Contract analysis

I. PURPOSE AND BACKGROUND This memorandum is delivered pursuant to the wind-down instruction communicated by Theresa Nakamura, General Counsel and Vice President of Regulatory Affairs of Genome Dx Therapeutics Inc. ("GDT"), to Miriam Calloway, Partner at Calderwood & Harkness LLP ("Calderwood & Harkness" or the "Firm"), on May 23, 2024. That instruction followed the GDT Board of Directors' resolution adopted on May 2

II. ENGAGEMENT SUMMARY A. Scope of Engagement The engagement was formalized through an engagement letter executed on February 14, 2024 (the "Engagement Letter"), addressed to Theresa Nakamura in her capacity as General Counsel of GDT. The Engagement Letter defined the scope of Calderwood & Harkness's representation as the development and execution of a Medicare coverage and coding strategy for OncoPrecise GXP-47, enc

III. SUMMARY OF COMPLETED WORK PRODUCT AND DELIVERABLES During the approximately three-and-a-half-month engagement period, Calderwood & Harkness produced a substantial body of work product across all four engagement workstreams, as well as ancillary analyses and presentations. This section provides a detailed summary of each completed deliverable, organized by workstream. A. Coding Strategy Workstream The coding stra

1. Coding Strategy Memorandum (March 11, 2024). The Coding Strategy Memorandum was prepared by Sean Morrissey and Christopher Aiken, with review by Miriam Calloway, and was delivered to Theresa Nakamura and Kevin Driscoll on March 11, 2024. This memorandum presented a comprehensive analysis of the coding alternatives available for OncoPrecise GXP-47 under the AMA Current Procedural Terminology ("CPT") system. Specifi

2. Draft PLA Code Application (March 22, 2024). The draft PLA Code Application was prepared jointly by Calderwood & Harkness (Morrissey and Aiken) and Carraway Regulatory Advisors (Janet Carraway), and was delivered to GDT on March 22, 2024 for review and comment. The application was prepared in conformity with the AMA's required submission format and included the following key elements: Proposed PLA Code Descriptor:

3. Draft PLA Code Application Cover Letter. A draft cover letter to accompany the PLA code application was prepared by Christopher Aiken and reviewed by Miriam Calloway. The cover letter was addressed to the AMA CPT Editorial Panel and served to introduce GDT as the applicant, provide a high-level summary of OncoPrecise GXP-47 and its clinical utility, and reference the key supporting evidence, including the analytic

1. LCD Regulatory Landscape Memorandum (Late February 2024). This background research memorandum was prepared by Morrissey and Aiken in the initial weeks of the engagement and served as a foundational reference document for the entire LCD/MolDx workstream. The memorandum provided: (a) A comprehensive overview of the current Medicare coverage landscape for next-generation sequencing ("NGS")-based oncology diagnostic t

2. Clinical Evidence Gap Analysis Memorandum (April 15, 2024). The Clinical Evidence Gap Analysis Memorandum was prepared by Miriam Calloway and Sean Morrissey and was delivered to Theresa Nakamura, Kevin Driscoll, and Dr. Priya Sundaram (GDT's VP of Clinical Development) on April 15, 2024. This memorandum was prepared in direct response to the release of the CLARITY-LUNG interim analysis results on March 29, 2024, a

3. Revised LCD/MolDx Strategy Memorandum (April 22, 2024). The Revised LCD/MolDx Strategy Memorandum was prepared by Miriam Calloway and Sean Morrissey and was delivered to Theresa Nakamura and Kevin Driscoll on April 22, 2024. This memorandum was prepared at the direction of the GDT Board of Directors, which, at its April 9, 2024 meeting, requested a formal reassessment and revision of the LCD filing strategy in lig

4. Draft MolDx Technical Assessment Dossier — Version 1.0 (April 30, 2024). The Draft MolDx Technical Assessment Dossier (Version 1.0) was the most substantial single work product delivered during the engagement. This comprehensive dossier was prepared by the Calderwood & Harkness team for submission to RAS as part of the MolDx program's technical assessment process, which is a prerequisite to LCD issuance by CFI. Th

5. MolDx Dossier Bibliography — 43 Publications. The annotated bibliography was compiled by Morrissey and Aiken as a component of the MolDx Technical Assessment Dossier. The bibliography encompasses 43 peer-reviewed publications organized into the following categories: • Analytical Validation (7 publications): Including the GDT analytical validation study (Journal of Molecular Oncology Diagnostics, Vol. 18, Issue 4,

6. Draft LCD Request Letter to CFI. A draft letter requesting initiation of an LCD for OncoPrecise GXP-47 was prepared for GDT's use. The letter was addressed to CFI at its principal office at 2800 SW Moody Avenue, Suite 500, Portland, OR 97201, for the attention of Dr. William Hargrove, Medical Director, and Sandra Phu, LCD Analyst. The letter was formatted for execution by Dr. Anisha Raval, Chief Executive Officer

7. Review Memorandum — Larkfield HEOR Analysis. This internal Calderwood & Harkness memorandum was prepared by Sean Morrissey with review by Miriam Calloway. The memorandum documented Calderwood & Harkness's review of the HEOR analysis prepared by Larkfield Health Economics, LLC (Dr. Nathan Ostroff) for incorporation into Section 5 of the MolDx Technical Assessment Dossier. The review memorandum identified several ar

1. Reimbursement Rate Analysis (Crosswalk/Gapfill) Memorandum (May 14, 2024). The Reimbursement Rate Analysis Memorandum was prepared by Morrissey and Aiken and was delivered to Kevin Driscoll and Raymond Ota (GDT Chief Financial Officer) on May 14, 2024. The memorandum presented a crosswalk analysis identifying three existing codes with comparable test characteristics as crosswalk comparators for OncoPrecise GXP-47:

2. Reimbursement Rate Crosswalk Model (Excel Workbook). An accompanying Excel workbook was prepared to support the Reimbursement Rate Analysis Memorandum. The workbook contained the following analytical tabs: (1) Crosswalk Comparator Analysis. Detailed data on each of the three crosswalk comparators, including test descriptions, clinical indications, methodology comparisons, and current Medicare reimbursement rates.

1. NCD Feasibility Assessment Memorandum (May 10, 2024). The NCD Feasibility Assessment Memorandum was prepared by Miriam Calloway and Joel Strauss and was delivered to Theresa Nakamura, Kevin Driscoll, and Dr. Anisha Raval on May 10, 2024. This memorandum assessed the feasibility, strategic advisability, and anticipated timeline for pursuing a national coverage determination for OncoPrecise GXP-47 through CMS. The m

1. GDT Board Presentation (April 9, 2024). A Northgate Services Inc. presentation was prepared by Miriam Calloway and Sean Morrissey for delivery at the GDT Board of Directors meeting on April 9, 2024. The presentation summarized the status of the Medicare coverage and coding strategy and addressed the impact of the CLARITY-LUNG interim results on the strategic timeline. The presentation covered the following topics:

1. Analysis of Pacific Coast National Bank Milestone Covenant (May 28, 2024). The Analysis of Pacific Coast National Bank Milestone Covenant Memorandum (the "PCNB Covenant Analysis") was prepared by Miriam Calloway and Sean Morrissey and is being delivered concurrently with this Wind-Down Memorandum to Theresa Nakamura and Raymond Ota. A copy is attached hereto as Attachment B. This memorandum analyzed the impact of

Section 7.14 of the Credit Agreement requires GDT to: "obtain a final Medicare coverage determination (whether by LCD, NCD, or equivalent published coverage policy) for at least one proprietary laboratory-developed test developed by Borrower" on or before December 31, 2024. The memorandum addressed the following key issues: (a) Covenant Compliance Analysis. The memorandum analyzed whether GDT's existing LCD for OncoP

IV. PENDING DELIVERABLES NOT COMPLETED The following deliverables and workstreams were pending at the time of the engagement wind-down and will not be completed as part of this engagement. This section describes each pending item, the status at termination, and the consequences of non-completion. A. PLA Code Application Submission The draft PLA code application and accompanying cover letter, as described in Sections

V. WORK PRODUCT PRESERVATION AND DOCUMENT RETENTION A. Document Inventory A comprehensive Work Product Index and Deliverables Tracker has been prepared in Excel format and is attached to this memorandum as Attachment A. The tracker catalogs every deliverable and work product item created during the engagement, including internal memoranda, research materials, and correspondence. Each entry in the tracker is indexed b

VI. RECOMMENDATIONS FOR REACTIVATION OF THE REIMBURSEMENT STRATEGY Calderwood & Harkness provides the following recommendations to assist GDT in planning for the eventual reactivation of the Medicare coverage and coding strategy for OncoPrecise GXP-47. These recommendations are intended to ensure that GDT can resume the coverage strategy promptly and efficiently when the clinical and commercial conditions warrant, le