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Contract analysis / conflict-check-memo.docx
conflict-check-memo.docx
1013-00004 · 32 clauses
High · 0 Medium · 4 Standard · 0
I. Purpose and Scope of Conflicts Review Medium
⚑ Liability cap to check against exposure
I. Purpose and Scope of Conflicts Review This memorandum documents the results of a comprehensive conflicts of interest check conducted by the New Engagement / Conflicts Review Unit of the Office of the General Counsel of Calderwood & Harkness LLP (the "Firm" or "C&H") in connection with the proposed engagement of Genome Dx Therapeutics Inc. ("GDT") as a new client of the Firm. The purpose of this memorandum is to id
II. Identification of Parties Checked
II. Identification of Parties Checked The following parties, entities, and individuals were identified by the requesting attorney and the Conflicts Review Unit as requiring inclusion in the conflicts search. The identification of these parties was based upon information provided in the New Business Intake form, the GDT RFP, publicly available corporate filings, and supplemental inquiries directed to GDT's General Cou
1. Genome Dx Therapeutics Inc.
1. Genome Dx Therapeutics Inc. Also searched as: "GenomeDx," "GDT," "Genome Dx," "Genome Diagnostics Therapeutics" Entity Type: Corporation (Delaware) Employer Identification Number (EIN): 83-2947156 Principal Office and Laboratory: 4720 Torrey Pines Road, Suite 300, San Diego, CA 92130 Registered Agent (Delaware): Pemberton Industries, 251 Little Falls Drive, Wilmington, DE 19808 Business Description: GDT is a clini
2. Pinnacle Health Ventures, L.P. ("PHV")
2. Pinnacle Health Ventures, L.P. ("PHV") Also searched as: "Pinnacle Health Ventures," "PHV," "Pinnacle Health" Entity Type: Limited Partnership (Delaware) Principal Office: 200 Clarendon Street, 48th Floor, Boston, MA 02116 Relationship to GDT: Majority investor holding a 41.3% fully diluted equity stake in GDT. PHV led GDT's $78 million Series C financing round, which closed on March 28, 2022. PHV holds two seats
3. Westbrook Life Sciences Fund, L.P.
3. Westbrook Life Sciences Fund, L.P. Also searched as: "Westbrook Life Sciences," "Westbrook Fund," "WLSF" Entity Type: Limited Partnership (Delaware) Relationship to GDT: Series B investor in GDT. Westbrook Life Sciences Fund, L.P. holds one board representative seat on the GDT Board of Directors, occupied by Reginald Odom. B. Key Client Personnel and Board Members The following individuals were identified as key p
1. Cascade Fiscal Intermediaries, LLC ("CFI")
1. Cascade Fiscal Intermediaries, LLC ("CFI") Also searched as: "Cascade Fiscal," "CFI," "Cascade Intermediaries" Entity Type: Limited Liability Company (Oregon) Principal Office: 2800 SW Moody Avenue, Suite 500, Portland, OR 97201 Relationship to Engagement: CFI is the Medicare Administrative Contractor ("MAC") for Jurisdiction E (California), the jurisdiction in which GDT's CLIA-certified laboratory is located and
2. Ridgeline Administrative Services, LLC ("RAS")
2. Ridgeline Administrative Services, LLC ("RAS") Also searched as: "Ridgeline Administrative," "RAS," "Ridgeline Services" Entity Type: Limited Liability Company (South Carolina) Principal Office: 1600 Hampton Street, Suite 700, Columbia, SC 29201 Relationship to Engagement: RAS is the administrator of the Molecular Diagnostic Services ("MolDx") Program, a CMS-contracted program that conducts technical assessments o
3. Centers for Medicare & Medicaid Services ("CMS")
3. Centers for Medicare & Medicaid Services ("CMS") Federal agency within the United States Department of Health and Human Services. Relationship to Engagement: CMS is the federal agency responsible for administering the Medicare program, including establishing national coverage policies and overseeing the MAC and MolDx programs. The proposed engagement may involve direct or indirect interaction with CMS if the NCD p
4. American Medical Association ("AMA") — CPT Editorial Panel
4. American Medical Association ("AMA") — CPT Editorial Panel Relationship to Engagement: The AMA CPT Editorial Panel is the body responsible for maintaining the Current Procedural Terminology ("CPT") code set, including Proprietary Laboratory Analyses ("PLA") codes. The proposed engagement will include preparation and submission of a PLA code application for the OncoPrecise GXP-47 test to the AMA CPT Editorial Panel
1. Whitford & Sable LLP
1. Whitford & Sable LLP Also searched as: "Whitford Sable," "W&S" Entity Type: Limited Liability Partnership (California) Principal Office: 501 West Broadway, Suite 1400, San Diego, CA 92101 Relationship to GDT/Engagement: Whitford & Sable LLP serves as GDT's regular outside counsel for corporate and intellectual property matters. Co-counsel coordination is anticipated between Calderwood & Harkness and Whitford & Sab
2. Ashby & Garner, LLP
2. Ashby & Garner, LLP Also searched as: "Ashby Garner," "A&G" Entity Type: Limited Liability Partnership (New York) Principal Office: 599 Lexington Avenue, 22nd Floor, New York, NY 10022 Relationship to GDT/Engagement: Ashby & Garner, LLP serves as outside counsel to Pinnacle Health Ventures, L.P., GDT's majority investor, on portfolio company matters. Ashby & Garner may interact with Calderwood & Harkness on board-
3. Larkfield Health Economics, LLC
3. Larkfield Health Economics, LLC Also searched as: "Larkfield Health," "Larkfield HEOR" Entity Type: Limited Liability Company (Maryland) Principal Office: 7910 Woodmont Avenue, Suite 610, Bethesda, MD 20814 Relationship to GDT/Engagement: Larkfield Health Economics, LLC is a health economics and outcomes research ("HEOR") consulting firm retained by GDT to develop the clinical utility and economic evidence package
4. Carraway Regulatory Advisors, Inc.
4. Carraway Regulatory Advisors, Inc. Also searched as: "Carraway Regulatory," "Carraway Advisors," "CRA" Entity Type: Corporation (Illinois) Principal Office: 233 South Wacker Drive, Suite 4100, Chicago, IL 60606 Relationship to GDT/Engagement: Carraway Regulatory Advisors, Inc. is a coding and billing consulting firm retained by GDT to provide CPT and PLA coding expertise. Carraway will work alongside the Calderwoo
5. Verdant Life Sciences Capital, LLC
5. Verdant Life Sciences Capital, LLC Also searched as: "Verdant Life Sciences," "Verdant Capital," "VLSC" Entity Type: Limited Liability Company (California) Principal Office: 101 Montgomery Street, Suite 2600, San Francisco, CA 94104 Relationship to GDT/Engagement: Verdant Life Sciences Capital, LLC is serving as GDT's investment banking and financial advisory firm. Verdant is advising GDT on pre-commercial valuati
6. Pacific Coast National Bank ("PCNB")
6. Pacific Coast National Bank ("PCNB") Also searched as: "Pacific Coast National," "PCNB," "Pacific Coast Bank" Entity Type: National Banking Association (California) Principal Office: 633 West 5th Street, 18th Floor, Los Angeles, CA 90071 Relationship to GDT/Engagement: PCNB is GDT's commercial lender. PCNB extended a $15 million Revolving Credit Facility to GDT pursuant to a Credit Agreement dated September 22, 20
7. Hawthorne Mutual Insurance Company
7. Hawthorne Mutual Insurance Company Also searched as: "Hawthorne Mutual," "Hawthorne Insurance," "HMI" Entity Type: Mutual Insurance Company (Connecticut) Principal Office: 280 Trumbull Street, Suite 1200, Hartford, CT 06103 Relationship to GDT: Hawthorne Mutual Insurance Company is GDT's directors' and officers' liability insurer and professional liability insurer. • Directors & Officers Liability Policy No. HMI-D
8. Summit Ridge Accounting Group, LLP
8. Summit Ridge Accounting Group, LLP Also searched as: "Summit Ridge Accounting," "Summit Ridge," "SRAG" Entity Type: Limited Liability Partnership (California) Principal Office: 1250 Sixth Avenue, Suite 800, San Diego, CA 92101 Relationship to GDT: Summit Ridge Accounting Group, LLP serves as GDT's independent auditor. Key Personnel Checked: • Brian Castellano, CPA — Engagement Partner E. Competitive / Related Enti
1. Elara Genomic Sciences, Inc.
1. Elara Genomic Sciences, Inc. Also searched as: "Elara Genomic," "Elara Genomics," "EGS" Entity Type: Corporation (Massachusetts) Relationship to Engagement: Elara Genomic Sciences, Inc. is the proprietor of "GeneSight Onco-48," a genomic diagnostic test that has been assigned PLA Code 0250U. GeneSight Onco-48 has been identified by GDT and its consultants as a primary crosswalk comparator for establishing the Medi
2. Marlowe Asset Management Molecular Diagnostics, Inc.
2. Marlowe Asset Management Molecular Diagnostics, Inc. Also searched as: "Marlowe Asset Management Molecular," "Marlowe Asset Management Diagnostics," "VMD" Entity Type: Corporation (California) Relationship to Engagement: Marlowe Asset Management Molecular Diagnostics, Inc. is the proprietor of "TumorMap Pro," a genomic diagnostic test that has been assigned PLA Code 0239U. TumorMap Pro has been identified by GDT a
III. Conflicts Database Search Methodology
III. Conflicts Database Search Methodology The conflicts review was conducted in accordance with the Firm's Conflicts of Interest Policy (revised January 1, 2024) and applicable Rules of Professional Conduct, including Rule 1.7 (Conflict of Interest: Current Clients), Rule 1.9 (Duties to Former Clients), and Rule 1.10 (Imputation of Conflicts of Interest) of the Model Rules of Professional Conduct, as adopted in the
IV. Results of Conflicts Check
IV. Results of Conflicts Check A. No Conflicts Identified Based upon the comprehensive review described in Sections II and III above, the Conflicts Review Unit has determined that no conflicts of interest have been identified that would preclude Calderwood & Harkness LLP from accepting the proposed engagement of Genome Dx Therapeutics Inc. as a new client of the Firm for Matter No. 1043-00002. Specifically, the revie
1. Ridgeline Administrative Services, LLC — Prior Closed Matter
1. Ridgeline Administrative Services, LLC — Prior Closed Matter Calderwood & Harkness represented an unrelated client in connection with a MolDx technical assessment matter in 2021 (Matter No. 1013-00004, "MolDx Technical Assessment Appeal — [Client Name Redacted]"). That matter was closed upon completion of the technical assessment appeal, and the Firm has no ongoing relationship with Ridgeline Administrative Servic
2. Pacific Coast National Bank — Prior Closed Matter Medium
⚑ Liability cap to check against exposure
2. Pacific Coast National Bank — Prior Closed Matter Calderwood & Harkness's Banking & Finance Practice Group represented Pacific Coast National Bank as lender's counsel in an unrelated commercial real estate financing transaction in 2022 (Matter No. 1013-00004, "PCNB — Hillcrest Commons Acquisition Financing"). That matter was closed upon the completion of the financing, and the Firm has no current engagement with P
3. Sean Morrissey — Prior CMS Employment
3. Sean Morrissey — Prior CMS Employment As discussed in detail in Section III above, Sean Morrissey, Senior Associate, served as a policy analyst in CMS's Coverage and Analysis Group prior to joining Calderwood & Harkness. The enhanced review conducted by the Conflicts Review Unit confirmed that Mr. Morrissey had no involvement in any coverage decisions or policy analyses relating to GDT, the OncoPrecise platform, o
V. Engagement Team Confirmation
V. Engagement Team Confirmation The Conflicts Review Unit confirms that all proposed members of the engagement team have been individually cleared through the conflicts search process. The engagement team, as identified in the New Business Intake form and confirmed by the requesting attorney, consists of the following individuals: With respect to paralegal staff, the requesting attorney has been advised that individu
VI. Scope Limitations and Ongoing Obligations
VI. Scope Limitations and Ongoing Obligations The requesting attorney and the engagement team are advised of the following scope limitations and ongoing obligations in connection with this conflicts clearance:
1. Limitations as of Date of Memorandum. This conflicts check is limited to the informatio Medium
⚑ Liability cap to check against exposure
1. Limitations as of Date of Memorandum. This conflicts check is limited to the information available to the Conflicts Review Unit as of the date of this memorandum, February 12, 2024. The check was conducted based upon the parties and entities identified by the requesting attorney and supplemented by the Conflicts Review Unit's independent review. The accuracy and completeness of the conflicts analysis is dependent
2. Ongoing Duty to Update. Members of the engagement team have an ongoing obligation under
2. Ongoing Duty to Update. Members of the engagement team have an ongoing obligation under the Firm's Conflicts of Interest Policy to update the conflicts system if new parties, entities, or individuals are identified during the course of the representation that were not included in the initial conflicts check. This obligation extends to, without limitation: (a) New adverse parties or interested parties that become r
3. Supplemental Conflicts Check for Expanded Scope. If the scope of the engagement expands
3. Supplemental Conflicts Check for Expanded Scope. If the scope of the engagement expands to include representation of GDT adverse to any party identified in this memorandum — including, specifically, representation adverse to Pacific Coast National Bank in connection with the Revolving Credit Facility milestone covenant (see Section IV.B.2) — a supplemental conflicts check must be initiated immediately and complete
4. Periodic Re-Check Requirement. Pursuant to the Firm's Conflicts of Interest Policy, a r
4. Periodic Re-Check Requirement. Pursuant to the Firm's Conflicts of Interest Policy, a re-check of the conflicts database must be conducted if: (a) The engagement extends beyond twelve (12) months from the date of initial clearance (i.e., beyond February 12, 2025); or (b) A material change in the scope, nature, or parties involved in the engagement occurs at any point during the representation. The requesting attor
VII. Conclusion and Clearance
VII. Conclusion and Clearance Based upon the comprehensive conflicts review documented in this memorandum, the engagement of Genome Dx Therapeutics Inc. as a new client of Calderwood & Harkness LLP (Client No. 47832) for Matter No. 1043-00002 (Medicare Coverage and Coding Strategy for OncoPrecise GXP-47 Genomic Diagnostic Test) is hereby CLEARED with no conflicts of interest identified. The engagement letter prepared
VIII. Signature block Medium
⚑ Assignment / subcontracting
VIII. Signature block Prepared by: ________________________________________ Jonathan R. Whitfield Conflicts Analyst, Office of the General Counsel Calderwood & Harkness LLP Date: February 12, 2024 Reviewed by: ________________________________________ Katharine M. Ellsworth Deputy General Counsel Calderwood & Harkness LLP Date: February 12, 2024 Approved for Clearance: ________________________________________ Date: Fe