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INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT

dated as of August 8, 2023

by and between

GENOME DX THERAPEUTICS INC.

and

MERIDIAN PRECISION DIAGNOSTICS, INC.

INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT

This INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT (this "Agreement") is entered into as of August 8, 2023 (the "Effective Date"), by and between:

Genome Dx Therapeutics Inc., a Delaware corporation ("Assignor" or "GDT"), with its principal place of business at 10250 Science Center Drive, Suite 600, San Diego, California 92121;

and

Meridian Precision Diagnostics, Inc., a Delaware corporation ("Assignee" or "Meridian"), with its principal place of business at 2400 Meridian Parkway, Suite 300, Durham, North Carolina 27713.

Assignor and Assignee are each referred to herein individually as a "Party" and collectively as the "Parties."

RECITALS

WHEREAS, GDT and Meridian are parties to that certain Asset Purchase Agreement, dated as of May 11, 2023 (as amended, supplemented, or otherwise modified from time to time in accordance with its terms, the "Asset Purchase Agreement" or "APA"), pursuant to which GDT agreed to sell, assign, transfer, convey, and deliver to Meridian, and Meridian agreed to purchase and acquire from GDT, certain assets, properties, and rights constituting the OncuPath™ companion diagnostics assay line and the business conducted by GDT exclusively in connection therewith (the "OncuPath Business"), for aggregate consideration of One Hundred Forty Million Dollars ($140,000,000), subject to the adjustments and other terms and conditions set forth in the APA;

WHEREAS, pursuant to Section 2.4(d) of the APA, GDT is required to execute and deliver this intellectual Property Assignment Agreement at the Closing (as defined in the APA) in order to assign, transfer, and convey to Meridian all of Assignor's right, title, and interest in and to the Assigned intellectual Property (as defined herein) used exclusively in, or held exclusively for, the conduct of the OncuPath Business;

WHEREAS, the Closing under the APA is occurring on the date hereof, August 8, 2023; and

WHEREAS, capitalized terms used but not otherwise defined herein shall have the meanings ascribed to such terms in the APA.

NOW, THEREFORE, in consideration of the premises, the mutual covenants and agreements contained in the APA, the payment of the purchase price thereunder, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged by each of the Parties, the Parties hereby agree as follows:

ARTICLE 1 — DEFINITIONS

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 incorporated herein by reference, together with all continuations, continuations-in-part, divisional applications, reissues, reexamination certificates, renewals, extensions (including any supplementary protection certificates), and foreign counterparts thereof, and all patents issuing therefrom or claiming priority thereto, in each case to the extent owned by Assignor. As of the Effective Date, the Assigned Patents include fourteen (14) issued United States patents and seven (7) pending United States patent applications, all of which relate to the OncuPath™ companion diagnostics assay technology, as more fully described on Exhibit A.

"Assigned Trademarks" means all trademarks, service marks, trade names, trade dress, logos, slogans, domain names, social media identifiers, and registrations and applications therefor, in each case listed on Exhibit B attached hereto and incorporated herein by reference, together with all goodwill of the business symbolized by and associated with such marks, all common law rights therein, and all rights to sue for and collect damages for past, present, and future infringement, dilution, or misappropriation thereof. The Assigned Trademarks specifically include, without limitation:

(a) OncuPath™ — United States Patent and Trademark Office ("USPTO") Registration No. 5,847,321;

(b) OncuPath-HER3™ — USPTO Registration No. 6,412,088; and

"Assigned Trade Secrets" means all trade secrets, proprietary information, know-how, formulations, assay protocols, standard operating procedures, manufacturing processes, reagent compositions, probe designs, probe-labeling methodologies, algorithms, software source code and object code, databases, clinical data sets, biobank sample data, regulatory strategy documents, quality control and quality assurance procedures, and other confidential business information, in each case exclusively related to the OncuPath Business, as more fully described on Exhibit C attached hereto and incorporated herein by reference.

"Assigned Copyrights and Other IP" means all copyrights, copyright registrations and applications therefor, mask works, database rights, and all other intellectual property rights (other than patents, trademarks, and trade secrets) exclusively related to the OncuPath Business, including without limitation all copyrights in and to product labeling, instructions for use ("IFU") documentation, software (including source code and object code), training materials, internal technical manuals, research notebooks, and regulatory submissions (including submissions made to the United States Food and Drug Administration (the "FDA") under 510(k) clearance numbers K201847, K193215, and K210562, and Premarket Approval ("PMA") supplement P230014), and all rights to sue for and collect damages for past, present, and future infringement or misappropriation thereof.

"Excluded intellectual Property" means all intellectual property rights of GDT that do not constitute Assigned intellectual Property, including without limitation (i) all intellectual property rights related to the GenoStrat™ liquid biopsy platform, (ii) GDT's corporate name, corporate logos, and all trademarks, service marks, and trade names outside the OncuPath brand family, (iii) all patents, patent applications, trade secrets, copyrights, and other intellectual property rights that are not exclusively related to or exclusively used in the OncuPath Business, and (iv) all other intellectual property rights retained by GDT pursuant to the APA.

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 contradict) the corresponding definition in the APA.

ARTICLE 2 — ASSIGNMENT

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 patent applications identified therein. The foregoing assignment includes, without limitation:

(a) all rights to make, have made, use, sell, offer to sell, and import products and services covered by the Assigned Patents;

(b) all rights to file, prosecute, and maintain the pending patent applications included within the Assigned Patents, and to file and prosecute continuations, continuations-in-part, divisional applications, reissues, reexaminations, and any other patent filings claiming priority to or deriving from any of the Assigned Patents;

(c) all rights to sue for, collect, and retain damages, profits, and any other remedies for past, present, and future infringement, misappropriation, or other violation of any of the Assigned Patents, including the right to settle and compromise any such claims; and

(d) all rights of priority under the Paris Convention, the Patent Cooperation Treaty, and any other applicable international treaty or convention.

GDT shall, promptly following the Effective Date and at GDT's own expense, execute and deliver to Meridian all instruments, assignments, declarations, and other documents necessary or reasonably requested by Meridian to record the assignment of the Assigned Patents with the USPTO and with any foreign patent offices in jurisdictions where corresponding patent rights exist or are pending, in each case in form and substance reasonably satisfactory to Meridian and suitable for recordation in the applicable jurisdiction.

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-HER3™ — USPTO Registration No. 6,412,088;

together with all goodwill of the business symbolized by and associated with such trademarks, all common law rights therein and thereto, all rights to sue for and collect damages for past, present, and future infringement, dilution, or misappropriation thereof, and all rights to apply for and obtain registrations of such marks in any jurisdiction worldwide.

GDT shall, promptly following the Effective Date and at GDT's own expense, execute and deliver to Meridian all instruments, assignments, and other documents necessary or reasonably requested by Meridian to record the assignment of the Assigned Trademark registrations and applications with the USPTO and with any foreign or international trademark offices, in each case in form and substance reasonably satisfactory to Meridian and suitable for recordation in the applicable jurisdiction.

Following the Effective Date, GDT shall retain no right, license, or authorization to use the OncuPath brand family of trademarks, service marks, trade names, or trade dress in any manner, except as may be expressly required during the term of and in accordance with the Transition Services Agreement, dated as of August 8, 2023, by and between GDT and Meridian (the "Transition Services Agreement"). Any use of the Assigned Trademarks by GDT during the term of the Transition Services Agreement shall be subject to the quality control standards established by Meridian, and GDT shall promptly cease all use of the Assigned Trademarks upon expiration or earlier termination of the Transition Services Agreement.

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 methodologies, probe design libraries, reagent formulations and compositions, manufacturing specifications, signal-processing algorithms, software source code and object code, databases, clinical data sets, biobank sample data, quality control and quality assurance procedures, customer-specific assay customization specifications, regulatory strategy documents, pre-submission correspondence with the FDA, research notebooks, invention disclosures, and all other proprietary information and know-how exclusively related to the OncuPath Business, as more fully described on Exhibit C hereto.

In connection with the foregoing assignment, GDT shall deliver or cause to be delivered to Meridian, at or promptly following the Closing, all tangible and electronic embodiments of the Assigned Trade Secrets, including without limitation all physical documents, files, notebooks, laboratory records, electronic files, databases, software repositories, and other media in which any Assigned Trade Secrets are recorded, stored, or otherwise embodied. GDT shall not retain any copies of the Assigned Trade Secrets following such delivery, except to the extent (i) retention is required by applicable law or regulation, (ii) copies are contained in routine backup systems maintained by GDT in the ordinary course, which copies shall be subject to the confidentiality obligations set forth in the APA, or (iii) expressly permitted pursuant to the Transition Services Agreement.

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 source code and object code), training materials, internal technical manuals, research notebooks, and regulatory submissions made to the FDA, including submissions under 510(k) clearance numbers K201847, K193215, and K210562, and PMA supplement P230014 for the OncuPath-HER3™ assay. The foregoing assignment includes all rights to reproduce, prepare derivative works, distribute, publicly perform, publicly display, and digitally transmit or otherwise exploit such copyrighted works, and all rights to sue for and collect damages for past, present, and future infringement or misappropriation thereof.

GDT shall execute and deliver to Meridian all instruments and documents necessary or reasonably requested by Meridian to record the assignment of any registered copyrights included within the Assigned Copyrights and Other IP with the United States Copyright Office or any foreign copyright office, as applicable.

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 and enforceability of the trademark assignments contemplated by Section 2.2.

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 secrets, copyrights, trademarks, and other intellectual property rights associated therewith;

(b) GDT's corporate name, corporate logos, and all trademarks, service marks, trade names, and trade dress outside the OncuPath brand family;

(c) all patents, patent applications, trade secrets, copyrights, and other intellectual property rights that are not exclusively related to, or exclusively used in, the OncuPath Business; and

(d) all other intellectual property rights expressly retained by GDT pursuant to the terms of the APA.

Nothing in this Agreement shall be construed to limit or restrict GDT's right to use, exploit, license, or otherwise dispose of any Excluded intellectual Property.

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 exclusive license to certain proprietary probe-labeling technology owned by Vantage and used in connection with the OncuPath companion diagnostics assays.

(b) The Vantage License is not assigned, transferred, or conveyed under this intellectual Property Assignment Agreement. The Vantage License is separately assigned to Meridian pursuant to that certain Assignment and Assumption Agreement, dated as of August 8, 2023, by and between GDT and Meridian, executed and delivered at the Closing pursuant to the APA (the "Vantage License Assignment").

(c) Consent to the assignment of the Vantage License from GDT to Meridian was obtained from Vantage by that certain consent letter dated July 14, 2023, a copy of which has been delivered to Meridian.

(d) This Agreement assigns only GDT's own proprietary intellectual property constituting the Assigned intellectual Property, and this Agreement does not purport to assign, transfer, or convey any rights, title, or interest in or to any intellectual property owned by Vantage or licensed to GDT under the Vantage License. All rights in and to the probe-labeling technology licensed under the Vantage License remain the property of Vantage, subject to the terms and conditions of the Vantage License as assigned to Meridian pursuant to the Vantage License Assignment.

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 transactions contemplated hereby, have been duly authorized by all necessary corporate action on the part of GDT, including resolutions of the Board of Directors of GDT approved at a meeting duly convened and held on May 8, 2023, and no other corporate action or proceedings on the part of GDT are necessary to authorize the execution, delivery, and performance of this Agreement.

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 to assign, transfer, and convey the Assigned intellectual Property to Meridian as contemplated by this Agreement, and no consent of any third party (other than consents that have been obtained and are in full force and effect as of the Effective Date) is required in connection with such assignment.

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 business method review, or other adversarial proceeding is pending or, to Assignor's knowledge, threatened with respect to any of the Assigned Patents before the USPTO, the Patent Trial and Appeal Board, or any foreign patent office.

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 made and filed. No opposition, cancellation, or other adversarial proceeding is pending or, to Assignor's knowledge, threatened with respect to any of the Assigned Trademarks before the USPTO, the Trademark Trial and Appeal Board, or any foreign trademark office.

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 the Assigned intellectual Property has been asserted, filed, or, to Assignor's knowledge, threatened against GDT, except as set forth in the Disclosure Schedules to the APA.

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, the Vantage License pertains to technology owned by Vantage (and not by GDT) and does not constitute an assignment, transfer, or exclusive license of any Assigned intellectual Property.

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 other terms and conditions set forth in the APA. Nothing in this Article 4 is intended to expand the scope of, or create obligations separate from, the representations and warranties set forth in the APA.

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 Meridian of the transactions contemplated hereby, have been duly authorized by all necessary corporate action on the part of Meridian, including resolutions of the Board of Directors of Meridian approved at a meeting duly convened and held on May 10, 2023, and no other corporate action or proceedings on the part of Meridian are necessary to authorize the execution, delivery, and performance of this Agreement.

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 (regardless of whether such enforceability is considered in a proceeding in equity or at law).

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 reasonably request in order to effectuate the purposes and intent of this Agreement, including without limitation:

(a) executing and delivering short-form patent assignment documents in form suitable for recordation with the USPTO and with any foreign patent offices in jurisdictions where Assigned Patents or corresponding patent rights exist or are pending;

(b) executing and delivering short-form trademark assignment documents in form suitable for recordation with the USPTO and with any foreign or international trademark offices;

(c) executing and delivering copyright assignment documents in form suitable for recordation with the United States Copyright Office or any foreign copyright office;

(d) cooperating in the prosecution and maintenance of the seven (7) pending patent applications included within the Assigned Patents, including providing access to inventors for the purpose of executing declarations, oaths, powers of attorney, and other documents required by the USPTO or any foreign patent office;

(e) cooperating in the prosecution, defense, enforcement, or other handling of any claims, actions, or proceedings relating to the Assigned intellectual Property, including any infringement claims, opposition proceedings, cancellation proceedings, inter partes review proceedings, or other adversarial proceedings; and

(f) taking all other actions as may be reasonably necessary or desirable to vest in Meridian full, complete, and exclusive ownership of the Assigned intellectual Property, free and clear of all liens, encumbrances, and adverse claims.

The requesting Party shall reimburse the other Party for all reasonable out-of-pocket costs and expenses incurred by such other Party in connection with performing its obligations under this Section 6.1, unless otherwise provided in the APA or the Transition Services Agreement.

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 attorney, and other papers that may be necessary or desirable to effectuate the assignment, transfer, and conveyance of the Assigned intellectual Property contemplated by this Agreement, in the event that GDT fails or is unable to execute and deliver any such instrument or document within fifteen (15) business days following a written request therefor from Meridian. This power of attorney is coupled with an interest and shall be irrevocable for so long as any obligation of GDT under this Article 6 remains outstanding.

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 declarations, assignment records, and other documentation in GDT's possession or control that are related to the Assigned intellectual Property and that are not otherwise delivered to Meridian at or prior to the Closing. GDT shall use commercially reasonable efforts to preserve and maintain such records during such three-year period and shall not destroy or dispose of any such records without first offering Meridian the opportunity to take possession thereof. This Section 6.3 shall not require GDT to provide access to any records that are subject to attorney-client privilege, work product protection, or other applicable legal privilege, provided that GDT shall use commercially reasonable efforts to provide such access in a manner that does not waive such privilege.

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 provisions of this Agreement and the terms and provisions of the APA, the terms and provisions of the APA shall control and prevail in all respects.

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 indemnification cap of Twenty-Eight Million Dollars ($28,000,000), representing twenty percent (20%) of the Total Consideration;

(b) an eighteen (18)-month general survival period for representations and warranties, expiring on February 8, 2025;

(c) a sixty (60)-month survival period for fundamental representations (including representations regarding title to the Assigned intellectual Property), expiring on August 8, 2028;

(d) a tipping basket (deductible) of One Million Four Hundred Thousand Dollars ($1,400,000), representing one percent (1%) of the Total Consideration, with full recovery from the first dollar once the basket is exceeded; and

(e) a de minimis threshold of Seventy-Five Thousand Dollars ($75,000) per individual claim, below which no claim shall count toward the tipping basket or be subject to indemnification.

Nothing in this Agreement is intended to create, and nothing herein shall be construed as creating, any separate or additional indemnification obligations beyond those expressly set forth in the APA. All indemnification claims relating to the Assigned intellectual Property or this Agreement shall be made and resolved exclusively in accordance with the procedures, limitations, and other terms set forth in Article IX of the APA.

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 Policy may provide coverage to Assignee with respect to Losses (as defined in the APA) arising from breaches of the intellectual property-related representations and warranties set forth in the APA and incorporated herein by reference, subject to the terms, conditions, exclusions, and limitations of the R&W Insurance Policy. Nothing in this Section 7.3 shall limit or modify the indemnification obligations of the Parties under the APA or affect the rights of Assignee under the R&W Insurance Policy.

ARTICLE 8 — MISCELLANEOUS

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 hereby irrevocably submits to the exclusive jurisdiction of the Court of Chancery of the State of Delaware (or, if the Court of Chancery declines to accept jurisdiction, the Superior Court of the State of Delaware or the United States District Court for the District of Delaware) in connection with any dispute arising out of or relating to this Agreement, and each Party hereby irrevocably waives any objection to venue in any such court.

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 contemporaneous agreements, negotiations, representations, warranties, understandings, and communications, whether written or oral, between the Parties with respect to such subject matter.

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 by either Party in exercising any right, power, or remedy hereunder operate as a waiver thereof.

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 negotiate in good faith to replace any such invalid, illegal, or unenforceable provision with a valid, legal, and enforceable provision that, to the greatest extent possible, achieves the original intent and economic effect of the invalid, illegal, or unenforceable provision.

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 the U.S. federal ESIGN Act of 2000, the Uniform Electronic Transactions Act, or any other applicable law) shall be effective as delivery of a manually executed counterpart.

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 this Agreement or any of its rights hereunder to (a) any Affiliate of Meridian, or (b) any successor to all or substantially all of the business or assets of Meridian to which this Agreement relates, whether by merger, consolidation, sale of assets, or otherwise; provided that no such assignment shall relieve Meridian of its obligations hereunder.

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 Chiang, General Counsel

Email: rchiang@genomedx.com

with a copy (which shall not constitute notice) to:

Calderwood & Harkness LLP 555 South Hope Street, Suite 4400 Los Angeles, California 90071

Attention: James Prentice

Email: jprentice@calderwoodharkness.com

If to Assignee:

Meridian Precision Diagnostics, Inc. 2400 Meridian Parkway, Suite 300 Durham, North Carolina 27713

Attention: David Pruitt, General Counsel

Email: dpruitt@meridianprecision.com

with a copy (which shall not constitute notice) to:

Whitfield Sayer & Gregg LLP 200 South Tryon Street, Suite 2800 Charlotte, North Carolina 28202

Attention: Jonathan Whitfield

Email: jwhitfield@wsglaw.com

Either Party may change its address for notices by providing written notice of such change to the other Party in accordance with this Section 8.7.

[Remainder of page intentionally left blank. Signature page follows.]

SIGNATURE PAGE TO INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT

IN WITNESS WHEREOF, the Parties have executed and delivered this intellectual Property Assignment Agreement as of the date first written above.

GENOME DX THERAPEUTICS INC.

By: ________

Name: Dr. Helena Vasquez

Title: Chief Executive Officer

Date: August 8, 2023

MERIDIAN PRECISION DIAGNOSTICS, INC.

By: ________

Name: Thomas Ellsworth

Title: Chief Executive Officer

Date: August 8, 2023

EXHIBIT A

SCHEDULE OF ASSIGNED PATENTS

The following sets forth all Assigned Patents as of the Effective Date. Unless otherwise indicated, all patents and patent applications listed below are United States patents or patent applications filed with the United States Patent and Trademark Office.

Part I — Issued U.S. Patents

Part II — Pending U.S. Patent Applications

Note: This Exhibit A is subject to and qualified by the terms and conditions of the intellectual Property Assignment Agreement to which it is attached. All continuations, continuations-in-part, divisionals, reissues, reexaminations, renewals, extensions, supplementary protection certificates, and foreign counterparts of the foregoing patents and patent applications are included within the definition of "Assigned Patents" whether or not separately listed above.

EXHIBIT B

SCHEDULE OF ASSIGNED TRADEMARKS

The following sets forth all Assigned Trademarks as of the Effective Date, including all registered trademarks, pending trademark applications, and associated domain names. Unless otherwise indicated, all trademark registrations and applications listed below are with the United States Patent and Trademark Office.

Part I — Registered Trademarks

Part II — Pending Trademark Applications

Part III — Domain Names

Note: This Exhibit B is subject to and qualified by the terms and conditions of the intellectual Property Assignment Agreement to which it is attached. All listed Assigned Trademarks include the goodwill of the business symbolized by and associated with such marks. All common law trademark rights in and to the marks listed above are also included within the Assigned Trademarks whether or not separately listed.

EXHIBIT C

DESCRIPTION OF ASSIGNED TRADE SECRETS AND KNOW-HOW

The following sets forth the categories of Assigned Trade Secrets and know-how assigned, transferred, and conveyed to Assignee pursuant to the intellectual Property Assignment Agreement to which this Exhibit C is attached. This description is intended to identify the categories of proprietary information included within the Assigned Trade Secrets and is not intended to limit the scope of the assignment to the specific items or examples listed below. All trade secrets, proprietary information, and know-how exclusively related to the OncuPath Business are included within the Assigned Trade Secrets, whether or not specifically identified below.

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 includes all analytical validation data, clinical validation data, and performance verification data generated in connection with such assays.

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 owned by Vantage Molecular Sciences, Inc. and licensed to GDT under the Vantage License.

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 production of OncuPath assay kits and reagent components.

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 interpretation, and quality assessment in connection with the OncuPath companion diagnostics assays. This includes all versions of the OncuPath Analyzer™ software platform and associated modules.

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 the OncuPath Business and subject to applicable data privacy laws, regulations, and agreements.

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. Part 820) and applicable ISO standards (including ISO 13485:2016) for the OncuPath product line.

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 diagnostics assays, including all documentation associated with 510(k) clearances K201847, K193215, and K210562, and PMA supplement P230014 for OncuPath-HER3™. This category also includes all regulatory submissions to and correspondence with foreign regulatory authorities related to the OncuPath assays.

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 qualification, equipment qualification (IQ/OQ/PQ), and process validation performed at such facility.

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 Certificate ID: 05D2178493), including all documentation related to CLIA compliance, CAP accreditation, and state laboratory licensure for such facility.

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, operation, and maintenance of OncuPath companion diagnostics assays and associated instruments and software.

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 exclusively related to the OncuPath Business.

Exclusion: For the avoidance of doubt, trade secrets, proprietary information, and know-how related to the GenoStrat™ liquid biopsy platform and all other retained GDT businesses are expressly excluded from this Exhibit C and do not constitute Assigned Trade Secrets. In addition, trade secrets, proprietary information, and know-how owned by third parties (including Vantage Molecular Sciences, Inc.) and licensed to GDT are not included within the Assigned Trade Secrets and are not assigned under the intellectual Property Assignment Agreement, notwithstanding any reference thereto in this Exhibit C or elsewhere.

[End of Exhibit C]

Item No.	Patent No.	Title	Filing Date	Issue Date	Inventor(s)	Status
1	US 9,284,517 B2	Probe-Hybridization Methods for Companion Diagnostic Assays in Oncology	March 14, 2014	March 15, 2016	Vasquez, H.; Kim, S.J.; Okafor, N.	Issued
2	US 9,561,243 B2	Assay Kit for Detection of HER3 Biomarker Expression in Tumor Tissue Samples	July 22, 2014	February 7, 2017	Kim, S.J.; Patel, R.M.	Issued
3	US 9,803,118 B2	Signal Amplification Methods for Chromogenic In Situ Hybridization Assays	January 9, 2015	October 31, 2017	Okafor, N.; Vasquez, H.; Lindgren, E.A.	Issued
4	US 10,041,962 B2	Sample Preparation Techniques for Formalin-Fixed Paraffin-Embedded Tissue in Companion Diagnostics	September 18, 2015	August 7, 2018	Lindgren, E.A.; Chen, W.	Issued
5	US 10,267,794 B2	Biomarker Detection Methods Using Multi-Probe Panels for Solid Tumor Characterization	April 5, 2016	April 23, 2019	Vasquez, H.; Kim, S.J.; Desai, P.K.	Issued
6	US 10,429,387 B2	Automated Slide Staining and Imaging System for OncuPath Companion Diagnostic Assays	November 12, 2016	October 1, 2019	Patel, R.M.; Okafor, N.	Issued
7	US 10,612,081 B2	Reagent Compositions for Enhanced Probe Binding Specificity in Oncology Assays	February 28, 2017	April 7, 2020	Chen, W.; Lindgren, E.A.; Kim, S.J.	Issued
8	US 10,788,493 B2	HER3 Companion Diagnostic Assay with Quantitative Scoring Algorithm	August 3, 2017	September 29, 2020	Kim, S.J.; Vasquez, H.; Nguyen, T.L.	Issued
9	US 10,954,512 B2	Methods for Multiplexed Biomarker Detection in Companion Diagnostics Applications	January 19, 2018	March 23, 2021	Desai, P.K.; Okafor, N.; Patel, R.M.	Issued
10	US 11,078,483 B2	Quality Control Methods for Companion Diagnostic Assay Manufacturing	June 7, 2018	August 3, 2021	Lindgren, E.A.; Chen, W.	Issued
11	US 11,214,796 B2	Probe Design Methods for Detecting Gene Amplification in Solid Tumors	October 25, 2018	January 4, 2022	Vasquez, H.; Nguyen, T.L.; Kim, S.J.	Issued
12	US 11,387,041 B2	Thermal Cycling Protocols for Improved Hybridization Efficiency in FISH-Based Assays	March 11, 2019	July 12, 2022	Okafor, N.; Desai, P.K.	Issued
13	US 11,542,518 B2	Integrated Sample-to-Result Workflow for OncuPath Companion Diagnostics	July 29, 2019	January 3, 2023	Patel, R.M.; Lindgren, E.A.; Vasquez, H.	Issued
14	US 11,694,207 B2	Machine Learning-Based Image Analysis for Companion Diagnostic Scoring	December 16, 2019	July 4, 2023	Nguyen, T.L.; Kim, S.J.; Chen, W.	Issued
Item No.	Application No.	Title	Filing Date	Inventor(s)	Status
15	US 17/412,836	Next-Generation HER3 Companion Diagnostic Assay with Enhanced Sensitivity and Specificity	August 26, 2021	Kim, S.J.; Vasquez, H.; Nguyen, T.L.	Pending
16	US 17/549,102	Novel Biomarker Panel for Multi-Analyte Companion Diagnostic Testing in Non-Small Cell Lung Cancer	December 13, 2021	Desai, P.K.; Okafor, N.; Patel, R.M.	Pending
17	US 17/683,475	Methods for Simultaneous Detection of Multiple Genomic Alterations Using Combinatorial Probe Sets	February 28, 2022	Lindgren, E.A.; Kim, S.J.; Chen, W.	Pending
18	US 17/814,290	Rapid Companion Diagnostic Assay Platform with Reduced Turnaround Time	July 22, 2022	Vasquez, H.; Patel, R.M.	Pending
19	US 17/952,618	Artificial intelligence-Assisted Pathology Workflow for OncuPath Assay Interpretation	September 26, 2022	Nguyen, T.L.; Desai, P.K.	Pending
20	US 18/103,447	Multi-Analyte Detection Methods Using Spatial Transcriptomics in Companion Diagnostics	January 30, 2023	Kim, S.J.; Okafor, N.; Lindgren, E.A.	Pending
21	US 18/178,962	Improved Reagent Formulations for Next-Generation OncuPath-HER3 Assay Kits	March 6, 2023	Chen, W.; Vasquez, H.; Nguyen, T.L.	Pending
Mark	Registration No.	Registration Date	International Class(es)	Status	Goods/Services Description
OncuPath™	5,847,321	September 3, 2019	Class 10	Registered	Companion diagnostic assay kits and related instruments for use in oncology, namely, in vitro diagnostic kits comprising reagents, probes, and slides for the detection of biomarkers in tumor tissue samples

OncuPath-HER3™	6,412,088	July 12, 2022	Class 10	Registered	HER3 companion diagnostic assay kits for use in oncology, namely, in vitro diagnostic kits comprising reagents, probes, and slides for the detection and quantification of HER3 protein expression in tumor tissue samples
OncuPath-GENOMARK™	6,118,754	August 17, 2021	Class 10	Registered	Genomic marker identification assay kits for companion diagnostics, namely, in vitro diagnostic kits comprising reagents, probes, and slides for the identification of genomic markers associated with therapeutic response in solid tumors
Mark	Application No.	Filing Date	International Class(es)	Status	Goods/Services Description
OncuPath-MULTIPLEX™	97/618,204	November 14, 2022	Class 10	Pending (Published for Opposition)	Multi-analyte companion diagnostic assay kits for use in oncology
OncuPath PRECISION PANEL™	97/841,573	February 22, 2023	Class 10	Pending (Under Examination)	Companion diagnostic biomarker panel kits for precision oncology applications
Domain Name	Registrar	Registration Date	Expiration Date
oncupath.com	Adriatic & Co.	March 7, 2017	March 7, 2027
oncupath-her3.com	Adriatic & Co.	January 15, 2020	January 15, 2026
oncupathdiagnostics.com	Adriatic & Co.	March 7, 2017	March 7, 2027
oncupath-genomark.com	Adriatic & Co.	April 22, 2020	April 22, 2026

INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT
dated as of August 8, 2023
by and between
GENOME DX THERAPEUTICS INC.
and
MERIDIAN PRECISION DIAGNOSTICS, INC.
INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT
This INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT (this "Agreement") is entered into as of August 8, 2023 (the "Effective Date"), by and between:
Genome Dx Therapeutics Inc., a Delaware corporation ("Assignor" or "GDT"), with its principal place of business at 10250 Science Center Drive, Suite 600, San Diego, California 92121;
and
Meridian Precision Diagnostics, Inc., a Delaware corporation ("Assignee" or "Meridian"), with its principal place of business at 2400 Meridian Parkway, Suite 300, Durham, North Carolina 27713.
Assignor and Assignee are each referred to herein individually as a "Party" and collectively as the "Parties."
RECITALS
WHEREAS, GDT and Meridian are parties to that certain Asset Purchase Agreement, dated as of May 11, 2023 (as amended, supplemented, or otherwise modified from time to time in accordance with its terms, the "Asset Purchase Agreement" or "APA"), pursuant to which GDT agreed to sell, assign, transfer, convey, and deliver to Meridian, and Meridian agreed to purchase and acquire from GDT, certain assets, properties, and rights constituting the OncuPath™ companion diagnostics assay line and the business conducted by GDT exclusively in connection therewith (the "OncuPath Business"), for aggregate consideration of One Hundred Forty Million Dollars ($140,000,000), subject to the adjustments and other terms and conditions set forth in the APA;
WHEREAS, pursuant to Section 2.4(d) of the APA, GDT is required to execute and deliver this intellectual Property Assignment Agreement at the Closing (as defined in the APA) in order to assign, transfer, and convey to Meridian all of Assignor's right, title, and interest in and to the Assigned intellectual Property (as defined herein) used exclusively in, or held exclusively for, the conduct of the OncuPath Business;
WHEREAS, the Closing under the APA is occurring on the date hereof, August 8, 2023; and
WHEREAS, capitalized terms used but not otherwise defined herein shall have the meanings ascribed to such terms in the APA.
NOW, THEREFORE, in consideration of the premises, the mutual covenants and agreements contained in the APA, the payment of the purchase price thereunder, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged by each of the Parties, the Parties hereby agree as follows:
ARTICLE 1 — DEFINITIONS
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 incorporated herein by reference, together with all continuations, continuations-in-part, divisional applications, reissues, reexamination certificates, renewals, extensions (including any supplementary protection certificates), and foreign counterparts thereof, and all patents issuing therefrom or claiming priority thereto, in each case to the extent owned by Assignor. As of the Effective Date, the Assigned Patents include fourteen (14) issued United States patents and seven (7) pending United States patent applications, all of which relate to the OncuPath™ companion diagnostics assay technology, as more fully described on Exhibit A.
"Assigned Trademarks" means all trademarks, service marks, trade names, trade dress, logos, slogans, domain names, social media identifiers, and registrations and applications therefor, in each case listed on Exhibit B attached hereto and incorporated herein by reference, together with all goodwill of the business symbolized by and associated with such marks, all common law rights therein, and all rights to sue for and collect damages for past, present, and future infringement, dilution, or misappropriation thereof. The Assigned Trademarks specifically include, without limitation:
(a) OncuPath™ — United States Patent and Trademark Office ("USPTO") Registration No. 5,847,321;
(b) OncuPath-HER3™ — USPTO Registration No. 6,412,088; and
(c) OncuPath-GENOMARK™ — USPTO Registration No. 6,118,754.
"Assigned Trade Secrets" means all trade secrets, proprietary information, know-how, formulations, assay protocols, standard operating procedures, manufacturing processes, reagent compositions, probe designs, probe-labeling methodologies, algorithms, software source code and object code, databases, clinical data sets, biobank sample data, regulatory strategy documents, quality control and quality assurance procedures, and other confidential business information, in each case exclusively related to the OncuPath Business, as more fully described on Exhibit C attached hereto and incorporated herein by reference.
"Assigned Copyrights and Other IP" means all copyrights, copyright registrations and applications therefor, mask works, database rights, and all other intellectual property rights (other than patents, trademarks, and trade secrets) exclusively related to the OncuPath Business, including without limitation all copyrights in and to product labeling, instructions for use ("IFU") documentation, software (including source code and object code), training materials, internal technical manuals, research notebooks, and regulatory submissions (including submissions made to the United States Food and Drug Administration (the "FDA") under 510(k) clearance numbers K201847, K193215, and K210562, and Premarket Approval ("PMA") supplement P230014), and all rights to sue for and collect damages for past, present, and future infringement or misappropriation thereof.
"Excluded intellectual Property" means all intellectual property rights of GDT that do not constitute Assigned intellectual Property, including without limitation (i) all intellectual property rights related to the GenoStrat™ liquid biopsy platform, (ii) GDT's corporate name, corporate logos, and all trademarks, service marks, and trade names outside the OncuPath brand family, (iii) all patents, patent applications, trade secrets, copyrights, and other intellectual property rights that are not exclusively related to or exclusively used in the OncuPath Business, and (iv) all other intellectual property rights retained by GDT pursuant to the APA.
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 contradict) the corresponding definition in the APA.
ARTICLE 2 — ASSIGNMENT
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 patent applications identified therein. The foregoing assignment includes, without limitation:
(a) all rights to make, have made, use, sell, offer to sell, and import products and services covered by the Assigned Patents;
(b) all rights to file, prosecute, and maintain the pending patent applications included within the Assigned Patents, and to file and prosecute continuations, continuations-in-part, divisional applications, reissues, reexaminations, and any other patent filings claiming priority to or deriving from any of the Assigned Patents;
(c) all rights to sue for, collect, and retain damages, profits, and any other remedies for past, present, and future infringement, misappropriation, or other violation of any of the Assigned Patents, including the right to settle and compromise any such claims; and
(d) all rights of priority under the Paris Convention, the Patent Cooperation Treaty, and any other applicable international treaty or convention.
GDT shall, promptly following the Effective Date and at GDT's own expense, execute and deliver to Meridian all instruments, assignments, declarations, and other documents necessary or reasonably requested by Meridian to record the assignment of the Assigned Patents with the USPTO and with any foreign patent offices in jurisdictions where corresponding patent rights exist or are pending, in each case in form and substance reasonably satisfactory to Meridian and suitable for recordation in the applicable jurisdiction.
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-HER3™ — USPTO Registration No. 6,412,088;
(c) OncuPath-GENOMARK™ — USPTO Registration No. 6,118,754;
together with all goodwill of the business symbolized by and associated with such trademarks, all common law rights therein and thereto, all rights to sue for and collect damages for past, present, and future infringement, dilution, or misappropriation thereof, and all rights to apply for and obtain registrations of such marks in any jurisdiction worldwide.
GDT shall, promptly following the Effective Date and at GDT's own expense, execute and deliver to Meridian all instruments, assignments, and other documents necessary or reasonably requested by Meridian to record the assignment of the Assigned Trademark registrations and applications with the USPTO and with any foreign or international trademark offices, in each case in form and substance reasonably satisfactory to Meridian and suitable for recordation in the applicable jurisdiction.
Following the Effective Date, GDT shall retain no right, license, or authorization to use the OncuPath brand family of trademarks, service marks, trade names, or trade dress in any manner, except as may be expressly required during the term of and in accordance with the Transition Services Agreement, dated as of August 8, 2023, by and between GDT and Meridian (the "Transition Services Agreement"). Any use of the Assigned Trademarks by GDT during the term of the Transition Services Agreement shall be subject to the quality control standards established by Meridian, and GDT shall promptly cease all use of the Assigned Trademarks upon expiration or earlier termination of the Transition Services Agreement.
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 methodologies, probe design libraries, reagent formulations and compositions, manufacturing specifications, signal-processing algorithms, software source code and object code, databases, clinical data sets, biobank sample data, quality control and quality assurance procedures, customer-specific assay customization specifications, regulatory strategy documents, pre-submission correspondence with the FDA, research notebooks, invention disclosures, and all other proprietary information and know-how exclusively related to the OncuPath Business, as more fully described on Exhibit C hereto.
In connection with the foregoing assignment, GDT shall deliver or cause to be delivered to Meridian, at or promptly following the Closing, all tangible and electronic embodiments of the Assigned Trade Secrets, including without limitation all physical documents, files, notebooks, laboratory records, electronic files, databases, software repositories, and other media in which any Assigned Trade Secrets are recorded, stored, or otherwise embodied. GDT shall not retain any copies of the Assigned Trade Secrets following such delivery, except to the extent (i) retention is required by applicable law or regulation, (ii) copies are contained in routine backup systems maintained by GDT in the ordinary course, which copies shall be subject to the confidentiality obligations set forth in the APA, or (iii) expressly permitted pursuant to the Transition Services Agreement.
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 source code and object code), training materials, internal technical manuals, research notebooks, and regulatory submissions made to the FDA, including submissions under 510(k) clearance numbers K201847, K193215, and K210562, and PMA supplement P230014 for the OncuPath-HER3™ assay. The foregoing assignment includes all rights to reproduce, prepare derivative works, distribute, publicly perform, publicly display, and digitally transmit or otherwise exploit such copyrighted works, and all rights to sue for and collect damages for past, present, and future infringement or misappropriation thereof.
GDT shall execute and deliver to Meridian all instruments and documents necessary or reasonably requested by Meridian to record the assignment of any registered copyrights included within the Assigned Copyrights and Other IP with the United States Copyright Office or any foreign copyright office, as applicable.
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 and enforceability of the trademark assignments contemplated by Section 2.2.
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 secrets, copyrights, trademarks, and other intellectual property rights associated therewith;
(b) GDT's corporate name, corporate logos, and all trademarks, service marks, trade names, and trade dress outside the OncuPath brand family;
(c) all patents, patent applications, trade secrets, copyrights, and other intellectual property rights that are not exclusively related to, or exclusively used in, the OncuPath Business; and
(d) all other intellectual property rights expressly retained by GDT pursuant to the terms of the APA.
Nothing in this Agreement shall be construed to limit or restrict GDT's right to use, exploit, license, or otherwise dispose of any Excluded intellectual Property.
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 exclusive license to certain proprietary probe-labeling technology owned by Vantage and used in connection with the OncuPath companion diagnostics assays.
(b) The Vantage License is not assigned, transferred, or conveyed under this intellectual Property Assignment Agreement. The Vantage License is separately assigned to Meridian pursuant to that certain Assignment and Assumption Agreement, dated as of August 8, 2023, by and between GDT and Meridian, executed and delivered at the Closing pursuant to the APA (the "Vantage License Assignment").
(c) Consent to the assignment of the Vantage License from GDT to Meridian was obtained from Vantage by that certain consent letter dated July 14, 2023, a copy of which has been delivered to Meridian.
(d) This Agreement assigns only GDT's own proprietary intellectual property constituting the Assigned intellectual Property, and this Agreement does not purport to assign, transfer, or convey any rights, title, or interest in or to any intellectual property owned by Vantage or licensed to GDT under the Vantage License. All rights in and to the probe-labeling technology licensed under the Vantage License remain the property of Vantage, subject to the terms and conditions of the Vantage License as assigned to Meridian pursuant to the Vantage License Assignment.
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 transactions contemplated hereby, have been duly authorized by all necessary corporate action on the part of GDT, including resolutions of the Board of Directors of GDT approved at a meeting duly convened and held on May 8, 2023, and no other corporate action or proceedings on the part of GDT are necessary to authorize the execution, delivery, and performance of this Agreement.
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 to assign, transfer, and convey the Assigned intellectual Property to Meridian as contemplated by this Agreement, and no consent of any third party (other than consents that have been obtained and are in full force and effect as of the Effective Date) is required in connection with such assignment.
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 business method review, or other adversarial proceeding is pending or, to Assignor's knowledge, threatened with respect to any of the Assigned Patents before the USPTO, the Patent Trial and Appeal Board, or any foreign patent office.
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 made and filed. No opposition, cancellation, or other adversarial proceeding is pending or, to Assignor's knowledge, threatened with respect to any of the Assigned Trademarks before the USPTO, the Trademark Trial and Appeal Board, or any foreign trademark office.
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 the Assigned intellectual Property has been asserted, filed, or, to Assignor's knowledge, threatened against GDT, except as set forth in the Disclosure Schedules to the APA.
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, the Vantage License pertains to technology owned by Vantage (and not by GDT) and does not constitute an assignment, transfer, or exclusive license of any Assigned intellectual Property.
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 other terms and conditions set forth in the APA. Nothing in this Article 4 is intended to expand the scope of, or create obligations separate from, the representations and warranties set forth in the APA.
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 Meridian of the transactions contemplated hereby, have been duly authorized by all necessary corporate action on the part of Meridian, including resolutions of the Board of Directors of Meridian approved at a meeting duly convened and held on May 10, 2023, and no other corporate action or proceedings on the part of Meridian are necessary to authorize the execution, delivery, and performance of this Agreement.
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 (regardless of whether such enforceability is considered in a proceeding in equity or at law).
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 reasonably request in order to effectuate the purposes and intent of this Agreement, including without limitation:
(a) executing and delivering short-form patent assignment documents in form suitable for recordation with the USPTO and with any foreign patent offices in jurisdictions where Assigned Patents or corresponding patent rights exist or are pending;
(b) executing and delivering short-form trademark assignment documents in form suitable for recordation with the USPTO and with any foreign or international trademark offices;
(c) executing and delivering copyright assignment documents in form suitable for recordation with the United States Copyright Office or any foreign copyright office;
(d) cooperating in the prosecution and maintenance of the seven (7) pending patent applications included within the Assigned Patents, including providing access to inventors for the purpose of executing declarations, oaths, powers of attorney, and other documents required by the USPTO or any foreign patent office;
(e) cooperating in the prosecution, defense, enforcement, or other handling of any claims, actions, or proceedings relating to the Assigned intellectual Property, including any infringement claims, opposition proceedings, cancellation proceedings, inter partes review proceedings, or other adversarial proceedings; and
(f) taking all other actions as may be reasonably necessary or desirable to vest in Meridian full, complete, and exclusive ownership of the Assigned intellectual Property, free and clear of all liens, encumbrances, and adverse claims.
The requesting Party shall reimburse the other Party for all reasonable out-of-pocket costs and expenses incurred by such other Party in connection with performing its obligations under this Section 6.1, unless otherwise provided in the APA or the Transition Services Agreement.
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 attorney, and other papers that may be necessary or desirable to effectuate the assignment, transfer, and conveyance of the Assigned intellectual Property contemplated by this Agreement, in the event that GDT fails or is unable to execute and deliver any such instrument or document within fifteen (15) business days following a written request therefor from Meridian. This power of attorney is coupled with an interest and shall be irrevocable for so long as any obligation of GDT under this Article 6 remains outstanding.
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 declarations, assignment records, and other documentation in GDT's possession or control that are related to the Assigned intellectual Property and that are not otherwise delivered to Meridian at or prior to the Closing. GDT shall use commercially reasonable efforts to preserve and maintain such records during such three-year period and shall not destroy or dispose of any such records without first offering Meridian the opportunity to take possession thereof. This Section 6.3 shall not require GDT to provide access to any records that are subject to attorney-client privilege, work product protection, or other applicable legal privilege, provided that GDT shall use commercially reasonable efforts to provide such access in a manner that does not waive such privilege.
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 provisions of this Agreement and the terms and provisions of the APA, the terms and provisions of the APA shall control and prevail in all respects.
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 indemnification cap of Twenty-Eight Million Dollars ($28,000,000), representing twenty percent (20%) of the Total Consideration;
(b) an eighteen (18)-month general survival period for representations and warranties, expiring on February 8, 2025;
(c) a sixty (60)-month survival period for fundamental representations (including representations regarding title to the Assigned intellectual Property), expiring on August 8, 2028;
(d) a tipping basket (deductible) of One Million Four Hundred Thousand Dollars ($1,400,000), representing one percent (1%) of the Total Consideration, with full recovery from the first dollar once the basket is exceeded; and
(e) a de minimis threshold of Seventy-Five Thousand Dollars ($75,000) per individual claim, below which no claim shall count toward the tipping basket or be subject to indemnification.
Nothing in this Agreement is intended to create, and nothing herein shall be construed as creating, any separate or additional indemnification obligations beyond those expressly set forth in the APA. All indemnification claims relating to the Assigned intellectual Property or this Agreement shall be made and resolved exclusively in accordance with the procedures, limitations, and other terms set forth in Article IX of the APA.
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 Policy may provide coverage to Assignee with respect to Losses (as defined in the APA) arising from breaches of the intellectual property-related representations and warranties set forth in the APA and incorporated herein by reference, subject to the terms, conditions, exclusions, and limitations of the R&W Insurance Policy. Nothing in this Section 7.3 shall limit or modify the indemnification obligations of the Parties under the APA or affect the rights of Assignee under the R&W Insurance Policy.
ARTICLE 8 — MISCELLANEOUS
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 hereby irrevocably submits to the exclusive jurisdiction of the Court of Chancery of the State of Delaware (or, if the Court of Chancery declines to accept jurisdiction, the Superior Court of the State of Delaware or the United States District Court for the District of Delaware) in connection with any dispute arising out of or relating to this Agreement, and each Party hereby irrevocably waives any objection to venue in any such court.
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 contemporaneous agreements, negotiations, representations, warranties, understandings, and communications, whether written or oral, between the Parties with respect to such subject matter.
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 by either Party in exercising any right, power, or remedy hereunder operate as a waiver thereof.
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 negotiate in good faith to replace any such invalid, illegal, or unenforceable provision with a valid, legal, and enforceable provision that, to the greatest extent possible, achieves the original intent and economic effect of the invalid, illegal, or unenforceable provision.
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 the U.S. federal ESIGN Act of 2000, the Uniform Electronic Transactions Act, or any other applicable law) shall be effective as delivery of a manually executed counterpart.
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 this Agreement or any of its rights hereunder to (a) any Affiliate of Meridian, or (b) any successor to all or substantially all of the business or assets of Meridian to which this Agreement relates, whether by merger, consolidation, sale of assets, or otherwise; provided that no such assignment shall relieve Meridian of its obligations hereunder.
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 Chiang, General Counsel
Email: rchiang@genomedx.com
with a copy (which shall not constitute notice) to:
Calderwood & Harkness LLP 555 South Hope Street, Suite 4400 Los Angeles, California 90071
Attention: James Prentice
Email: jprentice@calderwoodharkness.com
If to Assignee:
Meridian Precision Diagnostics, Inc. 2400 Meridian Parkway, Suite 300 Durham, North Carolina 27713
Attention: David Pruitt, General Counsel
Email: dpruitt@meridianprecision.com
with a copy (which shall not constitute notice) to:
Whitfield Sayer & Gregg LLP 200 South Tryon Street, Suite 2800 Charlotte, North Carolina 28202
Attention: Jonathan Whitfield
Email: jwhitfield@wsglaw.com
Either Party may change its address for notices by providing written notice of such change to the other Party in accordance with this Section 8.7.
[Remainder of page intentionally left blank. Signature page follows.]
SIGNATURE PAGE TO INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT
IN WITNESS WHEREOF, the Parties have executed and delivered this intellectual Property Assignment Agreement as of the date first written above.
GENOME DX THERAPEUTICS INC.
By: ________
Name: Dr. Helena Vasquez
Title: Chief Executive Officer
Date: August 8, 2023
MERIDIAN PRECISION DIAGNOSTICS, INC.
By: ________
Name: Thomas Ellsworth
Title: Chief Executive Officer
Date: August 8, 2023
EXHIBIT A
SCHEDULE OF ASSIGNED PATENTS
The following sets forth all Assigned Patents as of the Effective Date. Unless otherwise indicated, all patents and patent applications listed below are United States patents or patent applications filed with the United States Patent and Trademark Office.
Part I — Issued U.S. Patents
Part II — Pending U.S. Patent Applications
Note: This Exhibit A is subject to and qualified by the terms and conditions of the intellectual Property Assignment Agreement to which it is attached. All continuations, continuations-in-part, divisionals, reissues, reexaminations, renewals, extensions, supplementary protection certificates, and foreign counterparts of the foregoing patents and patent applications are included within the definition of "Assigned Patents" whether or not separately listed above.
EXHIBIT B
SCHEDULE OF ASSIGNED TRADEMARKS
The following sets forth all Assigned Trademarks as of the Effective Date, including all registered trademarks, pending trademark applications, and associated domain names. Unless otherwise indicated, all trademark registrations and applications listed below are with the United States Patent and Trademark Office.
Part I — Registered Trademarks
Part II — Pending Trademark Applications
Part III — Domain Names
Note: This Exhibit B is subject to and qualified by the terms and conditions of the intellectual Property Assignment Agreement to which it is attached. All listed Assigned Trademarks include the goodwill of the business symbolized by and associated with such marks. All common law trademark rights in and to the marks listed above are also included within the Assigned Trademarks whether or not separately listed.
EXHIBIT C
DESCRIPTION OF ASSIGNED TRADE SECRETS AND KNOW-HOW
The following sets forth the categories of Assigned Trade Secrets and know-how assigned, transferred, and conveyed to Assignee pursuant to the intellectual Property Assignment Agreement to which this Exhibit C is attached. This description is intended to identify the categories of proprietary information included within the Assigned Trade Secrets and is not intended to limit the scope of the assignment to the specific items or examples listed below. All trade secrets, proprietary information, and know-how exclusively related to the OncuPath Business are included within the Assigned Trade Secrets, whether or not specifically identified below.
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 includes all analytical validation data, clinical validation data, and performance verification data generated in connection with such assays.
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 owned by Vantage Molecular Sciences, Inc. and licensed to GDT under the Vantage License.
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 production of OncuPath assay kits and reagent components.
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 interpretation, and quality assessment in connection with the OncuPath companion diagnostics assays. This includes all versions of the OncuPath Analyzer™ software platform and associated modules.
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 the OncuPath Business and subject to applicable data privacy laws, regulations, and agreements.
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. Part 820) and applicable ISO standards (including ISO 13485:2016) for the OncuPath product line.
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 diagnostics assays, including all documentation associated with 510(k) clearances K201847, K193215, and K210562, and PMA supplement P230014 for OncuPath-HER3™. This category also includes all regulatory submissions to and correspondence with foreign regulatory authorities related to the OncuPath assays.
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 qualification, equipment qualification (IQ/OQ/PQ), and process validation performed at such facility.
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 Certificate ID: 05D2178493), including all documentation related to CLIA compliance, CAP accreditation, and state laboratory licensure for such facility.
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, operation, and maintenance of OncuPath companion diagnostics assays and associated instruments and software.
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 exclusively related to the OncuPath Business.
Exclusion: For the avoidance of doubt, trade secrets, proprietary information, and know-how related to the GenoStrat™ liquid biopsy platform and all other retained GDT businesses are expressly excluded from this Exhibit C and do not constitute Assigned Trade Secrets. In addition, trade secrets, proprietary information, and know-how owned by third parties (including Vantage Molecular Sciences, Inc.) and licensed to GDT are not included within the Assigned Trade Secrets and are not assigned under the intellectual Property Assignment Agreement, notwithstanding any reference thereto in this Exhibit C or elsewhere.
[End of Exhibit C]
Item No. | Patent No. | Title | Filing Date | Issue Date | Inventor(s) | Status
1 | US 9,284,517 B2 | Probe-Hybridization Methods for Companion Diagnostic Assays in Oncology | March 14, 2014 | March 15, 2016 | Vasquez, H.; Kim, S.J.; Okafor, N. | Issued
2 | US 9,561,243 B2 | Assay Kit for Detection of HER3 Biomarker Expression in Tumor Tissue Samples | July 22, 2014 | February 7, 2017 | Kim, S.J.; Patel, R.M. | Issued
3 | US 9,803,118 B2 | Signal Amplification Methods for Chromogenic In Situ Hybridization Assays | January 9, 2015 | October 31, 2017 | Okafor, N.; Vasquez, H.; Lindgren, E.A. | Issued
4 | US 10,041,962 B2 | Sample Preparation Techniques for Formalin-Fixed Paraffin-Embedded Tissue in Companion Diagnostics | September 18, 2015 | August 7, 2018 | Lindgren, E.A.; Chen, W. | Issued
5 | US 10,267,794 B2 | Biomarker Detection Methods Using Multi-Probe Panels for Solid Tumor Characterization | April 5, 2016 | April 23, 2019 | Vasquez, H.; Kim, S.J.; Desai, P.K. | Issued
6 | US 10,429,387 B2 | Automated Slide Staining and Imaging System for OncuPath Companion Diagnostic Assays | November 12, 2016 | October 1, 2019 | Patel, R.M.; Okafor, N. | Issued
7 | US 10,612,081 B2 | Reagent Compositions for Enhanced Probe Binding Specificity in Oncology Assays | February 28, 2017 | April 7, 2020 | Chen, W.; Lindgren, E.A.; Kim, S.J. | Issued
8 | US 10,788,493 B2 | HER3 Companion Diagnostic Assay with Quantitative Scoring Algorithm | August 3, 2017 | September 29, 2020 | Kim, S.J.; Vasquez, H.; Nguyen, T.L. | Issued
9 | US 10,954,512 B2 | Methods for Multiplexed Biomarker Detection in Companion Diagnostics Applications | January 19, 2018 | March 23, 2021 | Desai, P.K.; Okafor, N.; Patel, R.M. | Issued
10 | US 11,078,483 B2 | Quality Control Methods for Companion Diagnostic Assay Manufacturing | June 7, 2018 | August 3, 2021 | Lindgren, E.A.; Chen, W. | Issued
11 | US 11,214,796 B2 | Probe Design Methods for Detecting Gene Amplification in Solid Tumors | October 25, 2018 | January 4, 2022 | Vasquez, H.; Nguyen, T.L.; Kim, S.J. | Issued
12 | US 11,387,041 B2 | Thermal Cycling Protocols for Improved Hybridization Efficiency in FISH-Based Assays | March 11, 2019 | July 12, 2022 | Okafor, N.; Desai, P.K. | Issued
13 | US 11,542,518 B2 | Integrated Sample-to-Result Workflow for OncuPath Companion Diagnostics | July 29, 2019 | January 3, 2023 | Patel, R.M.; Lindgren, E.A.; Vasquez, H. | Issued
14 | US 11,694,207 B2 | Machine Learning-Based Image Analysis for Companion Diagnostic Scoring | December 16, 2019 | July 4, 2023 | Nguyen, T.L.; Kim, S.J.; Chen, W. | Issued
Item No. | Application No. | Title | Filing Date | Inventor(s) | Status
15 | US 17/412,836 | Next-Generation HER3 Companion Diagnostic Assay with Enhanced Sensitivity and Specificity | August 26, 2021 | Kim, S.J.; Vasquez, H.; Nguyen, T.L. | Pending
16 | US 17/549,102 | Novel Biomarker Panel for Multi-Analyte Companion Diagnostic Testing in Non-Small Cell Lung Cancer | December 13, 2021 | Desai, P.K.; Okafor, N.; Patel, R.M. | Pending
17 | US 17/683,475 | Methods for Simultaneous Detection of Multiple Genomic Alterations Using Combinatorial Probe Sets | February 28, 2022 | Lindgren, E.A.; Kim, S.J.; Chen, W. | Pending
18 | US 17/814,290 | Rapid Companion Diagnostic Assay Platform with Reduced Turnaround Time | July 22, 2022 | Vasquez, H.; Patel, R.M. | Pending
19 | US 17/952,618 | Artificial intelligence-Assisted Pathology Workflow for OncuPath Assay Interpretation | September 26, 2022 | Nguyen, T.L.; Desai, P.K. | Pending
20 | US 18/103,447 | Multi-Analyte Detection Methods Using Spatial Transcriptomics in Companion Diagnostics | January 30, 2023 | Kim, S.J.; Okafor, N.; Lindgren, E.A. | Pending
21 | US 18/178,962 | Improved Reagent Formulations for Next-Generation OncuPath-HER3 Assay Kits | March 6, 2023 | Chen, W.; Vasquez, H.; Nguyen, T.L. | Pending
Mark | Registration No. | Registration Date | International Class(es) | Status | Goods/Services Description
OncuPath™ | 5,847,321 | September 3, 2019 | Class 10 | Registered | Companion diagnostic assay kits and related instruments for use in oncology, namely, in vitro diagnostic kits comprising reagents, probes, and slides for the detection of biomarkers in tumor tissue samples
OncuPath-HER3™ | 6,412,088 | July 12, 2022 | Class 10 | Registered | HER3 companion diagnostic assay kits for use in oncology, namely, in vitro diagnostic kits comprising reagents, probes, and slides for the detection and quantification of HER3 protein expression in tumor tissue samples
OncuPath-GENOMARK™ | 6,118,754 | August 17, 2021 | Class 10 | Registered | Genomic marker identification assay kits for companion diagnostics, namely, in vitro diagnostic kits comprising reagents, probes, and slides for the identification of genomic markers associated with therapeutic response in solid tumors
Mark | Application No. | Filing Date | International Class(es) | Status | Goods/Services Description
OncuPath-MULTIPLEX™ | 97/618,204 | November 14, 2022 | Class 10 | Pending (Published for Opposition) | Multi-analyte companion diagnostic assay kits for use in oncology
OncuPath PRECISION PANEL™ | 97/841,573 | February 22, 2023 | Class 10 | Pending (Under Examination) | Companion diagnostic biomarker panel kits for precision oncology applications
Domain Name | Registrar | Registration Date | Expiration Date
oncupath.com | Adriatic & Co. | March 7, 2017 | March 7, 2027
oncupath-her3.com | Adriatic & Co. | January 15, 2020 | January 15, 2026
oncupathdiagnostics.com | Adriatic & Co. | March 7, 2017 | March 7, 2027
oncupath-genomark.com | Adriatic & Co. | April 22, 2020 | April 22, 2026

INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT

GENOME DX THERAPEUTICS INC.

MERIDIAN PRECISION DIAGNOSTICS, INC.

INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT

RECITALS

SIGNATURE PAGE TO INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT

GENOME DX THERAPEUTICS INC.

MERIDIAN PRECISION DIAGNOSTICS, INC.

EXHIBIT A

SCHEDULE OF ASSIGNED PATENTS

EXHIBIT B

SCHEDULE OF ASSIGNED TRADEMARKS

EXHIBIT C

DESCRIPTION OF ASSIGNED TRADE SECRETS AND KNOW-HOW

Record

Parties

Dates

Amounts