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Contract analysis / coordination-letter-pinnacle.docx
coordination-letter-pinnacle.docx
1037-00002 · 11 clauses
High · 0 Medium · 7 Standard · 1
1. Purpose and Background Medium
⚑ Confidentiality undertaking
1. Purpose and Background Calderwood & Harkness LLP ("C&H" or the "Firm") has been engaged by Solstice Biomedical Inc. ("SBI"), the U.S. subsidiary of Solstice Biomedical Devices Ltd. ("Solstice" or "SBD"), to provide legal counsel on FDA regulatory strategy for the Solstice Lumina™ Continuous Glucose Monitoring System (the "Lumina CGM System" or the "Device"). Our engagement was formally opened on April 22, 2025, an
2. Engagement Team Identification
2. Engagement Team Identification To facilitate effective communication and ensure accountability, we set forth below the key team members from each organization who will be involved in this engagement. 2.1 Calderwood & Harkness Team The C&H team for this engagement consists of the following individuals: • Miriam Calloway — Responsible Partner. Ms. Calloway brings twenty-two years of FDA regulatory law experience, in
3. Scope of Engagement and Delineation of Roles Medium
⚑ Liability cap to check against exposure
3. Scope of Engagement and Delineation of Roles The following section sets forth the respective responsibilities of C&H and Pinnacle. Clear delineation of roles is essential to avoid duplication of effort, ensure work product integrity, and maintain appropriate privilege protections. Both parties should promptly raise any questions regarding role assignments with their respective coordination leads. 3.1 Calderwood &
4. Regulatory Timeline and Key Milestones
4. Regulatory Timeline and Key Milestones A detailed master regulatory timeline and milestone tracker has been prepared and is maintained jointly by C&H and Solstice's regulatory affairs team. A summary excerpt of that tracker is enclosed with this letter. The following key dates are particularly relevant to the coordination between C&H and Pinnacle: Given these deadlines, we wish to emphasize the importance of timel
5. Work Product Sharing Protocols Medium
⚑ Liability cap to check against exposure
5. Work Product Sharing Protocols 5.1 Document Exchange Procedures To ensure the security and integrity of all documents exchanged between C&H and Pinnacle during this engagement, the following document exchange procedures shall be observed: Secure File-Sharing Platform. All draft documents, working papers, and related materials shall be exchanged via a secure, encrypted file-sharing platform designated by SBI. The s
6. Privilege and Confidentiality Considerations Medium
⚑ Confidentiality undertaking
6. Privilege and Confidentiality Considerations 6.1 Attorney-Client Privilege and Work Product Doctrine Pinnacle is engaged by Solstice as a regulatory consultant and is not engaged as legal counsel. Accordingly, Pinnacle's work product is not independently protected by the attorney-client privilege, and communications between Pinnacle and Solstice are not, standing alone, privileged communications. However, we wish
7. Third-Party Coordination Medium
⚑ Confidentiality undertaking
7. Third-Party Coordination The Lumina CGM System regulatory program involves several third-party service providers in addition to C&H and Pinnacle. The following section describes Pinnacle's coordination responsibilities with each such third party. Unless otherwise stated, all communications between Pinnacle and third parties should be conducted in Pinnacle's capacity as the technical regulatory consultant for Solst
8. Submission Budget Context Standard
⚑ Commercial term
8. Submission Budget Context We wish to provide brief context regarding the overall regulatory budget for this program. The total estimated external regulatory costs for the Lumina CGM System U.S. FDA program are approximately $6,127,417. This figure encompasses all external professional fees, testing costs, clinical study expenses, and related expenditures. Within this total: • Pinnacle consulting fees are budgeted
9. Conflict of Interest Disclosure Request Medium
⚑ Confidentiality undertaking
9. Conflict of Interest Disclosure Request Consistent with professional best practices and the client's expectations, C&H respectfully requests that Pinnacle confirm, in writing, that it has no current or recent engagements — including any engagements concluded within the past twenty-four (24) months — with any of the following entities or their affiliates: (a) NovaSense Medical Technologies Inc. (4800 Innovation Par
10. Points of Contact Summary
10. Points of Contact Summary For ease of reference, the following table summarizes the primary contacts for each organization involved in this engagement: Direct contact information, including email addresses and telephone numbers, will be exchanged separately via secure channel to avoid inclusion of personal contact data in a document that may be stored across multiple systems. We ask that Pinnacle provide its team
11. Acknowledgment and Next Steps Medium
⚑ Assignment / subcontracting
11. Acknowledgment and Next Steps We respectfully request that Pinnacle acknowledge receipt of this letter and confirm its agreement with the coordination protocols set forth herein. Such acknowledgment may be provided by return letter, email confirmation from Dr. Ellison, or a countersigned copy of this letter, at Pinnacle's preference. If Pinnacle has any suggested modifications to the protocols described herein, w