1013-00004 · Calderwood & Harkness LLP · Closing

letter-calloway-to-nakamura-matter-closure.docx DOCUMENT M&A / Corporate

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CALDERWOOD & HARKNESS LLP Attorneys at Law

1700 K Street NW, Suite 900 Washington, DC 20006 Telephone: (202) 555-7400 Facsimile: (202) 555-7401 www.calderwoodharkness.com

June 3, 2024

VIA EMAIL AND OVERNIGHT DELIVERY

Theresa Nakamura General Counsel & Vice President of Regulatory Affairs Genome Dx Therapeutics Inc. 4720 Torrey Pines Road, Suite 300 San Diego, CA 92130

Re: Formal Closure of Engagement — Medicare Coverage and Coding Strategy for OncoPrecise GXP-47 Matter No. 1043-00002 / Client No. 47832

Dear Ms. Nakamura:

I. Purpose and Confirmation of Matter Closure

This letter confirms the formal closure of the above-referenced matter, effective June 3, 2024. We write to provide Genome Dx Therapeutics Inc. ("GDT") with a comprehensive record of the engagement activities undertaken, the work product delivered, the financial status of the matter, and certain important advisories relating to deadlines, ongoing obligations, and the preservation of client materials.

As you know, Calderwood & Harkness LLP ("Calderwood & Harkness" or the "Firm") was engaged by GDT pursuant to the engagement letter dated February 14, 2024 (the "Engagement Letter"), to develop and execute a comprehensive Medicare coverage and coding strategy for GDT's novel multi-gene genomic diagnostic test, OncoPrecise GXP-47. The OncoPrecise GXP-47 test, a next-generation sequencing (NGS)-based multi-gene panel designed to guide treatment selection in advanced non-small cell lung carcinoma (NSCLC), represented a significant extension of GDT's existing OncoPrecise product family and a critical component of GDT's commercial pipeline.

The scope of the engagement, as set forth in the Engagement Letter and as subsequently refined through discussions among the parties, encompassed the following principal workstreams:

(a) Analysis and pursuit of a Proprietary Laboratory Analyses ("PLA") code through the American Medical Association ("AMA") CPT Editorial Panel, including preparation of the PLA code application, proposed code descriptor, and supporting documentation;

(b) Preparation of a local coverage determination ("LCD") application for filing with Cascade Fiscal Intermediaries, LLC ("CFI"), the Medicare Administrative Contractor ("MAC") for Jurisdiction E, including assembly of the requisite clinical evidence package and supporting analytical memoranda;

(c) Preparation of a technical assessment dossier for submission to Ridgeline Administrative Services, LLC ("RAS") under the Molecular Diagnostic Services ("MolDx") program, encompassing the analytical and clinical validity evidence required by the MolDx technical assessment framework;

(d) Medicare reimbursement rate analysis, including crosswalk and gapfill pricing methodologies, comparator test identification, and projected reimbursement rate modeling; and

(e) Assessment of national coverage determination ("NCD") pathways through the Centers for Medicare & Medicaid Services ("CMS"), including an evaluation of feasibility, timing, and strategic considerations for a potential CMS-initiated or stakeholder-requested NCD.

The closure of this matter is effected at GDT's instruction, as communicated by you to Miriam Calloway, partner at Calderwood & Harkness, via telephone and confirmed by email on May 23, 2024. As you indicated at that time, the GDT Board of Directors adopted a resolution on May 22, 2024, to defer the commercial launch of OncoPrecise GXP-47 indefinitely. This decision was precipitated by the inconclusive results of the CLARITY-LUNG clinical validation trial (ClinicalTrials.gov Identifier: NCT05891247), the interim analysis of which failed to meet the pre-specified primary endpoint thresholds for positive predictive value and negative predictive value in the intended-use population. We understand that GDT is continuing to evaluate its options with respect to the CLARITY-LUNG trial, including the possibility of an expanded enrollment cohort and a revised statistical analysis plan, and that a final data readout is now projected for the second quarter of 2025.

We respect and support GDT's decision, and we have structured this closure letter to facilitate any future reactivation of the engagement should circumstances warrant.

II. Summary of Engagement Activities and Work Product Delivered

A detailed and comprehensive catalog of all work product and deliverables produced during the engagement is set forth in the Matter Wind-Down Memorandum dated May 28, 2024, and the accompanying Work Product Index (collectively, the "Wind-Down Package"), which were delivered to your attention under separate cover on that date. The Wind-Down Package should be treated as the controlling record of deliverables. For convenience, however, we provide below a brief recapitulation of the key work product delivered during the course of the engagement:

1. Coding Strategy Memorandum (PLA vs. CPT Analysis) — Delivered March 11, 2024. This memorandum analyzed the relative advantages and disadvantages of pursuing a Proprietary Laboratory Analyses (PLA) code versus a standard Category I CPT code for OncoPrecise GXP-47, and recommended pursuit of the PLA pathway based on timing, procedural, and strategic considerations. The memorandum addressed the AMA CPT Editorial Panel's current criteria for PLA code eligibility, the applicable code descriptor conventions, and the implications for Medicare reimbursement rate-setting under both crosswalk and gapfill methodologies.

2. Draft PLA Code Application and Proposed Code Descriptor — Delivered March 22, 2024. The draft PLA code application included all required elements for submission to the AMA CPT Editorial Panel, including the proposed code descriptor, the clinical use case narrative, specimen type and methodology description, laboratory certification documentation, and supporting clinical evidence citations. The proposed code descriptor was developed in close coordination with GDT's laboratory operations team and Dr. Marcus Feldstein, GDT's Vice President of Laboratory Sciences.

3. Draft Cover Letter for PLA Code Application Submission to AMA CPT Editorial Panel — Prepared in connection with the PLA code application but never sent. This cover letter was finalized in draft form and was ready for execution and submission as of the date of matter closure.

4. Clinical Evidence Gap Analysis Memorandum — Delivered April 15, 2024. This memorandum systematically evaluated the existing body of published clinical evidence supporting the analytical and clinical validity and clinical utility of OncoPrecise GXP-47, mapped that evidence against the evidentiary requirements of the MolDx technical assessment framework and the CFI LCD coverage criteria, and identified specific gaps in the evidence base. The memorandum identified the CLARITY-LUNG trial as a critical source of prospective clinical validation data and flagged the risk that inconclusive trial results could materially impair the LCD and MolDx applications.

5. Revised LCD/MolDx Strategy Memorandum (Recommending Deferral of LCD Filing) — Delivered April 22, 2024. Following the release of the CLARITY-LUNG interim analysis results, we prepared a revised strategy memorandum recommending that GDT defer the planned LCD filing with CFI and the MolDx technical assessment submission to RAS pending the availability of final CLARITY-LUNG trial data. The memorandum analyzed the risks associated with premature filing, including the potential for an adverse LCD determination that could create precedential difficulties for any subsequent filing, and recommended a revised timeline contingent on the availability of satisfactory final trial data.

6. Draft MolDx Technical Assessment Dossier (Version 1.0) — Delivered April 30, 2024. The draft dossier was prepared in the format prescribed by the MolDx technical assessment submission guidelines and included an annotated bibliography of forty-three (43) peer-reviewed publications relevant to the analytical validation, clinical validation, and clinical utility of the OncoPrecise GXP-47 multi-gene panel. The dossier was structured to address each of the MolDx assessment criteria, including test description, specimen requirements, analytical performance characteristics, clinical validity, clinical utility, and cost-effectiveness. Version 1.0 was delivered in draft for GDT's review and was not finalized prior to the closure of the matter.

7. NCD Feasibility Assessment Memorandum — Delivered May 10, 2024. This memorandum assessed the feasibility and strategic advisability of pursuing a national coverage determination for OncoPrecise GXP-47 through CMS, evaluated the procedural pathways available (including formal NCD request, Coverage with Evidence Development, and the Parallel Review process with the FDA), and concluded that the NCD pathway was premature at the current stage of clinical evidence development but could become viable following completion of the CLARITY-LUNG trial and accumulation of additional real-world evidence data.

8. Reimbursement Rate Analysis Memorandum (Crosswalk/Gapfill Pricing) and Supporting Excel Workbook — Delivered May 14, 2024. The memorandum analyzed the expected Medicare reimbursement rate for OncoPrecise GXP-47 under both crosswalk and gapfill pricing methodologies, identified appropriate comparator tests and CPT/PLA codes for crosswalk purposes, modeled projected reimbursement rates under multiple scenarios, and assessed the timing and procedural steps for gapfill pricing in the event a crosswalk comparator was not accepted. The accompanying Excel workbook contained the detailed financial models and sensitivity analyses supporting the memorandum's conclusions.

9. Analysis of Pacific Coast National Bank Milestone Covenant — Delivered May 28, 2024. At GDT's request, we prepared an analysis of Section 7.14 of the Revolving Facility Credit Agreement between GDT and Pacific Coast National Bank ("PCNB") (Ref. PCNB-GDT-RF-2023-0922), which requires GDT to obtain a final Medicare coverage determination for at least one proprietary laboratory-developed test by December 31, 2024. The analysis evaluated the covenant language, assessed whether the existing LCD for OncoPrecise GXP-12 (LCD L38472, effective August 15, 2021) may satisfy the covenant, and identified potential remedial pathways in the event of a covenant breach.

10. Matter Wind-Down Memorandum and Work Product Index — Delivered May 28, 2024. The Wind-Down Memorandum provided a comprehensive narrative summary of the engagement activities, the status of each workstream at the time of closure, and recommendations for preserving GDT's optionality for future reactivation. The Work Product Index cataloged all deliverables, working papers, correspondence, and research materials produced during the engagement, organized by workstream and delivery date.

11. Board Presentation Materials — Prepared for and delivered in advance of the April 9, 2024 GDT Board of Directors meeting. These materials included a slide presentation summarizing the Medicare coverage and coding strategy, the status of each workstream, the clinical evidence landscape, the reimbursement rate projections, and the key risks and contingencies identified by the engagement team. The presentation was delivered by Ms. Calloway to the GDT Board.

12. Internal Review Memorandum on Larkfield Health Economics, LLC HEOR Analysis — Prepared at GDT's request, this memorandum provided Calderwood & Harkness's legal and regulatory review of the health economics and outcomes research ("HEOR") analysis prepared by Larkfield Health Economics, LLC ("Larkfield"), under the direction of Dr. Nathan Ostroff, for potential inclusion in the MolDx technical assessment dossier and LCD application. The memorandum assessed the HEOR analysis for consistency with MolDx evidentiary standards and CMS cost-effectiveness criteria and identified several areas requiring revision or supplementation.

The foregoing represents a summary of the principal deliverables; additional working papers, research memoranda, correspondence, and internal analytical materials are cataloged in the Work Product Index and are maintained in the engagement files.

III. Pending Deliverables Not Completed

Due to the termination of the engagement prior to completion of the full scope of work contemplated under the Engagement Letter, the following items were not completed or submitted:

(a) Final PLA Code Application. The PLA code application for OncoPrecise GXP-47 was not submitted to the AMA CPT Editorial Panel. The application was completed in draft form and was ready for final review and submission. We note that the submission deadline for consideration at the September 2024 AMA CPT Editorial Panel meeting was June 28, 2024. As that deadline has not yet passed as of the date of this letter, GDT retains the option of submitting the application independently or through other counsel should it elect to do so; however, Calderwood & Harkness will not take any action to submit the application absent a new or reactivated engagement.

(b) LCD Request Letter to CFI. A draft LCD request letter addressed to Dr. William Hargrove, Medical Director, and Sandra Phu, LCD Analyst, at Cascade Fiscal Intermediaries, LLC, was prepared but was never sent. The target filing date for the LCD request had been August 2024, and the request was contingent upon the availability of satisfactory final CLARITY-LUNG trial data. As noted in the Revised LCD/MolDx Strategy Memorandum delivered April 22, 2024, we had recommended deferral of this filing prior to the Board's decision to close the matter.

(c) Finalization and Submission of MolDx Technical Assessment Dossier. The MolDx Technical Assessment Dossier was delivered in draft (Version 1.0) but was not finalized or submitted to Ridgeline Administrative Services, LLC. The dossier was intended to be submitted to Dr. Catherine Embry, MolDx Technical Assessment Director at RAS, following finalization of the clinical evidence package and incorporation of the final CLARITY-LUNG trial data. Substantial additional work, including integration of final trial results, revision of the clinical utility section, and final formatting and quality review, would have been required prior to submission.

(d) NCD Application Materials. The development of NCD application materials did not proceed beyond the feasibility assessment stage. As set forth in the NCD Feasibility Assessment Memorandum delivered May 10, 2024, our recommendation was that the NCD pathway should not be pursued until a substantially more robust body of clinical evidence — including final CLARITY-LUNG data and ideally at least one additional prospective study or real-world evidence dataset — was available.

GDT should be aware that the draft work product described above remains available in the engagement files and, subject to appropriate updating and revision, could serve as a foundation for any future engagement addressing the same or substantially similar subject matter.

IV. Work Product Preservation and Document Retention

All work product created during the engagement has been cataloged in the Work Product Index delivered to GDT on May 28, 2024, as referenced above. Calderwood & Harkness will retain copies of all engagement files, including correspondence, memoranda, draft submissions, research materials, working papers, internal notes, electronic communications, and all related documents and data, in accordance with the Firm's standard document retention policy for closed client matters.

The Firm's retention period for closed matter files is seven (7) years from the date of matter closure. Accordingly, files relating to Matter No. 1043-00002 will be retained through June 3, 2031, unless a longer retention period is required by applicable law or regulation, or unless GDT provides written instruction to extend the retention period beyond that date. At the conclusion of the retention period, the Firm reserves the right to destroy engagement files in accordance with its standard procedures, without further notice to GDT, unless GDT has provided written instructions to the contrary.

Electronic files will be maintained on the Firm's secure document management system, which employs encryption, access controls, and regular backup procedures consistent with industry standards for the protection of confidential client information. Physical files, if any, will be transferred to the Firm's off-site records storage facility managed by Ridgeway Systems, and will be maintained in secure, climate-controlled conditions for the duration of the retention period.

GDT has been provided with complete copies of all final work product as noted in the Work Product Index. GDT is strongly advised to maintain its own copies of all materials received from Calderwood & Harkness during the engagement, including all memoranda, draft submissions, correspondence, and supporting documentation. While the Firm will endeavor to make files available upon request during the retention period, GDT should not rely solely on the Firm's retained copies for its own records.

Any requests by GDT for retrieval of files from the engagement record during the retention period should be directed to:

Miriam Calloway, Partner Calderwood & Harkness LLP Telephone: (202) 555-7418

Email: mcalloway@calderwoodharkness.com

Sean Morrissey, Senior Associate Calderwood & Harkness LLP Telephone: (202) 555-7435

Email: smorrissey@calderwoodharkness.com

The Firm will use commercially reasonable efforts to respond to file retrieval requests within ten (10) business days. Reasonable charges for document retrieval, copying, and delivery may apply in accordance with the Firm's standard schedule.

V. Return of Client Materials

To the extent that GDT provided original documents, proprietary data, confidential materials, or other client-owned materials to Calderwood & Harkness during the engagement — including, without limitation, original clinical trial data, laboratory records, internal corporate documents, financial records, or board materials — such materials will be returned to GDT promptly upon request. GDT should contact Sean Morrissey at the contact information set forth in Section IV above to arrange the return of any specific materials.

In the absence of a return request from GDT, original client materials will be retained with the engagement files, subject to the document retention policy described in Section IV above. We note that the Firm received certain proprietary materials from GDT during the engagement, including clinical trial data summaries, internal GDT laboratory validation reports, and financial projections related to OncoPrecise GXP-47 reimbursement revenue. These materials are maintained in a segregated, access-restricted folder within the Firm's document management system.

We encourage GDT to review the Work Product Index and to identify any materials that GDT wishes to have returned at this time, and to communicate any such request to Mr. Morrissey within sixty (60) days of the date of this letter. The Firm will, of course, honor return requests submitted after that period, but prompt identification of materials will facilitate the orderly administration of the closed matter file.

VI. Financial Summary and Outstanding Balance

Set forth below is a summary of the total engagement billing for Matter No. 1043-00002. The final invoice for the engagement, Invoice No. INV-1043-00002-003, covering professional services rendered and disbursements incurred for the period April 15 through June 3, 2024, will be transmitted to GDT under separate cover on or about June 10, 2024.

Summary of Invoices:

Disbursement Detail:

Grand Total Billed Across All Invoices: $220,777.68

We note that the actual professional fees incurred of $218,437.50 fell well below the budgeted fee estimate of $475,000 to $575,000 set forth in Section 4 of the Engagement Letter, reflecting the early termination of the engagement prior to completion of the full scope of work contemplated therein. The fee estimate in the Engagement Letter was premised on the assumption that all five workstreams would be carried through to completion, including final submission of the PLA code application, the LCD request, and the MolDx technical assessment dossier.

Payment terms applicable to the final invoice are as set forth in the Engagement Letter, specifically net thirty (30) days from the date of invoice. Please direct any questions regarding the final invoice to the Firm's billing department or to Sean Morrissey at the contact information provided in this letter.

VII. Statute of Limitations and Timeliness Considerations

IMPORTANT ADVISORY NOTICE: The closure of this matter does not toll, suspend, or otherwise affect any applicable statutes of limitations, regulatory filing deadlines, contractual deadlines, or other time-sensitive obligations that may pertain to GDT's Medicare coverage and coding strategy for OncoPrecise GXP-47 or to GDT's broader business and regulatory obligations. GDT is solely responsible for monitoring and complying with all such deadlines following the effective date of this matter closure.

Without limitation, GDT is specifically advised to take note of the following deadlines and time-sensitive matters that remain potentially relevant to GDT's interests:

(a) AMA CPT Editorial Panel — PLA Code Application Submission Deadlines. PLA code applications are accepted by the AMA CPT Editorial Panel on a rolling basis, subject to specific quarterly submission deadlines that determine the panel meeting at which the application will be considered. If and when GDT resumes pursuit of a PLA code for OncoPrecise GXP-47, GDT should confirm the applicable submission deadline for the desired panel meeting cycle. As noted above, the submission deadline for consideration at the September 2024 meeting was June 28, 2024. The Firm will not monitor or provide notice of future submission deadlines.

(b) LCD/MolDx Submission. No statutory statute of limitations applies to the filing of an LCD request with CFI or the submission of a technical assessment dossier to RAS under the MolDx program. However, GDT should be aware that MolDx program requirements, technical assessment criteria, and CFI coverage policies may evolve over time. Before any future filing, GDT should confirm current submission requirements, evidentiary standards, and applicable coverage policies with CFI and RAS, as the materials prepared during this engagement may require updating to reflect interim changes in the regulatory and policy landscape.

(c) PCNB Milestone Covenant — Section 7.14 of the Revolving Facility Credit Agreement. GDT should carefully monitor its compliance with Section 7.14 of the Revolving Facility Credit Agreement between GDT and Pacific Coast National Bank (Ref. PCNB-GDT-RF-2023-0922, dated September 22, 2023), which requires GDT to obtain a final Medicare coverage determination for at least one proprietary laboratory-developed test by December 31, 2024. In the event of a failure to satisfy this milestone covenant, the ninety (90)-day cure period set forth in Section 8.01(c) of the Credit Agreement would expire on March 31, 2025. GDT should consult with Whitford & Sable LLP (Harrison Whitford and Danielle Reeves), GDT's regular outside corporate counsel, and with GDT's own internal advisors regarding covenant compliance. As discussed in our Analysis of Pacific Coast National Bank Milestone Covenant dated May 28, 2024, there is a reasonable basis for the argument that the existing LCD for OncoPrecise GXP-12 (LCD L38472, effective August 15, 2021, issued by CFI under the MolDx program) may satisfy the covenant, depending on the interpretation of the phrase "proprietary laboratory-developed test" and whether the covenant is read to require a new coverage determination or merely a final coverage determination for any GDT proprietary test. However, this question involves issues of contract interpretation that are outside the scope of this engagement, and GDT should obtain a definitive analysis from Whitford & Sable LLP or other appropriate counsel.

(d) CLARITY-LUNG Trial Data Readout. GDT's revised projection for the final data readout of the CLARITY-LUNG clinical validation trial (NCT05891247) is Q2 2025. GDT should plan for the potential reactivation of its Medicare reimbursement strategy in advance of that date, to ensure that updated work product can be prepared in a timely manner following the availability of final trial data. We recommend that GDT establish an internal timeline for reactivation planning no later than Q4 2024, to allow sufficient lead time for engagement of counsel, updating of draft materials, and coordination with regulatory advisors.

Calderwood & Harkness is not responsible for monitoring or enforcing any deadlines following the closure of this matter. The foregoing list is intended as a courtesy advisory and is not exhaustive. GDT is encouraged to consult with its own internal counsel, Whitford & Sable LLP, and GDT's other retained advisors regarding all ongoing obligations, deadlines, and time-sensitive matters.

VIII. Cessation of Representation and No Ongoing Obligations

Effective June 3, 2024, Calderwood & Harkness has ceased all work on Matter No. 1043-00002 and has no further obligation to perform legal services, provide legal advice, or take any action in connection with this matter. The attorney-client relationship between Calderwood & Harkness and GDT with respect to this matter is concluded as of this date. This closure does not affect any separate engagement that may exist between Calderwood & Harkness and GDT with respect to any other matter, although no such separate engagement currently exists.

Following the effective date of closure, Calderwood & Harkness will not monitor legal, regulatory, or policy developments affecting OncoPrecise GXP-47, Medicare coverage for NGS-based oncology diagnostics, CMS reimbursement policies, MolDx program requirements, AMA CPT Editorial Panel actions, or any other matters relevant to the subject of this engagement. GDT should not assume that advice previously provided by Calderwood & Harkness in connection with this matter remains current or applicable. Laws, regulations, agency policies, and industry standards in the Medicare coverage and coding space are subject to frequent change, and the passage of time since the preparation of the engagement work product may render certain analyses, recommendations, or conclusions outdated or inapplicable.

GDT should not rely on any advice previously provided in connection with this matter without independently confirming its continued applicability in light of any intervening changes in law, regulation, CMS or MolDx policy, AMA CPT coding guidelines, or other relevant authority. GDT is encouraged to engage qualified legal counsel to review and update any work product from this engagement before relying upon it in connection with future regulatory filings, business decisions, or corporate transactions.

IX. Confidentiality

Calderwood & Harkness's obligations of confidentiality with respect to GDT's information, proprietary data, and the work product developed during this engagement survive the closure of the matter and continue in full force and effect in accordance with the applicable Rules of Professional Conduct governing the Firm's attorneys, the terms of the Engagement Letter, and any separate confidentiality or non-disclosure agreements executed between the parties. All materials relating to this engagement will continue to be maintained in confidence and will not be disclosed to any third party without GDT's prior written consent, except as required by applicable law, regulation, court order, or the applicable rules of professional conduct.

The Firm's confidentiality obligations extend to all information received from GDT, all work product prepared for GDT, and all communications between the Firm and GDT in connection with this engagement, regardless of whether such information is designated as "confidential" or "proprietary" by GDT. The Firm's attorneys and staff who had access to engagement materials have been and will continue to be bound by these confidentiality obligations.

X. Reactivation of Engagement

Calderwood & Harkness would welcome the opportunity to resume work on the OncoPrecise GXP-47 Medicare coverage and coding strategy if and when GDT determines to proceed with the commercialization of OncoPrecise GXP-47. The substantial body of work product developed during this engagement provides a strong foundation that could be updated, refined, and finalized at materially reduced cost and in significantly less time relative to starting the engagement de novo.

Should GDT wish to explore reactivation of the engagement, we note the following key considerations:

(a) Clinical Trial Results. The final results of the CLARITY-LUNG trial (NCT05891247) should be available and should demonstrate sufficient clinical validity to support an LCD application and MolDx technical assessment. As discussed in the Clinical Evidence Gap Analysis Memorandum and the Revised LCD/MolDx Strategy Memorandum, the pre-specified performance thresholds — a positive predictive value (PPV) at or above 0.75 and a negative predictive value (NPV) at or above 0.80 in the intended-use population — represent the minimum evidentiary benchmarks that the Firm believes are necessary to support a credible LCD application and a favorable MolDx technical assessment determination.

(b) Leveraging Existing Work Product. The existing draft work product — including the PLA code application, the MolDx Technical Assessment Dossier (Version 1.0), the LCD request letter, the Reimbursement Rate Analysis, and the various supporting memoranda — would provide a strong foundation for a reactivated engagement. Substantial portions of these materials could be updated and finalized rather than recreated, resulting in materially reduced costs relative to a new engagement of comparable scope.

(c) New Engagement Letter and Conflicts Check. A reactivated engagement would require an updated conflicts check in accordance with the Firm's standard procedures and the execution of a new or amended engagement letter reflecting the revised scope, staffing, fee estimates, and other terms applicable to the reactivated matter.

(d) Updated Policy and Regulatory Analysis. The reimbursement rate analysis, crosswalk comparator identification, MolDx program requirements, CMS coverage policies, and the broader regulatory landscape would need to be refreshed to reflect any changes that may have occurred during the intervening period between closure and reactivation. In particular, GDT should be aware that CMS periodically updates the Clinical Laboratory Fee Schedule, that the MolDx program may revise its technical assessment criteria, and that new LCD or NCD actions by CMS or MACs could affect the strategic analysis.

GDT should contact Miriam Calloway (mcalloway@calderwoodharkness.com; (202) 555-7418) or Joel Strauss (jstrauss@calderwoodharkness.com; (202) 555-7422) to initiate any discussion regarding reactivation of the engagement. We would be pleased to schedule a call at GDT's convenience to discuss the path forward.

XI. Coordination with Other Advisors

Calderwood & Harkness has coordinated with Whitford & Sable LLP — specifically Harrison Whitford, Partner, and Danielle Reeves, Senior Associate — GDT's regular outside corporate counsel, regarding the Board's decision to defer the commercial launch of OncoPrecise GXP-47 and the implications for the PCNB milestone covenant. This coordination is reflected in correspondence between the firms dated May 24, 2024, copies of which were provided to you. We understand that Whitford & Sable LLP will continue to advise GDT on matters relating to the PCNB Credit Agreement and the milestone covenant.

GDT's other retained advisors on matters relating to OncoPrecise GXP-47 — specifically, Carraway Regulatory Advisors, Inc. (Janet Carraway, Principal) and Larkfield Health Economics, LLC (Dr. Nathan Ostroff, Managing Director) — should be notified of the matter closure to the extent GDT has not already done so. Calderwood & Harkness will not separately communicate with those advisors regarding the closure of this matter absent express instruction from GDT.

In addition, we note that Verdant Life Sciences Capital, LLC (Christine Lau, Managing Director), GDT's financial advisor, had incorporated OncoPrecise GXP-47 Medicare reimbursement revenue projections — based in part on the Firm's Reimbursement Rate Analysis Memorandum and supporting Excel workbook — into its financial models for GDT. GDT may wish to coordinate with Verdant regarding any necessary revisions to forward revenue projections in light of the deferral of the OncoPrecise GXP-47 commercial launch and the uncertainty surrounding the CLARITY-LUNG trial timeline.

XII. Closing

We wish to express our sincere appreciation for GDT's confidence in retaining Calderwood & Harkness for this engagement. It has been a privilege to work with you, Dr. Raval, Mr. Driscoll, and the entire GDT team on the Medicare coverage and coding strategy for OncoPrecise GXP-47. We believe that the work product developed during this engagement positions GDT well for a future reactivation of its reimbursement strategy, and we remain enthusiastic about the potential of the OncoPrecise platform to improve outcomes for patients with advanced NSCLC.

We look forward to the opportunity to work with GDT again in the future, whether in connection with the reactivation of the OncoPrecise GXP-47 coverage and coding strategy or in any other capacity in which our healthcare and life sciences practice may be of service.

Please do not hesitate to contact me or Joel Strauss with any questions regarding this letter or the closure of this matter.

Sincerely,

CALDERWOOD & HARKNESS LLP

By: ________

Miriam Calloway Partner, Healthcare & Life Sciences Practice Group

1700 K Street NW, Suite 900 Washington, DC 20006 Telephone: (202) 555-7418

Email: mcalloway@calderwoodharkness.com

cc:

Kevin Driscoll, Vice President of Market Access & Reimbursement, Genome Dx Therapeutics Inc. Dr. Anisha Raval, Co-Founder & Chief Executive Officer, Genome Dx Therapeutics Inc. Joel Strauss, Partner, Calderwood & Harkness LLP Sean Morrissey, Senior Associate, Calderwood & Harkness LLP Christopher Aiken, Associate, Calderwood & Harkness LLP

Enclosures: None. The Matter Wind-Down Memorandum, Work Product Index, and Analysis of Pacific Coast National Bank Milestone Covenant were previously transmitted to GDT under separate cover on May 28, 2024.

CONFIDENTIAL — ATTORNEY-CLIENT PRIVILEGED — ATTORNEY WORK PRODUCT This letter and any accompanying documents contain information that is confidential and protected by the attorney-client privilege and/or the work product doctrine. This communication is intended solely for the use of the addressee and the individuals identified in the copy line above. If you have received this communication in error, please notify the sender immediately and destroy all copies.

Invoice No.	Billing Period	Amount	Status
INV-1043-00002-001	February 14 – March 14, 2024	$62,437.50	Paid
INV-1043-00002-002	March 15 – April 14, 2024	$78,747.62	Paid
INV-1043-00002-003	April 15 – June 3, 2024	$79,592.56	To be issued
Total Professional Fees	$218,437.50
Total Disbursements	$2,340.18
Category	Amount
Westlaw / legal research charges	$1,875.50
Printing and copying	$214.68
Travel (Washington, D.C. to San Diego, April 8–10, 2024)	$250.00
Total Disbursements	$2,340.18

CALDERWOOD & HARKNESS LLP Attorneys at Law
1700 K Street NW, Suite 900 Washington, DC 20006 Telephone: (202) 555-7400 Facsimile: (202) 555-7401 www.calderwoodharkness.com
June 3, 2024
VIA EMAIL AND OVERNIGHT DELIVERY
Theresa Nakamura General Counsel & Vice President of Regulatory Affairs Genome Dx Therapeutics Inc. 4720 Torrey Pines Road, Suite 300 San Diego, CA 92130
Re: Formal Closure of Engagement — Medicare Coverage and Coding Strategy for OncoPrecise GXP-47 Matter No. 1043-00002 / Client No. 47832
Dear Ms. Nakamura:
I. Purpose and Confirmation of Matter Closure
This letter confirms the formal closure of the above-referenced matter, effective June 3, 2024. We write to provide Genome Dx Therapeutics Inc. ("GDT") with a comprehensive record of the engagement activities undertaken, the work product delivered, the financial status of the matter, and certain important advisories relating to deadlines, ongoing obligations, and the preservation of client materials.
As you know, Calderwood & Harkness LLP ("Calderwood & Harkness" or the "Firm") was engaged by GDT pursuant to the engagement letter dated February 14, 2024 (the "Engagement Letter"), to develop and execute a comprehensive Medicare coverage and coding strategy for GDT's novel multi-gene genomic diagnostic test, OncoPrecise GXP-47. The OncoPrecise GXP-47 test, a next-generation sequencing (NGS)-based multi-gene panel designed to guide treatment selection in advanced non-small cell lung carcinoma (NSCLC), represented a significant extension of GDT's existing OncoPrecise product family and a critical component of GDT's commercial pipeline.
The scope of the engagement, as set forth in the Engagement Letter and as subsequently refined through discussions among the parties, encompassed the following principal workstreams:
(a) Analysis and pursuit of a Proprietary Laboratory Analyses ("PLA") code through the American Medical Association ("AMA") CPT Editorial Panel, including preparation of the PLA code application, proposed code descriptor, and supporting documentation;
(b) Preparation of a local coverage determination ("LCD") application for filing with Cascade Fiscal Intermediaries, LLC ("CFI"), the Medicare Administrative Contractor ("MAC") for Jurisdiction E, including assembly of the requisite clinical evidence package and supporting analytical memoranda;
(c) Preparation of a technical assessment dossier for submission to Ridgeline Administrative Services, LLC ("RAS") under the Molecular Diagnostic Services ("MolDx") program, encompassing the analytical and clinical validity evidence required by the MolDx technical assessment framework;
(d) Medicare reimbursement rate analysis, including crosswalk and gapfill pricing methodologies, comparator test identification, and projected reimbursement rate modeling; and
(e) Assessment of national coverage determination ("NCD") pathways through the Centers for Medicare & Medicaid Services ("CMS"), including an evaluation of feasibility, timing, and strategic considerations for a potential CMS-initiated or stakeholder-requested NCD.
The closure of this matter is effected at GDT's instruction, as communicated by you to Miriam Calloway, partner at Calderwood & Harkness, via telephone and confirmed by email on May 23, 2024. As you indicated at that time, the GDT Board of Directors adopted a resolution on May 22, 2024, to defer the commercial launch of OncoPrecise GXP-47 indefinitely. This decision was precipitated by the inconclusive results of the CLARITY-LUNG clinical validation trial (ClinicalTrials.gov Identifier: NCT05891247), the interim analysis of which failed to meet the pre-specified primary endpoint thresholds for positive predictive value and negative predictive value in the intended-use population. We understand that GDT is continuing to evaluate its options with respect to the CLARITY-LUNG trial, including the possibility of an expanded enrollment cohort and a revised statistical analysis plan, and that a final data readout is now projected for the second quarter of 2025.
We respect and support GDT's decision, and we have structured this closure letter to facilitate any future reactivation of the engagement should circumstances warrant.
II. Summary of Engagement Activities and Work Product Delivered
A detailed and comprehensive catalog of all work product and deliverables produced during the engagement is set forth in the Matter Wind-Down Memorandum dated May 28, 2024, and the accompanying Work Product Index (collectively, the "Wind-Down Package"), which were delivered to your attention under separate cover on that date. The Wind-Down Package should be treated as the controlling record of deliverables. For convenience, however, we provide below a brief recapitulation of the key work product delivered during the course of the engagement:
1. Coding Strategy Memorandum (PLA vs. CPT Analysis) — Delivered March 11, 2024. This memorandum analyzed the relative advantages and disadvantages of pursuing a Proprietary Laboratory Analyses (PLA) code versus a standard Category I CPT code for OncoPrecise GXP-47, and recommended pursuit of the PLA pathway based on timing, procedural, and strategic considerations. The memorandum addressed the AMA CPT Editorial Panel's current criteria for PLA code eligibility, the applicable code descriptor conventions, and the implications for Medicare reimbursement rate-setting under both crosswalk and gapfill methodologies.
2. Draft PLA Code Application and Proposed Code Descriptor — Delivered March 22, 2024. The draft PLA code application included all required elements for submission to the AMA CPT Editorial Panel, including the proposed code descriptor, the clinical use case narrative, specimen type and methodology description, laboratory certification documentation, and supporting clinical evidence citations. The proposed code descriptor was developed in close coordination with GDT's laboratory operations team and Dr. Marcus Feldstein, GDT's Vice President of Laboratory Sciences.
3. Draft Cover Letter for PLA Code Application Submission to AMA CPT Editorial Panel — Prepared in connection with the PLA code application but never sent. This cover letter was finalized in draft form and was ready for execution and submission as of the date of matter closure.
4. Clinical Evidence Gap Analysis Memorandum — Delivered April 15, 2024. This memorandum systematically evaluated the existing body of published clinical evidence supporting the analytical and clinical validity and clinical utility of OncoPrecise GXP-47, mapped that evidence against the evidentiary requirements of the MolDx technical assessment framework and the CFI LCD coverage criteria, and identified specific gaps in the evidence base. The memorandum identified the CLARITY-LUNG trial as a critical source of prospective clinical validation data and flagged the risk that inconclusive trial results could materially impair the LCD and MolDx applications.
5. Revised LCD/MolDx Strategy Memorandum (Recommending Deferral of LCD Filing) — Delivered April 22, 2024. Following the release of the CLARITY-LUNG interim analysis results, we prepared a revised strategy memorandum recommending that GDT defer the planned LCD filing with CFI and the MolDx technical assessment submission to RAS pending the availability of final CLARITY-LUNG trial data. The memorandum analyzed the risks associated with premature filing, including the potential for an adverse LCD determination that could create precedential difficulties for any subsequent filing, and recommended a revised timeline contingent on the availability of satisfactory final trial data.
6. Draft MolDx Technical Assessment Dossier (Version 1.0) — Delivered April 30, 2024. The draft dossier was prepared in the format prescribed by the MolDx technical assessment submission guidelines and included an annotated bibliography of forty-three (43) peer-reviewed publications relevant to the analytical validation, clinical validation, and clinical utility of the OncoPrecise GXP-47 multi-gene panel. The dossier was structured to address each of the MolDx assessment criteria, including test description, specimen requirements, analytical performance characteristics, clinical validity, clinical utility, and cost-effectiveness. Version 1.0 was delivered in draft for GDT's review and was not finalized prior to the closure of the matter.
7. NCD Feasibility Assessment Memorandum — Delivered May 10, 2024. This memorandum assessed the feasibility and strategic advisability of pursuing a national coverage determination for OncoPrecise GXP-47 through CMS, evaluated the procedural pathways available (including formal NCD request, Coverage with Evidence Development, and the Parallel Review process with the FDA), and concluded that the NCD pathway was premature at the current stage of clinical evidence development but could become viable following completion of the CLARITY-LUNG trial and accumulation of additional real-world evidence data.
8. Reimbursement Rate Analysis Memorandum (Crosswalk/Gapfill Pricing) and Supporting Excel Workbook — Delivered May 14, 2024. The memorandum analyzed the expected Medicare reimbursement rate for OncoPrecise GXP-47 under both crosswalk and gapfill pricing methodologies, identified appropriate comparator tests and CPT/PLA codes for crosswalk purposes, modeled projected reimbursement rates under multiple scenarios, and assessed the timing and procedural steps for gapfill pricing in the event a crosswalk comparator was not accepted. The accompanying Excel workbook contained the detailed financial models and sensitivity analyses supporting the memorandum's conclusions.
9. Analysis of Pacific Coast National Bank Milestone Covenant — Delivered May 28, 2024. At GDT's request, we prepared an analysis of Section 7.14 of the Revolving Facility Credit Agreement between GDT and Pacific Coast National Bank ("PCNB") (Ref. PCNB-GDT-RF-2023-0922), which requires GDT to obtain a final Medicare coverage determination for at least one proprietary laboratory-developed test by December 31, 2024. The analysis evaluated the covenant language, assessed whether the existing LCD for OncoPrecise GXP-12 (LCD L38472, effective August 15, 2021) may satisfy the covenant, and identified potential remedial pathways in the event of a covenant breach.
10. Matter Wind-Down Memorandum and Work Product Index — Delivered May 28, 2024. The Wind-Down Memorandum provided a comprehensive narrative summary of the engagement activities, the status of each workstream at the time of closure, and recommendations for preserving GDT's optionality for future reactivation. The Work Product Index cataloged all deliverables, working papers, correspondence, and research materials produced during the engagement, organized by workstream and delivery date.
11. Board Presentation Materials — Prepared for and delivered in advance of the April 9, 2024 GDT Board of Directors meeting. These materials included a slide presentation summarizing the Medicare coverage and coding strategy, the status of each workstream, the clinical evidence landscape, the reimbursement rate projections, and the key risks and contingencies identified by the engagement team. The presentation was delivered by Ms. Calloway to the GDT Board.
12. Internal Review Memorandum on Larkfield Health Economics, LLC HEOR Analysis — Prepared at GDT's request, this memorandum provided Calderwood & Harkness's legal and regulatory review of the health economics and outcomes research ("HEOR") analysis prepared by Larkfield Health Economics, LLC ("Larkfield"), under the direction of Dr. Nathan Ostroff, for potential inclusion in the MolDx technical assessment dossier and LCD application. The memorandum assessed the HEOR analysis for consistency with MolDx evidentiary standards and CMS cost-effectiveness criteria and identified several areas requiring revision or supplementation.
The foregoing represents a summary of the principal deliverables; additional working papers, research memoranda, correspondence, and internal analytical materials are cataloged in the Work Product Index and are maintained in the engagement files.
III. Pending Deliverables Not Completed
Due to the termination of the engagement prior to completion of the full scope of work contemplated under the Engagement Letter, the following items were not completed or submitted:
(a) Final PLA Code Application. The PLA code application for OncoPrecise GXP-47 was not submitted to the AMA CPT Editorial Panel. The application was completed in draft form and was ready for final review and submission. We note that the submission deadline for consideration at the September 2024 AMA CPT Editorial Panel meeting was June 28, 2024. As that deadline has not yet passed as of the date of this letter, GDT retains the option of submitting the application independently or through other counsel should it elect to do so; however, Calderwood & Harkness will not take any action to submit the application absent a new or reactivated engagement.
(b) LCD Request Letter to CFI. A draft LCD request letter addressed to Dr. William Hargrove, Medical Director, and Sandra Phu, LCD Analyst, at Cascade Fiscal Intermediaries, LLC, was prepared but was never sent. The target filing date for the LCD request had been August 2024, and the request was contingent upon the availability of satisfactory final CLARITY-LUNG trial data. As noted in the Revised LCD/MolDx Strategy Memorandum delivered April 22, 2024, we had recommended deferral of this filing prior to the Board's decision to close the matter.
(c) Finalization and Submission of MolDx Technical Assessment Dossier. The MolDx Technical Assessment Dossier was delivered in draft (Version 1.0) but was not finalized or submitted to Ridgeline Administrative Services, LLC. The dossier was intended to be submitted to Dr. Catherine Embry, MolDx Technical Assessment Director at RAS, following finalization of the clinical evidence package and incorporation of the final CLARITY-LUNG trial data. Substantial additional work, including integration of final trial results, revision of the clinical utility section, and final formatting and quality review, would have been required prior to submission.
(d) NCD Application Materials. The development of NCD application materials did not proceed beyond the feasibility assessment stage. As set forth in the NCD Feasibility Assessment Memorandum delivered May 10, 2024, our recommendation was that the NCD pathway should not be pursued until a substantially more robust body of clinical evidence — including final CLARITY-LUNG data and ideally at least one additional prospective study or real-world evidence dataset — was available.
GDT should be aware that the draft work product described above remains available in the engagement files and, subject to appropriate updating and revision, could serve as a foundation for any future engagement addressing the same or substantially similar subject matter.
IV. Work Product Preservation and Document Retention
All work product created during the engagement has been cataloged in the Work Product Index delivered to GDT on May 28, 2024, as referenced above. Calderwood & Harkness will retain copies of all engagement files, including correspondence, memoranda, draft submissions, research materials, working papers, internal notes, electronic communications, and all related documents and data, in accordance with the Firm's standard document retention policy for closed client matters.
The Firm's retention period for closed matter files is seven (7) years from the date of matter closure. Accordingly, files relating to Matter No. 1043-00002 will be retained through June 3, 2031, unless a longer retention period is required by applicable law or regulation, or unless GDT provides written instruction to extend the retention period beyond that date. At the conclusion of the retention period, the Firm reserves the right to destroy engagement files in accordance with its standard procedures, without further notice to GDT, unless GDT has provided written instructions to the contrary.
Electronic files will be maintained on the Firm's secure document management system, which employs encryption, access controls, and regular backup procedures consistent with industry standards for the protection of confidential client information. Physical files, if any, will be transferred to the Firm's off-site records storage facility managed by Ridgeway Systems, and will be maintained in secure, climate-controlled conditions for the duration of the retention period.
GDT has been provided with complete copies of all final work product as noted in the Work Product Index. GDT is strongly advised to maintain its own copies of all materials received from Calderwood & Harkness during the engagement, including all memoranda, draft submissions, correspondence, and supporting documentation. While the Firm will endeavor to make files available upon request during the retention period, GDT should not rely solely on the Firm's retained copies for its own records.
Any requests by GDT for retrieval of files from the engagement record during the retention period should be directed to:
Miriam Calloway, Partner Calderwood & Harkness LLP Telephone: (202) 555-7418
Email: mcalloway@calderwoodharkness.com
Sean Morrissey, Senior Associate Calderwood & Harkness LLP Telephone: (202) 555-7435
Email: smorrissey@calderwoodharkness.com
The Firm will use commercially reasonable efforts to respond to file retrieval requests within ten (10) business days. Reasonable charges for document retrieval, copying, and delivery may apply in accordance with the Firm's standard schedule.
V. Return of Client Materials
To the extent that GDT provided original documents, proprietary data, confidential materials, or other client-owned materials to Calderwood & Harkness during the engagement — including, without limitation, original clinical trial data, laboratory records, internal corporate documents, financial records, or board materials — such materials will be returned to GDT promptly upon request. GDT should contact Sean Morrissey at the contact information set forth in Section IV above to arrange the return of any specific materials.
In the absence of a return request from GDT, original client materials will be retained with the engagement files, subject to the document retention policy described in Section IV above. We note that the Firm received certain proprietary materials from GDT during the engagement, including clinical trial data summaries, internal GDT laboratory validation reports, and financial projections related to OncoPrecise GXP-47 reimbursement revenue. These materials are maintained in a segregated, access-restricted folder within the Firm's document management system.
We encourage GDT to review the Work Product Index and to identify any materials that GDT wishes to have returned at this time, and to communicate any such request to Mr. Morrissey within sixty (60) days of the date of this letter. The Firm will, of course, honor return requests submitted after that period, but prompt identification of materials will facilitate the orderly administration of the closed matter file.
VI. Financial Summary and Outstanding Balance
Set forth below is a summary of the total engagement billing for Matter No. 1043-00002. The final invoice for the engagement, Invoice No. INV-1043-00002-003, covering professional services rendered and disbursements incurred for the period April 15 through June 3, 2024, will be transmitted to GDT under separate cover on or about June 10, 2024.
Summary of Invoices:
Disbursement Detail:
Grand Total Billed Across All Invoices: $220,777.68
We note that the actual professional fees incurred of $218,437.50 fell well below the budgeted fee estimate of $475,000 to $575,000 set forth in Section 4 of the Engagement Letter, reflecting the early termination of the engagement prior to completion of the full scope of work contemplated therein. The fee estimate in the Engagement Letter was premised on the assumption that all five workstreams would be carried through to completion, including final submission of the PLA code application, the LCD request, and the MolDx technical assessment dossier.
Payment terms applicable to the final invoice are as set forth in the Engagement Letter, specifically net thirty (30) days from the date of invoice. Please direct any questions regarding the final invoice to the Firm's billing department or to Sean Morrissey at the contact information provided in this letter.
VII. Statute of Limitations and Timeliness Considerations
IMPORTANT ADVISORY NOTICE: The closure of this matter does not toll, suspend, or otherwise affect any applicable statutes of limitations, regulatory filing deadlines, contractual deadlines, or other time-sensitive obligations that may pertain to GDT's Medicare coverage and coding strategy for OncoPrecise GXP-47 or to GDT's broader business and regulatory obligations. GDT is solely responsible for monitoring and complying with all such deadlines following the effective date of this matter closure.
Without limitation, GDT is specifically advised to take note of the following deadlines and time-sensitive matters that remain potentially relevant to GDT's interests:
(a) AMA CPT Editorial Panel — PLA Code Application Submission Deadlines. PLA code applications are accepted by the AMA CPT Editorial Panel on a rolling basis, subject to specific quarterly submission deadlines that determine the panel meeting at which the application will be considered. If and when GDT resumes pursuit of a PLA code for OncoPrecise GXP-47, GDT should confirm the applicable submission deadline for the desired panel meeting cycle. As noted above, the submission deadline for consideration at the September 2024 meeting was June 28, 2024. The Firm will not monitor or provide notice of future submission deadlines.
(b) LCD/MolDx Submission. No statutory statute of limitations applies to the filing of an LCD request with CFI or the submission of a technical assessment dossier to RAS under the MolDx program. However, GDT should be aware that MolDx program requirements, technical assessment criteria, and CFI coverage policies may evolve over time. Before any future filing, GDT should confirm current submission requirements, evidentiary standards, and applicable coverage policies with CFI and RAS, as the materials prepared during this engagement may require updating to reflect interim changes in the regulatory and policy landscape.
(c) PCNB Milestone Covenant — Section 7.14 of the Revolving Facility Credit Agreement. GDT should carefully monitor its compliance with Section 7.14 of the Revolving Facility Credit Agreement between GDT and Pacific Coast National Bank (Ref. PCNB-GDT-RF-2023-0922, dated September 22, 2023), which requires GDT to obtain a final Medicare coverage determination for at least one proprietary laboratory-developed test by December 31, 2024. In the event of a failure to satisfy this milestone covenant, the ninety (90)-day cure period set forth in Section 8.01(c) of the Credit Agreement would expire on March 31, 2025. GDT should consult with Whitford & Sable LLP (Harrison Whitford and Danielle Reeves), GDT's regular outside corporate counsel, and with GDT's own internal advisors regarding covenant compliance. As discussed in our Analysis of Pacific Coast National Bank Milestone Covenant dated May 28, 2024, there is a reasonable basis for the argument that the existing LCD for OncoPrecise GXP-12 (LCD L38472, effective August 15, 2021, issued by CFI under the MolDx program) may satisfy the covenant, depending on the interpretation of the phrase "proprietary laboratory-developed test" and whether the covenant is read to require a new coverage determination or merely a final coverage determination for any GDT proprietary test. However, this question involves issues of contract interpretation that are outside the scope of this engagement, and GDT should obtain a definitive analysis from Whitford & Sable LLP or other appropriate counsel.
(d) CLARITY-LUNG Trial Data Readout. GDT's revised projection for the final data readout of the CLARITY-LUNG clinical validation trial (NCT05891247) is Q2 2025. GDT should plan for the potential reactivation of its Medicare reimbursement strategy in advance of that date, to ensure that updated work product can be prepared in a timely manner following the availability of final trial data. We recommend that GDT establish an internal timeline for reactivation planning no later than Q4 2024, to allow sufficient lead time for engagement of counsel, updating of draft materials, and coordination with regulatory advisors.
Calderwood & Harkness is not responsible for monitoring or enforcing any deadlines following the closure of this matter. The foregoing list is intended as a courtesy advisory and is not exhaustive. GDT is encouraged to consult with its own internal counsel, Whitford & Sable LLP, and GDT's other retained advisors regarding all ongoing obligations, deadlines, and time-sensitive matters.
VIII. Cessation of Representation and No Ongoing Obligations
Effective June 3, 2024, Calderwood & Harkness has ceased all work on Matter No. 1043-00002 and has no further obligation to perform legal services, provide legal advice, or take any action in connection with this matter. The attorney-client relationship between Calderwood & Harkness and GDT with respect to this matter is concluded as of this date. This closure does not affect any separate engagement that may exist between Calderwood & Harkness and GDT with respect to any other matter, although no such separate engagement currently exists.
Following the effective date of closure, Calderwood & Harkness will not monitor legal, regulatory, or policy developments affecting OncoPrecise GXP-47, Medicare coverage for NGS-based oncology diagnostics, CMS reimbursement policies, MolDx program requirements, AMA CPT Editorial Panel actions, or any other matters relevant to the subject of this engagement. GDT should not assume that advice previously provided by Calderwood & Harkness in connection with this matter remains current or applicable. Laws, regulations, agency policies, and industry standards in the Medicare coverage and coding space are subject to frequent change, and the passage of time since the preparation of the engagement work product may render certain analyses, recommendations, or conclusions outdated or inapplicable.
GDT should not rely on any advice previously provided in connection with this matter without independently confirming its continued applicability in light of any intervening changes in law, regulation, CMS or MolDx policy, AMA CPT coding guidelines, or other relevant authority. GDT is encouraged to engage qualified legal counsel to review and update any work product from this engagement before relying upon it in connection with future regulatory filings, business decisions, or corporate transactions.
IX. Confidentiality
Calderwood & Harkness's obligations of confidentiality with respect to GDT's information, proprietary data, and the work product developed during this engagement survive the closure of the matter and continue in full force and effect in accordance with the applicable Rules of Professional Conduct governing the Firm's attorneys, the terms of the Engagement Letter, and any separate confidentiality or non-disclosure agreements executed between the parties. All materials relating to this engagement will continue to be maintained in confidence and will not be disclosed to any third party without GDT's prior written consent, except as required by applicable law, regulation, court order, or the applicable rules of professional conduct.
The Firm's confidentiality obligations extend to all information received from GDT, all work product prepared for GDT, and all communications between the Firm and GDT in connection with this engagement, regardless of whether such information is designated as "confidential" or "proprietary" by GDT. The Firm's attorneys and staff who had access to engagement materials have been and will continue to be bound by these confidentiality obligations.
X. Reactivation of Engagement
Calderwood & Harkness would welcome the opportunity to resume work on the OncoPrecise GXP-47 Medicare coverage and coding strategy if and when GDT determines to proceed with the commercialization of OncoPrecise GXP-47. The substantial body of work product developed during this engagement provides a strong foundation that could be updated, refined, and finalized at materially reduced cost and in significantly less time relative to starting the engagement de novo.
Should GDT wish to explore reactivation of the engagement, we note the following key considerations:
(a) Clinical Trial Results. The final results of the CLARITY-LUNG trial (NCT05891247) should be available and should demonstrate sufficient clinical validity to support an LCD application and MolDx technical assessment. As discussed in the Clinical Evidence Gap Analysis Memorandum and the Revised LCD/MolDx Strategy Memorandum, the pre-specified performance thresholds — a positive predictive value (PPV) at or above 0.75 and a negative predictive value (NPV) at or above 0.80 in the intended-use population — represent the minimum evidentiary benchmarks that the Firm believes are necessary to support a credible LCD application and a favorable MolDx technical assessment determination.
(b) Leveraging Existing Work Product. The existing draft work product — including the PLA code application, the MolDx Technical Assessment Dossier (Version 1.0), the LCD request letter, the Reimbursement Rate Analysis, and the various supporting memoranda — would provide a strong foundation for a reactivated engagement. Substantial portions of these materials could be updated and finalized rather than recreated, resulting in materially reduced costs relative to a new engagement of comparable scope.
(c) New Engagement Letter and Conflicts Check. A reactivated engagement would require an updated conflicts check in accordance with the Firm's standard procedures and the execution of a new or amended engagement letter reflecting the revised scope, staffing, fee estimates, and other terms applicable to the reactivated matter.
(d) Updated Policy and Regulatory Analysis. The reimbursement rate analysis, crosswalk comparator identification, MolDx program requirements, CMS coverage policies, and the broader regulatory landscape would need to be refreshed to reflect any changes that may have occurred during the intervening period between closure and reactivation. In particular, GDT should be aware that CMS periodically updates the Clinical Laboratory Fee Schedule, that the MolDx program may revise its technical assessment criteria, and that new LCD or NCD actions by CMS or MACs could affect the strategic analysis.
GDT should contact Miriam Calloway (mcalloway@calderwoodharkness.com; (202) 555-7418) or Joel Strauss (jstrauss@calderwoodharkness.com; (202) 555-7422) to initiate any discussion regarding reactivation of the engagement. We would be pleased to schedule a call at GDT's convenience to discuss the path forward.
XI. Coordination with Other Advisors
Calderwood & Harkness has coordinated with Whitford & Sable LLP — specifically Harrison Whitford, Partner, and Danielle Reeves, Senior Associate — GDT's regular outside corporate counsel, regarding the Board's decision to defer the commercial launch of OncoPrecise GXP-47 and the implications for the PCNB milestone covenant. This coordination is reflected in correspondence between the firms dated May 24, 2024, copies of which were provided to you. We understand that Whitford & Sable LLP will continue to advise GDT on matters relating to the PCNB Credit Agreement and the milestone covenant.
GDT's other retained advisors on matters relating to OncoPrecise GXP-47 — specifically, Carraway Regulatory Advisors, Inc. (Janet Carraway, Principal) and Larkfield Health Economics, LLC (Dr. Nathan Ostroff, Managing Director) — should be notified of the matter closure to the extent GDT has not already done so. Calderwood & Harkness will not separately communicate with those advisors regarding the closure of this matter absent express instruction from GDT.
In addition, we note that Verdant Life Sciences Capital, LLC (Christine Lau, Managing Director), GDT's financial advisor, had incorporated OncoPrecise GXP-47 Medicare reimbursement revenue projections — based in part on the Firm's Reimbursement Rate Analysis Memorandum and supporting Excel workbook — into its financial models for GDT. GDT may wish to coordinate with Verdant regarding any necessary revisions to forward revenue projections in light of the deferral of the OncoPrecise GXP-47 commercial launch and the uncertainty surrounding the CLARITY-LUNG trial timeline.
XII. Closing
We wish to express our sincere appreciation for GDT's confidence in retaining Calderwood & Harkness for this engagement. It has been a privilege to work with you, Dr. Raval, Mr. Driscoll, and the entire GDT team on the Medicare coverage and coding strategy for OncoPrecise GXP-47. We believe that the work product developed during this engagement positions GDT well for a future reactivation of its reimbursement strategy, and we remain enthusiastic about the potential of the OncoPrecise platform to improve outcomes for patients with advanced NSCLC.
We look forward to the opportunity to work with GDT again in the future, whether in connection with the reactivation of the OncoPrecise GXP-47 coverage and coding strategy or in any other capacity in which our healthcare and life sciences practice may be of service.
Please do not hesitate to contact me or Joel Strauss with any questions regarding this letter or the closure of this matter.
Sincerely,
CALDERWOOD & HARKNESS LLP
By: ________
Miriam Calloway Partner, Healthcare & Life Sciences Practice Group
1700 K Street NW, Suite 900 Washington, DC 20006 Telephone: (202) 555-7418
Email: mcalloway@calderwoodharkness.com
cc:
Kevin Driscoll, Vice President of Market Access & Reimbursement, Genome Dx Therapeutics Inc. Dr. Anisha Raval, Co-Founder & Chief Executive Officer, Genome Dx Therapeutics Inc. Joel Strauss, Partner, Calderwood & Harkness LLP Sean Morrissey, Senior Associate, Calderwood & Harkness LLP Christopher Aiken, Associate, Calderwood & Harkness LLP
Enclosures: None. The Matter Wind-Down Memorandum, Work Product Index, and Analysis of Pacific Coast National Bank Milestone Covenant were previously transmitted to GDT under separate cover on May 28, 2024.
CONFIDENTIAL — ATTORNEY-CLIENT PRIVILEGED — ATTORNEY WORK PRODUCT This letter and any accompanying documents contain information that is confidential and protected by the attorney-client privilege and/or the work product doctrine. This communication is intended solely for the use of the addressee and the individuals identified in the copy line above. If you have received this communication in error, please notify the sender immediately and destroy all copies.
Invoice No. | Billing Period | Amount | Status
INV-1043-00002-001 | February 14 – March 14, 2024 | $62,437.50 | Paid
INV-1043-00002-002 | March 15 – April 14, 2024 | $78,747.62 | Paid
INV-1043-00002-003 | April 15 – June 3, 2024 | $79,592.56 | To be issued
Total Professional Fees | $218,437.50
Total Disbursements | $2,340.18
Category | Amount
Westlaw / legal research charges | $1,875.50
Printing and copying | $214.68
Travel (Washington, D.C. to San Diego, April 8–10, 2024) | $250.00
Total Disbursements | $2,340.18

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