1013-00004 · Calderwood & Harkness LLP · Engagement

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PRIVILEGED & CONFIDENTIAL — ATTORNEY-CLIENT COMMUNICATION

CALDERWOOD & HARKNESS LLP Attorneys at Law

1700 K Street NW, Suite 900 Washington, DC 20006 Telephone: (202) 554-8200 Facsimile: (202) 554-8201 www.calderwoodharkness.com

February 14, 2024

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

Re: Engagement of Calderwood & Harkness LLP by Genome Dx Therapeutics Inc. — Medicare Coverage and Coding Strategy for OncoPrecise GXP-47 Matter No.: 1043-00002 Client No.: 47832

Dear Ms. Nakamura:

We are pleased to confirm that Calderwood & Harkness LLP ("we," "the Firm," or "C&H") has been retained to represent Genome Dx Therapeutics Inc. ("GDT," "you," or "the Company") in connection with the matters described below. This engagement letter sets forth the terms and conditions governing the attorney-client relationship between the Firm and GDT and should be read carefully.

1. Introduction and Purpose

This engagement letter confirms that Calderwood & Harkness LLP is pleased to represent Genome Dx Therapeutics Inc., a Delaware corporation headquartered in San Diego, California, in connection with the development and execution of a comprehensive Medicare coverage and coding strategy for OncoPrecise GXP-47, GDT's proprietary 47-gene expression panel genomic diagnostic test. The Firm has significant experience in Medicare coverage and reimbursement matters for molecular diagnostic technologies and looks forward to bringing that experience to bear on behalf of GDT.

This engagement letter is being provided in response to GDT's January 22, 2024 Request for Proposal for Medicare coverage and coding counsel, and following the Firm's February 6, 2024 engagement proposal submitted in response thereto. We appreciate the thorough evaluation process GDT undertook in selecting outside counsel for this matter, and we are honored by your confidence in the Firm.

This engagement letter supersedes any and all prior proposals, discussions, and understandings between the parties — including, without limitation, the Firm's February 6, 2024 engagement proposal — and sets forth the binding terms and conditions of the attorney-client relationship between Calderwood & Harkness LLP and Genome Dx Therapeutics Inc. with respect to the subject matter described herein. This engagement shall be effective as of the date of mutual execution by the parties as set forth in the signature blocks below.

2. Description of the Client

Our client in this engagement is Genome Dx Therapeutics Inc., a Delaware corporation (EIN: 83-2947156), with its principal place of business at 4720 Torrey Pines Road, Suite 300, San Diego, California 92130. GDT is a clinical-stage molecular diagnostics company specializing in next-generation sequencing ("NGS") based genomic tests for oncology applications. GDT operates a CLIA-certified, CAP-accredited reference laboratory located in San Diego, California (CLIA No. 05D2187432; CAP No. 9074821; NPI: 1902847365), from which it performs and reports results for its proprietary laboratory-developed tests.

For purposes of this engagement, Theresa Nakamura, General Counsel & VP of Regulatory Affairs, is designated as the primary client contact and is authorized to provide instructions to the Firm, approve work product, authorize the incurrence of expenses, and receive privileged communications on behalf of GDT. All material communications, draft submissions, and strategic recommendations will be directed to Ms. Nakamura unless she designates an alternative recipient in writing.

In addition, Kevin Driscoll, VP of Market Access & Reimbursement, is designated as the day-to-day operational point person for this engagement. Mr. Driscoll will serve as the Firm's primary contact for routine communications, scheduling, document collection, and coordination with GDT's internal teams and third-party advisors. The Firm is authorized to communicate with and take direction from Mr. Driscoll on operational and logistical matters; provided, however, that any material strategic decisions, final work product approvals, and authorizations to make external filings or submissions shall require the express approval of Ms. Nakamura.

3. Scope of Representation

The Firm is engaged to provide legal advisory services related to the Medicare coverage, coding, and reimbursement strategy for GDT's laboratory-developed test, OncoPrecise GXP-47 (the "Test"). OncoPrecise GXP-47 is a 47-gene RNA expression panel performed on formalin-fixed, paraffin-embedded ("FFPE") tumor tissue specimens. The Test produces a composite Therapy Response Index ("TRI") score designed to predict response to immune checkpoint inhibitor ("ICI") therapy in patients with Stage IIIB/IV non-small-cell lung cancer ("NSCLC"). The scope of the Firm's engagement encompasses the following workstreams:

3.1 CPT/PLA Code Strategy and Application

The Firm will provide legal counsel and strategic guidance regarding the optimal coding pathway for OncoPrecise GXP-47. This workstream will include:

(a) A thorough analysis of available coding options for the Test, including an evaluation of whether to pursue a Proprietary Laboratory Analyses ("PLA") code through the American Medical Association ("AMA") CPT Editorial Panel, or whether to utilize existing CPT codes (e.g., CPT 81455, Targeted Genomic Sequence Analysis Panel, solid organ or hematolymphoid neoplasm, DNA and RNA analysis, 51 or greater genes) or other applicable Category I or Category III CPT codes, or a combination thereof. The analysis will consider the relative advantages and disadvantages of each approach with respect to Medicare reimbursement rate positioning, payer recognition, and administrative simplicity.

(b) Preparation and submission of a PLA code application to the AMA CPT Editorial Panel, if the parties determine that the PLA pathway is strategically advantageous. This will include drafting of the proposed code descriptor in conformity with AMA formatting requirements, preparation of all supporting documentation required by the AMA, and management of the application through the AMA review process.

(c) Coordination with GDT's independently retained coding and billing consultant, Carraway Regulatory Advisors, Inc. (Janet Carraway, CPC, CCS-P, Principal), on coding mechanics, AMA submission formatting requirements, and related billing compliance considerations. The Firm will work collaboratively with Ms. Carraway's team to ensure alignment between the legal strategy and the operational coding and billing implementation.

(d) The Firm will target the AMA CPT Editorial Panel's September 2024 meeting cycle for consideration of the PLA code application, which requires submission of a complete application package by no later than June 28, 2024. The Firm will develop a detailed timeline and work plan to ensure that all components of the application are prepared, reviewed, and finalized in advance of this deadline.

3.2 Local Coverage Determination (LCD) Strategy

The Firm will develop and execute a strategy for obtaining a local coverage determination ("LCD") from the applicable Medicare Administrative Contractor ("MAC") for OncoPrecise GXP-47. This workstream will include:

(a) Identification and confirmation of the appropriate MAC jurisdiction for GDT's laboratory. Based on GDT's San Diego, California laboratory location, the applicable MAC is Cascade Fiscal Intermediaries, LLC ("CFI"), the MAC responsible for Jurisdiction E (which covers California and certain additional western states).

(b) Development of a comprehensive LCD request strategy, including determination of the optimal timing for submission relative to the PLA code application and MolDx technical assessment processes, identification of the evidentiary standards CFI will apply, and preparation of a submission roadmap.

(c) Preparation and filing of a formal LCD request with CFI, addressed to Dr. William Hargrove, Medical Director for molecular diagnostics coverage, and Sandra Phu, LCD Analyst for genomic diagnostics. The LCD request will include a detailed clinical summary, a description of the intended patient population and clinical use case, a comprehensive evidence review, and proposed coverage criteria.

(d) Management of the LCD review process, including responses to CFI inquiries, preparation for and attendance at any open meetings or comment periods, and coordination with GDT's clinical and scientific teams to address medical director questions.

3.3 MolDx Technical Assessment

The Firm will prepare a comprehensive technical assessment dossier for submission to the MolDx (Molecular Diagnostic Services) program. This workstream will include:

(a) Preparation of a technical assessment dossier for submission to Ridgeline Administrative Services, LLC ("RAS"), the contractor administering the MolDx program, for review by Dr. Catherine Embry, MolDx Technical Assessment Director. The dossier will be prepared in conformity with MolDx submission guidelines and will be designed to support a favorable technical assessment determination.

(b) The technical assessment dossier will include the following components: (i) a detailed description of the OncoPrecise GXP-47 test methodology, technology platform, and intended clinical use; (ii) analytical validation data, including precision, accuracy, reproducibility, reportable range, and specimen stability studies; (iii) clinical validation data, with particular emphasis on results from GDT's CLARITY-LUNG trial (a multi-center, prospective-retrospective validation study) and any supporting studies; (iv) clinical utility evidence demonstrating that the Test results change clinical management decisions and improve patient outcomes; (v) health economic analysis demonstrating the cost-effectiveness of utilizing the Test in clinical decision-making for ICI therapy selection in advanced NSCLC patients; and (vi) a comprehensive peer-reviewed publication bibliography listing all relevant publications supporting the analytical validity, clinical validity, and clinical utility of the Test.

(c) Coordination with Larkfield Health Economics, LLC (Dr. Nathan Ostroff, PhD, MS, Principal Consultant), GDT's independently retained health economics and outcomes research ("HEOR") consultant, regarding incorporation of health economics and cost-effectiveness analyses into the MolDx technical assessment dossier. The Firm will review and incorporate the HEOR analyses prepared by Dr. Ostroff's team and will advise on the presentation and framing of economic evidence to best support the MolDx assessment.

3.4 Medicare Reimbursement Rate Analysis

The Firm will provide analysis and strategic advice regarding Medicare reimbursement rate positioning for OncoPrecise GXP-47. This workstream will include:

(a) Analysis of applicable Medicare reimbursement rate-setting methodologies, including the crosswalk methodology (mapping the Test to an existing CPT code with an established rate) and the gapfill methodology (establishing a new rate based on cost and market data), and recommendation of the optimal approach for the Test.

(b) Identification of appropriate comparator codes and their associated Medicare reimbursement rates for use in crosswalk or gapfill analysis, including analysis of reimbursement rates for comparable multi-gene expression panel tests.

(c) Preparation of reimbursement rate recommendations and supporting justification documentation that can be submitted to CFI or CMS as part of the pricing determination process.

3.5 National Coverage Determination (NCD) Feasibility Assessment

The Firm will conduct a preliminary assessment of the feasibility and strategic considerations for pursuing a national coverage determination ("NCD") for OncoPrecise GXP-47. This workstream will include:

(a) Analysis of the CMS national coverage determination process and its applicability to the Test, including an assessment of the traditional NCD pathway and the Coverage with Evidence Development ("CED") framework, and the relative merits and risks of each.

(b) Evaluation of the evidentiary threshold required for an NCD and the extent to which GDT's existing and anticipated evidence base would support a favorable determination.

(c) Estimated timeline analysis for the NCD process, including consideration of the typical duration of CMS review, the impact of concurrent LCD coverage, and the strategic sequencing of LCD and NCD submissions.

(d) A written memorandum summarizing the Firm's preliminary NCD feasibility assessment for presentation to GDT's management and board, with a recommendation as to whether and when to initiate the NCD process.

3.6 Related Advisory Services

In addition to the specific workstreams described above, the Firm's engagement encompasses the following related advisory services:

(a) Preparation and delivery of board-level presentations and strategic advice on Medicare reimbursement matters, including attendance at meetings of GDT's board of directors or designated board committees, as reasonably requested by GDT.

(b) Review and analysis of the impact of clinical validation study results — including interim and final results from the CLARITY-LUNG trial — on the overall Medicare coverage strategy, and adjustment of strategic recommendations as warranted by evolving evidence.

(c) Coordination with GDT's other outside counsel, Whitford & Sable LLP (Harrison Whitford, Lead Partner), on related corporate and regulatory board matters as necessary to ensure alignment between the Medicare coverage strategy and GDT's broader corporate and regulatory objectives.

(d) Such other related advisory services as may be mutually agreed upon in writing between the Firm and GDT from time to time during the course of the engagement.

3.7 Scope Exclusions

The scope of this engagement is limited to the matters described in Sections 3.1 through 3.6 above. For the avoidance of doubt, this engagement does not include any of the following:

(a) FDA regulatory submissions or advice, including but not limited to premarket approval ("PMA") applications, 510(k) premarket notifications, de novo classification requests, or laboratory-developed test ("LDT") regulatory strategy under any current or proposed FDA regulatory framework;

(b) Patent prosecution, intellectual property counseling, licensing, or any other intellectual property matters;

(d) Commercial payer contracting, negotiations, or coverage disputes with private health insurers or managed care organizations;

(e) Clinical trial design, management, regulatory oversight, or institutional review board ("IRB") interactions;

(f) Federal, state, or local tax advice of any kind;

(g) Representation of GDT in any litigation, arbitration, administrative proceeding, government investigation, or enforcement action, including without limitation any Medicare audit, overpayment proceeding, or False Claims Act matter.

The Firm is not engaged to represent or advise any entity other than Genome Dx Therapeutics Inc. in connection with this engagement. Without limiting the generality of the foregoing, the Firm does not represent Pinnacle Health Ventures, L.P. (or any of its affiliates, general partners, or limited partners), any of GDT's other investors, or any individual officer, director, employee, or affiliate of GDT. Any such representation would require a separate engagement letter.

The Firm does not undertake to advise on matters relating to GDT's credit facility with Pacific Coast National Bank or any loan covenant compliance issues arising thereunder, except to the extent that the Medicare reimbursement strategy may have implications for financial projections or covenant compliance metrics and GDT specifically requests the Firm's analysis of such implications. Any such request will be addressed within the scope of this engagement only to the extent it relates directly to Medicare coverage and reimbursement matters and does not constitute independent banking or finance advice.

4. Engagement Team

The Firm will staff this engagement with the following professionals:

Miriam Calloway, Partner — Responsible Partner. Ms. Calloway is based in the Firm's Washington, D.C. office at 1700 K Street NW, Suite 900, Washington, DC 20006. She is a member of the Healthcare & Life Sciences practice group and has 28 years of experience in Medicare coverage and reimbursement law, including direct involvement in more than fifteen LCD and NCD proceedings for molecular diagnostic and genomic tests. Ms. Calloway will provide overall strategic direction for the engagement, supervise all work product, and serve as the Firm's primary point of contact for senior-level client communications. She will be personally involved in all material strategic decisions, key submissions, and client presentations.

Joel Strauss, Partner — Billing Partner. Mr. Strauss is based in the Firm's San Francisco office at 555 California Street, Suite 3200, San Francisco, CA 94104. He is a member of the Healthcare & Life Sciences practice group and specializes in health technology assessment and the intersection of FDA and CMS regulatory frameworks. Mr. Strauss will contribute to the NCD feasibility analysis and health technology assessment aspects of the engagement, and will serve as the billing partner responsible for matter administration.

Sean Morrissey, Senior Associate — Lead Associate. Mr. Morrissey is based in the Firm's Washington, D.C. office. He has six years of experience in healthcare regulatory and reimbursement law and previously served as a policy analyst at the Centers for Medicare & Medicaid Services ("CMS"), Coverage and Analysis Group, where he supported the review of national coverage determinations for diagnostic tests. Mr. Morrissey will serve as the day-to-day lead for work product preparation, legal research, drafting, and routine client communications. He will be the primary point of contact for Mr. Driscoll and will coordinate the Firm's activities with GDT's third-party advisors.

Christopher Aiken, Associate — Working Associate. Mr. Aiken is based in the Firm's San Francisco office. He has three years of experience with a focus on CPT/HCPCS coding, laboratory billing compliance, and Medicare reimbursement rate analysis. Mr. Aiken will take primary responsibility for PLA code application drafting, AMA submission preparation, and crosswalk/gapfill reimbursement rate analysis.

Brief biographies for each member of the engagement team are attached hereto as Exhibit A.

Paralegals and other support staff will be assigned to the matter as needed to ensure efficient execution of the work. The Firm reserves the right to adjust staffing assignments during the course of the engagement, with appropriate notice to GDT, as workload requirements, scheduling, and professional development considerations may warrant; provided, however, that Miriam Calloway will remain as the Responsible Partner throughout the engagement unless otherwise agreed in writing by GDT.

5. Fees and Billing Arrangements

5.1 Hourly Rates

Professional services rendered in connection with this engagement will be billed at the following hourly rates:

These rates are the Firm's standard rates for calendar year 2024. Rates are subject to annual adjustment, typically effective January 1 of each year, consistent with the Firm's standard rate-setting practices. The Firm will provide GDT with advance written notice of any rate adjustments at least thirty (30) days prior to the effective date of such adjustments. Time will be recorded and billed in increments of one-tenth (0.1) of an hour (i.e., six-minute increments).

5.2 Fee Estimate / Budget

Based on the scope of work described in Section 3 of this engagement letter, and taking into account the Firm's experience with comparable engagements, the Firm estimates that total professional fees for the full scope of the engagement through issuance of a local coverage determination by CFI will be in the range of $475,000 to $575,000. This estimate encompasses all workstreams described in Sections 3.1 through 3.6, including the PLA code application, LCD request, MolDx technical assessment, reimbursement rate analysis, NCD feasibility assessment, and related advisory services.

This estimate is provided for GDT's internal budgeting and financial planning purposes only and is not a cap, fixed fee, guaranteed maximum price, or not-to-exceed amount. The estimate does not constitute a guarantee or commitment that the Firm's fees will fall within the stated range. Actual fees may be higher or lower than the estimated range depending on a number of factors, including but not limited to: the complexity and novelty of legal and regulatory issues encountered during the engagement; the volume and nature of clinical validation evidence to be analyzed and incorporated into submissions; the timing, interim results, and final outcome of the CLARITY-LUNG trial; the responsiveness and information requests of CFI, RAS, and the AMA CPT Editorial Panel; changes in applicable Medicare coverage policies or CMS guidance; and other factors that are outside the Firm's control.

If it becomes apparent during the course of the engagement that total fees are likely to exceed the upper end of the estimated range, the Firm will promptly notify GDT and discuss the reasons for the variance, the scope of remaining work, and revised fee expectations. The Firm and GDT will work together in good faith to manage costs while ensuring the quality and effectiveness of the representation.

Fees for any out-of-scope work — that is, work falling outside the scope described in Section 3, including any work relating to the matters identified as scope exclusions in Section 3.7 — will be addressed by separate written agreement between the parties prior to the commencement of such work.

5.3 Disbursements and Expenses

In addition to professional fees, GDT will be responsible for reimbursement of reasonable out-of-pocket expenses and disbursements incurred by the Firm in connection with the representation. Reimbursable expenses include, but are not limited to, the following:

(a) Electronic legal research charges, including charges for use of Westlaw, Sundial Solutions, and specialized healthcare regulatory databases;

(b) Printing, copying, and document reproduction charges;

(c) Travel expenses incurred with the prior approval of GDT for trips reasonably necessary to the engagement, including coach-class airfare, reasonable hotel accommodations, ground transportation, and meals. The Firm will seek GDT's advance approval before incurring any single trip expense expected to exceed $2,500;

(d) Filing fees assessed by the AMA, CMS, or any other governmental or quasi-governmental body in connection with submissions made on GDT's behalf, if applicable;

(e) Courier, express mail, and delivery charges;

(f) Long-distance telephone and videoconference charges, to the extent separately billed;

(g) Other reasonable out-of-pocket costs directly attributable to the engagement.

Disbursements will be itemized on the Firm's monthly invoices and will be billed at cost without markup.

6. Billing and Payment Terms

6.1 Invoice Schedule

The Firm will issue invoices on a monthly basis, reflecting professional fees earned and disbursements incurred during the preceding billing period. Invoices will be transmitted electronically to Ms. Nakamura (or such other person as GDT may designate in writing) and will include detailed time entries showing, for each entry, the identity of the timekeeper, the date on which the services were performed, the number of hours billed, the applicable hourly rate, and a narrative description of the services performed. Disbursements will be separately itemized with supporting detail.

6.2 Payment Terms

Invoices are due and payable within thirty (30) days of the date of issuance. Payments should be made by wire transfer to the Firm's client trust account or operating account, as applicable, using the wire transfer instructions that will be provided with the first invoice and are attached hereto as Exhibit B. Alternatively, payments may be made by check drawn on a United States bank and made payable to "Calderwood & Harkness LLP," mailed to the Firm's Washington, D.C. office at the address set forth above. GDT agrees to reference the Matter Number (1043-00002) on all payments to ensure proper crediting.

6.3 Late Payment

Amounts not paid within thirty (30) days of the date of invoicing may be subject to a late payment charge of 1.0% per month (12.0% per annum) on the outstanding balance, or the maximum rate permitted by applicable law, whichever is lower. Late payment charges will begin to accrue on the thirty-first (31st) day following the invoice date and will continue to accrue until the outstanding balance is paid in full.

The Firm reserves the right to suspend work on this engagement if any invoice remains unpaid for more than sixty (60) days after the date of issuance, upon not less than fifteen (15) days' prior written notice to GDT. The Firm will not exercise this right without first providing GDT a reasonable opportunity to cure the delinquency or to discuss any billing dispute in good faith.

7. Confidentiality

All information provided by GDT to the Firm in connection with this engagement, whether provided orally, in writing, or in electronic form, will be treated as confidential by the Firm and its personnel. Such information will be subject to the protections of the attorney-client privilege and/or the work product doctrine, as applicable under the circumstances, and the Firm will take reasonable measures to preserve those protections.

The Firm will not disclose confidential client information to any third party without GDT's prior written consent, except as may be required by law, by order of a court or tribunal of competent jurisdiction, or by applicable rules of professional conduct (including the District of Columbia Rules of Professional Conduct).

GDT acknowledges that the effective performance of the Firm's engagement will require the Firm to share certain information — including clinical data, test descriptions, evidence summaries, and related technical information — with GDT's other retained advisors, specifically Carraway Regulatory Advisors, Inc. and Larkfield Health Economics, LLC, in furtherance of the collaborative workstreams described in Section 3. GDT hereby authorizes the Firm to make such disclosures to these advisors as the Firm determines to be reasonably necessary for the purposes described in this engagement letter. GDT represents that it has entered into appropriate confidentiality agreements with each of these third-party advisors.

Communications between the Firm and Whitford & Sable LLP (GDT's outside corporate and regulatory counsel) on matters within the scope of this engagement will be treated as protected under the common interest doctrine, to the extent applicable, subject to GDT's continuing authorization. GDT may revoke this authorization at any time by written notice to the Firm.

8. Conflicts of Interest

The Firm has conducted a conflicts check in accordance with its standard procedures and the requirements of the applicable rules of professional conduct. Based on the information currently available to the Firm, including the conflicts check conducted against the following parties, the Firm has identified no conflicts of interest that would preclude this engagement:

• Genome Dx Therapeutics Inc. and its officers and directors;

• Pinnacle Health Ventures, L.P.;

• Cascade Fiscal Intermediaries, LLC;

• Ridgeline Administrative Services, LLC;

• Pacific Coast National Bank;

• Carraway Regulatory Advisors, Inc.;

• Larkfield Health Economics, LLC;

• Whitford & Sable LLP; and

• Other relevant parties identified by GDT in its conflict questionnaire dated January 30, 2024.

GDT acknowledges that Calderwood & Harkness LLP is a large, multi-office law firm with attorneys practicing in numerous jurisdictions and across a wide range of practice areas, and that the Firm currently represents, and may in the future represent, other clients whose interests may be adverse to GDT in matters that are wholly unrelated to this engagement. GDT consents to such unrelated representations, provided that they do not involve the specific subject matter of this engagement.

The Firm agrees that it will not knowingly accept representation of any other party adverse to GDT in connection with the specific subject matter of this engagement — namely, the Medicare coverage, coding, and reimbursement strategy for OncoPrecise GXP-47 — without GDT's prior written consent.

If a conflict of interest arises during the course of this engagement, including a conflict that could not reasonably have been identified at the outset, the Firm will promptly notify GDT and will take appropriate steps in accordance with the applicable rules of professional conduct, which may include seeking a waiver from GDT, implementing an ethical screen, or withdrawing from the representation if the conflict cannot be resolved.

9. Third-Party Coordination

The Firm's scope of work under this engagement will involve ongoing coordination with the following third-party advisors that have been independently retained by GDT. The Firm wishes to clarify that none of these third-party advisors are clients of Calderwood & Harkness LLP, and the Firm does not owe any duty of representation, loyalty, or confidentiality to them except as may arise from the Firm's obligations to GDT:

Carraway Regulatory Advisors, Inc. Janet Carraway, CPC, CCS-P, Principal 233 South Wacker Drive, Suite 4100 Chicago, Illinois 60606 Role: Coding and billing consultant — CPT/PLA coding mechanics, AMA submission formatting, billing compliance

Larkfield Health Economics, LLC Dr. Nathan Ostroff, PhD, MS, Principal Consultant 7910 Woodmont Avenue, Suite 610 Bethesda, Maryland 20814 Role: HEOR consultant — health economics and cost-effectiveness analyses for MolDx dossier

The Firm will review, incorporate, and rely upon work product prepared by these consultants as appropriate in the preparation of submissions and strategic analyses. However, the Firm does not assume responsibility for the accuracy, completeness, or reliability of any independent work product prepared by these third-party advisors. GDT is responsible for the retention, direction, supervision, and payment of these advisors, and GDT represents that it has appropriate engagement agreements in place with each of them.

10. Document Retention

The Firm will maintain all files related to this engagement — including correspondence, memoranda, work product, research materials, drafts, and final submissions — in accordance with the Firm's standard document retention policy, a copy of which is available upon request. Upon conclusion of the engagement, whether by completion of the scope of work or termination pursuant to Section 11, work product and client documents will be preserved in the Firm's records and will be made available to GDT upon reasonable written request, subject to the terms of the Firm's retention policy.

Electronic files will be retained for a minimum of seven (7) years following the closure of the matter in the Firm's records management system, unless a longer retention period is otherwise agreed in writing between the parties or is required by applicable law or regulation. Following the expiration of the applicable retention period, the Firm may destroy or dispose of engagement files in accordance with its standard procedures without further notice to GDT, unless GDT has submitted a written preservation request.

11. Termination

Either party may terminate this engagement at any time, with or without cause, upon written notice to the other party. In the event of termination by either party, GDT will remain responsible for payment of all professional fees earned and disbursements incurred through the effective date of termination, in accordance with the billing and payment terms set forth in Sections 5 and 6 of this engagement letter.

Upon termination, the Firm will take reasonable steps to wind down the engagement in an orderly manner so as to protect GDT's interests, including preparation of a comprehensive work product summary describing the status of all pending workstreams, deadlines, and open matters, and preservation of all client materials and files. The Firm will cooperate fully in the transition of the matter to successor counsel, if any, designated by GDT, including providing copies of all work product and client files and making the engagement team available for reasonable transition discussions.

The Firm's obligations regarding confidentiality (Section 7) and document retention (Section 10) will survive the termination of this engagement.

12. Limitation of Engagement

This engagement is limited to the specific scope of representation described in Section 3 of this engagement letter. The Firm's responsibility does not extend beyond the matters specifically described herein, and the Firm is not obligated to monitor legal developments, regulatory changes, or factual circumstances affecting GDT outside the scope of this engagement unless separately agreed.

The Firm's advice and work product are based on the laws, regulations, CMS policies, and CMS sub-regulatory guidance in effect at the time such advice is rendered or such work product is prepared. The Firm does not undertake to account for, or to update its advice to reflect, subsequent changes in law, regulation, CMS policy, or administrative practice, except to the extent such changes occur during the active course of the engagement and are directly relevant to pending workstreams.

GDT acknowledges that the outcome of any local coverage determination, national coverage determination, PLA code application, MolDx technical assessment, or reimbursement rate determination is subject to the discretion of the applicable decision-making body (including CFI, RAS, the AMA CPT Editorial Panel, and CMS) and cannot be guaranteed. The Firm makes no representations or warranties regarding the likelihood of success of any filing, submission, or application made in connection with this engagement.

The Firm's role under this engagement is advisory in nature. All decisions regarding whether to proceed with particular filings, submissions, or applications, and all decisions regarding commercial launch timing, market access strategy, and other business matters, remain solely with GDT and its board of directors. The Firm will provide its professional judgment and recommendations, but the ultimate responsibility for strategic and business decisions rests with GDT.

13. Governing Law

This engagement letter will be governed by and construed in accordance with the laws of the District of Columbia, without regard to principles of conflict of laws that might direct the application of the laws of another jurisdiction. Any dispute arising under or in connection with this engagement letter will be subject to the exclusive jurisdiction of the courts of the District of Columbia or, if applicable, the United States District Court for the District of Columbia.

14. Entire Agreement

This engagement letter constitutes the entire agreement between Calderwood & Harkness LLP and Genome Dx Therapeutics Inc. with respect to the subject matter hereof and supersedes all prior and contemporaneous proposals, discussions, negotiations, representations, and understandings, whether oral or written, between the parties, including without limitation the Firm's February 6, 2024 engagement proposal. There are no oral or written agreements, understandings, or commitments between the parties relating to the subject matter of this engagement letter that are not expressly set forth herein.

Any amendments, modifications, or supplements to this engagement letter must be in writing and signed by authorized representatives of both parties in order to be effective. No waiver of any provision of this engagement letter will be effective unless made in writing and signed by the waiving party.

15. Acceptance and Execution

We would be grateful if you would indicate GDT's acceptance of the terms set forth in this engagement letter by countersigning in the space provided below and returning one fully executed copy to the Firm. A scanned copy transmitted by electronic mail to miriam.calloway@calderwoodharkness.com will be accepted as an original for purposes of confirming the engagement, with original signature copies to follow by mail.

We are enthusiastic about this engagement and look forward to working with you, Kevin Driscoll, and the broader GDT team on this important matter. The development of a sound Medicare coverage and reimbursement strategy for OncoPrecise GXP-47 is a critical milestone for GDT, and we are committed to bringing the full resources of our Healthcare & Life Sciences practice to bear in support of your objectives. Please do not hesitate to contact me or Sean Morrissey at any time with questions.

Very truly yours,

CALDERWOOD & HARKNESS LLP

By: ________

Miriam Calloway, Partner Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP 1700 K Street NW, Suite 900 Washington, DC 20006 Telephone: (202) 554-8247

Email: miriam.calloway@calderwoodharkness.com

By: ________

Joel Strauss, Partner (Billing Partner) Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP 555 California Street, Suite 3200 San Francisco, CA 94104 Telephone: (415) 291-6330

Email: joel.strauss@calderwoodharkness.com

ACCEPTED AND AGREED

GENOME DX THERAPEUTICS INC.

By: ________

Name: Theresa Nakamura

Title: General Counsel & VP of Regulatory Affairs

Genome Dx Therapeutics Inc. 4720 Torrey Pines Road, Suite 300 San Diego, CA 92130

Date: February 14, 2024

Enclosures:

Exhibit A: Engagement Team Biographies (Calloway, Strauss, Morrissey, Aiken)

Exhibit B: Wire Transfer Payment Instructions

DC\1043-00002\ENGMT LETTER\v3 — 02/14/2024

Timekeeper	Position	Hourly Rate
Miriam Calloway	Partner	$1,350.00
Joel Strauss	Partner	$1,275.00
Sean Morrissey	Senior Associate	$875.00
Christopher Aiken	Associate	$650.00
Paralegals	—	$375.00

PRIVILEGED & CONFIDENTIAL — ATTORNEY-CLIENT COMMUNICATION
CALDERWOOD & HARKNESS LLP Attorneys at Law
1700 K Street NW, Suite 900 Washington, DC 20006 Telephone: (202) 554-8200 Facsimile: (202) 554-8201 www.calderwoodharkness.com
February 14, 2024
Theresa Nakamura General Counsel & VP of Regulatory Affairs Genome Dx Therapeutics Inc. 4720 Torrey Pines Road, Suite 300 San Diego, CA 92130
Re: Engagement of Calderwood & Harkness LLP by Genome Dx Therapeutics Inc. — Medicare Coverage and Coding Strategy for OncoPrecise GXP-47 Matter No.: 1043-00002 Client No.: 47832
Dear Ms. Nakamura:
We are pleased to confirm that Calderwood & Harkness LLP ("we," "the Firm," or "C&H") has been retained to represent Genome Dx Therapeutics Inc. ("GDT," "you," or "the Company") in connection with the matters described below. This engagement letter sets forth the terms and conditions governing the attorney-client relationship between the Firm and GDT and should be read carefully.
1. Introduction and Purpose
This engagement letter confirms that Calderwood & Harkness LLP is pleased to represent Genome Dx Therapeutics Inc., a Delaware corporation headquartered in San Diego, California, in connection with the development and execution of a comprehensive Medicare coverage and coding strategy for OncoPrecise GXP-47, GDT's proprietary 47-gene expression panel genomic diagnostic test. The Firm has significant experience in Medicare coverage and reimbursement matters for molecular diagnostic technologies and looks forward to bringing that experience to bear on behalf of GDT.
This engagement letter is being provided in response to GDT's January 22, 2024 Request for Proposal for Medicare coverage and coding counsel, and following the Firm's February 6, 2024 engagement proposal submitted in response thereto. We appreciate the thorough evaluation process GDT undertook in selecting outside counsel for this matter, and we are honored by your confidence in the Firm.
This engagement letter supersedes any and all prior proposals, discussions, and understandings between the parties — including, without limitation, the Firm's February 6, 2024 engagement proposal — and sets forth the binding terms and conditions of the attorney-client relationship between Calderwood & Harkness LLP and Genome Dx Therapeutics Inc. with respect to the subject matter described herein. This engagement shall be effective as of the date of mutual execution by the parties as set forth in the signature blocks below.
2. Description of the Client
Our client in this engagement is Genome Dx Therapeutics Inc., a Delaware corporation (EIN: 83-2947156), with its principal place of business at 4720 Torrey Pines Road, Suite 300, San Diego, California 92130. GDT is a clinical-stage molecular diagnostics company specializing in next-generation sequencing ("NGS") based genomic tests for oncology applications. GDT operates a CLIA-certified, CAP-accredited reference laboratory located in San Diego, California (CLIA No. 05D2187432; CAP No. 9074821; NPI: 1902847365), from which it performs and reports results for its proprietary laboratory-developed tests.
For purposes of this engagement, Theresa Nakamura, General Counsel & VP of Regulatory Affairs, is designated as the primary client contact and is authorized to provide instructions to the Firm, approve work product, authorize the incurrence of expenses, and receive privileged communications on behalf of GDT. All material communications, draft submissions, and strategic recommendations will be directed to Ms. Nakamura unless she designates an alternative recipient in writing.
In addition, Kevin Driscoll, VP of Market Access & Reimbursement, is designated as the day-to-day operational point person for this engagement. Mr. Driscoll will serve as the Firm's primary contact for routine communications, scheduling, document collection, and coordination with GDT's internal teams and third-party advisors. The Firm is authorized to communicate with and take direction from Mr. Driscoll on operational and logistical matters; provided, however, that any material strategic decisions, final work product approvals, and authorizations to make external filings or submissions shall require the express approval of Ms. Nakamura.
3. Scope of Representation
The Firm is engaged to provide legal advisory services related to the Medicare coverage, coding, and reimbursement strategy for GDT's laboratory-developed test, OncoPrecise GXP-47 (the "Test"). OncoPrecise GXP-47 is a 47-gene RNA expression panel performed on formalin-fixed, paraffin-embedded ("FFPE") tumor tissue specimens. The Test produces a composite Therapy Response Index ("TRI") score designed to predict response to immune checkpoint inhibitor ("ICI") therapy in patients with Stage IIIB/IV non-small-cell lung cancer ("NSCLC"). The scope of the Firm's engagement encompasses the following workstreams:
3.1 CPT/PLA Code Strategy and Application
The Firm will provide legal counsel and strategic guidance regarding the optimal coding pathway for OncoPrecise GXP-47. This workstream will include:
(a) A thorough analysis of available coding options for the Test, including an evaluation of whether to pursue a Proprietary Laboratory Analyses ("PLA") code through the American Medical Association ("AMA") CPT Editorial Panel, or whether to utilize existing CPT codes (e.g., CPT 81455, Targeted Genomic Sequence Analysis Panel, solid organ or hematolymphoid neoplasm, DNA and RNA analysis, 51 or greater genes) or other applicable Category I or Category III CPT codes, or a combination thereof. The analysis will consider the relative advantages and disadvantages of each approach with respect to Medicare reimbursement rate positioning, payer recognition, and administrative simplicity.
(b) Preparation and submission of a PLA code application to the AMA CPT Editorial Panel, if the parties determine that the PLA pathway is strategically advantageous. This will include drafting of the proposed code descriptor in conformity with AMA formatting requirements, preparation of all supporting documentation required by the AMA, and management of the application through the AMA review process.
(c) Coordination with GDT's independently retained coding and billing consultant, Carraway Regulatory Advisors, Inc. (Janet Carraway, CPC, CCS-P, Principal), on coding mechanics, AMA submission formatting requirements, and related billing compliance considerations. The Firm will work collaboratively with Ms. Carraway's team to ensure alignment between the legal strategy and the operational coding and billing implementation.
(d) The Firm will target the AMA CPT Editorial Panel's September 2024 meeting cycle for consideration of the PLA code application, which requires submission of a complete application package by no later than June 28, 2024. The Firm will develop a detailed timeline and work plan to ensure that all components of the application are prepared, reviewed, and finalized in advance of this deadline.
3.2 Local Coverage Determination (LCD) Strategy
The Firm will develop and execute a strategy for obtaining a local coverage determination ("LCD") from the applicable Medicare Administrative Contractor ("MAC") for OncoPrecise GXP-47. This workstream will include:
(a) Identification and confirmation of the appropriate MAC jurisdiction for GDT's laboratory. Based on GDT's San Diego, California laboratory location, the applicable MAC is Cascade Fiscal Intermediaries, LLC ("CFI"), the MAC responsible for Jurisdiction E (which covers California and certain additional western states).
(b) Development of a comprehensive LCD request strategy, including determination of the optimal timing for submission relative to the PLA code application and MolDx technical assessment processes, identification of the evidentiary standards CFI will apply, and preparation of a submission roadmap.
(c) Preparation and filing of a formal LCD request with CFI, addressed to Dr. William Hargrove, Medical Director for molecular diagnostics coverage, and Sandra Phu, LCD Analyst for genomic diagnostics. The LCD request will include a detailed clinical summary, a description of the intended patient population and clinical use case, a comprehensive evidence review, and proposed coverage criteria.
(d) Management of the LCD review process, including responses to CFI inquiries, preparation for and attendance at any open meetings or comment periods, and coordination with GDT's clinical and scientific teams to address medical director questions.
3.3 MolDx Technical Assessment
The Firm will prepare a comprehensive technical assessment dossier for submission to the MolDx (Molecular Diagnostic Services) program. This workstream will include:
(a) Preparation of a technical assessment dossier for submission to Ridgeline Administrative Services, LLC ("RAS"), the contractor administering the MolDx program, for review by Dr. Catherine Embry, MolDx Technical Assessment Director. The dossier will be prepared in conformity with MolDx submission guidelines and will be designed to support a favorable technical assessment determination.
(b) The technical assessment dossier will include the following components: (i) a detailed description of the OncoPrecise GXP-47 test methodology, technology platform, and intended clinical use; (ii) analytical validation data, including precision, accuracy, reproducibility, reportable range, and specimen stability studies; (iii) clinical validation data, with particular emphasis on results from GDT's CLARITY-LUNG trial (a multi-center, prospective-retrospective validation study) and any supporting studies; (iv) clinical utility evidence demonstrating that the Test results change clinical management decisions and improve patient outcomes; (v) health economic analysis demonstrating the cost-effectiveness of utilizing the Test in clinical decision-making for ICI therapy selection in advanced NSCLC patients; and (vi) a comprehensive peer-reviewed publication bibliography listing all relevant publications supporting the analytical validity, clinical validity, and clinical utility of the Test.
(c) Coordination with Larkfield Health Economics, LLC (Dr. Nathan Ostroff, PhD, MS, Principal Consultant), GDT's independently retained health economics and outcomes research ("HEOR") consultant, regarding incorporation of health economics and cost-effectiveness analyses into the MolDx technical assessment dossier. The Firm will review and incorporate the HEOR analyses prepared by Dr. Ostroff's team and will advise on the presentation and framing of economic evidence to best support the MolDx assessment.
3.4 Medicare Reimbursement Rate Analysis
The Firm will provide analysis and strategic advice regarding Medicare reimbursement rate positioning for OncoPrecise GXP-47. This workstream will include:
(a) Analysis of applicable Medicare reimbursement rate-setting methodologies, including the crosswalk methodology (mapping the Test to an existing CPT code with an established rate) and the gapfill methodology (establishing a new rate based on cost and market data), and recommendation of the optimal approach for the Test.
(b) Identification of appropriate comparator codes and their associated Medicare reimbursement rates for use in crosswalk or gapfill analysis, including analysis of reimbursement rates for comparable multi-gene expression panel tests.
(c) Preparation of reimbursement rate recommendations and supporting justification documentation that can be submitted to CFI or CMS as part of the pricing determination process.
3.5 National Coverage Determination (NCD) Feasibility Assessment
The Firm will conduct a preliminary assessment of the feasibility and strategic considerations for pursuing a national coverage determination ("NCD") for OncoPrecise GXP-47. This workstream will include:
(a) Analysis of the CMS national coverage determination process and its applicability to the Test, including an assessment of the traditional NCD pathway and the Coverage with Evidence Development ("CED") framework, and the relative merits and risks of each.
(b) Evaluation of the evidentiary threshold required for an NCD and the extent to which GDT's existing and anticipated evidence base would support a favorable determination.
(c) Estimated timeline analysis for the NCD process, including consideration of the typical duration of CMS review, the impact of concurrent LCD coverage, and the strategic sequencing of LCD and NCD submissions.
(d) A written memorandum summarizing the Firm's preliminary NCD feasibility assessment for presentation to GDT's management and board, with a recommendation as to whether and when to initiate the NCD process.
3.6 Related Advisory Services
In addition to the specific workstreams described above, the Firm's engagement encompasses the following related advisory services:
(a) Preparation and delivery of board-level presentations and strategic advice on Medicare reimbursement matters, including attendance at meetings of GDT's board of directors or designated board committees, as reasonably requested by GDT.
(b) Review and analysis of the impact of clinical validation study results — including interim and final results from the CLARITY-LUNG trial — on the overall Medicare coverage strategy, and adjustment of strategic recommendations as warranted by evolving evidence.
(c) Coordination with GDT's other outside counsel, Whitford & Sable LLP (Harrison Whitford, Lead Partner), on related corporate and regulatory board matters as necessary to ensure alignment between the Medicare coverage strategy and GDT's broader corporate and regulatory objectives.
(d) Such other related advisory services as may be mutually agreed upon in writing between the Firm and GDT from time to time during the course of the engagement.
3.7 Scope Exclusions
The scope of this engagement is limited to the matters described in Sections 3.1 through 3.6 above. For the avoidance of doubt, this engagement does not include any of the following:
(a) FDA regulatory submissions or advice, including but not limited to premarket approval ("PMA") applications, 510(k) premarket notifications, de novo classification requests, or laboratory-developed test ("LDT") regulatory strategy under any current or proposed FDA regulatory framework;
(b) Patent prosecution, intellectual property counseling, licensing, or any other intellectual property matters;
(c) Corporate governance, securities law compliance, or capital markets matters;
(d) Commercial payer contracting, negotiations, or coverage disputes with private health insurers or managed care organizations;
(e) Clinical trial design, management, regulatory oversight, or institutional review board ("IRB") interactions;
(f) Federal, state, or local tax advice of any kind;
(g) Representation of GDT in any litigation, arbitration, administrative proceeding, government investigation, or enforcement action, including without limitation any Medicare audit, overpayment proceeding, or False Claims Act matter.
The Firm is not engaged to represent or advise any entity other than Genome Dx Therapeutics Inc. in connection with this engagement. Without limiting the generality of the foregoing, the Firm does not represent Pinnacle Health Ventures, L.P. (or any of its affiliates, general partners, or limited partners), any of GDT's other investors, or any individual officer, director, employee, or affiliate of GDT. Any such representation would require a separate engagement letter.
The Firm does not undertake to advise on matters relating to GDT's credit facility with Pacific Coast National Bank or any loan covenant compliance issues arising thereunder, except to the extent that the Medicare reimbursement strategy may have implications for financial projections or covenant compliance metrics and GDT specifically requests the Firm's analysis of such implications. Any such request will be addressed within the scope of this engagement only to the extent it relates directly to Medicare coverage and reimbursement matters and does not constitute independent banking or finance advice.
4. Engagement Team
The Firm will staff this engagement with the following professionals:
Miriam Calloway, Partner — Responsible Partner. Ms. Calloway is based in the Firm's Washington, D.C. office at 1700 K Street NW, Suite 900, Washington, DC 20006. She is a member of the Healthcare & Life Sciences practice group and has 28 years of experience in Medicare coverage and reimbursement law, including direct involvement in more than fifteen LCD and NCD proceedings for molecular diagnostic and genomic tests. Ms. Calloway will provide overall strategic direction for the engagement, supervise all work product, and serve as the Firm's primary point of contact for senior-level client communications. She will be personally involved in all material strategic decisions, key submissions, and client presentations.
Joel Strauss, Partner — Billing Partner. Mr. Strauss is based in the Firm's San Francisco office at 555 California Street, Suite 3200, San Francisco, CA 94104. He is a member of the Healthcare & Life Sciences practice group and specializes in health technology assessment and the intersection of FDA and CMS regulatory frameworks. Mr. Strauss will contribute to the NCD feasibility analysis and health technology assessment aspects of the engagement, and will serve as the billing partner responsible for matter administration.
Sean Morrissey, Senior Associate — Lead Associate. Mr. Morrissey is based in the Firm's Washington, D.C. office. He has six years of experience in healthcare regulatory and reimbursement law and previously served as a policy analyst at the Centers for Medicare & Medicaid Services ("CMS"), Coverage and Analysis Group, where he supported the review of national coverage determinations for diagnostic tests. Mr. Morrissey will serve as the day-to-day lead for work product preparation, legal research, drafting, and routine client communications. He will be the primary point of contact for Mr. Driscoll and will coordinate the Firm's activities with GDT's third-party advisors.
Christopher Aiken, Associate — Working Associate. Mr. Aiken is based in the Firm's San Francisco office. He has three years of experience with a focus on CPT/HCPCS coding, laboratory billing compliance, and Medicare reimbursement rate analysis. Mr. Aiken will take primary responsibility for PLA code application drafting, AMA submission preparation, and crosswalk/gapfill reimbursement rate analysis.
Brief biographies for each member of the engagement team are attached hereto as Exhibit A.
Paralegals and other support staff will be assigned to the matter as needed to ensure efficient execution of the work. The Firm reserves the right to adjust staffing assignments during the course of the engagement, with appropriate notice to GDT, as workload requirements, scheduling, and professional development considerations may warrant; provided, however, that Miriam Calloway will remain as the Responsible Partner throughout the engagement unless otherwise agreed in writing by GDT.
5. Fees and Billing Arrangements
5.1 Hourly Rates
Professional services rendered in connection with this engagement will be billed at the following hourly rates:
These rates are the Firm's standard rates for calendar year 2024. Rates are subject to annual adjustment, typically effective January 1 of each year, consistent with the Firm's standard rate-setting practices. The Firm will provide GDT with advance written notice of any rate adjustments at least thirty (30) days prior to the effective date of such adjustments. Time will be recorded and billed in increments of one-tenth (0.1) of an hour (i.e., six-minute increments).
5.2 Fee Estimate / Budget
Based on the scope of work described in Section 3 of this engagement letter, and taking into account the Firm's experience with comparable engagements, the Firm estimates that total professional fees for the full scope of the engagement through issuance of a local coverage determination by CFI will be in the range of $475,000 to $575,000. This estimate encompasses all workstreams described in Sections 3.1 through 3.6, including the PLA code application, LCD request, MolDx technical assessment, reimbursement rate analysis, NCD feasibility assessment, and related advisory services.
This estimate is provided for GDT's internal budgeting and financial planning purposes only and is not a cap, fixed fee, guaranteed maximum price, or not-to-exceed amount. The estimate does not constitute a guarantee or commitment that the Firm's fees will fall within the stated range. Actual fees may be higher or lower than the estimated range depending on a number of factors, including but not limited to: the complexity and novelty of legal and regulatory issues encountered during the engagement; the volume and nature of clinical validation evidence to be analyzed and incorporated into submissions; the timing, interim results, and final outcome of the CLARITY-LUNG trial; the responsiveness and information requests of CFI, RAS, and the AMA CPT Editorial Panel; changes in applicable Medicare coverage policies or CMS guidance; and other factors that are outside the Firm's control.
If it becomes apparent during the course of the engagement that total fees are likely to exceed the upper end of the estimated range, the Firm will promptly notify GDT and discuss the reasons for the variance, the scope of remaining work, and revised fee expectations. The Firm and GDT will work together in good faith to manage costs while ensuring the quality and effectiveness of the representation.
Fees for any out-of-scope work — that is, work falling outside the scope described in Section 3, including any work relating to the matters identified as scope exclusions in Section 3.7 — will be addressed by separate written agreement between the parties prior to the commencement of such work.
5.3 Disbursements and Expenses
In addition to professional fees, GDT will be responsible for reimbursement of reasonable out-of-pocket expenses and disbursements incurred by the Firm in connection with the representation. Reimbursable expenses include, but are not limited to, the following:
(a) Electronic legal research charges, including charges for use of Westlaw, Sundial Solutions, and specialized healthcare regulatory databases;
(b) Printing, copying, and document reproduction charges;
(c) Travel expenses incurred with the prior approval of GDT for trips reasonably necessary to the engagement, including coach-class airfare, reasonable hotel accommodations, ground transportation, and meals. The Firm will seek GDT's advance approval before incurring any single trip expense expected to exceed $2,500;
(d) Filing fees assessed by the AMA, CMS, or any other governmental or quasi-governmental body in connection with submissions made on GDT's behalf, if applicable;
(e) Courier, express mail, and delivery charges;
(f) Long-distance telephone and videoconference charges, to the extent separately billed;
(g) Other reasonable out-of-pocket costs directly attributable to the engagement.
Disbursements will be itemized on the Firm's monthly invoices and will be billed at cost without markup.
6. Billing and Payment Terms
6.1 Invoice Schedule
The Firm will issue invoices on a monthly basis, reflecting professional fees earned and disbursements incurred during the preceding billing period. Invoices will be transmitted electronically to Ms. Nakamura (or such other person as GDT may designate in writing) and will include detailed time entries showing, for each entry, the identity of the timekeeper, the date on which the services were performed, the number of hours billed, the applicable hourly rate, and a narrative description of the services performed. Disbursements will be separately itemized with supporting detail.
6.2 Payment Terms
Invoices are due and payable within thirty (30) days of the date of issuance. Payments should be made by wire transfer to the Firm's client trust account or operating account, as applicable, using the wire transfer instructions that will be provided with the first invoice and are attached hereto as Exhibit B. Alternatively, payments may be made by check drawn on a United States bank and made payable to "Calderwood & Harkness LLP," mailed to the Firm's Washington, D.C. office at the address set forth above. GDT agrees to reference the Matter Number (1043-00002) on all payments to ensure proper crediting.
6.3 Late Payment
Amounts not paid within thirty (30) days of the date of invoicing may be subject to a late payment charge of 1.0% per month (12.0% per annum) on the outstanding balance, or the maximum rate permitted by applicable law, whichever is lower. Late payment charges will begin to accrue on the thirty-first (31st) day following the invoice date and will continue to accrue until the outstanding balance is paid in full.
The Firm reserves the right to suspend work on this engagement if any invoice remains unpaid for more than sixty (60) days after the date of issuance, upon not less than fifteen (15) days' prior written notice to GDT. The Firm will not exercise this right without first providing GDT a reasonable opportunity to cure the delinquency or to discuss any billing dispute in good faith.
7. Confidentiality
All information provided by GDT to the Firm in connection with this engagement, whether provided orally, in writing, or in electronic form, will be treated as confidential by the Firm and its personnel. Such information will be subject to the protections of the attorney-client privilege and/or the work product doctrine, as applicable under the circumstances, and the Firm will take reasonable measures to preserve those protections.
The Firm will not disclose confidential client information to any third party without GDT's prior written consent, except as may be required by law, by order of a court or tribunal of competent jurisdiction, or by applicable rules of professional conduct (including the District of Columbia Rules of Professional Conduct).
GDT acknowledges that the effective performance of the Firm's engagement will require the Firm to share certain information — including clinical data, test descriptions, evidence summaries, and related technical information — with GDT's other retained advisors, specifically Carraway Regulatory Advisors, Inc. and Larkfield Health Economics, LLC, in furtherance of the collaborative workstreams described in Section 3. GDT hereby authorizes the Firm to make such disclosures to these advisors as the Firm determines to be reasonably necessary for the purposes described in this engagement letter. GDT represents that it has entered into appropriate confidentiality agreements with each of these third-party advisors.
Communications between the Firm and Whitford & Sable LLP (GDT's outside corporate and regulatory counsel) on matters within the scope of this engagement will be treated as protected under the common interest doctrine, to the extent applicable, subject to GDT's continuing authorization. GDT may revoke this authorization at any time by written notice to the Firm.
8. Conflicts of Interest
The Firm has conducted a conflicts check in accordance with its standard procedures and the requirements of the applicable rules of professional conduct. Based on the information currently available to the Firm, including the conflicts check conducted against the following parties, the Firm has identified no conflicts of interest that would preclude this engagement:
•  Genome Dx Therapeutics Inc. and its officers and directors;
•  Pinnacle Health Ventures, L.P.;
•  Cascade Fiscal Intermediaries, LLC;
•  Ridgeline Administrative Services, LLC;
•  Pacific Coast National Bank;
•  Carraway Regulatory Advisors, Inc.;
•  Larkfield Health Economics, LLC;
•  Whitford & Sable LLP; and
•  Other relevant parties identified by GDT in its conflict questionnaire dated January 30, 2024.
GDT acknowledges that Calderwood & Harkness LLP is a large, multi-office law firm with attorneys practicing in numerous jurisdictions and across a wide range of practice areas, and that the Firm currently represents, and may in the future represent, other clients whose interests may be adverse to GDT in matters that are wholly unrelated to this engagement. GDT consents to such unrelated representations, provided that they do not involve the specific subject matter of this engagement.
The Firm agrees that it will not knowingly accept representation of any other party adverse to GDT in connection with the specific subject matter of this engagement — namely, the Medicare coverage, coding, and reimbursement strategy for OncoPrecise GXP-47 — without GDT's prior written consent.
If a conflict of interest arises during the course of this engagement, including a conflict that could not reasonably have been identified at the outset, the Firm will promptly notify GDT and will take appropriate steps in accordance with the applicable rules of professional conduct, which may include seeking a waiver from GDT, implementing an ethical screen, or withdrawing from the representation if the conflict cannot be resolved.
9. Third-Party Coordination
The Firm's scope of work under this engagement will involve ongoing coordination with the following third-party advisors that have been independently retained by GDT. The Firm wishes to clarify that none of these third-party advisors are clients of Calderwood & Harkness LLP, and the Firm does not owe any duty of representation, loyalty, or confidentiality to them except as may arise from the Firm's obligations to GDT:
Carraway Regulatory Advisors, Inc. Janet Carraway, CPC, CCS-P, Principal 233 South Wacker Drive, Suite 4100 Chicago, Illinois 60606 Role: Coding and billing consultant — CPT/PLA coding mechanics, AMA submission formatting, billing compliance
Larkfield Health Economics, LLC Dr. Nathan Ostroff, PhD, MS, Principal Consultant 7910 Woodmont Avenue, Suite 610 Bethesda, Maryland 20814 Role: HEOR consultant — health economics and cost-effectiveness analyses for MolDx dossier
The Firm will review, incorporate, and rely upon work product prepared by these consultants as appropriate in the preparation of submissions and strategic analyses. However, the Firm does not assume responsibility for the accuracy, completeness, or reliability of any independent work product prepared by these third-party advisors. GDT is responsible for the retention, direction, supervision, and payment of these advisors, and GDT represents that it has appropriate engagement agreements in place with each of them.
10. Document Retention
The Firm will maintain all files related to this engagement — including correspondence, memoranda, work product, research materials, drafts, and final submissions — in accordance with the Firm's standard document retention policy, a copy of which is available upon request. Upon conclusion of the engagement, whether by completion of the scope of work or termination pursuant to Section 11, work product and client documents will be preserved in the Firm's records and will be made available to GDT upon reasonable written request, subject to the terms of the Firm's retention policy.
Electronic files will be retained for a minimum of seven (7) years following the closure of the matter in the Firm's records management system, unless a longer retention period is otherwise agreed in writing between the parties or is required by applicable law or regulation. Following the expiration of the applicable retention period, the Firm may destroy or dispose of engagement files in accordance with its standard procedures without further notice to GDT, unless GDT has submitted a written preservation request.
11. Termination
Either party may terminate this engagement at any time, with or without cause, upon written notice to the other party. In the event of termination by either party, GDT will remain responsible for payment of all professional fees earned and disbursements incurred through the effective date of termination, in accordance with the billing and payment terms set forth in Sections 5 and 6 of this engagement letter.
Upon termination, the Firm will take reasonable steps to wind down the engagement in an orderly manner so as to protect GDT's interests, including preparation of a comprehensive work product summary describing the status of all pending workstreams, deadlines, and open matters, and preservation of all client materials and files. The Firm will cooperate fully in the transition of the matter to successor counsel, if any, designated by GDT, including providing copies of all work product and client files and making the engagement team available for reasonable transition discussions.
The Firm's obligations regarding confidentiality (Section 7) and document retention (Section 10) will survive the termination of this engagement.
12. Limitation of Engagement
This engagement is limited to the specific scope of representation described in Section 3 of this engagement letter. The Firm's responsibility does not extend beyond the matters specifically described herein, and the Firm is not obligated to monitor legal developments, regulatory changes, or factual circumstances affecting GDT outside the scope of this engagement unless separately agreed.
The Firm's advice and work product are based on the laws, regulations, CMS policies, and CMS sub-regulatory guidance in effect at the time such advice is rendered or such work product is prepared. The Firm does not undertake to account for, or to update its advice to reflect, subsequent changes in law, regulation, CMS policy, or administrative practice, except to the extent such changes occur during the active course of the engagement and are directly relevant to pending workstreams.
GDT acknowledges that the outcome of any local coverage determination, national coverage determination, PLA code application, MolDx technical assessment, or reimbursement rate determination is subject to the discretion of the applicable decision-making body (including CFI, RAS, the AMA CPT Editorial Panel, and CMS) and cannot be guaranteed. The Firm makes no representations or warranties regarding the likelihood of success of any filing, submission, or application made in connection with this engagement.
The Firm's role under this engagement is advisory in nature. All decisions regarding whether to proceed with particular filings, submissions, or applications, and all decisions regarding commercial launch timing, market access strategy, and other business matters, remain solely with GDT and its board of directors. The Firm will provide its professional judgment and recommendations, but the ultimate responsibility for strategic and business decisions rests with GDT.
13. Governing Law
This engagement letter will be governed by and construed in accordance with the laws of the District of Columbia, without regard to principles of conflict of laws that might direct the application of the laws of another jurisdiction. Any dispute arising under or in connection with this engagement letter will be subject to the exclusive jurisdiction of the courts of the District of Columbia or, if applicable, the United States District Court for the District of Columbia.
14. Entire Agreement
This engagement letter constitutes the entire agreement between Calderwood & Harkness LLP and Genome Dx Therapeutics Inc. with respect to the subject matter hereof and supersedes all prior and contemporaneous proposals, discussions, negotiations, representations, and understandings, whether oral or written, between the parties, including without limitation the Firm's February 6, 2024 engagement proposal. There are no oral or written agreements, understandings, or commitments between the parties relating to the subject matter of this engagement letter that are not expressly set forth herein.
Any amendments, modifications, or supplements to this engagement letter must be in writing and signed by authorized representatives of both parties in order to be effective. No waiver of any provision of this engagement letter will be effective unless made in writing and signed by the waiving party.
15. Acceptance and Execution
We would be grateful if you would indicate GDT's acceptance of the terms set forth in this engagement letter by countersigning in the space provided below and returning one fully executed copy to the Firm. A scanned copy transmitted by electronic mail to miriam.calloway@calderwoodharkness.com will be accepted as an original for purposes of confirming the engagement, with original signature copies to follow by mail.
We are enthusiastic about this engagement and look forward to working with you, Kevin Driscoll, and the broader GDT team on this important matter. The development of a sound Medicare coverage and reimbursement strategy for OncoPrecise GXP-47 is a critical milestone for GDT, and we are committed to bringing the full resources of our Healthcare & Life Sciences practice to bear in support of your objectives. Please do not hesitate to contact me or Sean Morrissey at any time with questions.
Very truly yours,
CALDERWOOD & HARKNESS LLP
By: ________
Miriam Calloway, Partner Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP 1700 K Street NW, Suite 900 Washington, DC 20006 Telephone: (202) 554-8247
Email: miriam.calloway@calderwoodharkness.com
By: ________
Joel Strauss, Partner (Billing Partner) Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP 555 California Street, Suite 3200 San Francisco, CA 94104 Telephone: (415) 291-6330
Email: joel.strauss@calderwoodharkness.com
ACCEPTED AND AGREED
GENOME DX THERAPEUTICS INC.
By: ________
Name: Theresa Nakamura
Title: General Counsel & VP of Regulatory Affairs
Genome Dx Therapeutics Inc. 4720 Torrey Pines Road, Suite 300 San Diego, CA 92130
Date: February 14, 2024
Enclosures:
Exhibit A: Engagement Team Biographies (Calloway, Strauss, Morrissey, Aiken)
Exhibit B: Wire Transfer Payment Instructions
DC\1043-00002\ENGMT LETTER\v3 — 02/14/2024
Timekeeper | Position | Hourly Rate
Miriam Calloway | Partner | $1,350.00
Joel Strauss | Partner | $1,275.00
Sean Morrissey | Senior Associate | $875.00
Christopher Aiken | Associate | $650.00
Paralegals | — | $375.00

PRIVILEGED & CONFIDENTIAL — ATTORNEY-CLIENT COMMUNICATION

CALDERWOOD & HARKNESS LLP

ACCEPTED AND AGREED

GENOME DX THERAPEUTICS INC.

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