Contract analysis

I. Purpose and Scope of This Memorandum The purpose of this memorandum is to outline the submission requirements, document preparation timeline, and ongoing compliance obligations associated with obtaining initial Institutional Review Board ("IRB") approval from Clearwater Institutional Review Board LLC ("Clearwater IRB") for the clinical study designated as Protocol SBD-LUM-CL-001, titled "LUMINA-US" (the "Study").

II. Overview of Clearwater Institutional Review Board LLC A. IRB Identification and Registration The IRB selected to serve as the reviewing body for the LUMINA-US Study is Clearwater Institutional Review Board LLC, a limited liability company organized under the laws of the State of Florida. The relevant identifying information for Clearwater IRB is as follows: • Full Legal Name: Clearwater Institutional Review Board

1. Streamlined Multi-Site Review. The central IRB approach eliminates the need to submit separate IRB applications to institutional IRBs at each of the six clinical sites, which would introduce variability in review timelines, consent form language, and approval conditions. Under the single-IRB model, Clearwater IRB will conduct a single protocol review and approve a single informed consent form template for use at a

2. Timeline Efficiency. The use of a central IRB significantly reduces the overall timeline for obtaining IRB approval across all sites. Rather than managing six parallel IRB review processes—each with its own submission requirements, meeting schedules, and review timelines—Solstice will manage a single submission and a single review cycle, which is essential given the compressed timeline between the planned IRB subm

3. Medical Device Study Experience. Clearwater IRB has substantial experience reviewing clinical studies involving medical devices, including studies of continuous glucose monitoring systems and other diagnostic devices classified as non-significant risk under 21 C.F.R. § 812.2(c)(3). This experience is particularly important in the context of the NSR determination, as Clearwater IRB's familiarity with the applicable

4. Uniform Consent and Protocol Review. The use of a central IRB ensures that all subjects enrolled at all six sites will receive the same IRB-approved informed consent form, with consistent risk disclosures, compensation terms, and procedural descriptions. This uniformity supports both regulatory compliance and the integrity of the clinical data generated by the Study.

5. Efficient Ongoing Oversight. During the course of the Study, Clearwater IRB will serve as the single point of contact for all continuing review, protocol amendment, adverse event reporting, and deviation reporting obligations, reducing the administrative burden on both the Sponsor and the clinical sites. Calderwood & Harkness notes that each of the six clinical sites will need to enter into a reliance agreement or

III. Regulatory Framework for IRB Review A. Applicable Regulations The IRB review of the LUMINA-US Study is governed by a set of interrelated federal regulations administered by the FDA. The following regulatory provisions are directly applicable: 21 C.F.R. Part 56 — Institutional Review Boards. Part 56 establishes the requirements for the composition, functions, operations, and review standards of IRBs that review c

1. Sponsor's Initial Determination. The sponsor (Solstice Biomedical Inc.) makes an initial determination that the clinical investigation presents no significant risk to study subjects. The sponsor must document this determination in writing, along with the supporting rationale, and must submit the determination to the IRB as part of the initial review package.

2. IRB's Independent Assessment. The IRB must make its own independent assessment of whether the investigation presents a significant risk or a non-significant risk. The IRB is not bound by the sponsor's determination and must evaluate the risk based on the information presented in the protocol, investigator's brochure, and other submission documents. In making this assessment, the IRB considers the definition of "si

3. Concurrence or Disagreement. If the IRB concurs with the sponsor's NSR determination, the investigation may proceed under the abbreviated IDE requirements. If the IRB determines that the investigation presents a significant risk, the sponsor must obtain an approved IDE from FDA before the study may commence. A disagreement on the NSR determination would materially affect the regulatory timeline for the LUMINA-US S

1. Risks to subjects are minimized. The IRB must find that the study procedures are designed to minimize risks to subjects, and that procedures already being performed on subjects for diagnostic or treatment purposes are used whenever appropriate. For the LUMINA-US Study, this analysis will focus on the risks associated with subcutaneous sensor insertion and 14-day continuous wear, as well as any risks associated wit

2. Risks are reasonable in relation to anticipated benefits. The IRB must determine that the risks to subjects are reasonable in relation to the anticipated benefits to the subjects and the importance of the knowledge that may reasonably be expected to result from the investigation. Because the LUMINA-US Study is a diagnostic accuracy study and is not designed to provide a direct therapeutic benefit to study subjects

3. Selection of subjects is equitable. The IRB must assess the inclusion and exclusion criteria, recruitment procedures, and overall study design to ensure that the selection of subjects is equitable, taking into account the purposes of the research and the setting in which it will be conducted. The IRB should give particular attention to whether the study population (adults with Type 1 or Type 2 diabetes) is appropr

4. Informed consent is obtained and documented. The IRB must review the informed consent form to verify that it contains all of the elements required by 21 C.F.R. § 50.25 and that the consent process is adequate to ensure that subjects are making a truly voluntary and informed decision to participate.

5. Data monitoring provisions are adequate. The IRB must determine that the study includes adequate provisions for monitoring the data collected to ensure the safety of subjects. This analysis will focus on the Data Safety Monitoring Plan, including the adverse event reporting procedures, stopping rules, and the role of the medical monitor or Data Safety Monitoring Board.

6. Privacy and confidentiality are protected. The IRB must find that the study includes adequate provisions for protecting the privacy of subjects and maintaining the confidentiality of data. This includes an assessment of the data management procedures, the use of study identifiers, and the security measures applied to electronic data systems.

7. Additional safeguards for vulnerable populations. Where a study involves subjects who are likely to be vulnerable to coercion or undue influence—such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons—the IRB must determine that additional safeguards are included in the study to protect the rights and welfare of these subjects. The LUMINA-US St

IV. Required Submission Documents This section identifies the documents that must be assembled and included in the IRB submission package to Clearwater IRB. The submission package should be comprehensive, well-organized, and responsive to Clearwater IRB's submission requirements as set forth in its standard operating procedures and new study application form. Each document is described below, along with the responsib

1. Clinical Investigation Protocol The cornerstone of the IRB submission is the Clinical Investigation Protocol, designated as Protocol SBD-LUM-CL-001, titled "LUMINA-US." The protocol must be presented in its final, approved version as of the date of IRB submission. The protocol must include, at a minimum, the following elements: • Study Title: "A Prospective, Single-Arm, Multicenter Clinical Study to Evaluate the S

2. Protocol Synopsis/Summary In addition to the full protocol, the IRB submission should include a concise Protocol Synopsis or Protocol Summary, typically two to four pages in length, designed to provide IRB reviewers with a high-level overview of the Study before they review the full protocol. The synopsis should highlight the following: • Study objectives (primary and secondary) • Study design and methodology • Su

I. Insurance and Indemnification Documentation The IRB submission must include evidence of adequate insurance coverage for the clinical investigation. Clearwater IRB, like most commercial IRBs, typically requires confirmation that the Sponsor has product liability and clinical trial insurance in place to cover potential claims arising from the conduct of the Study and the use of the investigational device. The curren

V. Submission Timeline and Key Deadlines A. Reverse-Engineered Timeline from September 15, 2025 Study Start The following timeline has been reverse-engineered from the target date for first subject enrollment (September 15, 2025) and takes into account the expected duration of the Clearwater IRB review process, the document preparation timelines, and the parallel FDA Pre-Sub process. This timeline assumes that the IR

1. Submit the IRB package based on the protocol as finalized as of late June/early July 2025. The protocol should be prepared with due consideration of FDA's published guidance documents (including the September 2023 iCGM guidance) and any informal feedback received from FDA during the Pre-Sub meeting request process. By aligning the protocol with FDA's known expectations, Solstice can minimize the likelihood of mate

2. If the FDA Pre-Sub meeting on August 14, 2025 results in material changes to the clinical study design or endpoints, Solstice should promptly prepare and submit a protocol amendment to Clearwater IRB for review before study commencement. Because the Pre-Sub meeting is scheduled approximately two and a half weeks before the target IRB approval date, there may be sufficient time for the IRB to review a limited proto

3. Contingency planning is essential. If FDA feedback at the Pre-Sub meeting necessitates significant protocol revisions—such as a change to the primary endpoint, the addition of a comparator arm, or a material change to the subject population—the September 15, 2025 study start date may need to be delayed to allow adequate time for protocol revision, IRB review of the amended protocol, and site initiation. This risk

4. Prepare a contingency protocol amendment plan in advance of the August 14, 2025 Pre-Sub meeting, so that if material changes are required, the amendment can be prepared, reviewed, and submitted to the IRB with minimal delay. Calderwood & Harkness (Amy Whitfield and Kevin Morrissey) will prepare this contingency plan by August 15, 2025, following the Pre-Sub meeting. C. Coordination with Veltrano CRO Effective coor

VI. Clearwater IRB Submission Procedures A. Submission Mechanics Clearwater IRB accepts submissions through its online electronic portal system. The submission must be made electronically and must include the following components:

1. Completed New Study Application Form. Clearwater IRB provides a standardized new study application form that must be completed by the Sponsor. The application form typically requests identifying information about the Sponsor, the study protocol, the principal investigators, the clinical sites, the device under investigation, and the proposed subject population. The application form may also include specific questi

2. All Documents Listed in Section IV. The complete set of submission documents described in Section IV of this memorandum must be uploaded to the Clearwater IRB portal as part of the new study application. Each document should be clearly labeled and organized according to Clearwater IRB's submission guidelines.

3. Applicable IRB Review Fee. Clearwater IRB charges a review fee for the initial full-board review of a new study. The fee varies based on the complexity of the study, the number of sites, and the type of review. For a multicenter medical device study with six sites, the initial review fee typically ranges from $3,000 to $7,500. The specific fee should be confirmed with Clearwater IRB's administrative office before

4. Sponsor Cover Letter. A cover letter from Solstice Biomedical Inc. should accompany the submission, summarizing the Study, identifying the Lumina CGM System as the investigational device, referencing the Sponsor's NSR determination, and confirming the single-IRB arrangement under which Clearwater IRB will serve as the IRB of record for all six U.S. clinical sites. The cover letter should also identify the Sponsor'