding the FDA pre-submission strategy, 510(k) planning, and related regulatory

Section 2: Engagement Team The following table sets forth the current composition of the Calderwood & Harkness LLP engagement team assigned to this matter. Any changes to team composition during the reporting period are noted below. Changes to Team Composition During Reporting Period: [Placeholder — e.g., "No changes to the engagement team composition occurred during this reporting period." Alternatively: "Effective

Section 3: Work Completed During Reporting Period The following subsections describe in detail the work completed by the Calderwood & Harkness engagement team, in coordination with the Client and third-party consultants, during the reporting period of [Month/Year]. 3.1 Regulatory Strategy and Classification During this reporting period, the engagement team [continued/completed/advanced] the device classification anal

Section 4: Regulatory Milestone Tracker The following table tracks all key regulatory milestones for the Lumina CGM System U.S. regulatory program. Status designations are as follows: Completed (milestone achieved), On Track (milestone expected to be achieved by target date), At Risk (milestone may be delayed; monitoring required), Delayed (milestone will not be achieved by target date; revised date indicated). Criti

Section 5: Open Issues and Action Items The following table identifies open issues and action items requiring attention. Items are tracked from period to period until closed.

Section 6: Budget and Financial Tracking 6.1 Calderwood & Harkness Legal Fees The following table tracks Calderwood & Harkness legal fees incurred during the reporting period and cumulatively to date, measured against the total engagement fee estimate of $650,000. This estimate was provided in C&H's engagement letter dated April 22, 2025, and is based on the assumed scope of work, regulatory pathway, and timeline des

Section 7: Key Client and Third-Party Contacts The following table provides a reference list of key contacts for the engagement. Solstice Biomedical Devices Ltd. (Ireland — Parent Entity) Solstice Biomedical Inc. (U.S. — Subsidiary) Pinnacle Regulatory Consulting Group LLC Crestline IP Advisory LLC Whitmore Laboratories Inc. Veltrano Clinical Research Organization Inc. Clearwater Institutional Review Board LLC Hargro

Section 8: Next Steps and Upcoming Priorities The following priorities and planned activities are identified for the next reporting period, [Month/Year]:

1. Pre-Sub Meeting Request Submission. [If applicable — e.g., "Finalize and submit the Pre-Sub (Q-Sub) meeting request letter to FDA CDRH by June 2, 2025. The request will identify the proposed meeting date (August 14, 2025), meeting type (written feedback meeting or in-person/teleconference meeting, as appropriate), and the subject matter of the Pre-Sub."]

2. Pre-Sub Meeting Package Finalization and Submission. [If applicable — e.g., "Complete all Pre-Sub meeting package components and submit the full package to FDA by June 16, 2025 (60 days in advance of the proposed meeting date). This requires timely receipt of outstanding engineering deliverables from SBD, including final device description specifications, bench testing summaries, and software documentation."]

3. Clinical Study Agreement Execution. [If applicable — e.g., "Finalize negotiation of the clinical study agreement with Veltrano CRO and execute the agreement. Resolution of outstanding contractual terms (indemnification, data ownership) is required prior to execution."]

4. IRB Submission. [If applicable — e.g., "Submit the complete IRB submission package to Clearwater IRB, including Protocol SBD-LUM-CL-001, investigator's brochure, informed consent form, and supporting documents."]

5. Biocompatibility Testing Monitoring. [If applicable — e.g., "Continue monitoring Whitmore Laboratories' biocompatibility testing program. Review interim test results as they become available. Escalate any testing anomalies or failures immediately."]

6. FTO Analysis Completion. [If applicable — e.g., "Receive and review Crestline's completed claim chart analysis for U.S. Patent No. 10,847,221. Evaluate the adequacy of SBD's proposed design-around. Provide updated FTO risk assessment to the Client."]

7. Software and Cybersecurity Documentation Remediation. [If applicable — e.g., "Continue coordination with SBD engineering team on software documentation gap remediation. Review and comment on updated software documentation deliverables. Advance cybersecurity premarket submission checklist completion."]

8. Insurance Renewal. [If applicable — e.g., "Initiate the renewal process for the Atlas Underwriting Partners product liability insurance policy (Policy No. AUP-PL-2024-00893, expiring September 30, 2025). Ensure that renewed coverage is adequate for clinical study operations and anticipated U.S. commercial launch activities."] Decisions and Inputs Needed from the Client: • [Description of specific decisions or inpu

Section 9: Risk Register The following table identifies key risks to the Lumina CGM System U.S. regulatory program and the associated mitigation strategies. Risks are assessed based on their likelihood and potential impact on the program timeline, budget, and/or regulatory outcome. The risk register is updated monthly to reflect changes in risk profile. Appendix A: Glossary of Key Terms and Acronyms Appendix B: Docum