Contract analysis

I. Executive Summary Calderwood & Harkness LLP ("Calderwood & Harkness" or the "Firm") has completed its review of the draft Master Services Agreement ("MSA") and the associated Work Order No. 1 (the "Work Order") proposed by Veltrano Clinical Research Organization Inc. ("Veltrano CRO") for the conduct of the LUMINA-US pivotal clinical study (Protocol SBD-LUM-CL-001) (the "Study"). This memorandum sets forth our anal

II. Background and Context A. The LUMINA-US Study The full protocol designation for the pivotal clinical study is SBD-LUM-CL-001, with the short title "LUMINA-US." The Study is designed as a prospective, single-arm, multicenter investigation to generate clinical evidence supporting the safety and effectiveness of the Solstice Lumina™ CGM System sufficient for inclusion in a 510(k) premarket notification to FDA CDRH.

III. Scope of Services A. Summary of CRO Services in Draft MSA The draft MSA defines the scope of services to be performed by Veltrano CRO under the Work Order in the following general categories:

1. Project Management and Study Oversight. Veltrano CRO will assign a dedicated project manager and clinical operations team to provide overall study management, including study planning, timeline management, and resource allocation. The draft contemplates regular project team meetings, although the frequency and format of such meetings are not specified.

2. Clinical Site Identification, Qualification, and Initiation. Veltrano CRO will identify, qualify, and initiate six (6) U.S. clinical sites for the Study. Site qualification activities include feasibility assessments, site qualification visits, and execution of clinical trial agreements between Veltrano CRO (on behalf of SBI) and each site.

3. Clinical Monitoring. Veltrano CRO will conduct site monitoring throughout the Study, including site initiation visits ("SIVs"), interim monitoring visits ("IMVs"), and close-out visits ("COVs"). The draft also references remote monitoring capabilities, although the scope of remote monitoring is not defined with specificity.

4. Subject Recruitment Support and Enrollment Management. Veltrano CRO will provide support for subject recruitment and enrollment management, including development of recruitment materials (subject to SBI and IRB approval), enrollment tracking, and management of the screen failure process. The draft contemplates enrollment of 350 subjects (175 Type 1 diabetes, 175 Type 2 diabetes) across the six sites.

5. Data Management. Veltrano CRO will design, build, validate, and maintain an electronic data capture ("EDC") system for the Study. The draft references data management services including case report form ("CRF") design, data entry, data cleaning, query management, and medical coding.

6. Statistical Analysis. Veltrano CRO will perform all statistical analyses specified in the Study protocol and statistical analysis plan ("SAP"), including MARD calculation, Clarke Error Grid analysis, and safety data analysis.

7. Safety Monitoring and Adverse Event Reporting. Veltrano CRO will monitor safety throughout the Study, including processing, evaluation, and reporting of adverse events ("AEs") and serious adverse events ("SAEs"). The draft references compliance with applicable reporting requirements, although it does not specify the particular reporting timelines or notification procedures in detail.

8. Clinical Study Report Drafting. Veltrano CRO will prepare a clinical study report ("CSR") in accordance with applicable regulatory requirements and in a format suitable for inclusion in the 510(k) submission.

9. Regulatory Submissions Support. Veltrano CRO will provide regulatory submissions support, including preparation and filing of IRB submissions and coordination of FDA communications as directed by SBI. The foregoing scope is generally consistent with standard industry practice for a CRO engaged to manage a pivotal medical device clinical investigation. However, we have identified several areas in which the scope re

IV. Study Budget and Payment Terms A. Budget Overview The total proposed study budget under Work Order No. 1 is Four Million Two Hundred Thousand Dollars ($4,200,000). The budget is calculated on a per-subject basis at a rate of Twelve Thousand Dollars ($12,000) per enrolled subject, multiplied by the target enrollment of 350 subjects ($12,000 × 350 = $4,200,000). The per-subject cost of $12,000 is inclusive of all C

1. Execution Payment. A payment of approximately $630,000 (15% of total budget) upon execution of the MSA, intended to cover CRO start-up activities, including project team mobilization, EDC system design and development, and initiation of site identification and qualification activities.

2. Site Initiation Payments. Payments tied to the completion of site initiation visits at each of the six (6) clinical sites. The draft proposes a payment of approximately $420,000 (10% of total budget) upon completion of all site initiation visits.

3. Enrollment Milestones. Payments tied to the enrollment of specified numbers of subjects, structured as follows: (a) 25% enrollment (88 subjects) — approximately $630,000; (b) 50% enrollment (175 subjects) — approximately $630,000; (c) 75% enrollment (263 subjects) — approximately $420,000; and (d) 100% enrollment (350 subjects) — approximately $420,000.

4. Database Lock. A payment of approximately $420,000 (10% of total budget) upon database lock.

5. Final CSR Delivery. A payment of approximately $630,000 (15% of total budget) upon delivery of the final clinical study report. The proposed milestone schedule reflects the anticipated study timeline: study commencement on September 15, 2025; enrollment completion in approximately late December 2025; last subject last visit in approximately mid-January 2026; database lock in approximately mid-February 2026; and st

V. Intellectual Property Ownership A. Draft MSA IP Provisions The draft MSA includes intellectual property provisions that are generally structured in a manner consistent with industry practice for CRO agreements. As drafted, the IP provisions contemplate that all study data, results, clinical study reports, and other work product generated specifically in connection with the performance of the Study will be assigned

VI. Regulatory Compliance Obligations A. FDA Regulatory Requirements The draft MSA contains general provisions requiring Veltrano CRO to comply with applicable laws and regulations. However, the level of specificity is insufficient for a CRO agreement governing a pivotal clinical investigation that will support a 510(k) submission. We recommend that the MSA be revised to require Veltrano CRO to comply with the follow

VII. Data Integrity Requirements A. Electronic Data Capture and 21 C.F.R. Part 11 Compliance The integrity and reliability of the clinical data generated by the LUMINA-US Study are paramount, given that these data will form the basis of the pivotal clinical evidence in the 510(k) submission. Accordingly, the MSA must include robust data integrity provisions. Veltrano CRO is responsible under the draft MSA for providi

VIII. Confidentiality The draft MSA includes confidentiality provisions, but in our view these provisions require strengthening to adequately protect Solstice's proprietary and confidential information. Given the sensitivity of the technology, regulatory strategy, and commercial plans associated with the Lumina CGM System, we recommend that the confidentiality provisions be revised to include the following elements:

IX. Indemnification A. Draft MSA Indemnification Structure The draft MSA includes a mutual indemnification provision under which each party agrees to indemnify, defend, and hold harmless the other party and its officers, directors, employees, and agents from and against third-party claims, losses, damages, liabilities, costs, and expenses (including reasonable attorneys' fees) arising from the indemnifying party's br