Contract analysis

I. Introduction and Executive Summary On behalf of Calderwood & Harkness LLP, I am pleased to submit this proposal in response to Genome Dx Therapeutics Inc.'s ("GDT" or the "Company") Request for Proposals dated January 22, 2024, seeking Medicare coverage and coding counsel for OncoPrecise GXP-47. My name is Miriam Calloway, and I am a Partner in Calderwood & Harkness's Healthcare & Life Sciences practice group. I h

II. Firm Overview and Healthcare & Life Sciences Practice Qualifications About Calderwood & Harkness LLP Calderwood & Harkness LLP is a national law firm organized as a Limited Liability Partnership under the laws of the State of New York. The firm maintains a broad platform of legal services across a number of practice areas, but our Healthcare & Life Sciences practice group is among the most well-established and de

III. Understanding of GDT and OncoPrecise GXP-47 A successful coverage and coding engagement requires a thorough understanding of the company, the test at issue, the clinical context, and the evidentiary record. Below, we summarize our current understanding of GDT and OncoPrecise GXP-47, based on the materials provided with the RFP and publicly available information. We expect to refine and deepen this understanding

IV. Proposed Scope of Work We propose to organize the engagement around five integrated workstreams, each designed to address a discrete but interrelated component of the overall Medicare coverage and coding strategy for OncoPrecise GXP-47. The workstreams are intended to proceed in a sequenced and overlapping manner, as described in the proposed timeline in Section VII below. Workstream 1: Coding Strategy and PLA Co

1. Coding Strategy Memorandum — A detailed analysis of coding options (PLA versus existing CPT codes) with a recommended pathway, risk assessment, and implementation plan.

2. Draft PLA Code Application — A complete draft of the PLA code application package, including proposed code descriptor, supporting clinical and technical documentation, and cover letter.

3. Cover Letter to AMA CPT Editorial Panel — A formal transmittal letter for the PLA code application submission. Workstream 2: LCD Application and MolDx Technical Assessment The local coverage determination is the gateway to Medicare reimbursement for OncoPrecise GXP-47. Obtaining a favorable LCD from CFI, supported by a successful MolDx technical assessment, is the single most consequential milestone in the engagem

1. LCD Regulatory Landscape Memorandum — An analysis of the LCD regulatory landscape for NGS-based oncology diagnostics within Jurisdiction E, including a review of existing CFI LCDs, relevant MolDx precedent, and an assessment of the evidentiary bar for coverage.

2. Draft LCD Request Letter — A formal LCD request letter to CFI's Medical Director and LCD Analyst, suitable for submission upon GDT's approval.

3. Draft MolDx Technical Assessment Dossier — A comprehensive MolDx dossier structured in accordance with Ridgeline's technical assessment requirements, incorporating all six evidentiary components described above.

4. Review and Mark-Up of HEOR Analysis — Marked-up version of the HEOR consultant's clinical utility and cost-effectiveness analyses, with recommendations for revisions to ensure regulatory compliance and strategic alignment. Workstream 3: Reimbursement Rate Analysis Securing the right reimbursement rate is essential to the commercial viability of OncoPrecise GXP-47. The Medicare reimbursement rate will serve as the

1. Reimbursement Rate Analysis Memorandum — A detailed analysis of the crosswalk and gapfill pricing methodologies as applied to OncoPrecise GXP-47, with recommended rate targets and pricing justification strategy.

2. Crosswalk/Gapfill Pricing Model (Excel) — A working pricing model identifying comparable codes, their reimbursement rates, and the basis for GDT's proposed rate, in Excel format for integration with GDT's financial models. Workstream 4: NCD Pathway Assessment While the LCD represents the near-term priority, GDT's long-term Medicare coverage strategy should contemplate the possibility — and the potential strategic

1. NCD Feasibility Assessment Memorandum — A comprehensive assessment of NCD feasibility, pathway options, sequencing recommendations, timeline estimates, and resource implications. Workstream 5: Ongoing Advisory and Board Support The Medicare coverage and coding process is dynamic and extends well beyond the initial filings. We propose to provide GDT with ongoing strategic advisory support throughout the engagement,

V. Proposed Engagement Team We have assembled a team that combines deep Medicare coverage and reimbursement expertise, direct CMS institutional experience, health technology assessment knowledge, and hands-on coding and billing compliance skills. Each member of the proposed team has been selected for a specific role, and the team is structured to ensure efficient and cost-effective execution of the engagement. Miriam

VI. Coordination with GDT's Other Advisors We recognize that an engagement of this nature does not occur in isolation — GDT's Medicare coverage and coding strategy must be developed in coordination with a number of other advisors and consultants whose work product will interface with the engagement. Effective coordination among advisors is essential to avoiding duplication of effort, ensuring strategic alignment, and

VII. Proposed Timeline The following table sets forth our proposed timeline for the engagement, organized by milestone. We emphasize that this timeline is contingent on two key external factors: (a) the availability of clinical validation data from the CLARITY-LUNG trial, and (b) GDT's commercialization schedule. We will revisit and adjust the timeline as necessary in coordination with GDT's team. Note: The timeline

VIII. Fee Estimate and Billing Arrangements Fee Arrangement. Calderwood & Harkness proposes to bill for this engagement on an hourly basis at the following rates: These rates are the firm's standard rates for the proposed timekeepers as of the date of this proposal and are subject to annual adjustment in accordance with the firm's standard rate review process. Any rate adjustments would be communicated to GDT in adva

IX. Engagement Terms The following is a summary of the key terms that we propose to govern the engagement. These terms will be set forth in greater detail in a formal engagement letter, which we will prepare and circulate for GDT's review upon acceptance of this proposal. Scope of Engagement. The engagement is limited to Medicare coverage and coding strategy for OncoPrecise GXP-47 as described in this proposal. Calde

X. Conflicts Calderwood & Harkness has initiated a preliminary conflicts review in connection with this proposal. Based on the results of that preliminary review, the firm is not currently aware of any conflicts of interest that would preclude Calderwood & Harkness from representing GDT in the engagement described herein. A full formal conflicts check will be completed and documented prior to execution of the engagem

XI. Why Calderwood & Harkness We recognize that GDT has choices in selecting outside counsel for this critical engagement, and we believe that several factors differentiate Calderwood & Harkness from other firms that may be under consideration: Deep Medicare Coverage and Reimbursement Expertise. Calderwood & Harkness's Healthcare & Life Sciences practice group has a concentrated focus on Medicare coverage and reimbur