Contract analysis

Section 1.1 Definitions. As used in this Agreement, the following terms shall have the following meanings: "Assigned intellectual Property" means, collectively, the Assigned Patents, the Assigned Trademarks, the Assigned Trade Secrets, and the Assigned Copyrights and Other IP, each as defined in this Section 1.1. "Assigned Patents" means all patents and patent applications listed on Exhibit A attached hereto and inco

Section 1.2 APA Definitions. All capitalized terms used but not otherwise defined in this Agreement shall have the meanings ascribed to such terms in the APA. In the event of any conflict between the definitions set forth in this Agreement and the definitions set forth in the APA, the definitions set forth in the APA shall control, except to the extent that a definition herein is intended to supplement (rather than c

Section 2.1 Assignment of Patents. Effective as of the Effective Date, GDT hereby irrevocably and unconditionally assigns, transfers, conveys, and delivers to Meridian, and Meridian hereby accepts, all of Assignor's right, title, and interest in and to the Assigned Patents, as listed and described on Exhibit A hereto, including all fourteen (14) issued United States patents and all seven (7) pending United States pat

Section 2.2 Assignment of Trademarks. Effective as of the Effective Date, GDT hereby irrevocably and unconditionally assigns, transfers, conveys, and delivers to Meridian, and Meridian hereby accepts, all of Assignor's right, title, and interest in and to the Assigned Trademarks, as listed and described on Exhibit B hereto, including without limitation: (a) OncuPath™ — USPTO Registration No. 5,847,321; (b) OncuPath-H

Section 2.3 Assignment of Trade Secrets and Know-How. Effective as of the Effective Date, GDT hereby irrevocably and unconditionally assigns, transfers, conveys, and delivers to Meridian, and Meridian hereby accepts, all of Assignor's right, title, and interest in and to the Assigned Trade Secrets, including without limitation all proprietary assay protocols, standard operating procedures, probe-labeling methodologie

Section 2.4 Assignment of Copyrights and Other IP. Effective as of the Effective Date, GDT hereby irrevocably and unconditionally assigns, transfers, conveys, and delivers to Meridian, and Meridian hereby accepts, all of Assignor's right, title, and interest in and to the Assigned Copyrights and Other IP, including without limitation all copyrights in and to IFU documentation, product labeling, software (including so

Section 2.5 Associated Goodwill. All goodwill associated with or symbolized by the Assigned intellectual Property, including all goodwill associated with the OncuPath Business and the Assigned Trademarks, is hereby transferred to Meridian as an integral part of this assignment. The Parties acknowledge that the goodwill transferred hereunder is inseparable from the Assigned Trademarks and is essential to the validity

Section 2.6 Excluded intellectual Property. For the avoidance of doubt, this Agreement does not assign, transfer, convey, or deliver any Excluded intellectual Property. Without limiting the generality of the foregoing, Assignor retains all right, title, and interest in and to: (a) all intellectual property rights related to the GenoStrat™ liquid biopsy platform, including all patents, patent applications, trade secre

ARTICLE 3 — VANTAGE LICENSE ACKNOWLEDGMENT

Section 3.1 Vantage Molecular Sciences License. The Parties acknowledge and agree as follows: (a) GDT is a party to that certain License Agreement, dated as of September 12, 2019 (the "Vantage License"), by and between GDT and Vantage Molecular Sciences, Inc., a Massachusetts corporation ("Vantage"), with offices at 75 Hayden Avenue, Lexington, Massachusetts 02421, pursuant to which Vantage granted to GDT an exclusiv

ARTICLE 4 — REPRESENTATIONS AND WARRANTIES OF ASSIGNOR Assignor hereby represents and warrants to Assignee as follows:

Section 4.1 Authority. GDT is a corporation duly organized, validly existing, and in good standing under the laws of the State of Delaware. GDT has full corporate power and authority to execute, deliver, and perform its obligations under this Agreement and to consummate the transactions contemplated hereby. The execution, delivery, and performance by GDT of this Agreement, and the consummation by GDT of the transacti

Section 4.2 Title. GDT is the sole and exclusive owner of the entire right, title, and interest in and to the Assigned intellectual Property, free and clear of all liens, pledges, security interests, charges, encumbrances, equities, claims, options, rights of first refusal, and adverse claims of any kind or nature whatsoever, except as disclosed in the Disclosure Schedules to the APA. GDT has the unrestricted right t

Section 4.3 Validity and Enforceability. To Assignor's knowledge, all issued Assigned Patents are valid, enforceable, and subsisting as of the Effective Date. All required maintenance fees, annuities, renewal fees, and other payments required to maintain the Assigned Patents in force have been timely paid through the Effective Date. No interference, reexamination, inter partes review, post-grant review, covered busin

Section 4.4 Trademark Registrations. The Assigned Trademarks listed on Exhibit B are valid, subsisting, and enforceable registrations with the USPTO as of the Effective Date. All required filings, declarations, affidavits, and renewals (including declarations of continued use under Section 8 of the Lanham Act and declarations of incontestability under Section 15 of the Lanham Act, where applicable) have been timely m

Section 4.5 No Infringement. To Assignor's knowledge, as of the Effective Date, the Assigned intellectual Property does not infringe, misappropriate, or otherwise violate the intellectual property rights or other proprietary rights of any third party. No claim, demand, suit, action, or proceeding asserting infringement, misappropriation, or other violation of any third party's intellectual property rights by any of t

Section 4.6 No Prior Assignments. GDT has not previously assigned, transferred, granted, or conveyed any exclusive license in or to any of the Assigned intellectual Property to any third party, and no third party has any right, title, or interest in or to any of the Assigned intellectual Property (other than non-exclusive rights, if any, disclosed in the Disclosure Schedules to the APA). For the avoidance of doubt, t

Section 4.7 Incorporation of APA Representations. The representations and warranties of Assignor set forth in the APA (including, without limitation, the intellectual property representations and warranties set forth in Section 3.14 of the APA) are incorporated herein by reference, and such representations and warranties are subject to the survival periods, indemnification provisions, limitations on liability, and ot

ARTICLE 5 — REPRESENTATIONS AND WARRANTIES OF ASSIGNEE Assignee hereby represents and warrants to Assignor as follows:

Section 5.1 Authority. Meridian is a corporation duly organized, validly existing, and in good standing under the laws of the State of Delaware. Meridian has full corporate power and authority to execute, deliver, and perform its obligations under this Agreement and to consummate the transactions contemplated hereby. The execution, delivery, and performance by Meridian of this Agreement, and the consummation by Merid

Section 5.2 Binding Agreement. This Agreement has been duly executed and delivered by Meridian and constitutes a legal, valid, and binding obligation of Meridian, enforceable against Meridian in accordance with its terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent transfer, and other similar laws affecting creditors' rights generally, and to general principles of equity (rega

ARTICLE 6 — FURTHER ASSURANCES

Section 6.1 Cooperation and Further Instruments. Each Party agrees, at any time and from time to time after the Effective Date, to execute, acknowledge, and deliver, or cause to be executed, acknowledged, and delivered, all such further instruments, assignments, powers of attorney, declarations, certificates, and other documents, and to take, or cause to be taken, all such further actions, as the other Party may reas

Section 6.2 Power of Attorney. GDT hereby irrevocably constitutes and appoints Meridian, and each of Meridian's duly authorized officers and agents, as GDT's true and lawful attorney-in-fact, with full power of substitution and resubstitution, to execute, deliver, acknowledge, certify, file, and record, in GDT's name and on GDT's behalf, any and all instruments, documents, assignments, declarations, oaths, powers of

Section 6.3 Access to Records. For a period of three (3) years following the Effective Date (i.e., through August 8, 2026), GDT shall provide Meridian and its authorized representatives with reasonable access, during normal business hours and upon reasonable prior written notice, to all files, prosecution histories, invention records, correspondence with patent and trademark offices, laboratory notebooks, inventor de

ARTICLE 7 — RELATIONSHIP TO THE APA

Section 7.1 Subject to the APA. This Agreement is delivered pursuant to, and in furtherance of, the APA. This Agreement is subject to, and is governed by, the terms and conditions of the APA, including the representations and warranties, covenants, indemnification obligations, limitations on liability, and other provisions set forth therein. In the event of any conflict or inconsistency between the terms and provisio

Section 7.2 Indemnification. The indemnification obligations of the Parties with respect to the Assigned intellectual Property, including with respect to any breach of the representations and warranties set forth in Article 4 and Article 5 hereof, shall be governed exclusively by Article IX of the APA, and shall be subject to the following limitations and other terms set forth therein: (a) an aggregate indemnificatio

Section 7.3 Representations and Warranties Insurance. The Parties acknowledge that Apex Mutual Insurance Company has issued a buyer-side representations and warranties insurance policy, bearing Policy No. RWI-2023-07182, with a policy limit of Twenty-Eight Million Dollars ($28,000,000) and a retention amount of One Million Four Hundred Thousand Dollars ($1,400,000) (the "R&W Insurance Policy"). The R&W Insurance Poli

Section 8.1 Governing Law. This Agreement shall be governed by, and construed and enforced in accordance with, the internal laws of the State of Delaware, without giving effect to any choice of law or conflict of law rules, provisions, or principles (whether of the State of Delaware or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of Delaware. Each Party

Section 8.2 Entire Agreement. This Agreement, together with the APA, the Exhibits hereto, and the other transaction documents executed and delivered in connection with the APA (including the Transition Services Agreement, the Vantage License Assignment, and the other ancillary agreements), constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior and conte

Section 8.3 Amendment and Waiver. No amendment, modification, supplement, or waiver of any provision of this Agreement shall be effective unless made in a written instrument duly executed by both Parties. No waiver by either Party of any breach or default of any provision of this Agreement shall be deemed a waiver of any subsequent breach or default of the same or any other provision, nor shall any delay or omission

Section 8.4 Severability. If any provision of this Agreement is held to be invalid, illegal, or unenforceable in any respect by a court of competent jurisdiction, such invalidity, illegality, or unenforceability shall not affect any other provision of this Agreement, and this Agreement shall be construed as if such invalid, illegal, or unenforceable provision had never been contained herein. The Parties shall negotia

Section 8.5 Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original and all of which, taken together, shall constitute one and the same instrument. Delivery of an executed counterpart of a signature page to this Agreement by facsimile transmission, portable document format (.pdf), or other electronic means (including any electronic signature complying with t

Section 8.6 Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors, assigns, heirs, executors, administrators, and legal representatives. Neither Party may assign this Agreement or any of its rights or obligations hereunder without the prior written consent of the other Party, except that Meridian may, without the consent of GDT, assign thi

Section 8.7 Notices. All notices, requests, demands, consents, and other communications required or permitted under this Agreement shall be in writing and shall be delivered in accordance with the notice provisions set forth in Section 11.3 of the APA. Notices shall be addressed as follows: If to Assignor: Genome Dx Therapeutics Inc. 10250 Science Center Drive, Suite 600 San Diego, California 92121 Attention: Rebecca

1. Assay Protocols, Standard Operating Procedures, and Validation Methodologies. All assay protocols, standard operating procedures (SOPs), work instructions, validation plans, validation reports, and related documentation for all OncuPath™ companion diagnostics assays, including the OncuPath™, OncuPath-HER3™, and OncuPath-GENOMARK™ assays, as well as all assays under development for the OncuPath product line. This i

2. Probe Design Libraries and Probe-Labeling Formulations. All proprietary probe design libraries, probe sequence databases, probe selection algorithms, probe-labeling formulations and protocols, and related technical documentation developed by or on behalf of GDT exclusively for use in the OncuPath companion diagnostics assays. For the avoidance of doubt, this category does not include any probe-labeling technology

3. Reagent Compositions and Manufacturing Specifications. All proprietary reagent compositions, reagent formulations, buffer compositions, fixation protocols, antigen retrieval formulations, hybridization solutions, wash buffer compositions, chromogen formulations, and manufacturing specifications (including bills of materials, batch records, and manufacturing process descriptions) exclusively related to the producti

4. Proprietary Algorithms and Software for Signal Processing and Result Interpretation. All proprietary algorithms, software source code, software object code, machine learning models, artificial intelligence models, neural network architectures, training data sets, and related documentation developed by or on behalf of GDT exclusively for use in signal processing, image analysis, biomarker scoring, result interpreta

5. Clinical Data Sets and Biobank Sample Data. All clinical data sets, biobank sample data, patient-deidentified data sets, clinical trial data, clinical study reports, and related documentation generated or collected by or on behalf of GDT in connection with the development, validation, and regulatory clearance or approval of OncuPath companion diagnostics assays, in each case to the extent exclusively related to th

6. Quality Control and Quality Assurance Procedures. All quality control (QC) and quality assurance (QA) procedures, protocols, specifications, acceptance criteria, lot release testing procedures, stability testing protocols, environmental monitoring procedures, and related documentation specific to the OncuPath assay line, including all procedures maintained in compliance with FDA Quality System Regulation (21 C.F.R

7. Customer-Specific Assay Customization Specifications. All customer-specific assay customization specifications, configuration files, custom probe panels, custom scoring algorithms, and related technical documentation developed by or on behalf of GDT to meet the specific requirements of OncuPath customers, including pharmaceutical company partners and reference laboratories.

8. Regulatory Strategy Documents and FDA Correspondence. All regulatory strategy documents, pre-submission meeting requests and minutes, pre-submission correspondence, FDA review correspondence, deficiency letters and responses thereto, summary of safety and effectiveness data, FDA clearance letters, approval orders, and other regulatory submissions and correspondence with the FDA related to the OncuPath companion di

9. Manufacturing Process Know-How — Carlsbad Kitting Facility. All manufacturing process know-how, facility layouts, equipment specifications, process flow diagrams, environmental control specifications, clean room protocols, and related technical documentation specific to the OncuPath assay kitting facility located at 925 Industrial Court, Carlsbad, California 92010, including all documentation related to facility q

10. Laboratory Operations Know-How — San Diego Reference Laboratory. All laboratory operations know-how, workflow procedures, instrument protocols, calibration procedures, proficiency testing procedures, laboratory information system (LIS) configurations, and related technical documentation specific to the OncuPath reference laboratory located at 4820 Towne Centre Drive, Suite 200, San Diego, California 92121 (CLIA C

11. Training Materials and Internal Technical Manuals. All training materials, training curricula, competency assessment tools, internal technical manuals, troubleshooting guides, frequently asked questions documents, and related educational materials developed by or on behalf of GDT for the training and instruction of laboratory personnel, field application scientists, and customer support staff in the use, operatio

12. Research Notebooks and Invention Disclosures. All research notebooks, laboratory notebooks, experimental records, invention disclosures, inventor notebooks, and related documentation generated by GDT employees, contractors, or consultants in connection with the development of the Assigned Patents, the pending patent applications included within the Assigned Patents, and any other inventions or discoveries exclusi