CALDERWOOD & HARKNESS LLP

CALDERWOOD & HARKNESS LLP
Attorneys at Law
375 Park Avenue, 30th Floor · New York, New York 10152
Washington, D.C. · San Francisco · Boston · London
INVOICE
Invoice No.: INV-1043-00002-003 Invoice Date: June 10, 2024
Payment Terms: Net 30 Days
FINAL INVOICE
Billed To
Genome Dx Therapeutics Inc.
Attn: Theresa Nakamura, General Counsel & VP of Regulatory Affairs
4720 Torrey Pines Road, Suite 300 San Diego, CA 92130
Matter Information
Billing offices for this matter: 1700 K Street NW, Suite 900, Washington, D.C. 20006 (Calloway) and 555 California Street, Suite 3200, San Francisco, CA 94104 (Strauss).
Summary of Current Charges
Professional Services Rendered
The following professional services were rendered during the billing period April 15, 2024 through June 3, 2024. Time entries have been consolidated by timekeeper. Detailed daily entries are available upon request.
Miriam Calloway, Partner — Healthcare & Life Sciences
Rate: $1,350.00 per hour
Joel Strauss, Partner — Healthcare & Life Sciences
Rate: $1,275.00 per hour
Sean Morrissey, Senior Associate — Healthcare & Life Sciences
Rate: $875.00 per hour
Christopher Aiken, Associate — Healthcare & Life Sciences
Rate: $650.00 per hour
Paralegal Services.  Rate: $375.00 per hour
Professional Fees Subtotal — This Period
Reconciliation note: Certain time reflected in the daily entries above spans work streams initiated in the immediately preceding billing period. The subtotal shown reflects only the portion allocable to the current billing period (April 15 – June 3, 2024) after reconciliation with amounts previously invoiced. Aggregate engagement totals appear in the Cumulative Engagement Summary below and reconcile in full to $218,437.50 in professional fees across the three invoices comprising this engagement.
Disbursements Detail
Billing Summary
Cumulative Engagement Summary (All Invoices)
Timekeeper Summary — Full Engagement
Note: 0.2 hours of associate time (C. Aiken) has been written off from the total 72.0 hours worked, resulting in 71.8 billed hours across the full engagement, in accordance with billing partner review.
Matter Status Notation
This is the final invoice for Matter No. 1043-00002 (Medicare Coverage and Coding Strategy — OncoPrecise GXP-47). The matter was formally closed effective June 3, 2024, following the resolution of the Genome Dx Therapeutics Inc. board of directors dated May 22, 2024 to defer the OncoPrecise GXP-47 commercial launch indefinitely and the client's subsequent wind-down instruction of May 23, 2024.
All work product has been delivered to the client or preserved in accordance with the Matter Wind-Down Memorandum dated May 28, 2024, and cataloged in the Work Product Index and Deliverables Tracker of the same date. Physical and electronic files have been transferred to the firm's long-term records retention system in accordance with the firm's document retention policy and the terms of the engagement letter dated February 14, 2024.
Should Genome Dx Therapeutics wish to reactivate the engagement or engage the firm on any related matter (including without limitation the potential covenant issue arising under Section 7.14 of the Pacific Coast National Bank Revolving Facility Credit Agreement, No. PCNB-GDT-RF-2023-0922), please contact:
Miriam Calloway, Partner Calderwood & Harkness LLP 1700 K Street NW, Suite 900 Washington, D.C. 20006 Direct: (202) 555-0184
Email: mcalloway@calderwoodharkness.com
Payment Instructions
Please make payment payable to Calderwood & Harkness LLP and reference Invoice No. INV-1043-00002-003 on all remittances.
Wire Transfer Instructions:
Beneficiary: Calderwood & Harkness LLP Operating Account Bank: Meridian Trust & Commerce Bank, N.A. Bank Address: 200 Vesey Street, New York, NY 10281 ABA Routing Number: 026009721 Account Number: 4471-882-3906 SWIFT (international): MTCBUS33 Reference: INV-1043-00002-003 / Client 47832
Check Payments:
Calderwood & Harkness LLP
Attn: Accounts Receivable
375 Park Avenue, 30th Floor New York, NY 10152
Federal Tax ID (EIN): 13-4218507
Please remit within thirty (30) days of the invoice date.
Interest on past-due balances accrues at 1.0% per month (12.0% per annum) from the date thirty (30) days following the invoice date, or the maximum rate permitted by applicable law, whichever is less. Questions regarding this invoice should be directed to Joel Strauss, Billing Partner, at Calderwood & Harkness LLP, 555 California Street, Suite 3200, San Francisco, CA 94104; direct (415) 555-0227; jstrauss@calderwoodharkness.com. This invoice and its contents are confidential and subject to attorney-client privilege and the work product doctrine. Retain for your records.
CALDERWOOD & HARKNESS LLP — CONFIDENTIAL
Client Number: | 47832
Matter Number: | 1043-00002
Matter Description: | Medicare Coverage and Coding Strategy — OncoPrecise GXP-47
Billing Partner: | Joel Strauss (San Francisco Office)
Responsible Partner: | Miriam Calloway (Washington, D.C. Office)
Billing Period: | April 15, 2024 – June 3, 2024 (Final)
Matter Status: | Closed effective June 3, 2024
Total Professional Fees for Period | $77,252.38
Total Disbursements for Period | $2,340.18
Total Current Charges | $79,592.56
Less: Payment Received (June 5, 2024) | ($6,000.00)
Balance Due | $73,592.56
Date | Description | Hours
04/15/2024 | Review and analysis of CLARITY-LUNG interim clinical validation data (PPV 0.68/NPV 0.71) and preliminary impact assessment on Local Coverage Determination filing strategy with Cascade Fiscal Intermediaries; internal conference with S. Morrissey regarding scope of Clinical Evidence Gap Analysis memorandum. | 2.4
04/16/2024 | Continued review and analysis of CLARITY-LUNG interim data; supervise preparation of Clinical Evidence Gap Analysis memorandum; teleconference with T. Nakamura regarding preliminary findings. | 1.8
04/17/2024 | Draft Revised LCD/MolDx Strategy Memorandum, including recommendation to defer LCD filing with Cascade Fiscal Intermediaries pending final CLARITY-LUNG trial data (anticipated Q2 2025). | 2.6
04/18/2024 | Continue drafting Revised LCD/MolDx Strategy Memorandum; research regarding precedent for deferred LCD submissions where analytical validation exceeds clinical validation performance thresholds. | 2.2
04/19/2024 | Revise Strategy Memorandum; conference call with T. Nakamura and K. Driscoll (Chief Medical Officer) regarding proposed board direction and timing of Physician Advisory Board (PHV) review. | 1.9
04/22/2024 | Finalize Revised LCD/MolDx Strategy Memorandum for transmittal; supervise associate work on MolDx Technical Assessment Dossier framework. | 1.5
04/23/2024 | Review draft MolDx Technical Assessment Dossier (Version 1.0); coordination call with Dr. N. Ostroff of Larkfield Health Economics regarding HEOR analysis integration into dossier. | 1.4
04/25/2024 | Continued review and mark-up of MolDx Technical Assessment Dossier draft; review Larkfield HEOR analysis work product for regulatory compliance and consistency with Ridgeline Administrative Services technical assessment expectations. | 1.7
04/29/2024 | Supervise revisions to MolDx Technical Assessment Dossier; conference with S. Morrissey regarding bibliography adequacy and clinical utility narrative. | 1.1
04/30/2024 | Coordination call with Larkfield Health Economics team; final review of integrated dossier draft. | 0.8
05/06/2024 | Draft NCD Feasibility Assessment Memorandum; analyze CMS Coverage with Evidence Development (CED) framework applicability to OncoPrecise GXP-47; assess traditional National Coverage Determination pathway. | 2.3
05/07/2024 | Continue drafting NCD Feasibility Assessment Memorandum; research regarding recent CED determinations in oncology molecular diagnostics; conference with J. Strauss regarding NCD strategy considerations. | 1.9
05/09/2024 | Revise NCD Feasibility Assessment Memorandum to incorporate J. Strauss comments; develop estimated 18–24 month NCD timeline analysis measured from prospective LCD issuance. | 1.4
05/10/2024 | Finalize NCD Feasibility Assessment Memorandum for transmittal to client. | 0.6
05/14/2024 | Review draft Reimbursement Rate Analysis Memorandum (crosswalk/gapfill analysis); mark-up comments to S. Morrissey. | 0.9
05/17/2024 | Monitor Physician Advisory Board formal recommendation (May 17, 2024) to defer commercial launch of OncoPrecise GXP-47; internal conference regarding potential engagement scope implications. | 0.7
05/20/2024 | Preparation for potential engagement wind-down contingent on GDT board action; internal review of open workstreams. | 0.8
05/22/2024 | Continued monitoring; brief T. Nakamura re: contingency planning. | 0.4
05/23/2024 | Conference call with T. Nakamura regarding GDT board resolution dated May 22, 2024 deferring OncoPrecise GXP-47 commercial launch indefinitely; receipt of formal wind-down instruction. | 1.1
05/24/2024 | Draft coordination email to Harrison Whitford, Esq. (Whitford & Sable LLP) regarding board decision and potential covenant issue arising under Section 7.14 of the Pacific Coast National Bank Revolving Facility Credit Agreement (PCNB-GDT-RF-2023-0922); initial analysis of coverage-determination covenant language. | 1.2
05/27/2024 | Draft Matter Wind-Down Memorandum; review Work Product Preservation Summary. | 1.6
05/28/2024 | Finalize Matter Wind-Down Memorandum, Work Product Preservation Summary, and PCNB Covenant Analysis Memorandum; analyze whether existing OncoPrecise GXP-12 LCD (LCD L38472, effective August 15, 2021, issued by CFI) satisfies covenant language requiring GDT to "obtain" a final Medicare coverage determination by December 31, 2024; transmittal of wind-down deliverables to T. Nakamura. | 2.4
05/29/2024 | Final review of work product index; administrative matter closure activities. | 0.7
05/31/2024 | Matter closing procedures; supervisory sign-off on final document assembly. | 0.5
06/03/2024 | Final matter closure supervision; execute matter closure certification. | 0.3
Total Hours (Calloway, this period): | 32.2
Total Fees: | $43,470.00
Date | Description | Hours
05/08/2024 | Collaboration with M. Calloway on NCD Feasibility Assessment Memorandum; analysis of CMS national coverage pathways and Coverage with Evidence Development framework applicability to OncoPrecise GXP-47. | 1.6
05/09/2024 | Continued review of NCD Feasibility Assessment Memorandum draft; mark-up and comments returned to M. Calloway. | 1.2
05/10/2024 | Final review of NCD Feasibility Assessment Memorandum. | 0.4
05/14/2024 | Review of Reimbursement Rate Analysis Memorandum; discussion with S. Morrissey regarding crosswalk methodology and gapfill alternative. | 0.9
05/28/2024 | Review of Matter Wind-Down Memorandum, Work Product Preservation Summary, and PCNB Covenant Analysis Memorandum. | 1.1
05/31/2024 | Final billing reconciliation; review of timekeeper detail for final invoice. | 0.9
06/03/2024 | Matter closure supervision; final sign-off. | 0.5
Total Hours (Strauss, this period): | 6.6
Total Fees: | $8,415.00
Date | Description | Hours
04/15/2024 | Draft Clinical Evidence Gap Analysis memorandum analyzing CLARITY-LUNG interim results (PPV = 0.68 vs. target ≥ 0.75; NPV = 0.71 vs. target ≥ 0.80); assessment of evidence gaps and risk of non-coverage determination by Cascade Fiscal Intermediaries. | 3.8
04/16/2024 | Continue drafting Clinical Evidence Gap Analysis memorandum; research precedent non-coverage determinations for molecular diagnostic tests with inconclusive clinical validation data. | 3.4
04/17/2024 | Finalize Clinical Evidence Gap Analysis memorandum for M. Calloway review; commence drafting Revised LCD/MolDx Strategy Memorandum. | 2.9
04/18/2024 | Draft Revised LCD/MolDx Strategy Memorandum sections regarding alternative timeline options for LCD filing with CFI and MolDx technical assessment submission to Ridgeline Administrative Services. | 3.6
04/19/2024 | Continue drafting Strategy Memorandum; research technical assessment submission requirements under MolDx program. | 2.7
04/22/2024 | Revise Strategy Memorandum per M. Calloway comments; incorporate additional precedent research. | 2.2
04/23/2024 | Commence drafting MolDx Technical Assessment Dossier (Version 1.0); test description and analytical validation sections. | 3.9
04/24/2024 | Continue drafting MolDx Technical Assessment Dossier; incorporate CLARITY-LUNG interim clinical validation data. | 3.5
04/25/2024 | Draft clinical utility evidence section of dossier; coordination with C. Aiken regarding bibliography compilation. | 3.1
04/26/2024 | Draft HEOR analysis integration section; incorporate Larkfield Health Economics work product. | 2.8
04/29/2024 | Revise dossier per M. Calloway comments; compile bibliography of 43 peer-reviewed publications. | 3.4
04/30/2024 | Finalize MolDx Technical Assessment Dossier (Version 1.0) for internal review; coordinate with Larkfield. | 2.6
05/01/2024 | Commence crosswalk comparator analysis; identify candidate comparator codes. | 2.9
05/02/2024 | Research and confirm Elara Genomic Sciences PLA Code 0250U ("GeneSight Onco-48," $3,742/test) as candidate comparator; analyze CPT Code 81455 (NGS solid organ neoplasm 51+ genes, $2,919/test). | 2.7
05/03/2024 | Confirm Marlowe Asset Management Molecular Diagnostics PLA Code 0239U ("TumorMap Pro," $4,206/test) as third comparator; calculate weighted average of $3,622.33 across comparator set. | 2.4
05/06/2024 | Draft email to K. Driscoll presenting preliminary crosswalk analysis; commence Reimbursement Rate Analysis Memorandum. | 2.8
05/07/2024 | Continue drafting Reimbursement Rate Analysis Memorandum; develop justification for target rate of $3,850/test representing 6.28% premium over weighted average, supported by proprietary Tumor Response Index (TRI) algorithm. | 3.2
05/08/2024 | Draft gapfill alternative analysis section of Reimbursement Rate Analysis Memorandum. | 3.0
05/13/2024 | Revise Reimbursement Rate Analysis Memorandum per M. Calloway and J. Strauss comments. | 2.6
05/14/2024 | Finalize Reimbursement Rate Analysis Memorandum. | 1.7
05/15/2024 | Review Larkfield Health Economics HEOR analysis work product; commence internal review memorandum. | 2.9
05/16/2024 | Continue review of Larkfield HEOR analysis; prepare mark-up recommendations. | 2.7
05/17/2024 | Finalize internal Larkfield review memorandum with mark-up recommendations. | 2.1
05/22/2024 | Commence drafting PCNB Covenant Analysis Memorandum; research covenant interpretation issue ("obtain" as prospective/future tense) vis-à-vis existing LCD L38472. | 3.3
05/23/2024 | Continue drafting PCNB Covenant Analysis Memorandum; analyze $9,200,000 outstanding draw under Revolving Facility and cure period expiring March 31, 2025. | 3.1
05/24/2024 | Finalize covenant analysis; commence Work Product Index and Deliverables Tracker. | 2.9
05/27/2024 | Assist M. Calloway with Matter Wind-Down Memorandum; continue Work Product Index compilation. | 2.6
05/28/2024 | Finalize Work Product Index and Deliverables Tracker; coordinate transmittal package. | 2.3
05/29/2024 | Final document assembly; work product preservation coordination with paralegal team. | 1.9
05/31/2024 | Final quality review; matter closure tasks. | 1.4
06/03/2024 | Final matter closure tasks; sign-off. | 0.6
Total Hours (Morrissey, this period): | 83.0
Total Fees: | $72,625.00
Date | Description | Hours
04/15–04/22/2024 | Research supporting Clinical Evidence Gap Analysis and Revised LCD/MolDx Strategy Memorandum; review of MolDx program technical assessment submission requirements and Ridgeline Administrative Services procedural guidance. | 5.4
04/23–04/30/2024 | Compile and annotate bibliography of 43 peer-reviewed publications for MolDx Technical Assessment Dossier; draft initial versions of test description and analytical validation summary sections of dossier. | 6.1
05/01–05/08/2024 | Supporting research for crosswalk comparator analysis; compile CMS Clinical Laboratory Fee Schedule data for Codes 0250U, 81455, and 0239U; prepare reimbursement rate crosswalk model (Excel workbook) for use in memorandum. | 4.8
05/09–05/14/2024 | Continued support on Reimbursement Rate Analysis Memorandum; verify pricing data and weighted-average calculation; prepare exhibits. | 3.2
05/15–05/22/2024 | Update project timeline tracker; assist with Larkfield HEOR review; commence organization of work product files for preservation. | 2.7
05/23–05/28/2024 | Assist with Work Product Index compilation; support drafting of covenant analysis exhibits; organize matter file for closure. | 3.6
05/29–06/03/2024 | Administrative matter closure tasks; final document organization; work product preservation logistics. | 2.0
Total Hours (Aiken, this period, before write-off): | 27.8
Less: Write-off (billing review adjustment) | (0.2)
Total Billed Hours (Aiken, this period): | 27.6
Total Fees: | $17,940.00
Date Range | Description | Hours
04/15–04/30/2024 | Document management; cite-checking of Clinical Evidence Gap Analysis, Revised LCD/MolDx Strategy Memorandum, and MolDx Technical Assessment Dossier; formatting of dossier and bibliography. | 3.2
05/01–05/17/2024 | Cite-checking Reimbursement Rate Analysis Memorandum, NCD Feasibility Assessment Memorandum, and Larkfield review memorandum; exhibit preparation. | 2.8
05/20–05/31/2024 | Preparation of Work Product Index; coordination of document preservation with records management; matter file organization for closure. | 3.4
06/01–06/03/2024 | Final matter file closure; work product preservation logistics; coordination with client for delivery. | 0.5
Total Paralegal Hours (this period): | 9.9
Total Fees: | $3,712.50
Timekeeper | Hours | Rate | Fees
M. Calloway, Partner | 32.2 | $1,350.00 | $43,470.00
J. Strauss, Partner | 6.6 | $1,275.00 | $8,415.00
S. Morrissey, Sr. Associate | 83.0 | $875.00 | $72,625.00
C. Aiken, Associate (billed) | 27.6 | $650.00 | $17,940.00
Paralegals | 9.9 | $375.00 | $3,712.50
Subtotal | 159.3 | $146,162.50
Less: Amounts previously billed on this period's timekeeper hours in Invoice No. INV-1043-00002-002 (partial-period allocation) and reconciliation adjustments | ($68,910.12)
Total Professional Fees — This Period | $77,252.38
Description | Amount
Westlaw — Online Legal Research (Medicare coverage law, MolDx program requirements, LCD/NCD regulatory analysis, CMS policy research, covenant interpretation research) | $1,875.50
Printing / Copying (reproduction of memoranda, MolDx Technical Assessment Dossier drafts, and wind-down deliverables for client delivery) | $214.68
Travel (local travel for client and consultant meetings; courier/shipping of work product) | $250.00
Total Disbursements | $2,340.18
Category | Amount
Professional Fees | $77,252.38
Disbursements | $2,340.18
Total Current Charges | $79,592.56
Payment Received (June 5, 2024) | ($6,000.00)
Balance Due | $73,592.56
Invoice No. | Billing Period | Amount | Status
INV-1043-00002-001 | Feb 14 – Mar 14, 2024 | $62,437.50 | PAID
INV-1043-00002-002 | Mar 15 – Apr 14, 2024 | $78,747.62 | PAID
INV-1043-00002-003 | Apr 15 – Jun 3, 2024 (Final) | $79,592.56 | $6,000.00 paid; $73,592.56 outstanding
Total Billed (All Invoices) | $220,777.68
Total Payments Received | $147,185.12
Total Outstanding | $73,592.56
Total Professional Fees (All Invoices) | $218,437.50
Total Disbursements (All Invoices) | $2,340.18
Total Billed (All Invoices) | $220,777.68
Timekeeper | Rate | Total Hours | Total Fees
Miriam Calloway, Partner | $1,350.00/hr | 42.5 | $57,375.00
Joel Strauss, Partner | $1,275.00/hr | 18.0 | $22,950.00
Sean Morrissey, Senior Associate | $875.00/hr | 98.5 | $86,187.50
Christopher Aiken, Associate (billed) | $650.00/hr | 71.8 | $46,670.00
Paralegals | $375.00/hr | 14.0 | $5,250.00
Write-off (Aiken, 0.2 hrs) | ($130.00)
Reconciliation adjustment | $5.00
Total Fees (Full Engagement) | 244.8 | $218,437.50