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CALDERWOOD & HARKNESS LLP

Attorneys at Law

375 Park Avenue, 30th Floor New York, NY 10152

Telephone: (212) 554-7800

Washington, DC Office 1700 K Street NW, Suite 900 Washington, DC 20006 Telephone: (202) 661-4400

San Francisco Office 555 California Street, Suite 3200 San Francisco, CA 94104 Telephone: (415) 732-9100

INVOICE

Bill To:

Theresa Nakamura General Counsel & Vice President of Regulatory Affairs Genome Dx Therapeutics Inc. 4720 Torrey Pines Road, Suite 300 San Diego, CA 92130 EIN: 83-2947156

Summary of Professional Services

During the billing period of March 15, 2024 through April 14, 2024, Calderwood & Harkness LLP rendered professional services to Genome Dx Therapeutics Inc. ("GDT") in connection with the Medicare coverage and coding strategy for OncoPrecise GXP-47. The principal areas of activity during this period included: (a) finalization and delivery to GDT of the draft Proprietary Laboratory Analyses ("PLA") code application for OncoPrecise GXP-47, which was transmitted to GDT on March 22, 2024; (b) coordination with Carraway Regulatory Advisors, Inc. (Janet Carraway) on PLA code application mechanics, AMA CPT Editorial Panel submission formatting requirements, and the June 28, 2024 submission deadline for the September 2024 CPT Editorial Panel meeting; (c) preparation and transmittal of the draft PLA cover letter for the AMA CPT Editorial Panel submission; (d) receipt and initial analysis of the CLARITY-LUNG interim analysis results released on March 29, 2024, which reflected a positive predictive value ("PPV") of 0.68 (against a target of ≥ 0.75) and a negative predictive value ("NPV") of 0.71 (against a target of ≥ 0.80); (e) preliminary assessment of the impact of the CLARITY-LUNG interim results on the planned local coverage determination ("LCD") filing timeline and MolDx technical assessment strategy, as communicated to Theresa Nakamura via email dated April 1, 2024; (f) commencement of preparation of the Clinical Evidence Gap Analysis memorandum (which was delivered on April 15, 2024, outside this billing period, but for which substantive research and drafting commenced during this period); (g) response to the GDT Board of Directors' April 9, 2024 request to reassess the LCD filing strategy in light of the interim clinical data, as communicated to Ms. Nakamura via email dated April 10, 2024; (h) commencement of the revised LCD/MolDx strategy analysis; (i) continued research on MolDx program requirements and the existing coverage landscape for next-generation sequencing ("NGS")-based oncology diagnostics; (j) coordination with Kevin Driscoll, Vice President of Market Access & Reimbursement at GDT, on reimbursement strategy inputs and projected reimbursement rate analysis; and (k) coordination with Dr. Priya Sundaram, Vice President of Clinical Development at GDT, on CLARITY-LUNG data interpretation and the revised timeline for final data readout following the Data Safety Monitoring Board ("DSMB") recommendation to continue enrollment.

Detailed Time Entries — Professional Services

Miriam Calloway, Partner

Hourly Rate: $1,350.00

Calloway Subtotal: 18.0 hours × $1,350.00 = $24,300.00

Joel Strauss, Partner

Hourly Rate: $1,275.00

Strauss Subtotal: 5.5 hours × $1,275.00 = $7,012.50

Sean Morrissey, Senior Associate

Hourly Rate: $875.00

Morrissey Subtotal: 35.2 hours × $875.00 = $30,800.00

Christopher Aiken, Associate

Hourly Rate: $650.00

Aiken Subtotal: 23.7 hours × $650.00 = $15,405.00

Paralegal Support. Hourly Rate: $375.00

Paralegal Subtotal: 3.0 hours × $375.00 = $1,125.00

Fee Summary

Disbursements / Costs

Invoice Total

Prior Billing Summary / Account Status

Payment Instructions

Payment may be made by wire transfer or check as set forth below.

Wire Transfer:

Please ensure that the invoice number, client number, and matter number are included in the wire transfer reference field to ensure proper credit to your account.

Payment by Check:

Checks should be made payable to Calderwood & Harkness LLP and mailed to:

Calderwood & Harkness LLP 375 Park Avenue, 30th Floor New York, NY 10152

Attn: Accounts Receivable

Please include a copy of this invoice or reference Invoice No. INV-1043-00002-002 with your remittance.

Payment is due within 30 days of the invoice date — i.e., by May 15, 2024.

TERMS AND CONDITIONS

Interest on overdue balances shall accrue at the rate of 1.5% per month (18% per annum), or the maximum rate permitted by applicable law, whichever is less, commencing on the thirty-first (31st) day following the invoice date.

Questions regarding this invoice should be directed to Joel Strauss, Billing Partner, at Calderwood & Harkness LLP, San Francisco Office, 555 California Street, Suite 3200, San Francisco, CA 94104; telephone (415) 732-9100; email jstrauss@calderwoodharkness.com.

This invoice is rendered for professional services and costs incurred in connection with the above-referenced matter and is subject to the terms and conditions set forth in the engagement letter between Calderwood & Harkness LLP and Genome Dx Therapeutics Inc. dated February 14, 2024.

CONFIDENTIALITY NOTICE: This invoice and all accompanying detail, including the description of services rendered, contain information that is subject to the attorney-client privilege, the work product doctrine, and/or other applicable protections. This invoice is intended solely for the use of the addressee. Any unauthorized review, use, disclosure, or distribution of this invoice or the information contained herein is strictly prohibited. If you have received this invoice in error, please contact Calderwood & Harkness LLP immediately and destroy all copies of this document.

Calderwood & Harkness LLP — New York	Washington, DC	San Francisco	London	Hong Kong
Invoice Number:	INV-1043-00002-002
Invoice Date:	April 15, 2024
Billing Period:	March 15, 2024 – April 14, 2024
Client Number:	47832
Matter Number:	1043-00002
Matter Description:	Genome Dx Therapeutics Inc. — Medicare Coverage & Coding Strategy — OncoPrecise GXP-47
Payment Terms:	Net 30 days from invoice date
Responsible Partner:	Miriam Calloway
Billing Partner:	Joel Strauss
Date	Hours	Description
03/15/2024	1.5	Review and comment on revised draft PLA code application for OncoPrecise GXP-47, including evaluation of descriptor language, specimen type specifications, and clinical indications section; conference call with S. Morrissey (0.4 hrs) regarding AMA CPT Editorial Panel submission timeline and June 28, 2024 deadline for September 2024 meeting; provide direction on remaining open items in application package.
03/18/2024	1.0	Review of C. Aiken email to Janet Carraway (Carraway Regulatory Advisors, Inc.) transmitting draft PLA code application for review and comment; telephone call with Theresa Nakamura (0.3 hrs) providing update on PLA application status, anticipated Carraway turnaround, and next steps for cover letter preparation; internal correspondence to team regarding Nakamura feedback on timeline.
03/20/2024	1.5	Review and revision of PLA code application incorporating feedback received from Janet Carraway on March 19; strategy discussion with J. Strauss (0.5 hrs) regarding crosswalk reimbursement positioning approach and comparative analysis of existing PLA code reimbursement rates for NGS-based oncology diagnostics; direction to S. Morrissey on cover letter revisions.
03/21/2024	1.3	Continued review and finalization of PLA code application and cover letter draft; review of S. Morrissey's revised descriptor language; correspondence with C. Aiken regarding document assembly and final formatting requirements for submission package to GDT.
03/22/2024	0.7	Final review of completed PLA code application package delivered to GDT; review of transmittal correspondence to T. Nakamura; confirmation of deliverable checklist items.
03/29/2024	1.5	Receipt and detailed review of CLARITY-LUNG Phase III pivotal trial interim analysis results (PPV = 0.68 vs. protocol-specified target of ≥ 0.75; NPV = 0.71 vs. target of ≥ 0.80); internal team discussion (0.6 hrs) with J. Strauss, S. Morrissey, and C. Aiken regarding implications of interim data shortfall for Medicare coverage strategy, LCD filing timeline, and MolDx technical assessment dossier; identification of key strategic considerations and direction to S. Morrissey to commence detailed impact analysis.
04/01/2024	1.5	Drafting and transmission of email to Theresa Nakamura providing preliminary assessment of CLARITY-LUNG interim results and their impact on LCD filing timeline and MolDx technical assessment strategy; review and revision of S. Morrissey's supporting analysis of evidence gaps; discussion of potential supplemental evidence strategies to address clinical validation shortfall.
04/03/2024	1.3	Research on precedent for LCD applications filed with inconclusive or interim clinical validation data; review of analogous MolDx technical assessments for molecular diagnostic assays where pivotal trial data did not meet pre-specified primary endpoints at interim analysis; analysis of MAC non-coverage determination precedents in molecular diagnostics space.
04/04/2024	1.0	Continued research and analysis of precedent LCD filings submitted with interim clinical trial data; review of Palmetto GBA MolDx program guidance documents regarding minimum evidentiary requirements for clinical validation; identification of risk factors for non-coverage determination.
04/05/2024	0.7	Review of DSMB meeting outcome and recommendation to continue enrollment in CLARITY-LUNG trial without modification; assessment of implications of DSMB recommendation for revised trial timeline and coverage strategy; correspondence with S. Morrissey regarding updated timeline projections.
04/09/2024	2.0	Preparation for and attendance at GDT Board of Directors meeting (1.5 hrs), including presentation on Medicare coverage strategy overview, impact of CLARITY-LUNG interim data on LCD filing timeline, projected reimbursement rate of $3,850 per test, and revenue projection analysis; follow-up discussion with T. Nakamura (0.3 hrs) regarding board's request to reassess LCD filing strategy and provide revised strategic options.
04/10/2024	0.8	Email to T. Nakamura acknowledging board request to reassess LCD filing strategy; scoping of revised analysis deliverable, including identification of key work streams, estimated timeline for delivery, and team resource allocation; internal direction to S. Morrissey and C. Aiken on revised analysis scope.
04/11/2024	1.0	Commencement of Clinical Evidence Gap Analysis memorandum; review and comment on S. Morrissey's preliminary outline and research compilation; supervision of research direction for analysis of supplemental evidence strategies including retrospective study data, sub-group analyses, and published real-world evidence.
04/12/2024	0.7	Continued supervision of Clinical Evidence Gap Analysis memorandum preparation; review of C. Aiken's research memorandum on Medicare coverage determination administrative law precedents; direction on revised LCD/MolDx strategy memorandum outline.

04/14/2024	0.5	Review of S. Morrissey and C. Aiken's draft sections of Clinical Evidence Gap Analysis memorandum; commentary and redline edits; outline of revised LCD/MolDx strategy memorandum.
Date	Hours	Description
03/19/2024	2.0	Conference call with M. Calloway (0.5 hrs) regarding crosswalk reimbursement positioning strategy for OncoPrecise GXP-47; review of PLA code application for FDA/CMS regulatory intersection considerations, including analysis of potential implications of FDA breakthrough device designation pathway on Medicare coverage timeline; review of comparator product crosswalk reimbursement data and assessment of competitive positioning for reimbursement rate determination.
03/27/2024	1.8	Review of GDT's published analytical validation data (Sundaram et al., Journal of Molecular Diagnostics, 2023) and assessment of its sufficiency for MolDx technical assessment dossier; analysis of analytical validation evidence standards under MolDx program requirements and comparison to existing precedent dossiers for NGS-based multi-gene panel tests; correspondence to M. Calloway and S. Morrissey with observations and recommendations.
04/09/2024	1.7	Review of board presentation materials prepared by S. Morrissey and M. Calloway; advisory input on coverage timeline presentation, including recommended characterization of risk factors and strategic alternatives; review of revenue projection assumptions and projected reimbursement rate analysis.
Date	Hours	Description
03/15/2024	2.5	Continued drafting of PLA code application sections, including test descriptor, specimen type, clinical indications, and methodology description; research on PLA code descriptor requirements under AMA CPT Editorial Panel submission guidelines; review and analysis of comparator PLA codes, including Elara Genomic Sciences 0250U (genomic classifier for prostate cancer prognosis) and Marlowe Asset Management Molecular Diagnostics 0239U (NGS-based tumor profiling panel), for descriptor formatting, clinical utility characterization, and submission structure.
03/16/2024	1.5	Continued drafting of PLA code application methodology section; research on PLA code numbering conventions and administrative requirements for new code applications; review of AMA CPT Editorial Panel meeting schedule and submission deadline requirements.
03/17/2024	1.0	Finalization of initial draft PLA code application sections; internal review and self-editing; preparation of draft for M. Calloway review; compilation of supporting reference documents for application package.
03/18/2024	1.0	Coordination with C. Aiken on PLA application transmittal to Carraway Regulatory Advisors, Inc.; review of transmittal email and attached application materials; discussion with C. Aiken regarding outstanding Carraway comments on prior draft and anticipated turnaround timeline.
03/19/2024	1.2	Review of Carraway Regulatory Advisors comments received on draft PLA code application; detailed analysis of suggested revisions to descriptor language and methodology section; preparation of summary of Carraway comments for M. Calloway review; conference call with M. Calloway regarding Carraway feedback and crosswalk strategy (0.4 hrs).
03/20/2024	1.5	Revisions to PLA code application based on M. Calloway's direction and Carraway feedback; revision of test descriptor language to address Carraway's comments regarding specificity of clinical indication description; drafting of revised methodology section incorporating updated analytical platform specifications.
03/21/2024	1.3	Continued revisions to PLA code application; revision of cover letter draft for AMA CPT Editorial Panel submission; coordination with C. Aiken on document formatting and assembly requirements.
03/22/2024	0.8	Finalization of PLA code application package for delivery to GDT; final review of all application components, including descriptor form, cover letter, and supporting documentation; coordination with paralegal staff on document assembly and delivery logistics.
03/25/2024	1.5	Continued compilation of bibliography for MolDx technical assessment dossier; identification and cataloguing of 43 publications relevant to clinical validity, clinical utility, and analytical validation of NGS-based oncology diagnostic assays; research on clinical utility evidence standards under MolDx program requirements.
03/26/2024	1.5	Continued bibliography compilation and annotation for MolDx dossier; review of MolDx technical assessment template and section-by-section identification of required evidence categories; analysis of evidentiary requirements for clinical validation section.
03/27/2024	1.2	Research on MolDx program clinical utility evidence standards; review of published MolDx technical assessments for comparator NGS-based oncology diagnostic products; analysis of evidence sufficiency determinations in prior technical assessments.
03/28/2024	1.0	Continued research on existing Medicare coverage landscape for NGS-based oncology diagnostics; review of current LCDs and National Coverage Determinations applicable to molecular diagnostic tests; identification of relevant coverage criteria and evidentiary thresholds.
03/29/2024	2.0	Detailed review and analysis of CLARITY-LUNG Phase III pivotal trial interim analysis results; preparation of internal memorandum summarizing key findings (PPV = 0.68 vs. target ≥ 0.75; NPV = 0.71 vs. target ≥ 0.80; statistical significance not achieved for primary endpoint at interim analysis); participation in internal team discussion with M. Calloway, J. Strauss, and C. Aiken (0.6 hrs) regarding implications for coverage strategy.
03/30/2024	1.0	Continued analysis of CLARITY-LUNG interim results; identification of specific evidence gaps created by interim data shortfall relative to pre-specified clinical validation endpoints; preparation of preliminary evidence gap summary for M. Calloway review.
03/31/2024	0.8	Finalization of preliminary evidence gap summary; research on statistical methodologies for interim analysis interpretation and implications for final data readout projections.
04/01/2024	1.5	Preparation of supporting analysis for M. Calloway's email to T. Nakamura regarding CLARITY-LUNG interim results impact on LCD filing timeline and MolDx technical assessment strategy; research on supplemental evidence strategies including potential use of retrospective study data and published sub-group analyses to address clinical validation shortfall.
04/02/2024	1.3	Research on supplemental evidence strategies, including review of retrospective clinical data from GDT's single-center experience at Memorial Sloan Kettering Cancer Center and multi-site retrospective cohort study published in Clinical Cancer Research; analysis of evidentiary weight of retrospective data in MolDx technical assessments.
04/03/2024	1.2	Review of analogous MolDx technical assessments where interim clinical trial data was submitted in support of coverage applications; identification of three precedent cases involving molecular diagnostic assays with incomplete pivotal trial data at time of LCD application; analysis of MolDx program response to interim data submissions.
04/04/2024	1.0	Analysis of DSMB recommendation to continue CLARITY-LUNG enrollment without protocol modification; assessment of revised trial timeline (final data readout revised from Q4 2024 to Q2 2025) and implications for LCD filing strategy; preparation of timeline analysis memorandum for M. Calloway.

04/05/2024	0.8	Continued analysis of revised CLARITY-LUNG timeline and coverage strategy implications; research on MolDx program procedures for LCD reconsideration following receipt of updated clinical data; analysis of strategic options for phased LCD filing approach.
04/08/2024	2.0	Preparation of slides for GDT Board of Directors presentation, including: Medicare coverage strategy overview slides; CLARITY-LUNG interim data impact analysis summary; projected reimbursement rate analysis ($3,850/test based on crosswalk to comparable PLA codes); revenue projection slides incorporating coverage timeline scenarios.
04/09/2024	1.5	Finalization of board presentation materials; preparation of backup data slides and appendix materials; review of presentation with M. Calloway prior to board meeting; attendance at board presentation in advisory capacity.
04/10/2024	1.0	Follow-up from GDT board meeting; preparation of revised analysis scope memorandum in response to board's request to reassess LCD filing strategy; identification of key analytical work streams for revised strategy analysis; coordination with M. Calloway on deliverable timeline.
04/11/2024	1.3	Commencement of detailed drafting of Clinical Evidence Gap Analysis memorandum; preparation of memorandum outline and section-by-section analysis framework; research on risk of non-coverage determination if LCD application filed with current interim clinical validation data.
04/12/2024	1.2	Continued drafting of Clinical Evidence Gap Analysis memorandum; analysis of CFI and Ridgeline Diagnostics, Inc. precedent decisions for molecular diagnostic tests where LCD applications were filed with incomplete clinical validation data; assessment of applicability of precedent to OncoPrecise GXP-47 coverage strategy.
04/13/2024	0.8	Continued research and drafting for Clinical Evidence Gap Analysis memorandum; review of Ridgeline Diagnostics, Inc. non-coverage determination and analysis of distinguishing factors relative to OncoPrecise GXP-47.
04/14/2024	0.8	Supervision of C. Aiken research supporting Clinical Evidence Gap Analysis memorandum; review and editing of C. Aiken draft sections; integration of research findings into memorandum draft; preparation of revised LCD/MolDx strategy memorandum outline for M. Calloway review.
Date	Hours	Description
03/15/2024	1.5	Drafting PLA code descriptor language for OncoPrecise GXP-47, including clinical indication specification, specimen type description, and methodology characterization; research on AMA CPT Editorial Panel submission requirements, including format specifications, required attachments, and administrative prerequisites.
03/16/2024	1.2	Continued research on AMA CPT Editorial Panel submission requirements; analysis of September 2024 CPT Editorial Panel meeting agenda and confirmation of June 28, 2024 submission deadline; review of prior PLA code application submissions for formatting precedent.
03/17/2024	1.0	Finalization of draft PLA code descriptor language; compilation of supporting documentation for PLA application package; coordination with paralegal staff on document formatting requirements.
03/18/2024	1.3	Preparation and transmission of email to Janet Carraway (Carraway Regulatory Advisors, Inc.) transmitting draft PLA code application for review and comment; preparation of cover memorandum summarizing outstanding issues and areas where Carraway guidance was specifically requested; coordination on coding mechanics and PLA code numbering procedures.
03/19/2024	1.2	Receipt and initial review of Carraway feedback on draft PLA application; preparation of summary of Carraway comments for S. Morrissey and M. Calloway review; analysis of Carraway's recommended revisions to descriptor language regarding clinical utility characterization.
03/20/2024	1.3	Incorporating Carraway feedback into draft PLA application under M. Calloway's direction; revision of descriptor language and methodology section; drafting initial version of PLA code application cover letter for AMA CPT Editorial Panel submission.
03/21/2024	1.0	Continued revision of PLA code application cover letter; coordination with S. Morrissey on cover letter content and formatting; review of application package completeness against AMA CPT Editorial Panel submission checklist.
03/22/2024	0.5	Final formatting and assembly review of PLA code application package for delivery to GDT; coordination with paralegal staff on document delivery logistics; confirmation of deliverable checklist completion.
03/25/2024	1.5	Research on MolDx technical assessment submission requirements, including review of Palmetto GBA MolDx program website, published guidance documents, and technical assessment template; compilation of supporting documentation for MolDx dossier.
03/26/2024	1.3	Continued research on MolDx submission requirements; bibliography research for MolDx technical assessment dossier; identification of publications supporting analytical validation, clinical validation, and clinical utility of OncoPrecise GXP-47.
03/27/2024	1.0	Continued bibliography research; review and annotation of identified publications for relevance to MolDx technical assessment evidence categories; coordination with S. Morrissey on bibliography organization and annotation format.
03/28/2024	1.0	Finalization of bibliography compilation for current period; research on existing Medicare coverage landscape for NGS-based oncology diagnostics; review of published LCDs for comparable molecular diagnostic products.
03/29/2024	1.2	Research on CLARITY-LUNG interim data statistical significance, including review of interim analysis statistical methodology and comparison to pre-specified stopping rules; participation in internal team discussion (0.6 hrs) regarding interim data implications.
04/01/2024	1.0	Continued research on CLARITY-LUNG interim analysis; review of comparable interim analyses for other molecular diagnostic tests in MolDx program, including identification of precedent cases where interim clinical trial data was available at time of MolDx technical assessment submission.
04/02/2024	1.0	Research on comparable MolDx technical assessments; analysis of evidentiary standards applied in technical assessments for molecular diagnostic products with interim clinical validation data; preparation of research summary for S. Morrissey.
04/03/2024	1.2	Research supporting Clinical Evidence Gap Analysis memorandum; Westlaw research on Medicare coverage determination case studies, including analysis of CMS administrative law precedents governing LCD promulgation and non-coverage determinations for molecular diagnostic tests.

04/04/2024	1.0	Continued Westlaw research on Medicare coverage determination administrative law precedents; review of ALJ decisions and Departmental Appeals Board rulings relevant to molecular diagnostic test coverage disputes; preparation of research memorandum for M. Calloway.
04/08/2024	1.0	Research and data compilation supporting GDT Board of Directors presentation; preparation of supporting data tables for revenue projection slides and coverage timeline scenario analysis.
04/09/2024	0.5	Assisting with board presentation preparation; finalization of appendix materials and backup data slides; coordination with S. Morrissey on presentation logistics.
04/10/2024	1.0	Research on supplemental evidence strategies to address CLARITY-LUNG clinical validation data shortfall; review of published literature on use of real-world evidence and retrospective study data in Medicare coverage determinations for molecular diagnostics.
04/11/2024	1.0	Drafting of sections of Clinical Evidence Gap Analysis memorandum under S. Morrissey supervision, including section on existing published evidence base and analysis of evidentiary gaps relative to MolDx technical assessment requirements.
04/12/2024	0.8	Continued drafting of Clinical Evidence Gap Analysis memorandum sections; research on CFI precedent decisions for molecular diagnostic test coverage determinations.
04/14/2024	0.7	Continued drafting and research for Clinical Evidence Gap Analysis memorandum; preparation of appendix summarizing Ridgeline Diagnostics, Inc. and CFI precedent decisions; submission of draft sections to S. Morrissey for review.
Date	Hours	Description
03/18/2024	0.5	Document formatting for PLA code application package, including formatting of descriptor form, cover letter, and supporting attachments in accordance with AMA CPT Editorial Panel submission specifications.
03/20/2024	0.5	Continued document formatting and assembly of PLA code application package; cite-checking of references and supporting documentation included in application materials.
03/22/2024	0.5	Finalization of PLA code application document assembly; coordination of document delivery to GDT via secure file transfer; confirmation of receipt by T. Nakamura's office.
04/08/2024	0.5	Formatting of GDT Board of Directors presentation slides; document organization for CLARITY-LUNG interim data analysis materials; preparation of presentation handout packages.
04/09/2024	0.3	Final formatting revisions to board presentation materials; preparation of supplemental appendix documents for board meeting.
04/11/2024	0.3	Research assistance for Clinical Evidence Gap Analysis memorandum; compilation of source documents and published MolDx technical assessments for attorney review.
04/14/2024	0.4	Bibliography formatting for Clinical Evidence Gap Analysis memorandum; cite-checking of references cited in memorandum draft sections; document organization for working file.
Timekeeper	Title	Rate ($/hr)	Hours	Amount
Miriam Calloway	Partner	$1,350.00	18.0	$24,300.00
Joel Strauss	Partner	$1,275.00	5.5	$7,012.50
Sean Morrissey	Senior Associate	$875.00	35.2	$30,800.00
Christopher Aiken	Associate	$650.00	23.7	$15,405.00
Paralegal Staff	—	$375.00	3.0	$1,125.00
Total Professional Fees	85.4	$78,642.50
Description	Amount
Westlaw / Online Legal Research (March 15 – April 14, 2024)	$72.62
Printing and Document Reproduction	$32.50

Total Disbursements	$105.12
Item	Amount
Professional Fees	$78,642.50
Disbursements / Costs	$105.12
Total Due This Invoice	$78,747.62
Invoice No.	Billing Period	Amount	Status
INV-1043-00002-001	February 14, 2024 – March 14, 2024	$62,437.50	Paid — received 04/08/2024
INV-1043-00002-002	March 15, 2024 – April 14, 2024	$78,747.62	Current — Due May 15, 2024
Total Billed to Date	$141,185.12
Payments Received to Date	$62,437.50
Outstanding Balance	$78,747.62
Bank Name:	Greaves Bancorp
Bank Address:	270 Park Avenue, New York, NY 10017
ABA Routing Number:	021000021
Account Name:	Calderwood & Harkness LLP — Operating Account
Account Number:	8834-7291-0056
SWIFT Code:	CHASUS33
Reference:	Invoice No. INV-1043-00002-002 / Client No. 47832 / Matter No. 1043-00002

CALDERWOOD & HARKNESS LLP
Attorneys at Law
375 Park Avenue, 30th Floor New York, NY 10152
Telephone: (212) 554-7800 | Facsimile: (212) 554-7801 www.calderwoodharkness.com
Washington, DC Office 1700 K Street NW, Suite 900 Washington, DC 20006 Telephone: (202) 661-4400
San Francisco Office 555 California Street, Suite 3200 San Francisco, CA 94104 Telephone: (415) 732-9100
INVOICE
Bill To:
Theresa Nakamura General Counsel & Vice President of Regulatory Affairs Genome Dx Therapeutics Inc. 4720 Torrey Pines Road, Suite 300 San Diego, CA 92130 EIN: 83-2947156
Summary of Professional Services
During the billing period of March 15, 2024 through April 14, 2024, Calderwood & Harkness LLP rendered professional services to Genome Dx Therapeutics Inc. ("GDT") in connection with the Medicare coverage and coding strategy for OncoPrecise GXP-47. The principal areas of activity during this period included: (a) finalization and delivery to GDT of the draft Proprietary Laboratory Analyses ("PLA") code application for OncoPrecise GXP-47, which was transmitted to GDT on March 22, 2024; (b) coordination with Carraway Regulatory Advisors, Inc. (Janet Carraway) on PLA code application mechanics, AMA CPT Editorial Panel submission formatting requirements, and the June 28, 2024 submission deadline for the September 2024 CPT Editorial Panel meeting; (c) preparation and transmittal of the draft PLA cover letter for the AMA CPT Editorial Panel submission; (d) receipt and initial analysis of the CLARITY-LUNG interim analysis results released on March 29, 2024, which reflected a positive predictive value ("PPV") of 0.68 (against a target of ≥ 0.75) and a negative predictive value ("NPV") of 0.71 (against a target of ≥ 0.80); (e) preliminary assessment of the impact of the CLARITY-LUNG interim results on the planned local coverage determination ("LCD") filing timeline and MolDx technical assessment strategy, as communicated to Theresa Nakamura via email dated April 1, 2024; (f) commencement of preparation of the Clinical Evidence Gap Analysis memorandum (which was delivered on April 15, 2024, outside this billing period, but for which substantive research and drafting commenced during this period); (g) response to the GDT Board of Directors' April 9, 2024 request to reassess the LCD filing strategy in light of the interim clinical data, as communicated to Ms. Nakamura via email dated April 10, 2024; (h) commencement of the revised LCD/MolDx strategy analysis; (i) continued research on MolDx program requirements and the existing coverage landscape for next-generation sequencing ("NGS")-based oncology diagnostics; (j) coordination with Kevin Driscoll, Vice President of Market Access & Reimbursement at GDT, on reimbursement strategy inputs and projected reimbursement rate analysis; and (k) coordination with Dr. Priya Sundaram, Vice President of Clinical Development at GDT, on CLARITY-LUNG data interpretation and the revised timeline for final data readout following the Data Safety Monitoring Board ("DSMB") recommendation to continue enrollment.
Detailed Time Entries — Professional Services
Miriam Calloway, Partner
Hourly Rate: $1,350.00
Calloway Subtotal: 18.0 hours × $1,350.00 = $24,300.00
Joel Strauss, Partner
Hourly Rate: $1,275.00
Strauss Subtotal: 5.5 hours × $1,275.00 = $7,012.50
Sean Morrissey, Senior Associate
Hourly Rate: $875.00
Morrissey Subtotal: 35.2 hours × $875.00 = $30,800.00
Christopher Aiken, Associate
Hourly Rate: $650.00
Aiken Subtotal: 23.7 hours × $650.00 = $15,405.00
Paralegal Support.  Hourly Rate: $375.00
Paralegal Subtotal: 3.0 hours × $375.00 = $1,125.00
Fee Summary
Disbursements / Costs
Invoice Total
Prior Billing Summary / Account Status
Payment Instructions
Payment may be made by wire transfer or check as set forth below.
Wire Transfer:
Please ensure that the invoice number, client number, and matter number are included in the wire transfer reference field to ensure proper credit to your account.
Payment by Check:
Checks should be made payable to Calderwood & Harkness LLP and mailed to:
Calderwood & Harkness LLP 375 Park Avenue, 30th Floor New York, NY 10152
Attn: Accounts Receivable
Please include a copy of this invoice or reference Invoice No. INV-1043-00002-002 with your remittance.
Payment is due within 30 days of the invoice date — i.e., by May 15, 2024.
TERMS AND CONDITIONS
Interest on overdue balances shall accrue at the rate of 1.5% per month (18% per annum), or the maximum rate permitted by applicable law, whichever is less, commencing on the thirty-first (31st) day following the invoice date.
Questions regarding this invoice should be directed to Joel Strauss, Billing Partner, at Calderwood & Harkness LLP, San Francisco Office, 555 California Street, Suite 3200, San Francisco, CA 94104; telephone (415) 732-9100; email jstrauss@calderwoodharkness.com.
This invoice is rendered for professional services and costs incurred in connection with the above-referenced matter and is subject to the terms and conditions set forth in the engagement letter between Calderwood & Harkness LLP and Genome Dx Therapeutics Inc. dated February 14, 2024.
CONFIDENTIALITY NOTICE: This invoice and all accompanying detail, including the description of services rendered, contain information that is subject to the attorney-client privilege, the work product doctrine, and/or other applicable protections. This invoice is intended solely for the use of the addressee. Any unauthorized review, use, disclosure, or distribution of this invoice or the information contained herein is strictly prohibited. If you have received this invoice in error, please contact Calderwood & Harkness LLP immediately and destroy all copies of this document.
Calderwood & Harkness LLP — New York | Washington, DC | San Francisco | London | Hong Kong
Invoice Number: | INV-1043-00002-002
Invoice Date: | April 15, 2024
Billing Period: | March 15, 2024 – April 14, 2024
Client Number: | 47832
Matter Number: | 1043-00002
Matter Description: | Genome Dx Therapeutics Inc. — Medicare Coverage & Coding Strategy — OncoPrecise GXP-47
Payment Terms: | Net 30 days from invoice date
Responsible Partner: | Miriam Calloway
Billing Partner: | Joel Strauss
Date | Hours | Description
03/15/2024 | 1.5 | Review and comment on revised draft PLA code application for OncoPrecise GXP-47, including evaluation of descriptor language, specimen type specifications, and clinical indications section; conference call with S. Morrissey (0.4 hrs) regarding AMA CPT Editorial Panel submission timeline and June 28, 2024 deadline for September 2024 meeting; provide direction on remaining open items in application package.
03/18/2024 | 1.0 | Review of C. Aiken email to Janet Carraway (Carraway Regulatory Advisors, Inc.) transmitting draft PLA code application for review and comment; telephone call with Theresa Nakamura (0.3 hrs) providing update on PLA application status, anticipated Carraway turnaround, and next steps for cover letter preparation; internal correspondence to team regarding Nakamura feedback on timeline.
03/20/2024 | 1.5 | Review and revision of PLA code application incorporating feedback received from Janet Carraway on March 19; strategy discussion with J. Strauss (0.5 hrs) regarding crosswalk reimbursement positioning approach and comparative analysis of existing PLA code reimbursement rates for NGS-based oncology diagnostics; direction to S. Morrissey on cover letter revisions.
03/21/2024 | 1.3 | Continued review and finalization of PLA code application and cover letter draft; review of S. Morrissey's revised descriptor language; correspondence with C. Aiken regarding document assembly and final formatting requirements for submission package to GDT.
03/22/2024 | 0.7 | Final review of completed PLA code application package delivered to GDT; review of transmittal correspondence to T. Nakamura; confirmation of deliverable checklist items.
03/29/2024 | 1.5 | Receipt and detailed review of CLARITY-LUNG Phase III pivotal trial interim analysis results (PPV = 0.68 vs. protocol-specified target of ≥ 0.75; NPV = 0.71 vs. target of ≥ 0.80); internal team discussion (0.6 hrs) with J. Strauss, S. Morrissey, and C. Aiken regarding implications of interim data shortfall for Medicare coverage strategy, LCD filing timeline, and MolDx technical assessment dossier; identification of key strategic considerations and direction to S. Morrissey to commence detailed impact analysis.
04/01/2024 | 1.5 | Drafting and transmission of email to Theresa Nakamura providing preliminary assessment of CLARITY-LUNG interim results and their impact on LCD filing timeline and MolDx technical assessment strategy; review and revision of S. Morrissey's supporting analysis of evidence gaps; discussion of potential supplemental evidence strategies to address clinical validation shortfall.
04/03/2024 | 1.3 | Research on precedent for LCD applications filed with inconclusive or interim clinical validation data; review of analogous MolDx technical assessments for molecular diagnostic assays where pivotal trial data did not meet pre-specified primary endpoints at interim analysis; analysis of MAC non-coverage determination precedents in molecular diagnostics space.
04/04/2024 | 1.0 | Continued research and analysis of precedent LCD filings submitted with interim clinical trial data; review of Palmetto GBA MolDx program guidance documents regarding minimum evidentiary requirements for clinical validation; identification of risk factors for non-coverage determination.
04/05/2024 | 0.7 | Review of DSMB meeting outcome and recommendation to continue enrollment in CLARITY-LUNG trial without modification; assessment of implications of DSMB recommendation for revised trial timeline and coverage strategy; correspondence with S. Morrissey regarding updated timeline projections.
04/09/2024 | 2.0 | Preparation for and attendance at GDT Board of Directors meeting (1.5 hrs), including presentation on Medicare coverage strategy overview, impact of CLARITY-LUNG interim data on LCD filing timeline, projected reimbursement rate of $3,850 per test, and revenue projection analysis; follow-up discussion with T. Nakamura (0.3 hrs) regarding board's request to reassess LCD filing strategy and provide revised strategic options.
04/10/2024 | 0.8 | Email to T. Nakamura acknowledging board request to reassess LCD filing strategy; scoping of revised analysis deliverable, including identification of key work streams, estimated timeline for delivery, and team resource allocation; internal direction to S. Morrissey and C. Aiken on revised analysis scope.
04/11/2024 | 1.0 | Commencement of Clinical Evidence Gap Analysis memorandum; review and comment on S. Morrissey's preliminary outline and research compilation; supervision of research direction for analysis of supplemental evidence strategies including retrospective study data, sub-group analyses, and published real-world evidence.
04/12/2024 | 0.7 | Continued supervision of Clinical Evidence Gap Analysis memorandum preparation; review of C. Aiken's research memorandum on Medicare coverage determination administrative law precedents; direction on revised LCD/MolDx strategy memorandum outline.
04/14/2024 | 0.5 | Review of S. Morrissey and C. Aiken's draft sections of Clinical Evidence Gap Analysis memorandum; commentary and redline edits; outline of revised LCD/MolDx strategy memorandum.
Date | Hours | Description
03/19/2024 | 2.0 | Conference call with M. Calloway (0.5 hrs) regarding crosswalk reimbursement positioning strategy for OncoPrecise GXP-47; review of PLA code application for FDA/CMS regulatory intersection considerations, including analysis of potential implications of FDA breakthrough device designation pathway on Medicare coverage timeline; review of comparator product crosswalk reimbursement data and assessment of competitive positioning for reimbursement rate determination.
03/27/2024 | 1.8 | Review of GDT's published analytical validation data (Sundaram et al., Journal of Molecular Diagnostics, 2023) and assessment of its sufficiency for MolDx technical assessment dossier; analysis of analytical validation evidence standards under MolDx program requirements and comparison to existing precedent dossiers for NGS-based multi-gene panel tests; correspondence to M. Calloway and S. Morrissey with observations and recommendations.
04/09/2024 | 1.7 | Review of board presentation materials prepared by S. Morrissey and M. Calloway; advisory input on coverage timeline presentation, including recommended characterization of risk factors and strategic alternatives; review of revenue projection assumptions and projected reimbursement rate analysis.
Date | Hours | Description
03/15/2024 | 2.5 | Continued drafting of PLA code application sections, including test descriptor, specimen type, clinical indications, and methodology description; research on PLA code descriptor requirements under AMA CPT Editorial Panel submission guidelines; review and analysis of comparator PLA codes, including Elara Genomic Sciences 0250U (genomic classifier for prostate cancer prognosis) and Marlowe Asset Management Molecular Diagnostics 0239U (NGS-based tumor profiling panel), for descriptor formatting, clinical utility characterization, and submission structure.
03/16/2024 | 1.5 | Continued drafting of PLA code application methodology section; research on PLA code numbering conventions and administrative requirements for new code applications; review of AMA CPT Editorial Panel meeting schedule and submission deadline requirements.
03/17/2024 | 1.0 | Finalization of initial draft PLA code application sections; internal review and self-editing; preparation of draft for M. Calloway review; compilation of supporting reference documents for application package.
03/18/2024 | 1.0 | Coordination with C. Aiken on PLA application transmittal to Carraway Regulatory Advisors, Inc.; review of transmittal email and attached application materials; discussion with C. Aiken regarding outstanding Carraway comments on prior draft and anticipated turnaround timeline.
03/19/2024 | 1.2 | Review of Carraway Regulatory Advisors comments received on draft PLA code application; detailed analysis of suggested revisions to descriptor language and methodology section; preparation of summary of Carraway comments for M. Calloway review; conference call with M. Calloway regarding Carraway feedback and crosswalk strategy (0.4 hrs).
03/20/2024 | 1.5 | Revisions to PLA code application based on M. Calloway's direction and Carraway feedback; revision of test descriptor language to address Carraway's comments regarding specificity of clinical indication description; drafting of revised methodology section incorporating updated analytical platform specifications.
03/21/2024 | 1.3 | Continued revisions to PLA code application; revision of cover letter draft for AMA CPT Editorial Panel submission; coordination with C. Aiken on document formatting and assembly requirements.
03/22/2024 | 0.8 | Finalization of PLA code application package for delivery to GDT; final review of all application components, including descriptor form, cover letter, and supporting documentation; coordination with paralegal staff on document assembly and delivery logistics.
03/25/2024 | 1.5 | Continued compilation of bibliography for MolDx technical assessment dossier; identification and cataloguing of 43 publications relevant to clinical validity, clinical utility, and analytical validation of NGS-based oncology diagnostic assays; research on clinical utility evidence standards under MolDx program requirements.
03/26/2024 | 1.5 | Continued bibliography compilation and annotation for MolDx dossier; review of MolDx technical assessment template and section-by-section identification of required evidence categories; analysis of evidentiary requirements for clinical validation section.
03/27/2024 | 1.2 | Research on MolDx program clinical utility evidence standards; review of published MolDx technical assessments for comparator NGS-based oncology diagnostic products; analysis of evidence sufficiency determinations in prior technical assessments.
03/28/2024 | 1.0 | Continued research on existing Medicare coverage landscape for NGS-based oncology diagnostics; review of current LCDs and National Coverage Determinations applicable to molecular diagnostic tests; identification of relevant coverage criteria and evidentiary thresholds.
03/29/2024 | 2.0 | Detailed review and analysis of CLARITY-LUNG Phase III pivotal trial interim analysis results; preparation of internal memorandum summarizing key findings (PPV = 0.68 vs. target ≥ 0.75; NPV = 0.71 vs. target ≥ 0.80; statistical significance not achieved for primary endpoint at interim analysis); participation in internal team discussion with M. Calloway, J. Strauss, and C. Aiken (0.6 hrs) regarding implications for coverage strategy.
03/30/2024 | 1.0 | Continued analysis of CLARITY-LUNG interim results; identification of specific evidence gaps created by interim data shortfall relative to pre-specified clinical validation endpoints; preparation of preliminary evidence gap summary for M. Calloway review.
03/31/2024 | 0.8 | Finalization of preliminary evidence gap summary; research on statistical methodologies for interim analysis interpretation and implications for final data readout projections.
04/01/2024 | 1.5 | Preparation of supporting analysis for M. Calloway's email to T. Nakamura regarding CLARITY-LUNG interim results impact on LCD filing timeline and MolDx technical assessment strategy; research on supplemental evidence strategies including potential use of retrospective study data and published sub-group analyses to address clinical validation shortfall.
04/02/2024 | 1.3 | Research on supplemental evidence strategies, including review of retrospective clinical data from GDT's single-center experience at Memorial Sloan Kettering Cancer Center and multi-site retrospective cohort study published in Clinical Cancer Research; analysis of evidentiary weight of retrospective data in MolDx technical assessments.
04/03/2024 | 1.2 | Review of analogous MolDx technical assessments where interim clinical trial data was submitted in support of coverage applications; identification of three precedent cases involving molecular diagnostic assays with incomplete pivotal trial data at time of LCD application; analysis of MolDx program response to interim data submissions.
04/04/2024 | 1.0 | Analysis of DSMB recommendation to continue CLARITY-LUNG enrollment without protocol modification; assessment of revised trial timeline (final data readout revised from Q4 2024 to Q2 2025) and implications for LCD filing strategy; preparation of timeline analysis memorandum for M. Calloway.
04/05/2024 | 0.8 | Continued analysis of revised CLARITY-LUNG timeline and coverage strategy implications; research on MolDx program procedures for LCD reconsideration following receipt of updated clinical data; analysis of strategic options for phased LCD filing approach.
04/08/2024 | 2.0 | Preparation of slides for GDT Board of Directors presentation, including: Medicare coverage strategy overview slides; CLARITY-LUNG interim data impact analysis summary; projected reimbursement rate analysis ($3,850/test based on crosswalk to comparable PLA codes); revenue projection slides incorporating coverage timeline scenarios.
04/09/2024 | 1.5 | Finalization of board presentation materials; preparation of backup data slides and appendix materials; review of presentation with M. Calloway prior to board meeting; attendance at board presentation in advisory capacity.
04/10/2024 | 1.0 | Follow-up from GDT board meeting; preparation of revised analysis scope memorandum in response to board's request to reassess LCD filing strategy; identification of key analytical work streams for revised strategy analysis; coordination with M. Calloway on deliverable timeline.
04/11/2024 | 1.3 | Commencement of detailed drafting of Clinical Evidence Gap Analysis memorandum; preparation of memorandum outline and section-by-section analysis framework; research on risk of non-coverage determination if LCD application filed with current interim clinical validation data.
04/12/2024 | 1.2 | Continued drafting of Clinical Evidence Gap Analysis memorandum; analysis of CFI and Ridgeline Diagnostics, Inc. precedent decisions for molecular diagnostic tests where LCD applications were filed with incomplete clinical validation data; assessment of applicability of precedent to OncoPrecise GXP-47 coverage strategy.
04/13/2024 | 0.8 | Continued research and drafting for Clinical Evidence Gap Analysis memorandum; review of Ridgeline Diagnostics, Inc. non-coverage determination and analysis of distinguishing factors relative to OncoPrecise GXP-47.
04/14/2024 | 0.8 | Supervision of C. Aiken research supporting Clinical Evidence Gap Analysis memorandum; review and editing of C. Aiken draft sections; integration of research findings into memorandum draft; preparation of revised LCD/MolDx strategy memorandum outline for M. Calloway review.
Date | Hours | Description
03/15/2024 | 1.5 | Drafting PLA code descriptor language for OncoPrecise GXP-47, including clinical indication specification, specimen type description, and methodology characterization; research on AMA CPT Editorial Panel submission requirements, including format specifications, required attachments, and administrative prerequisites.
03/16/2024 | 1.2 | Continued research on AMA CPT Editorial Panel submission requirements; analysis of September 2024 CPT Editorial Panel meeting agenda and confirmation of June 28, 2024 submission deadline; review of prior PLA code application submissions for formatting precedent.
03/17/2024 | 1.0 | Finalization of draft PLA code descriptor language; compilation of supporting documentation for PLA application package; coordination with paralegal staff on document formatting requirements.
03/18/2024 | 1.3 | Preparation and transmission of email to Janet Carraway (Carraway Regulatory Advisors, Inc.) transmitting draft PLA code application for review and comment; preparation of cover memorandum summarizing outstanding issues and areas where Carraway guidance was specifically requested; coordination on coding mechanics and PLA code numbering procedures.
03/19/2024 | 1.2 | Receipt and initial review of Carraway feedback on draft PLA application; preparation of summary of Carraway comments for S. Morrissey and M. Calloway review; analysis of Carraway's recommended revisions to descriptor language regarding clinical utility characterization.
03/20/2024 | 1.3 | Incorporating Carraway feedback into draft PLA application under M. Calloway's direction; revision of descriptor language and methodology section; drafting initial version of PLA code application cover letter for AMA CPT Editorial Panel submission.
03/21/2024 | 1.0 | Continued revision of PLA code application cover letter; coordination with S. Morrissey on cover letter content and formatting; review of application package completeness against AMA CPT Editorial Panel submission checklist.
03/22/2024 | 0.5 | Final formatting and assembly review of PLA code application package for delivery to GDT; coordination with paralegal staff on document delivery logistics; confirmation of deliverable checklist completion.
03/25/2024 | 1.5 | Research on MolDx technical assessment submission requirements, including review of Palmetto GBA MolDx program website, published guidance documents, and technical assessment template; compilation of supporting documentation for MolDx dossier.
03/26/2024 | 1.3 | Continued research on MolDx submission requirements; bibliography research for MolDx technical assessment dossier; identification of publications supporting analytical validation, clinical validation, and clinical utility of OncoPrecise GXP-47.
03/27/2024 | 1.0 | Continued bibliography research; review and annotation of identified publications for relevance to MolDx technical assessment evidence categories; coordination with S. Morrissey on bibliography organization and annotation format.
03/28/2024 | 1.0 | Finalization of bibliography compilation for current period; research on existing Medicare coverage landscape for NGS-based oncology diagnostics; review of published LCDs for comparable molecular diagnostic products.
03/29/2024 | 1.2 | Research on CLARITY-LUNG interim data statistical significance, including review of interim analysis statistical methodology and comparison to pre-specified stopping rules; participation in internal team discussion (0.6 hrs) regarding interim data implications.
04/01/2024 | 1.0 | Continued research on CLARITY-LUNG interim analysis; review of comparable interim analyses for other molecular diagnostic tests in MolDx program, including identification of precedent cases where interim clinical trial data was available at time of MolDx technical assessment submission.
04/02/2024 | 1.0 | Research on comparable MolDx technical assessments; analysis of evidentiary standards applied in technical assessments for molecular diagnostic products with interim clinical validation data; preparation of research summary for S. Morrissey.
04/03/2024 | 1.2 | Research supporting Clinical Evidence Gap Analysis memorandum; Westlaw research on Medicare coverage determination case studies, including analysis of CMS administrative law precedents governing LCD promulgation and non-coverage determinations for molecular diagnostic tests.
04/04/2024 | 1.0 | Continued Westlaw research on Medicare coverage determination administrative law precedents; review of ALJ decisions and Departmental Appeals Board rulings relevant to molecular diagnostic test coverage disputes; preparation of research memorandum for M. Calloway.
04/08/2024 | 1.0 | Research and data compilation supporting GDT Board of Directors presentation; preparation of supporting data tables for revenue projection slides and coverage timeline scenario analysis.
04/09/2024 | 0.5 | Assisting with board presentation preparation; finalization of appendix materials and backup data slides; coordination with S. Morrissey on presentation logistics.
04/10/2024 | 1.0 | Research on supplemental evidence strategies to address CLARITY-LUNG clinical validation data shortfall; review of published literature on use of real-world evidence and retrospective study data in Medicare coverage determinations for molecular diagnostics.
04/11/2024 | 1.0 | Drafting of sections of Clinical Evidence Gap Analysis memorandum under S. Morrissey supervision, including section on existing published evidence base and analysis of evidentiary gaps relative to MolDx technical assessment requirements.
04/12/2024 | 0.8 | Continued drafting of Clinical Evidence Gap Analysis memorandum sections; research on CFI precedent decisions for molecular diagnostic test coverage determinations.
04/14/2024 | 0.7 | Continued drafting and research for Clinical Evidence Gap Analysis memorandum; preparation of appendix summarizing Ridgeline Diagnostics, Inc. and CFI precedent decisions; submission of draft sections to S. Morrissey for review.
Date | Hours | Description
03/18/2024 | 0.5 | Document formatting for PLA code application package, including formatting of descriptor form, cover letter, and supporting attachments in accordance with AMA CPT Editorial Panel submission specifications.
03/20/2024 | 0.5 | Continued document formatting and assembly of PLA code application package; cite-checking of references and supporting documentation included in application materials.
03/22/2024 | 0.5 | Finalization of PLA code application document assembly; coordination of document delivery to GDT via secure file transfer; confirmation of receipt by T. Nakamura's office.
04/08/2024 | 0.5 | Formatting of GDT Board of Directors presentation slides; document organization for CLARITY-LUNG interim data analysis materials; preparation of presentation handout packages.
04/09/2024 | 0.3 | Final formatting revisions to board presentation materials; preparation of supplemental appendix documents for board meeting.
04/11/2024 | 0.3 | Research assistance for Clinical Evidence Gap Analysis memorandum; compilation of source documents and published MolDx technical assessments for attorney review.
04/14/2024 | 0.4 | Bibliography formatting for Clinical Evidence Gap Analysis memorandum; cite-checking of references cited in memorandum draft sections; document organization for working file.
Timekeeper | Title | Rate ($/hr) | Hours | Amount
Miriam Calloway | Partner | $1,350.00 | 18.0 | $24,300.00
Joel Strauss | Partner | $1,275.00 | 5.5 | $7,012.50
Sean Morrissey | Senior Associate | $875.00 | 35.2 | $30,800.00
Christopher Aiken | Associate | $650.00 | 23.7 | $15,405.00
Paralegal Staff | — | $375.00 | 3.0 | $1,125.00
Total Professional Fees | 85.4 | $78,642.50
Description | Amount
Westlaw / Online Legal Research (March 15 – April 14, 2024) | $72.62
Printing and Document Reproduction | $32.50
Total Disbursements | $105.12
Item | Amount
Professional Fees | $78,642.50
Disbursements / Costs | $105.12
Total Due This Invoice | $78,747.62
Invoice No. | Billing Period | Amount | Status
INV-1043-00002-001 | February 14, 2024 – March 14, 2024 | $62,437.50 | Paid — received 04/08/2024
INV-1043-00002-002 | March 15, 2024 – April 14, 2024 | $78,747.62 | Current — Due May 15, 2024
Total Billed to Date | $141,185.12
Payments Received to Date | $62,437.50
Outstanding Balance | $78,747.62
Bank Name: | Greaves Bancorp
Bank Address: | 270 Park Avenue, New York, NY 10017
ABA Routing Number: | 021000021
Account Name: | Calderwood & Harkness LLP — Operating Account
Account Number: | 8834-7291-0056
SWIFT Code: | CHASUS33
Reference: | Invoice No. INV-1043-00002-002 / Client No. 47832 / Matter No. 1043-00002

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