Contract analysis

I. Executive Summary This memorandum serves as a comprehensive tracker of all third-party consents, governmental approvals, and regulatory notifications required in connection with the $140,000,000 asset purchase of the OncuPath™ companion diagnostics assay line (the "OncuPath Business") by Meridian Precision Diagnostics, Inc. from Genome Dx Therapeutics Inc. The transaction was consummated pursuant to the Asset Purc

II. Antitrust / Hart-Scott-Rodino Act Approval A. HSR Act Applicability Analysis This Section provides a summary of the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (15 U.S.C. § 18a) (the "HSR Act"), analysis conducted by C&H in connection with the transaction. A detailed HSR Filing Analysis Memorandum, prepared by Andrew Fitzpatrick and dated May 14, 2023, is maintained in the matter file and sho

III. Third-Party Contractual Consents A. Consent to Assignment — Vantage Molecular Sciences, Inc. License Agreement

1. Background. GDT is party to that certain License Agreement dated September 12, 2019 (the "Vantage License Agreement"), by and between GDT, as licensee, and Vantage Molecular Sciences, Inc. ("Vantage"), a Massachusetts corporation headquartered at 75 Hayden Avenue, Lexington, MA 02421, as licensor. The Vantage License Agreement grants GDT an exclusive, worldwide license to certain proprietary probe-labeling technol

Section 12.3 of the Vantage License Agreement provides, in relevant part: "This Agreement and the rights and obligations hereunder may not be assigned or otherwise transferred by either party without the prior written consent of the other party, whether by operation of law or otherwise, and any purported assignment or transfer without such consent shall be null and void." Based on this provision, the assignment of th

3. Consent Process C&H prepared an initial draft of the consent letter in May 2023, promptly following the execution of the APA. The draft was transmitted to Vantage's outside counsel, Quelston Paige LLP (Attention: Catherine Engel), on May 22, 2023, together with a summary of the transaction structure and the relevant provisions of the APA. Negotiations with Vantage's counsel extended over approximately seven weeks

4. Consent Obtained Vantage's written consent to the assignment of the Vantage License Agreement was executed on July 14, 2023, by David Moriarty, Executive Vice President and General Counsel of Vantage Molecular Sciences, Inc., an authorized officer of Vantage. The consent letter was countersigned by authorized representatives of both GDT and Meridian. The consent is unconditional and is effective upon the closing o

5. Status. STATUS: COMPLETED — Consent obtained July 14, 2023. No further action required. B. Other Material Contract Consents In connection with the due diligence review and the preparation of the Disclosure Schedules to the APA, C&H conducted a comprehensive review of all contracts related to the OncuPath Business that were listed in Disclosure Schedule 3.8 (Material Contracts). Each material contract was reviewed

IV. Real Property / Lease Consents A. Consent to Assignment of Lease — Towne Centre Properties LLC (4820 Towne Centre Drive, San Diego)

1. Background. GDT leases the OncuPath reference laboratory and research and development facility located at 4820 Towne Centre Drive, Suite 200, San Diego, California 92121 (the "Towne Centre Facility") pursuant to that certain Commercial Lease Agreement dated March 1, 2018, as amended by the First Amendment to Lease dated February 15, 2020 and the Second Amendment to Lease dated September 30, 2021 (collectively, the

2. Consent Requirement The Towne Centre Lease contains a standard anti-assignment clause at Article 15, Section 15.1, which provides: "Tenant shall not assign this Lease or any interest herein, or sublet the Premises or any part thereof, or permit the use of the Premises by any party other than Tenant, without the prior written consent of Landlord, which consent shall not be unreasonably withheld, conditioned, or del

3. Consent Process C&H prepared a formal request letter and draft landlord consent form and transmitted these to Towne Centre Properties LLC, with a copy to the landlord's property manager (CBRE, Inc., Attention: Michael Sandoval), on June 5, 2023. The request was accompanied by a summary description of the transaction and the identity of the proposed assignee (Meridian). The landlord's review and consent process ext

4. Consent Obtained The landlord consent to the assignment of the Towne Centre Lease was executed on July 28, 2023, by Richard Amato, Managing Member of Towne Centre Properties LLC. The consent was countersigned by authorized representatives of both GDT and Meridian. The consent is effective upon the closing of the asset purchase. The executed landlord consent letter is filed in the closing binder (Tab 16) and is ref

5. Status. STATUS: COMPLETED — Consent obtained July 28, 2023. No further action required (subject to GDT's secondary liability period through August 8, 2024). B. Assignment of Sublease — 925 Industrial Court, Carlsbad, CA 92010

1. Background. GDT subleases approximately 6,200 square feet of warehouse and manufacturing/kitting space at 925 Industrial Court, Carlsbad, California 92010 (the "Carlsbad Facility") pursuant to that certain Sublease Agreement dated July 1, 2022 (the "Carlsbad Sublease"), by and between GDT, as subtenant, and Pacific Coast BioFacilities, Inc. ("PCBF"), a California corporation, as sublandlord. The Carlsbad Facility

2. Consent / Notice Requirement

Section 9.1 of the Carlsbad Sublease requires that the subtenant provide written notice to the sublandlord of any proposed assignment at least thirty (30) days prior to the effective date of the assignment, together with reasonable information regarding the proposed assignee. The sublandlord's consent is required, but the sublease provides that such consent "shall not be unreasonably withheld or delayed." In addition

3. Status. STATUS: COMPLETED — Sublandlord consent obtained July 18, 2023; master landlord consent obtained July 27, 2023. Assignment of Sublease executed at closing on August 8, 2023. No further action required. The executed Assignment of Sublease and the sublandlord and master landlord consent letters are filed in the closing binder (Tab 17) and are included in Appendix A to this memorandum.

V. Healthcare Regulatory Approvals and Notifications A. CLIA Certificate Transfer — OncuPath Reference Laboratory

1. Background. GDT holds a Clinical Laboratory Improvement Amendments ("CLIA") certificate of accreditation for the OncuPath reference laboratory located at the Towne Centre Facility, 4820 Towne Centre Drive, Suite 200, San Diego, California 92121. The certificate was issued by the Centers for Medicare & Medicaid Services ("CMS") and is identified by CLIA ID No. 05D2178493. The certificate was most recently renewed e

2. Transfer Process Under 42 C.F.R. § 493.1840, a change of ownership of a CLIA-certified laboratory requires the new owner to submit a completed CMS Form 116 (Application for Clinical Laboratory Certification or Registration) to the applicable CMS regional office. The application must identify the new owner/operator and provide all required information regarding the laboratory's location, personnel (including the la

3. Filing Status CMS Form 116 was submitted to the CMS San Francisco Regional Office (Region IX) on or about August 8, 2023, the closing date. Submission was made by Meridian's regulatory affairs team, with copies provided to C&H and WSG. The application was submitted via the CMS-approved electronic submission portal, with a hard copy mailed to the regional office as a backup. Based on C&H's experience with similar c

4. Status. STATUS: POST-CLOSING — CMS Form 116 application submitted August 8, 2023. Awaiting CMS processing. Laboratory operations continue under existing CLIA ID No. 05D2178493 during transition. Expected completion: October–November 2023. B. FDA Establishment Registration Update

1. Background. GDT is currently registered as a medical device establishment with the U.S. Food and Drug Administration ("FDA") for the manufacture and distribution of the OncuPath™ diagnostic products. The establishment registration covers the Towne Centre Facility (4820 Towne Centre Drive, Suite 200, San Diego, CA 92121) and the Carlsbad Facility (925 Industrial Court, Carlsbad, CA 92010), as applicable. The OncuPa

2. Registration Transfer Requirements Under the Federal Food, Drug, and Cosmetic Act and the implementing regulations at 21 C.F.R. Part 807, the owner or operator of a medical device establishment engaged in the manufacture, preparation, propagation, compounding, or processing of devices intended for commercial distribution in the United States must register the establishment with the FDA and list the devices manufac

4. PMA Supplement — OncuPath-HER3™ (P230014) The pending PMA supplement (P230014) for the OncuPath-HER3™ Companion Diagnostic Assay was submitted by GDT to CDRH on January 30, 2023. As of the closing date, the submission remains in active review. GDT received an acknowledgment of receipt from the FDA and a file number assignment, but no substantive review correspondence (including any major deficiency or additional i

5. Status. STATUS: POST-CLOSING — Meridian is responsible for filing the updated FDA establishment registration and device listing (via FURLS) and for submitting ownership-change notification letters to CDRH for the three 510(k) clearances and the pending PMA supplement (P230014). C&H will provide transition support under the TSA if requested by Meridian or WSG. Target completion for all FDA-related filings and notif

VI. Summary Tracker Table The following consolidated table summarizes all consent, approval, and regulatory items tracked in this memorandum:

VII. Post-Closing Action Items and Responsibilities A. Allocation of Responsibility Responsibility for the remaining post-closing regulatory tasks is allocated between the parties as follows: Meridian Precision Diagnostics, Inc. / Whitfield Sayer & Gregg LLP. As the new owner and operator of the OncuPath Business, Meridian bears primary responsibility for all post-closing regulatory filings, notifications, and regist

1. FDA Establishment Registration Update (FURLS). Due within 30 calendar days of closing, per 21 C.F.R. § 807.22. Deadline: September 7, 2023.

2. FDA 510(k) Holder Notification Letters (K201847, K193215, K210562). While there is no statutory deadline for submitting ownership-change notification letters to the FDA for 510(k) clearances, best practice dictates that such letters be submitted concurrently with or promptly after the establishment registration update. Target: September 7, 2023.

3. FDA PMA Supplement Sponsor Transfer (P230014 — OncuPath-HER3™). There is no fixed regulatory deadline for notifying the FDA of a change of sponsor for a pending PMA supplement. However, timely notification is critical to avoid disruption to the FDA's review process and to preserve the timeline for Earnout Milestone 1 (FDA clearance or approval of OncuPath-HER3™ by August 8, 2025). Target: As soon as practicable, n

4. CLIA Certificate Transfer (CMS Form 116). Application submitted on August 8, 2023. CMS processing is expected to take approximately 60 to 90 days. Estimated completion: October–November 2023. No additional action required from Meridian unless CMS requests supplemental information or schedules a site survey.

5. State Laboratory License Notifications. Deadlines vary by state: • California — 30 days post-closing — September 7, 2023 • New York — As soon as practicable (new permit application required; extended processing expected) • Pennsylvania — 30 days post-closing — September 7, 2023 • Florida — 60 days post-closing — October 7, 2023 • Maryland — 30 days post-closing — September 7, 2023 • Rhode Island — 30 days post-clo

VIII. Conclusion Based on the foregoing, we confirm the following:

1. All pre-closing regulatory approvals and third-party consents required as Closing Conditions under Articles VII of the APA have been obtained. This includes the HSR early termination (June 22, 2023), the Vantage Molecular Sciences license consent (July 14, 2023), and the Towne Centre Properties landlord consent (July 28, 2023), as well as the additional contractual and lease consents described in Sections III.B an

2. Closing occurred on August 8, 2023. The one-week delay from the target closing date of August 1, 2023 was attributable to the finalization of certain ancillary documentation and did not result from the failure to satisfy any closing condition.

3. Remaining items are post-closing regulatory notifications and transfers. These items are the primary responsibility of Meridian as the new owner and operator of the OncuPath Business, with cooperation from GDT as required under the APA and the TSA. The key post-closing items include the CLIA certificate transfer (CMS processing underway), FDA establishment registration and device listing updates, FDA ownership-cha

4. No material risks have been identified with respect to the pending post-closing items. All such items are ministerial and administrative in nature. The OncuPath reference laboratory is authorized to continue operations under the existing CLIA certificate, FDA registration, and state licenses during the applicable transition periods, provided that timely filings are made by Meridian. C&H has reviewed the regulatory

5. Calderwood & Harkness LLP will continue to monitor and assist as requested by GDT under the TSA and as needed to fulfill GDT's cooperation obligations under Section 6.5 of the APA. This tracker will be updated on a periodic basis, with the next scheduled update on September 15, 2023. This memorandum is provided for the internal use of the client and its authorized representatives and is protected by the attorney-c